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The World Journal of Biological , 2010; 11: 604–655

GUIDELINES

The World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for the biological treatment of

FLORENCE THIBAUT 1 , FLORA DE LA BARRA 2 , HARVEY GORDON3,4 , PAUL COSYNS5 , JOHN M. W. BRADFORD6 & the WFSBP Task Force on Sexual Disorders∗

1 Faculty of Medicine, Rouen University Hospital Ch. Nicolle, University of Rouen, Rouen, France, 2 East Psychiatry and Department, University of Chile, Clinica las Condes, Chile, 3 Littlemore Mental Health Centre, Oxford, UK, 4 Department of Forensic Psychiatry, University of Oxford, Oxford, UK, 5 University of Antwerp, Antwerp, Belgium, and 6 University of Ottawa, Queen ’ s University and Royal Ottawa HealthCare Group, Ottawa, Canada

Abstract Objectives. The primary aim of these guidelines was to evaluate the role of pharmacological agents in the treatment and management of , with a focus on the treatment of adults males. Because such treatments are not delivered in isolation, the role of specifi c psychosocial and psychotherapeutic interventions was also briefl y covered. These guidelines are intended for use in clinical practice by clinicians who diagnose and treat patients with paraphilia. The aim of these guidelines is to improve the quality of care and to aid physicians in clinical decisions. Methods. The aim of these guidelines was to bring together different views on the appropriate treatment of paraphilias from experts representing different con- tinents. To achieve this aim, an extensive literature search was conducted using the English language literature indexed on MEDLINE/PubMed (1990– 2009 for SSRIs) (1969– 2009 for treatments), supplemented by other sources, including published reviews. Results. Each treatment recommendation was evaluated and discussed with respect to the strength of evidence for its effi cacy, safety, tolerability and feasibility. Conclusions. An algorithm was proposed with six levels of treatment for different categories of paraphilias.

Key words: Paraphilia , sex offenders , , antidepressants , treatment guidelines

An historical perspective A range of factors are relevant to social perceptions Whilst it is almost certainly the case that all human as to whether certain sexual behaviour is to be regarded societies through history have imposed boundaries as sexually deviant. These include the degree of or limits on the types of sexual behaviour regarded , the location of the sexual behaviour, the age as acceptable, a degree of variation across cultures of those involved, the nature of the sexual act, whether has occurred, whilst within cultural traditions, change any distress or harm may occur, the frequency of the in sexual mores may occur over time. Within this type of sexual practice in society and the degree of historical context, it is therefore evident that societies distaste felt by others about the particular sexual require a concept of sexual deviancy, but that it is behaviour (Tewksbury 2003). subject to evolving changes of social perspective. It was not, however, till the end of the nineteenth Reference to biblical Israel as well as ancient Greece century that sexual deviance was to become regarded indicate historical infl uences of both a religious as a medical phenomenon, with the publication of and a secular nature, of which the religious is more Psychopathia Sexualis describing cases of sexual mur- associated with moral condemnation of sexual devi- der by the German psychiatrist, Krafft-Ebing (1886). ance and the secular with greater liberalism (Group Krafft-Ebing’ s emphasis on the connection between for the Advancement of Psychiatry 2000). and the compulsion to kill refl ects the

∗ WFSBP Task Force on Sexual Disorders: Florence Thibaut (Chair, France), Paul Cosyns (Co-Chair, Belgium), John M. W. Bradford (Co-chair, Canada), Flora de la Barra (Secretary, Chile), Harvey Gordon (UK), Ariel Rosler (Israel). Correspondence: Professor F. Thibaut Psychiatry, University Hospital Charles Nicolle, 1 Rue de Germont, 76031 Rouen, France. E-mail: fl [email protected]

(Received 2 February 2010; accepted 2 February 2010) ISSN 1562-2975 print/ISSN 1814-1412 online © 2010 Informa UK Ltd. (Informa Healthcare, Taylor & Francis AS) DOI: 10.3109/15622971003671628 WFSBP Treatment guidelines of Paraphilias 605 laying down of knowledge on paraphilias already with elevated risk of harm to self and others and that over a century ago (Schlesinger 2004). The interest there is increasingly effective treatment available. The by German psychiatry in sexual deviance at the turn validity however of paraphilias as a medical diagnosis of the twentieth century is further illustrated by a case is ambiguous in that they are excluded in the mental of a man with paedophilic tendencies described by health legislation of many nations as a basis for com- another great German psychiatrist, Emil Kraepelin pulsory detention (Gordon 2008). Additionally fur- (Johnstone 1913). ther debate and greater clarity is required in resolution Despite the initial origins of medicalisation of some of the problems in diagnosis of paraphilias, of sexual deviance having been claimed by clinical including are deviant sexual fantasies a suffi cient psychiatry, during the twentieth century the main parameter or whether they require to be acted upon focus of study and indeed treatment was that of psy- in overt behaviour, or conversely where sexual fanta- choanalysis. Freud’ s early theory of sexuality remains sies are denied but deviant sexual behaviour is pres- the basis of the psychoanalytic understanding of ent, the duration necessary of the fantasies or sexual deviance (Freud 1905/1953; Rosen 1997). behaviour, whether the paraphilia is regarded as pres- Subsequently a century of psychoanalytic thought ent when opportunity for exposure to potential vic- has contributed to the assessment and treatment tims is absent, for example when in prison, the of sexual deviance (see especially Fenichel 1954; evaluation of the intensity of the fantasies or urges and Stoller 1975; Kernberg 1991; Rosen 1997). the degree of occupational or social deterioration Yet running alongside the psychoanalytic perspec- (Laws and O’ Donohue 1997; Marshall 2006). tive of sexual deviance resulting from a psychological The beginnings of treatment of the paraphilias can developmental abnormality of sexual maturation was be traced back to the late nineteenth century at a also a trend towards the pathology being more one similar time though not directly connected to the new which was organically determined. Freud himself concept of sexual deviance as a medical condition. saw the roots of in a combination of bio- This initial treatment approach was that of surgical logical and developmental factors (Rosen 1997). , used fi rst for therapeutic purposes in 1892 The British author, (Ellis 1933) and in Switzerland in regard to a patient with imbecility the German physician, Magnus Hirschfi eld (1948), and neuralgic pain of the testis and attempted to reform public attitudes towards a range (Sturup, 1972). In his paper, the Danish psychiatrist of sexual behaviour especially , by Sturup (1972) outlined that castration had been advocating that such behaviour constituted a medi- known throughout history, being reported in Greek cal condition rather than merely sinful decadence. mythology and a particular problem of auto-castration Having rescued the paraphilias from the purview for religious reasons during early Christianity, but also of sin, their delineation as , for which the used elsewhere for judicial reasons for sex crimes, psychoanalysts received most criticism, came under and as a deliberate measure to produce euneuchs in challenge after the Second World War (Group for the eastern harems and to produce operatic sopranos Advancement of Psychiatry, 2000). The particular in Italian boys up till the eighteenth century. During preferred categories of used in major the twentieth century, surgical castration for some sex textbooks were now to be seen in relation to the offenders was used not only in the United States, but beginning of a unifying tradition of international in certain European countries including Denmark, classifi cations by the World Health Organisation and Norway and The Netherlands as well as in Germany the American Psychiatric Association. and Switzerland (Bremer 1959; Langeluddeke 1963; The evolution of the notion of deviant sexuality has Sturup 1972; Cornu 1973; Heim and Hursch 1979; led to a degree of confusion as to its legitimacy as Ortmann 1980; Heim 1981; Wille and Beier 1989). genuine medical conditions rather than sexual lifestyle Patients in these European studies were varied in diag- choices or in some cases sexual behaviour determined nosis and the type of but the effects of by criminal disposition. The case for paraphilias as surgical castration seems to have resulted in marked real medical entities is based on their inclusion in the reduction in sex offence recidivism. Surgical castration international classifi cations, that they can be diag- for sex offenders in Europe has not been continued nosed according to various defi ned symptoms and since the early 1970s, though it is still available with behaviour, that they might be regarded as a form of careful safeguards in Germany. As a therapeutic control disorder (Pearson 1990) or on the technique for sex offenders it was never embraced in obsessional compulsive spectrum (Stein et al. 1992), Britain and its legality even on a voluntary basis ques- or as an intrinsic abnormality of sexual development tioned (Stone and Thurston 1959). Surgical castration as earlier noted, that they have a high level of co- was legally reintroduced for sex offenders in certain morbidity with a range of other mental disorders US states in 1996 and thereafter (Weinberger et al. (Gordon and Grubin 2004), they may be associated 2005). 606 F. Thibaut et al.

Whilst surgical castration for selected sex offenders clinical and ethical dilemmas. There have been ethi- has been the predominant surgical approach used, cal objections to the treatment of sex offenders using some limited use was also made in post-war West psychodynamic (Adshead and Mezey Germany of neurosurgery (Roeder 1966; Roeder 1993), aversion therapy (King and Bartlett 1999), et al. 1972). As with surgical castration the technique surgical castration (Alexander et al. 1993) and antil- is irreversible. However, given the complexity of the ibido (Mellela et al. 1989). The major treatment of paraphilias, the reality that treatments ethical issues regarding sex offenders including used in the past can be rejuvenated, and the biological paraphilias may refl ect the need for public safety aspects of paraphilias, the past use of psychosurgery balanced against the public and even professional should not be overlooked. orientation towards punishment rather than treatment By the 1940s, some attempts had been made to even where treatment is appropriate and effective treat sex offenders by medical methods using oestro- (Bowden 1991; Berlin 2003; Ward et al. 2007 on gens (Foote 1944; Golla and Hodge 1949; Symmers the human rights of the sex offender in the context 1968), but due to feminising side-effects, this was of treatment and rehabilitation; Elger 2008 about supplanted in the 1960s by antilibido medication prisoners included in research programs). reducing testosterone levels. is Paraphiliac sex offenders referred for hormonal available in most countries, administered orally; but treatment are often the object of some external coercion, a depot form is available which is also used in Europe be it from a court decision or under the pressure of (Gordon and Grubin, 2004; Sammet, 2005), whilst their family, employers or other involved persons. in the United States, medroxyprogesterone acetate From an ethical point of view, the patient may be is the drug of choice (Meyer et al. 1992a). Unlike subjected to hormonal treatment only if all of the surgical castration, the effects of antilibido medication following conditions are met (Belgian Advisory are reversible on discontinuation. A more recent and Committee on 2006 [www.health.fgov.be/ promising development in the treatment of paraphil- bioeth ]; Council of Europe 2004). ias is the use of luteinizing hormone releasing hor- mone agonists. These are given by depot , • The person has a paraphiliac disorder diagnosed reduce testosterone to very low levels and result in by a psychiatrist after a careful psychiatric very low levels of recidivism (Rousseau et al. 1990; examination. Dickey 1992; Thibaut et al. 1993). • The hormonal treatment address specifi c clinical There is also emerging evidence for the use of signs, symptoms and behaviours and is adapted selective serotonin reuptake inhibitors, SSRIs to the person’ s state of health . (Stein et al. 1992; Saleh 2004). This follows long- • The person ’s condition represents a signifi cant standing evidence for reduction in male risk of serious harm to his health or to the phys- using almost any psychotropic medication includ- ical or moral integrity of other persons. ing benperidol (Sterkmans and Geerts 1966), thi- • No less intrusive treatment means of providing oridazine (Sanderson 1960), fl uphenazine depot care are available . ( Bartholomew 1968), clomipramine (Wawrose and • The psychiatrist in charge of the patient agrees to Sisto 1992), lithium (Cesnik and Coleman 1989) inform the patient and receive his or her consent, and buspirone (Fedoroff 1992). to take the responsibility for the indication of the Whilst a biological approach is probably essential treatment and for the follow-up including in the treatment of patients with severe paraphilias, somatic aspects with the help of a consultant a psychotherapeutic context to the treatment is endocrinologist, if necessary. equally necessary. Aversion therapy had tapered out • The hormonal treatment is part of a written by the 1980s and gradually gave way to cognitive treatment plan to be reviewed at appropriate behavioural therapy. An optimum formula for intervals and, if necessary, revised. treatment of paraphilias may well be a combination of cognitive behavioural therapy and antilibido med- When a sex offender is subject to coerced treat- ication administered in a dynamic psychotherapeutic ment, the decision to subject that person to hor- framework. monal treatment may be taken by a psychiatrist having the requisite competence and experience, after examination of the person concerned and after his or her informed consent has been obtained. Ethical issues However, consent is sometimes given in circum- The treatment of patients with paraphilias, irre- stances (e.g., prison or detention in a secure hospi- spective of which method of treatment is employed, tal), where the person is subject to some constraint. has always been undertaken through a minefi eld of Whilst treatment may facilitate improvement and WFSBP Treatment guidelines of Paraphilias 607 release or discharge, this is not necessarily the case. subclass of sociopathic personality disturbances In cases of doubt of the validity of patient’ s consent, (Malin and Saleh 2007). afterwards withdrawal of his consent or non-compli- Patients with the exclusive form of a paraphilia ance with the treatment the decision to subject a sex may not be able to be sexually aroused by anything offender to coerced treatment should be taken by a other than their paraphiliac imagery or behaviour. court or another competent body. The court or other By contrast, patients with the non-exclusive form competent body should: may be aroused by other sexual fantasies, stimuli and behaviours, although their paraphilias may interfere • act in accordance with procedures provided with their overall sexual preferences. by law based on the principle that the person Most paraphilias are chronic, lasting for many concerned should be seen and consulted . years if not a lifetime. • not specify the content of the treatment but Simply having paraphilia is obviously not illegal. force the sex offender to comply with the treat- Acting in response to paraphiliac urges, however, ment plan negotiated with the psychiatrist. may be illegal and, in some cases, subjects the person with paraphilia to severe sanctions. Paraphilias include: Clinical context : The individual has recurrent, The terms sex offenders and paraphilias will be used intense, sexually arousing fantasies, sexual urges or in the following text. In order to clarify the respec- behaviours involving the exposure of one’s genitals tive use of these words, it is important to remember to an unsuspecting stranger. The onset usually occurs that, not all sex offenders suffer from a paraphilia, before the age of 18 and the condition seems to but only part of them, and that, not all patients with become less severe after the age of 40. a paraphilia are sex offenders (in many cases, they only suffer from deviant sexual fantasies or urges, : The individual has recurrent, intense, or their deviant sexual behaviour does not involve a sexually arousing fantasies, sexual urges or behav- non consent person or a child). iours involving touching and rubbing against a non- consenting person. Usually, it begins by adolescence. Most acts of frottage occur when the person is aged Defi nition and classifi cation 15 – 25 years, after which there is a gradual decline in frequency. According to the Diagnostic and Statistical Manual Disorder, Fourth Edition, Text Revision (DSM : The individual has recurrent, intense, IV-TR) or to the International Classifi cation of sexually arousing fantasies, sexual urges or behav- Mental Diseases (ICD-10th), paraphilias are defi ned iours involving the act of observing an unsuspecting as sexual disorders which are characterized by “ recur- person who is naked, in the process of disrobing, or rent, intense, sexually arousing fantasies, sexual engaging in sexual activity. The onset in usually urges or behaviours, generally involving (1) non before the age of 15. human objects, (2) the suffering or humiliation of oneself or one’ s partner, or (3) children or other non- consenting persons that occur over a period of 6 Fetishism : The individual has recurrent, intense, months ” (criterion A), which “ cause clinically sig- sexually arousing fantasies, sexual urges or behaviours nifi cant distress or impairment in social, occupa- involving the use of nonliving objects (e.g., female tional, or other important areas of functioning” undergarnments or shoes, etc.). Usually, it begins by (criterion B). DSM IV-TR describes eight specifi c adolescence and it concerns mostly males. disorders of this type (exhibitionism, fetishism, - teurism, paedophilia, sexual masochism, sexual : Suffering or humiliation of oneself sadism, voyeurism and ) along or one’s partner (i.e. sexual masochism and sadism, with a residual category called “ paraphilia not oth- respectively) may be considered as paraphilias. erwise specifi ed” . The term paraphilia comes from the Greek prefi x Sexual masochism : The individual has recurrent, “ para ” meaning around or beside and “ philia ” an intense, sexually arousing fantasies, sexual urges or ancient Greek word for . The term paraphilia behaviours involving the act (real, not simulated) of fi rst appeared in the third version of the DSM clas- being humiliated, beaten, bound, or otherwise made sifi cation. In the fi rst version of the DSM published to suffer. It may eventually result in injury or even in 1952, sexual deviations were conceptualized as a death. 608 F. Thibaut et al.

Sexual sadism : The individual has recurrent, fondling of the child. Others perform or cun- intense, sexually arousing fantasies, sexual urges or nilingus on the child or penetrate the child’s , behaviours involving acts (real, not simulated) in mouth or anus with their fi ngers, foreign objects, or which the psychological or physical suffering (includ- penis and use varying degrees of force to do so. ing humiliation) of the victim is sexually exciting to These activities are commonly explained with the person. It begins commonly by early adulthood. excuses or rationalizations that they have educational Sexual sadism may be associated with . value for the child, that the child derives sexual plea- is not included in this classifi cation as it rep- sure from them, or that the child was sexually attrac- resents an expression of aggression rather than a tive, especially in those attracted to males. Violence specifi c paraphilia. However a small number of is rarely used (Cohen and Galinker 2002; Hall and rapists may meet the criteria for having a paraphilia Hall 2007). Child molestation is not necessarily syn- (often exhibitionism or paedophilia, sometimes sexual onymous with paedophilia (Abel and Harlow, sadism). 2001).

Paraphilias not other specifi ed: Paraphilias not : (for review see Hall and Hall 2007) other specifi ed are also mentioned in the DSM-IV- The sexual activity involves prepubescent children, TR classifi cation. They include, but they are not generally aged 13 years or younger. Paedophiles limited to: telephone scatologia (obscene telephone must be at least 16 years old and must be at least 5 calls), (corpses), (exclusive years older than the victim. For juvenile paedophiles, focus on part of a body), (animals), no age is specifi ed and clinical judgment must be (), () and used (the sexual maturity of the child and the age urophilia (). difference must be taken into account). In at least 90% of cases, paedophiles are males. Dickey et al. In total, more than 50 types of paraphilias have (2002), in their sample of 168 sex offenders, reported been described, most of them being far more com- that paedophiles were older as compared with rapists mon in men (about 99% in Europe) than in women, and sexual sadists. However, there is a clearly scien- but the percentage of women is increasing in the US tifi cally established reduction in recidivism related to (Abel and Harlow 2001; Hall and Hall 2007, for age. There are also age related changes in libido due review). Except for sexual masochism, which is to reduction in testosterone levels. about 20 times less likely to affect men than women, Paedophiles may be sexually attracted to males paraphilias are quite unlikely to be diagnosed in (9 – 40% of cases according to Hall and Hall (2007)), women. Paraphiliacs often have more than one type females (even more frequent) or both. Those attracted of deviant sexual behaviour (e.g., one-third of pae- to females usually prefer 8- to 10-year-old children, dophiles are also exhibitionists) (Bradford et al. whereas, those attracted to males usually prefer 1992; Bradford 1999, 2001); according to Hall and slightly older children. Paedophilia may be limited Hall (2007), 50– 70% of paedophiles have more to (inside the family), this subgroup may rep- than one paraphilia. The onset of paraphiliac sexual resent 20% of paedophilic subjects (Cohen and interest usually occurs before the age of 18. Galinker 2002; Cohen et al. 2007). Paedophilia may be exclusive (attracted only to children) or not. Comorbidities associated with Paraphilias Among about 2500 male paedophiles, Hall and Hall (2007) reported that only 7% were exclusively Many paraphiliacs show evidence of major axis I attracted to children. The term is used to mental illness including affective disorders, sub- describe sexual interest for either male or female stance abuse disorders, , other psychotic peripubescent children or adolescents. Infantophilia disorders, (especially temporal and/or is used to describe individuals interested in children frontotemporal ) and other cognitive younger than 5 years. Paedophiles may also be disorders (Kafka and Hennen 2002). Paraphilias can classifi ed as to whether child and/or a occur within the context of axis II disorders, such as computer was used to engage the child in sexual borderline or antisocial personality disorders and activity (Seto et al. 2006). These distinctions are mental retardation, and axis III disorders, such as important in the selection criteria for studies of sexual temporal lobe epilepsy or brain trauma (trauma to behaviour. the limbic system may lead to changes in sexual Paedophilic subjects who act on their urges with preference; previous head trauma may be a predis- children may limit their activity to undressing the posing risk factor for paedophilia, especially child and looking, exposing themselves, masturbating when head trauma occurred before the age of 6, in the presence of the child, or gentle touching and Blanchard et al. 2002); Kleine Levin and Klü ver Bucy WFSBP Treatment guidelines of Paraphilias 609 syndromes (50% of patients have inappropriate sex- result in a variety of psychological disturbances, such ual behaviours); Huntington’ s disease (10% of as guilt, , shame, isolation, and impaired patients complain of inappropriate sexual behav- capacity for normal social and sexual iours). Paraphilias can also occur in patients under- relationships. going dopamine agonist therapy (e.g., in For some individuals, paraphiliac fantasies or Parkinson’ s disease). Few data are available regarding stimuli are obligatory for erotic arousal and are the treatment of dopamine-associated inappropriate always included in sexual activity. In other cases, the sexual behaviours. Use of dose reduc- paraphiliac preferences occur only episodically tion and antidepressants or neuroleptics have been (during periods of ), whereas, at other times the proposed (Guay 2008). person is able to function sexually without deviant Paraphilia is not often associated with schizo- stimuli or fantasies. phrenia or ; in a review, Marshall (2006) have reported a low prevalence of psychotic disorders (1.7– 16%). In some cases, the paraphilia Sex offending and Paraphilias is secondary to the psychotic illness and subsides when the is successfully treated, whilst in While some paraphilias can be associated with other cases, the paraphilia is independent of the strange sexual behaviour, they are not necessarily psychosis and may need treatment in its own right associated with offences. These patients may (Smith and Taylor 1999; Baker and White 2002). In present for treatment because of associated distress contrast, the prevalence of addictive disorders to their personal lives. In contrast, other paraphiliac varied from 8 to 85%, the prevalence of personality behaviours may lead to sex offences, a major public disorders from 33 to 52% (among them antisocial health problem defi ned as any violation of estab- was the most frequently lished legal or moral codes of sexual behaviour. The observed), the prevalence of depressive disorders paraphilias can be graded from mild to catastrophic, varied from 3 to 95% and the prevalence of depending on history of victimization and if disorders may vary from 3 to 64%, attention defi cit positive, the number of victims, their age and the and hyperactivity disorders (ADHD) may also degree of victimization (level of intrusiveness: represent 36% of cases and eating disorders 10% of penetration or not) are considered. Severe cases cases (Kafka and Prentky (1998, 110 adult out- would involve more than one victim or a child and patients); Dunsieth et al. (2004, 113 male forensic there would be penetration to some degree. There patients); Raymond et al. (1999, 45 male paedophilic are few studies about sexual murderers, Briken et sex offenders)). A high comorbidity of impulse al. (2006) have reported a higher level of sexual control disorders (e.g., explosive personality disorder, sadism in sexual murderers with paraphilias or , , pathological gambling) paraphilia-related disorders. has been noted in paedophiles (30– 55%) (in Hall In general, individuals with exhibitionism or and Hall 2007). Methodological biases, such as the paedophilia make up the majority of apprehended heterogeneity of both the samples and the diagnosis sex offenders. Paedophilia can devastate the lives of criteria used, may have contributed to the dis- the victims. The mean number of victims for one crepancies observed between the studies. paedophile is around 20. Cohen et al. (2002) In juvenile sexual offenders, from 60 to 90% of reported a median number of 11 unknown victims psychiatric comorbidity has been reported (in most for those who are attracted to males and of 1.5 cases, personality disorders such as conduct or for those attracted to females. In case of intra- borderline personality disorders, substance use dis- familial paedophilia, the median number was 4.5 orders, ADHD or impulse control disorders and for those attracted to females and 5 for those mood or anxiety disorders were observed) (Abel et al. attracted to males. Moreover, in an anonymous 1988; Kavousi et al. 1988; Shaw et al. 1996; Galli et survey conducted among 377 extra-familial paedo- al. 1999; Bladon et al. 2005 (141 cases)); high rates philic subjects, the mean number of victims reported of learning diffi culties were also reported. Juvenile by paedophiles attracted to females was 20 as offenders constitute a heterogeneous population. compared with 150 among those attracted to When treated they show lower recidivism rates than males; in the case of intrafamilial paedophilia adults; but the recidivism risk is higher for those with the rates dropped, respectively, to 1.8 and 1.7 (Hall antisocial/impulsive and unusual/isolated personality and Hall 2007). (Worling, 2001). Incarceration may stop a paedophile from com- Paraphilias are commonly associated with sexual mitting illegal sexuality against children, but it does hyperactivity, often with compulsive and/or impulsive not change a paedophile’s internal . features (Kafka and Prentky 1992a). Paraphilias often Treating paedophilia provides a more human 610 F. Thibaut et al. and lasting solution than incarceration and may at dependent remains controversial (Meston and least be used concomitantly. Frohlich, 2000). There is no clear evidence that subjects with paraphilias have higher basic testosterone levels, nor Aetiology data indicating an increased receptor is dependent on neural, hormonal, activity. In paraphiliacs, no difference in self- genetic factors and on the complex infl uence of reported measures of sexual behaviour was reported culture and context. The aetiology of paraphilias is with regards to baseline serum testosterone levels still unclear despite years of research. Various psy- (below or above 300 ng/dl) (Kravitz et al. 1996). A chological, developmental, environmental, genetic, marked hypersecretion of LH was reported in and organic factors have been discussed, but none response to GnRH in paedophiles, as compared to of the theories fully explains paraphiliac behaviours. controls and other paraphiliacs, whereas baseline The causes are probably multifactorial, rendering LH and testosterone values were within the normal treatment diffi cult. range. These data may indicate a hypothalamo-pitu- The frequency reported for paedophiles who were itary-gonadal dysfunction in paedophiles (Gaffney abused as children range from 28 to 93% vs. 15% and Berlin, 1984). The expected benefi t of suppress- for controls (for review about social factors, see Hall ing testosterone to castration level probably derived and Hall 2007). from decreasing sexual arousal in general.

We will focus on the major biological determinants Serotonin and dopamine affect to a lesser extent sexual of paraphiliac behaviours: behaviour, as shown in animal and human studies (Bradford 1999, 2001; Kafka 2003). Enhancing cen- Testosterone , the main androgen produced by the tral serotonin activity in the hypothalamus may inhibit testes, plays clearly a major role, not only in the sexual behaviour in some mammalian species (Lor- development and maintenance of the male sexual rain et al. 1999). Low 5-hydroxyindole acetic acid characteristics, but also in the regulation of sexual- concentrations in the cerebrospinal fl uid are associ- ity, aggression, cognition, emotion, and personality ated with severe aggression, which results from (Rubinow and Schmidt 1996). In particular, it is a impaired impulse control in juvenile male primates major determinant of , fantasies and while testosterone is more associated with competitive behaviour, and basically it controls the frequency, aggression (Dee Higley et al. 1996). Selective sero- duration and magnitude of spontaneous . tonin reuptake inhibitors (SSRIs) are associated in The effects of testosterone (and of its reduced humans with sexual side effects (e.g., decreased libido, metabolite 5α -dihydrotestosterone (DHT)) are impaired and ). Activation of the mediated through their actions on the intracellular 5HT2 receptors may impair sexual functioning and androgen receptor. Testosterone secretion is regu- stimulation of the 5HT1A receptors may facilitate lated by a feedback mechanism in the hypothalamo- sexual functioning (Meston and Frohlich 2000). pituitary-testis axis. The hypothalamus produces Paedophilia was accompagnied by increased the gonadotrophin hormone-releasing hormone plasma concentrations of catecholamines in one (GnRH), which is released in a pulsatile manner study (Maes et al. 2001). Nine paedophiles had a and stimulates the anterior pituitary gland to pro- greater magnitude of cortisone and prolactin duce the luteinizing hormone (LH). LH stimulates level responses to metachlorophenylpiperazine (a the release of testosterone from the testes, which in serotonine agonist) vs. controls. It may indicate turn inhibits the hypothalamus and the pituitary. a serotoninergic disturbance in paedophilia. Testosterone has been shown to restore nocturnal penile tumescence responses in hypogonadal adult Oestrogens have little direct infl uence on sexual desire man with impaired nocturnal penile tumescence. A in either males or females (Meston and Frohlich minimal level of testosterone is necessary for sexual 2000). drive in males; however, the threshold remains questionable. Testosterone levels do not correlate Specifi c brain regions are involved in sexual behaviour. with the intensity of sexual drive. Although rigidity In animals, lesions to the medial preoptic area, which and tumescence seem androgen-dependent, erec- is connected to the limbic system and brainstem, sig- tions in response to visual erotic stimuli are not nifi cantly impair the male copulatory behaviour dependent on , but erections in response (Meisell and Sachs 1994) by impairing the ability to to auditory stimuli possibly are (Carani et al. 1992). recognize a (McKenna 1999). Electri- Whether, or to what extent, erections as a result of cal stimulation of the paraventricular nucleus elicits fantasies and tactile stimulation are androgen- penile erections (Chen et al. 1997). WFSBP Treatment guidelines of Paraphilias 611

Paraphilias or at least conditions that look very Criminal reports. Few paedophiles ask for treatment much like paraphilias, have also been reported as the before sex offending. The prevalence is usually esti- result of brain trauma especially during childhood mated through criminal reports. In France, 22% of (Lehne 1984; Simpson et al. 1999; Langevin 2006), the prisoners are sex offenders. In the UK prisons, temporal or frontal lobe damage (Hucker et al. 1986; about 11% of the population had committed sexual Langevin et al. 1989; Mendez et al. 2000) Kluver-Bucy offences in 1998; in the United States, juveniles syndrome or epilepsy (Hill et al. 1957; Mitchell account for 17% of individuals arrested for sex et al. 1954), especially in men. offences (Home Offi ce Recording crime statistics Recently, the brain areas activated in eight adult 1998– 2001, Report UK Government, London, healthy males during visually evoked sexual arousal 1997). Rape and indecent on a female were evidenced using positron emission tomography constitute by far the majority of sex offences notifi ed (Stol é ru et al. 1999). There were visual association to the UK recording crime statistics in 1998. How- areas (inferior temporal cortex, bilateral) and paral- ever, the prevalence of sexual offences reported imbic areas related to highly processed sensory infor- against children is increasing. Of men born in mation with motivational states and to the control of England and Wales in 1953, seven in 1000 had a autonomic and endocrine functions (right insula, conviction for a sexual offence against a child by the right inferior frontal cortex, left anterior cingulated age of 40 years (Marshall 1997). cortex). Activation of some of these areas was posi- tively correlated with plasma testosterone levels. Prevalence of paraphiliac fantasies in the general However, the link between neuronal activity and population . In a population of 193 students, Briere deviant sexual behaviour remains unclear. and Runtz (1989) have reported 21% of subjects hav- The temporal lobe is involved in erotic discrimi- ing paedophilic fantasies. According to Pithers (1995), nation and arousal threshold and deserves special 15– 20% of their population of male students and 2% attention in paedophilia. Cohen et al. (2002) of females would like to have a sexual relationship with reported decreased glucose in the right a child if that would be allowed, 40% of males reported inferior temporal cortex and the superior ventral sexual fantasies of women’ rapes. frontal gyrus of seven heterosexual non-exclusive, non-incest paedophiles vs. seven controls. Cantor Prevalence of sex offences reported by the general popula- et al. (2008) have reported in the left and right tion. Many sexual assaults are unreported. The major temporal and parietal brain regions a decreased methodological biases are the defi nition of sex offend- white matter volume in 44 male pe dophiles as com- ing, the victims’ ages, the choice of the sample and pared with 53 subjects convicted for non-sexual the type of interview (self questionaire, face to face crimes. Schiltz et al. (2007) have observed a interview, phone interview, number and type of ques- decreased right volume in 13 male pae- tions), the response rate (Goldman et al. 2000). In a dophiles (heterosexual in six cases, homosexual in survey of students, when using the defi nition of sex- three cases and bisexual in four cases) as compared ual abuse as “any event that the young person reported with 15 controls (without any paedophilia). This as unwanted or abusive before they were 18 years abnormality could appear early in life in relation old” , 59% of women and 27% of men answered with environmental or hormonal factors and could positively. When the defi nition was narrowed to later be associated with changes in sexual interest. “those cases involving some form of penetration or The amygdala could be involved in sexual behav- coerced where the abuser was at least iour in relationship with past sexual experiences. 5 years older”, the percentage felt to 4% of women Some of the changes may have resulted from life and 2% of men (Creighton 2002). In France, 11% experiences such as being physically or sexually of women aged 18– 39 reported unwanted sexual abused as children. relationship (Bajos 2008). In a review, Hall and Hall Schiffer et al. (2007) using MRI in 18 paedophiles (2007) found that 17– 31% of women and 7– 16% of (nine homosexual and nine heterosexual) vs. 24 males declared unwanted sexual relationship before controls (12 homosexual and 12 heterosexual) found the age of 18. decreased gray matter volume bilaterally in the The National Society for the Prevention of Cruelty ventral striatum, insula, orbitofrontalcortex and to Children reported, in the year 2000, that 16% of cerebellum of the paedophiles. girls and 7% of boys had been sexually assaulted before the age of 13. The incidence of children aged below 18 placed on child protection registers for Prevalence of paraphiliac behaviour was six in 10,000 in the year 2000. The Actual prevalence/incidence fi gures are not available mean number of victims for one paedophilic was for paraphilias. estimated around 20 children. 612 F. Thibaut et al.

Sexual offence is noteworthy underestimated, either 5 years to 27% at 20 years of follow-up. Paedophiles because offenders have never been apprehended or the attracted to boys are more likely to reoffend (35% offence did not result in conviction (Elliot et al. 1995; at 15 years) as compared to those attracted to girls Harris and Grace 1999). For example, men convicted (16% at 15 years) and to those who offended within of sexual offences against children claim fi ve or more their family (13% at 5 years) (Harris and Hanson undetected sexual assaults for which they have never 2004, 4700 sex offenders). been apprehended (Elliot et al. 1995). In a study of Some dynamic risk factors were identifi ed such as 360 reported rape cases, only about 10% resulted in and antisocial behaviour. Denial, low conviction (Harris and Grace 1999). self estim, addictive disorders (mostly or The consequences of sexual offences clearly drug abuse) and psychiatric comorbid disorders may depend on the type of sexual offence. In the case of also increase the risk of recidivism. Dynamic risks raped paedophilia, the consequences to the victim may be addressed and psychotherapeutic treatments are serious and the effects apparent many years after may help to improve these factors. the initial event (Banyard et al. 2001; Leonard and The following risk factors need precise evaluation Follette 2002). of sexual offenders in order to identify them but unfortunately they cannot be improved: previous Recidivism rate. Recidivism is a major concern, in sexual offences (especially rapes) or non-sexual the treatment of paraphilia, especially in paedophilia. offences (especially those with violence) increase the Most people recognize that incarceration alone will risk of recidivism (Hall and Hall 2007). Sex offenders not solve . Treating the offenders is with intellectual disabilities or sequels of head injury critical in an approach to preventing sexual violence are particularly susceptible to re-offend after stop- and reducing victimization. ping therapy. The strongest predictor of sexual re- The defi nition of the term recidivism needs to be offence was sexual interest in children as measured clarifi ed. According to Greenberg (1998) and Prentky by phlethysmography (especially when victims are et al. (1997) different defi nitions may include sexual unknown). An early age of onset is also associated offences, non-sexual offences or both, convictions or with an increased risk (Barbaree et al. 2003). A past self-reported offenses. Comparison between studies is history of sexual abuse or physical violence diffi cult due to methodological differences: duration during childhood may increase the risk (Hanson and of follow-up, type of paraphilias, defi nition of recidivism, Bussi e re 1998). Finally, a great number of paraphilic type of victims, previous offences and or previous con- interests reported by the offender increase the likeli- victions, retrospective or prospective design, outpa- hood of reoffense (Hall and Hall 2007). tients or prisoners, type of treatment and compliance, Some scales have been proposed in order to drop-out rate, period of active treatment only or short improve the evaluation of the risk of recidivism in periods after treatment is terminated in addition in sex offenders but until now, none is really predictive some studies, statistical analyses, etc. It remains dif- of any risk (for review Seifert et al. 2005; Hall and fi cult to identify those individuals at risk of relapse. Hall 2007). The mean estimate re-conviction rate for sexual offences is 13% (lower with incest offenders 4%, as compared with boy victim paedophiles 21%) (Hanson Evaluation of a paraphiliac and Bussiere 1998) and it has been found to double (from 11 to 22%) after 5 years in untreated offenders Demographic and clinical characteristics. (Morrison et al. 1994). Soothill and Gibbens (1978) demographic characteristics of the subject: age, found that in sex offenders, the recidivism rate rose gender, current and past marital status, number by about 3% per year, and at the end of the follow- of children (age and gender if any), current and up period (22 years), 48% had recidivated. Current past employment status (with or without chil- estimates from the prison service suggest that 15% dren), education level; of child abusers leaving prison are reconvicted for a further sexual offence within 2 years (Beech et conventional and paraphiliac sexual fantasies and al. 2002). Treated offenders had less reconviction activity (frequency and type), exclusive or non than non treated offenders, both at 2-year (5.5 and exclusive paraphiliac behaviour, age at onset of 12.5%, respectively) and at 4-year follow-up (25 and paraphiliac behaviour, type and number of 64%, respectively) (Marshall and Barbaree 1990). paraphilia, gender and age of victims, intra famil- Three recent meataanalyses have reported rates of ial or not (known or unknown victim), recidivism and risk factors (Hanson et al. 2003; use or video use, violence, previous convictions for Hanson and Morton-Bourgon 2005; Craig et al. sexual or non-sexual offences, family and personal 2008). The recidivism rate increased from 15% at history of sexual disorders, previous treatments WFSBP Treatment guidelines of Paraphilias 613

for sexual offending and compliance, or management of paraphilia, with a focus on the treat- illicit drug consumption before paraphiliac sexual ment of adults males. Because such treatments are behaviour, age of puberty, …; not delivered in isolation, the role of specifi c psycho- social and psychotherapeutic interventions is also family and personal history of psychiatric disor- briefl y covered. ders, suicide attempts, history of brain trauma, The aim of these guidelines is to bring together current dementia, previous or current psychiatric different views on the appropriate treatment of or non psychiatric diseases and treatment, previous paraphilias from experts representing all conti- history of sexual abuse or use of violence, …; nents. To achieve this aim, an extensive literature empathy, coping with stress, , interper- search was conducted using the English-language sonal relationships, insight, motivation for treat- literature indexed on MEDLINE/PubMed (1990– ment, cognitive distorsions, denial, degree of 2009 for SSRIs) (1969– 2009 for antiandrogen mental retardation if any…. treatments), supplemented by other sources, including published reviews. The guidelines pre- Diagnosis of paraphilia. Number and type of paraphil- sented here are based on data from publications in ias; comorbidity with axis 1 or axis 2 of the DSM peer-reviewed journals (according to previous classifi cation (especially addictive disorders or per- WFSBP guidelines, Soyka et al. 2008). The evi- sonality disorders); comorbidity with somatic diseases dence from the literature research was summarized if any; cognitive evaluation if mental retardation or and categorized to refl ect its susceptibility to bias dementia; careful medical examination, blood mea- (Shekelle 1999). Each treatment recommendation surements and/or plasma hormone levels if hormonal was evaluated and discussed with respect to the treatment is needed. Baseline osteodensitometry strength of evidence for its effi cacy, safety, tolera- could be necessary in case of hormonal treatment. bility and feasibility. It must be kept in mind that the strength of recommendation is due to the level of effi cacy and not necessarily of its importance. Therapeutic approaches Four categories were used to determine the hierar- chy of recommendations (related to the described Treatment modalities currently used in paraphili- level of evidence): acs behaviours fall into three categories: bilat- eral orchidectomy (surgical castration, for review Level A: there is good research-based evidence to see Heim and Hursch 1979), psychotherapy, and support this recommendation. The evidence was pharmacotherapy. Stereotaxic neurosurgery and obtained from at least three moderately large, posi- oestrogen administration have been attempted but tive, randomised, controlled, double-blind trials are not any more in use, due to the high risks dis- (RCTs). In addition, at least one of the three studies played (respectively, those inherent to the invasive must be a well-conducted, placebo-controlled study. technique, and serious side effects or complications such as carcinoma). Pharmacotherapy and Level B: there is fair research-based evidence to hormonal treatment should be part of a compre- support this recommendation. The evidence was hensive treatment including psychotherapy and, in obtained from at least two moderately large, posi- most cases, behavioural therapy. tive, randomised, double-blind trials (this can be either two or more comparator studies or one comparator-controlled and one placebo-controlled Methods and limitations study) or from one moderately large, positive, ran- Methods . These guidelines are intended for use in domised, double-blind study (comparator-controlled clinical practice by clinicians who diagnose and treat or placebo-controlled) and at least one prospective, patients with paraphilia. The aim of these guidelines moderately large (sample size equal to or greater than is to improve the quality of care and to aid physicians 50 participants), open-label, naturalistic study. in clinical decisions. Although these guidelines are based on the available published evidence, the treat- Level C: there is minimal research-based evidence to ing clinician is ultimately responsible for the assess- support this recommendation. The evidence was ment and the choice of treatment options, based on obtained from at least one randomised, double-blind knowledge of the individual patient. These guidelines study with a comparator treatment and one prospec- do not establish a standard of care nor do they ensure tive, open-label study/case series (with a sample of a favourable clinical outcome if followed. The at least 10 participants), or at least two prospective, primary aim of the guidelines is to evaluate the role open-label studies/case series (with a sample of at of pharmacological agents in the treatment and least 10 participants) showing effi cacy. 614 F. Thibaut et al.

Level D: evidence was obtained from expert Bilateral orchidectomy opinions (from authors and members of the WFSBP Task Force) supported by at least one prospective, In Europe, surgical castration was done on modern open-label study/case series (with a sample of at least psychiatric indication for the fi rst time in Switzerland 10 participants). in 1892, as an “imbecile” was cured from his neuralgic pain from the testes and his hypersexuality. In Europe, estimated recidivism rates based on No level of evidence or Good Clinical Practice (GCP): re-arrest or conviction were 2.5 – 7.5% in surgically This category includes expert opinion-based castrated sex offenders versus 60– 84% before statements for general treatment procedures and castration ( n 1200) with a maximal follow-up of principles. The guidelines were developed by the 20 years (Heim and Hursch 1979). There was no authors and arrived at by consensus with the change in the object of the sexual desire or sexual WFSBP Task Force, consisting of international orientation. The effect on non-sexual crimes was less experts in the fi eld. obvious. Forty to 50% of subjects were satisfi ed with the outcome of castration, whereas 20– 30% felt Limitations. Most reports on the treatments of often depressed following castration. Thirty-fi ve paraphilias are case reports or series. In general, percent of young surgical castrates retained sexual treatment effi cacy studies are marked by some functioning (sex drive and ) (Heim and methodological biases and are being extremely Hursch 1979) and 19 out of 38 castrated sex offend- diffi cult to conduct for several reasons: small ers, whose penile erections were measured while sample sizes leading to false negative results; viewing a sex movie, exhibited full erections (Eibl diffi culties to conduct studies with forensic 1978). In a prospective study (follow-up 15 years), patients; sex offending is not socially acceptable Zverina et al. (1991) reported that 18% of 84 and those who suffer from them rarely seek treat- castrated sex offenders retained sexual functioning ment voluntarily (many studies obtained their and that 21% were able to maintain sexual relation- paedophilic or sexual offender populations from ships with their sexual partner. A recent review of prisons or legally mandated sexual treatment studies of castrated sex offenders reported a very low groups; paedophiles able to control their impulses level of recidivism (a Danish study including 900 sex are usually not included in studies. This sampling offenders reported a risk of 1%) (Weinberger et al. introduces the possibility that the fi ndings of lower 2005). Stepan et al. (1989) reported an increased IQ and personality disorders are more characteristic risk of bone demineralization in these castrated of paedophiles who were arrested); ethical consid- subjects. erations would not allow performing double-blind In several states in the USA, and in some placebo-controlled studies in potential offenders European countries, surgical castration is still (for review Marshall and Marshall 2007); the out- allowed. In some countries (e.g., Germany) the come measurements such as self reports of “Law on Voluntary Castration” provided that conventional and paraphiliac sexual activity, voluntary castration could be available to men aged plasma testosterone levels which may not be at least 25, when they are seriously disturbed and reliable indicators of treatment response, etc. potentially dangerous. A board of experts reviews Comparisons between studies is often diffi cult due the request in order to establish if castration is to methodological differences: duration of follow-up, necessary for the prevention of further sexual type of paraphilias, defi nition of recidivism, type of offences. California passed a law in 1996 that victims, previous offences and or previous convic- mandated for repeat child tions, retrospective or prospective design, outpatients molesters. Several other states have considered or prisoners, type of treatment and compliance, passing such laws (e.g., California, Florida, Louisiana, statistical analyses, etc. Iowa, Colorado, Massachusetts, Michigan, Texas, In addition, specifi c problems occur when ran- Washington, etc.). domisation is adapted to psychological treatments Although it has been shown that surgical castration (Guay 2009). The therapist can have a signifi cant reduces paraphiliac fantasies and behaviours ( Level D impact on therapeutic outcomes if, he or she, can of evidence) , there are alternative and less invasive adapt treatment to the learning style and interper- treatments available. Surgical castration has now sonal approach of each subject and ajust therapy to been abandoned in most European countries. It is the fl uctuations in the subject’ s motivation and worthwhile to mention, however, that post-castration mood. Controlled study design do not allow many recidivism rates are among the lowest rates among of the features of an effective therapist– subject all forms of treatments. However, some physically relationship. castrated paedophiles have restored their potency by WFSBP Treatment guidelines of Paraphilias 615 taking exogenous testosterone and then abused again explorative insight-oriented, supportive or directive (Stone et al. 2000). activity applied fl exibly. Therapists should have used The main effect of surgical castration is a reduction a less strict technique than in . of the circulating androgen level by removing the The general strategy toward psychotherapy with testes where approximately 95% of the testosterone paedophiles is a cognitive behavioural approach is produced. Current knowledge about hormonal (addressing their cognitive distorsions) combined treatment arises from surgical castration of sex with empathy training, sexual impulse control offenders. training, relapse prevention and biofeedback (Hall and Hall 2007). In almost all published studies, cognitive behavioural therapy was used. Sex offend- Psychotherapy and behaviour therapy ers employ distorted patterns of thinking which This treatment approach is beyond the scope of this allow them to rationalize their behaviour, including study. beliefs such as children can consent to sex with an Psychotherapy is an important aspect of treatment, adult and/or victims are responsible for being sexu- although debate exists concerning its overall effective- ally assaulted. Behavioural therapy programs for sex ness for long term prevention of new offenses. Several offenders seek to tackle and change these distorted studies have reported that the best outcomes in attitudes as well as other major factors which can preventing repeat offenses against children occur when contribute to sexual offending, including inability pharmacological agents and psychotherapy are used to control anger, inability to express feelings and together (Mc Conaghy 1998; Hanson and Morton communicate effectively, problems in managing Bourgon 2005). stress, alcohol and drug abuse, or deviant sexual Psychotherapy can be divided into individual arousal. In North America, cognitive-behavioural and group/family therapies. Most commonly it is a therapy is the standard treatment for paraphiliacs combination of individual and group therapies. who are not at high risk of victimization (Marshall Individual therapy is represented by insight- et al. 2005). oriented, cognitive behavioural and supportive Research studies in the USA into different treat- . There could be as many defi nitions ment programs in prisons and in the community have of psychodynamic or psychoanalytic therapy as they identifi ed reductions in re-offence rates (Grossmann are studies. et al. 1999) or no statistically signifi cant difference In a recent review about psychological interven- (Marques et al. 2005). Hall (1995) in an overview tions in sex offenders, Brooks-Gordon et al. (2006) reported a small but signifi cant overall reduction of evaluated adults who have been convicted or recidivism rate in treated subjects vs. comparison cautioned for sexual offences or who sought treat- groups (12 controlled studies), comprehensive ment or were considered to be at risk of sexual cognitive-behavioural and hormonal treatments were offending. They gave interesting defi nitions of superior to purely behavioural treatment. The psychotherapies used in sex offender populations. average rate of sexual recidivism was 19% in treated They suggested that “ well-defi ned” cognitive behav- groups vs. 27% in controls (mean effect size: ioural therapy occured when the report made explicit d – 0.24). The strongest effect came from compari- that the intervention involved: (1) recipients estab- sons between treatment completers and dropouts. lishing links between their thoughts, feelings and When the dropout studies were removed, the treat- actions with respect to target symptoms; (2) correc- ment effect was no longer signifi cant. Alexander tion of person’ s misperceptions, irrational beliefs and (1999) reviewed 79 studies on psychosocial sex reasoning biases related to target symptoms and (3) offender treatment. The mean difference in recidi- either or both of the following: recipients monitoring vism was 5% in favour of treatment (d 0.12). their own thoughts, feelings and behaviours with However, the majority of studies contained no respect to target symptoms and/or promotion of control group. In the same way, Gallagher et al. alternative ways of coping with target symptoms. (1999), considered 23 comparison-group studies Psychoanalysis was defi ned as regular individual examining psychological treatments. Treated groups sessions with a trained psychoanalyst. Analysts were showed 10% less sexual recidivism than controls and required to adhere to a strict defi nition of psycho- the overall effect size was large (d 0.47) with a analytic technique. Psychodynamic psychotherapy signifi cant treatment effect for cognitive-behavioural was defi ned as regular individual therapy sessions treatments. with a trained psychotherapist or a therapist under In a comprehensive metaanalysis of different treat- supervision. Therapy sessions were based on a ment programs (Hanson et al. 2002) (cognitive- psychodynamic or psychoanalytic model. Sessions behavioural n 29, behavioural n 2, systemic n 3, could rely on a variety of strategies, including other psychotherapeutic n 7, unknown category 616 F. Thibaut et al.

n 2 vs. no treatment) (43 studies, 23 in institutions, However, when they calculated the recidivism rates 17 in the community and three in both, 5000 treated for treated and comparison subjects, taking into sex offenders vs. 4300 not treated), the sexual offence account the respective sizes of treatment and recidivism rate was 12.3% in treated sex offenders comparison groups, the difference in recidivism rates as compared with 16.8% in the no-treatment group disappeared completely (11% in each group). The during an average 46-month follow-up period using effects measured using odds ratios (OR) ranged a variety of recidivism criteria (OR: 0.81; 95% CI: from 0.17 to 33.33. The mean OR for sexual 0.71 – 0.94 with considerable variability across recidivism was highly signifi cant (all kinds of treat- studies; mean effect size d 0.13). These treatments ment) (OR: 1.70, 95% CI: 1.35– 2.13; equivalent were equally effective for adults and adolescents d 0.29) with a absolute difference between treat- (three studies, 237 subjects) and for institutional and ment and comparison groups of 6.4% (37% reduc- community treatments. Cognitive behavioural and tion from the baseline rate of comparison groups). systemic treatments were associated with reductions There was considerable heterogeneity. For violent in sexual recidivism (from 17.4 to 9.9%). Older recidivism, the mean OR was 1.90 with a absolute forms of treatment (prior to 1980) appeared to have difference between treatment and comparison groups little effect. of 5.2% (44% reduction from the baseline rate of Kenworthy et al. (2004) published a recent comparison groups). Physical treatment (surgical Cochrane metaanalysis of nine randomised con- castration) had higher effects than non-physical trolled trials (RCT) (500 adult sex offenders of whom treatment (psychosocial) (OR: 7.37, 95% CI: 4.14– 52% were paedophiles, maximal duration of follow- 13.11 vs.OR: 1.32, 95% CI: 1.07– 1.62). Of non- up of 10 years). Psychodynamic, psychoanalytic, physical treatment, only cognitive-behavioural behavioural or cognitive– behavioural therapies were treatments and classic behaviour therapy had a sig- compared with each other, drug treatment or standard nifi cant impact on sexual recidivism. When only care in institutional or community settings. Among behavioural therapies were considered (35 studies) all studies, the most interesting were the two follow- the OR was 1.45, 95% CI: 1.12– 1.86).Whether the ing studies: (1) cognitive-behavioural group therapy treatment was delivered in an individual or group (Marques et al. 1994) may reduce re-offence at 1 year format did not result in signifi cant outcome differ- for child molesters when compared with no treatment ences. The effect size for cognitive-behavioural treat- (n 155, 1 RCT, relative risk (RR) any crime: 0.41, ment is slightly smaller than that reported by Hanson 95% CI: 0.2–0.82, number needed to treat (NNT): 6, et al. (2002) (OR 1.45 vs. 1.67, respectively). The 95% CI: 3– 20); (2) the largest trial (Romero 1978, in other approaches (insight-oriented treatment, thera- Romero and Williams 1983) compared broadly psy- peutic communities, other psychosocial programs) chodynamic group therapy with no group therapy in did not signifi cantly infl uence recidivism. 231 paedophiles, exhibitionists or guilty for sexual In summary, the effi cacy of cognitive behavioural assaults. Re-arrest over 10 years was greater, but not therapy for sex offenders is such as to indicate a signifi cantly, for those allocated to group therapy modest reduction in recidivism (Losel and Schmucker (n 231, 1 RCT, RR 1.87 95% CI: 0.78– 4.47). In 2005), but this is doubted by studies with longer summary, this Cochrane analysis concluded that the follow-up periods (Maletzki and Steinhauser 2002; effects in clinical trials have been extremely variable Kentworthy et al. 2004) (Level C of evidence) . The (from helpful to harmful even in the same study): one other approaches (insight-oriented treatment, thera- study suggested that a cognitive approach resulted in peutic communities, other psychosocial programs) a decline in re-offending after 1 year; another large do not seem to reduce recidivism (No level of study showed no benefi t for group psychotherapy and evidence) . Moreover, the longer the observation suggested the potential for harm at 10 years. periods, the higher the recidivism rates, leaving the Losel and Schmucker (2005), in a recent metaanal- impression that the durability of psychological ysis of 69 studies containing 80 independent therapies is limited. Furthermore, most of these stud- comparison studies (more than 22,000 individuals ies were not conducted with the most dangerous sex in total), reported the effi cacy of psychotherapy or offenders which means that they cannot be general- pharmacological treatment on the recidivism risk in ized to all sex offenders. Well conducted studies, sex offenders (primary outcome) as compared with randomised controlled trials with longer follow-up no treatment. Nearly one-half of the comparisons durations are needed. addressed cognitive-behavioural programs and one- third of the studies have been published since 2000. Pharmacotherapy with psychotropic drugs The 74 studies reporting data on sexual recidivism revealed an average recidivism rate of 11.1% for Pharmacological treatments are used in order to treated groups and 17.5% for comparison groups. decrease the general level of sexual arousal. WFSBP Treatment guidelines of Paraphilias 617

Psychotropic drugs. The use of psychotropic medica- as compared with placebo reduced equally paraphiliac tions in paraphiliac behaviours is not new. No behaviour in eight subjects (from 50 to 70% as randomized controlled trials have documented their compared to baseline scores) (seven out of 15 effi cacy. Unfortunately, the level of evidence is very dropped out of the study) (Kruesi et al. 1992: poor (case reports, small sample size, lack of power, 15 subjects with paraphilias (paedophilia, two; phone lack of controlled studies) (No level of evidence). sex, seven; exhibitionism, four; sexual sadism, one) Lithium carbonate (Ward 1975; Cesnik and and/or compulsive masturbation (four), mean age 31 Coleman 1989; Balon 2000; Zourkova 2000) (no years, treatment periods of 5 weeks, mean dose controlled studies were conducted); tricyclic antide- clomipramine: 163 mg/day (75– 250), mean dose pressants (clomipramine, desimipramine) (for review, : 213 mg/day (100– 250)). There was no Krueger and Kaplan 2000), (Coskun and preferential response to the more specifi c serotonin- Mukaddes 2008); antipsychotics (benperidol, thior- ergic antidepressant. In two cases, treatment was idazine, haloperidol, risperidone (Tennent et al. 1974; restarted after paraphilic relapse. However, the side Zbytovsky 1993; Bourgeois and Klein 1996 (fl uoxetine effects observed with clomipramine have limited its plus risperidone 6 mg/day); Zourkova 2000, 2002; use in paraphilias (Leo and Kim 1995). for review, Hall and Hall 2007; Hughes 2007)); and An open study reported the effi cacy of naltrexone anticonvulsivants (carbamazepine, , dival- (100 – 200 mg/day for at least 2 months) in 15 out proate) (Nelson et al. 2001; Varela and Black 2002) of 21 juvenile males with sexual hyperactivity and have been sporadically used over the years. compulsive masturbation (Ryback 2004) (reduction No clear effi cacy was observed using lithium or in time spent in sexual fantasies and masturbation). anticonvulsivants when no bipolar disorder was Increasing dosage to 200 mg/day did not increase associated with paraphilia. However, Bartova et al. effi cacy in poor or non-responders. Five out of six (1978) evaluated lithium therapy in 11 patients non-responders benefi ted from leuprolide therapy. treated with 900 mg/day for 5 months. Deviant Relapse occured in the 13 patients in whom naltrex- sexual tendencies disappeared in six patients. Nau- one was decreased below 50 mg/day. sea occured in two cases. No prospective trials have documented topiramate effectiveness in paedophilia Serotoninergic selective reuptake inhibitors (SSRIs). The but several case reports have described topiramate’ s rationale for the use of serotoninergic antidepressants in effectiveness in reducing unwanted sexual behav- sexual offenders is based on several lines of evidence: iours (prostitutes, compulsive viewers of pornogra- phy, compulsive masturbation (dose range 50– 200 • The fi rst piece of evidence comes from advances mg, 2 – 6 weeks are required before effi cacy) (Fong in research on the role of serotonin and specifi c et al. 2005; Khazaal and Zullino 2006; Shiah et al. subtypes of 5HT brain receptors on sexual 2006). behaviours. Animal models showed that Concerning the use of antipsychotics, in a decreased 5HT levels increased sexual appeti- placebo-controlled cross-over study (18 weeks), tive behaviours while enhanced central 5HT chlorpromazine 125 mg/day, benperidol 1.25 mg/ activity reduced them. Increased levels of day and placebo were compared in 12 paedophiles serotonin in the hypothalamus inhibited sexual in a security hospital (Murray et al. 1975). There motivation and the testosterone signal while were no statistically signifi cant differences in most increased levels of serotonin in the prefrontal comparisons. Extrapyramidal side effects were cortex enhanced emotional resilience and frequently observed with benperidol. In spite of rare impulse control. In paedophilia, decreased cases of sex offences related to in schizo- activity of the 5HT presynaptic neurons and up phrenic patients, no clear effi cacy was reported with regulation of postsynaptic 5HT2A receptors had the use of antipsychotics in paraphilia. Ten patients been reported. (Bartova et al. 1978) were receiving fl uphenazine • Another line of support comes from the clinical decanoate (12.5– 25 mg every 2 –3 weeks i.m. for 3 –4 observation of the similarities of paraphiliac months). Deviant sexual tendencies disappeared in fantasies, urges and behaviours with obsessive/ fi ve cases and were reduced in four cases. Extrapy- compulsive and Tourette symptoms. Similar ramidal symptoms and orthostasis occurred in eight brain abnormalities in corticostriatal circuits patients. have been documented. As SSRIs have been Concerning tricyclic antidepressants, methodolog- proved to be effi cacious in the treatment of ical biases are observed, most of the studies are case OCD, it seems logical to use them in paraphiliacs reports and few research-based evidence was and hypersexual subjects. reported. Interestingly, a double-blind crossover • Relationships have been found between 5HT study showed that clomipramine and desipramine dysregulation and specifi c dimensions of 618 F. Thibaut et al.

: antisocial impulsivity, anxiety, conducted (from year 1990-to year 2009). The depression and hypersexuality (Kafka and Cole- following search terms were used: antidepressants, man 1991; Beech and Mitchell 2005). SSRIs sex offenders. Additional publications were identi- use has shown to decrease impulsivity. fi ed through internet. Papers were analyzed critically, • Important Axis I and Axis 2 comorbidities have to assess current state of research on this topic. been reported in juvenile and adult paraphiliacs Two meta-analysis on the effectiveness of all and hypersexual subjects: mood and/or anxiety kinds of treatments for sexual abusers including only disorders; conduct and impulse control disorders; controlled randomized studies stated that no ADHD; substance and alcohol abuse; borderline, controlled randomized studies have been published avoidant, schizoid and antisocial personality dis- on antidepressants (White et al. 2000, Cochrane orders. It is recommended that this comorbid Library; Losel and Schmuker 2005, Campbell disorders should be treated as well. Collaboration Group). • Increased knowledge about secondary effects of Comissioned by the Health Technology Assess- SSRIs on sexual behaviour suggested the oppor- ment Program at Birmingham University, UK, Adi tunity of using these side effects for treatment et al. (2002) conducted a systematic review of the of sexual deviance. Indeed, a medication that currently available evidence on effectiveness of the enhances central serotoninergic transmission use of SSRIs for the treatment of sex offenders. has been found to reduce fantasies and paraphil- The search was conducted up to 2001, and iac behaviour (Jacobsen 1992). Abusive subjects included qualitative analysis of cohort and case also report high feelings of loneliness, fear of studies, using Cochrane ’s criteria for assessment intimacy and isolation. SSRIs can increase affi l- of bias risk. One hundred and thirty studies were iative behaviours secondary to increase of found, but only nine studies were fi nally consid- vasopressin and oxytocin, and thus produce ered acceptable for the metaanalysis: Perilstein additional benefi cial effect. et al. 1991; Stein et al. 1992; Kafka and Prentky • Lastly, chronic administration of SSRIs increases 1992b; Kafka, 1994; Coleman et al. 1992; the level of BDNF, which has neuroprotective Bradford et al. 1995; Fedoroff 1995; Greenberg et effects on hippocampal, striatal and mesencephalic al. 1996; Kafka and Hennen 2000). Altogether, dopaminergic neurons. This results in increased these studies included a total number of 225 neuronal plasticity and consequently in an patients (3– 58). All of them were case series, increased capacity for changing behaviour. In reporting pre-post psychometric comparisons conjunction with cognitive-behaviour therapy, or within subjects in a short time. Only one study had schema based interventions that address endur- more than 1 year follow-up, only one was prospec- ing personality characteristics and defi cits arising tive and none of them included measures of from childhood problems such as abuse, SSRIs recidivism reduction. The research group consid- may increase the impact of such therapies. ered that all of the studies were vulnerable to bias, which may have affected their validity. The main Thus, raising synaptic 5HT levels by SSRIs would one was the lack of control groups. The scales used have a range of benefi cial effects on the brain of in assessing the outcomes were subjective. The sexual offenders (Bradford 1996; Saleh 2004). length of follow-up was insuffi cient to assess major Research evidence on the effi cacy of antidepressants long-term consequences on re-offence. In many for treatment of sexual offenders has been reported. studies, heterogeneous groups of paraphiliacs were In the past decade, numerous case reports have included. Exhibitionism, compulsive masturbation described the effi cacy of SSRIs or clomipramine in and paedophilia were the most frequent paraphil- the treatment of paraphilias, as well as non-paraphiliac ias in which SSRIs showed improvement. In most hypersexuality (Gijs and Gooren 1996; Bradford and cases, other psychiatric diagnoses were associated Greenberg 1996; Balon 1998). Interestingly, a dou- to paraphilias (mostly affective disorders or OCDs). ble-blind crossover study showed that clomipramine In spite of these methodological limitations, the and desipramine reduced equally paraphiliac behav- results are promising. Eight studies showed some iour in eight subjects (seven of 15 dropped out) signifi cant reduction from baseline in the frequency (Kruesi et al. 1992). There was no preferential of masturbation and in the intensity of deviant fan- response to the more specifi c serotoninergic antide- tasies; depression, anxiety, sexual activity, penile pressant. The effi cacy of paroxetine in one case and tumescence and general adaptation in paraphiliac clomipramine side effects limited clomipramine use and sexually compulsive patients were also decreased. (Leo and Kim 1995; Stewart and Shin 1997). One study conducted by Stein et al. in 1992 showed A bibliographic search of the English-language- only effi cacy in compulsive patients. The researchers literature indexed on MEDLINE/PubMed was concluded that there is preliminary evidence of WFSBP Treatment guidelines of Paraphilias 619 potential value of SSRIs in treatment for sexual desipramine versus placebo. Both were found to be abusers. Their recommendation for future studies effective. was to include control groups receiving only psycho- By contrast, fl uvoxamine (200– 300 mg/day, one therapy, only medication, combined treatments and case), clomipramine (400 mg/day) or fl uoxetine placebo. Their economic analysis showed potential (60 – 80 mg/day, three cases) did not improve for cost-effectiveness, as they stated that additional paraphiliac behaviours in fi ve subjects after 2– 10 cost would only include drugs cost. months of treatment (Stein et al. 1992, retrospective A review of the studies showed effectiveness of open study). However, co-morbid non-sexual obses- different antidepressants in sexual abusers: fl uoxetine sive-compulsive disorder (OCD) symptoms improved (Bianchi 1990; Kafka 1991, Kafka and Prentky in these patients. 1992b; Lorefi ce 1991; Perilstein et al. 1991; There are several other interesting reports on Bradford and Gratzer 1995; Emmanuel et al. 1991); SSRIs treatment combined with other interventions: sertraline (Kafka 1994; Bradford et al. 1995); Bradford and Greenberg (1996) reported that clomipramine (Kruesi et al. 1992; Ruby et al. 1993); psychotherapy plus SSRIs was more effective than fl uvoxamine (Zohar et al. 1994; Greenberg et al. psychotherapy alone. 1996); paroxetine (Abouesh and Clayton 1999) and Kafka and Hennen (2000) added , nefazodone (Coleman et al. 2000, retrospective study, methylphenidate, pemoline or to SSRIs to 14 males with non paraphilic sexual compulsions). counteract tolerance effects and to treat residual Kafka and Prentky (1992b) reported that fl uoxetine depressive or ADHD symptoms (open study, 26 male (20– 60 mg/day) for 12 weeks reduced preferentially patients with paraphilias). The adjunction led to a sig- the frequency of paraphiliac behaviours in 20 male nifi cant additional decrease in paraphilia or paraphilia- paraphilic subjects (exhibitionism, phone sex, sadism, related disorders. The same authors gave anecdotal fetishism, frotteurism) at week 4, and hypothesized unpublished information in 2006 about 50– 100 non- that SSRIs may even facilitate normal sexual arousal. bipolar, non-psychotic paedophiles treated with In the same way, physiological measures of sexual SSRIs, mood stabilizers or psychostimulants. arousal () showed a decrease Greenberg and Bradford (1997) compared 95 pati- in paedophilic arousal (by 53%), and improved or ents receiving SSRIs plus psychosocial intervention maintained normal arousal after 12 weeks of versus 104 subjects having only psychosocial treat- sertraline treatment (Bradford 1999, 2001). ment. Both strategies reduced paraphiliac behaviours, Some authors have compared effectiveness of but only the SSRIs reduced fantasies and desires SSRIs to other treatments: a retrospective study, within 12 weeks. conducted by Greenberg et al. (1996), in 58 paraphil- Krauss et al. (2006) reported marked reduction iacs, 17– 72 years of age (mean age: 36), compared of paraphiliac symptoms in an open, uncontrolled the effectiveness of fl uvoxamine (N 16), fl uoxetine retrospective study of 16 male paraphiliacs receiving ( N 17) and sertraline (N 25). Seventy-nine SSRIs in combination with psychotherapy. The percent of subjects received concurrent psychotherapy. only double-blind study by Wainberg et al. (2006), The major paraphilias were paedophilia (74%), compared 20– 60 mg citalopram versus placebo in 28 exhibitionism (14%), sexual sadism (12%). Comor- homosexual men with compulsive sexual behaviour in bid disorders were borderline personality disorder a 12-week trial. Effi cacy was measured using the (31%), depression (28%), Yale-Brown OCD scale. Treatment effects were seen (17%). Results showed a signifi cant decrease in on sexual desire/drive (P 0.05), frequency of mas- deviant fantasy intensity and frequency from weeks turbation (P 0.01) and pornography use (P 0.05). 4 to 8, and no further improvement at week 12. A 23-year-old female paedophile was treated with Fluvoxamine, fl uoxetine and sertraline were found sertraline (50 mg/day) (Chow and Choy 2002). The equally effective. Adverse effects were similar for frequency and intensity of sexual interest in female the three drugs (, , children decreased and the effect was maintained at , drowsiness, reduced sexual drive, 1 year. Concurrent impulsive behaviours were also , ). decreased. Paraphiliacs and hypersexual males not responding A critical analysis of all studies that involved to sertraline for at least 4 weeks were offered fl uox- the use of SSRIs in the treatment of paraphilias etine and six of the nine subjects showed clinical concluded that the results of psychotropic drug improvement (Kafka 1994). No paedophiles were interventions are not favourable (Level C of included in this study, and most subjects had evidence) . The only double-blind study by co-morbid mood disorders. Wainberg et al. (2006), was conducted in males Kruesi et al. (1992) studied 15 paraphiliacs in a with compulsive behaviour and cannot be general- double-blind comparison of clomipramine and ized to sex offenders. 620 F. Thibaut et al.

Rö sler and Witzum (2000) suggested that they 2004, Oregon) included SSRIs as one of the inter- might be effective only in men with a defi nite OCD ventions for the control of sexual arousal, within component to their sexual behaviour. Indeed, one a comprehensive treatment program. They stated proposed relates the anti- that this medication was supported by multiple obsessional effects of SSRIs to the hypothesis that clinical trials and specifi ed that SSRIs could have hypersexuality and some paraphilias may be related a specifi c effect of reducing arousal, independently to OCDs, or even impulsive control disorders (Stein of their antidepressant quality. Though not for- et al. 1992). mally approved, their off label use had become a However, the above-mentioned studies draw atten- standard of care. These guidelines recommends tion to an alternative for treating paraphilias that are SSRIs for patients with high level of arousal that accompanied by OCD, impulse control disorders, or cannot be controlled with cognitive behavioural depressive disorders. But, despite the increasing therapies, adding that informed and motivated clinical use of SSRIs for paraphilias and hypersexuality, patients are good candidates. double-blind controlled trials with these agents are • In his algorithm, Hill et al. (2003) integrates still lacking. SSRIs have already been included in levels of severity and comorbid conditions, clinical practice for the treatment of sexual offenders, within a comprehensive treatment plan, where with specifi c indications, although more research all patients receive psychotherapy and pharma- demonstrating effi cacy is very much needed. Several cotherapy for comorbid disorders. Pharmaco- authors conclude that many reasons exist for the lack therapy is recommended for all patients with of research on antidepressant treatment of sexual strong paraphiliac fantasies/compulsions and offenders: risk of sexual offenses. In mild and moderate cases, SSRIs are signaled as fi rst choice of • lack of interest of governments to promote their treatment, especially for those with depressive, use in these patients and to fund research; anxious or obsessive/compulsive features. • ethical barriers prevent double-blind studies in • The American Academy of Child and Adoles- paraphiliac men being carried out; cent Psychiatry (AACAP 1999; Shaw 1999) • sexual offenders constitute a highly stigmatized practice parameters for the assessment and population of patients. treatment of children and juveniles who are sexual abusers recommend the following aims Clinical recommendations for the use of SSRIs in for treatment: confronting denial; decreasing the treatment of sexual abusers are the following: deviant sexual arousal; facilitating non deviant sexual interests; promoting victim empathy; • there is some evidence that sertraline reduces enhancing interpersonal and social skills; assist- deviant sexual behaviours without affecting or ing with value clarifi cations; clarifying cognitive even with improving normal sexuality (Bradford distortions; teaching to recognize internal and et al. 1995; Bradford, 2000); external antecedents of sexual offending. The • paraphilias usually start at adolescence and are treatments recommended for these age groups limited to deviant fantasies related to masturba- are cognitive behavioural interventions, psycho- tion between 12 and 18 years. SSRIs given at social interventions and SSRIs. The use of anti- this stage could prevent acting out of deviant androgens is discouraged under 17 years of age. behaviours (Bradford and Fedoroff 2006); Research showed that they may delay onset of • taking into account clinical data, Bradford puberty and bone growth. (2000), Bradford and Fedoroff (2006) and Kafka (personal communication), recom- mended SSRIs prescription in mild paraphilias, Oestrogens in paraphiliac juveniles, in cases that have The fi rst study was published in 1949 (Golla and comorbidity with OCD and depression and in Hodge). Despite its effi cacy (Whittaker 1959; maintenance treatment. Bancroft et al. 1974), numerous side effects have Several guidelines have been developed for the been reported (nausea, weight gain, feminization, treatment of sexual offenders, which are summarized breast cancer, cardiovascular and cerebrovascular regarding to the indication of SSRIs: ischemic disease, thromboembolism) (Field 1973). Breast carcinoma was also reported in transsexual • The Association for the Treatment of Sexual individuals during the use of Oestrogen treatment Abusers (ATSA Practice Standards and (Symmers 1968). They must not be used in sex Guidelines for the Evaluation, Treatment and offenders or subjects with paraphilia (No level of Management of Adult Male Sexual Abusers evidence and major side effects) . WFSBP Treatment guidelines of Paraphilias 621

Pharmacotherapy with antiandrogens or GnRH the availability of free testosterone, and fi nally it may analogues also bind to androgen receptors (Southren et al. 1977). Methods . A review of the existing literature was MPA is currently used as a contraceptive, as a conducted using MEDLINE/PubMed (1969– 2009). treatment for endometriosis or breast cancer. MPA The following key words were used: androgen was the fi rst drug studied in the treatment of antagonists, gonadotrophin-releasing hormone, paraphilias. MPA is available in some countries and cyproterone acetate, medroxyprogesterone 17-acetate, may be prescribed as an intra muscular (i.m.) depot paraphilias, sex offences, sexual behaviour, incest. All preparation (150 or 400 mg/ml) (300– 500 mg/week) available papers reporting hormonal treatment of or per os (2.5, 5 or 10 mg) (50 – 100 mg/day); oral paraphilias in English or French were considered. administration may be used even if its absorption is Sixty-fi ve studies concerning hormonal treatment more erratic (Gottesman and Schubert 1993). The were used in this review. Within these 65 papers, about fi rst report of its effi cacy in reducing sexual drive was 30 studies were included, among them few were published in 1958 in healthy males (Heller et al. controlled studies. 1958). The drug was fi rst noted for its effi cacy in the treatment of one case of paraphilia by Money in Limitations. The criteria used for the measurement of 1968 and has since been used in the USA. treatment effi cacy differed between the studies More than 600 cases have been reported among (frequency of conventional and paraphiliac sexual different studies including 12 case reports (23 activity or fantasies reported by the patient, plasma subjects), 13 open or controlled studies (including testosterone levels, sexual or non-sexual reoffence; three double-blind cross-over studies). penile plethysmography (using audio or visual erotic stimuli, video including chidren, rapes or adults may Case reports. Twelve case reports including 23 be used but, according to Marshall and Fernandez subjects were found (Berlin and Coyle 1981; Berlin (2000), many methodological fl awns may limit the and Meinecke 1981; Cordoba and Chapel 1983; use of this technique), different types of paraphilias Bourget and Bradford 1987; Cooper et al. 1987, were included, the duration of follow-up may vary 1990; Ross et al. 1987; Cooper 1988; Weiner et al. from months to years, side effects were not reported 1992; Stewart 2005; Light and Holroyd 2006; in many studies, in most of controlled studies a Krueger et al. 2006). All subjects were males, aged cross-over methodology was used). In most countries, from 17 to 85 years (in 13 cases, subjects were aged clinical trials are not allowed while sex offenders are above 65 years old and exhibitionism or hypersexu- in jail, moreover conducting controlled studies ality was associated with dementia). Paedophilia comparing antiandrogen treatment with placebo in was observed in fi ve cases (in association with exhi- outpatients is not ethical. bitionism, mental retardation or schizophrenia in four of fi ve cases). In one case, testosterone level Antiandrogens. Steroidal antiandrogens have proges- before treatment was 880 ng/100 ml (Berlin and togenic activities in addition to their antiandrogenic Meinecke 1981). MPA (100 mg/4 weeks to 750 mg/ effects, which, through feedback effects on the hypo- week i.m. or 100 – 300 mg/day per os) was used for thalamo-pituitary axis inhibit the secretion of LH, 2 months to 4 years. Testosterone, FSH and LH resulting in a decrease in circulating levels of both levels, clinical interviews, self reports of sexual testosterone and dihydrotestosterone (DHT). These activity and fantasies, penile plethysmography (in compounds interfere with the binding of DHT (the two cases using audio stimuli and in one case using androgen which plays the dominant role in andro- nocturnal plethysmography) were used as outcome genic response) to androgen receptors and they measurements. In all cases, except for one, deviant have been shown to block the cellular uptake of sexual behaviour and fantasies disappeared within androgens. 3 weeks; in the remaining case, erectile reponses to Medroxyprogesterone acetate (MPA) is a progesterone audio sexual stimuli were increased with MPA derivative that acts as a and, like tes- (Cooper et al. 1987). Testosterone levels decreased tosterone itself, exerts negative feedback on the to 10 – 20% of baseline levels. Four weeks after treat- hypothalamo-pituitary axis, resulting in decreases in ment interruption, the clinical effects returned to both GnRH and LH release. MPA also induces the baseline and, in two cases, the subjects relapsed. testosterone-α -reductase, which accelerates testos- Weight gain was reported in three cases, depressive terone metabolism, and reduces plasma testosterone disorder was observed in one case, adrenal suppres- by enhancing its clearance. In addition, MPA sion (MPA was replaced with GnRH agonists) was increases testosterone binding to the testosterone described in one case; in the remaining cases, side hormone-binding globulin (TeBG), which reduces effects were not reported. In eight cases, previous 622 F. Thibaut et al. antipsychotic treatment was used without any effi - (Money et al. 1981; Meyer et al. 1992a,b; Gottesman cacy. Some case reports support the use of MPA and Schubert 1993). Drug abuse, previous head for the treatment of hypersexuality or paraphiliac trauma, learning disabilities, single status, personal- behaviours in older patients with dementia. Benefi - ity disorders increased the recidivism risk, higher cial effect of MPA (300 mg/week for 1 year) on initial testosterone levels (Meyer et al. 1992a). acting out (compulsive masturbation, exhibitionism Early treatment interruption was also a risk factor. and rape attempts) was reported in four patients McConaghy et al. (1989) reported a lower effi cacy (75 – 84 years old) with dementia (Cooper 1987). of MPA in juveniles. Exhibitionism and rape attempts in two men with Gottesman and Schubert (1993) reported no dementia (71 and 84 years old) were successfully deviant sexual behaviour with 60 mg/day of MPA. treated with MPA (150 – 200 mg/2 weeks) (Weiner These authors recommanded a low dose when side et al. 1992). effects were observed and when there was a low risk of sex offence. Open and controlled studies (13 studies, see Table I). Cooper (1986) recommended a minimal duration Among the 13 studies, three were double-blind cross- of MPA treatment of 2 years. over studies (comparing MPA and placebo) includ- ing 51 paedophiles and eight sex offenders (Wincze et al. 1986; Hucker et al. 1988; Kiersch 1990), nine Side effects were open studies and one was a retrospective study The adverse effects of MPA included weight gain (275 sex offenders, Maletzky et al. 2006). (18%, max 9 kg), headache (9%), nausea, asthenia, Effi cacy, dosage, duration of treatment: gynecomastia, lethargy, insomnia, leg cramps ( 1%), spermogram abnormalities, , Treatment outcome measures were the following: increased blood pressure, hot fl ushes, diabetes mel- self reports of deviant and/or non-deviant sexual fan- litus ( 1%), gallstones (1%) (Meyer et al. 1992b), tasies and activity, testosterone levels; plethysmogra- transient increased levels of hepatic , depres- phy was used in four studies. Paedophilia or sive syndrome, adrenal suppression, decrease in tes- exhibitionism were reported in 27 and 15% of about ticular volume, Cushing syndrome (in a 30-year-old 600 cases, respectively. Paraphiliacs were only males male with paedophilia treated with MPA, 300 mg/ aged from 14 to 85 years old. Psychiatric comor- day for 4 years) (Krueger et al. 2006) and throm- bidities were the following: dementia, alcoholism, boembolic phenomena (1%). Pulmonary embolism is mental retardation and psychopathy in most cases. the most severe side effect reported. No bone mineral Only three schizophrenic patients were included in loss was described but osteodensitometry was not these studies. MPA was prescribed as an i.m. depot used. Mean plasma concentrations of LH and total preparation (100– 900 mg/week) or per os (60– 300 testosterone were signifi cantly reduced, FSH levels mg/day). Reduction of sexual behaviour and com- did not change (for review see Guay 2009). plete disappearence of deviant sexual behaviour and fantasies were observed after 1– 2 months in the majority of cases in spite of maintained erectile func- Guidelines tion during plethysmography in some studies. In contrast, Langevin et al. (1979) reported no reduc- In conclusion many subjects received MPA treat- tion of sexual behaviour in healthy controls with ment but most studies were not controlled, and some MPA treatment (100 mg/day). biases were observed (small size of samples, short The re-offence rate for 334 individuals taking duration of follow-up, cross-over study design, ret- depot MPA was greater than with CPA, with a mean rospective study design). In addition, severe side rate of 27% at the end of the follow-up (range 6 effects were observed with MPA. The benefi t/risk months to 13 years) as compared with 50% before ratio did not favor the use of MPA which was treatment (Meyer and Cole 1997). Money et al. abandonned in Europe ( Level C of evidence) . (1975), using MPA in a few cases, reported no Testosterone, FSH, LH and prolactine plasma levels, reduction in nonsexual crimes in sex offenders with hepatocellular blood tests, blood cell count, electrocar- antisocial behaviour. diogram, fasting glucose blood level, blood pressure, In 12 cases, recidivism of deviant sexual behaviour weight, calcium and phosphate blood levels, kidney during MPA treatment was reported using different function, bone mineral density must be checked before criteria (Langevin et al. 1979; Money et al. 1981; treatment. Informed consent must be obtained. McConaghy et al. 1989; Cooper et al. 1987; Kiersch The use of MPA has to be carefully managed 1990; Kravitz et al. 1995, 1996). Some studies medically, via physical examination, especially for reported increased recidivism after MPA was stopped the effects of feminisation. Depression, emotional WFSBP Treatment guidelines of Paraphilias 623 (Continued) Erectile dysfunction(1) Glaucoma (1) Headache (1) Not reported None

cacy Side effects Placebo levels with MPA with MPA levels and non-deviant sexual stimuli (6) on treatment frequency (6) deviant sexual fantasies with MPA while on placebo fantasies disappeared MPA activity (self report) plethysmography with MPA levels the end of the placebo period Reduction of testosterone Reduction of response to deviant Effect maintained while placebo Reduction of masturbation In 1 case increase of In 1 case sex offending No change in sexual orientation Reduction of sexual Less obvious with Reduction of testosterone at No increase of sexual behaviour MPA)(open and controlled studies). and controlled studies). MPA)(open (audio deviant and non-deviant sexual stimuli) spontaneous sexual activity (visual erotic deviant stimuli) plethysmography Testosterone levels Testosterone Plethysmography Self reports Self reports of levels Testosterone plethysmography Penile Nocturnal penile Self reports Deviant sexual 42 –

placebo 400 mg/week 400 mg/week (6) – (saline i.m.) (16 weeks) 56 days, placebo for 21 56 days, – 64 weeks (4 cases) 64 weeks – 3 months – i.m. (16 weeks) versus (16 weeks) i.m. 22 their consent for and 11 remained in the treatment study until the end of follow-up: per os (5) 300 mg/day MPA Placebo placebo 14 days, MPA 160 mg/day 160 mg/day MPA placebo 14 days, for 42 days) 1 os and/or MPA 100 MPA Placebo of follow-up: Duration 18 subjects gave 18 subjects gave (No treatment 7 days, 7 days, (No treatment of follow-up: Duration MPA 160 mg/day per 160 mg/day MPA

40 years old) 60 years old) 8 ( 48 males 3 males – behaviour Other conditionsbehaviour conditions Treatment Outcome measures Effi paraphilias or sex offending with previous convictions Characteristics of the patients N Sex offenders No comorbidity Exclusion criteria Mental retardation Psychosis Brain lesion disorder Depressive N (36 (3) Paedophiles N Paedophilia Comorbidity: Mental retardation

8 males 3 males 48 males USA study controlled study Canada study cross-over Kiersch 1990 Double blind cross-over N Double-blind studies Double-blind 1986 USA Wincze et al. Double-blind cross-over N Table I. Changes in sexually deviant behaviours in chronic paraphiliac male patients treated with medroxyprogesterone acetate ( acetate with medroxyprogesterone treated Changes in sexually deviant behaviours in chronic paraphiliac male patients I. Table Reference Hucker et al. 1988 Hucker et al. Double blind N 624 F. Thibaut et al. 25% of (Continued) ushes (14) Nausea (1) gain (1) Weight None Nausea (1) Thrombophlebitis (1) Impotence (when levels testosterone approached levels) baseline Asthenia for after 3 days (40) injection gain Weight (max 9 kg) (28/48) Headache (10) Insomnia (7) Hot fl None Not reported 3 months – cacy Side effects 3 no n cant decrease MPA MPA 11 stopped cacy n Psychotherapy 40 Improvement 40 Improvement 17 No deviant 3 relapse (1 with alcohol) deviant sexual behaviour deviant sexual behaviour 20/37 early ttt interruption 6/17 relapse 1/5 relapse of testosterone levels fantasies Placebo and placebo MPA in controls MPA and relapsed MPA sexual behaviour study

After 2 years: After 2 years: Psychotherapy alone: MPA signifi MPA: Reduction of deviant sexual Plethysmography: No difference between N to 3 weeks within 10 days Reduction of deviant sexual activity and fantasies and arousal Reduction of testosterone (25% of baseline levels) levels of social Improvement functioning within 2 Similar effi those with between or without previous convictions interruption: Treatment 1 case (thrombophlebitis) 5 cases against medical no relapse advice: N N At the end of Clinical interviews Testosterone levels Testosterone Clinical interviews Recidivism rate Self levels, Testosterone reports with Plethysmography deviant sexual stimuli Plethysmography Testosterone Testosterone (1/month) levels Clinical interviews (2/month) 2 times – 17) 15) 5) 4 weeks for 4 weeks n – n n 3 times per – 600 mg i.m. per week per week 600 mg i.m. 150 mg/day per 150 mg/day – – rst 4 weeks Psychotherapy ( Psychotherapy MPA 150 MPA of follow-up: Duration 3 months to 5 years Duration of follow-up: 15 weeks of follow-up: Duration per os) (100 mg/day MPA placebo or per os) (100 mg/day MPA placebo or MPA 100 MPA os Versus Psychotherapy alone ( Versus MPA alone ( MPA Versus MPA MPA 2 200 mg i.m. then 1 for 2 weeks week then 100 or for 4 weeks per week 200 mg everyfor 12 weeks 2 weeks then 100 mg every 1 months 8 of follow-up: Duration months 12 Hospitalization for the fi

56 years – 20 males 37 males exhibitionists 8 males exhibitionists 10 heterosexual male subjects 48 behaviour Other conditionsbehaviour conditions Treatment Outcome measures Effi paraphilias or sex offending Characteristics of the patients N Aged 26 (11) Paedophilia Exhibitionism (5) Sexual sadism (1) (1) Voyeurism Sexual masochism (1) (1) Incest (1) N N N without paraphilia without N Previous convictions for sex Previous convictions (39) offences (27) Paedophiles Exhibitionism (6) (1) Voyeurism Incest (3) Rape (4) Others (2) (2) Transvestism Comorbidity Alcoholism (7) (7) Psychopathy (Continued) 8 males 20 males 37 10 48 males Money et al. 1981 Money et al. USA Open study N Table I. I. Table Open studies 1979 Langevin et al. Canada Open study N Control group N Gagne 1981 Canada Open study N Reference WFSBP Treatment guidelines of Paraphilias 625 5 (Continued) Weight gain (13) Weight Gastro intestinal symptoms (2) Dizziness (1) Headache (1) Increased blood (3) pressure Diabetes mellitus (3) None Weight gain Weight (2/3 cases pounds) Increased blood pressure Spermogram changes Gallstones (3) Gut diverticulosis (1) Diabetes mellitus (1) Increased insuline (3) levels Headache (1) (decrease dosage) of MPA Sedation Decreased testis volume increased Transient of hepatic levels (3) enzymes 3 while of treatment MPA partners male

cacy Side effects imaginal cacy

covert cacy between cacy in juveniles: 50 ng/ml study study st nd Reduction of testosterone with MPA levels Recidivism decreased with MPA (7/40) versus 12/21 with alone psychotherapy 10 treatment At the end of MPA relapsed sensitization sensitization desensitization 2 Same effi reduction of the 3 groups, deviant sexual behaviour Less effi while receiving 3 juveniles sex offence MPA: 3 cases without MPA: offence sex 1 Reduction of levels testosterone plasma levels MPA No report of effi treatment cacy Testosterone, Testosterone, FSH levels LH, Recidivism rate of deviant sexual behaviour Testosterone Testosterone levels Self reports Testosterone, Testosterone, FSH levels LH, levels MPA Spermograms volume Testis (every 6 months) No evaluation effi of treatment 12 years 83 – – 800 mg/week i.m.) 800 mg/week 400 mg/week i.m. 400 mg/week – MPA (4 juveniles, (4 juveniles, MPA – Psychotherapy alone (20) Study Study st nd ID (10) MPA (400 MPA Psychotherapy alone Versus 6 of follow-up: Duration (Covert sensitization, (Covert sensitization, Imaginal desensitization) 2 later) 7 required MPA 12 adults, or Psychotherapy (10) (imaginal or both MPA desensitization) per month for 150 mg i.m. MPA months 4 1 year of follow-up: Duration MPA 300 MPA 1 of follow-up: Duration months (mean 18 months) 1 19)

45 years (mean 29) 72 years – – behaviour Other conditionsbehaviour conditions Treatment Outcome measures Effi paraphilias or sex offending 40 (MPA treatment) treatment) 40 (MPA 23 males 45 Characteristics of the patients N Aged 16 to 78 years Sex offenders (23) Paedophilia Rapist (7) Exhibitionism (10) N Aged 22 (12) Paedophilia Rapists (6) Exhibitionism (2) (3) Genital self mutilation Comorbidity: Alcoholism (2) N Aged 14 6 cases (mean 32; Sex offenders Paedophilia Exhibitionism Fetishism Voyeurism Comorbidity (1) Mental retardation (Continued) 61 males 23 males 45 males Meyer et al. 1992a et al. Meyer USA Open study N Table I. I. Table Reference Meyer et al. 1985 et al. Meyer USA Open study N Mc Conaghy et al. 1989 et al. Mc Conaghy Australia Open study N 626 F. Thibaut et al. week (1) week st (Continued) Headache 1 Weight gain (2) Weight Gallstones (4) Leg cramps (2) cacy Side effects 75%) – Reduction of testosterone (50 levels Reduction of deviant sexual and fantasies erections morning No deviant sexual behaviour in 6 cases Increase of sexual desire in onset treatment 2 cases at resistance 1 case of treatment 3 weeks at In 2 cases early treatment interruption (10 and 12 1 lost to weeks) 1 recidivism follow-up, (rape) Risk factor of recidivism: Risk factor of recidivism: drug abuse, single, previous head trauma, disabilities, learning personalityhigher disorders, initial testosterone level Testosterone, Testosterone, FSH levels LH, (1/month) Self reports of deviant sexual behaviour Number of morning and erections/week number of / week

60 mg/day 18 months) – MPA MPA (10 Psychotherapy

?) 47 years – n s disease ’ 2 paraphilias behaviour Other conditionsbehaviour conditions Treatment Outcome measures Effi paraphilias or sex offending 21 (Psychotherapy) 7 males Characteristics of the patients Paedophilia (3) Paedophilia Sexual sadism (1) Zoophilia (1) (3) Voyeurism Exhibitionism (3) Sexual masochism (1) (1) Fetishism (1) Transvestism Phone scatologia (1) Comorbidity: Hodgin Schizophrenia No previous pharmacologicalin 4 treatment, cases previous psychotherapy failed N Sex offenders who disagree with treatment MPA (14) Paedophilia Exhibitionism (6) (1) Voyeurism No denial No psychopathy Comorbidity: Head trauma (5) Drug or alcohol ( abuse Personality disorders Personality or depressive disorders (33%) Micro penis (2) N Aged 25 With (Continued) 7 males Reference Gottesman and Schubert 1993 USA Open study N Table I. I. Table WFSBP Treatment guidelines of Paraphilias 627 s partner ’ Not reported Not reported Pulmonary (1) embolism Leg cramps (12) gain (10) Weight Headache (10) Asthenia (7) (5) Sedation Depressive (4) disorder pain, Testis Erectile dysfunction (4) Virus (1) hepatitis of 1 case: the male cacy Side effects cant difference for MPA cant difference for MPA no treatment: no no treatment: deviant sexual behaviour with deviant sexual behaviour versus deviant sexual MPA observedbehaviour in respectively 30% and 26% of subjects in groups 2 and 3 levels levels no self report, (exhibitionism, conviction) interruption early MPA 7 cases: most cases fantasies in 6 cases (group 1) and 2 cases (group 2) normal after treatment levels interruption in (longer duration older subjects) MPA No deviant sexual behaviour No deviant sexual behaviour Reduction of non-deviant behaviour sexual Reduction of testosterone recidivism with MPA 1 case: Reduction of testosterone levels in Reduction of testosterone levels or No deviant sexual behaviour No signifi group dosage between 1 and 2 1 case of recidivism with MPA returned levels to Testosterone (deviant and non- deviant sexual fantasies, sexual activity, masturbation) and every (before MPA 6 months (every 3 months) weight Recidivism of deviant sexual behaviour Self report Plethysmography levels Testosterone Blood pressure and Recidivism Id above Id above Subjects divided into Normal groups: two pretreatment (9) testosterone levels pretreatment Low (4) testosterone levels (and longer duration treatment) of 5) 7 1) n n 4)

55) 1) 600 mg/week 1) 600 mg/week 5) n n N + 400 mg/week i.m.) 400 mg/week Behavioural therapy Behavioural 500 mg i.m./week 500 mg i.m./week –

– : : : 5) 900 mg/week ( 5) 900 mg/week 79) (mostly paedophiles) 141) 12 months ( – n N N MPA i.m. 300 mg/week ( 300 mg/week i.m. MPA Group 1 (200 MPA ( Group 2 recommanded MPA not used ( but Scale score DepoProvera 99 score or Static Group 3 not recommanded MPA ( MPA 300 MPA Psychotherapy (group)(26/29) of follow-up: Duration months 6 ( 400 mg/week ( Psychotherapy (10/13 cases) of follow-up: Duration 6 les)

? 77 years 77 years (mean 38) – – behaviour Other conditionsbehaviour conditions Treatment Outcome measures Effi paraphilias or sex offending 13 males 275 (clinical fi 29 males Characteristics of the patients 2 paraphilias (6) N Aged 24 43) (mean (10) Paedophilia Exhibitionism (3) Mean IQ 102 N Sex offenders, Sex offenders, prisoners Paedophilia Exhibitionism Rapist Comorbidity N Aged 18 (22) Paedophilia Exhibitionism (6) Frotteurism (1) Comorbidity: Mild mental (5) retardation (Continued) 13 males 275 males 29 males Table I. I. Table Kravitz et al. 1996 et al. Kravitz USA Open study N Reference study Retrospective 2006 Maletzky et al. USA studies Retrospective records) (hospital N Kravitz et al. 1995 et al. Kravitz USA Open study N 628 F. Thibaut et al. disturbances must be evaluated every 1– 3 months. et al. 1991; Byrne et al. 1992; Cooper et al. 1992; Every 6 months, glucose blood levels, calcium and Eriksson and Eriksson 1998; Gooren et al. 2001). phosphate blood levels, blood pressure, weight must Two paedophiles with mild to moderate mental be controlled. Bone mineral density must be checked retardation, one exhibitionist, other non-specifi ed every year in case of increased osteoporosis risk. sex offenders (aged from 23 to 70 years, in two cases MPA treatment must not be used in case of dementia was associated with sexual desinhibition) non-consent, puberty not completed especially when were receiving CPA (50– 200 mg/day or 275– 300 mg bone growth is not achieved, adrenal disease, i.m. every 2 weeks), from 4 weeks to 10 years. Hor- pregnancy and breast feeding, severe hypertension, monal levels, self report rating scales and, in some previous thromboembolic disease, breast or cases, plethysmography were used. In most cases, uterine diseases, diabetis mellitus, severe depressive deviant sexual behaviour disappeared within 2 weeks disorder, allergy to MPA, active pituitary disease. except for one case; in this latter case, CPA was with- drawn after 2 weeks due to side effects (Byrne et al. Cyproterone acetate (CPA) is a synthetic steroid, sim- 1992). Cooper et al. (1992) reported a better effi cacy ilar to progesterone, which acts both as a progesto- with 200 mg/day of CPA as compared with 100 mg/ gen and an antiandrogen. Direct CPA binding to all day. Some side effects were reported: asthenia, erectile androgen receptors (including brain receptors) dysfunction, gynecomastia (one case was treated using blocks intracellular testosterone uptake and metabo- radiotherapy), osteoporosis and hip fracture (one lism. Indeed, CPA is a competitive inhibitor of case, 52 years old, 300 mg/2 weeks, after 10 years of testosterone and DHT at androgen receptor sites. CPA) (Gooren et al. 2001), depressive disorder (one In addition, it has a strong progestational action, case). In one case, treatment was stopped after 2 which causes an inhibition of GnRH secretion and weeks due to asthenia and muscular loss (Byrne et al. a decrease in both GnRH and LH release (Jeffcoate 1992). Thibaut et al (1991) reported a concurrent et al. 1980; Neuman 1977). decrease in non-sexual aggressiveness while CPA was CPA is used predominantly in Canada, the Middle used. In most cases, testosterone levels decreased. East and Europe and is registered in more than 20 countries for the moderation of sexual drive in adult Open and controlled studies (10 studies, see Table II). men with sexual deviations as well as for non-oper- Among the 10 studies, two were double-blind cross- able prostate cancer (Androcur). It is also used as a over comparative studies (CPA vs. ethinyl-, treatment for precocious puberty or hirsutism. CPA 12 sex offenders, Bancroft et al. 1974) (CPA vs. may be given either by injection (depot form: 100 MPA, seven paedophiles, Cooper et al. 1992b), two mg/ml (200– 400 mg once weekly or every 2 weeks) were double-blind cross-over studies including, or as tablets (50 and 100 mg, 50– 200 mg/day). In respectively, nine sex offenders and 19 subjects with the United States, it is only available in a low dosage paraphilias and comparing CPA with placebo form in a combination product with ethinyl-estra- (Cooper 1981; Bradford and Pawlack 1993a), one diol. was a single-blind study (fi ve paedophiles, CPA vs. The fi rst clinical use of CPA in sex offenders (pre- placebo, Cooper et al. 1992a) and the fi ve remaining dominantly exhibitionists) occurred in Germany studies were open studies. (Laschet and Laschet 1967, 1971), in a open study, Effi cacy, dosage, duration of treatment which showed an effi cacy of CPA in 80% of abnor- About 900 male subjects were included in 10 open mal sexual behaviour. and double- or single-blind cross-over studies. About 20% of the cases were paedophilic patients. The most Case reports. Melior et al. (1988) reported the case frequent comorbidities observed were mental retarda- of a female aged 40 with compulsive masturbation tion and psychopathy. CPA (50– 300 mg/day per os or and sexual aggression. CPA (50 mg/day from J1 to i.m. 300– 600 mg every 1 or 2 weeks) was associated J15) and ethinyl-estradiol (50 μ g/day from J5 to J25 with a signifi cant decrease of self-reported sexual fan- every month) decreased signifi cantly deviant fanta- tasies or activity and frequency of masturbation and a sies, erotic dreams. Compulsive masturbation disap- disappearance of deviant sexual behaviour in about peared. CPA was stopped at 6 months after lactose 80– 90% of cases within 4– 12 weeks. Morning erec- intolerance and reintroduced at a dosage of 25 mg/ tions, ejaculations and spermatogenesis were decreased. day with the same effi cacy. Previous treatments In most cases, 100– 200 mg/day was suffi cient. More- (psychotherapy, antidepressants, antipsychotics) over, in 80% of the cases, 100 mg/day oral CPA was had failed. suffi cient. Depending on dosage, the authors Fourteen patients were reported in nine case suggested that CPA could be used as a chemical reports (Cooper et al. 1972; Lederer 1974; Bradford castration agent or as a reducer of sexual drive, allowing and Pawlack 1987; Grinshpoon et al. 1991; Thibaut erecting ability in non-deviant sexual behaviour. WFSBP Treatment guidelines of Paraphilias 629 (Continued) case on day 3 of CPA 3 of CPA case on day (treatment interruption) volume Not reported Depressive disorder 1 Depressive Not reported Reduced ejaculate Reduced ejaculate

28) in 0.35), 0.35), to cacy within cacy dose dependent cacy Side effects cantly decreased sexual 0.05) audio stimuli (23% reduction)) P pen and controlled studies). pen and controlled studies). 365), decrease of sexual activity (0.7 365), 40) ( to to 0.25), number of erections (1 0.25), 8 weeks, (maximal effect at 8 weeks) (maximal effect at 8 weeks, – to orgasm and sexual interest (70.7 to general and while masturbation general and while masturbation (94 interest and activity stimuli (plethysmography) (485 of erections after sexual stimuli (video (67% reduction) interruption 4 morning erections, penile response to erotic morning erections, same effi and MPA CPA stimuli, Reversible within 30 days of CPA interruption of CPA Reversible within 30 days CPA or ethinyloestradiol: CPA Both drugs signifi decreased responses to erotic Only CPA With CPA, reduction of testosterone levels reduction of testosterone levels With CPA, Decrease of nocturnal erections (by 62%) and Decrease of testosterone (78%) LH (42%) treatment (14%) during FSH levels CPA analyses No statistical Returned after CPA to baseline 4 weeks Decrease of testosterone, LH, FSH levels with FSH levels LH, Decrease of testosterone, returned levels to normal both treatments, of placebo after 3 weeks levels and 3 CPA preferred 5 patients MPA analyses No statistical Decrease of sexual fantasies, masturbations, masturbations, Decrease of sexual fantasies, CPA and MPA: same effi and MPA: CPA 100) –

for the last 7 days (visual masturbation scale 0 rating 1/month prolactine levels sequence) with audio and visual deviant and non-deviant sexual stimuli plethysmography Sexual interest, sexual activity Plethysmography levels Testosterone Testosterone levels Testosterone Sexual fantasies and activity Number of erections/day Sexual interest and FSH, LH, Testosterone, Nocturnal erections, (1 per Plethysmography Nocturnal penile Testosterone FSH Testosterone LH levels Sexual fantasies, morning masturbations, deviant sexual erections, behaviour, (audio Plethysmography, and visual deviant sexual non-deviant stimuli)

tment conditions Outcome measures Effi 200 mg/day – 100 mg/day 100 mg/day 100 mg/day 100 mg/day ethinyl-estradiol or CPA treatment, estradiol) versus placebo versus 100 CPA treatment, No mg/day/Placebo, Placebo/ treatment, No treatment) CPA, or placebo of follow-up: Duration 16 weeks 8 weeks/ 100 mg/day placebo 4 weeks) 100 or 100 mg/day/MPA 200 mg/day/ CPA or CPA Placebo/MPA or 100 mg/day/MPA 200 mg/day/ CPA Placebo CPA CPA versus 0.01 mg/day 3 periods(no of 6 weeks CPA 5 periods(No of 4 weeks 100 mg/day CPA (Placebo 4 weeks/CPA CPA versus MPA versus CPA 7 periods of 4 weeks or CPA (Placebo/MPA 37) –

other conditions Trea

34 years 31 years – – 89 (3 cases) – 12 Males 5 Males 9 Males 10 paedophiles (3 / 2 paraphilias behaviour behaviour (hypersexuality 4 and voyeurism exhibitionism 4, and fetishism 1, 2, 1 case) incestuous behaviour dropped out during the initial placebo period) Paraphilias and sex offending Paraphilias Characteristics of the patients N Aged 22 Sex offenders N Aged 21 Paedophiles Comorbidity N (2) Psychopathy Alcoholism (1) IQ 75 Sex offenders N Mean age: 30 years (23 Mean age: Exhibitionism 1 Sexual sadism 4 Rapist 1 2 Fetishism Zoophilia 1 2 Transvestism

12 males 5 males 9 males 7 males over study over over study over over study over over study over Single blind cross- Cooper et al. 1992a Cooper et al. Canada N Double-blind studies Double-blind 1974 Bancroft et al. USA Double blind cross- N Table II. Changes in sexually deviant behaviours in chronic paraphiliac male patients treated with cyproterone acetate (CPA) (o with cyproterone (CPA) treated Changes in sexually deviant behavioursacetate in chronic paraphiliac male patients II. Table Reference Cooper 1981 Canada Double blind cross- N Cooper et al. 1992b Cooper et al. Canada Double blind cross- N 630 F. Thibaut et al. (Continued) cant difference for side effects 1.3 kg CPA: No signifi gain with Mean weight 4.2) and o treatment on o treatment cacy Side effects 4.7 to 3.59 Placebo and CPA cant reduction of testosterone (50%) (X2) cant increase of prolactine levels fantasies cant decrease of sexual arousal, and FSH (30%) levels and activity (5.65 decrease of BPRS scores sexual fantasies and desire phallometry Signifi Signifi No change for LH Signifi CPA CPA difference observedNo statistical using sexual activity stimuli) BPRS, Buss stimuli) BPRS, Durkee Inventory, scales for sexual Rating interest and activity Each year self reportEach year of Testosterone, LH, Testosterone, prolactine levels FSH, (visual Plethysmography Not reported 200

–

300 mg/day 200 mg/day 200 mg/day – – tment conditions Outcome measures Effi 50 200 mg/day – max 3 years versus placebo versus months (four 3-month periods)treatment 1 month/ (No treatment or 200 mg/day CPA placebo double-blind 3 50 months/CPA or placebo for 3 mg/day months double-blind (CPA successively) dosage could be changed every month during the last period) performed No statistical analyses No statistical CPA 100 CPA of follow-up: Duration Duration of follow-up: 13 of follow-up: Duration analyses Statistical CPA Cyproterone acetate 50 of follow-up: Duration 4 months-4 years

other conditions Trea 45 years – 19 Males 352 110 Males behaviour behaviour were excluded were vascular disease, carcinoma, carcinoma, disease, vascular cellular disease, hepato diabetis, psychosis, organic disorders, depressive brain disease Paraphilias and sex offending Paraphilias Characteristics of the patients N Comorbidity: 3 Psychopathy Alcoholism 2 Drug 1 abuse 1 Mental retardation In 3 cases denial and patients 30 years Mean age: 19 Range: N 30% paedophiles Paedophiles 12 Paedophiles Frotteurism 1 Rapists 2 1 Fetishism Incest 2 Exhibitionism 1 Exclusion criteria cardio Thromboembolism, N 29 paedophiles Exhibitionism Sexual sadism 80% sex offenders

(Continued)

19 males 352 males 110 males 1993a study over Double blind cross- Bradford and Pawlack Bradford and Pawlack Canada N Reference Open study N Table II. II. Table Open studies Laschet et 1971 Germany Open study N 1971 Mothes et al. Germany WFSBP Treatment guidelines of Paraphilias 631

diabetis mellitus (1) of erections and ejaculations decreased No side effects reported Blood tests: no change Blood tests: Gynecomastia (2) Increased severity of At onset: Decrease of number Spermatogenesis Asthenia symptoms Depressive gain Weight At 6–8 months Gynecomastia (20%) Decreased pilosity Decreased sebum non-deviant) 12 weeks – cacy Side effects cacy within 8 28 nMol/l) baseline levels type of visual stimuli (deviant non-deviant sexual fantasies offenders) offenders patients with higher (7 cases/17) (but with higher (7 cases/17) (but patients normal Decrease of spontaneous erections and Reduction of deviant sexual behaviour (16 sex Reduction of deviant sexual behaviour No relapse 3 years after ttt interruption in sex Maximal effi Decrease of testosterone levels mostly in Decrease of testosterone levels Decrease of penile tumescence depends on Testosterone levelsTestosterone in 90% of cases Improvement deviant and non-deviant sexual stimuli) before and after 2 to 3 CPA months Clinical observation scales No rating Testosterone levels Testosterone (audio Plethysmography 600 mg – 200 mg/day 200 mg/day – 200 mg/day 200 mg/day – 12 weeks – mg/day max 3 years 8 years 50 acetate 300 oral or i.m. every 1 or 2 weeks (mean 85) 9 CPA 50–100 mg/day CPA In some cases (n?) 200 of follow-up: Duration CPA of follow-up: Duration cyproterone Dosage: CPA 50 CPA of follow-up: Duration : 60 years – 300 Males 20 Males behaviour Other conditionsbehaviour conditions Treatment Outcome measures Effi N children) masturbation compulsive exhibitionism cellular disease, hepato diabetis disorder, depressive alcoholism, mellitus, psychosis, Paraphilias and sex offending Paraphilias Characteristics of the patients N=50 Males 16 Sex offendersor (women 4 violent sexual fantasies oligophrenia with 13: 10 hypersexuality 4 chromosomal aberrations 3 elderly with sexual disorders Exhibitionism/hypersexuality Comorbidity: Mental retardation N Aged 18 15 Paedophiles 3 Incest and 2 Paedophilia Exclusion criteria thromboembolism, Carcinoma,

(Continued) 300 males 20 males (case reports) Pawlack 1993b Pawlack Davies 1974 Davies USA Open study N=50 males Laschet et 1975 Germany Open study N Reference Bradford and Canada Open study N Table II. II. Table 632 F. Thibaut et al.

The effi cacy was maintained while on treatment who did not comply with therapy. In addition, a for up to 8 years in a sample of 300 males with signifi cant number of patients re-offended after stop- paraphilia (cyproterone acetate 50– 200 mg/day oral ping therapy. Some studies have reported reduced or i.m. 300– 600 mg every 1 or 2 weeks ) (Lashet and anxiety and irritability with CPA in their patients Lashet 1975). (Cooper et al. 1992a,b; Bradford and Pawlak 1993b). Davies (1974) reported CPA effi cacy in fi ve juve- In most studies, the duration of antiandrogen nile males with deviant sexual behaviour or hyper- treatment was less than one year, Davies (1974) sexuality (mental retardation was observed in three reported no recidivism during 3 years of follow-up cases); however, CPA must not be used before after cessation of 5 years of CPA treatment in differ- puberty and bone growth are completed. ent types of paraphilias. According to Cooper (1986) Five comparative double- (or single-) blind cross- a minimal duration of treatment of 2 years would be over studies (Table II) have compared CPA with necessary. Although there is no consensus on the placebo, MPA or ethinyl-estradiol in 52 sex offenders. optimal duration of CPA or MPA treatment, many Brancroft et al. (1974) compared the effects of CPA authors have written that 3– 5 years of treatment are with those of 0.01 mg ethinyl-estradiol twice a day. necessary (Gijs and Gooren, 1996). Both treatments equally decreased sexual interest, Serum FSH and LH concentrations were either sexual activity with no major side effects (except for decreased or not affected by cyproterone acetate one case of early depressive disorder). Only CPA administration. Plasma testosterone levels were mod- decreased responses to erotic stimuli (plethysmogra- erately decreased (for review, Guay 2009). phy). The fi rst double-blind comparison between CPA and MPA concluded that MPA and CPA per- formed equally in seven sex offenders with no side Side effects effects except for those related to hypoandrogenism (no statistical analyses were performed) (Cooper et Side effects were related to hypoandrogenism: asthe- al. 1992b). In all studies, CPA, MPA and ethiny- nia, sleep disorders, depressive symptoms or disorders loestradiol showed the same effi cacy which was (Cooper et al. 1992a,b), hot fl ushes, pilosity changes, higher as compared with placebo. The results of the decreased sebum rate, leg cramps, loss, evaluation of penile responses to a variety of erotic spermatogenesis reduction (reversible), impotence, stimuli, using plethysmography, for CPA and MPA, decrease of sexual activity and fantasies, reduced ejac- have been less impressive than when subjective mea- ulate volume and osteoporosis (Gis and Gooren 1996; sures of improvement have been used. Using visual Grasswick and Bradford 2003) were reported. erotic stimuli, CPA or MPA had no signifi cant or One hip fracture due to bone mineral loss was more variable effects on the erectile responses of sex observed in a 52 year-old man after 10 years of CPA offenders (Bancroft et al. 1974; Cooper et al. 1992a,b; treatment (Gooren et al. 2001). Bradford and Pawlak 1993). These results are in Or side effects were related to CPA itself: headache, accordance with the view that erections in response dyspnea, weight gain, gynecomastia (20% of cases, to visual stimuli are less androgen-dependent. By reversible), thrombo-embolic phenomena (Czerny contrast, a consistent trend toward preferential sup- et al. 2002), increased level of prolactine, adrenal pression of deviant arousal using phallometric mea- insuffi ciency or hyperplasia (0.5% of cases) (primarily sures was observed during CPA treatment in a group described in juveniles with CPA (Laron and Kauli of paedophiles with high but normal levels of testos- 2000)), hypertension, cardiac insuffi ciency (Reilly et al. terone (Bradford and Pawlak, 1993b). Among dou- 2000), decreased glucose tolerance, kidney dysfunc- ble-blind studies, only Bradford and Pawlak (1993a) tion, pituitary dysfunction, anaemia (Hill et al. 2003), performed statistical analyses and reported a statisti- local pain at the injection site (depot formulation), cally signifi cant decrease in deviant sexual activity nausea were reported, hepatocellular damage (CPA placebo and CPA no treatment). (especially when CPA dosage is 200– 300 mg/day, The treatment effects of CPA or MPA were com- after several months of treatment) it may be fatal, but pletely reversible, 1 or 2 months after medication serious hepatotoxicity is uncommon 1%) (Heine- interruption. mann et al. 1997). According to animal research data, Seven studies examined the re-offence rates of 127 CPA is suspected to induce cell carcinoma individuals taking CPA (Meyer and Cole 1997). A (Neuman et al. 1992; Kasper 2001). In patients with mean rate of 6% was found at the end of the follow- prostate cancer, cyproterone acetate increased the risk up period (less than the rate observed with MPA), of venous thromboembolism more often as compared as compared with 85% before treatment, with a to fl utamide or GnRH agonists monotherapy duration of follow-up ranging from 2 months to 4.5 (3.5-fold). A history of venous thromboembolism or years. Many re-offences were committed by individuals recent surgery or trauma increased the risk by 4- and WFSBP Treatment guidelines of Paraphilias 633

13-fold, respectively (for review of CPA side effects, CPA have shown inconsistent results in the treat- Guay, 2009). ment of sex offenders. In addition, poor treatment compliance is a major concern with oral CPA. Because of a substantial number of side effects, including gynecomastia, weight gain, thrombo- Guidelines embolic phenomena and hepatocellular damage, In conclusion, many subjects received CPA there is a need for other effective treatments with treatment but most studies were not controlled, fewer side effects. and some biases were observed (small size of The results obtained using surgical castration have samples, short duration of follow-up in most cases, motivated further research in GnRH analogues cross-over studies, retrospective studies) ( Level C of treatments. evidence) . GnRH analogues act initially at the level of the In addition, some severe side effects were observed pituitary to stimulate LH release, resulting in a tran- with CPA. sient increase in serum testosterone levels (fl are-up). In some countries the oral form is the only form After an initial stimulation, continuous administra- available and treatment observance may be erratic. tion of GnRH analogues causes rapid desensitiza- Testosterone level is not systematically decreased tion of GnRH receptors, resulting in reduction of and measurements of plasma levels of CPA are not LH (and to a lesser extent of FSH) and testosterone available in many countries. Poor treatment compli- to castrate levels within 2 – 4 weeks (Belchetz et al. ance is a major concern with oral CPA. 1978; McEvoy 1999). They do not interfere with the Testosterone, FSH, LH and prolactine plasma action of androgens of adrenal origin. Forty percent levels, hepatocellular blood tests, blood cell count, of normal controls reported reduction in normal electrocardiogram, fasting glucose blood level, blood sexual desire with GnRH treatment (Loosen et al. pressure, weight, calcium and phosphate blood lev- 1994). In addition, GnRH containing neurons proj- els, kidney function, bone mineral density must be ect into pituitary and extra-pituitary sites, such as checked before treatment. the olfactory bulb or the amygdale. At these latter Side effects are dose related and careful monitoring sites, GnRH is believed to act as a neuromodulator of CPA dosage should decrease side effects and, in and, through this action, may be also involved in some cases, would allow non-deviant sexual behav- sexual behaviour (Kendrick and Dixson 1985; Moss iour (Hill et al. 2003). The use of CPA has to be and Dudley 1989). Moreover, the intracerebroven- carefully managed medically, via physical examina- tricular administration of GnRH suppresses aggres- tion, especially for the effects of feminisation. sion in male rats (Kadar et al. 1992). Depression, emotional disturbances must be evalu- Three analogues of the gonadotrophin-releasing ated every 1– 3 months. Every month for 3 months hormone are available. GnRH analogues were approved and then every 3 – 6 months biochemical monitoring in many countries for the treatment of advanced pros- of liver function is required (Reilly 2000; Hill et al. tate cancer (Vance and Smith 1984; Smith 1986), 2003). Every 6 months, prolactine, glucose blood endometriosis, precocious puberty, uterine fi bromyo- levels, blood cell count, calcium and phosphate mas, and female infertility (in vitro fertilization). blood levels, blood pressure, weight must be controlled. Bone mineral density must be checked Triptorelin is a synthetic decapeptide agonist, ana- every year in case of increased osteoporosis risk logue of the gonadotropin-releasing hormone (Reilly et al. 2000; Hill et al. 2003). Informed (GnRH). Triptorelin was developed as a pamoate salt consent must be obtained. (3 mg, 1 month formulation or 11.25 mg, 3 month CPA must not be used in case of: non-consent, formulation). It was recently approved in Europe for puberty not completed especially when bone growth the reversible decrease in plasma testosterone to cas- is not achieved, hepatocellular disease, liver tration levels in order to reduce drive in sexual devi- carcinoma, diabetis mellitus, severe hypertension, ations of adult men (triptorelin LA 11.25 mg). carcinoma except prostate carcinoma, pregnancy or breast feeding, previous thromboembolic disease, is a synthetic analogue of GnRH. It was cardiac or adrenal disease, severe depressive disorder, developed as daily i.m. or monthly depot injections tuberculosis, cachexia, epilepsy, psychosis, allergy to (3.75 or 7.5 mg, 1 month formulation or 11.25 mg, CPA, drepanocytosis, pituitary disease (Reilly et al. 3 month formulation). 2000; Hill et al. 2003). Goserelin is also a synthetic analogue of GnRH. It Pharmacotherapy with gonadotrophin releasing was developed as daily i.m. or monthly depot injec- hormone (GnRH) analogues. In fact, MPA and tions (3.6 or 10.8 mg subcutaneously). 634 F. Thibaut et al.

Case reports bitionism and Huntington’s disease (Rich and Osview 1994), or of a 43-year-old male patient Triptorelin : Hoogeveen and Van der Veer (2008) with exhibitionism, hypersexuality, frontotemporal reported one case of male paedophilia with mental dementia and Kl ü ver-Bucy syndrome (Ott, 1995) retardation and alcoholism treated with triptorelin were also published. Effi cacy was reported at 3 (3.75 mg/month) for 37 months with good effi cacy. months. Weight gain, aesthenia and muscular pain Previous treatment with SSRIs, antipsychotic or were reported. psychotherapy failed. Biphosphonates and calcium Grasswick and Bradford (2003) reported bone were added preventively to GnRH for 35 months but mineral demineralization in 1/1 case of leuprorelide bone mineral demineralization occured after 37 treatment (plus CPA 300 mg/day) as compared with months, triptorelin had to be withdrawn and deviant 2/4 of CPA treatment and 2/2 cases of surgical cas- sexual fantasies returned. Hot fl ushes and erectile tration (plus CPA) during a follow-up of 4 years in dysfunction were also observed during treatment. seven paraphiliac males aged from 36 to 61 years old Testosterone levels decreased from 22.8 before treat- (paedophilia in fi ve cases, sexual sadism in one case). ment to 1.3 nmol/l during treatment. Vitamin D and calcium were used. In the remaining case reports (Briken et al. 2004; Leuprorelin: In 1985, Allolio et al. successfully Saleh et al. 2004; Saleh 2005), eight male paraphiliacs treated a homosexual paedophiliac with leuprorelin. (exhibitionism, paedophilia, sexual sadism or Rousseau et al. (1990) reported the case of a male paraphilia not specifi ed) were receiving leuprorelin exhibitionist (35 years old) who received a combi- acetate (7.5 mg/month or 11.25 mg every 3 months nation of short-acting leuprorelin and the antiandro- in one case) for several months to one and a half gen fl utamide with no side effects reported during years. Psychotherapy was associated with hormonal 26 weeks. The assessment of the sexual fantasies treatment. In seven cases, psychiatric comorbidities and activities was achieved through self-reports. were associated. In seven cases, fl utamide was used Concurrently with the decrease of testosterone, a for 15 days to 6 weeks in association with leuprore- sharp decline in the deviant sexual activities and fan- lin acetate. In addition to self reports of sexual activity tasies was observed. The deviant activities completely and fantasies, hormonal levels were measured and, ended after 2– 4 weeks. At 26 weeks, triptorelin was in one case, plethysmography was also used. Using withdrawn and the deviant sexual behaviour returned self report or plethysmography, deviant sexual behav- 2 months after treatment discontinuation. iour and fantasies disappeared within 1– 3 months Dickey (1992, 2002) reported the case of a male after treatment introduction in seven of eight cases, patient (28 years old) with multiple paraphilia and concurrently to the decrease of testosterone levels hypersexuality successfully treated for 6 months (1992) (one relapse occured while the patient was receiving and 10 years (2002) with long-acting leuprorelin (7.5 leuprorelin acetate). In most cases, side effects were then 3.75 mg/month) as compared with previous MPA not reported. Erectile dysfunction was reported in (max 550 mg/week for 32 months) or CPA treatment one case. (200– 500 mg/week for 14 months). He observed that suppression of androgen of testis origin alone was Goserelin: Brahams (1988) reported the effi cacy suffi cient for treatment. Testosterone levels decreased of goserelin acetate in one case of homosexual from 28.9 to 0.8 nmol/l. Bone demineralization was paedophilia in a male patient with previous sex observed after 3 years and treated with calcium and offences. Previous MPA (800 mg i.m. per week) or Vitamin D. Gynecomastia was also reported. CPA (600 mg/day) treatments were unsuccessful. In one case of male paedophilia, a signifi cantly Czerny et al. (2002) reported the effi cacy of greater decrease in self-report and phallometric mea- goserelin acetate in fi ve cases. sures of sexual arousal and activity was obtained with leuprorelin (7.5 mg/month), as compared with previ- ous CPA treatment (100 or 200 mg/day with a dose Open and controlled studies (see Tables III effect) or placebo. The study design was a complex and IV) cross-over trial of successive 16-week periods and No randomised controlled studies were published then, 36 and 42 weeks with CPA 100 and 200 mg/ day, respectively, leuprolide acetate for 24 weeks after a 10-week washout period. Testostererone level Triptorelin: Among the three studies, there were was reduced to castration level with leuprolide two open prospective studies (41 subjects with acetate (Cooper and Cernovski 1994). paraphilias including 32 paedophiles, 22/41 subjects Single case reports of successful leuprorelin were sex offenders, 1-month formulation) and one treatment (7.5 mg/month) of a patient with exhi- retrospective study (30 sex offenders). WFSBP Treatment guidelines of Paraphilias 635 (Continued) rst 2 cases, rst 2 cases, Evolution 10 weeks GnRH analogues – interruption (3 34 and 12, cases) at 58 months at relapse of deviant within behaviour 8 ask for patient treatment reintroduction (recurrence of deviant sexual fantasies) gradualrelapse but increase of testosterone levels with testosterone stopped (GnRH was due to bone mineral loss) returned to normal within levels 2 months 5/8 relapses after (in interruption 3 cases due to side effects) Treatment interruption Treatment Treatment Treatment In the fi the In the 2nd case, In the 3rd case no Hormonal levels died (AIDS) 1 patient 1 lost to follow-up ushes (1) ushes (6) (11/11) after 3 years (1) site (1) with suicidal (1) attempt and body hair growth (3) Decreased libido bone loss Vertebral Asthenia (1) the injection at Pain syndrome Depressive Decreased Erectile failure (2) Hot fl Hot fl

1 0.01) 0.3 nMol/l P 0.2 per week 0.2 per week 0.1 after 1st olled studies). olled studies). cacy Side effects 8) of self report – /1 year treatment) /1 year 0.01) P 2.8 to 1.2 10 to 0.6 13 to 0.2 0.1) and of LH 2 (range nMol/l for 9 months) frequent paedophilic fantasies were maintained and he tried to sexual contacts with a have child 40 after 1st month ( 57 (22.9 P TeBG not estradiol but disappeared in 10/11 behaviour cases month ( activity and erectile capacities maintained were 24 cases ( incidents of abnormal sexual baseline decreased at behaviour to 0 during treatment) Sexual activity decreased from Sexual fantasies decreased from Decreased levels of testosterone Decreased levels No change in testis volume Deviant sexual fantasies and (testosterone level In 1 case, In 4 cases non-deviant sexual analysis conducted on Statistical No deviant sexual behaviour (5 masturbation and masturbation sexual activity deviant fantasies and behaviour (Self-report scale: intensity of sexual desire and symptoms scale) (Testosterone, TeBG, LH, FSH, Estradiol) (intensity of sexual desire and symptoms scale) (8-point scale) sexual monthly, Three activity, main complaints Intensity of fantasies Frequency of Frequency of Hormonal levels volume Testis Osteodensitometry Self-report scale

7 years – conditions Outcome measures Effi Treatment Treatment Psychotherapy Psychotropic are-up effect) Psychotherapy CPA 200 mg/day 200 mg/day CPA to (10 days one week 1 year, before GnRHa a to prevent fl 7 follow-up: months mg/month mg/month drugs (7 cases and in 2 cases 2 drugs) of Duration Triptorelin 3.75 Triptorelin Triptorelin 3.75 Triptorelin No CPA – cacy 10 years 300 mg/d 300 mg/day 300 mg/day – – – (3 cases) (1 case) 150 for 6 months 3 years: 150 for 4 before 1 year the study at withdrawn least 2 months Gynecomastia CPA (4 patients) (4 patients) CPA Lack of effi CPA (9 patients) (9 patients) CPA least Stopped at SSRIs (7 cases) 57) 8 –

behaviour Other conditions Previous treatment 11 males (aged 15 30 (mean age 32 (mean age 25) exhibitionism (1) disorder (1) years) Paraphilias and sex offending Paraphilias Characteristics of the patients N Paedophilia (7) Paedophilia Exhibitionism (1) Sexual sadism and Rapists (2) Previous sex offences (6) Comorbidities: (3) Mild mental retardation Bipolar disorder (1) Borderline personality AIDS (1) N Paedophilia (25) Paedophilia Exhibitionism (7) (2) Voyeurism Frotteurism (2) (30) Sexual hyperactivity More than 1 paraphilia:

11 males 30 males sler and 1993, 1996, 1996, 1993, 1998 Witzum 1998 ö Open studies Thibaut et al. France Open study N R Israel Open study N Table III. Changes in sexually deviant behaviours in chronic paraphiliac male patients treated with triptorelin treated Changes in sexually deviant behaviours in chronic paraphiliac male patients (open and contr III. Table Reference 636 F. Thibaut et al. Evolution 1 death: cardiac 1 death: C hepatitis disease, in 4 cases (2 cases), withdrew patients treatment interruption after released from 1 relapse prison: returned to baseline within levels 2 months in 3/8 cases CPA (200 mg/day): relapse in 2 cases, reintroduction of triptorelin in 2/8 cases Treatment interruption Treatment Interruption (7 cases): treatment In 5 cases, Testosterone levels levels Testosterone Replacement with Calcium 0.05) ushes P (1) myalgia (2) myalgia injection site at bone mineral if necessary after 2 years (2 cases) up to 50% volume after 36 months ( Weight gain Weight Hot fl Urinary incontinence Gynecomastia Increased sweating Asthenia and Muscular pain and Erectile failure (21) Decreased lumbar density (11/18): Vitamin D Decreased testicular 5.3 0.05) 3 to 14 ng/dl P 0.2 to cant vs. 0.05) cacy Side effects 0.9 at 12 months 0.9 at 42 0.15 at P 196 to 26 0.4) and testosterone 2.3 at 6 months ( 2.3 at 0.001) 3 after 1-year treatment treatment 3 after 1-year deviant sexual fantasies while treated term treatment to 0.8 (545 levels 6 months at (intensity of sexual desire and 8 symptoms scale: 2.7 and to 1.7 and to 1.4 months) signifi months (but baseline after 1st month) Questionaire: severity (score from 10 4 P No follow-up clearly reportedNo follow-up No relapse and decrease of Only 5 cases maintained long Decrease in sexual behaviour Decrease in sexual behaviour Maximal effect after 3 to 10 Three main complaints paraphilia First problem cited: (10.6 Decrease in LH levels behaviour (13-point scale) before treatment 12 months and at (severity of the 3 problems ascertained to most affect the subject) 3 months) testosterone levels (1/month) (2/year) Self report of sexual Recidivism questionnaire scale) questionnaire (every volume Testis FSL LH Osteodensitometry 42 – conditions Outcome measures Effi Treatment Treatment CPA CPA Psychotherapy (dosage ?) (dosage ?) follow-up: 8 follow-up: months Duration of Duration No information Triptorelin before the study Lithium (2) Antipsychotics (9)

behaviour Other conditions Previous treatment

30 Males Paraphilias and sex offending Paraphilias Characteristics of the patients N Previous sex offences (? cases) Psychopathy Mental retardation Denial No sex offence No concurrent psychotherapy Prisoners Schizophrenia (5) disorders Personality (9) Exclusion criteria: 5 cases Previous sex offences (16) (22 cases) Comorbidities: (Continued)

30 males study Lykke- Olesen 1997 study Retrospective Retrospective Hansen and Retrospective N Table III. III. Table Reference WFSBP Treatment guidelines of Paraphilias 637

Leuprorelin: Among the three studies, there were decrease of testosterone and LH levels, a reduc- three open studies (28 subjects with paraphilias tion of non-deviant sexual behaviour was observed including 13 paedophiles, 16/28 subjects were sex with a maximal effect after 1 or 3 months and offenders, 1- or 3-month formulation) deviant sexual fantasies disappeared. One-third of One retrospective study with different GnRHa cases (13 cases) have previously received CPA treatments compared with CPA (58 subjects with without effi cacy. In 10 cases (in three cases due to paraphilias including 16 paedophiles, 19 cases with GnRH analogues side effects), treatment was data available, 11 with leuprorelin acetate, three with abruptly interrupted and deviant sexual behaviour triptorelin and fi ve with goserelin acetate as com- and fantasies reappeared in seven cases. In three pared with CPA alone in 29 cases). cases, triptorelin was resumed with good effi cacy In all studies, except for Rö sler et Witzum and in three cases, CPA (200 mg/day) was intro- (1998), CPA or fl utamide was used in combina- duced but without effi cacy in two of three cases. In tion with GnRHa during the fi rst weeks of GnRHa one additional case, triptorelin was gradually treatment. stopped using increasing testosterone supplementa- tion in a patient with bone mineral loss and no relapse was observed. Effi cacy, dosage In the retrospective study, in fi ve cases, subjects interrupted GnRHa treatment when released from Triptorelin: Two open prospective studies using trip- prison, one relapse was observed. These studies were torelin 1-month formulation were performed in sex only open studies without any comparison with pla- offenders or paraphiliacs (Thibaut et al. 1993, 1996, cebo. No plethysmography was used. However in all 1998; Rö sler and Witztum 1998). The data are sum- cases, but one, triptorelin was successful and the marized in Table III. Thibaut et al. (1993) reported deviant sexual behaviour completely disappeared the fi rst open study of triptorelin in six patients with during GnRH analogue treatment. Moreover, tri- paraphiliac behaviours. R ö sler and Witztum (1998) poreline effi cacy was superior to CPA effi cacy in 13 reported another open uncontrolled study of trip- out of 41 cases. In the Czerny et al. study, similar torelin in 30 patients with paraphiliac behaviours effi cacies were observed with CPA and triptorelin. using a similar design. Czerny et al. (2002) in an Since the new sustained-release triptorelin pal- open retrospective study compared different GnRHa moate 3-month formulation is as effective as the treatments with CPA and three patients were 1-month formulation in achieving and maintaining receiving triptorelin in this study. castrate testosterone levels, similar effi cacy of both In total, 75 male subjects (aged from 15 to 57 formulations on the reduction of drive in sex years) with paraphilia were included in two prospec- offenders can be inferred. Moreover, the 3-month tive open studies (n 41), two retrospective studies formulation is expected to strongly improve the (n 30 3) and one case report. The most frequent treatment compliance, on which long-term control paraphilias observed, whenever reported, were pae- of the paraphiliac behaviours largely depends. dophilia (n 33) and exhibitionism (n 8). In six However, similarly, no controlled studies were con- cases, at least two paraphilias were observed in the ducted with this compound. same patients. In some cases, comorbidities were associated to paraphilias (mental retardation, schizo- Leuprorelin: Four studies using leuprorelin (1- or phrenia or, in most cases, personality disorders). The 3-month formulations) were performed in patients outcome measures were self report of deviant and with paraphiliac behaviours (Briken et al. 2001; Briken non-deviant sexual behaviour and fantasies (type, fre- 2002; Krueger and Kaplan 2001; Czerny et al. 2002; quency, intensity), testosterone and LH levels. In Schober et al. 2005, 2006). The last of these studies Rö sler ’ study, two scales were used: Intensity of sexual was a double-blind study. The data are summarized in desire and symptoms scale, and the Three main com- Table IV. plaints questionaire. Subjects were receiving depot Forty-fi ve male subjects were receiving leupro- triptorelin for some months to 7 years (3.75 mg/ lide acetate (20– 61 years old), they were included month). In the Thibaut et al. study, CPA was concur- in three prospective studies including a cross-over rently used for the fi rst weeks of triptorelin in order study (Schober et al. 2005) (28 cases in total), to prevent the behavioural consequences of a fl are up one naturalistic study comparing CPA and GNRH effect. analogues (Czerny et al. 2002; 58 cases, 11 with During triptorelin treatment, no deviant sexual leuprorelin acetate) and 15 case reports (previ- behaviour was observed and no sexual offences ously described). The Schober et al. study was a were committed except for one case (Thibaut et al. “ masked ” cross-over study (versus placebo) (n 5 1993). Concomitantly to the rapid and sharp sex offenders) but unfortunately was not intended 638 F. Thibaut et al. 35 (Continued) accid penile ushes (3) months ttt one case (20 years old) Weight gain (mean 22 lbs) (5) Weight injection site (4) at Pain Decrease in fl circumference Hot fl Gynecomastia (1) Erectile dysfunction (5) no asthenia, No hair loss, Bone mineral loss (3) Nausea (1) disorder (1) Depressive Mild gynecomastia (3) Decrease of erections except for One relapse after ttt interruption Depressive disorder Depressive gain Weight injection site at Pain (1) Suicide attempt 8) n 4 years –

cacy Side effects /1 masturbation/ cacy 10.7 to 0.4 4/month at 3 4/month at – – lled studies). lled studies). and non-deviant sexual arousal and interest depending on pretreatment frequency and intensity decreased from 493 ng/dl (baseline) to 22 while treatment maintained after treatment interruption for 2 11/11 cases ( behaviour day to 3 day months and one masturbation/month 12 months) at from 3.5 No change in sexual interest analysis of GnRH No statistical analogues effi placebo vs. Leuprolide acetate: Reduction of deviant and non-deviant sexual activity rate (masturbation decreased No relapse 12/12 cases Marked reduction of deviant ( Mean testosterone level effect was In 2 cases, No deviant sexual behaviour No deviant sexual behaviour Decreased sexual activity and Fantasies decreased slightly less Fantasies decreased levels Testosterone measures Effi Outcome deviant and non-deviant sexual activity and fantasies LH levels masturbation and masturbation sexual activity fantasies and (self- behaviour report Lickert scale) Self reports levels Testosterone Plethysmography visual (erotic stimuli) (Abel assessment) Hare Scales: psychopathy Self reports of FSH, Testosterone Osteodensitometry Intensity of fantasies Frequency of Frequency of deviant levels Testosterone

conditions Treatment Treatment 57 months

– 12 months or 7.5 mg/month) for 30 days or individual supportive) 6 1 year Leuprorelin acetate Leuprorelin acetate 11.25 mg/ 3 months weeks) Leuprorelin acetate (7.5/ Leuprorelin acetate then 11.25/3 month, months) Flutamide tid 250 of follow-up: Duration Leuprorelin acetate (3.75 Leuprorelin acetate Flutamide 250 mg t.i.d. Flutamide 250 mg t.i.d. Psychotherapy (Cognitive of follow-up: Duration Psychotherapy of follow-up: Duration CPA (300 mg depot for 2 CPA Previous treatment mg/day dosages) psychotropic drugs (7) previous MPA in 1 case or SSRIs (6 cases) 300 mg (form?) for 2 to 14 months (2 cases) MPA (2) 120 MPA SSRIs (9) (high Other No effect of CPA (6 cases) CPA SSRIs (4 cases) Antipsychotics 48 years – 57 years old)

–

: behaviour other conditions behaviour 12 Males (aged 20 11 males (19 5 Males Paraphilias and sex offending Paraphilias Characteristics of the patients old) paedophilia (1) N= Mean age 50 years (38–58) Sex offenders convicted Comorbidities: Alcoholism (2) disorders Depressive (1) disorders Personality N (mean age 35.5) (6) Paedophilia Exhibitionism (5) (3) Voyeurism Sexual sadism (1) NOS (2) Paraphilias Comorbidities: (1) Mental retardation Head trauma (2) Personality Frontal lobectomy, disorders , Depressive Chromosomal disorders, Psychosis aberrations (1), N (7) Incest (1) Paedophilia Sadism with (3) or without Previous sexual offences (11) Comorbidities Sexual impulsivity (3) (5) Mental retardation Exclusion criteria: Prisoners Neurological disorders 12 males 11 males Kaplan 2001 2001, 2002 2001, repeated repeated measures, non- randomized Schober et al. 2006 2005, USA Prospective, Krueger and USA Open study N Reference Open studies Briken et al. Germany Open study N Table IV. Changes in sexually deviant behaviours in chronic paraphiliac male patients treated with leuprorelin (open and contro treated Changes in sexually deviant behaviours in chronic paraphiliac male patients IV. Table WFSBP Treatment guidelines of Paraphilias 639 (Continued) ushes CPA (2) GnRHa (4) ushes CPA GnRHa (1) GnRHa (2) GnRHa (1) GnRHa (1) GnRHa (4) GnRHa (4) Asthenia CPA (3) GnRHa (4) Asthenia CPA (1) Hypogonadism CPA (1) Thromboembolism CPA (2) disorder CPA Depressive (4) Hair loss CPA Blood pressure variations Bone demineralization (1) Hypogonadism CPA Weight gain CPA (14) gain CPA Weight (10) Gynecomastia CPA Hot fl no muscular pain nodule at In 1 case prostatic baseline decreased with GnRH 0.05) cacy of placebo P Effi cacy Side effects cacy in 3 cases cacy cacy of CPA cacy of CPA in each group deviant sexual fantasies increased unsuccesful and replaced with GnRHa good effi GnRH agonists and fantasies baseline at from 1.7/week 12 months) with to 0.1 at acetate leuprolide (plethysmography, (plethysmography, No deviant behaviour Decreased testosterone levels Placebo: Increased sexual activity, fantasies and deviant fantasies with placebo after 2 months in 3 cases including a high risk of recidivism in 1 case returned levels Testosterone to baseline levels Effi In 1 case with CPA treatment treatment In 1 case with CPA was In 2 cases CPA Reduction in sexual activity No effi measures Effi Outcome FSH levels offender risk assessment) or masturbation deviant sexual behaviour check list revised Minesota Sex Offender Screening tool revised Y BOCS 99 (sexual Static Frequency of Self reports LH, Testosterone,

conditions Treatment Treatment Placebo for (29) Dosage ?

acetate (11) acetate available) 10.3 months follow-up: (GnRH analogues) and 22.6 months (CPA) OR Then months 12 + therapy Behavioural for 2 years of duration Total 2 years follow-up: Leuprorelin (3) Triptorelin (5) Goserelin acetate are In 19 cases only data for 2 weeks CPA CPA of Mean duration Previous treatment None mg for 14 days No data

behaviour other conditions behaviour 58 Males (mean age 38 years Paraphilias and sex offending Paraphilias Characteristics of the patients old) personality alcoholism(8), disorders (26) Psychopathy (5) Psychopathy riskin 4 cases moderate of risk in 1 case low recidivism, in 2 case high risk of recidivism, in 2 cases risk, cases moderate risklow No denial No mental retardation At inclusion: Minesota scale before inclusion: in 1 99 before inclusion: Static in 3 cases severe Y BOCS: in 2 sexual compulsions, sexual cases moderate compulsions N Paedophilia (16), Sadomasochism (16), Paedophilia Fetichism, Exhibitionism, (3), Voyeurism Comorbidities: (24), Mental retardation

cacy (Continued) 58 males 5 males (2002) retrospective masked study cross-over evaluate GnRH effi Not designed to N= Retrospective study Retrospective Czerny et al. Germany Open study, N Reference Table IV. IV. Table 640 F. Thibaut et al.

for the study of leuprorelin effi cacy. Schober et al. (2005) have compared behavioural therapy with leuprolide acetate or with placebo in a cross-over study including fi ve paedophiles. In three cases, while subjects were receiving placebo treatment, deviant sexual fantasies returned and testosterone levels returned to baseline levels. The most frequent paraphilias observed were paedophilia, sexual sadism and exhibitionism. Pre-

Retrograde (1) ejaculation Erectile failure (1) vious sexual offences were reported in 16 cases. In some cases, paraphilias were not specifi ed. Mental retardation, alcohol abuse and personality disorders were the most frequently observed comorbidities. In addition to the outcome measures used, such as self report of deviant and non-deviant sexual behav- cacy Side effects iour and fantasies (type, frequency, intensity) or testosterone and LH levels, plethysmography was used in the Schober et al. study. In all cases, CPA or fl utamide was concurrently used for the fi rst fantasies disappeared

Sexual activity decreased and Deviant sexual behaviour weeks of triptorelin in order to prevent the behav- ioural consequences of a fl are-up effect. Maximal duration of follow-up was 57 months (mean dura- tion about 1 year). In most cases concurrent psy- chotherapy was used. measures Effi Outcome Concomitantly to the rapid decrease of testoster-

masturbation and masturbation sexual activity fantasies and (self- behaviour report scale Estradiol levels LH, one levels, a reduction of non-deviant sexual behav- Intensity of fantasies Frequency of Frequency of deviant FSH, Testosterone, iour was observed and deviant sexual fantasies

disappeared. However, in one case report (Briken et al. 2004) the patient relapsed while treated with leuprorelin treatment and committed a sex

offence. conditions Treatment Treatment Czerny et al. (2002), in an open retrospective study, compared the effi cacy of GnRH analogues mg/month 10–16 months and CPA in 58 subjects. CPA and GnRH analogues Flutamide for 14 days Flutamide for 14 days Psychotherapy of follow-up: Duration showed the same effi cacy with no effect on deviant sexual behaviour in three cases within each group. An increase in sexual fantasies was reported in one case with CPA treatment. In addition, in two cases Previous treatment previously treated with CPA, GnRH analogues were used instead of CPA because of insuffi cient None 7.5 Leuprorelin acetate reduction of sexual aggressive impulsiveness under CPA. In these latter cases, the intensity of sexual desire and symptoms was notabely reduced with

20 years GnRH analogues as compared with previous CPA – treatment. Cooper and Cernovsky (1994), using plethysmog- raphy in one male paedophile, have compared CPA ed paraphilia (3) and leuprolide acetate. The following treatment sequences were used: placebo (32 weeks in total), no behaviour other conditions behaviour 6 Males (aged 19 Paraphilias and sex offending Paraphilias Characteristics of the patients

old) treatment (52 weeks in total), CPA 100 mg/day (36 N Paedophilia (1) Paedophilia Frotteurism (1) Sexual sadism (1) Non specifi Comorbidities: ADHD (2) Drug (2) abuse Bipolar disorders (5) (2) Mental retardation (2) Psychopathy Border line disorder (1) (2) Klinefelter syndrome (1) weeks), CPA 200 mg/day (42 weeks), leuprolide acetate 7.5 mg/month (24 weeks). Leuprolide almost

(Continued) totally suppressed both self report and phallometric measures of sexual arousal and reduced testosterone

6 males levels to castration levels. Leuprolide effi cacy on Case reports: 2004 Saleh et al. USA N Reference Table IV. IV. Table phallometric data and self reports of sexual arousal WFSBP Treatment guidelines of Paraphilias 641 was superior to CPA effi cacy (100– 200 mg/day). No Side effects treatment and placebo shared the same lack of effect on all measurements. Bone mineral loss

Duration of GnRH agonist treatment In Thibaut et al. study, six young men (aged from The duration of treatment necessary to achieve a 15 to 39) with paraphiliac behaviours were receiving complete disappearance of deviant sexual behaviour triptorelin 3.75 mg/month. Duration of exposure to and the conditions of treatment interruption remains treatment ranged from 9 months to 7 years. open. Effi cacy was maintained for years and as long Vertebral and/or femoral bone mineral density was as the antiandrogen treatment was maintained (for measured before treatment and yearly in some example the maximal follow-up duration reported patients. Decreased values of vertebral and femoral 3 was 7 years for triptorelin and 10 years for leuprolide bone densities (0.95 and 0.8 g/cm , respectively), acetate). In Rousseau et al. study (1990), the authors without clinical signs but requiring medical super- reported recidivism when a successful treatment with vision, were recorded during the third year of leuprorelin and fl utamide was abruptly stopped at 26 triptorelin treatment in one patient aged 27. The weeks. In the Thibaut et al. study (1996), the authors corresponding normal ranges were 1.15 0.15 and 3 described recurrence of deviant sexual behaviour or 0.9 0.1 g/cm , respectively, for 17– 30 years of age. fantasies within 8– 10 weeks in two cases, when a suc- It is to be noted that pubertal development was cessful GnRH agonist treatment was abruptly inter- complete in the 15-year-old patient and bone age rupted after, respectively, 12 and 34 months. Both was 16 years 6 months when triptorelin treatment subjects relapsed within 8– 10 weeks. In the latter was started. Follow-up of bone mineral density case, GnRH agonist treatment was reintroduced and revealed no abnormality during treatment in this the deviant fantasies disappeared again. By contrast, young man. in a third case, after 4.5 years of effective GnRH In R ö sler ’ s study, 30 young men (mean age: 32 8 agonist treatment, testosterone was gradually added years) with paraphiliac behaviours were receiving to GnRH agonist (in order to avoid a possible rebound triptorelin 3.75 mg/month. Duration of exposure to effect in sexual deviant behaviour after abrupt inter- treatment varied from 8 months to 3.5 years. Bone ruption of GnRH agonist treatment). When GnRH mineral density of the femoral neck and lumbar agonist and testosterone were stopped after 10 months spine was measured before triptorelin treatment. The of concurrent prescription (as soon as the testoster- results were normal, except for 14 men who had low one level was back in the normal range), the deviant values for femoral neck (78 8% of the age-matched sexual behaviour did not return and this lack of devi- men values) or lumbar spine (85 8%) bone mineral ant sexual fantasies or behaviour was maintained 1 density. Seven had previously received CPA. The year later. In R ösler’s study (1998), in eight cases, effect of triptorelin on bone mineral density was fol- triptorelin was interrupted after 8– 10 months, lowed up in 18 men in whom all planned measure- paraphilia resumed in fi ve cases in whom follow-up ments were obtained. Among them, the bone mineral was possible. In Hanson’ s retrospective study (1997), density of the femoral neck or lumbar spine was fi ve subjects stopped triptorelin when they left prison decreased in 11 men and did not change in seven and in one case deviant sexual behaviour returned. men. In the group as a whole, the mean density In one additional case report, deviant sexual behav- decreased in the lumbar spine from 92.8 13.0% of iour resumed when triptorelin was stopped because the aged-matched men value before triptorelin ini- of bone mineral loss (Hoogeveen and Van der Veer tiation to 86.5 10.7% after 12 months of treatment; 2008). In the Krueger and Kaplan study (2001), in in the femoral neck it decreased from 84.5 15.7 to one case, leuprolide acetate was stopped and deviant 80.4 8.8% at the same timepoints. The decrease sexual behaviour reappeared. In Schober’ s study was signifi cant only in the lumbar spine (P 0.05 after (2005), when leuprolide acetate was replaced with 6 and 12 months of treatment versus the previous placebo, in three of fi ve cases, deviant sexual behav- months). Two patients, who had progressive demin- iour returned within 2 months and, in one case, there eralization, were given oral calcium and vitamin D was a high risk of sex offence. supplements after completing 24 months of triptore- In Thibaut et al.’ s experience, a minimal duration lin therapy. of 3 years is necessary to establish a stable relation- Hoogeveen and Van der Veer (2008) reported bone ship with the patient and to allow him to accept his demineralization in one patient aged 35 years after disease and the necessity of pharmacological 37 months of triptorelin treatment in spite of biphos- treatment. For some patients, a life-long treatment phonates and calcium treatment from 2 to 37 months. may be needed. Triptorelin had to be stopped. 642 F. Thibaut et al.

Krueger and Kaplan (2001) observed three cases (one case), diffuse muscular tenderness, sweating, of demineralization at 35 and 57 months, respec- depressive symptoms (two suicide attempts were tively, among 12 patients aged from 20 to 48 years reported, in one case in relationship with relapse at old, receiving leuprolide acetate. Czerny et al. (2002) the end of the study (Briken et al. 2001), in the other reported one case of bone mineral loss among 29 case, previous suicide attempts were reported (Thi- patients receiving GnRH analogues for a mean dura- baut et al. 1993)) and fi nally mild gynecomastia tion of 10 months. Dickey et al. (2002) observed (2 – 7%) (Hanson and Lykke-Olesen 1997; Krueger demineralization after 3 years of leuprolide acetate and Kaplan 2001; Czerny et al. 2002; Dickey 2002; treatment in a 28-year-old patient. Calcium and Schober et al. 2005; for review see Guay, 2009). vitamin D were used. Grasswick and Bradford Czerny et al. (2002) compared CPA with GnRH (2003) focused their study on bone mineral survey analogues (GnRHa) in 58 subjects (29 in each treat- and reported demineralization in two of four cases ment group) and reported more frequently with with CPA, one case with leuprorelin and two of two CPA as compared with GnRH analogues: weight with surgical castration, the follow-up duration was gain (14/29 vs. 4/29), gynecomastia (10/29 vs. 4/29), 4 years. depressive symptoms (2/29 vs. 0/29), thromboembo- A yearly osteodensitometry was recommended lism (1/29 vs. 0/29), hair loss (4/29 vs. 0/29). In con- by all authors as well as calcium and vitamin D trast, hot fl ushes (4/29 vs. 2/29), asthenia (4/29 vs. supplementation in case of bone loss. Although the 3/29), bone mineral loss (1/29 vs. 0/29) (at 10 effi cacy of calcium and vitamin D supplementation months), blood pressure variations (2/29 vs. 0/29) in osteoporosis prevention has not been studied in were more frequent with GnRHa as compared with men on antiandrogen treatment, they are likely to CPA. Hypogonadism was observed in one case with benefi t from calcium (1200– 1500 mg daily) and CPA versus one case with GnRHa. vitamin D supplementation (400– 800 IU daily), Most patients reported progressive erectile dys- and should be advised to abstain from smoking and function and decreased libido after 6– 12 months of excessive alcohol use. A class of drugs, the biphos- treatment. The lack of sexual interest toward women, phonates (e.g., oral alendronate or risedronate, with an inability to achieve or maintain an and parental pamidronate or zoledronic acid given or perform was proportional to every 12 weeks), inhibit bone resorption by their age, occurring in some younger men but in all men inhibitory effects on osteoclast activity. These drugs older than 35 years. have been successfully used in reducing bone loss The fact that one patient had severe gynecomastia in patients receiving antiandrogens. Alendronate under previous CPA treatment, which did not reoc- was found to reduce the incidence of vertebral cur under triptorelin, is also to be mentioned. fractures in men in randomized double-blind trials, In all patients, the standard blood biochemistry but as yet there have been no randomized trials results remained within the normal ranges as mea- of reduction in fracture rates in men treated with sured after 6 months of triptorelin treatment. antiandrogens. Nevertheless, the use of biphospho- nates is recommended in men with osteodensitom- Guidelines etry-proven osteoporosis or in men with osteopenia and pre-existing bone insuffi ciency fractures (due In conclusion, there were no controlled studies, and to minimal trauma). It should further be considered some biases were observed (small size of samples, when there is evidence of progressive bone loss short duration of follow-up in most cases, open or during antiandrogen treatment. Considering the retrospective studies) (Level C of evidence ). However, role of oestrogens also in male bone health, selec- the effi cacy observed in these open studies was very tive oestrogen receptor modulators are also being high and in most cases, subjects were previously investigated (for review see Giltay and Gooren treated with psychotherapy or other antiandrogens 2009). without effi cacy. Blood pressure measurement, physical examina- tion including weight measurement are necessary Other side effects before treatment. Testosterone, FSH, LH plasma The patients also complained of hot fl ushes, levels, electrocardiogram, fasting glucose blood asthenia, nausea, weight gain (2– 13%), transient level, lipide profi le, calcium and phosphate blood pain or site reaction at the site of injection (granu- levels, kidney function must be evaluated before lomas were observed with leuprolide in 4% of patients treatment. Bone mineral density must be checked among 118), decreased facial and body hair growth before treatment in case of personal or familial (2– 23%), blood pressure variations, decreased tes- osteoporosis risk, or in patients over 50 years old, ticular volume (4– 20%), episodic painful ejaculation and every 2 years during GnRH treatment (or every WFSBP Treatment guidelines of Paraphilias 643 year, if increased risk of osteoporosis or if the patient at high risk of sexual violence, such as paedophiles is over 50 years old). Active pituitary pathology, or serial rapists. severe chronic depressive disorder or allergy to hor- monal treatment, alcohol and tobacco consumption must be assessed through interview of each candi- Conclusion date before hormonal treatment. Informed consent In general, the quality of the evidence base must be obtained. supporting the use of all these treatments is rather The use of GnRHa treatment has to be care- poor. fully managed medically, via physical examination, A meta-analysis of 12 studies in sex offenders especially for the effects of feminisation. Depression, suggested a small but robust treatment effect (addi- emotional disturbances must be evaluated every 1– 3 tional offences in 19% of treated vs. 27% of non- months. Every 6 months, fasting blood glucose levels, treated offenders) (Hall 1995). The best treatment lipid profi le, blood cell count, calcium and phosphate effects were found with the following conditions: blood levels, blood pressure, weight must be con- the highest recidivism rates, a duration of follow-up trolled. Bone mineral density must be checked every greater than 4 years, outpatients vs. institutional year in case of increased osteoporosis risk (Reilly et samples, and cognitive-behavioural and hormonal al. 2000; Hill et al. 2003; Briken et al. 2003) or at treatments vs. behavioural ones. Self-referred or least every 2 years. Calcium, vitamine D or biphos- highly motivated subjects are best responders to phonates must be prescribed in case of osteoporosis. chemical treatment (Soothill and Gibbens 1978). Testosterone blood levels could be checked in case A meta-analysis of factors predicting recidivism, of risk of breaks in the therapy, or in case of risk of based on 61 follow-up studies and including masked testosterone supplementation. Indeed, there 23,400 sex offenders, found that failure to complete is a risk that patients could antagonize their GnRH treatment was associated with higher risk of recidi- agonist treatment with testosterone supplementation vism of sex offences (Hanson and Bussiere 1998). but we could not fi nd any specifi c data in the existing These data strongly suggest that therapeutic man- literature on this topic. agement of paraphiliac behaviours signifi cantly GnRHa must not be used in case of: non-consent, reduces recidivism rate. puberty not completed especially when bone growth Not every sex offender is a candidate for hormonal is not achieved, severe hypertension, pregnancy or treatment, even if it has the benefi t of being revers- breast feeding, severe cardiac or renal disease, severe ible once discontinued. Some authors have proposed osteoporosis especially in case of prior fractures, algorithms for treatment of paraphilias (Gijs and severe depressive disorder, allergy to GnRHa, active Gooren 1996; Bradford 2000; Rö sler and Witztum pituitary disease. 2000; Thibaut 2003; Maletzky et al. 2006; Guay When properly administered, with an appropriate 2009). protocol in place to detect and treat side effects should For paraphilias characterized by intense and fre- they develop, GnRHa treatments constitute no more quent deviant sexual desire and arousal, which or less of a risk than most other forms of frequently highly predispose the patient to severe abnormal prescribed psychopharmacological agents. behaviours (such as paedophilia or rape), a hor- GnRH agonist treatments should be used after monal intervention using GnRHa may be needed other alternatives have been ruled out or when there after other alternatives had been ruled out. GnRH is a high risk of sexual violence. Antiandrogens or agonists have to be prescribed by a physician after GnRH analogues signifi cantly reduce the intensity informed consent is given. GnRH analogues reduce and frequency of sexual arousal but do not change more dramatically and more consistently testoster- the content of paraphilias. In spite of their effi cacy, one levels, and produced less variable results in the MPA and CPA treatments are associated with a high treatment of paraphiliac behaviours than MPA or percentage of side effects which have considerably CPA (R ö sler and Witzum 1998; Thibaut et al. 1998). limited their use, especially for MPA in Europe. In GnRH analogues produced castrate testosterone addition, uncontrolled breaks in the therapy are levels in all patients within the fi rst months of treat- often observed with oral CPA or MPA treatments. ment and abolished deviant sexual behaviours in In contrast, long-acting GnRH analogues are more more than 95% of patients with severe paraphiliac potent than CPA or MPA. Moreover, they induce behaviours. Effi cacy was maintained throughout the fewer side effects, except for those related to hypoan- treatment duration in all responders. The direction drogenism. Long-acting GnRH analogues may be of the sexual drive was not affected. In men who administered parentally once every one to three interrupted treatment, testosterone levels progres- months. GnRH analogue treatment probably consti- sively returned to baseline. The studies did not sup- tutes the most promising treatment for sex offenders port the specifi city of GnRH analogues in reducing 644 F. Thibaut et al. sex drive for deviant versus normal stimuli. How- General guidelines ever, while treated, some patients maintained lower erectile capacities and were able to maintain some Most people recognize that incarceration alone will masturbation and coital activities, this was propor- not solve sexual violence. Treating the offenders is tional to age. critical in an approach to preventing sexual violence GnRH analogues are more potent than CPA in and reducing victimization. reducing the effects of testosterone in tissues, or Paraphiliac men may be ordered by the judge also may have a direct effect on the central to undergo psychiatric treatment as part of the nervous system in suppressing deviant sexual rehabilitative aspect of sentencing, but these situa- behaviour (Kadar et al. 1992). Furthermore, tions should leave treatment options up to the pro- GnRH neurons project to extrapituitary sites fessionals. In case of antiandrogen treatment, it must where the hormone may act as a neuromodulator include freely given informed consent. Indeed, these (Moss and Dudley, 1989). Finally, the use of long- treatments must remain a choice to be made by the acting GnRH analogues excluded the uncontrolled patient on the basis of medical advice. Somehow, in breaks in the therapy often observed with oral some cases, failure of the offender to accept the treat- CPA treatment. ment could lead to sanctions by the court. Thus, GnRH analogues, by inducing castrate tes- Prior to treatment, each individual should be tosterone levels, progressively led to and maintained carefully examined by at least one mental health the inhibition of the fundamental elements of male professional, in order to identify and evaluate sex sexuality: sexual fantasies, desire, and interest in sex- offenders (especially number and type of paraphilias ual activities, resulting in either a dramatic decrease and previous response to treatment if any), and if or an abolishment of the sexually deviant behaviour. necessary protect and adequately treat offenders However, hormonal agents cannot be easily used who are suffering from a major mental illness or in the treatment of sexually deviant juveniles owing mental retardation. to possible interference with the development or However, little is known about which treatments course of puberty (bone growth must be achieved are most effective, for which offenders, over what and should be checked using X-rays) (Kahn and duration, or in what combination. According to Lafond 1988; Bremer 1992; Bradford 1993; Worling numerous reviews or meta-analysis, the combination and Curwen 2000; Gé rardin and Thibaut 2004; of pharmacological and behavioural treatment cou- Reitzel and Carbonell 2006). pled with close legal supervision appears to reduce Maletzky et al. (2006) proposed a scale intended the risk of repeated offense. However, the treatments for the evaluation of sex offenders and to guide do not change the subject’ s basic sexual orientation. antiandrogen use in paraphiliac subjects. This scale Because of ethical issues (high risk of recidivism, is composed of 13 items, each item with a different low level of motivation of the patients, denial, prison- score number (1 or 2), a score superior or equal ers in most cases, etc.), the great majority of phar- to seven could be an indication for antiandrogen macological studies are uncontrolled studies without treatment. placebo comparison and some methodological prob- lems are observed. Marshall and Marshall (2007) Defi nition of the items Score number have proposed two alternative designs for future sex Several victims 1 offender studies: incidental designs and actuarially Several paraphilias 1 based evaluations. With incidental designs, the inci- Preferential deviant sexual behaviour 1 dental non-treatment group is selected from the Deviant sexual interest same population as the treatment group, the source (Plethysmography or Abel Screen) 2 being those not treated because limited resources Don ’t live with the victim 1 prevent the treatment of all sex offenders or histori- Use of strength during sex offending 1 cal “ controls ” from facility archives. In actuarially Male victim 2 based evaluations, the actual recidivism rates of Age 30 at liberation 1 treated subjects are compared with the expected Brain dysfunction 2 recidivism rates form actuarial risk assessment instru- Previous psychiatric history 1 ments. This could be used when all subjects enter Sex offending as outpatient 1 treatment. Sex offending within institution 1 Another major diffi culty is the identifi cation of Previous treatment failure 2 standardized and reliable measures of sexual behav- However, Maletzki concluded that clinical judge- iour. Sex offenders’ self-reports of their sexual activity ment must remain the fi rst criteria for treatment and arrest records reports are usually used, but they choice in case of sex offending. do not constitute reliable indices of conventional or WFSBP Treatment guidelines of Paraphilias 645 paraphiliac sexual behaviour. In addition, the defi ni- effi cacy of adequate treatment of the psychiatric dis- tion of recidivism is often different from one study to ease in order to control paraphiliac behaviour. How- another. In the same way, the validity and reliability of ever antiandrogen treatment may increase psychotic the evaluation of sexual response via penile plethys- symptoms if any. mography which measures penile erectile responses to Reduced libido seems to make some offenders various visual or auditory erotic stimuli in a laboratory, more responsive to psychotherapy (Murray 2000). are still a subject of debate. In any case, plethysmog- Pharmacological interventions should be part of a raphy should be used to predict further sex offences more comprehensive treatment plan including psy- or to make a diagnosis. Moreover, various types of sex chotherapy and, in most cases, behaviour therapy. offenders are included in the same studies and makes it diffi cult to draw defi nite conclusions owing to the great heterogeneity of the samples of patients. Dura- Pharmacological interventions include tion of follow-up periods is another source of variabil- ity among studies, long durations of follow-up being necessary to estimate the rates of recidivism. SSRIs Until now, there are no pharmacological studies SSRIs are useful in paraphilias associated with obses- conducted in sexual murderers and, in women, only sive-compulsive disorders, impulse control disorders, few case reports were described. or depressive disorders. Some paraphiliacs clearly suf- National or international collaborative studies fer from an inability to resist their sexual urges, which including large cohorts of well-defi ned paraphiliacs has a strong compulsive element and often causes with long durations of follow-up are clearly needed considerable subjective distress. SSRIs can be effec- to confi rm these preliminary data, reporting the tive in these cases, which are usually not associated effi cacy of pharmacological treatments in paraphilias. with dangerous sex offending, especially in pure exhi- It would be also informative for future research to bitionists. The dosage must be increased to the dos- include a focus on all sex offenders including women ages used in obsessive compulsive disorders in case of and juveniles. insuffi ciency or lack of effi cacy of usual dosage.

Hormonal treatments Based on the state of the art, we may propose the following guidelines: Not every sex offender is a candidate for hormonal treatment, even if it has the benefi t of being reversible The aims of the treatment of paraphilias are: once discontinued. For paraphilias characterized by intense and frequent deviant sexual desire and arousal, (1) to control paraphiliac fantasies and behav- which highly predispose the patient to severe paraphil- iours in order to decrease the risk of recidi- iac behaviour (such as paedophilia or serial rapes), a vism; hormonal intervention may be needed. The diagnosis (2) to control sexual urges; of paraphilia must be carefully established and clinical (3) to decrease the level of distress of the para- characteristics of the patients listed (see section 2.4). philiac subject. Antilibidinal drugs may also be used in the treatment of sex offenders with mental retardation or cognitive In addition to psychological and behavioural thera- dysfunctions. This has to be discussed with the patient’ s pies, several pharmacological treatment options are family or caregivers (Cooper 1995; Sherak 2000). available. The treatment choice will essentially Antiandrogens or GnRH analogues have to be depend on: prescribed by a physician, after appropriate medical assessment. ■ the patient’ s previous medical history, Recommended clinical assessment of men before ■ the patient’ s observance, the start of androgen deprivation therapy and during ■ the intensity of paraphiliac sexual fantasies, follow-up: ■ the risk of sexual violence.

In all cases, treatment of comorbidities is neces- Risk assessment before the initiation of hormonal sary if any. In case of psychiatric comorbidities, treatment: pharmacological treatment such as , physical examination; weight and blood pres- antipsychotics, SSRIs or specifi c types of psychother- sure measurements; electrocardiogram; testos- apy or behavioural therapy must be used. Hormonal terone, testosterone-binding protein, LH, FSH treatment may be co-prescribed in case of lack of and prolactine blood levels; hepatocellular and 646 F. Thibaut et al.

Table V. Algorithm of pharmacological treatment of paraphilias.

LEVEL 1

• Aim: control of paraphiliac sexual fantasies, compulsions • Psychotherapy (preferentially cognitive behavioural therapy and behaviours without impact on conventional sexual if available (Level C), no level of evidence for other forms activity and on sexual desire of psychotherapy)

LEVEL 2

• Aim: control of paraphiliac sexual fantasies, compulsions • SSRIs: increase the dosage at the same level as prescribed and behaviours with minor impact on conventional sexual in OCD (e.g., fl uoxetine 40–60 mg/day or paroxetine 40 activity and on sexual desire mg/day (Level C) • May be used in all mild cases (“ off” paraphilias with low risk of sexual violence, i.e. exhibitionism without any risk of rape or paedophilia) • No satisfactory results at level 1

LEVEL 3

• Aim: control of paraphiliac sexual fantasies, compulsions • Add a low dose antiandrogen (e.g., cyproterone acetate and behaviours with a moderate reduction of conventional 50–100 mg/day) to SSRIs (Level D) sexual activity and sexual desire • ‘Hands on’ paraphilias with fondling but without penetration • Paraphiliac sexual fantasies without sexual sadism • No satisfactory results at level 2 after 4–6 weeks of SSRIs at high dosages

LEVEL 4

• Aim: control of paraphiliac sexual fantasies, compulsions • First choice: full dosage of cyproterone acetate (CPA): and behaviours with a substantial reduction of sexual oral, 200–300 mg/day or i.m. 200–400 mg once weekly or activity and desire every 2 weeks; or use medroxyprogesterone acetate: • Moderate and high risk of sexual violence (severe 50–300 mg/day if CPA is not available (Level C) paraphilias with more intrusive fondling with limited • If co-morbidity with anxiety, depressive or obsessive number of victims) compulsive symptoms, SSRI’s might be associated with cyproterone acetate

• No sexual sadism fantasies and/or behaviour (if present: go to level 5) • Compliant patient, if not: use i.m. form or go to level 5 • No satisfactory results at level 3

LEVEL 5

• Aim: control of paraphiliac sexual fantasies, compulsions • Long acting GnRH agonists, i.e. triptorelin or leuprolide and behaviours with an almost complete suppression of acetate 3 mg/month or 11,25 mg i.m. every 3 months sexual desire and activity (Level C) • High risk of sexual violence and severe paraphilias • Testosterone levels measurements may be easily used to • Sexual sadism fantasies and/or behaviour or physical control the GnRH agonist treatment observance if violence necessary • No compliance or no satisfactory results at level 4 • Cyproterone acetate may be associated with GnRH agonist treatment (one week before and during the fi rst month of GNRHa) to prevent a fl are up effect and to control the relapse risk of deviant sexual behaviour associated with the fl are up effect

LEVEL 6

• Aim: control of paraphiliac sexual fantasies, compulsions • Use antiandrogen treatment, i.e. cyproterone acetate and behaviours with a complete suppression of sexual (50–200 mg/day per os or 200–400 mg once weekly or desire and activity every 2 weeks i.m.) or, medroxyprogesterone acetate • Most severe paraphilias (catastrophic cases) (300–500 mg/week i.m if CPA not available) in addition to • No satisfactory results at level 5 GnRH agonists (Level D) • SSRIs may also be added (No level of evidence) WFSBP Treatment guidelines of Paraphilias 647

renal functions evaluation; fasting blood glucose intensity and frequency of sexual arousal but do not levels; lipid profi le; blood count; calcium and change the content of paraphilias. In spite of their phosphate plasma levels; effi cacy, MPA and CPA treatments are associated previous history of thromboembolism (CPA or with a high percentage of side effects which have MPA), hepatic disease (CPA), liver carcinoma considerably limited their use, especially for MPA (CPA), tuberculosis (CPA), diabetis (CPA or in Europe. In addition, uncontrolled breaks in the MPA), cachexia (CPA), epilepsy (CPA), psy- therapy are often observed with oral CPA or MPA chosis (CPA), adrenal disease (CPA or MPA), treatments. In contrast, long-acting GnRH analogues severe renal disease, severe hypertension, severe are more potent than CPA or MPA. Moreover, they osteoporosis, prior fractures or cardiovascular induce fewer side effects, except for those related to events, family history of osteoporosis and car- hypoandrogenism. Long-acting GnRH analogues diovascular disease, active pituitary pathology, may be administered parentally once every 1– 3 severe chronic depressive disorder or allergy to months. GnRH analogue treatment probably consti- hormonal treatment, alcohol and tobacco con- tutes the most promising treatment for sex offenders sumption must be assessed through interview of at high risk of sexual violence, such as paedophiles each candidate for hormonal treatment; or serial rapists. In spite of these new treatments, in case of personal or familial osteoporosis risk which induce chemically reversible castration, in sev- or in patients over 50 year-old, baseline bone eral states of the United States and in some countries mineral density must be checked by using in Europe surgical castration is still allowed in place osteodensitometry; of chemical castration for repeat child molesters. antiandrogen treatment must not be used in When properly administered, with an appropriate case of: non-consent, puberty not completed protocol in place to detect and treat side effects especially when bone growth is not achieved. should they develop, antiandrogen therapy in general constitutes no more or less of a risk than most other Informed consent must be obtained. forms of frequently prescribed psychopharmaco- logical agents (Berlin 2009). Medical survey is necessary during hormonal There is a risk that patients could antagonize treatment: their GnRH agonist treatment with testosterone supplementation but we could not fi nd data in the paraphiliac and non-paraphiliac sexual activity existing literature about this risk. If there is any and fantasies (nature, intensity and frequency) doubt, testosterone levels should be checked. and the risk of sex offence must be evaluated However, hormonal agents cannot be easily used in during the interview at least every 1– 3 months the treatment of juvenile sex offenders owing to pos- through self reports of the patient; sible interference with the development or course of every 3– 6 months, blood pressure, weight, must puberty (bone growth must be achieved and should be controlled (plus blood cell counts, hepatocel- be checked using X-rays). In juvenile sex offenders, lular functions if CPA is used); depression, emo- behavioural therapy and SSRIs are the fi rst choice tional disturbances; risk of feminisation must be treatment (see section 3.3 on SSRIs). Bradford and evaluated; Fedoroff (2006) recommended SSRIs prescription in every 6 months, fasting blood glucose levels, mild paraphilias, in paraphiliac juveniles, in cases that lipid profi le; calcium and phosphate levels must have comorbidity with OCD and depression and in be controlled; maintenance treatment. Antiandrogens might be used every 2 years (or every year, if increased risk of in case of high risk of sexual violence but only if osteoporosis or if the patient is over 50 years puberty is achieved, especially bone maturation. old), bone mineral density must be checked using osteodensitometry. Calcium, vitamin D or This algorithm distinguishes six levels of biphosphonates must be prescribed in case of treatment for different categories of osteoporosis; paraphilias (see Table V) testosterone blood levels could be checked in case of risk of breaks in the therapy or in case of Psychotherapy is used in all offenders (in most cases risk of masked testosterone supplementation. behavioural therapy is preferred). In paraphilic subjects at high risk of reoffending, pharmacological treatment These hormonal treatments should be used after should be used as fi rst line treatment. The combination other alternatives have been ruled out or when of psychotherapy and pharmacological therapy is there is a high risk of sexual violence. Antiandro- associated with better effi cacy compared with either gens or GnRH analogues signifi cantly reduce the treatment as monotherapy (Hall and Hall 2007). 648 F. Thibaut et al.

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