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Double-Blind, Placebo-Controlled Safety and Ef®Cacy Trial with Yohimbine Hydrochloride in the Treatment of Nonorganic Erectile Dysfunction

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Double-Blind, Placebo-Controlled Safety and Ef®Cacy Trial with Yohimbine Hydrochloride in the Treatment of Nonorganic Erectile Dysfunction International Journal of Impotence Research (1997) 9, 155±161 ß 1997 Stockton Press All rights reserved 0955-9930/97 $12.00 Double-blind, placebo-controlled safety and ef®cacy trial with yohimbine hydrochloride in the treatment of nonorganic erectile dysfunction H-J Vogt1, P Brandl1, G. Kockott2, JR Schmitz2, MH Wiegand2, J Schadrack3 and M Gierend3 1 Dermatologische Klinik und Poliklinik; 2 Psychiatrische Klinik und Poliklinik, Technische UniversitaÈtMuÈnchen, Munich, Germany; and 3 Medicomp Gesellschaft fuÈr Versuchsplanung und Datenanalyse mbH, Ulm, Germany This double-blind, placebo-controlled clinical trial of yohimbine hydrochloride included 86 patients with erectile dysfunction and without clearly detectable organic or psychologic causes. The patient group ful®lled all entry criteria; 85 of these could be considered for the Safety- respectively 83 for the Intention-to-treat (ITT)-analysis. Yohimbine was administered orally in a dosage of 30mg a day (two 5mg tablets three times daily) for eight weeks. Patients were seen for follow-up after four weeks' treatment, and for a ®nal visit after eight weeks. Ef®cacy evaluation was based on both subjective and objective criteria. Subjective criteria included improvement in sexual desire, sexual satisfaction, frequency of sexual contacts, and quality of erection (penile rigidity) during sexual contact/intercourse. Objective criteria of outcome were based on improvement in penile rigidity determined by use of polysomnography in the sleep laboratory. Overall Yohimbine was found signi®cantly more effective than placebo in terms of response rate: 71 vs 45%. Yohimbine was well-tolerated: Only 7% of patients rated tolerability fair or poor, and most adverse experiences were mild. There was no serious adverse event. Keywords: yohimbine hydrochloride; erectile dysfunction; nocturnal penile tumescence (NPT); polysomnography; clinical trial Introduction gic receptor blocker with some loss of selectivity in higher doses. The drug has been used in numerous in vitro receptor binding studies.3±5 Moreover a large Erectile dysfunction affects at least 1±2% of the number of in vivo pharmacology studies are avail- male population and possibly up to 9%, according able to identify three major sites of action: (1) central to Spector and Carey.1 It is a serious problem for action in various regions of the central nervous many patients and therapeutic options that are system (CNS), where yohimbine blocks cerebral a2- convenient, safe, and effective are desirable. Oral adrenergic receptors, increasing norepinephrine treatment of erectile dysfunction with yohimbine release and turnover; (2) direct peripheral action hydrochloride, an a2-adrenergic receptor blocker, through modulation of autonomic nervous system has been the focus of persistent medical interest. (ANS) tone via presynaptic autoinhibitory a2 recep- Yohimbine is an indol alkaloid derived from the tors; (3) direct action on penile tissues and vascular bark of Corynanthe johimbe, a tree indigenous to smooth muscle cells, blocking postsynaptic vaso- Central Africa. It has been used for more than a constrictor a2 receptors. century in treatment of libido and erectile disorders. Although the mode of action of yohimbine As a nonstandardized whole or bark extract, yohim- suggests its effect may not be con®ned to erections bine was usually one ingredient in various com- while awake, clear evidence to support this assump- pounds and preparations. Once yohimbine was tion is still lacking. It was among the aims of the identi®ed as the main active constituent, puri®ed present study to include NPT measurements as a and standardized drug became available. Borelli2 possible additional indicator of the effect of yohim- considered it the prime aphrodisiac in terms of bine on erectile dysfunction. quality of medical documentation and clinical The clinical use of yohimbine has been docu- utility. mented by several open studies and anecdotal Yohimbine is a selective competitive a2-adrener- reports as well as by ®ve double-blind placebo- controlled trials6±10 conducted between 1987 and Correspondence: Dr H-J Vogt. 1990. Patients received daily oral doses of 16.2± Received 18 December 1996; accepted 28 December 1996 43.2mg for 4±10 weeks. While varied in design and Treatment of nonorganic erectile dysfunction H-J Vogt et al 156 outcome, all of these studies consistently indicated group (range, 28±71). The patients in the yohimbine a trend for improved erectile function with yohim- group were slightly shorter (176.5 vs 178.1cm) and bine [for a review see KoÈhler et al11; for meta- weighed slightly less (80.3 vs 82.3kg) than those of analytic considerations see Carey and Johnson12]. the placebo group. Other main characteristics of the Given the above considerations, and since pre- study population are summarized in Table 2. vious studies had focused on subjective aspects Blood counts, blood glucose, erythrocyte sedi- known to be exceedingly dependent on the patient's mentation rate, [serum] creatinine, liver enzymes, momentary suffering, the present clinical trial was urinalysis, and TPHA showed no deviations from designed to evaluate the ef®cacy of yohimbine in normal. The testosterone assay showed slightly terms of both objective and subjective variables. higher mean [serum] concentrations in the yohim- This study also aimed to establish the safety and bine group (14.88nmol/L) than in the placebo group tolerability pro®le of daily dosing with yohimbine (12.81nmol/L). Mean baseline luteinizing hormone over an eight week period of therapy. (LH) levels were essentially identical in the two groups. Nonetheless, all values including those determined for prolactin were within a normal Methods range. Psychiatric/psychologic evaluation using a de- pressive disorder evaluation questionnaire13 re- Subjects vealed evidence of mild paranoid or depressive ideation (yet without clinical signi®cance) in three yohimbine-treated patients (7.3%) and in one The target population consisted of men aged 18 and patient assigned to the placebo group (2.4%), and up suffering from erectile dysfunction. Criteria for evidence of a history of affective disorders (with no exclusion were: absence of sexual partner; severe current signi®cance) in two patients of the yohim- organic diseases such as severe heart disease, genital bine group. injury or serious intercurrent diseases; severe men- In both groups the baseline mean scores of a tal disease (for example depression); severe emo- Partnership Questionnaire14 and Insecurity in Socio- tional disturbances such as severe partner discord or sexual Situations Questionnaire15 showed no sig- overwhelming fear of sexual incompetence; severe ni®cant deviations from normal (Partnership sleep disorder; known allergy or hypersensitivity to Questionnaire: normal score, 64.9; yohimbine yohimbine; alcohol or drug abuse; participation in group, 59.6; placebo group, 59.0; Insecurity in another clinical trial within the last 30d; expected Sociosexual Situations Questionnaire: normal score, lack of cooperation and failure to give informed 21.64; patients with sexual disorders due to psycho- consent. genic factors: 46.53; yohimbine group, 29.3; placebo A total of 309 patients presented with erection group, 27.6). This con®rms that no patients with inadequacy at the Male Sexual Disorders Clinic of disinterest in sexual partner/marital discord or Dermatologische Klinik und Poliklinik, Technische clearly psychogenic sexual disorders had been UniversitaÈt MuÈ nchen, Munich, Germany, between included. 1993 and mid-1995. Out of the 309 patients 86 men were quali®ed for the trial, 223 patients with erectile impotence were screened and excluded for various Procedure reasons (see Table 1). All patients gave informed consent in writing prior to study entry. The study received institutional approval by the Ethics' Re- After the screening interview, patients were pro- view Board. vided with a diary to be completed and returned at Mean age of the study population was 53.9y for the time of the entry visit. After a thorough history the yohimbine group and 51.3y for the placebo and physical examination, subjects underwent a Table 1 Reasons for exclusion from the trial Primary reason for exclusion No. of patients Poor Compliance (for example no interest, too much hassle) 34 (15.3%) Criterion for Exclusion (for example no sexual partner, already takes yohimbine, 35 (15.7%) participates in another trial, currently receives psychotherapy) Disinterest in sexual partner/marital discord 19 (8.5%) Erectile dysfunction due to mental disorder 42 (18.8%) Erectile dysfunction due to organic cause (for example anorchism, prolactinoma, prostate cancer) 38 (17.1%) Severe serious concomitant disease or need for unacceptable comedication 55 (24.6%) Total exclusions (223 of 309 patients) 223 (100.0%) Treatment of nonorganic erectile dysfunction H-J Vogt et al 157 Table 2 Baseline demographics/population characteristics Yohimbine hydrochloride Placebo (n 41) (n 42) Impotence Loss of erection 41 (100.0%) 42 (100.0%) Loss of desire 3 (7.3%) 2 (4.8%) Absence of orgasm 1 (2.4%) 1 (2.4%) Absence of emission Ð 4 (9.5%) Prior treatment for erectile inadequacy None 32 (78.0%) 27 (64.3%) Androgens 4 (9.8%) 4 (9.5%) Vitamin E Ð 1 (2.4%) Yohimbine 2 (4.9%) 3 (7.1%) Cavernous body auto-injection therapy Ð 1 (2.4%) Suppositories 1 (2.4%) Ð Unknown 2 (4.9%) 5 (11.9%) Patients with prior psychotherapy 4 (9.8%) 6 (14.3%) Patients with concomitant diseases 16 (39.0%) 14 (33.3%) Patients with concomitant medications 11 (26.8%) 11 (26.2%) Smokers/exsmokers 23 (56.1%) 23 (54.8%) Sexual partner Spouse 35 (85.4%) 30 (71.4%) Other partner 6 (14.6%) 12 (28.6%) Partner's age (y) Mean 49.6 46.7 s.d. 8.92 9.81 cavernous body injection test using 5±10mg of interfered with erectile function or speci®c study prostaglandine (PGE-1) followed by penile artery procedures (for example sleep quality). Unaccepta- Doppler ultrasonography. Hormonal and serious ble comedications included aphrodisiacs, male sex organic causes were ruled out by a variety of hormones, and other drugs affecting sexual func- laboratory tests.
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