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Redalyc.Oral Fluphenazine Versus Placebo for Schizophrenia

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Redalyc.Oral Fluphenazine Versus Placebo for Schizophrenia Revista Colombiana de Psiquiatría ISSN: 0034-7450 [email protected] Asociación Colombiana de Psiquiatría Colombia El-Din Matar, Hosam; Qutayba Almerie, Muhammad; Giraldo, Ana María; Adams, Clive E. Oral fluphenazine versus placebo for schizophrenia: a Cochrane systematic review of 40 years of randomised controlled trials Revista Colombiana de Psiquiatría, vol. XXXVI, núm. 1, 2007, pp. 8-17 Asociación Colombiana de Psiquiatría Bogotá, D.C., Colombia Available in: http://www.redalyc.org/articulo.oa?id=80636102 How to cite Complete issue Scientific Information System More information about this article Network of Scientific Journals from Latin America, the Caribbean, Spain and Portugal Journal's homepage in redalyc.org Non-profit academic project, developed under the open access initiative Artículoso r i g i n a l e s Oral fluphenazine versus placebo for schizophrenia: a Cochrane systematic review of 40 years of randomised controlled trials Hosam El-Din Matar1 Muhammad Qutayba Almerie1 Ana María Giraldo2 Clive E. Adams3 Abstract: Background: Fluphenazine, one of only three antipsychotics on WHO’s list of essential drugs, has been widely available for five decades. Quantitative reviews of its effects compared with placebo are rare and out of date. Methods: We searched for all relevant randomised controlled trials comparing oral administration of fluphenazine with placebo on the Cochrane Schizo- phrenia Group’s register of trials (October 2006) and in reference lists of included studies. Data were extracted from reliably selected trials. Where possible, we calculated fixed effects relative risk (RR), the number needed to treat (NNT), and their 95% confidence intervals (CI). Results: We found over 1200 electronic records for 415 studies. Ninety papers were acqui- red; 59 were excluded and the remainder were reports of the seven trials we could include (total participants=349). Compared with placebo, in the short-term, global state outcomes for ‘not improved’ were not significantly different (n=75, 2 RCTs, RR 0.71 CI 0.5 to 1.1). There is evidence that oral fluphenazine, in the short term, increases a person’s chances of experiencing extrapyramidal effects such as akathisia (n=227, 2 RCTs, RR 3.43 CI 1.2 to 9.6, NNH 13 CI 4 to 128) and rigidity (n=227, 2 RCTs, RR 3.54 CI 1.8 to 7.1, NNH 6 CI 3 to 17). We found study attrition to be lower in the oral fluphenazine group, but data were not statistically significant (n=227, 2 RCTs, RR 0.70 CI 0.4 to 1.1). Conclusions: Fluphenazine is an imperfect treatment with surprisingly few data from trials to support its use. If acces- sible, other inexpensive drugs, less associated with adverse effects, may be a better choice for people with schizophrenia. It is time for the World Health Organisation to revise their list of essential antipsychotic drugs. Key words: Fluphenazine, schizophrenia, antipsychotics. Título: Flufenazina oral vs. placebo, en el tratamiento de la esquizofrenia. Una revisión sistemática de Cochrane de 40 años de estudios controlados aleatorizados. 1 Medical Student, Faculty of Medicine, Damascus University, Syria. 2 Medical Student, Pontificia Universidad Javeriana, Bogotá. 3 Cochrane Schizophrenia Group, Academic Unit of Psychiatry and Behavioural Sciences, University of Leeds, UK. 8 Revista Colombiana de Psiquiatría, vol. XXXVI / No. 1 / 2007 Oral fluphenazine versus placebo for schizophrenia: a Cochrane systematic review of 40 years... Resumen people with schizophrenia (1). They are generally regarded as highly Introducción: La flufenazina, uno de los tres antipsicóticos de la lista de drogas esencia- effective, especially in controlling les de la OMS, está disponible desde hace 5 symptoms such as hallucinations décadas. Las revisiones cuantitativas de sus and fixed false beliefs (delusions) efectos vs. placebo son escasas y desactuali- (2). Fluphenazine, a phenothiazine zadas. Método: Buscamos estudios controla- dos aleatorizados relevantes que compararan derivative, is one of the first drugs la administración de flufenazina oral contra to be classed as an ‘antipsychotic’. placebo, en los registros de ensayos de los Reports from 1959 and 1960 first grupos de esquizofrenia de Cochrane (oct. indicate its value in psychotic ill- 2006) y en referencias incluidas en los estu- ness (3-4) and it was approved for dios. Los estudios consistentes y confiables muestran datos de ensayos clínicos aleatori- clinical use in the USA in 1959. zados (ECA). Calculamos el RR mediante un Fluphenazine is thought to eli- modelo de efectos fijos, el número necesario cit its antipsychotic effects via inter- por tratar (NNT) y su intervalo de confianza ference with central dopaminergic de 95%. Resultados: En flufenazina vs. pla- cebo, a corto plazo, el resultado “no mejoría” pathways and blocking receptors, no fue muy diferente (n=75, 2 ECA, RR 0,71, particularly D2, in the mesolimbic IC 0,5 a 1,1). La flufenazina oral, a corto zone of the brain (5). Extrapyra- plazo, aumenta el riesgo de manifestaciones midal side effects are a result of extrapiramidales, como la acatisia (n=227, interaction with dopaminergic 2 ECA, RR 3,43, IC 1,2 a 9,6, NNT 13, IC 4 a 128) y rigidez (n=227, 2 ECA, RR 3,54, IC pathways in the basal ganglia. As 1,8 a 7,1, NNT 6, IC 3 a 17). La deserción fue fluphenazine is not specific to one más baja en el grupo de la flufenazina oral, action within the body it is known pero los datos no fueron estadísticamente to cause adverse effects ranging significativos (n=227, 2 ECA, RR 0,70 CI 0,4 a 1,1). Conclusión: La flufenazina es un from orthostatic hypotension as a tratamiento imperfecto con muy pocos datos result of its alpha adrenergic bloc- que sustenten su uso. Otras drogas de bajo king activity to anticholinergic and costo y pocos efectos adversos pueden ser extrapyramidal symptoms (tardive mejor opción para pacientes psicóticos. La dyskinesia, pseudo-parkinsonism, OMS debe revisar su lista de antipsicóticos esenciales. dystonia, dyskinesia, akathesia) (6). In addition, the use of fluphenazine Palabras clave: flufenazina, esquizofrenia, has been associated with a poten- antipsicóticos. tially fatal disturbance of blood pressure, temperature and muscle Background control (neuroleptic malignant syn- drome)(7) . Overall, the antipsychotic drugs, Fluphenazine is still commonly with their anti-dopaminergic effects, used for people with schizophre- are the mainstay treatment for nia and is given by mouth or by Revista Colombiana de Psiquiatría, vol. XXXVI / No. 1 / 2007 9 El-Din Matar H., Almerie MQ., Giraldo A., Adams C. short-acting injection. Although ridin* or mirenil*) in title, abstract we have not found precise data on and index fields in REFERENCE) or world wide use, fluphenazine, along (fluphenazin* in interventions field with only two other antipsychotics in STUDY)) (chlorpromazine and haloperidol) is This register is compiled by re- on the World Health Organization’s gular, systematic, searches of major list of essential drugs (8). In low and bibliographic databases, hand sear- middle income countries, where ches and conference proceedings. non-proprietary preparations of flu- A full description is given in the phenazine are inexpensive, it may Group’s module on the Cochrane be one of the only drug treatments Library (http://www.cochrane.org/ available. We, however, know of no contact/entities.htm#CRGLIST). In up-to-date systematic reviews of the addition, the references of all identi- absolute effects of this ‘essential’ fied studies were inspected for more antipsychotic. studies. Methods Data extraction and study appraisal All electronic records identified Inclusion criteria were independently inspected by The inclusion criteria were de- HEM and MQM, who then obtained fined and disseminated for peer re- full reports of studies of agreed rele- view within a Cochrane protocol (9). vance. We assessed the methodolo- We included articles if they reported gical quality of included trials using randomized controlled trials where criteria described in the Cochrane participants had schizophrenia or Handbook (10). These criteria are non-affective serious/chronic men- based on the evidence of a strong tal illness, and where the interven- relationship between allocation con- tions included oral administration cealment and direction of effect (11). of fluphenazine (any dose) versus Data relating to methods, partici- placebo or no treatment. pants, interventions and outcomes, were extracted and disagreement Identification of relevant trials discussed and documented. We identified relevant randomi- sed trials by searching the Cochrane Statistical methods Schizophrenia Group’s Register of trials (Oct 2006) using the phrase: Dichotomous and continuous (((fluphen* or flufen* or modec* data were not used if over half of or moditen* or eutimax* or prolixin* those randomised were not con- or siqualon* or anaten* or dapotum* tributing to the outcome due to or decazate* or decafen* or decen- early attrition from the study or tan* or fludecate* or lyogen* or lyo- non-compliance. Dichotomous data 10 Revista Colombiana de Psiquiatría, vol. XXXVI / No. 1 / 2007 Oral fluphenazine versus placebo for schizophrenia: a Cochrane systematic review of 40 years... were combined using fixed effects way as to make the outcomes unin- Relative Risk (RR) (12). Numbers telligible or impossible to use. needed to treat (NNT) (13) were also calculated and I-square tests Study quality for heterogeneity were performed All seven included studies either (14). Where less than 50% of people reported use of random allocation or were lost to follow-up at the end of a suggested it; one study reported the trial, ‘worst case’ intention-to-treat process used as the groups were analyses were undertaken by assu- matched on age, chronicity and ming that those who had left a trial severity of illness (16). Citations to early had had a poor outcome. The all included and excluded studies sensitivity of the final results to this are available in the full Cochrane assumption was tested. Continuous Review (10), otherwise the names data were excluded if derived from and dates cited in this text relate scales of unknown validity and if to Table 1.
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