Efficacy of prescribed injectable diacetylmorphine in the Andalusian trial: Bayesian analysis of responders and non-responders according to a multi domain outcome index

doi:10.1186/1745-6215-10-70

Trials

Volume 10

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Perea-Milla E
Ayçaguer LC
Cerdà JC
Saiz FG
Rivas-Ruiz F
Danet A
Vallecillo MR
Oviedo-Joekes E

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Perea-Milla E
Ayçaguer LC
Cerdà JC
Saiz FG
Rivas-Ruiz F
Danet A
Vallecillo MR
Oviedo-Joekes E
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Research

Efficacy of prescribed injectable diacetylmorphine in the Andalusian trial: Bayesian analysis of responders and non-responders according to a multi domain outcome index

Emilio Perea-Milla¹^,2 , Luis Carlos Silva Ayçaguer³ , Joan Carles March Cerdà²^,4 , Francisco González Saiz⁵ , Francisco Rivas-Ruiz¹^,2 , Alina Danet²^,4 , Manuel Romero Vallecillo²^,4 and Eugenia Oviedo-Joekes⁶

¹Research Support Unit, Hospital Costa del Sol, Ctra Nacional 340, km 187, 29603 Marbella, Spain

²CIBER Epidemiología y Salud Pública (CIBERESP), Spain

³National Center for Medical Science Information (INFOMED), 27 St N#110. Vedado, 10400 Ciudad de la Habana, Cuba

⁴Andalusian School of Public Health, Campus Universitario de Cartuja, Cuesta del Observatorio 4, Apartado 2070, 18080, Granada, Spain

⁵Andalusian Foundation for Drug Abuse Attendance (FADA), Avda. Hytasa Edf. Toledo II Planta 2 Oficina 3, 41006, Seville, Spain

⁶School of Population and Public Health, University of British Columbia & Centre for Health Evaluations and Outcomes, Providence Health Care, Vancouver, BC, Canada

author email corresponding author email

Trials 2009, 10:70doi:10.1186/1745-6215-10-70


Published:	14 August 2009

Abstract

Background

The objective of this research was to evaluate data from a randomized clinical trial that tested injectable diacetylmorphine (DAM) and oral methadone (MMT) for substitution treatment, using a multi-domain dichotomous index, with a Bayesian approach.

Methods

Sixty two long-term, socially-excluded heroin injectors, not benefiting from available treatments were randomized to receive either DAM or MMT for 9 months in Granada, Spain. Completers were 44 and data at the end of the study period was obtained for 50. Participants were determined to be responders or non responders using a multi-domain outcome index accounting for their physical and mental health and psychosocial integration, used in a previous trial. Data was analyzed with Bayesian methods, using information from a similar study conducted in The Netherlands to select a priori distributions. On adding the data from the present study to update the a priori information, the distribution of the difference in response rates were obtained and used to build credibility intervals and relevant probability computations.

Results

In the experimental group (n = 27), the rate of responders to treatment was 70.4% (95% CI 53.2-87.6), and in the control group (n = 23), it was 34.8% (95% CI 15.3-54.3). The probability of success in the experimental group using the a posteriori distributions was higher after a proper sensitivity analysis. Almost the whole distribution of the rates difference (the one for diacetylmorphine minus methadone) was located to the right of the zero, indicating the superiority of the experimental treatment.

Conclusion

The present analysis suggests a clinical superiority of injectable diacetylmorphine compared to oral methadone in the treatment of severely affected heroin injectors not benefiting sufficiently from the available treatments.

Trial Registration

Current Controlled Trials ISRCTN52023186