Efficacy of prescribed injectable diacetylmorphine in the Andalusian trial: Bayesian analysis of responders and non-responders according to a multi domain outcome index.
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 53.287.6), and in the control group (n = 23), it was 34.8% (95% CI 15.354.3). 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.


CONCLUSIONS
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.


BACKGROUND
Current Controlled Trials ISRCTN52023186.
Perea-Milla
Emilio
E
Research Support Unit, Hospital Costa del Sol, Ctra Nacional 340, km 187, 29603 Marbella, Spain. eperea@hcs.es
Ayçaguer
Luis Carlos Silva
LC
Cerdà
Joan Carles March
JC
Saiz
Francisco González
FG
Rivas-Ruiz
Francisco
F
Danet
Alina
A
Vallecillo
Manuel Romero
MR
Oviedo-Joekes
Eugenia
E
D000284:Administration, Oral; D001499:Bayes Theorem; D003932:Heroin / Q000008:administration & dosage*; D006556:Heroin Dependence / Q000188:drug therapy*; D006801:Humans; D007267:Injections; D008691:Methadone / Q000008:administration & dosage; D009294:Narcotics / Q000008:administration & dosage*; D016896:Treatment Outcome
D009294:Narcotics; D003932:Heroin; D008691:Methadone
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