1. Efficacy of prescribed injectable diacetylmorphine in the Andalusian trial: Bayesian analysis of responders and non-responders according to a multi domain outcome index
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Francisco González Saiz, Luis Carlos Silva Ayçaguer, Alina Danet Danet, Emilio Perea-Milla, Manuel Romero Vallecillo, Eugenia Oviedo-Joekes, Joan Carles March Cerdá, Francisco Rivas-Ruiz, [Perea-Milla, E, Rivas-Ruiz,F] Research Support Unit, Hospital Costa del Sol, Marbella, Spain. [Perea-Milla,E, March Cerdà,JC, Rivas-Ruiz,F, Danet,A, Romero Vallecillo,M] CIBER Epidemiología y Salud Pública (CIBERESP), Spain. [Silva Ayçaguer,LC] National Center for Medical Science Information (INFOMED), vedado, Ciudad de la Habana,Cuba. [March Cerdà,JC, Romero Vallecillo,M] Andalusian School of Public Health, Campus Universitario de Cartuja, Granada, Spain. [González Saiz,F] Andalusian Foundation for Drug Abuse Attendance (FADA), Seville, Spain. [Oviedo-Joekes,E] School of Population and Public Health, University of British Columbia & Centre for Health Evaluations and Outcomes, Providence Health Care, Vancouver,Canada., and Funded by the Drug Commission, Council for Equality and Social Welfare, Andalusian Government.
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Narcotics ,medicine.medical_specialty ,Bayesian probability ,dependencia de heroína ,Administration, Oral ,Medicine (miscellaneous) ,law.invention ,Heroin ,Injections ,Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings] ,Bayes' theorem ,Diseases::Substance-Related Disorders::Opioid-Related Disorders::Heroin Dependence [Medical Subject Headings] ,Randomized controlled trial ,law ,Internal medicine ,Metadona ,Statistics ,medicine ,Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Statistics as Topic::Probability::Bayes Theorem [Medical Subject Headings] ,Chemicals and Drugs::Chemical Actions and Uses::Pharmacologic Actions::Physiological Effects of Drugs::Central Nervous System Depressants::Narcotics [Medical Subject Headings] ,Chemicals and Drugs::Organic Chemicals::Ketones::Methadone [Medical Subject Headings] ,Humans ,Pharmacology (medical) ,Chemicals and Drugs::Heterocyclic Compounds::Alkaloids::Opiate Alkaloids::Morphinans::Morphine::Morphine Derivatives::Heroin [Medical Subject Headings] ,Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome [Medical Subject Headings] ,lcsh:R5-920 ,Inyecciones ,business.industry ,Heroin Dependence ,Research ,Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Drug Administration Routes::Administration, Oral [Medical Subject Headings] ,Narcoticos ,Diacetylmorphine ,Bayes Theorem ,Andalucía ,Outcome (probability) ,Administración oral ,Treatment Outcome ,Teorema de bayes ,Heroína ,Resultado del tratamiento ,business ,lcsh:Medicine (General) ,Psychosocial ,Methadone ,medicine.drug - 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
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