Randomised trials relevant to mental health conducted in low and middle-income countries: a survey.

Rebecca J Syed Sheriff,Mahesh Jayaram,Prathap Tharyan,Lelia Duley,Clive E Adams,Practihc Mental Health Group

doi:10.1186/1471-244x-8-69

Abstract

BackgroundA substantial proportion of the psychiatric burden of disease falls on the world's poorest nations, yet relatively little is known about randomised trials conducted in these countries. Our aim was to identify and describe a representative sample of mental health trials from low and middle-income countries.Methods6107 electronic records, most with full text copies, were available following extensive searches for randomised or potentially randomised trials from low and middle-income countries published in 1991, 1995 and 2000. These records were searched to identify studies relevant to mental health. Data on study characteristics were extracted from the full text copies.ResultsTrials relevant to mental health were reported in only 3% of the records. 176 records reporting 177 trials were identified: 25 were published in 1991, 45 in 1995, and 106 in 2000. Participants from China were represented in 46% of trials described. 68% of trials had <100 participants. The method of sequence generation was described in less than 20% of reports and adequate concealment of allocation was described in only 12% of reports. Participants were most frequently adults with unipolar depression (36/177) or schizophrenia (36/177). 80% of studies evaluated pharmacological interventions, a third of which were not listed by WHO as essential drugs. 41% of reports were indexed on PubMed; this proportion decreased from 68% in 1991 to 32% in 2000.ConclusionIn terms of overall health burden, trial research activity from low and middle-income countries in mental health appears to be low, and in no area adequately reflects need.

Highlights

A substantial proportion of the psychiatric burden of disease falls on the world's poorest nations, yet relatively little is known about randomised trials conducted in these countries
For 10% of the records not identified as being relevant to mental health by the electronic search, full text copies were checked to assess whether this was truly the case
Of the 5838 records not identified as being potentially relevant to mental health by electronic searching, full reports of 587 records in English, 380 in Spanish or Portuguese and 144 in Russian, Ukrainian or Romanian were hand searched to check if this was truly the case

Summary

Introduction

A substantial proportion of the psychiatric burden of disease falls on the world's poorest nations, yet relatively little is known about randomised trials conducted in these countries. Our aim was to identify and describe a representative sample of mental health trials from low and middle-income countries. Most of the global burden of mental illness falls to the poorest nations, where 80% of world's population live [1]. On average low and middle-income countries devote less than 1% of their health expenditure to mental health and have poorly developed mental health policies and legislation. Randomised trials are the gold-standard for evaluation of care, and systematic reviews of randomised trials increasingly provide the basis for health care practice and policy. Most trials are conducted in highincome countries [3]. The interventions assessed may be unaffordable, unavailable or inappropriate for people in other cultures and settings [4]

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