Sheriff Rebecca J Syed, Adams Clive E, Tharyan Prathap, Jayaram Mahesh, Duley Lelia
Unidad Epidemiologia Clinica, Hospital San Ignacio, Santafe de Bogota, Colombia.
BMC Psychiatry. 2008 Aug 14;8:69. doi: 10.1186/1471-244X-8-69.
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.
6107 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.
Trials 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.
In 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.
相当一部分精神疾病负担落在世界上最贫穷的国家，但对在这些国家开展的随机试验了解相对较少。我们的目的是识别并描述来自低收入和中等收入国家的具有代表性的心理健康试验样本。
在广泛检索1991年、1995年和2000年发表的来自低收入和中等收入国家的随机或潜在随机试验后，获得了6107份电子记录，其中大多数带有全文副本。对这些记录进行检索以识别与心理健康相关的研究。从全文副本中提取研究特征数据。
仅3%的记录报告了与心理健康相关的试验。识别出176份记录报告了177项试验：25项于1991年发表，45项于1995年发表，106项于2000年发表。在描述的试验中，46%有来自中国的参与者。68%的试验参与者少于100人。不到20%的报告描述了序列产生方法，仅12%的报告描述了充分的分配隐藏。参与者最常见的是患有单相抑郁症（36/177）或精神分裂症（36/177）的成年人。80%的研究评估了药物干预，其中三分之一未被世界卫生组织列为基本药物。41%的报告被收录在PubMed上；这一比例从1991年的68%降至2000年的32%。
就总体健康负担而言，低收入和中等收入国家在心理健康方面的试验研究活动似乎较少，且在任何领域都未充分反映需求。
