Patten S B
Alberta Heritage Foundation for Medical Research, University of Calgary.
CMAJ. 1992 Apr 1;146(7):1177-82.
To review published clinical trials comparing the efficacy of trazodone with that of tricyclic antidepressant medication.
MEDLINE was searched for relevant articles published from 1983 to 1991. The bibliography of a review article was searched for further references.
In all, 25 clinical trials were found. Six of these met the methodologic assessment criteria (adapted from the McMaster guidelines for the evaluation of clinical trials), which included the stipulation of a score of 18 or more on the Hamilton depression rating scale and a 50% reduction in that score as an outcome measure.
All six studies compared trazodone with imipramine. Data describing response to the treatments were extracted, and post-hoc power estimates were calculated. The analysis also involved statistical tests of a modified null hypothesis, the generation of confidence intervals (CIs) and a meta-analysis.
All the studies found no significant difference in the efficacy of trazodone and imipramine. However, the statistical power of most of them was less than 50% and often less than 10%; thus there was a low probability that differences would be detected. The results of statistical tests of the modified null hypothesis, inspection of the CIs and the results of the meta-analysis all suggested that trazodone, and imipramine are equally efficacious.
The application of various techniques for the analysis of equivalence data suggests that trazodone and imipramine are of approximately equivalent efficacy. The data are compatible with small differences in efficacy, but the differences are of a magnitude such that they are unlikely to be of clinical significance.
综述已发表的比较曲唑酮与三环类抗抑郁药物疗效的临床试验。
检索MEDLINE数据库中1983年至1991年发表的相关文章。检索一篇综述文章的参考文献以获取更多资料。
共找到25项临床试验。其中六项符合方法学评估标准(改编自麦克马斯特临床试验评估指南),包括汉密尔顿抑郁量表评分规定为18分或更高,且以该评分降低50%作为疗效指标。
所有六项研究均比较了曲唑酮与丙咪嗪。提取描述治疗反应的数据,并计算事后效能估计值。分析还包括对修正无效假设的统计检验、置信区间(CI)的生成以及荟萃分析。
所有研究均发现曲唑酮和丙咪嗪的疗效无显著差异。然而,大多数研究的统计效能低于50%,且常常低于10%;因此检测到差异的可能性较低。修正无效假设的统计检验结果、CI的检查结果以及荟萃分析结果均表明曲唑酮和丙咪嗪疗效相当。
应用各种等效性数据分析技术表明,曲唑酮和丙咪嗪疗效大致相当。数据与疗效上的微小差异相符,但差异程度不太可能具有临床意义。