Department Psychometrics and Statistics, University of Groningen, Groningen, the Netherlands.
Department of Developmental Psychology, University of Groningen, Groningen, the Netherlands.
Psychol Med. 2021 Dec;51(16):2752-2761. doi: 10.1017/S0033291721003950. Epub 2021 Oct 8.
Approval and prescription of psychotropic drugs should be informed by the strength of evidence for efficacy. Using a Bayesian framework, we examined (1) whether psychotropic drugs are supported by substantial evidence (at the time of approval by the Food and Drug Administration), and (2) whether there are systematic differences across drug groups. Data from short-term, placebo-controlled phase II/III clinical trials for 15 antipsychotics, 16 antidepressants for depression, nine antidepressants for anxiety, and 20 drugs for attention deficit hyperactivity disorder (ADHD) were extracted from FDA reviews. Bayesian model-averaged meta-analysis was performed and strength of evidence was quantified (i.e. ). Strength of evidence and trialling varied between drugs. Median evidential strength was extreme for ADHD medication ( = 1820.4), moderate for antipsychotics ( = 365.4), and considerably lower and more frequently classified as weak or moderate for antidepressants for depression ( = 94.2) and anxiety ( = 49.8). Varying median effect sizes ( = 0.45, = 0.30, = 0.37, = 0.72), sample sizes ( = 324, = 218, = 254, = 189.5), and numbers of trials ( = 3, = 5.5, = 3, = 2) might account for differences. Although most drugs were supported by strong evidence at the time of approval, some only had moderate or ambiguous evidence. These results show the need for more systematic quantification and classification of statistical evidence for psychotropic drugs. Evidential strength should be communicated transparently and clearly towards clinical decision makers.
批准和开具精神药物应当以疗效的证据强度为依据。我们采用贝叶斯框架，考察了 (1) 精神药物在获得美国食品和药物管理局 (FDA) 批准时是否有充分证据支持，以及 (2) 不同药物类别之间是否存在系统性差异。从 FDA 审查中提取了 15 种抗精神病药、16 种抗抑郁药（用于治疗抑郁症）、9 种抗抑郁药（用于治疗焦虑症）和 20 种治疗注意力缺陷多动障碍 (ADHD) 的药物的短期、安慰剂对照 II/III 期临床试验数据。进行了贝叶斯模型平均荟萃分析，并对证据强度进行了量化（即 ）。药物之间的证据强度和试验存在差异。ADHD 药物的证据强度中位数极高（ = 1820.4），抗精神病药的证据强度中位数中等（ = 365.4），而抗抑郁药（用于治疗抑郁症）和抗抑郁药（用于治疗焦虑症）的证据强度中位数则较低，且更频繁地被归类为弱或中等（ = 94.2 和 = 49.8）。不同的中位数效应大小（ = 0.45、 = 0.30、 = 0.37、 = 0.72）、样本量（ = 324、 = 218、 = 254、 = 189.5）和试验数量（ = 3、 = 5.5、 = 3、 = 2）可能导致了这些差异。尽管大多数药物在获得批准时都有强有力的证据支持，但有些药物只有中等或模糊的证据。这些结果表明，需要对精神药物的统计证据进行更系统的量化和分类。证据强度应当透明、清晰地传达给临床决策者。
