Lin Yi-Hsuan, Sahker Ethan, Shinohara Kiyomi, Horinouchi Noboru, Ito Masami, Lelliott Madoka, Cipriani Andrea, Tomlinson Anneka, Baethge Christopher, Furukawa Toshi A
Department of Health Promotion and Human Behavior, Kyoto University Graduate School of Medicine and School of Public Health, Kyoto, Japan.
Population Health and Policy Research Unit, Graduate School of Medicine, Kyoto University, Kyoto, Japan.
EClinicalMedicine. 2022 Jul 1;50:101505. doi: 10.1016/j.eclinm.2022.101505. eCollection 2022 Aug.
In double-blind randomized controlled trials (RCTs) of antidepressants, blinding can be broken due to the apparent side effects, and unsuccessful blinding can lead to overestimation of effect sizes. New generation antidepressants with less severe side effects may be less susceptible to broken blinding. However, successfulness of blinding in new generation antidepressant trials and its influence on trial effect size estimates remain unclear.
Extending a previous systematic review assessing blinding successfulness in psychiatric trials (2000-2010), we searched PubMed/Medline for double-blinded antidepressant RCTs (2010-2020) for trials assessing blinding success. Our primary outcome was the degree of blinding successfulness, measured as kappa statistics between guesses and true allocations. We used random-effects meta-analysis to synthesize studies. We used meta-regression and Pearson's r to examine the relationship between blinding success and effect sizes. This study is registered with PROSPERO (CRD42021249973).
Among 154 eligible studies, 11 (7·1%) contained information on blinding assessment between 2010 and 2020. Five studies were added from the previous review, and altogether nine of the 16 studies provided usable data. Agreement in individual studies ranged from -0·14 to 0·38. The summary agreement between guesses and the truth was 0·21 (95% CI: 0·14 to 0·28) among patients and 0·17 (95% CI: 0·05 to 0·30) among assessors. Blinding success was not associated with effect size (patients: = 0·37, = 0·32; assessors: = 0·28; = 0·72). Meta-regression also failed to find a significant relationship between blinding success and depression effect sizes (β=0·06, = 0·09).
Less than 10% of the antidepressant RCTs reported blinding assessment. The results in new generation antidepressant trials indicated that patients and assessors were unlikely to be able to judge treatment allocation. There was little evidence that the extent of unblinding biased the effect size estimates of new generation antidepressants.
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在抗抑郁药的双盲随机对照试验（RCT）中，由于明显的副作用可能导致盲法被打破，而盲法失败可能会导致效应量估计值被高估。副作用较轻的新一代抗抑郁药可能较不容易出现盲法被打破的情况。然而，新一代抗抑郁药试验中盲法的成功与否及其对试验效应量估计的影响仍不明确。
在之前一项评估精神科试验中盲法成功性的系统评价（2000 - 2010年）基础上进行扩展，我们在PubMed/Medline中检索了2010 - 2020年评估盲法成功性的双盲抗抑郁药RCT。我们的主要结局是盲法成功程度，用猜测与真实分配之间的kappa统计量来衡量。我们采用随机效应荟萃分析来综合各项研究。我们使用荟萃回归和Pearson相关系数r来检验盲法成功与效应量之间的关系。本研究已在PROSPERO（CRD42021249973）注册。
在154项符合条件的研究中，11项（7.1%）包含2010年至2020年期间的盲法评估信息。从之前的综述中增加了5项研究，16项研究中共有9项提供了可用数据。各研究中的一致性范围为 -0.14至0.38。患者中猜测与真实情况之间的总体一致性为0.21（95%CI：0.14至0.28），评估者中为0.17（95%CI：0.05至0.30）。盲法成功与效应量无关（患者：r = 0.37，p = 0.32；评估者：r = 0.28，p = 0.72）。荟萃回归也未发现盲法成功与抑郁效应量之间存在显著关系（β = 0.06，p = 0.09）。
不到10%的抗抑郁药RCT报告了盲法评估情况。新一代抗抑郁药试验的结果表明，患者和评估者不太可能判断出治疗分配情况。几乎没有证据表明盲法未成功的程度会使新一代抗抑郁药的效应量估计产生偏差。
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