Neurosciences, Mental Health, and Sensory Organs (NESMOS) Department, Faculty of Medicine and Psychology, Sapienza University, Sant'Andrea Hospital, Rome, Italy.
Società Psicoanalitica Italiana (SPI), Roma, Italy.
Curr Neuropharmacol. 2019;17(8):741-774. doi: 10.2174/1570159X16666181026163922.
Placebo response appears to be increasing in antidepressant, antipsychotic and various internal medicine trials. A similar trend has been reported for OCD during 1989-1999. Placebo response is generally considered as the extent to which placebo treatment is associated with core symptom improvement. In this analysis, we used Joinpoint regression to assess the time trend of both placebo response and placebo responder rates according to the year of publication with no time restriction in OCD drug trials.
We included drug and/or psychotherapy trials vs. placebo from PubMed, Embase, CINAHL, and PsycINFO retrieved through the search (placebo OR sham) AND (obsessive* OR OCD). We included studies through investigator consensus. We then performed on data of included studies log-linear joinpoint segmented regression models using a p<0.05 cutoff.
We included 113 studies from 112 published papers. Placebo mean annual response rates in OCD studies significantly increased from 1991 to 2017 with an annual percent change (APC) of 0.66%, while placebo mean annual responder rates also significantly increased from 2010 to 2017, with an APC of 5.45%. Drug mean annual response rates in OCD studies significantly increased from 1987 to 2012 with an APC of 0.72%, while the corresponding responder rates did not show statistically significant APC changes between 1984 and 2017.
We observed a tendency for placebo to increase both measures of response in OCD clinical drug trials through the years that tend to approximate the responses shown by drugs. Changes in the type of study (moving from classical head to head comparisons to add-on studies in treatmentresistant populations) and countries involved in experimentation may partially account for some portion of these results. It appears that placebo effects are becoming more elusive and out of control.
在抗抑郁药、抗精神病药和各种内科试验中,安慰剂效应似乎在增加。在 1989-1999 年期间,强迫症也出现了类似的趋势。安慰剂反应通常被认为是安慰剂治疗与核心症状改善相关的程度。在本分析中,我们使用 Joinpoint 回归评估了 OCD 药物试验中根据出版年份的无时间限制的安慰剂反应和安慰剂反应者率的时间趋势。
我们从 PubMed、Embase、CINAHL 和 PsycINFO 中检索到的搜索词(placebo 或 sham)AND(obsessive* 或 OCD)中纳入了药物和/或心理治疗与安慰剂对照的试验。我们通过调查员共识纳入了研究。然后,我们对纳入研究的数据使用 log-linear joinpoint 分段回归模型进行了分析,p<0.05 为截定点。
我们纳入了来自 112 篇已发表论文的 113 项研究。OCD 研究中安慰剂的平均年反应率从 1991 年到 2017 年显著增加,年百分比变化(APC)为 0.66%,而安慰剂的平均年反应者率也从 2010 年到 2017 年显著增加,APC 为 5.45%。OCD 研究中药物的平均年反应率从 1987 年到 2012 年显著增加,APC 为 0.72%,而相应的反应者率在 1984 年到 2017 年之间没有显示出统计学上显著的 APC 变化。
我们观察到,在 OCD 临床药物试验中,随着时间的推移,安慰剂在两种反应测量中的作用呈上升趋势,这一趋势与药物的反应趋势相似。试验所涉及的研究类型(从经典的头对头比较转向治疗抵抗人群的附加研究)和国家的变化可能在一定程度上解释了这些结果的部分原因。似乎安慰剂效应变得越来越难以捉摸和失控。