The Enigma of Placebo Adherence and Health Outcomes

安慰剂依从性和健康结果之谜

• 批准号: 7101149
• 负责人: Andrew L Avins
• 金额: $ 47.76万
• 依托单位: KAISER FOUNDATION RESEARCH INSTITUTE
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-08-15 至 2010-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7101149
• 关键词: behavioral /social science research tag; behavioral medicine; cardiovascular disorder chemotherapy; clinical research; clinical trials; epidemiology; experimental designs; human data; human morbidity; human mortality; outcomes research; placebos; therapy compliance

DESCRIPTION (provided by applicant): In 1980, researchers with the Coronary Drug Project (CDP) reported a startling finding from their data: participants in the placebo arm of the trial who were relatively adherent to their study medication had a substantially better five-year total mortality experience compared to participants who were less adherent to their placebo pills. Subsequently, similar results were reported in post-hoc analyses from three other cardiovascular clinical trials, with observed reductions in total mortality of 46% to 76%. The implication of these results for health care is profound: for reasons that are poorly understood, adherence to an inactive medication may be associated with marked improvement in health outcomes that exceeds the benefits of most effective medical interventions. This association, however, has not been confirmed in all studies. Investigators with the Lipid Research Clinics Coronary Primary Prevention Trial and the Cardiac Arrhythmia Suppression Trial did not find a similar relationship between adherence to placebo and mortality in their datasets. Why most studies that have examined this issue have found an association while others have not is unknown. In this application, we propose a large secondary-data-analysis study examining placebo groups from several previously reported cardiovascular trials. The data from twelve clinical trials will be obtained from collaborating investigators with the original trials, and through the NHLBI Data Distribution Program; these will be subjected to a uniform analytic strategy to examine the relationship between placebo adherence and several health outcomes. The purpose of these analyses is to examine the consistency of the initial CDP finding, to investigate potential mechanisms among those trials in which this relationship is identified, and to study methodologic and participant differences in the trials that found an association with those that did not. Outcomes to be examined include total mortality, cause-specific mortality, and cause-specific morbidity. The study will conclude with a synthesis of all data to estimate an overall association between placebo adherence and improved health outcomes. The results of this investigation will shed important light on powerful biomedical and non-biomedical determinants of health outcomes that, at present, are insufficiently documented and poorly understood.

描述（由申请人提供）：1980 年，冠心病药物项目 (CDP) 的研究人员从他们的数据中报告了一个惊人的发现：试验安慰剂组中相对坚持其研究药物的参与者的五年疗效要好得多与不太坚持服用安慰剂药的参与者相比，总死亡率经历。随后，其他三项心血管临床试验的事后分析也报告了类似的结果，观察到总死亡率降低了 46% 至 76%。这些结果对医疗保健的影响是深远的：由于人们知之甚少的原因，坚持非活性药物治疗可能与健康结果的显着改善有关，这种改善超过了最有效的医疗干预措施的益处。然而，这种关联尚未在所有研究中得到证实。脂质研究诊所冠状动脉一级预防试验和心律失常抑制试验的研究人员在他们的数据集中没有发现安慰剂依从性与死亡率之间存在类似的关系。为什么大多数研究这个问题的研究都发现了这种关联，而其他研究却没有发现这种关联，这一点尚不清楚。在此应用中，我们提出了一项大型二次数据分析研究，检查来自先前报告的几项心血管试验的安慰剂组。 12 项临床试验的数据将通过 NHLBI 数据分发计划从原始试验的合作研究人员处获得；这些将接受统一的分析策略，以检查安慰剂依从性与多种健康结果之间的关系。这些分析的目的是检查 CDP 最初发现的一致性，调查已确定这种关系的试验中的潜在机制，并研究发现相关性的试验与未发现相关性的试验中的方法学和参与者差异。要检查的结果包括总死亡率、特定原因死亡率和特定原因发病率。该研究将综合所有数据，以估计安慰剂依从性和改善健康结果之间的总体关联。这项调查的结果将为了解健康结果的强大生物医学和非生物医学决定因素提供重要线索，而这些决定因素目前记录不足且了解甚少。