Department of General Practice and Elderly Care Medicine, University Medical Centre Groningen, University of Groningen, PO Box 196, 9700 AD, Groningen, The Netherlands.
CNS Drugs. 2019 Sep;33(9):933-942. doi: 10.1007/s40263-019-00654-y.
Knowledge about treatment status can influence effects measured in trials when subjective scales are used.
The aim of this study was to compare subjective outcomes with objective outcomes of conventional and atypical antipsychotics for neuropsychiatric symptoms (NPS) in dementia.
We performed a meta-epidemiological study of 38 randomized, placebo-controlled trials. For effectiveness, we used change in NPS and response rate as subjective outcomes, while overall dropout and additional psychotropic use were used as objective outcomes. For side effects, extrapyramidal symptoms (EPS) and somnolence were used as subjective outcomes, while dropout due to adverse events, medication use for EPS, and participants falling were used as objective outcomes.
Conventional antipsychotics reduced NPS more than placebo (standardized mean difference [SMD] - 0.36, 95% confidence interval [CI] - 0.49 to - 0.23), as did atypical antipsychotics (SMD - 0.14, 95% CI - 0.19 to - 0.08). Response rates in the drug groups were also higher. Overall dropout did not differ between conventional antipsychotics and placebo (odds ratio [OR] 1.03, 95% CI 0.77-1.37) or atypical antipsychotics and placebo (OR 1.01, 95% CI 0.89-1.14). Furthermore, additional psychotropic use did not differ. The risk of EPS was higher for conventional (OR 2.93, 95% CI 2.04-4.22) and atypical antipsychotics (OR 1.52, 95% CI 1.23-1.88) versus placebo, as was the risk of somnolence and dropout due to adverse events, but medication use for EPS, as well as risk of falls, was not.
The effectiveness of antipsychotics for NPS in dementia based on subjective scales was not confirmed using objective outcomes, in contrast to the increased risk of side effects.
当使用主观量表时，治疗状况的知识会影响试验中测量的效果。
本研究旨在比较常规和非典型抗精神病药物治疗痴呆患者神经精神症状（NPS）的主观结局和客观结局。
我们对 38 项随机、安慰剂对照试验进行了荟萃流行病学研究。对于有效性，我们使用 NPS 的变化和反应率作为主观结局，而整体辍学和额外使用精神药物作为客观结局。对于副作用，使用锥体外系症状（EPS）和嗜睡作为主观结局，而因不良反应而辍学、使用 EPS 药物和参与者跌倒作为客观结局。
与安慰剂相比，常规抗精神病药更能降低 NPS（标准化均数差 [SMD] -0.36，95%置信区间 [CI] -0.49 至 -0.23），而新型抗精神病药也是如此（SMD -0.14，95%CI -0.19 至 -0.08）。药物组的反应率也更高。与安慰剂相比，常规抗精神病药和安慰剂之间的整体辍学率没有差异（比值比 [OR] 1.03，95%CI 0.77-1.37）或新型抗精神病药和安慰剂（OR 1.01，95%CI 0.89-1.14）。此外，额外使用精神药物的情况也没有差异。与安慰剂相比，常规（OR 2.93，95%CI 2.04-4.22）和非典型抗精神病药（OR 1.52，95%CI 1.23-1.88）发生 EPS 的风险更高，嗜睡和因不良反应而辍学的风险也更高，但 EPS 药物的使用以及跌倒的风险则没有。
与增加的副作用风险相反，使用客观结局并未证实抗精神病药治疗痴呆患者 NPS 的有效性基于主观量表。
