背景:在评估慢性鼻-鼻窦炎(CRS)药物治疗的临床试验中观察到的安慰剂效应尚未得到很好的理解。本系统综述和荟萃分析旨在表征CRS结果中存在的安慰剂效应。
方法:对PubMed,Scopus,并进行了护理和联合健康护理累积指数(CINAHL)。包括评估CRS与安慰剂的药物治疗的随机对照试验(RCT)。我们评估了患者报告(鼻窦结果测试22[SNOT-22],鼻塞,嗅觉,鼻塞视觉模拟评分[VAS],嗅觉VAS,鼻前漏,和鼻后滴漏)和客观(隆德-麦凯计算机断层扫描(CT)评分,峰值鼻吸气流量[PNIF],鼻息肉评分,40项气味识别测试,血清IgE,和血液嗜酸性粒细胞水平)结果。
结果:包括21个RCT,包括1437名患者(平均年龄49.2岁)。生物制剂是研究的最常见的治疗方法(n=9)。11项研究给予背景类固醇和安慰剂。服用安慰剂后,多个患者报告的结果显着下降,包括SNOT-22(平均差-9.49,95%置信区间[CI][-11.26,-7.73]),鼻塞(-0.33[-0.54,-0.13]),嗅觉(-0.22[-0.33,-0.11]),鼻塞VAS(-2.47[-2.87,-2.06]),和气味损失VAS(-2.31[-4.14,-0.47])评分。对于客观措施,安慰剂组Lund-MackayCT评分(-0.82,[-1.48,-0.16])和PNIF(4.70,[4.76,24.64])发生显著变化.当不使用背景药物时,安慰剂臂的影响最大。
结论:安慰剂治疗对患者报告和一些客观的CRS结果具有统计学和潜在的临床意义。需要进一步调查才能充分了解安慰剂效应,这可以改善RCT评估并影响患者护理。
BACKGROUND: The placebo effect observed in clinical trials evaluating medical treatments for chronic rhinosinusitis (CRS) is not well understood. This systematic review and meta-analysis sought to characterize the placebo effect present within CRS outcomes.
METHODS: A systematic review of PubMed, Scopus, and Cumulated Index in Nursing and Allied Health Nursing (CINAHL) was performed. Randomized controlled trials (RCTs) evaluating medical treatments for CRS versus placebo were included. We assessed patient-reported (sino-nasal outcome test 22 [SNOT-22], nasal obstruction, sense of smell, nasal obstruction visual analogue score [VAS], sense of smell VAS, anterior rhinorrhea, and postnasal drip) and objective (Lund-Mackay Computed tomography (CT) score, peak nasal inspiratory flow [PNIF], nasal polyp scores, 40-item Smell Identification Test, serum IgE, and blood eosinophil levels) outcomes.
RESULTS: Twenty-one RCTs were included, comprising 1437 patients (mean age 49.2 years). Biologics were the most common treatment investigated (n = 9). Eleven studies administered background steroids along with placebo. Following placebo administration, multiple patient-reported outcomes significantly decreased, including SNOT-22 (mean difference -9.49, 95% confidence interval [CI] [-11.26, -7.73]), nasal obstruction (-0.33 [-0.54, -0.13]), sense of smell (-0.22 [-0.33, -0.11]), nasal obstruction VAS (-2.47 [-2.87, -2.06]), and loss of smell VAS (-2.31 [-4.14, -0.47]) scores. For objective measures, significant changes occurred in Lund-Mackay CT score (-0.82, [-1.48, -0.16]) and PNIF (4.70, [4.76, 24.64]) with placebo. Placebo arms had the greatest impact when no background medications were used.
CONCLUSIONS: Placebo treatments have a statistically and potentially clinically significant effect on patient-reported and some objective CRS outcomes. Further investigation is required to fully understand placebo effect, which could improve assessment of RCTs and impact patient care.