RWTH Aachen University Hospital, Pauwelsstraße 30, 52074, Aachen, Germany.
Department of Medicine, Surgery and Dentistry, University of Salerno, 84081, Baronissi, SA, Italy.
Int J Clin Pharm. 2022 Oct;44(5):1087-1101. doi: 10.1007/s11096-022-01439-y. Epub 2022 Aug 8.
The efficacy of various common treatment options for dry eye disease (DED) has been investigated against placebo. However, the potential beneficial effect of placebo in the management of DED is still unclear.
This meta-analysis investigated the impact of placebo administration in DED in Ocular Surface Disease Index (OSDI), Schirmer I test (SIT), tear breakup time (TBUT), corneal staining, and complications.
This meta-analysis and systematic review was conducted according to the 2020 PRISMA guidelines. In March 2022, Pubmed, Web of Science, Google Scholar, and Embase were accessed. All the randomised clinical trials which investigated any active treatment against a placebo control group were considered. The following data were extracted at baseline and at last follow-up: Ocular Surface Disease Index (OSDI), tear breakup time test (TBUT), Schirmer I test (SIT), corneal staining.
Data from 56 studies (12,205 patients) were retrieved. Placebo administration is not effective in improving TBUT (P = 0.3), OSDI (P = 0.2), SIT (P = 0.1) and corneal staining (P = 0.1) from baseline to last follow-up. Active treatment led to a higher TBUT and SIT compared to placebo administration (P < 0.0001). The active treatment resulted in a lower OSDI compared to placebo administration (P = 0.0005). Five studies reported data on the corneal staining. No difference was found between placebo administration and active treatment (P = 0.8).
Placebo administration does not impact symptoms of DED and can be successfully employed to evaluate the efficacy of active treatments.
已经研究了各种常见干眼症 (DED) 治疗选择对安慰剂的疗效。然而，安慰剂在 DED 管理中的潜在有益效果仍不清楚。
本荟萃分析调查了在眼表面疾病指数 (OSDI)、泪液分泌试验 (SIT)、泪膜破裂时间 (TBUT)、角膜染色和并发症中给予安慰剂对 DED 的影响。
本荟萃分析和系统评价按照 2020 年 PRISMA 指南进行。2022 年 3 月，检索了 Pubmed、Web of Science、Google Scholar 和 Embase。所有研究任何活性治疗与安慰剂对照组的随机临床试验均被认为是有效的。在基线和最后一次随访时提取了以下数据：眼表面疾病指数 (OSDI)、泪膜破裂时间测试 (TBUT)、泪液分泌试验 (SIT)、角膜染色。
共检索到 56 项研究（12205 例患者）的数据。安慰剂给药在从基线到最后一次随访时不能有效改善 TBUT（P=0.3）、OSDI（P=0.2）、SIT（P=0.1）和角膜染色（P=0.1）。与安慰剂给药相比，活性治疗导致 TBUT 和 SIT 更高（P<0.0001）。与安慰剂给药相比，活性治疗导致 OSDI 更低（P=0.0005）。五项研究报告了角膜染色的数据。安慰剂给药与活性治疗之间无差异（P=0.8）。
安慰剂给药不会影响 DED 的症状，可以成功用于评估活性治疗的疗效。
