Abstract

BackgroundAdverse events (AEs) derived from nonspecific activity of treatments can impair the validity of trials, and even make it difficult to identify specific AEs associated with treatments. To better understand these nonspecific AEs, we investigated the AEs in placebo groups by using knee osteoarthritis clinical trials.MethodsRandomized, placebo-controlled, knee osteoarthritis trials were identified by searching electronic databases. We determined the rate of patients with AEs and the rate of dropouts caused by AEs in the active and placebo groups. Furthermore, we calculated the rate of patients for individual AEs in the placebo groups. Finally, we performed secondary analyses to identify the factors associated with these rates.ResultsOverall, 272 papers reporting 281 trials were included in the analysis. The rates of patients with AEs were 31.8% in the active groups and 27.4% in the placebo groups. The rate of the placebo groups accounted for 86.2% of the rate of the active groups. The rates of dropouts caused by AEs were 5.2% in the active groups and 4.8% in the placebo groups. The rate of the placebo groups accounted for 92.3% of the rate of the active groups. AEs in the placebo groups included a number of clinical conditions, with elevated alanine aminotransferase (0.59%; 95% CI: 0.46 to 0.77) being the most common objective outcome and headache (4.48%; 95% CI: 4.20 to 4.79) being the most frequent subjective outcome. The rate of patients with AEs and the rate of dropouts caused by AEs were associated with the treatment type, delivery route, and study design.ConclusionsThe nonspecific AEs substantially accounted for the development of AEs in the active groups and included conditions involving the entire body.

Highlights

  • Osteoarthritis is one of the most prevalent musculoskeletal diseases affecting the elderly

  • Numerous reviews have reported that the rate of patients with Adverse events (AEs) and the rate of dropouts caused by AEs in placebo groups were 10–50% and 2–6%, respectively [5,6,7,8,9,10,11,12,13,14,15,36]

  • With respect to the rate of dropouts caused by AEs, the rate in the placebo groups was 43.9–99.6% of that in the active groups [6,11]

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Summary

Introduction

Osteoarthritis is one of the most prevalent musculoskeletal diseases affecting the elderly Because it is characterized by the progressive degeneration of synovial joint structure [1], it causes pain, loss of motion, and physical disability, impairing quality of life. Current treatment strategies aim to alleviate joint pain, reduce physical disability, and limit the progression of joint damage [2]. Adverse events (AEs) derived from nonspecific activity of treatments can impair the validity of trials, and even make it difficult to identify specific AEs associated with treatments. To better understand these nonspecific AEs, we investigated the AEs in placebo groups by using knee osteoarthritis clinical trials

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