Article type
Abstract
Background: Double-blinding is commonly used in randomized controlled trials (RCTs). However, as the transparency and honesty of experimental research have increasingly received ethical concerns, more and more trials have tried to apply open-label placebo (OLP) in their designs. The participants were clearly informed that they were taking drugs or placebo, and it was found that the OLP group still had a certain degree of clinical effects.
Objectives: To systematic survey the applications of OLP design, explore the possible effects and developments of OLP, and illustrate the application value of OLP in clinical practice
Method: RCTs of OLP were searched in China National Knowledge Infrastructure (CNKI) and PubMed databases, and the status of research literature was analyzed. Taking chronic low back pain as an example to illustrate the application value of OLP, we selected the indicators of pain Numerical Rating Scale for meta-analysis of the retrieved RCT studies on OLP treatment of chronic low back pain and conducted a GRADE evaluation. The effect values and GRADE evaluation results were compared in systematic reviews of acupuncture for chronic low back pain.
Results: A total of 61 RCT trials were retrieved, and they showed an increasing trend year by year. In the treatment of chronic low back pain, combined use of OLP can further reduce pain compared with conventional treatment alone (mean difference [MD] 0.74, 95% CI 0.63 to 0.86; 3 studies, 257 participants), and the GRADE evaluation result is moderate. Compared with previous systematic reviews of acupuncture for chronic low back pain (MD -0.60, 95% CI -1.22 to 0.02; 1 study, 55 participants), the quality of the evidence is very low.
Conclusions: OLP might be effective for some diseases that lack specific drugs and have no side effects. In terms of ethics, it fully protects the participants' right to know. The results of this study showed that OLP had a certain effect in the treatment of chronic low back pain. Considering that it has no side effects, it will be a worthwhile auxiliary therapy.
Objectives: To systematic survey the applications of OLP design, explore the possible effects and developments of OLP, and illustrate the application value of OLP in clinical practice
Method: RCTs of OLP were searched in China National Knowledge Infrastructure (CNKI) and PubMed databases, and the status of research literature was analyzed. Taking chronic low back pain as an example to illustrate the application value of OLP, we selected the indicators of pain Numerical Rating Scale for meta-analysis of the retrieved RCT studies on OLP treatment of chronic low back pain and conducted a GRADE evaluation. The effect values and GRADE evaluation results were compared in systematic reviews of acupuncture for chronic low back pain.
Results: A total of 61 RCT trials were retrieved, and they showed an increasing trend year by year. In the treatment of chronic low back pain, combined use of OLP can further reduce pain compared with conventional treatment alone (mean difference [MD] 0.74, 95% CI 0.63 to 0.86; 3 studies, 257 participants), and the GRADE evaluation result is moderate. Compared with previous systematic reviews of acupuncture for chronic low back pain (MD -0.60, 95% CI -1.22 to 0.02; 1 study, 55 participants), the quality of the evidence is very low.
Conclusions: OLP might be effective for some diseases that lack specific drugs and have no side effects. In terms of ethics, it fully protects the participants' right to know. The results of this study showed that OLP had a certain effect in the treatment of chronic low back pain. Considering that it has no side effects, it will be a worthwhile auxiliary therapy.