A Clinical Comparison Of Verum And Placebo Acupuncture In The Treatment Of Primary Insomnia

Study Objective:To evaluate the curative effects of verum acupuncture for the treatment of patients with primary insomnia while keeping bias in favor or against Traditional Chinese Medicine to a minimum using a randomized, placebo-controlled clinical trial.Methods:This study was a single-blinded, randomized, placebo-controlled clinical trial. Patients who were acupuncture naive or had little interaction with acupuncture in the past year were selected to participate in the study. A total of 60 patients with primary insomnia, who have not received any form of treatment in the past 4 weeks, were randomly assigned to 2 groups:the verum acupuncture treatment group underwent verum acupuncture on neiguan (PC6), shenmen (HT7), baihui (GV20), zhaohai (KI6), shenmai (BL62), and sanyinjiao (SP6); the control group received placebo acupuncture on points unrelated to the treatment of insomnia according to TCM theory. Each treatment period consisted of a total of 10 acupuncture sessions, two sessions per week with at least 2 days between treatments. The outcome was measured by the Pittsburg Sleep Quality Index (PSQI) before the start of treatment, at the end of treatment, and 4 weeks after treatment to compare the difference in scores for the valuation of treatment efficacy.Results:Out of 60 participants in the study, no participants dropped-out or withdrew from the study. The recruits whom completed the study,60 in total, were included in the statistical analysis.1. Prior to treatment:There was no statistical discrepancy (P＞0.05) between the two groups in baseline characteristics nor were there any differences in PSQI scores, making the two groups comparable.2. By comparing each patient’s PSQI score as well as the scores of different components within the PSQI scale such as sleep quality, sleep latency, sleep disturbance, and daytime dysfunction before and after treatment, the data in the study were statistically comparable and significant (P＜ 0.05), with the decline in the total score on the PSQI scale in both groups after treatment (P＜0.05) bares a significant difference in results. The results for the verum acupuncture treatment group had a better overall effect than the placebo control group where improvements were present in all categories of the PSQI scale as well as the total PSQI score in the treatment group。 There showed no improvement in sleep efficiency as well as sleep disturbance score in the placebo acupuncture group.3. Of the 60 patients reviewed, the overall clinical effective rate of the verum acupuncture treatment group was 90%:9 completely treated,13 improved significantly,5 saw results, and 3 saw no improvements out of 30 participants; the effective rate for the placebo acupuncture control was 73.33%:6 completely treated,7 improved significantly,9 saw results, and 8 saw no improvements out of 30 participants.Conclusion:Although both verum acupuncture and placebo acupuncture groups had significant improvements in PSQI scores during the treatment of insomnia, verum acupuncture appeared to be more effective in improving sleep quality, sleep disturbances, sleep latency, and daytime functioning than placebo acupuncture especially when it came to the long-lasting maintenance of the results. Acupuncture can be considered a safe and effective treatment therapy for those suffering with insomnia conditions. Due to limited time and resources, this study cannot represent the total population of those suffering with insomnia, but it leads as a basis for future clinical studies to further validate the efficacy of acupuncture towards insomnia treatment.