Efficacy and Safety of Acupuncture Treatment on Primary Insomnia: A Randomized Controlled Trial

摘要

Background: Primary insomnia is a prevalent disorder with few satisfactory treatments, which poses great challenge to thephysical and mental health of individuals.Objective: The objective of this study was to evaluate the efficacy and safety of acupuncture treatment for primaryinsomnia.Participants and Methods: We conducted a single-center, single-blinded, and randomized controlled clinical trial. Seventytwo patients with primary insomnia were randomly assigned into two groups: the acupuncture group and the sham controlgroup. The treatment was given three times weekly for four weeks. Patients were asked to wear sleep monitors andcomplete questionnaires every two weeks for a total of eight weeks. The primary outcome was the Insomnia Severity Index(ISI). The secondary outcomes were sleep parameters including sleep efficiency (SE), sleep awakenings (SA) and total sleeptime (TST) recorded by the Actigraphy, as well as scores of the Self-Rating Anxiety Scale (SAS) and the Self-RatingDepression Scale (SDS).Results: Compared with baseline, patients in both groups had varying degrees of improvements in their sleep conditions.Acupuncture group showed significant improvements in all indicators as compared with baseline. Further analysis adjustedfor baseline scores indicated that the ISI improved dramatically in the acupuncture group at two weeks (F Z 11.3,p Z 0.001), four weeks (F Z 33.6, p < 0.001), 2 weeks follow-up (F Z 39.4, p < 0.001) and four weeks follow-up (F Z 34.1,p < 0.001). Similar significant improvements were observed in the SE, TST and SDS scores. Although no differences in SA andSAS were shown between two groups until the end of treatment, remarkable decrements in SA and SAS were found in theacupuncture treatment group after the two-week and four-week follow-ups.Conclusions: Acupuncture treatment is more effective than sham acupuncture treatment in increasing insomnia patients’sleep quality and improving their psychological health.