Scheme optimization of acupoints compatibility and influence factors of the effect

Abstract

Background: Acupuncture may be a clinically effective treatment for insomnia. We will perform a multicenter, large-scale, singleblinded, randomized controlled trial to compare the differences in the clinical efficacy between the use of singleacupoints and compatibilityacupoints in the treatment of primary insomnia. Methods/Design: A total of 333 participants will be randomly assigned to 2 acupoint treatment groups or 1 nonacupoint control group in a 1:1:1 ratio by a central stochastic system. The acupuncture groups are: the single acupoint group: Shenmen (HT7); and he compatibility acupoint group: Shenmen (HT7), Baihui (DU20), and Sanyinjiao (SP6). The observation period of this trial will be 10 weeks. All patients will be followed for 1week before randomization (baseline phase). After randomization, the patients will receive 30 minutes of electro-acupuncture once per day for 5weeks. In the fourth week after the treatment, follow-up will be performed once. The primary outcome will be the Pittsburgh sleep quality index score at 1week before randomization and 2 and 8weeks after randomization. The secondary outcomes will include data from sleep diaries, Athens insomnia scale scores, ShortForm-36 Health Survey scores, electroencephalogram technology results and polysomnogram) results. Patients will be required to complete a sleep diary every day during the treatment period. Patients will also undergo electroencephalogram technology and polysomnogram 1 week before randomization and 5weeks after randomization. The other secondary outcomes will be measured 1week before randomization and 5 and 9weeks after randomization. Discussion: This trial will be helpful in identifying whether acupuncture at compatibility acupoints is more effective than acupuncture at single acupoints. Trial registration: Clinical Trials.govNCT02448602, Registered 5May 2015, https://www.clinicaltrials.gov/ct2/show/ NCT02448602?term=NCT02448602&rank=1 Abbreviations: ALT = Alanine aminotransferase, APA = American Psychiatric Association, AST = Aspartate aminotransferase, BUN = Blood urea nitrogen, ET = Electroencephalogram technology, PSG = Polysomnogram, PSQI = Pittsburgh sleep quality index, SAS = Self-rating anxiety scale, SCr = Serum creatinine, SDS = Self-Rating Depression Scale, SF-36 = Short Form-36 Health Survey.