Effects of acupuncture in treating insomnia due to spleen-stomach disharmony syndrome and its influence on intestinal microbiome: Study protocol for a randomized controlled trial.

BACKGROUND: Insomnia is a common complaint that is closely related to gastrointestinal symptoms, which is consistent with the traditional Chinese medicine classical theory of "stomach disharmony leading to restless sleep." Acupuncture is an effective complementary and alternative medicine therapy to improve gastrointestinal function and restore the normal sleep-wake cycle. However, studies on the effectiveness of acupuncture for insomnia due to spleen-stomach disharmony syndrome are limited to case reports and few randomized controlled trials; deeper research on its mechanism is still lacking. This randomized controlled trial aims to assess the treatment efficacy of "harmonizing stomach to tranquilize mind" acupuncture for insomnia and its influence on the intestinal microbiome. METHODS/DESIGN: This is a randomized, single-blind, parallel-group study. Sixty eligible patients with insomnia due to spleen-stomach disharmony syndrome will be randomly divided into two groups (1:1 allocation ratio). The intervention group will use "harmonizing stomach to tranquilize mind" acupuncture, and the control group will receive sham acupuncture. Participants will receive 5 acupuncture treatment sessions per week for 4 consecutive weeks. The Pittsburgh Sleep Quality Index will be used to evaluate the clinical efficacy of acupuncture treatment by making assessments at baseline, the end of treatment and the end of the follow-up. High-throughput 16S ribosomal ribonucleic acid gene sequencing will be performed to detect changes in the intestinal microbial composition before and after treatment. DISCUSSION: The results of this trial are expected to confirm that "harmonizing stomach to tranquilize mind" acupuncture can effectively relieve insomnia and alter the intestinal microbiome. TRIAL REGISTRATION: Chinese Clinical Trials Registry: ChiCTR1800017092.

[Analysis on Randomized Controlled Trials for Acupuncture Treatment of Simple Obesity Collected from PubMed].

OBJECTIVE: To analyze studies published in journals included in PubMed in terms of randomized controlled trials (RCTs) examining the therapeutic effect of acupuncture for simple obesity, so as to provide a reference for subsequent RCT-related designs and results. METHODS: RCT literature about acupuncture treatment of simple obesity from the PubMed database and from 2000 to 2016 was retrieved by using keywords of "obesity" "fat" "acupuncture" "joint application of acupuncture and herbal medicine" or "auricular point" "electroacupuncture", "acupoint application", or "cupping", followed by screening, extraction and evaluation of the design methodology and outcomes using Consolidated Standards for Reporting of Trials (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA). RESULTS: Fourteen articles from six countries in Asia examining the therapeutic effect of acupuncture in the treatment of simple obesity mainly by using acupoints of the Stomach Meridian were included. Generally, acupuncture was found to be more effective than sham acupuncture. However, PubMed did not include any RCTs comparing acupuncture with western medicine for weight loss and many problems (as details of needling manipulation, etc.) remained in the the research reports available in the database. CONCLUSION: All the existing RCTs generally affirm the positive efficacy of acupuncture for simple obesity, but high-quality RCTs, particularly those comparing acupuncture with western medicines for weight loss are lacking.

[Effect of Acupuncture at Points in Heel Vessel for Circadian Clock Genes of Period 1 and Period 2 mRNAs in the Suprachiasmatic Nucleus in Insomnia Rats].

OBJECTIVE: To investigate the influence and mechanism of acupuncture at the points in Heel Vessel for the circadian clock genes of Period (Per) 1 and Per 2 mRNAs in the suprachiasmatic nucleus (SCN) in insomnia rats. METHODS: Thirty male SD rats were randomly divided into blank, model, acupuncture groups, 10 rats in each group. Insomnia model was established by intraperitoneal injection of PCPA (suspension, 1 mL/100 g). Acupuncture at "Shenmai" (BL 62) and "Zhaohai" (KI 6) was used in the acupuncture group for continuous 7 days, 15 min/day and once daily. The circadian rhythm was observed; the expressions of Per 1 and Per 2 mRNAs in SCN were examined with real time-PCR. RESULTS: The activity in the model group in rest period everyday increased compared with that in the blank group, and the expressions of Per 1 and Per 2 mRNAs in SCN decreased (P<0.05). Compared with the model group, the activity in the acupuncture group in rest period decreased and the expressions of Per 1 and Per 2 mRNAs in the SCN increased (P<0.05). CONCLUSIONS: Acupuncture at BL 62 and KI 6 can increase the expressions of Per 1 and Per 2 mRNAs in the SCN, so as to decrease the activity in rest period, and improve the quality of sleep in insomnia rats.