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Journal of Integrative Medicine ›› 2019, Vol. 17 ›› Issue (3): 161-167.doi: 10.1016/j.joim.2019.01.007

• Study Protocol • Previous Articles     Next Articles

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

Ya-ru Huangfu, Wei Peng, Bao-jun Guo, Zhi-fu Shen, Li Li, Shi-wei,Liu, Hui Zheng, You-ping Hu   

  1. Acupuncture and Tuina School, Chengdu University of Traditional Chinese Medicine, Chengdu 610075, Sichuan Province, China
  • Received:2018-10-20 Accepted:2018-12-21 Online:2019-05-05 Published:2019-05-01

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.

Key words: Insomnia, Gastrointestinal symptoms, Acupuncture, Intestinal microbiome, Randomized controlled trial, Study protocol

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