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

Morin, 2012, Chronic insomnia, Lancet, 379, 1129, 10.1016/S0140-6736(11)60750-2 Fass, 2000, Sleep disturbances in clinic patients with functional bowel disorders, Am J Gastroenterol, 95, 1195, 10.1111/j.1572-0241.2000.02009.x Morito, 2014, Association between sleep disturbances and abdominal symptoms, Intern Med, 53, 2179, 10.2169/internalmedicine.53.2591 Lacy, 2011, Functional dyspepsia is associated with sleep disorders, Clin Gastroenterol Hepatol, 9, 410, 10.1016/j.cgh.2011.02.010 Kim, 2018, Self-reported sleep impairment in functional dyspepsia and irritable bowel syndrome, J Neurogastroenterol Motil, 24, 280, 10.5056/jnm17098 Yamawaki, 2014, Impact of sleep disorders, quality of life and gastric emptying in distinct subtypes of functional dyspepsia in Japan, J Neurogastroenterol Motil, 20, 104, 10.5056/jnm.2014.20.1.104 Daley, 2009, The economic burden of insomnia: direct and indirect costs for individuals with insomnia syndrome, insomnia symptoms, and good sleepers, Sleep, 32, 55 Daley, 2009, Insomnia and its relationship to health-care utilization, work absenteeism, productivity and accidents, Sleep Med, 10, 427, 10.1016/j.sleep.2008.04.005 Riemann, 2009, The treatments of chronic insomnia: a review of benzodiazepine receptor agonists and psychological and behavioral therapies, Sleep Med Rev, 13, 205, 10.1016/j.smrv.2008.06.001 Schroeck, 2016, Review of safety and efficacy of sleep medicines in older adults, Clin Ther, 38, 2340, 10.1016/j.clinthera.2016.09.010 National Institutes of Health State-of-the-Science Panel, 2007, National Institutes of Health State-of-the-Science Conference Statement: multivitamin/mineral supplements and chronic disease prevention, Am J Clin Nutr, 85, 257S, 10.1093/ajcn/85.1.257S Wang, 2014, Application of “disharmony of stomach leads to insomnia” theory in acupuncture treatment for insomnia, Zhongguo Zhen Jiu, 34, 1228 Shergis, 2016, A systematic review of acupuncture for sleep quality in people with insomnia, Complement Ther Med, 2016, 11, 10.1016/j.ctim.2016.02.007 Lima, 2013, Acupuncture effectiveness as a complementary therapy in functional dyspepsia patients, Arq Gastroenterol, 50, 202, 10.1590/S0004-28032013000200036 Wang, 2012, Moxibustion inhibits interleukin-12 and tumor necrosis factor alpha and modulates intestinal flora in rat with ulcerative colitis, World J Gastroenterol, 18, 6819, 10.3748/wjg.v18.i46.6819 Xu, 2013, Effect of acupuncture treatment for weight loss on gut flora in patients with simple obesity, Acupunct Med, 31, 116, 10.1136/acupmed-2012-010209 Bruce-Keller, 2018, Harnessing gut microbes for mental health: getting from here to there, Biol Psychiatry, 83, 214, 10.1016/j.biopsych.2017.08.014 Collins, 2009, The relationship between intestinal microbiota and the central nervous system in normal gastrointestinal function and disease, Gastroenterology, 136, 2003, 10.1053/j.gastro.2009.01.075 Krueger, 2016, Sleep and microbes, Int Rev Neurobiol, 131, 207, 10.1016/bs.irn.2016.07.003 Kennedy, 2014, Irritable bowel syndrome: a microbiome-gut-brain axis disorder?, World J Gastroenterol, 20, 14105, 10.3748/wjg.v20.i39.14105 Poroyko, 2016, Chronic sleep disruption alters gut microbiota, induces systemic and adipose tissue inflammation and insulin resistance in mice, Sci Rep, 6, 35405, 10.1038/srep35405 Luo, 2018, The difference of intestinal flora in patients with primary insomnia with different TCM syndromes, Zhongguo Zhong Yi Yao Xin Xi Za Zhi, 25, 28 Kurokawa, 2018, The effect of fecal microbiota transplantation on psychiatric symptoms among patients with irritable bowel syndrome, functional diarrhea and functional constipation: an open-label observational study, J Affect Disord, 235, 506, 10.1016/j.jad.2018.04.038 Chan, 2013, SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials, BMJ, 346, 10.1136/bmj.e7586 Psychiatry Branch of Chinese Medical Association, 2001 State Administration of Traditional Chinese Medicine of the People’s Republic of China. Criteria of diagnosis and therapeutic effect evaluation of diseases and syndromes in traditional Chinese medicine. Beijing: China Medical Science Press; 2012 [Chinese]. National Standards of the People’s Republic of China. Clinic terminology of traditional Chinese medical diagnosis and treatment—syndromes. GB/T 16751.2-1997. (1997-03-04) [2018-07-01]. http://www.gov.cn/fuwu/bzxxcx/bzh.htm. MacPherson, 2010, STRICTA Revision Group. Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement, J Altern Complement Med, 16, 10.1089/acm.2010.1610 Buysse, 1989, The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research, Psychiatry Res, 28, 193, 10.1016/0165-1781(89)90047-4 Svedlund, 1988, GSRS—a clinical rating scale for gastrointestinal symptoms in patients with irritable bowel syndrome and peptic ulcer disease, Dig Dis Sci, 33, 129, 10.1007/BF01535722 Revicki, 1998, Reliability and validity of the Gastrointestinal Symptom Rating Scale in patients with gastroesophageal reflux disease, Qual Life Res, 7, 75, 10.1023/A:1008841022998 Bastien, 2001, Validation of the Insomnia Severity Index as an outcome measure for insomnia research, Sleep Med, 2, 297, 10.1016/S1389-9457(00)00065-4 Zung, 1971, A rating instrument for anxiety disorders, Psychosomatics, 12, 371, 10.1016/S0033-3182(71)71479-0 Zung, 1965, A self-rating depression scale, Arch Gen Psychiatry, 12, 63, 10.1001/archpsyc.1965.01720310065008 Zhang, 2005 Knight, 2018, Best practices for analysing microbiomes, Nat Rev Microbiol, 16, 410, 10.1038/s41579-018-0029-9 Li, 2018, The clinical observation of acupuncture and moxibustion on Beishu points for treating insomnia, Henan Zhong Yi, 38, 450 Liu, 2017, Effect of vitamin A supplementation on gut microbiota in children with autism spectrum disorders—a pilot study, BMC Microbiol, 17, 204, 10.1186/s12866-017-1096-1 Wang, 2014, A systematic review and meta-analysis of Baihui (GV20)-based scalp acupuncture in experimental ischemic stroke, Sci Rep, 4, 3981, 10.1038/srep03981