Abstract
BackgroundInsomnia is a global disease with a high incidence and acupuncture therapy is a well appropriate method to treat insomnia. Shenmen (HT 7) and Sanyinjiao (SP 6) are the acupoints most commonly used to treat insomnia. Although they can obviously relieve the clinical symptoms of insomnia, it is unclear whether they must be used together, whether the combination of two acupoints may have a synergistic or antagonistic effect, and whether there is a primary or secondary relationship between the two points in the treatment of insomnia. Further studies are needed. Therefore, in this study, we are exploring the acupoint combination effect and biological mechanism of HT 7 and SP 6 in treating insomnia.Methods/designThis will be a parallel group randomized controlled trial. The study will recruit 120 patients with insomnia randomly assigned to a control group, an electroacupuncture on HT 7 group, an electroacupuncture on SP 6 group, and an electroacupuncture on HT 7 and SP 6 group. The allocation ratio is 1:1:1:1, with 30 subjects in each group. Meanwhile, ten healthy subjects who meet the study criteria will be recruited as the healthy control group. Patients in the intervention groups will be given ten rounds of electroacupuncture stimulation on the corresponding acupoints for 2 weeks, five times per week, with 2 days of rest between the two treatment courses. Patients in the control group will also receive the same two courses of ten rounds of compensatory acupuncture therapy after a 2-week waiting period for treatment. The major outcome measures of this study include the Sleep Dysfunction Rating Scale, the Insomnia Severity Index, Epworth Sleepiness Scale, the Zung Self-Rating Anxiety Scale, and the Zung Self-Rating Depression Scale, combined with the Measure Your Medical Outcome Profile, to evaluate insomnia and the emotional state of patients with insomnia. The secondary outcome measures include sleep composition monitored by polysomnography and measurements of acetylcholine, serotonin, dopamine, norepinephrine, melatonin, gamma-aminobutyric acid, and metabolic biomarkers in serum.DiscussionIn this study, we are exploring the acupoint combination effect and biological mechanism of HT 7 and SP 6 in treating insomnia, which may provide evidence for the clinical application of acupuncture and acupoint selection in the treatment of insomnia.Trial registrationChinese Clinical Trial Registry, Chi-CTR-1800017483. Registered on 1 August 2018.
Highlights
Insomnia is a global disease with a high incidence and acupuncture therapy is a well appropriate method to treat insomnia
Exclusion criteria Participants with any of the following conditions will be excluded from this trial: (1) secondary insomnia caused by physical disease or mental disorder; (2) those who Criteria for healthy control subjects Inclusion criteria Inclusion criteria for healthy control subjects include: (1) without any physical or mental illness; (2) routine blood examination for liver function, kidney function, electrocardiogram, blood glucose, and lipids are normal; (3) aged from 20 to 60 years old; (4) have not participated in other clinical studies recently; (5) have signed the informed consent form and volunteered to participate in this study
PSG is a common method of neural electrophysiological monitoring in sleep research that is often used for objective analysis of sleep
Summary
This study is a parallel group randomized controlled trial exploring the effects and mechanisms of acupoint combination of HT 7 and SP 6 for treating insomnia. This study will quantify the Ach, 5-HT, DA, NE, MT, and GABA in serum of subjects in the healthy control group, the control group, and the three intervention groups using enzyme-linked immunosorbent assays to explore the neurotransmitter regulatory mechanism of the effect that improves sleep by acupoint combination. Metabolomics, guided by the theory of system biology, monitors the changes of endogenous metabolites of organisms and directly reflects the body’s response to external pathophysiological stimulation and intervention from the perspective of the whole system It depends on spectral research and pattern recognition methods with high throughput, high sensitivity, and high accuracy. This study will adopt the metabolomic research method to compare the changes of endogenous metabolites before and after acupuncture intervention in different groups to find the differences in their metabolic profiles and possible related metabolic pathways, and these differential metabolic markers may be associated with insomnia. The recruitment is expected to be completed on 31 March 2020
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