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Acupoint combination effect of Shenmen (HT 7) and Sanyinjiao (SP 6) in treating insomnia: study protocol for a randomized controlled trial.
Trials. 2020 Mar 12; 21(1):261.T

Abstract

BACKGROUND

Insomnia 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/DESIGN

This 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.

DISCUSSION

In 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 REGISTRATION

Chinese Clinical Trial Registry, Chi-CTR-1800017483. Registered on 1 August 2018.

Authors+Show Affiliations

Acupuncture and Tuina School/3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China.School of Basic Medicine, Chengdu University of Traditional Chinese Medicine, 1166 Liutai Avenue, Chengdu, 611137, Sichuan, China.Acupuncture and Tuina School/3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China.Chinese Acupuncture of 1st Teaching Hospital of Chengdu University of Traditional Chinese Medicine, 39 Shierqiao Road, Chengdu, Sichuan, China.School of Basic Medicine, Chengdu University of Traditional Chinese Medicine, 1166 Liutai Avenue, Chengdu, 611137, Sichuan, China.School of Basic Medicine, Chengdu University of Traditional Chinese Medicine, 1166 Liutai Avenue, Chengdu, 611137, Sichuan, China.Acupuncture and Tuina School/3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China.Acupuncture and Tuina School/3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China.School of Basic Medicine, Chengdu University of Traditional Chinese Medicine, 1166 Liutai Avenue, Chengdu, 611137, Sichuan, China.School of Basic Medicine, Chengdu University of Traditional Chinese Medicine, 1166 Liutai Avenue, Chengdu, 611137, Sichuan, China.School of Basic Medicine, Chengdu University of Traditional Chinese Medicine, 1166 Liutai Avenue, Chengdu, 611137, Sichuan, China.Acupuncture and Tuina School/3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China.Acupuncture and Tuina School/3rd Teaching Hospital, Chengdu University of Traditional Chinese Medicine, 37 Shierqiao Road, Chengdu, 610075, Sichuan, China. zhuyihui@cdutcm.edu.cn.

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

32164719

Citation

Wu, Pei, et al. "Acupoint Combination Effect of Shenmen (HT 7) and Sanyinjiao (SP 6) in Treating Insomnia: Study Protocol for a Randomized Controlled Trial." Trials, vol. 21, no. 1, 2020, p. 261.
Wu P, Cheng C, Song X, et al. Acupoint combination effect of Shenmen (HT 7) and Sanyinjiao (SP 6) in treating insomnia: study protocol for a randomized controlled trial. Trials. 2020;21(1):261.
Wu, P., Cheng, C., Song, X., Yang, L., Deng, D., Du, Z., Chen, X., Zou, T., Qiao, L., Li, N., Zhou, P., Du, L., & Zhu, Y. (2020). Acupoint combination effect of Shenmen (HT 7) and Sanyinjiao (SP 6) in treating insomnia: study protocol for a randomized controlled trial. Trials, 21(1), 261. https://doi.org/10.1186/s13063-020-4170-1
Wu P, et al. Acupoint Combination Effect of Shenmen (HT 7) and Sanyinjiao (SP 6) in Treating Insomnia: Study Protocol for a Randomized Controlled Trial. Trials. 2020 Mar 12;21(1):261. PubMed PMID: 32164719.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Acupoint combination effect of Shenmen (HT 7) and Sanyinjiao (SP 6) in treating insomnia: study protocol for a randomized controlled trial. AU - Wu,Pei, AU - Cheng,Cisong, AU - Song,Xiaojun, AU - Yang,Ling, AU - Deng,Dandan, AU - Du,Zhenrong, AU - Chen,Xingyu, AU - Zou,Tingting, AU - Qiao,Ling, AU - Li,Na, AU - Zhou,Pingping, AU - Du,Li, AU - Zhu,Yihui, Y1 - 2020/03/12/ PY - 2019/08/08/received PY - 2020/02/13/accepted PY - 2020/3/14/entrez PY - 2020/3/14/pubmed PY - 2020/3/14/medline KW - Acupoint combination KW - Insomnia KW - Randomized controlled trial KW - Sanyinjiao (SP 6) KW - Shenmen (HT 7) KW - Study protocol SP - 261 EP - 261 JF - Trials JO - Trials VL - 21 IS - 1 N2 - BACKGROUND: Insomnia 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/DESIGN: This 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. DISCUSSION: In 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 REGISTRATION: Chinese Clinical Trial Registry, Chi-CTR-1800017483. Registered on 1 August 2018. SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/32164719/Acupoint_combination_effect_of_Shenmen__HT_7__and_Sanyinjiao__SP_6__in_treating_insomnia:_study_protocol_for_a_randomized_controlled_trial_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-020-4170-1 DB - PRIME DP - Unbound Medicine ER -