Neural Regeneration Research ›› 2017, Vol. 12 ›› Issue (5): 831-840.doi: 10.4103/1673-5374.206655

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Cerebral mechanism of puncturing at He-Mu point combination for functional dyspepsia: study protocol for a randomized controlled parallel trial

Shuai Yin1, 2, Yuan Chen1, Du Lei3, Rui-rui Sun1, Ting-ting Ma4, Pei-min Feng4, Zhao-xuan He1, Xue-ling Suo3, Pei-hong Ma1, Yu-zhu Qu1, Ke Qiu1, Miao-miao Jing1, Qi-yong Gong3, Fan-rong Liang1, Jiao Chen1, Fang Zeng1   

  1. 1 Acupuncture and Tuina School/The Third Affiliated Hospital, Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, China; 2 First Affiliated Hospital of Henan University of Traditional Chinese Medicine, Zhengzhou, Henan Province, China; 3 Huaxi MR Research Center, Department of Radiology, West China Hospital of Sichuan University, Chengdu, Sichuan Province, China; 4 First Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Chengdu, Sichuan Province, China
  • Received:2017-05-09 Online:2017-05-15 Published:2017-05-15
  • Contact: Fan-rong Liang or Jiao Chen, M.D., acuresearch@126.com or cjthz@126.com.
  • Supported by:

    The study was financially supported by the National Scientific Foundation Committee in China, No. 81473602; the Education Ministry’s New Century Excellent Talents Supporting Plan in China; the Foundation for the Author of National Excellent Doctoral Dissertation of China, No. 201486; the Youth Foundation of Science and Technology Department of Sichuan Province in China, No. 15QNJJ0008; the National Natural Science Foundation—Excellent Youth Foundation in China, No. 81622052; the 2011 Co-Innovation Center of Sichuan Province named Acupoint Effects of Acupuncture Co-Innovation Center.

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Abstract:

Acupuncture is widely used to treat functional dyspepsia with satisfactory outcomes. Combination of the He and Mu acupoints is commonly used and has a synergistic effect on functional dyspepsia; however, its underlying mechanisms remain unclear. Therefore, a randomized controlled parallel clinical trial is currently underway at Chengdu University of Traditional Chinese Medicine, China. This trial is designed to explore the efficacy of and central responses to the He-Mu point combination in patients with functional dyspepsia using functional magnetic resonance imaging. A total of 105 patients with functional dyspepsia will be allocated into 3 groups: the low-He point group (puncturing at Zusanli (ST36)), Mu point group (puncturing at Zhongwan (CV12)), and He-Mu point combination group (puncturing at ST36 and CV12). Every participant will receive 20 sessions of manual acupuncture for 4 weeks. The needles will be inserted perpendicularly to a depth of 1 to 2 cun. The angle of rotation and twisting will range from 90 to 180 degrees, while lifting and thrusting will range from 0.3 to 0.5 cm. The various manipulations will be performed 60 to 90 times per minute. The needles will remain in place for 30 minutes, during which manipulation will be applied every 10 minutes. Magnetic resonance imaging will be performed before and after 20 sessions of acupuncture. The primary outcome is symptom improvement according to the Chinese version of the Nepean Dyspepsia Index. Secondary outcomes include the Leeds dyspepsia questionnaire, Self-Rating Anxiety Scale, Self-Rating Depression Scale, Beck Anxiety Inventory, Beck Depression Inventory, and visual analogue scale scores before and after 10 and 20 sessions of acupuncture. Needle sensaGraphicaldistion and adverse events will be used to assess the therapeutic effects. This study will promote more widespread awareness of the benefits of acupoint combination in the clinical setting and provide a further explanation of the neuromechanism by which acupuncture at the He-Mu point combination for functional dyspepsia. Registration: Chinese Clinical Trial Registry, ChiCTR-IOR-15006402.

Key words: nerve regeneration, dyspepsia, acupoint combination, acupuncture, traditional Chinese medicine, neuromechanism, functional magnetic resonance imaging, clinical trial, protocol, neural regeneration