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Efficacy of electroacupuncture compared with transcutaneous electric nerve stimulation for functional constipation: Study protocol for a randomized, controlled trial.

ABSTRACT: To treat functional constipation, both electroacupuncture (EA) therapy and transcutaneous electric nerve stimulation (TENS) are safe and effective. However, no head-to-head comparison trial has been conducted. This trial compares the efficacy of electroacupuncture relative to transcutaneous electric nerve stimulation for functional constipation.Individuals with functional constipation will be randomly allocated to receive either EA or TENS (n?=?51, each), 3 times per week for 8 weeks. The primary outcome is the percentage of participants with an average increase from baseline of 1 or more complete spontaneous bowel movements at week 8. The secondary outcome measures are the following: at the time of visits, changes in the number of complete spontaneous bowel movements, number of spontaneous bowel movements, stool character, difficulty in defecation, patients' assessment of quality of life regarding constipation (self-report questionnaire), and use of auxiliary defecation methods.The results of this trial should verify whether EA is more efficacious than TENS for relieving symptoms of functional constipation. The major limitation of the study is the lack of blinding of the participants and acupuncturist.

SUBMITTER: Zeng Y

PROVIDER: S-EPMC5959392 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Efficacy of electroacupuncture compared with transcutaneous electric nerve stimulation for functional constipation: Study protocol for a randomized, controlled trial.

Zeng Yuxiao Y Zhang Xuecheng X Zhou Jing J Wang Xinwei X Jiao Ruimin R Liu Zhishun Z

Medicine 20180501 19

<h4>Background</h4>To treat functional constipation, both electroacupuncture (EA) therapy and transcutaneous electric nerve stimulation (TENS) are safe and effective. However, no head-to-head comparison trial has been conducted. This trial compares the efficacy of electroacupuncture relative to transcutaneous electric nerve stimulation for functional constipation.<h4>Methods</h4>Individuals with functional constipation will be randomly allocated to receive either EA or TENS (n = 51, each), 3 tim ...[more]

PMID: 29742718

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Project description:BackgroundTranscutaneous electrical nerve stimulation (TENS) involves a neuromodulatory effect using electrical stimulation and has been widely used due to its safety and convenience. It has been used for treating tinnitus for decades. Acupuncture has also been used for tinnitus and several research studies have shown that acupuncture can improve a certain kind of tinnitus by stimulating the somatosensory system. Moreover, several studies have shown the efficacy of electroacupuncture, which is a combination of acupuncture and electrical stimulation, for tinnitus. However, the comparative effectiveness of TENS, manual acupuncture, and electroacupuncture for the treatment of tinnitus has not been determined previously. Herein, we design a randomized, non-blind clinical trial to investigate and compare the effects and safety of TENS, manual acupuncture, and electroacupuncture for tinnitus.MethodsAfter screening, 45 patients are randomly assigned to three groups: (1) patients in the TENS group are treated at four sites (tender points of masseter and the sternocleidomastoid muscle, in front of tragus, and mastoid process); (2) the manual acupuncture group patients are treated at 11 acupoints (TE21, SI19, GB2, TE22, ST7, TE17, GB20 of tinnitus affected side, and GB20, TE05, KI3 of both sides); (3) electroacupuncture group patients are treated by using acupuncture as in the manual acupuncture group and electrical stimulation at TE21, SI19, TE17, and GB20. Patients are treated for ten sessions, twice a week. The primary outcome measurement is the change of Tinnitus Handicap Inventory (THI) score between visit 1 and visit 10. The secondary outcome measurements are the response rate of THI, change in visual analogue scale associated with the loudness and annoyance of tinnitus, pure-tone audiometry and speech discrimination, and changes in parameters of heart rate variability.DiscussionThe purpose of this study is to compare the effect of TENS, manual acupuncture, and electroacupuncture in the auricular area on tinnitus. If the specific treatment shows a significant effect compared to other treatments, it could have potential for use in clinical practice as a primary treatment.Trial registrationClinical Research Information Service (CRIS), KCT0002117 . Registered October 21, 2016. Retrospectively registered.

Project description:BACKGROUND:At present, drug therapy for diarrhea-predominant irritable bowel syndrome (IBS-D) has made great progress; however, it does not often produce a satisfying curative effect. Transcutaneous electric nerve stimulation over acupoints (Acu-TENS) might be more effective in improving patient's symptoms and producing fewer side-effects as a result.Although with a great progress of the drug therapy for IBS-D, it is often hard to achieve its satisfactory curative effect. Acu-TENS that may be effective to improve patients' symptoms and fewer side-effects will be sought. There is no systematic review concerning the efficacy of Acu-TENS for IBS-D published. Therefore, this review aims to systematically evaluate the efficacy of Acu-TENS on IBS-D. METHODS:Four English (PubMed, EMBASE, The Cochrane Library, Web of Science) and 4 Chinese electronic databases (Biomedical Literature Database, CNKI, VIP, Wanfang Database) will be searched from their inception to November 26, 2018. Randomized controlled trials that evaluated the effect of Acu-TENS on patients with IBS-D will be included. The primary outcome measures will include average weekly stool frequency, visual analog scale (VAS), and the Bristol scale. The secondary outcome measures will include the MOS 36-item short-form health survey (SF-36), IBS Quality of Life Questionnaire (IBS-QOL), severity of IBS symptoms (IBS-SSS), and rectal perception. Quality evaluation and data extraction will be independently undertaken, respectively. The data from the eligible trials will be analyzed by RevMan5.3. RESULTS:For patients with IBS-D, this systematic review will provide evidences related to the efficacy of Acu-TENS in these evaluation aspects, stool frequency, VAS and the Bristol scale, SF-36, IBS-QOL, IBS-SSS, and rectal perception. CONCLUSION:This evidence may be useful to medical workers with regard to the use of Acu-TENS in the treatment of IBS-D.PROSPERO registration number: PROSPERO CRD442018109294.

Dataset Information

Efficacy of electroacupuncture compared with transcutaneous electric nerve stimulation for functional constipation: Study protocol for a randomized, controlled trial.

Publications

Efficacy of electroacupuncture compared with transcutaneous electric nerve stimulation for functional constipation: Study protocol for a randomized, controlled trial.

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