Moxibustion treatment for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized controlled trial

doi:10.1186/s12906-016-1386-4

Randomized Controlled Trial

. 2016 Oct 24;16(1):408.

doi: 10.1186/s12906-016-1386-4.

Moxibustion treatment for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized controlled trial

Chunhui Bao¹, Jingzhi Zhang¹, Jinmei Liu¹, Huirong Liu¹, Luyi Wu¹, Yin Shi², Jing Li³, Zhihai Hu⁴, Yongzheng Dong¹, Siyao Wang¹, Xiaoqing Zeng⁵, Huangan Wu⁶

Affiliations

¹ Key Laboratory of Acupuncture and Immunological Effects, Shanghai University of Traditional Chinese Medicine, 650 South Wanping Road, Shanghai, 200030, China.
² Outpatient Department, Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China.
³ Department of Acupuncture-Moxibustion, Yueyang Integrated Chinese and Western Medicine Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.
⁴ Department of Acupuncture-Moxibustion, Shanghai Traditional Chinese Medicine-Integrated Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200082, China.
⁵ Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.
⁶ Key Laboratory of Acupuncture and Immunological Effects, Shanghai University of Traditional Chinese Medicine, 650 South Wanping Road, Shanghai, 200030, China. wuhuangan@126.com.

PMID: 27776494
PMCID: PMC5075981
DOI: 10.1186/s12906-016-1386-4

Randomized Controlled Trial

Moxibustion treatment for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized controlled trial

Chunhui Bao et al. BMC Complement Altern Med. 2016.

. 2016 Oct 24;16(1):408.

doi: 10.1186/s12906-016-1386-4.

Authors

Chunhui Bao¹, Jingzhi Zhang¹, Jinmei Liu¹, Huirong Liu¹, Luyi Wu¹, Yin Shi², Jing Li³, Zhihai Hu⁴, Yongzheng Dong¹, Siyao Wang¹, Xiaoqing Zeng⁵, Huangan Wu⁶

Affiliations

¹ Key Laboratory of Acupuncture and Immunological Effects, Shanghai University of Traditional Chinese Medicine, 650 South Wanping Road, Shanghai, 200030, China.
² Outpatient Department, Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China.
³ Department of Acupuncture-Moxibustion, Yueyang Integrated Chinese and Western Medicine Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200437, China.
⁴ Department of Acupuncture-Moxibustion, Shanghai Traditional Chinese Medicine-Integrated Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 200082, China.
⁵ Department of Gastroenterology, Zhongshan Hospital, Fudan University, Shanghai, 200032, China.
⁶ Key Laboratory of Acupuncture and Immunological Effects, Shanghai University of Traditional Chinese Medicine, 650 South Wanping Road, Shanghai, 200030, China. wuhuangan@126.com.

PMID: 27776494
PMCID: PMC5075981
DOI: 10.1186/s12906-016-1386-4

Abstract

Background: Irritable bowel syndrome (IBS) is a worldwide disease with high morbidity. The effect of current treatment with Western medicine is not satisfactory. Although moxibustion treatment is widely used for gastrointestinal diseases, randomized controlled trials on the use of this treatment for IBS are limited. This study aims to evaluate the clinical efficacy and safety of moxibustion treatment in patients with diarrhea-predominant irritable bowel syndrome (IBS-D).

Methods/design: A multi-center, randomized, single-blind and placebo-controlled trial is employed. 104 cases will be divided into two groups: (1) a mild-warm moxibustion group in which moxa stick is 3-5 cm away from acupuncture points and the skin temperature is maintained at 43 ± 1 °C; and (2) a placebo moxibustion group in which moxa stick is 8-10 cm away from acupuncture points and the skin temperature is maintained at 37 ± 1 °C. Moxibustion is performed on bilateral ST25 and ST36 in the two groups for 30 min each time, three times a week for 6 weeks. The patients are followed up at the 12th and 18th weeks. Adequate relief is used as a primary outcome measure; IBS symptom severity score, Bristol stool form scale, IBS quality-of-life questionnaire, and hospital anxiety and depression scale are used as secondary outcome measures.

Discussion: This study aims to demonstrate the safety and efficacy of moxibustion treatment for IBS-D, which may validate moxibustion as an effective therapy for treating IBS-D.

Trial registration: ClinicalTrials.gov identifier NCT02421627 (8 April 2015).

Keywords: Diarrhea; Irritable bowel syndrome; Moxibustion; Randomized controlled trial.

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References

1. Keszthelyi D, Troost FJ, Masclee AA. Irritable bowel syndrome: methods, mechanisms, and pathophysiology. Methods to assess visceral hypersensitivity in irritable bowel syndrome. Am J Physiol Gastrointest Liver Physiol. 2012;303:G141–54. doi: 10.1152/ajpgi.00060.2012. - DOI - PubMed
1. Chey WD, Kurlander J, Eswaran S. Irritable bowel syndrome: a clinical review. JAMA. 2015;313:949–58. doi: 10.1001/jama.2015.0954. - DOI - PubMed
1. Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012;10(7):712–721.e4. doi: 10.1016/j.cgh.2012.02.029. - DOI - PubMed
1. Soubieres A, Pimentel M, Purdy C, Magar R. Inclusion of a novel IBS blood panel for diagnosing diarrhea predominant irritable bowel syndrome (IBS-D): a UK perspective. Value Health. 2015;18:A350. doi: 10.1016/j.jval.2015.09.634. - DOI - PubMed
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[1] Keszthelyi D, Troost FJ, Masclee AA. Irritable bowel syndrome: methods, mechanisms, and pathophysiology. Methods to assess visceral hypersensitivity in irritable bowel syndrome. Am J Physiol Gastrointest Liver Physiol. 2012;303:G141–54. doi: 10.1152/ajpgi.00060.2012. - DOI - PubMed

[2] Keszthelyi D, Troost FJ, Masclee AA. Irritable bowel syndrome: methods, mechanisms, and pathophysiology. Methods to assess visceral hypersensitivity in irritable bowel syndrome. Am J Physiol Gastrointest Liver Physiol. 2012;303:G141–54. doi: 10.1152/ajpgi.00060.2012. - DOI - PubMed

[3] Chey WD, Kurlander J, Eswaran S. Irritable bowel syndrome: a clinical review. JAMA. 2015;313:949–58. doi: 10.1001/jama.2015.0954. - DOI - PubMed

[4] Chey WD, Kurlander J, Eswaran S. Irritable bowel syndrome: a clinical review. JAMA. 2015;313:949–58. doi: 10.1001/jama.2015.0954. - DOI - PubMed

[5] Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012;10(7):712–721.e4. doi: 10.1016/j.cgh.2012.02.029. - DOI - PubMed

[6] Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012;10(7):712–721.e4. doi: 10.1016/j.cgh.2012.02.029. - DOI - PubMed

[7] Soubieres A, Pimentel M, Purdy C, Magar R. Inclusion of a novel IBS blood panel for diagnosing diarrhea predominant irritable bowel syndrome (IBS-D): a UK perspective. Value Health. 2015;18:A350. doi: 10.1016/j.jval.2015.09.634. - DOI - PubMed

[8] Soubieres A, Pimentel M, Purdy C, Magar R. Inclusion of a novel IBS blood panel for diagnosing diarrhea predominant irritable bowel syndrome (IBS-D): a UK perspective. Value Health. 2015;18:A350. doi: 10.1016/j.jval.2015.09.634. - DOI - PubMed

[9] Camilleri M. Management of the irritable bowel syndrome. Gastroenterology. 2001;120:652–68. doi: 10.1053/gast.2001.21908. - DOI - PubMed

[10] Camilleri M. Management of the irritable bowel syndrome. Gastroenterology. 2001;120:652–68. doi: 10.1053/gast.2001.21908. - DOI - PubMed

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Moxibustion treatment for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized controlled trial

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Moxibustion treatment for diarrhea-predominant irritable bowel syndrome: study protocol for a randomized controlled trial

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