scholarly journals Acupuncture for the treatment of diarrheal-predominant irritable bowel syndrome: study protocol for a pilot randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ling-Yu Qi ◽  
Yu Wang ◽  
Li-Qiong Wang ◽  
Yan-Fen She ◽  
Guang-Xia Shi ◽  
...  
Keyword(s):  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Controlled Trial ◽  
Alternative Therapy ◽  
Depression Scale ◽  
Gastrointestinal Diseases ◽  
Controlled Clinical Trial ◽  
Randomized Controlled ◽  
Quality Of Life Scale ◽  
Irritable Bowel

Abstract Background Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal diseases. Although acupuncture has become a common alternative therapy for IBS, there is insufficient evidence for its effectiveness. This study was designed to assess the efficacy and feasibility of acupuncture in the treatment of IBS. Methods/design This is a multicenter randomized controlled clinical trial. According to the ratio of 1:1:1, 90 patients with irritable bowel syndrome will be randomly divided into specific acupoints (SA) group, non-specific acupoints (NSA) group, and non-acupoints (NA) group. All patients will be treated with acupuncture 12 times within 4 weeks and followed up for 8 weeks. The primary outcome is the response rate, the percentage of patients whose average value of worst abdominal pain is 30% better and the days of loose stool is 50% less than the baseline, at week 4 after randomization. The secondary outcomes include the response rates at other time points, IBS Symptom Severity Scale (IBS-SSS), Patient Health Questionnaire-9 depression scale (PHQ-9), IBS-Quality of Life scale (IBS-QOL), IBS Adequate Relief (IBS-AR), Abdominal Pain Score, Abdominal Bloating Score, Bristol Stool Score (BBS), blinding assessment, and credibility evaluation. Adverse events will be monitored and recorded during the trial. Trial registration Chictr.org.cn ChiCTR2000030670. Registered on 9 March 2020.

Hypnotherapy for Children With Functional Abdominal Pain or Irritable Bowel Syndrome: A Randomized Controlled Trial

2007 ◽  
Vol 133 (5) ◽  
pp. 1430-1436 ◽  
Author(s):  
Arine M. Vlieger ◽  
Carla Menko–Frankenhuis ◽  
Simone C.S. Wolfkamp ◽  
Ellen Tromp ◽  
Marc A. Benninga
Keyword(s):  
Randomized Controlled Trial ◽  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Controlled Trial ◽  
Functional Abdominal Pain ◽  
Randomized Controlled ◽  
Irritable Bowel

scholarly journals Acupuncture For The Treatment of Diarrhoea-Predominant Irritable Bowel Syndrome (ATIBS-D): A Pilot Randomized Controlled Trial

2021 ◽  
Author(s):  
Ling-Yu Qi ◽  
Jing-Wen Yang ◽  
Shi-Yan Yan ◽  
Jian-Feng Tu ◽  
Yan-Fen She ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Adverse Events ◽  
Controlled Trial ◽  
Common Disease ◽  
Randomized Controlled ◽  
Multicenter Randomized Controlled Trial ◽  
Irritable Bowel ◽  
Composite Response

Abstract Background: Diarrhoea-predominant irritable bowel syndrome (IBS-D) is a common disease without an established optimal treatment. Acupuncture has promising effects on IBS-D, but high-quality evidence is scarce.Methods: In this parallel, multicenter, randomized controlled trial, participants with IBS-D were assigned to three groups: specific acupoints (SA), non-specific acupoints (NSA) and non-acupoints (NA). Participants received 12 sessions (3 sessions per week) treatment over 4 weeks. The primary endpoint was a composite response rate at week 4 of treatment. An eligible composite responder was responded in both abdominal pain intensity and stool consistency, defined as at least 30% decrease in the weekly average of worst abdominal pain score and 50% or greater reduction in the number of Type 6 or 7 stool days weekly compared with baseline.Results: Of 201 screened patients with IBS-D, 90 (44.8%) patients were enrolled, and 88.9% patients completed this study (26 in NSA; 27 in SA and NA). The composite response rates at week 4 were 46.7%, 46.7% and 26.7% (P＞0.05) of the participants who received SA, NSA and NA acupuncture, respectively. Adverse events were reported in 2 (6.7%) patients in SA, 3 (10%) patients in NSA and NA. There were no serious adverse events.Conclusions: The present study suggests that acupuncture treatment is feasible and safe for IBS-D patients. The further adequately powered trials can be achieved by recruiting more patients, increasing treatment dose, prolonging follow-up, choosing specific acupoints, setting up sham-acupuncture control, or a combination thereof.Trial registration: Chinese Clinical Trial Registry, ChiCTR2000030670. Registered on 9 March 2020. https://www.chictr.org.cn/edit.aspx?pid=50167&htm=4

scholarly journals Effect of Samryungbaekchul-san Combined with Otilonium Bromide on Diarrhea-Predominant Irritable Bowel Syndrome: A Pilot Randomized Controlled Trial

2019 ◽  
Vol 8 (10) ◽  
pp. 1558 ◽  
Author(s):  
Jin-Hyun Lee ◽  
Joong Il Kim ◽  
Myong Ki Baeg ◽  
Yun-Young Sunwoo ◽  
Kwangsun Do ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Multiple Logistic Regression Analysis ◽  
Symptom Improvement ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Irritable Bowel

Conventional and herbal drugs are frequently used together to treat many disorders. Samryungbaekchul-san (SRS, a herbal formula) and otilonium bromide (OB, an antispasmodic agent) are widely used to treat diarrhea-predominant irritable bowel syndrome (D-IBS) in Eastern Asian countries. However, there have been no studies on the co-administration of SRS and OB. Therefore, we aimed to preliminarily assess the feasibility of SRS combined with OB for D-IBS treatment in a pilot double-blind, four-arm, parallel-group, randomized controlled trial (RCT), including 80 patients diagnosed with D-IBS according to the Rome III criteria. The patients were randomly assigned to four treatment groups and were administered drugs for eight weeks after a two-week preparatory period. Follow-up was conducted four weeks after the administration period. The primary outcome was evaluated by using a global D-IBS symptom improvement score; no statistically significant difference was observed between the groups. However, multiple logistic regression analysis of primary outcome scores shows that SRS significantly improved D-IBS symptoms (p < 0.05). For secondary outcomes, better results were observed in the SRS + OB group, in terms of symptoms, including abdominal pain, discomfort, frequency of abdominal pain, and stool form than in OB alone or placebo groups (p < 0.05). In conclusion, the co-administration of SRS and OB might be an effective and safe strategy for the treatment of D-IBS. Large-scale RCTs are warranted to further confirm and clarify these findings.

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