Dataset Information

Efficacy and Safety of a Novel Herbal Medicine in the Treatment of Irritable Bowel Syndrome: A Randomized Double-Blinded Clinical Trial.

ABSTRACT:

Background

The unresponsiveness to conventional pharmacological treatments and their side effects have led patients with irritable bowel syndrome (IBS) to use complementary and alternative medicine such as herbal remedies. Beside, Zataria multiflora Boiss (ZM), Trachyspermum ammi L. (TA), and Anethum graveolens L. (AG) are being used as an antiseptic, carminative, and antispasmodic in traditional medicine. This trial investigated the efficacy and safety of a combination of ZM, AG, and TA essential oils in the treatment of IBS.

Method

The present study was a randomized double-blind clinical trial with parallel groups in Iran. Patients in the control arm received three tablets of 10?mg hyoscine butylbromide daily for two weeks, and the intervention arm was daily treated with two 250?mg softgel capsules containing 180?mg of essential oils of ZM, AG, and TA for two weeks. Primary outcomes were the response rates based on the IBS Symptom Severity Scale (IBS-SSS), IBS Adequate Relief (IBS-AR), and IBS Global Assessment Improvement (IBS-GAI) at the end and two weeks after the end of the intervention. Secondary outcomes were the improvement rates in IBS-SSS scores, improving the quality of life, safety, and tolerability.

Results

The posttreatment improvement percentage based on IBS-AR, IBS-GAI, and IBS-SSS scales was 83.9%, 75%, and 87% in the intervention group and 37.9%, 27.5%, and 34.4% in the control group, respectively (P < 0.001). Also, the improvement of the quality of life in the herbal medicine arm was significantly more than that in the control arm (P < 0.001).

Conclusions

According to the results, the herbal medicine investigated in this study can be considered an appropriate alternative treatment for IBS.

SUBMITTER: Bordbar G

PROVIDER: S-EPMC7273440 | biostudies-literature | 2020

REPOSITORIES: biostudies-literature

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Publications

Efficacy and Safety of a Novel Herbal Medicine in the Treatment of Irritable Bowel Syndrome: A Randomized Double-Blinded Clinical Trial.

Bordbar Ghasem G Miri Mohammad Bagher MB Omidi Mahmoud M Shoja Saeed S Akhavan Malihe M

Gastroenterology research and practice 20200527

<h4>Background</h4>The unresponsiveness to conventional pharmacological treatments and their side effects have led patients with irritable bowel syndrome (IBS) to use complementary and alternative medicine such as herbal remedies. Beside, <i>Zataria multiflora</i> Boiss (ZM), <i>Trachyspermum ammi</i> L. (TA), and <i>Anethum graveolens</i> L. (AG) are being used as an antiseptic, carminative, and antispasmodic in traditional medicine. This trial investigated the efficacy and safety of a combinat ...[more]

PMID: 32565786

Similar Datasets

Project description:Background Irritable bowel syndrome (IBS) is a common gastrointestinal functional disease. Adults with IBS may experience abdominal pain, change of bowel habits, and abnormal stool form without organic disease. IBS can seriously affect their work productivity and quality of life, especially diarrhea-predominant irritable bowel syndrome (IBS-D). The Chinese medicine JCM-16021 has been shown to be potentially effective in improving the symptoms of IBS-D based on a small scale clinical trial. Hence, a large scale clinical study is designed to further evaluate the efficacy and safety of the Chinese medicine JCM-16021 for IBS-D with traditional Chinese medicine (TCM) pattern of Liver Stagnation and Spleen Deficiency (LSSD). Methods This study is a multi-center, randomized, double-blind, placebo-controlled clinical trial. 392 eligible participants will be enrolled with 2-week run-in, 8-week treatment and 8-week follow-up. After run-in period, participants will be randomized to receive either the Chinese medicine JCM-16021 or placebo for 8 weeks, and will have post-treatment follow up for another 8 weeks. The primary outcome is the improvement rate on the global assessment of improvement (GAI) at week 10. The secondary outcomes consist of changes of IBS-D symptoms, TCM pattern improvement, IBS-Quality of Life (IBS-QoL), IBS-Symptom Severity Score (IBS-SSS), safety, etc. Results A standard protocol has been developed for the study. The protocol will provided a detailed procedure to conduct a clinical trial and verify if the Chinese medicine JCM-16021 would significantly improve the overall symptoms of IBS-D with LSSD pattern of TCM by relieving abdominal pain, reducing stool frequency, improving the stool consistency and improving quality of life. The consolidated evidence from the study can shed light on the treatment of IBS-D with Chinese medicine. Conclusion The protocol will provide details for investigators about the study following SPIRIT Statement. High-quality evidence on the efficacy and safety of Chinese medicine JCM-16021 for IBS-D will be provided through strict compliance with the protocol. Trial registration: ClinicalTrial.gov identifier: NCT03457324. Registered 8 February 2018, https://clinicaltrials.gov/ct2/show/NCT03457324?term=NCT03457324&draw=2&rank=1 Supplementary Information The online version contains supplementary material available at 10.1186/s13020-021-00530-2.

Project description:BACKGROUND:Obesity is associated with metabolic syndrome, a condition that increases one's risk for heart disease and other conditions. The prevalence of obesity and associated diseases have steadily increased among Korean adults. The effect of the herbal medicines Daesiho-tang (DSHT) and Chowiseungcheng-tang (CST) on obesity have been reported. The purpose of this study is to evaluate the efficacy and safety of Daesiho-tang and Chowiseungcheng-tang on obese Korean women with high risk for metabolic syndrome. METHODS/DESIGN:This study is a randomized, double-blinded, placebo-controlled, multi-center, 3-arm, parallel group clinical trial. A total of 120 participants will be enrolled and randomly assigned to the Daesiho-tang group, the Chowiseungcheng-tang group, or the placebo group in a 1:1:1 ratio using an internet-based randomization system at visit 2. Each group will be administered DSHT, CST, or placebo 3 times per day for 12 weeks. The primary outcome is to evaluate the changes in mean body weight of participants in the DSHT and CST groups and compare with those in the placebo group, and determine their statistical significance, if any, after 12 weeks. The secondary outcomes are the following: changes in body fat percentage and body fat mass, changes in waist circumference, waist-to-hip ratio, and body mass index, changes in serum lipids, fasting blood sugar, blood pressure, and C-reactive proteins (CRP) levels between visit 1 and visit 5 measurements. Changes in visceral fat volume determined through abdominal computed tomography, patient-reported health outcomes surveys-the Korean version of the Obesity-related Quality of Life and the Korean version of Eating Attitudes Test. DISCUSSION:This study will provide research methodologies for evaluating the efficacy and safety of Daesiho-tang and Chowiseungcheng-tang on obese Korean women with high risk for metabolic syndrome. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02651454. Registered on 11 January 2016.Protocol version: The final approved version of the trial protocol is V1.3.(2017.11.10).

Dataset Information

Efficacy and Safety of a Novel Herbal Medicine in the Treatment of Irritable Bowel Syndrome: A Randomized Double-Blinded Clinical Trial.

Background

Method

Results

Conclusions

Publications

Efficacy and Safety of a Novel Herbal Medicine in the Treatment of Irritable Bowel Syndrome: A Randomized Double-Blinded Clinical Trial.

Similar Datasets

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