scholarly journals Sa2030 – Randomized Clinical Trial to Compare Two Dietary Interventions in the Improvement of Symptoms and Quality of Life in Patients with Irritable Bowel Syndrome

2019 ◽  
Vol 156 (6) ◽  
pp. S-478
Author(s):  
Enrique Coss-Adame ◽  
Maria F. Huerta de la Torre ◽  
Maria F. Garcia Cedillo ◽  
Emmanuel Martinez Hernandez ◽  
Viviana Villegas-Cervantes ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Irritable Bowel Syndrome ◽  
Randomized Clinical Trial ◽  
Dietary Interventions ◽  
Irritable Bowel

scholarly journals Effectiveness of Two Dietary Approaches on the Quality of Life and Gastrointestinal Symptoms of Individuals with Irritable Bowel Syndrome

2020 ◽  
Vol 9 (1) ◽  
pp. 125 ◽  
Author(s):  
Maria Margarida Guerreiro ◽  
Zélia Santos ◽  
Elisabete Carolino ◽  
Julieta Correa ◽  
Marilia Cravo ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Irritable Bowel Syndrome ◽  
Gastrointestinal Symptoms ◽  
Standard Diet ◽  
Before And After ◽  
Irritable Bowel ◽  
Fodmap Diet ◽  
Third Moment

To evaluate the effectiveness of a low FODMAP (fermentable oligosaccharides, monosaccharaides, disaccharides and polyols) diet in the relief of symptoms and an improvement of the quality of life in individuals with irritable bowel syndrome in comparison to a standard diet according to the British Dietetic Association’s guidelines. A non-randomized clinical trial of adult patients with IBS was compared two diet interventions. An assessment of symptoms, quality of life, and nutritional status was performed before and after the four-week mark of intervention. Individuals from the Low FODMAP Diet (LFD) group were evaluated on a third moment, after the controlled reintroduction of FODMAPs. A total of 70 individuals were divided in two groups: Low FODMAP Diet (LFD; n = 47) and Standard Diet (SD; n = 23). 57 individuals completed the four-week intervention (LFD; n = 39; SD; n = 18). At the completion of four weeks, the symptoms improved in both groups (LFD: p < 0.01; DC: p < 0.05) but LFD led to a higher relief (p < 0.05), primarily with respect to abdominal pain and diarrhoea. Quality of life improved significantly in both groups, with no significant differences between SD vs LFD (p > 0.05). In the LFD group, the relief of symptoms observed at the four-week mark remained constant after reintroduction of FODMAPs. Both interventions seem to be effective for the relief of symptoms and quality of life, however LFD had higher effectiveness in the former. The results with LFD suggest it can be a preferred approach in individuals with diarrhoeal profile.

Efficacy and safety of Achillea wilhelmsii C. Koch capsules on symptom severity and quality of life in patients with irritable bowel syndrome: a randomized, placebo-controlled clinical trial

2019 ◽  
Vol 16 (4) ◽  
Author(s):  
Padide Derakhshande ◽  
Seyed Jafar Navabi ◽  
Yalda Shokoohinia ◽  
Hojjat Rouhi-Broujeni ◽  
Fateme Deris ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Irritable Bowel Syndrome ◽  
Symptom Severity ◽  
Significant Difference ◽  
Before And After ◽  
The Mean ◽  
Achillea Wilhelmsii ◽  
Irritable Bowel

Abstract Background Irritable bowel syndrome (IBS) is one of the most common digestive diseases. The aim of this clinical trial was to determine the effectiveness of Achillea wilhelmsii C. Koch on the symptom severity and quality of life (QOL) in patients with IBS. Methods The patients were randomized into two groups of 45 each. The QOL and symptom severity of the patients were evaluated at baseline and at completion of the treatments by means of IBS-QOL and IBS severity index. Results The mean severity of clinical symptoms in the Achillea wilhelmsii C. Koch receiving groups before and after the treatment was 282.56 ± 103.57 and 178.06 ± 88.40, and in the placebo group was 265.93 ± 93.56 and 197.74 ± 106.26, respectively. The mean QOL in the Achillea wilhelmsii C. Koch receiving group before and after treatment was 51.49 ± 11.98 and 50.44 ± 13.39 and in the placebo group was 60.71 ± 11.97 and 58.39 ± 11.67, respectively. In both groups, there was a significant difference in the recovery rate in each group (p<0.05). However, the mean difference between the two groups before and after intervention was not significantly different (p>0.05). Also, no patient reported any adverse events during the trial. Although the symptom severity and QOL in both groups were improved compared to those before intervention, there was no significant difference between the two groups. Conclusion It is recommended to conduct future studies with larger sample size and longer treatment periods, and also investigate the efficacy on the IBS subtypes, separately.

scholarly journals Efficacy and safety of Chinese medicine JCM-16021 for diarrhea-predominant irritable bowel syndrome: study protocol for a multi-center, randomized, double-blind, placebo controlled clinical trial

2021 ◽  
Vol 16 (1) ◽  
Author(s):  
Ya Zheng ◽  
Jessica Ching ◽  
Chung Wah Cheng ◽  
Wai Ching Lam ◽  
Kam Leung Chan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Irritable Bowel Syndrome ◽  
Chinese Medicine ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Irritable Bowel

Abstract 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

Efficacy and Safety of Chinese Medicine JCM-16021 for Diarrhea-predominant Irritable Bowel Syndrome: Study Protocol for a Multi-center, Randomized, Double-blind, Placebo Controlled Clinical Trial

2021 ◽  
Author(s):  
Ya Zheng ◽  
Jessica Ching ◽  
Chung-wah Cheng ◽  
Wai-ching Lam ◽  
Kam-Leung Chan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Irritable Bowel Syndrome ◽  
Chinese Medicine ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Irritable Bowel

Abstract 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). Chinese Herbal 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 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 two-week run-in, eight-week treatment and eight-week follow-up. After run-in period, participants will be randomized to receive either JCM-16021 or placebo for eight 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

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

2020 ◽  
Vol 2020 ◽  
pp. 1-11
Author(s):  
Ghasem Bordbar ◽  
Mohammad Bagher Miri ◽  
Mahmoud Omidi ◽  
Saeed Shoja ◽  
Malihe Akhavan
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Irritable Bowel Syndrome ◽  
Herbal Medicine ◽  
Essential Oils ◽  
Herbal Remedies ◽  
Control Group ◽  
Efficacy And Safety ◽  
Irritable Bowel

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.

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