Does propolis affect the quality of life and complications in subjects with irritable bowel syndrome (diagnosed with Rome IV criteria)? A study protocol of the randomized, double-blinded, placebo-controlled clinical trial

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

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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

10.21203/rs.3.rs-958987/v1 ◽

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

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Digestive symptoms in daily life of chronic adrenal insufficiency patients are similar to irritable bowel syndrome symptoms

Scientific Reports ◽

10.1038/s41598-021-87158-2 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

L. Quénéhervé ◽

D. Drui ◽

J. Blin ◽

M. Péré ◽

E. Coron ◽

...

Keyword(s):

Quality Of Life ◽

Irritable Bowel Syndrome ◽

Adrenal Insufficiency ◽

Gastrointestinal Symptoms ◽

Control Group ◽

Non Profit ◽

Acute Adrenal Insufficiency ◽

Irritable Bowel ◽

Rome Iv

AbstractGastrointestinal symptoms are frequent in acute adrenal insufficiency. Although digestive symptoms can significantly reduce quality of life, they are rarely described in patients with treated chronic adrenal insufficiency (CAI). We aimed to characterize digestive symptoms in CAI patients. We used the section pertaining functional bowel disorders of the Rome IV questionnaire. A questionnaire was published on the website of the non-profit patient association “Adrenals” (NPPA of CAI patients) for five months. Information on demographics, characteristics of adrenal insufficiency, digestive symptoms and quality of life was collected. The relatives of CAI patients served as a control group. We analyzed responses of 33 control subjects and 119 patients (68 primary adrenal insufficiency (PAI), 30 secondary adrenal insufficiency (SAI) and 21 congenital adrenal hyperplasia (CAH)). Abdominal pain at least once a week over the past 3 months was reported by 40%, 47% and 33% of patients with PAI, SAI and CAH respectively versus 15% for the controls (p = 0.01). Symptoms were consistent with the Rome IV criteria for irritable bowel syndrome in 27%, 33% and 33% of patients respectively versus 6% for the controls (p < 0.0001). Quality of life was described as poor or very poor in 35%, 57% and 24% of patients respectively versus 5% for the controls (p < 0.0001). In conclusion, digestive symptoms are frequent and incapacitating in CAI patients and similar to symptoms of irritable bowel syndrome in 30% of CAI patients. Assessment and management of digestive symptoms should be considered a priority for physicians treating patients with CAI.

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Impact of vitamin D on spirometry findings and quality of life in patients with chronic obstructive pulmonary disease: a randomized, double-blinded, placebo-controlled clinical trial

International Journal of Chronic Obstructive Pulmonary Disease ◽

10.2147/copd.s207400 ◽

2019 ◽

Vol Volume 14 ◽

pp. 1495-1501 ◽

Cited By ~ 4

Author(s):

Ali Alavi Foumani ◽

Mojtaba Mehrdad ◽

Alireza Jafarinezhad ◽

Khadijeh Nokani ◽

Alireza Jafari

Keyword(s):

Quality Of Life ◽

Chronic Obstructive Pulmonary Disease ◽

Clinical Trial ◽

Vitamin D ◽

Pulmonary Disease ◽

Controlled Clinical Trial ◽

Chronic Obstructive ◽

Obstructive Pulmonary Disease ◽

Double Blinded

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Case management in oncology rehabilitation (CAMON): The effect of case management on the quality of life in patients with cancer after one year of ambulant rehabilitation. A study protocol for a randomized controlled clinical trial in oncology rehabilitation

Trials ◽

10.1186/1745-6215-12-103 ◽

2011 ◽

Vol 12 (1) ◽

Cited By ~ 7

Author(s):

Irene Bachmann-Mettler ◽

Claudia Steurer-Stey ◽

Oliver Senn ◽

Mathyas Wang ◽

Katarina Bardheci ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Case Management ◽

Study Protocol ◽

Controlled Clinical Trial ◽

Randomized Controlled Clinical Trial ◽

Patients With Cancer ◽

Randomized Controlled ◽

One Year

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Effect of Multispecies Probiotic Supplementation on Irritable Bowel Syndrome

Journal of Pharmaceutical Research International ◽

10.9734/jpri/2019/v28i630221 ◽

2019 ◽

pp. 1-9

Author(s):

Saeed Yazdani Ashtiani ◽

Mersad Amery

Keyword(s):

Quality Of Life ◽

Irritable Bowel Syndrome ◽

Abdominal Pain ◽

Therapeutic Option ◽

Intervention Group ◽

Control Group ◽

Controlled Clinical Trial ◽

Probiotic Supplementation ◽

Irritable Bowel

Background: Irritable bowel syndrome (IBS) is a common, chronic and sometimes disabling functional disorder of the gastrointestinal system and its treatment remains as health problem. Thus the aim of this study was to evaluate the Effect of multispecies probiotic supplementation, as a novel and Controversial therapeutic method on Irritable bowel syndrome. Materials and Methods: In this randomized double blind Placebo-controlled clinical trial, 60 patients with IBS were enrolled. The patients were divided randomly into two groups. Patients in intervention group received two 500 mg probiotic capsules (Familact®) and in control group, received two 500 mg placebo capsules daily for 30 consecutive days. The symptoms and quality of life were measured and compared at the beginning and just after the end of study for each case. Results: Results showed the mean score of Abdominal pain after 1 month of treatment in the probiotic group was significantly lower than the control group (1.76 ± 2.04 vs. 2.88 ± 2.25, P=0.049, respectively). While, other symptoms and quality of life did not change significantly (P>0.05). Furthermore, defecation habit and global symptoms improvement was similar after intervention in both groups and we did not observe significant differences in these items (P>0.05). Conclusion: The results of this study showed the beneficial effects of multispecies probiotic supplementation in controlling IBS patients’ abdominal pain. thus it can be prescribed as a therapeutic option in addition to standard therapy and significantly lead to better control of this symptom in the short term.

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Neuromodulators in the Brain-Gut Axis: their Role in the Therapy of the Irritable Bowel Syndrome

Journal of Gastrointestinal and Liver Diseases ◽

10.15403/jgld-4090 ◽

2021 ◽

Author(s):

Mihaela Fadgyas Stanculete ◽

Dan Lucian Dumitrascu ◽

Douglas Drossman

Keyword(s):

Quality Of Life ◽

Irritable Bowel Syndrome ◽

Evidence Based ◽

Health Related Quality ◽

Related Quality ◽

Health Related ◽

Irritable Bowel ◽

The Brain ◽

Rome Iv

Irritable bowel syndrome (IBS) is a clinically well-defined chronic condition that is now understood as a disorder of gut-brain regulation, as established in the work of the Rome IV committees coordinated by Drossman, 2016. People with IBS often report high disability levels and poor health-related quality of life. Drug therapy focuses on reducing main symptoms and disability and improving health-related quality of life. Central neuromodulators reduce IBS symptoms by targeting dysregulated pain and motility related to gut-brain dysregulation. It can also treat associated mental health symptoms. Based on their multiple effects on central and peripheral mechanisms, neuromodulators have been used to treat IBS patients. This review presents the rationale supporting medication treatments for specific IBS symptoms, discusses evidence-based management of IBS with central neuromodulators, and reviews the progress in the research for new neuromodulators.

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The Effectiveness of Combination of Viola odorata L., Rosa damascena Mill. and Coriandrum sativum L. on Quality of Life of Patients with Migraine Headaches: A Randomized, Double Blinded, Placebo - Controlled Clinical Trial

Traditional and Integrative Medicine ◽

10.18502/tim.v4i4.2139 ◽

2019 ◽

Author(s):

Mohadese Kamali ◽

Haleh Tajadini ◽

Rostam Seifadini ◽

Mitra Mehrabani ◽

Yunes Jahani ◽

...

Keyword(s):

Quality Of Life ◽

Clinical Trial ◽

Coriandrum Sativum ◽

Control Group ◽

Controlled Clinical Trial ◽

Rosa Damascena ◽

Viola Odorata ◽

Migraine Headaches ◽

Double Blinded

Headache is one of the most common public health problems in the world, which causes patients to see a doctor. Migraine is the second most common cause of headaches after tension headaches. This study is a randomized, double blinded, placebo - controlled clinical trial, using SF36 questionnaire, to evaluate the effect of combination of Viola odorata L., Rosa damascena Mill. and Coriandrum sativum L. on the quality of life, in patients with migraine after 4 weeks. In all domains of the SF36 questionnaire, the scores after intervention in the drug group were significantly higher than the control group after 4 weeks. This study showed that, combination of V. odorata, R. damascena and C. sativum, improves the quality of life of patients with migraine.

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