scholarly journals Is Irritable Bowel Syndrome Considered as Comorbidity in Clinical Trials of Physical Therapy Interventions in Fibromyalgia? A Scoping Review

2021 ◽  
Vol 10 (20) ◽  
pp. 4776
Author(s):  
Paula Mª Rodríguez-Castillejo ◽  
César Fernández-de-las-Peñas ◽  
Francisco Alburquerque-Sendín ◽  
Daiana P. Rodrigues-de-Souza
Keyword(s):  
Clinical Trials ◽  
Irritable Bowel Syndrome ◽  
Physical Therapy ◽  
Selection Criteria ◽  
Journal Citation Report ◽  
High Impact ◽  
Eligibility Criteria ◽  
Irritable Bowel ◽  
Evidence Database ◽  
Highly Cited

Evidence supports the presence of comorbid conditions, e.g., irritable bowel syndrome (IBS), in individuals with fibromyalgia (FM). Physical therapy plays an essential role in the treatment of FM; however, it is not currently known whether the IBS comorbidity is considered in the selection criteria for clinical trials evaluating physiotherapy in FM. Thus, the aim of the review was to identify whether the presence of IBS was considered in the selection criteria for study subjects for those clinical trials that have been highly cited or published in the high-impact journals investigating the effects of physical therapy in FM. A literature search in the Web of Science database for clinical trials that were highly cited or published in high-impact journals, i.e., first second quartile (Q1) of any category of the Journal Citation Report (JCR), investigating the effects of physical therapy in FM was conducted. The methodological quality of the selected trials was assessed with the Physiotherapy Evidence Database (PEDro) scale. Authors, affiliations, number of citations, objectives, sex/gender, age, and eligibility criteria of each article were extracted and analyzed independently by two authors. From a total of the 412 identified articles, 20 and 61 clinical trials were included according to the citation criterion or JCR criterion, respectively. The PEDro score ranged from 2 to 8 (mean: 5.9, SD: 0.1). The comorbidity between FM and IBS was not considered within the eligibility criteria of the participants in any of the clinical trials. The improvement of the eligibility criteria is required in clinical trials on physical therapy that include FM patients to avoid selection bias.

scholarly journals Is Irritable Bowel Syndrome Considered in Clinical Trials on Physical Therapy Applied to Patients with Temporo-Mandibular Disorders? A Scoping Review

2020 ◽  
Vol 17 (22) ◽  
pp. 8533
Author(s):  
Daiana P. Rodrigues-de-Souza ◽  
Javier Paz-Vega ◽  
César Fernández-de-las-Peñas ◽  
Joshua A. Cleland ◽  
Francisco Alburquerque-Sendín
Keyword(s):  
Clinical Trials ◽  
Irritable Bowel Syndrome ◽  
Physical Therapy ◽  
Scoping Review ◽  
Randomized Clinical Trials ◽  
Journal Citation Report ◽  
High Impact ◽  
Eligibility Criteria ◽  
Irritable Bowel ◽  
Journal Citation

The aim of the current scoping review was to identify if the presence of irritable bowel syndrome was included as eligibility criteria of participants included in clinical trials investigating the effects of physical therapy in individuals with temporomandibular pain disorders (TMDs). A systematic electronic literature search in the Web of Science database was conducted. Scientifically relevant, randomized clinical trials (those cited in other studies at least 5 times, or clinical trials published in high-impact journals, i.e., first and second quartiles (Q1-Q2) of any category of the Journal Citation Report (JCR)) evaluating the effects of any physical therapy intervention in patients with TMDs were included. The Physiotherapy Evidence Database (PEDro) scale was used to evaluate the methodological quality of the selected trials. Authors affiliated to a clinical or non-clinical institution, total number of citations, objective, sex/gender, age, and eligibility criteria in each article were extracted and analyzed independently by two authors. From a total of 98 identified articles, 12 and 19 clinical trials were included according to the journal citation criterion or JCR criterion, respectively. After removing duplicates, a total of 23 trials were included. The PEDro score ranged from 4 to 8 (mean: 6.26, SD: 1.48). Based on the eligibility criteria of the trials systematically reviewed, none considered the presence of comorbid irritable bowel syndrome in patients with TMDs. The comorbidity between TMDs and irritable bowel syndrome is not considered within the eligibility criteria of participants in highly cited clinical trials, or published in a high-impact journal, investigating the effects of physical therapy in TMDs.

Rome I versus Rome II; Overlap in patients enrolled in tegaserod phase III clinical trials for irritable bowel syndrome (IBS)

2001 ◽  
Vol 120 (5) ◽  
pp. A284-A284
Author(s):  
B NAULT ◽  
S SUE ◽  
J HEGGLAND ◽  
S GOHARI ◽  
G LIGOZIO ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Irritable Bowel Syndrome ◽  
Phase Iii ◽  
Phase Iii Clinical Trials ◽  
Irritable Bowel ◽  
Rome I

Su1383 Effects of Eluxadoline on Abdominal Pain in Patients With Irritable Bowel Syndrome With Diarrhea: Results of 2 Phase 3 Clinical Trials

2015 ◽  
Vol 148 (4) ◽  
pp. S-493 ◽  
Author(s):  
Anthony Lembo ◽  
Scott Dove ◽  
David Andrae ◽  
Lisa Turner ◽  
J. Michael Davenport ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Irritable Bowel Syndrome ◽  
Abdominal Pain ◽  
Phase 3 ◽  
Irritable Bowel

Digital instruments for reporting of gastrointestinal symptoms in clinical trials: comparison of end-of-day diaries versus experience sampling method (Preprint)

2021 ◽  
Author(s):  
Abraham B. Beckers ◽  
Johanna T.W. Snijkers ◽  
Zsa Zsa R.M. Weerts ◽  
Lisa Vork ◽  
Tim Klaassen ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trial ◽  
Irritable Bowel Syndrome ◽  
Sampling Method ◽  
Sampling Methods ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Randomized Controlled ◽  
Pre Treatment ◽  
Irritable Bowel

BACKGROUND Questionnaires are necessary tools for assessing symptoms of disorders of the brain-gut interaction in clinical trials. We previously reported on the excellent compliance to a smartphone app used as symptom diary in a randomized clinical trial in irritable bowel syndrome (IBS). Other sampling methods, such as the experience sampling method (ESM), are better equipped to measure symptom variability over time, provide useful information regarding possible symptom triggers and are free of ecological and recall bias. The high frequency of measurements, however, could limit the feasibility of ESM in clinical trials. OBJECTIVE This study aimed to compare compliance rates of a smartphone-based end-of-day diary and ESM for symptom assessment in irritable bowel syndrome and functional dyspepsia (FD). METHODS Data from four studies were included. Patients with IBS participated in a randomized controlled trial, which involved a smartphone end-of-day diary of 2+8 weeks (pre-treatment + treatment period), and an observational study, during which patients completed ESM assessments using a smartphone application for one week. Patients with FD participated in a randomized controlled trial, which involved a smartphone end-of-day diary of 2+12 weeks (pre-treatment + treatment period), and an observational study, during which patients completed ESM assessments using a smartphone application for one week. Compliance rates were compared between these two symptom sampling methods. RESULTS Twenty-five patients with IBS and fifteen patients with FD were included. Overall compliance rates for the end-of-day diaries were significantly higher than for ESM (IBS: 92.7% versus 69.8%, FD: 90.1% versus 61.4%, respectively). CONCLUSIONS We here demonstrate excellent compliance rates for smartphone application-based end-of-day diaries as used in two separate clinical trials. Overall compliance rates for ESM were significantly lower, rendering it more suitable for intermittent sampling periods rather than continuously during longer clinical trials.

Validation of global improvement scale in irritable bowel syndrome (IBS) symptoms as an endpoint in IBS clinical trials

2001 ◽  
Vol 120 (5) ◽  
pp. A756
Author(s):  
Priti Jhingran ◽  
Barbara A. Bagby ◽  
Britt S. Carr ◽  
Susan H. Gordon ◽  
Michael Markowitz ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Irritable Bowel Syndrome ◽  
Global Improvement ◽  
Irritable Bowel
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