Definition of a responder in clinical trials for functional gastrointestinal disorders: report on a symposium

Whitehead, W. E.; Corazziari, E.; Prizont, Roberto; Senior, John R.; Thompson, W G; Zanten, S. J. O. Veldhuyzen Van

doi:10.1136/gut.45.2008.ii78

Cited by 31 publications

(31 citation statements)

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“…Although the Rome II panel identified the need for standardized outcome measures, they could not agree on what specific outcomes should be used. 60 Nevertheless, they did agree that outcomes should be reported by the patient rather than by the clinician or the researcher; a standardized scale should be used to measure pain episodes; and a predefined criterion of clinical significance should be used with efficacy on the basis of the percentage of patients who meet that criterion. In addition, because Apley's original definition of RAP referred to painful episodes that interfere with normal activities, we believe that some measure of disability, such as school absences, should also be reported.…”

Section: Discussionmentioning

confidence: 99%

Systematic Review of Treatments for Recurrent Abdominal Pain

Weydert

Ball²,

Davis³

2003

Pediatrics

193

100

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ABSTRACT.Objective. To conduct a systematic review of evaluated treatments for recurrent abdominal pain (RAP) in children.Methods. Online bibliographic databases were searched for the terms "recurrent abdominal pain," "functional abdominal pain," "children," or "alternative therapies" in articles classified as randomized controlled trials. The abstracts or full text of 57 relevant articles were examined; 10 of these met inclusion criteria. Inclusion criteria required that the study involve children aged 5 to 18 years, subjects have a diagnosis of RAP, and that subjects were allocated randomly to treatment or control groups. The methodology and findings of these articles were evaluated critically, and data were extracted from each article regarding study methods, specific interventions, outcomes measured, and results.Results. Studies that evaluated famotidine, pizotifen, cognitive-behavioral therapy, biofeedback, and peppermint oil enteric-coated capsules showed a decrease in measured pain outcomes for those who received the interventions when compared with others in control groups. The studies that evaluated dietary interventions had conflicting results, in the case of fiber, or showed no efficacy, in the case of lactose avoidance.Conclusions. Evidence for efficacy of treatment of RAP in children was found for therapies that used famotidine, pizotifen, cognitive-behavioral therapy, biofeedback, and peppermint oil enteric-coated capsules. The effects of dietary fiber were less conclusive, and the use of a lactose-free diet showed no improvement. There seemed to be greater improvement when therapy (famotidine, pizotifen, peppermint oil) was targeted to the specific functional gastrointestinal disorder (dyspepsia, abdominal migraine, irritable bowel syndrome). The behavioral interventions seemed to have a general positive effect on children with nonspecific RAP. Many of these therapies have not been used widely as standard treatment for children with RAP. Although the mechanism of action for each effective therapy is not fully understood, each is believed to be safe for use in RAP. Pediatrics 2003;111:e1-e11. URL: http://www.pediatrics.org/cgi/ content/full/111/1/e1; recurrent abdominal pain, treatment, children, alternative therapies, systematic review.ABBREVIATIONS. RAP, recurrent abdominal pain; IBS, irritable bowel syndrome; RCT, randomized controlled trial; SPC, standard pediatric care; CBFI, cognitive-behavioral family intervention; BF, biofeedback; CBI, cognitive-behavioral intervention.

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Section: Discussionmentioning

confidence: 99%

Systematic Review of Treatments for Recurrent Abdominal Pain

Weydert

Ball²,

Davis³

2003

Pediatrics

193

100

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“…; PEP, primary end point; GSS, global symptom score (patient rating of improvement of symptoms overall post-treatment v. pretreatment (42) ). *Diarrhoea-predominant IBS.…”

Section: Lactobacillus Ggmentioning

confidence: 99%

Treating irritable bowel syndrome with probiotics: the evidence

2010

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Irritable bowel syndrome (IBS) is a disorder of chronic abdominal pain, altered bowel habit and abdominal distension. It is the commonest cause of referral to gastroenterologists in the developed world and yet current therapeutic strategies are often unsatisfactory. There is now increasing evidence linking alterations in the gastrointestinal (GI) microbiota and IBS. Changes in faecal and mucosa-associated microbiota, post-infectious IBS, a link with small intestinal bacterial overgrowth and an up-regulation of the GI mucosal immune system all suggest a role for the GI microbiota in the pathogenesis of IBS. Given this evidence, therapeutic alteration of the GI microbiota by probiotic bacteria could be beneficial. The present paper establishes an aetiological framework for the use of probiotics in IBS and comprehensively reviews randomised placebo-controlled trials of probiotics in IBS using multiple electronic databases. It highlights safety concerns over the use of probiotics and attempts to establish guidelines for their use in IBS in both primary and secondary care.Probiotics: Irritable bowel syndrome: Small bowel intestinal overgrowth: Gastrointestinal microbiota

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“…An unambiguous criterion of quantifiable symptom status of the target symptoms, as experienced by the patients, should be the primary criterion for success (Whitehead et al, 1999), and it is highly desirable for the same primary outcome measures to be used across all studies of BF for the same condition. 4.…”

Section: Adoption Of Standard Outcome Measures and Ways To Define Trementioning

confidence: 99%