ArticleThe American journal of gastroenterology2009
Editorial: is adequate relief fatally flawed or adequate as an end point in irritable bowel syndrome?
Article in The American journal of gastroenterology, 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01247935 (Electroacupuncture and Trancutaneous Electrical Nervous Stimulation Analgesia for Colonoscopy), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Electroacupuncture and Trancutaneous Electrical Nervous Stimulation Analgesia for Colonoscopy: a Prospective, Randomized, Controlled Study
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it, 19 citations in OpenAlex.
- How fragile the positive results of Chinese herbal medicine randomized controlled trials on irritable bowel syndrome are?BMC complementary medicine and therapies · 2024Pooled it
- Effect of the probiotic strain Bifidobacterium animalis subsp. lactis, BB-12®, on defecation frequency in healthy subjects with low defecation frequency and abdominal discomfort: a randomised, double-blind, placebo-controlled, parallel-group trial.The British journal of nutrition · 2015Trial
- Effect of Amitriptyline and Escitalopram on Functional Dyspepsia: A Multicenter, Randomized Controlled Study.Gastroenterology · 2015Trial
- Article
- Online Guided Self-help Cognitive Behavioral Therapy With Exposure to Anxiety and Problem Solving in Type 1 Diabetes Mellitus: Case Study.JMIR formative research · 2022Article
- Efficacy of acupuncture in refractory irritable bowel syndrome: study protocol for a randomised controlled trial.BMJ open · 2021Article
- Efficacy and Safety of a Novel Herbal Medicine in the Treatment of Irritable Bowel Syndrome: A Randomized Double-Blinded Clinical Trial.Gastroenterology research and practice · 2020Article
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1 author.
Funding
Abstract
There is controversy on the validity of binary end points used in irritable bowel syndrome (IBS) clinical trials. In a usual-care observational study, baseline severity influenced the response measured as satisfactory relief. This editorial reviews the observations from a non-pharmacological study to assess the effect of baseline severity on the performance of binary end points in large drug trials. The pivotal finding is that once the patients who reported adequate relief at baseline were excluded from the analysis, baseline severity no longer affected the proportion of patients reporting adequate relief of IBS with treatment. As large drug trials enriched the study cohorts for at least moderate severity after a no-treatment, run-in period, it seems likely that the precaution of excluding mild disease de facto resolved the hypothetical weakness of the adequate relief end point. Given the high responsiveness and longitudinal construct validity demonstrated with adequate relief end point, it should be accepted as a trial end point.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.