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Randomised clinical trial: pregabalin vs placebo for irritable bowel syndrome.

ABSTRACT: BACKGROUND:Pregabalin is a calcium channel ?2? ligand that modifies visceral hypersensitivity in IBS patients. Clinical data for pregabalin in IBS are lacking. AIM:To test the efficacy of pregabalin on gastrointestinal symptoms in IBS patients. METHODS:A double-blind, placebo-controlled trial was performed. Adults meeting IBS Rome III criteria with ?3 pain attacks per month were randomised to pregabalin 225 mg vs placebo twice daily for 12 weeks. Questionnaires were completed weekly. The primary endpoint was average pain Bowel Symptom Scale (BSS) scores weeks 9-12. An intention-to-treat analysis of covariance evaluated treatment effects on quantitative endpoints, adjusting for age and gender. Adequate relief and change in pain score were assessed using a chi-squared test. RESULTS:Eighty-five patients were recruited and randomised. Sample characteristics include: mean age 39.4 (SD = 14.6); 73 (86%) female; 37 (44%) IBS-D, 29 (35%) IBS-M, 18 (21%) IBS-C. The pregabalin arm had lower average pain-BSS scores weeks 9-12 (25 vs 42, P = 0.008). Compared with placebo, the overall IBS BSS severity score was lower in the pregabalin arm (26 vs 42, P = 0.009). Differences were observed for the diarrhoea-BSS and bloating-BSS scores (P = 0.049 and 0.016, respectively). No differences between groups were seen for constipation-BSS scores. Adequate relief was not different between the two arms (46% vs 36%, P = 0.35). 63% pregabalin vs 45% placebo had a change in pain score ?30 at week 12 from baseline (P = 0.10). Post-treatment IBS-QoL scores did not differ between groups. CONCLUSION:This trial suggests that pregabalin may be beneficial for IBS abdominal pain, bloating and diarrhoea.

SUBMITTER: Saito YA

PROVIDER: S-EPMC6349499 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Randomised clinical trial: pregabalin vs placebo for irritable bowel syndrome.

Saito Yuri A YA Almazar Ann E AE Tilkes Katherine E KE Choung Rok Seon RS Van Norstrand Michael D MD Schleck Cathy D CD Zinsmeister Alan R AR Talley Nicholas J NJ

Alimentary pharmacology & therapeutics 20190120 4

<h4>Background</h4>Pregabalin is a calcium channel α2δ ligand that modifies visceral hypersensitivity in IBS patients. Clinical data for pregabalin in IBS are lacking.<h4>Aim</h4>To test the efficacy of pregabalin on gastrointestinal symptoms in IBS patients.<h4>Methods</h4>A double-blind, placebo-controlled trial was performed. Adults meeting IBS Rome III criteria with ≥3 pain attacks per month were randomised to pregabalin 225 mg vs placebo twice daily for 12 weeks. Questionnaires were complet ...[more]

PMID: 30663077

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Project description:ObjectiveTo investigate whether placebo effects can experimentally be separated into the response to three components-assessment and observation, a therapeutic ritual (placebo treatment), and a supportive patient-practitioner relationship-and then progressively combined to produce incremental clinical improvement in patients with irritable bowel syndrome. To assess the relative magnitude of these components.DesignA six week single blind three arm randomised controlled trial.SettingAcademic medical centre.Participants262 adults (76% women), mean (SD) age 39 (14), diagnosed by Rome II criteria for and with a score of > or =150 on the symptom severity scale.InterventionsFor three weeks either waiting list (observation), placebo acupuncture alone ("limited"), or placebo acupuncture with a patient-practitioner relationship augmented by warmth, attention, and confidence ("augmented"). At three weeks, half of the patients were randomly assigned to continue in their originally assigned group for an additional three weeks.Main outcome measuresGlobal improvement scale (range 1-7), adequate relief of symptoms, symptom severity score, and quality of life.ResultsAt three weeks, scores on the global improvement scale were 3.8 (SD 1.0) v 4.3 (SD 1.4) v 5.0 (SD 1.3) for waiting list versus "limited" versus "augmented," respectively (P<0.001 for trend). The proportion of patients reporting adequate relief showed a similar pattern: 28% on waiting list, 44% in limited group, and 62% in augmented group (P<0.001 for trend). The same trend in response existed in symptom severity score (30 (63) v 42 (67) v 82 (89), P<0.001) and quality of life (3.6 (8.1) v 4.1 (9.4) v 9.3 (14.0), P<0.001). All pairwise comparisons between augmented and limited patient-practitioner relationship were significant: global improvement scale (P<0.001), adequate relief of symptoms (P<0.001), symptom severity score (P=0.007), quality of life (P=0.01). Results were similar at six week follow-up.ConclusionFactors contributing to the placebo effect can be progressively combined in a manner resembling a graded dose escalation of component parts. Non-specific effects can produce statistically and clinically significant outcomes and the patient-practitioner relationship is the most robust component.Trial registrationClinical Trials NCT00065403.

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Randomised clinical trial: pregabalin vs placebo for irritable bowel syndrome.

Publications

Randomised clinical trial: pregabalin vs placebo for irritable bowel syndrome.

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