Habit training versus habit training with direct visual biofeedback in adults with chronic constipation: A randomized controlled trial

Christine Norton, Sybil Bannister, Lesley Booth, Steve R Brown, Samantha Cross, Sandra Eldridge, Christopher Emmett, Ugo Grossi, Mary Jordan, Jon Lacy-Colson, James Mason, John McLaughlin, Rona Moss-Morris, S Mark Scott, Natasha Stevens, Shiva Taheri, Stuart A Taylor, Yan Yiannakou, Charles H Knowles

Research output: Contribution to journalArticlepeer-review

Abstract

AIM: The aim was to determine whether specialist-led habit training using Habit Training with Biofeedback (HTBF) is more effective than specialist-led habit training alone (HT) for chronic constipation and whether outcomes of interventions are improved by stratification to HTBF or HT based on diagnosis (functional defaecation disorder vs. no functional defaecation disorder) by radio-physiological investigations (INVEST).

METHOD: This was a parallel three-arm randomized single-blinded controlled trial, permitting two randomized comparisons: HTBF versus HT alone; INVEST- versus no-INVEST-guided intervention. The inclusion criteria were age 18-70 years; attending specialist hospitals in England; self-reported constipation for >6 months; refractory to basic treatment. The main exclusions were secondary constipation and previous experience of the trial interventions. The primary outcome was the mean change in Patient Assessment of Constipation Quality of Life score at 6 months on intention to treat. The secondary outcomes were validated disease-specific and psychological questionnaires and cost-effectiveness (based on EQ-5D-5L).

RESULTS: In all, 182 patients were randomized 3:3:2 (target 384): HT n = 68; HTBF n = 68; INVEST-guided treatment n = 46. All interventions had similar reductions (improvement) in the primary outcome at 6 months (approximately -0.8 points of a 4-point scale) with no statistically significant difference between HT and HTBF (-0.03 points; 95% CI -0.33 to 0.27; P = 0.85) or INVEST versus no-INVEST (0.22; -0.11 to 0.55; P = 0.19). Secondary outcomes showed a benefit for all interventions with no evidence of greater cost-effectiveness of HTBF or INVEST compared with HT.

CONCLUSION: The results of the study at 6 months were inconclusive. However, with the caveat of under-recruitment and further attrition at 6 months, a simple, cheaper approach to intervention may be as clinically effective and more cost-effective than more complex and invasive approaches.

Original languageEnglish
Pages (from-to)2243-2256
Number of pages14
JournalColorectal disease : the official journal of the Association of Coloproctology of Great Britain and Ireland
Volume25
Issue number11
Early online date8 Sept 2023
DOIs
Publication statusPublished - Nov 2023

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