Interferential therapy for chronic constipation in adults: The CON-COUR randomizedcontrolled trial

Veronique Vitton; François Mion; Anne-Marie Leroi; Charlène Brochard; Benoit Coffin; Frank Zerbib; Henri Damon; Chloé Melchior; Henri Duboc; Michel Queralto; Karine Baumstarck

doi:10.1002/ueg2.12373

Interferential therapy for chronic constipation in adults: The CON-COUR randomizedcontrolled trial

United European Gastroenterol J. 2023 Apr 25;11(4):337-349. doi: 10.1002/ueg2.12373. Online ahead of print.

Authors

Veronique Vitton¹, François Mion², Anne-Marie Leroi^{3

4

5}, Charlène Brochard⁶, Benoit Coffin^{7

8}, Frank Zerbib⁹, Henri Damon², Chloé Melchior³, Henri Duboc^{7

8}, Michel Queralto¹⁰, Karine Baumstarck¹¹

Affiliations

¹ Gastroenterology Unit, Assistance Publique-Hôpitaux de Marseille, Aix-Marseille Université, Marseille, France.
² Digestive Physiology Department, Université de Lyon, Hospices Civils de Lyon, INSERM U1032, Lyon, France.
³ Digestive Physiology Department, Rouen University Hospital, Rouen, France.
⁴ Nutrition, Brain and Gut Laboratory UMR 1073, Rouen University, Rouen, France.
⁵ Rouen University Hospital, INSERM CIC-CRB 1404, Rouen, France.
⁶ Digestive Physiology Unit, University Hospital of Rennes, University of Rennes 1, CIC 1414, Rennes, France.
⁷ Gastroenterology Department, DMU ESPRIT, Hôpital Louis-Mourier, Colombes, France.
⁸ University of Paris, Paris, France.
⁹ Gastroenterology Department, Hôpital Haut-Lévêque, Bordeaux, France.
¹⁰ Service de Colo-Proctologie, Clinique des Cèdres, Cornebarrieu, France.
¹¹ Service d'Epidémiologie et Economie en Santé, Direction de la Recherche en Santé, AP-HM, Marseille, France.

Abstract

Background: Chronic constipation (CC) is a frequent condition, and the first-line treatment includes dietary rules, the use of laxatives, and biofeedback for evacuation disorders. However, almost half of the patients are dissatisfied with their current treatment. We report the first double-blind randomized multicenter trial assessing the effectiveness of transabdominal electrical stimulation by interferential therapy (IFT) in the treatment of CC in adults.

Methods: A prospective, multicenter, randomized, double-blind, sham-controlled, parallel-group, phase 3 trial was conducted at 7 centers in France. The primary endpoint was 8-week efficacy as defined by the number of complete spontaneous bowel movements during the last 4 weeks of the 8-week stimulation period. Secondary endpoints included the evaluation of the effects of IFT on symptoms (Patient Assessment of Constipation Symptoms questionnair (PAC-SYM)), quality of life (QOL) (Patient Assessment of Constipation Quality of Life), Colonic transit time (CTT), anorectal manometry, and patient satisfaction.

Results: The proportion of 8-week responders was not significantly different between the two groups (73.2% in the IFT group vs. 67.1% in the sham group). After 8 weeks of stimulation, the mean overall PAC-SYM score and the mean reduction in the overall PAC-SYM score were significantly greater in the IFT group than in the sham group. No differences were observed concerning CTT, anorectal manometry, or patient satisfaction.

Conclusions: Although the primary endpoint was not reached, IFT can significantly alleviate the symptoms and improve the QOL of CC patients. It can be assumed that new treatments require different modes of evaluation and that the assessment of patient-reported outcomes may become a priority among therapeutic targets of CC. Trial registration number NCT02381665.

Keywords: chronic constipation; double blind; interferential therapy; quality of life; randomized clinical trial; transabdominal electrical stimulation.

Associated data

ClinicalTrials.gov/NCT02381665