BACKGROUND:Chronic functional diarrhea is an embarrassing symptom, causing the impairment of the quality of life. AIM: We looked for the effect of two antidiarrheal drugs, diosmectite and loperamide on the psychosocial adjustment to illness, a predictor for the health-related quality of life, in chronic functional diarrhea. METHODS: Prospective controlled randomized trial including 50 consecutive patients with chronic functional diarrhea. They received either diosmectite 3 g b.i.d (n=25, 11M/14F, age 43+/-12 years) or loperamide 2 mg b.i.d. (n=25, 12M/13F, 47+/-11 years) for 2 weeks. Diarrhea and four other digestive symptoms were evaluated on a 0-16 scale, as well as patient's satisfaction (scale 1-10) and physician's satisfaction (scale 0-4). Psychosocial adjustment to illness was assessed with the PAIS-SR scale. RESULTS:Symptom score for diarrhea was reduced from 10.5+/-5.7 to 2.6+/-1.2 (mean+/-SD), p<0.001 by diosmectite and from 8.5+/-4.2 to 1.2+/-0.6, p<0.0001 by loperamide. Diosmectite had a stronger effect than loperamide on accompanying pain (p<0.05) and bloating (p<0.01), but not on nausea, anorexia and emesis. The overall ratings of the patient's satisfaction (8.7+/-0.9 vs. 8.2+/-1.1, NS) and physician's satisfaction (3.2+/-0.3 vs. 3.1+/-0.4, NS) were similar. Psychological adjustment to illness was not changed for following items: health care orientation and domestic environment. Diosmectite improved more than loperamide the psychological distress (from 12.7+/-3.8 to 7.7+/-2.1 vs. 11.8+/-3.3 to 9.05+/-2.2, p<0.05), vocational environment (from 3.2+/-1.1 to 2.2+/-1.2 vs. 3.3+/-1.2 to 3.4+/-1.5, p<0.05) and sexual relationship scores (from 6.4+/-2.2 to 3.0+/-1.5 vs. 7.2+/-2.2 to 5.5+/-2.1, p<0.05). Both drugs similarly improved the items: family relationship and social environment. CONCLUSIONS:Diosmectite and loperamide are both potent drugs for chronic functional diarrhea. Diosmectite has better effects on associated symptoms and some items of psychosocial adjustment to illness (distress, sexual activity and vocational environment).
RCT Entities:
BACKGROUND:Chronic functional diarrhea is an embarrassing symptom, causing the impairment of the quality of life. AIM: We looked for the effect of two antidiarrheal drugs, diosmectite and loperamide on the psychosocial adjustment to illness, a predictor for the health-related quality of life, in chronic functional diarrhea. METHODS: Prospective controlled randomized trial including 50 consecutive patients with chronic functional diarrhea. They received either diosmectite 3 g b.i.d (n=25, 11M/14F, age 43+/-12 years) or loperamide 2 mg b.i.d. (n=25, 12M/13F, 47+/-11 years) for 2 weeks. Diarrhea and four other digestive symptoms were evaluated on a 0-16 scale, as well as patient's satisfaction (scale 1-10) and physician's satisfaction (scale 0-4). Psychosocial adjustment to illness was assessed with the PAIS-SR scale. RESULTS: Symptom score for diarrhea was reduced from 10.5+/-5.7 to 2.6+/-1.2 (mean+/-SD), p<0.001 by diosmectite and from 8.5+/-4.2 to 1.2+/-0.6, p<0.0001 by loperamide. Diosmectite had a stronger effect than loperamide on accompanying pain (p<0.05) and bloating (p<0.01), but not on nausea, anorexia and emesis. The overall ratings of the patient's satisfaction (8.7+/-0.9 vs. 8.2+/-1.1, NS) and physician's satisfaction (3.2+/-0.3 vs. 3.1+/-0.4, NS) were similar. Psychological adjustment to illness was not changed for following items: health care orientation and domestic environment. Diosmectite improved more than loperamide the psychological distress (from 12.7+/-3.8 to 7.7+/-2.1 vs. 11.8+/-3.3 to 9.05+/-2.2, p<0.05), vocational environment (from 3.2+/-1.1 to 2.2+/-1.2 vs. 3.3+/-1.2 to 3.4+/-1.5, p<0.05) and sexual relationship scores (from 6.4+/-2.2 to 3.0+/-1.5 vs. 7.2+/-2.2 to 5.5+/-2.1, p<0.05). Both drugs similarly improved the items: family relationship and social environment. CONCLUSIONS:Diosmectite and loperamide are both potent drugs for chronic functional diarrhea. Diosmectite has better effects on associated symptoms and some items of psychosocial adjustment to illness (distress, sexual activity and vocational environment).
Authors: Edoardo Savarino; Fabiana Zingone; Brigida Barberio; Giovanni Marasco; Filiz Akyuz; Hale Akpinar; Oana Barboi; Giorgia Bodini; Serhat Bor; Giuseppe Chiarioni; Gheorghe Cristian; Maura Corsetti; Antonio Di Sabatino; Anca Mirela Dimitriu; Vasile Drug; Dan L Dumitrascu; Alexander C Ford; Goran Hauser; Radislav Nakov; Nisha Patel; Daniel Pohl; Cătălin Sfarti; Jordi Serra; Magnus Simrén; Alina Suciu; Jan Tack; Murat Toruner; Julian Walters; Cesare Cremon; Giovanni Barbara Journal: United European Gastroenterol J Date: 2022-06-13 Impact factor: 6.866