Abstract
AIM: To investigate in symptomatic uncomplicated diverticular disease the efficacy of symbiotics associated with a high-fibre diet on abdominal symptoms. METHODS: This study was a multicentre, 6-mo randomized, controlled, parallel-group intervention with a preceding 4-wk washout period. Consecutive outpatients with symptomatic uncomplicated diverticular disease, aged 40-80 years, evaluated in 4 Gastroenterology Units, were enrolled. Symptomatic uncomplicated diverticular disease patients were randomized to two treatment arms A or B. Treatment A (n = 24 patients) received 1 symbiotic sachet Flortec(©) (Lactobacillus paracasei B21060) once daily plus high-fibre diet for 6 mo. Treatment B (n = 21 patients) received high-fibre diet alone for 6 mo. The primary endpoint was regression of abdominal symptoms and change of symptom severity after 3 and 6 mo of treatment. RESULTS: In group A, the proportion of patients with abdominal pain < 24 h decreased from 100% at baseline to 35% and 25% after 3 and 6 mo, respectively (P < 0.001). In group B the proportion of patients with this symptom decreased from 90.5% at baseline to 61.9% and 38.1% after 3 and 6 mo, respectively (P = 0.001). Symptom improvement became statistically significant at 3 and 6 mo in group A and B, respectively.The proportion of patients with abdominal pain >24 h decreased from 60% to 20% then 5% after 3 and 6 mo, respectively in group A (P < 0.001) and from 33.3% to 9.5% at both 3 and 6 mo in group B (P = 0.03). In group A the proportion of patients with abdominal bloating significantly decreased from 95% to 60% after 3 mo, and remained stable (65%) at 6-mo follow-up (P = 0.005) while in group B, no significant changes in abdominal bloating was observed (P = 0.11). After 6 mo of treatment, the mean visual analogic scale (VAS) values of both short-lasting abdominal pain (VAS, mean ± SD, group A: 4.6 ± 2.1 vs 2.2 ± 0.8, P = 0.02; group B: 4.6 ± 2.9 vs 2.0 ± 1.9, P = 0.03) and abdominal bloating (VAS, mean ± SD, group A: 5.3 ± 2.2 vs 3.0 ± 1.7, P = 0.005; group B: 5.3 ± 3.2 vs 2.3 ± 1.9, P = 0.006) decreased in both groups, whilst the VAS values of prolonged abdominal pain decreased in the Flortec(©) group, but remained unchanged in the high-fibre diet group (VAS, mean ± SD, group A: 6.5 ± 1.5 vs 4.5 ± 2.1, P = 0.052; group B: 4.5 ± 3.8 vs 5.5 ± 3.5). CONCLUSION: A high-fibre diet is effective in relieving abdominal symptoms in symptomatic uncomplicated diverticular disease. This treatment may be implemented by combining the high-fibre diet with Flortec(©).