Ficus carica (fig) paste supplementation in patients with multiple sclerosis associated constipation; a double blind randomized clinical trial

Abstract

Constipation is one of the most prevalent complications in patients with multiple sclerosis affecting up to 36% of these patients. Fig paste is used in traditional Persian medicine for the treatment of constipation. This study aimed to evaluate the efficacy of this natural product for patients suffering multiple sclerosis associated constipation. The study was designed as a two-arm, double-blind randomized placebo-controlled clinical trial using a parallel design. Forty patients with multiple sclerosis (based on McDonald criteria) and constipation (based on ROME III criteria) were randomly allocated to receive 10 gram of the Ficus carica (fig) paste or placebo (1:1 allocation ratio) three times a day for three months. The patients were evaluated before and after the intervention in terms of frequency of spontaneous bowl movement, hard stool, straining during defecation, sensation of incomplete evacuation and need for manual maneuvers to facilitate defecations per week and any reported adverse events. The study protocol was approved by the Local Medical Ethics Committee of Tehran University of Medical Sciences. Comparing to placebo, patients in fig paste group experienced a significant higher reduction in the frequency of spontaneous bowl movement (p < 0.001), straining during defecation (p = 0.019), sensation of incomplete evacuation (p = 0.013) and need for manual maneuvers to facilitate defecations (p = 0.045) per week. The mean reductions in frequency of hard stool in intervention group showed no significant difference (p = 0.518) with the value in placebo group (Table 1). One patient in fig paste group reported nausea after taking the supplement. This study provides a preliminary evidence for Ficus carica (fig) paste supplementation of patients suffering multiple sclerosis related constipation.