BACKGROUND: Laxatives are much utilized, but few clinical trials assessed the efficacy of phytotherapics in the functional constipation. AIM: The aim of this study was to evaluate the efficacy of the tincture of jalapa in the treatment of patients with functional constipation. METHODS: Double-blind, randomized, placebo-controlled clinical trial was used in this study. Seventy-six patients were assigned to two treatment groups, jalapa or placebo. The study consisted of three phases: pre-treatment, treatment, and post-treatment, each phase lasting 7 days. The mean frequency of stools, the mean consistency of stools, and the presence of pain and effort to evacuate were assessed. We monitored adverse events before, during, and after the administration of 15 mL of tincture of jalapa or placebo. RESULTS: After treatment, the mean frequency of stools of the jalapa group (0.58 ± 0.25 stools/day; P < 0.0001) was higher than in the placebo group (0.36 ± 0.20 stools/day). In the pre-treatment, stool consistency, according to the Bristol scale, ranged from types 1 to 3 for both groups. The jalapa group showed improved mean consistency of stools (P = 0.0102) after treatment, approximately ranging between types 2 and 4, while the placebo group did not show statistically significant differences (P = 0.1446). The reduction of pain (P = 0.0061) and effort (P = 0.0289) in the jalapa group were statistically significant. Both treatments were well tolerated by the patients. CONCLUSION: The tincture of jalapa was shown to be effective in the acute treatment of functional constipation.
RCT Entities:
BACKGROUND: Laxatives are much utilized, but few clinical trials assessed the efficacy of phytotherapics in the functional constipation. AIM: The aim of this study was to evaluate the efficacy of the tincture of jalapa in the treatment of patients with functional constipation. METHODS: Double-blind, randomized, placebo-controlled clinical trial was used in this study. Seventy-six patients were assigned to two treatment groups, jalapa or placebo. The study consisted of three phases: pre-treatment, treatment, and post-treatment, each phase lasting 7 days. The mean frequency of stools, the mean consistency of stools, and the presence of pain and effort to evacuate were assessed. We monitored adverse events before, during, and after the administration of 15 mL of tincture of jalapa or placebo. RESULTS: After treatment, the mean frequency of stools of the jalapa group (0.58 ± 0.25 stools/day; P < 0.0001) was higher than in the placebo group (0.36 ± 0.20 stools/day). In the pre-treatment, stool consistency, according to the Bristol scale, ranged from types 1 to 3 for both groups. The jalapa group showed improved mean consistency of stools (P = 0.0102) after treatment, approximately ranging between types 2 and 4, while the placebo group did not show statistically significant differences (P = 0.1446). The reduction of pain (P = 0.0061) and effort (P = 0.0289) in the jalapa group were statistically significant. Both treatments were well tolerated by the patients. CONCLUSION: The tincture of jalapa was shown to be effective in the acute treatment of functional constipation.