A randomized clinical trial on treatment of chronic constipation by traditional persian medicine recommendations compared to allopathic medicine: A pilot study

Background: The aim of this study was to compare the effcacy and side effects of lactulose plus traditional Persian medicine with only lactulose on the functional chronic constipation. Methods: Participants included 20 patients (10 in each group) aged 18–80 years, with major inclusion criteria of ROME III. They were assigned into two parallel therapeutic groups, including the intervention group (lactulose plus traditional Persian medicine [TPM] advices) and control group (only lactulose) through a block randomization. Weekly follow‑up was done for 1 month for both groups. Results: After the intervention, the frequency of bowel habit increased signifcantly in patients of both groups (P = 0.001), and the frequency of hard stool defecation, sensation of painful defecation, sensation of incomplete evacuation, sensation of anorectal obstruction, and manual maneuver for evacuation were decreased signifcantly in patients of both groups (P < 0.001 for all comparisons and 0.025 for manual maneuver). However, the only signifcant difference between the two groups was more reduction in the sensation of painful defecation in the lactulose group versus lactulose plus TPM advices (P = 0.014). Conclusions: Based on the pilot study, no signifcant difference was shown between TPM with lactulose and lactulose only in the management of chronic functional constipation. However, the easy recommendations of TPM can be useful in improving chronic constipation.