Assessment of the impacts of traditional Persian medical schemes and recommendations on functional chronic constipation compared to a classic medicine lactulose, a randomized clinical trial.

BACKGROUND: To manage chronic constipation, numerous lifestyle modification schemes and recommendations as well as applications of natural medicaments have been mentioned in manuscripts of traditional Persian medicine (TPM). This study was aimed to compare the impacts of some of those recommendations with lactulose, on functional chronic constipation.
METHODS: Via a blocked randomization, 100 patients were enrolled. Schemes and recommendations from TPM as intervention group were evaluated versus lactulose as control by weekly follow-ups with standard questionnaire for 3 months. Stool frequency, hard stool, painful defecation, incomplete evacuation sensation, anorectal obstruction sensation and manual maneuvers were considered as outcome measures.
RESULTS: Eighty-six patients (42 in schemes and 44 in lactulose groups) completed the study. Median weekly stool frequency in 0, 4, 8 and 12 weeks of treatment was 1.76±1.79, 2.88±0.89, 2.95±1.05 and 2.93±1.11 in the schemes and 2.41±1.67, 2.57±0.90, 2.84±0.91 and 2.77±1.00 in lactulose groups, respectively (p=0.10, 0.11, 0.60, 0.51). Thirty-two (76.2%) patients in schemes and 24 (54.5%) patients in lactulose groups were treated at the end of the protocol as they did not meet the Rome III criteria for constipation (p=0.04). In schemes group, patients reported no undesirable effects, whereas seven (15.9%) in lactulose group reported flatulence (p=0.02).
CONCLUSIONS: Studied schemes were as effective as lactulose, a gold standard to manage constipation. Results demonstrated that TPM schemes and recommendations, as lifestyle modification, for at least 3 months can be introduced as cheap, available and accessible approaches for the management of constipation.

RCT Entities:   Population Interventions Outcomes