[The efficacy and safety of testa triticum tricum purif in treatment of functional constipation in the late middle-aged and elderly patients: a multicenter randomized controlled clinical trial].

Objective: To evaluate the efficacy and safety of testa triticum tricum purif for the treatment of functional constipation(FC) in the late middle-aged and elderly patients. Methods: This study was designed as a multicenter randomized controlled trial. Patients who met Rome Ⅲ diagnostic criteria of FC were enrolled, with age between 55-85 years old. Those with organic diseases were excluded. The patients were randomly allocated to receive testa triticum tricum purif (3.5 g bid) or polyethylene glycol 4000 powder (PEG4000, 10g bid) for 8 weeks, followed by single dose of maintenance therapy for 4 weeks. Follow-up visits were at 4 and 12 weeks after treatment discontinuation. The independent investigators in each center evaluated the constipation symptoms scores. The primary endpoints included rates of significant improvement, improvement and overall improvement at the end of 2, 4 and 8 weeks of therapy, which were calculated by the reduction of symptom scores ≥75%, 50%-74%, ≥25% respectively. Results: A total of 127 FC subjects were enrolled from 3 centers, and 122 cases valid for final analysis. The mean age was (69.4±6.9) years old, including 62 cases in testa triticum tricum purif group and 60 cases in PEG4000 group. The demographic data, constipated symptoms scores and proportion of FC subtypes at baseline were comparable. The rates of significant improvement, improvement and overall improvement in testa triticum tricum purif and PEG4000 groups at the end of 2, 4 and 8 weeks were 37.70% (23/61) vs 59.32% (35/59) ( P =0.018), 57.38% (35/61) vs 74.14% (43/58) ( P =0.054), and 64.41% (38/59) vs 79.31% (46/58) ( P =0.073) respectively. Testa triticum tricum purif therapy significantly improved the proportion of spontaneous bowel movement(SBM) ≥3 times/week from 43.55% (27/62) to 80.33% (49/61), 83.61% (51/61) and 93.22% (55/59) at 2, 4, and 8 weeks respectively (all P <0.01), which were comparable with PEG4000 group (all P >0.05). The proportion of normalized stool forms in study group was significant higher than that of control group at the end of 8 weeks [86.44% (51/59) vs 67.24% (39/58), P =0.014]. Only one patient complained mild abdominal distension during testa triticum tricum purif therapy. Conclusions: The efficacy of testa triticum tricum purif for the treatment of FC in late middle-aged and older patients is comparable with osmotic laxatives PEG4000, which has significant effect on normalization of fecal forms and reliable safety.