Efficacy of an Iranian herbal medicine formula for postoperative constipation in trauma patients with hip and lower limb fractures: A triple-blind, placebo-controlled randomized clinical trial

Abstract

Aim of the study

This trial aimed to evaluate the efficacy of the “Herbal Laxative Capsule” (HLC) formulation in alleviating symptoms of postoperative constipation (POC) in patients undergoing surgeries for traumatic fractures of the hip or lower extremities. The HLC is a novel polyherbal formulation that integrates both scientifically validated botanicals, such as Cassia angustifolia and Aloe barbadensis, with traditionally employed herbs like Foeniculum vulgare, Coriandrum sativum, and Carum carvi, all of which are recognized for their laxative properties.

Materials and methods

A triple-blind, placebo-controlled, randomized clinical trial was conducted at an academic hospital in Kashan, Iran. A total of 61 orthopedic patients with POC were randomized to receive either HLC (n = 31) in the treatment group or a placebo (n = 30) in the placebo group. Both were administered as 520 mg capsules, taken twice daily for one week. The primary outcomes included assessments of constipation severity and stool consistency, while the secondary outcomes evaluated patient satisfaction using validated clinical scales.

Results

The treatment group demonstrated a statistically significant reduction in constipation severity and improvement in stool consistency compared with the placebo group (P < 0.001). No significant adverse effects were reported. Additionally, patient satisfaction was notably higher in the treatment group (P < 0.001).

Conclusion

The HLC formulation demonstrated significant efficacy in effectively managing POC, which is often opioid-induced constipation (OIC), in orthopedic patients. These findings suggest that HLC could serve as a promising alternative to conventional laxatives, warranting further investigation in larger-scale clinical trials.