Functional constipation is a common clinical complaint.
Despite a lack of consolidated evidence, Chinese herbal medicine has become a popular alternative treatment for this condition.
Dr Chung-Wah Cheng and colleagues from China assessed the efficacy and safety of a Chinese herbal medicine proprietary medicine, Hemp Seed Pill, in optimal dosage for treating functional constipation.
The researchers study comprised 2 parts including Trial 1, a dose determination study, and trial 2, a placebo-controlled clinical study.
|Regained response was maintained for 12 months in 40%|
|American Journal of Gastroenterology|
In Trial 1, the optimal dosage of HSP was first determined from among 3 doses.
In Trial 2, a randomized double-blind study, the efficacy and safety of HSP for functional constipation patients in excessive syndrome as defined by traditional Chinese medicine theory were compared with placebo.
All participants in trials underwent a 2-week run-in, an 8-week treatment, and an 8-week follow-up.
The research team's primary end point was the responder rate for complete spontaneous bowel movement during treatment.
Participants with a mean increase of complete spontaneous bowel movement 1/week compared with their baselines were defined as responders.
The team's secondary outcome measures included responder rate during follow-up, individual and global symptom assessments, and reported adverse effects.
The dose of 7.5 g b.i.d. showed better therapeutic effect than that of 2.5 and 5.0 g b.i.d. among 96 subjects in Trial 1, and was therefore selected for comparison with placebo in Trial 2.
In Trial 2, 120 subjects were randomized into 2 arms.
The research team reported that responder rates for the Hemp Seed Pill and placebo groups were 43% and 8% during treatment and 30% and 15% in the follow-up period, respectively.
Those in the Hemp Seed Pill group showed benefit in terms of increased complete spontaneous bowel movement, relief in the severity of constipation and straining of evacuation, and effective reduction in the use of rescue therapy when compared with placebo.
No serious adverse events was reported.
Dr Cheng's team commented, "Hemp Seed Pill is safe and effective for alleviating functional constipation for subjects in excessive syndrome."
"Optimal dose determination may be crucial for all Chinese herbal medicine studies."