Constipation Clinical Trial
Official title:
A Randomized Controlled Trial of Chinese Herbal Medicine in Three-dose Regimen for the Treatment of Functional Constipation
Functional constipation (FC) is common with 14.3% estimated prevalence in Hong Kong, but treatment for this condition in conventional medicine is suboptimal. Complementary and alternative medicines, especially Chinese herbal medicine (CHM) are used frequently by patients with FC, but there is little research evidence about these commonly used CHM. The purpose of the study is evaluate the efficacy and safety of CHM, as well as determining the optimal dosage.
Functional constipation (FC) is a common complaint in clinical practice, with the estimated
prevalence 14.3% in Hong Kong, as nearly affecting 1 million Hong Kong People in different
extent. It is comparable with western population, which is 15% in North America. By the
definition of Rome II criteria, FC comprises a group of functional disorders, which presents
as persistent difficult, infrequent or seemingly incomplete defecation.
Constipation is often perceived to be benign, easily treated condition with short-term
treatment being relatively straightforward. However, the fact is the management of FC is
perplexed as some subjects complain of constipation more than decade. Moreover, chronic
constipation can develop into more serious bowel complaints, such as faecal impaction,
incontinence and bowel perforations. There is also accumulating evidence shown that
constipated subjects have significantly higher anxiety and depression scores and lower
quality of life. Therefore, the demand of effective agents to normalize bowel function is
extremely large.
Conventional treatment for constipation mainly relies on dietary fibre and laxatives.
Although there is no credible evidence that any serious problem is associated with their
prolonged use, the treatment of it has been suboptimal. First, a recent systematic review
pointed out that there were paucity of trials for many commonly used agents, therefore,
their use might not be well validated. Second, many patients with severe constipation do not
respond adequately or lose of effectiveness after a short period of time. Third, many
patients who intake dietary fibre complain of flatulence, distension, bloating and poor
taste. As a result, the compliance is low as about 50%. Fourth, the use of osmotic
laxatives, such as polyethylene glycol, become increasingly popular due to fewer side
effects and better taste, however, the prices are much more expensive than other
medications. Many constipation sufferers seek help from alternative medicine, especially
from Chinese herbal medicine. For example, according to a telephone survey in Hong Kong,
more than 85% of constipated subjects seek for coping strategies, such as asking for medical
consultations, taking prescribed medicine and seeking for alternative therapy, involving
Chinese medicine.
Traditional Chinese medicine (TCM) is particularly attractive as their effectiveness in
treating functional disorders and retaining balance of body functions. The CHM used in study
is derived from classic text of Chinese medicine (Shang Han Lun, Discussion of Cold-induced
Disorders), which can "moisten the intestines, drain heat, promote the movement of qi and
unblock the bowel".
It is well known that randomized controlled trial (RCT) is the gold standard to test the
efficacy of intervention, thus in this project, we attempt to follow the basic requirements
of RCT to testify the efficacy and safety of CHM on FC, as well as to determine the optimal
dosage. We believe such study will benefit the advancement of CHM, or even as the foundation
of research study in future.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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