[Dinggui Oil Capsule in treating irritable bowel syndrome with stagnation of qi and cold: a prospective, multi-center, randomized, placebo-controlled, double-blind trial].
OBJECTIVE
To evaluate the efficacy and safety of Dinggui Oil Capsule in treating irritable bowel syndrome (IBS) with stagnation of qi and cold.


METHODS
A prospective, randomized, placebo-controlled, double-blind clinical study was undertaken. One hundred and ninety-eight patients with IBS and syndrome of stagnation of qi and cold were randomly divided into high-dose Dinggui Oil group (DGO-H, 1.2 g, 3 times daily; n=66), low-dose Dinggui Oil group (DGO-L, 0.8 g, 3 times daily, n=66), and placebo group (placebo, 5.0 g, 3 times daily, n=66). Patients in the three groups were all treated for 2 weeks.


RESULTS
The total significant effective rates for IBS were 54.1%, 28.8% and 21.9% in the DGO-H, DGO-L, and placebo groups, and the total effective rates for the syndrome of stagnation of qi and cold were 54.1%, 25.8% and 23.4% in the three groups, respectively. Dinggui Oil Capsule showed a higher efficacy than the placebo in relieving the abdominal pain (P<0.01). No adverse effects were found in this trial.


CONCLUSIONS
Dinggui Oil Capsule is effective and safe in relieving abdominal pain due to IBS with stagnation of qi and cold.
Zhang
Rui-ming
RM
Department of Integrated Chinese and Western Medicine, West China Hospital, Sichuan University, Chengdu, Sichuan Province 610041, China.
Wang
Lei
L
Yang
Xiao-nan
XN
Xia
Qing
Q
Jiang
Ming-de
MD
Fan
Zong-jiang
ZJ
Zhang
Fang-xing
FX
Zhang
Hai-rong
HR
Yu
Zheng
Z
Li
Ting-qian
TQ
D000293:Adolescent; D000328:Adult; D000368:Aged; D002214:Capsules; D003937:Diagnosis, Differential; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D043183:Irritable Bowel Syndrome / Q000188:drug therapy*; D008297:Male; D008516:Medicine, Chinese Traditional; D008875:Middle Aged; D008517:Phytotherapy; D011446:Prospective Studies; D055815:Young Adult
D002214:Capsules; D004365:Drugs, Chinese Herbal