Efficacy and safety of herbal medicine yun-cai tea in the treatment of hyperlipidemia: A double-blind placebo-controlled clinical trial.
- Author:
Chien-Ying LEE
1
;
Min-Chien YU
;
Chun-Che LIN
;
Ming-Yung LEE
;
James Cheng-Chung WEI
;
Hung-Che SHIH
Author Information
- Publication Type:Journal Article
- MeSH: Adult; Double-Blind Method; Drugs, Chinese Herbal; therapeutic use; Female; Herbal Medicine; Humans; Hyperlipidemias; drug therapy; Hypolipidemic Agents; therapeutic use; Male; Middle Aged; Placebos
- From: Chinese journal of integrative medicine 2015;21(8):587-593
- CountryChina
- Language:English
-
Abstract:
OBJECTIVEAnimal studies have demonstrated a lipid-modulating effect of yun-cai tea. However, little is known about the lipid-lowering effect in humans.The aim of this study was to evaluate the lipid lowering effects and safety of yun-cai tea in patients with elevated lipid levels in a human clinical trial.
METHODSThis was a 12-week, randomly assigned, parallel-group, double-blind, and placebo-controlled pilot clinical study. Sixty primary hyperlipidemia patients were included and randomly assigned to the yun-cai tea group (30 patients) and the placebo group (30 patients), for 8 weeks of treatment and 4 weeks of follow-up. The primary endpoint was changes in plasma low-density lipoprotein-cholesterol (LDL-C) at 8 weeks. The secondary endpoints included total cholesterol (TC) and triglycerides (TG).
RESULTSOur results revealed no statistically signifificant differences in LDL-C and TC between the two groups. Despite the lack of a statistically signifificant difference in the level of TG between the two groups, a declining trend was noted. A signifificant reduction of TG was observed in the yun-cai tea group at week 8, compared to baseline (P=0.048). The incidence of stomach discomfort, gastroesophageal reflfl ux, diarrhea, and constipation was slightly higher in the yun-cai tea group. No other signifificant adverse events were found.
CONCLUSIONIt is unlikely that yun-cai tea used had a blood lipid reduction effect. Further larger scale clinical trials with a longer duration and larger dose are necessary.