OBJECTIVE: Previous studies have shown the association between menopause and dyslipidemia. This study was aimed to evaluate the effect of Chinese herbal medicine, tonifying kidney and descending turbidity (TKDT) granule, on serum lipid profiles in postmenopausal women with dyslipidemia. METHODS: A double-blind randomized, placebo-controlled trial was conducted among 104 postmenopausal Chinese women with mild dyslipidemia. Participants were randomized into treatment group (n = 53) and control group (n = 51). The participants in the treatment group received TKDT granule once per day for 24 weeks, whereas the control group received placebo in the same manner. All participants were subjected to healthy lifestyle during the study. Serum lipid profiles, body weight, waist circumference, and safety indicators were measured both at baseline and 24 weeks after admission. RESULTS: Compared with placebo, significant improvements in total cholesterol, low-density lipoprotein cholesterol, apolipoprotein-B (Apo-B), weight, and waist circumference in the TKDT group (P < 0.05) were observed after 24 weeks of treatment. Total cholesterol, low-density lipoprotein cholesterol, and Apo-B were decreased by 0.84 (0.77) mmol/L, 0.72 (0.77) mmol/L, and 0.12 (0.27) mmol/L, mean ± SD respectively. The weight, waist circumference, and body mass index were decreased by 4.07 (3.01) kg, 3.10 (2.95) cm, 1.60 (1.13), respectively. There were no significant differences in triglycerides, high-density lipoprotein cholesterol, and Apo-A between the two groups. Seven participants in the treatment group and six participants in the placebo group had mild or moderate adverse reactions. CONCLUSION:TKDT granule improved the lipid profile and reduced the related metabolic abnormalities in postmenopausal women with mild dyslipidemia based on lifestyle changes.
RCT Entities:
OBJECTIVE: Previous studies have shown the association between menopause and dyslipidemia. This study was aimed to evaluate the effect of Chinese herbal medicine, tonifying kidney and descending turbidity (TKDT) granule, on serum lipid profiles in postmenopausal women with dyslipidemia. METHODS: A double-blind randomized, placebo-controlled trial was conducted among 104 postmenopausal Chinese women with mild dyslipidemia. Participants were randomized into treatment group (n = 53) and control group (n = 51). The participants in the treatment group received TKDT granule once per day for 24 weeks, whereas the control group received placebo in the same manner. All participants were subjected to healthy lifestyle during the study. Serum lipid profiles, body weight, waist circumference, and safety indicators were measured both at baseline and 24 weeks after admission. RESULTS: Compared with placebo, significant improvements in total cholesterol, low-density lipoprotein cholesterol, apolipoprotein-B (Apo-B), weight, and waist circumference in the TKDT group (P < 0.05) were observed after 24 weeks of treatment. Total cholesterol, low-density lipoprotein cholesterol, and Apo-B were decreased by 0.84 (0.77) mmol/L, 0.72 (0.77) mmol/L, and 0.12 (0.27) mmol/L, mean ± SD respectively. The weight, waist circumference, and body mass index were decreased by 4.07 (3.01) kg, 3.10 (2.95) cm, 1.60 (1.13), respectively. There were no significant differences in triglycerides, high-density lipoprotein cholesterol, and Apo-A between the two groups. Seven participants in the treatment group and six participants in the placebo group had mild or moderate adverse reactions. CONCLUSION: TKDT granule improved the lipid profile and reduced the related metabolic abnormalities in postmenopausal women with mild dyslipidemia based on lifestyle changes.