Dyslipidemia, which is characterized by abnormal levels of triglycerides (TGs), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and very-low-density lipoprotein (VLDL), is a major risk factor for developing atherosclerosis and other cardiovascular diseases (CVDs). Amla (Phyllanthus emblica syn. Emblica officinalis, Phyllanthaceae) fruit extracts have demonstrated beneficial effects on lipid profiles in animal models of dyslipidemia and in three small clinical studies. In this randomized, double-blind, placebo-controlled, multicenter clinical trial, the efficacy and safety of amla in patients with dyslipidemia were evaluated.
The study was conducted from March 2015 to November 2015 at four centers in South India. A total of 98 patients with dyslipidemia (45 males and 53 females) aged 30 to 65 years were enrolled in the study. The included patients had TG levels ˃ 200 mg/dL, LDL-C > 130 mg/dL, TC > 200 mg/dL, and HDL-C < 40 mg/dL for men and < 50 mg/dL for women. Patients were excluded if they had taken any medications or herbal products to manage their dyslipidemia during the preceding four weeks. All patients completed the study.
The patients were randomized to take one capsule of either amla (n=49) or placebo (n=49) twice daily (after breakfast and after dinner) for 12 weeks. Each 500 mg capsule of amla fruit extract (Arjuna Natural Ltd.; Aluva, Kerala, India) contained 175 mg polyphenols, 40 mg triterpenoids, and 50 mg oil. The capsules also contained omega-3 fatty acids. Each placebo capsule contained 500 mg of roasted rice (Oryza sativa, Poaceae) powder without any husk, bran, or germ, which could have impacted the lipid profiles of the patients. Patients were instructed to follow a healthy diet and to exercise at least four days a week.
Blood was drawn at screening, at baseline, and at follow-up visits on days 28 ± 5, 56 ± 5, and 84 ± 5. The following parameters were assessed: TC, TG, LDL-C, HDL-C, VLDL-C, apolipoprotein A1 (Apo A1), Apo B, coenzyme Q10 (CoQ10), thyroid-stimulating hormone (TSH), fasting plasma glucose (FPG), serum glutamic oxaloacetic transaminase, serum glutamic pyruvic transaminase, bilirubin, creatinine, and blood urea nitrogen. At baseline, demographic characteristics and vital statistics did not significantly differ between groups.
After 12 weeks, the amla group had a significant decrease in mean TG (P=0.0003), TC (P=0.0003), LDL-C (P=0.0064), VLDL-C (P=0.0001), atherogenic index of the plasma (API) (P=0.0177), and Apo B/Apo A1 ratio (P=0.0866) compared to the placebo group. API is a marker used to predict the risk of atherosclerosis. Statistically, the Apo B/Apo A ratio is a better predictor of CVD than conventional lipid indices. No significant between-group differences in HDL-C, FSH, FPG, and CoQ10 levels were seen. The lack of change in the latter suggests that amla may be a safer alternative to statins, which can decrease CoQ10 levels.
Compliance rates were 87.7% in the amla group and 87.3% in the placebo group. In both groups, all safety parameters (vital signs, hematology, biochemistry, and urine parameters) remained within normal limits. Four mild and transient adverse effects (AEs) were reported (n=3 in the placebo group).
“A very significant reduction in the TC, TG, AIP and other lipid parameters strongly supports the efficacy of amla extract in patients at risk for CVD,” the authors conclude. Limitations of the study include the small sample size, short study duration, no controls for between-group differences in diet and exercise, lack of follow-up to monitor the persistence of the therapeutic effects, and the bioavailability of amla (markers) was not assessed.
The study was sponsored by Arjuna Natural Ltd., Kerala, which provided the study capsules but had no role in study design, data collection, and analysis, decision to publish, or preparation of the manuscript.
Upadya H, Prabhu S, Prasad A, Subramanian D, Gupta S, Goel A. A randomized, double-blind, placebo-controlled, multicenter clinical trial to assess the efficacy and safety of Emblica officinalis extract in patients with dyslipidemia. BMC Complement Altern Med. January 22, 2019;19(1):27. DOI: 10.1186/s12906-019-2430-y.