AMLAMAX, 02 Jul 2006

Background: Hypercholesterolemia is the major cause of cardiovascular diseases leading to myocardial infarctions leading to considerable morbidity and mortality. During the past decade a group of molecules referred to as statins such as simvastatin, atrovastatin have been tried with great success in reducing total cholesterol. These molecules act by inhibiting the HMG CoA reductase enzyme thereby interfering with the synthesis of cholesterol. But statins reduce all the cholesterol including HDL cholesterol. Long term drug vigilance activity has revealed serious side effects of tendinopathy and related musculoskeletal disorders in some of the subjects. In an effort to manage hypercholesterolemia without serious side effects in a natural way we had tried the use of Amlamax TM a reconstituted, purified, standardized dried extract of amla ( Emblica officinalis ) containing 30% ellagitannins with other hydrolysable tannins on humans. We report the hitherto unobserved significant elevation of HDL cholesterol by the administration of Amlamax TM

Methods: Fresh fruits of amla were collected from Coimbatore during August 2001 and pharmacognostically identified by comparing with voucher specimen number AEHBRS- 011. The chemicals used for the reactions were purchased from Merck. Fresh fruits of amla (E. offi cinalis) (100 kg) were cleaned, crushed, deseeded and refluxed with 50% methanol for 2 h. Then it was cooled and filtered. The filtrate was collected and the residue re-extracted with 50% methanol. The process was repeated twice and all the filtrates were pooled. The combined extracts were stripped of methanol under reduced pressure and subjected to membrane filtration (reverse osmosis) to obtain a concentrate of ca 40% TDS (total dissolved solids). The retentate was dried using ATFD (agitated thin film dryer) under controlled conditions, to obtain dried powdered extract containing ca 30% polyphenols of light greenish to dark greenish-brown, free-flowing slightly hygroscopic powder. The yield obtained was 4.2%. This hygroscopic extract was standardized to contain approximately 30% of total ellagitannins (emblicanin A and B) and kept at standardized conditions for further studies. This dry extract in a free-flowing powder form was filled in hard gelatin capsules (500 mg per capsule).

Result: All patients visited the clinic five times during the treatment period. During the first visit, informed consent from the patients was obtained. After getting the medical history, a general examination was performed and lipid profile was checked (TC, HDL, LDL, VLDL and TG). Serum total cholesterol and HDL were estimated by the enzymatic method. Triglyceride was estimated by GPO-PAP method. LDL and VLDL were calculated using Friedwald formula.

During the second visit i.e., the treatment initiation visit, pre-examination was done on screened patients. Baseline testing parameters like vital signs (systolic/ diastolic pressure, pulse rates), haemogram (RBC, WBC, TC, DC, Hb, ESR) were analysed and started appropriate treatment as per randomised schedule. After starting the treatment, the patients were asked to visit the department for periodic check-ups such as BMI, vital signs, lipid profile and haemogram. After 4 mo treatment, liver function tests (LFT, serum bilirubin, AST, ALT and ALP) and renal function tests (blood urea, serum creatinine) were assessed. Data analysis was carried out by multifactorial analysis of variance (ANOVA).

Conclusion: Many studies have come to the conclusion that with a 1% decrease in total cholesterol levels, the incidence of coronary artery disease (CAD) decreases by 2%19. The present results indicate the potential of Amlamax^TM to treat dyslipidemia in hypercholesterolemic patients. Improvements in all the lipid parameters in the treatment group, namely, reduction in the total cholesterol, LDL cholesterol and triglycerides and more importantly, enhancement of the beneficial HDL cholesterol observed for the first time, support this conclusion, although a larger study group would have allowed us to make firm conclusions. Nevertheless, the result of the present pilot study deserves attention because the enhancement in HDL cholesterol is more significant than those achieved with current drugs (e.g. statins). A study with direct comparison with statins is also planned. The present results may prompt other research groups to explore amla as a safe drug to treat dyslipidemia and atherosclerosis through well-controlled randomised trials involving a larger study group.