Biswas TK, Chakrabarti S, Pandit S, Jana U, Dey SK. Pilot study evaluating the use of Emblica officinalis standardized fruit extract in cardio-respiratory improvement and antioxidant status of volunteers with smoking history. J Herb Med. 2014;4(4):188-194.
Double-blind, randomized, placebo-controlled trial
There were 20 men in the intervention group and 10 in the control group (ages 20 y-60 y) evaluable at the conclusion of the study (day 60). All participants were smokers (>15 cigarettes/d) for 10 years or more. Many had symptoms of cardiorespiratory compromise, including cough, poor immune status (recurrent infections), cardiovascular abnormalities (assessed with electrocardiogram [ECG]), and/or lipid profile irregularities, decreased appetite or digestive function, or poor libido. Exclusion criteria included those less than 20 years or greater than 60 years of age, lessening cigarette consumption during the trial period (<15 cigarettes/d), jaundice, venereal diseases, diabetes mellitus, exposure to radiation, and severe nutrient deficiency or chronic illness of any kind (eg, carcinoma, overt cardiac disorders, hemoglobin less than 6 g/dL).
Group I received 250 mg of Emblica officinalis (Phyllanthus emblica, Indian Gooseberry, amla) fruit extract (EOE) containing not less than 60% (w/w) hydrolysable tannoids (Emblicanin-A, Emblicanin-B, Pedunculagin, Punigluconin) twice daily with or after meals. The study used a branded product, Capros® by Natreon Inc (New Brunswick, New Jersey). The control group received 250 mg twice daily of placebo capsules containing the same excipients as the intervention group (microcrystalline cellulose, lactose, and magnesium stearate).
Study duration was 60 days total with subjective parameters measured at baseline, day 30, and day 60. Objective parameters were assessed at baseline and day 60.
The subjective parameters were provided through a symptom frequency questionnaire using an arbitrary scale (0=never, 1=occasional, 2=mild/poor, 3=moderate, 4=severe). Parameters interrogated included mouth hygiene, cough with expectoration, shortness of breath on exertion, loss of appetite, feelings of impending doom, palpitations, sleep deprivation, irritability, heartburn, and tiredness.
Given there is no toxic risk to including amla fruit, the relevant question to ask is not “Why take it?” but “Why not?”
Objective parameters included blood pressure; lipid profile (total cholesterol, triglyceride, high-density lipoprotein [HDL] cholesterol, low-density lipoprotein [LDL] cholesterol); fasting glucose; lipoprotein a; high sensitivity C-reactive protein (HsCRP); platelet aggregation; spirometry; ECG;, mitotic index and chromosomal aberration; antioxidant activity (Ferric reducing ability of plasma and malondialdehyde content); and oxidative load (8-hydroxy-2-deoxyguanosine).
Using mean levels for intragroup analysis, none of the objective parameters reached statistically significant differences in the placebo group from baseline to study end (day 60). The EOE intervention group, however, did show significant differences in mean scores from baseline to study conclusion. The most significant differences (P<.001) were found for HDL cholesterol (37.4 mg/dL vs 47.0 mg/dL); cholesterol/HDL ratio (5.16 vs 3.85); LDL/HDL ratio (3.32 vs 2.39); lipoprotein a (31.20 mg/dL vs 23.13 mg/dL); and platelet aggregation (54.75% vs 37.68%). Significant differences (P<.05) were also found for hemoglobin (14.06 mg/dL vs 14.42 mg/dL); red blood cell count (4.68 m/cmm vs 4.86 m/cmm); total cholesterol (192.2 mg/dL vs 180.5 mg/dL); LDL (124.3 mg/dL vs 112.6 mg/dL); and HsCRP (3.4 mg/dL vs 2.9 mg/dL). Mean mitotic index was also only significantly improved (P<.01) in the intervention group (0.78 + ‒0.174 vs 0.32 + ‒0.08). There were no significant changes in the lung function tests in either group.
E officinalis (P emblica), popularly known as Indian gooseberry, amalika, or amla, is a traditional rasayana herb used in Ayurvedic medicine. Rasayana literally means “the path of juice” or “juice incorporate,”1 but the best translation is encompassed in the concept of rejuvenation. Rasayana herbal medicines, through combinations as well as singular plants, restore immune competence, aid in cellular repair and renewal, inhibit free radical stress, and act as antimutagenics.2 The concept of rasayana is more than the absence of disease; rasayana is the maintenance of vitality and vigor of mind, body, and spirit.
The current trial adds to the body of evidence that corroborates the traditional uses of amla in maintaining health. In this small trial, there are measurable and significant changes in many cardiovascular risk parameters in just 2 months. While no clinician would condone continued smoking, the improvement in blood parameters despite the continuance of inhaled toxicants in the study population is an impressive feat. The protection of organ systems from toxic compounds is one of the many traditional benefits attributed to amla and validated in animal studies.3-5
This is not the first trial to suggest that amla lowers cholesterol. A 2011 publication found favorable changes in lipid profiles after 3 weeks of 2 or 3 g amla powder daily. Specifically, total cholesterol and triglycerides significantly decreased while HDL increased and LDL decreased (P<.05 for all parameters). A prior study of uremic patients failed to show any changes in lipid profiles. It did, however, show a lessening in oxidative burden through the lessening of circulating 8-iso-prostaglandin.
There are traditional plants that remain in obscurity, found only in ethnobotanical texts and faraway lands. Then there are those that find their way to our shelves, gaining “legitimacy” of their traditional use through scientific means. Amla is clearly the latter. A 2012 publication reviewing the potential applications based on preclinical evidence concluded that “E officinalis possesses antipyretic, analgesic, antitussive, antiatherogenic, adaptogenic, cardioprotective, gastroprotective, antianemic, antihypercholesterolemic, wound healing, antidiarrheal, antiatherosclerotic, hepatoprotective, nephroprotective, and neuroprotective properties.”6 Several recent reviews outline the constituents, traditional uses, and current state of the evidence.7-10 While the traditional and preclinical evidence is clearly in sync, there continues to be sparse clinical outcome data on amla usage.
As the clinical trial data catch up to the traditional knowledge, it seems that using this highly valued fruit in whole, dried, or extract form may be helpful to anyone seeking to maintain optimal health. This pilot study suggests those with hypercholesterolemia or ongoing exposure to toxicants may be particularly suited to its health benefits. Given there is no toxic risk to including amla fruit, the relevant question to ask is not “Why take it?” but “Why not?”
- Mahdihassan S. The tradition of alchemy in India. Am J Chin Med. 1981;9(1):23-33.
- Vayalil PK, Kuttan G, Kuttan R. Rasayanas: evidence for the concept of prevention of diseases. Am J Chin Med. 2002;30(1):155-171.
- Tasanarong A, Kongkham S, Itharat A. Antioxidant effect of Phyllanthus emblica extract prevents contrast-induced acute kidney injury. BMC Complement Alternat Med. 2014 Apr 22;14:138.
- Islam A, Auddy B, Mazumder UK, Gupta M, Ghosal S. Beneficial effect of Phyllanthus emblica fruit extract on cigarette smoke induced Impaired antioxidant status in rats. Pharmacologyonline. 2008:2:255-264.
- Sharief, Dawood. Role of Emblica officinalis (Amla) on nicotine toxicity to rats (Rattus orvegicus). Int J Pharmaceut Biol Arch. 2103;4(4):775-780.
- Bhandari PR, Kamdod MA. Emblica officinalis (amla): A review of potential therapeutic applications. Int J Green Pharm. 2012;6(4):257-269.
- Kumar KS, Bhowmik D, Dutta A, et al. Recent trends in potential traditional Indian herbs Emblica officinalis and its medicinal importance. J Pharmacognos Phytochem. 2012;1(1):18-28.
- Thomas MB. Perspectives on amla: a wonder herb. J Drug Discov Therapeut. 2013;1(09).
- Kaur J, Kaur D, Singh H, Khan MU. Emblica officinalis: A meritocratic drug for treating various disorders. Indo Am J Pharmaceut Res. 2013;3(6):4477-4496.
- Singh E, Sharma S, Pareek A, Dwivedi J, Yadav S, Sharma S. Phytochemistry, traditional uses and cancer chemopreventive activity of amla (Phyllanthus emblica): The sustainer. J Appl Pharmaceut Sci. 2012;2(1):176-183.