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Safety and efficacy of health supplement for weight loss.

INTRODUCTION

According to Pharmaceutical Division Services, Ministry Of Health, acai berry ABC is listed under product adulterated with poison which is contained Sibutramine as active ingredient. [1]

INDICATION

Anti-obesity drug used to promote weight loss by inhibiting the re-uptake of noradrenaline, serotonin and dopamine into the nerve cells of the brain. The increased level of serotonin and dopamine enhance satiety thus reducing the food intake by people and as a result, contribute to weight loss. [2]

DOSAGE AND ROUTE

Acai berry ABC recommended to take one capsule/time (before breakfast with 350-500 ml water)/day. [3] However, recommended dose for sibutramine for adult: Initially, 10 mg daily in the morning. Re-evaluate treatment in patients whose weight loss is <2 kg in the first 4 weeks of treatment. May increase dose to 15 mg daily. Reassess 4 weeks later. Discontinue treatment if weight loss is still <2 kg. Max dose for sibutramine is 15 mg daily. [2]

CONTRAINDICATIONS

History of cerebrovascular disease. History of cardiovascular disease, including the history of coronary artery disease, history of stroke or transient ischemic attack, history of heart arrhythmias, history of congestive heart failure, history of the peripheral arterial disease, and uncontrolled hypertension. History of eating disorders (e.g., anorexia nervosa and bulimia nervosa); bipolar disorder, Tourette's syndrome, hyperthyroidism, pheochromocytoma, benign prostatic hyperplasia; history of drug or alcohol abuse. Pregnancy, lactation. Severe renal or hepatic impairment. [2]

PRECAUTIONS AND WARNING

Hypertension, narrow-angle glaucoma, seizures, history of gallstones, family history of motor, or verbal tics. Should not drive or operate machinery. Mild-moderate renal impairment. History of depression. History of hypertension, coronary artery disease, congestive heart failure, arrhythmias, or stroke. Monitor blood pressure (BP) and heart rate. [2]

ADVERSE EFFECTS

Dry mouth, drowsiness, dizziness, rhinitis, depression, emotional lability, migraine, skin rash, mydriasis, insomnia, constipation, diarrhea, peripheral edema, and menstrual disorders. [2]

MARKETING ISSUES

Selling of acai berry ABC in Malaysia was against S7 (1) (a) control, drug, and regulation 1984 where no person shall manufacture, sell, supply, import, possess or administer any product unless the product is a registered product. Acai berry is an unregistered product with Drug Control Authority (DCA). Furthermore, acai berry also categorized as an adulterated product under Ministry of Health which is against the Sale of Drugs Act 1952. On conviction, a fine of RM25,000 or 3 years imprisonment or both for individuals and a fine of RM50,000 for a company can be imposed. [4]

Acai berry ABC widely advertised throughout social media such as Facebook, website services, and online marketing. Medicine Advertisement Board (MAB) defines an advertisement including any notice, circular, report, commentary, pamphlet, label, wrapper or other document, and any announcement made orally or by any means of producing or transmitting light or sound which includes websites and other internet materials including brand homepages and banner advertising.^

Since acai berry ABC has been an unregistered product with DCA, the advertisement is against clause 4.3 MAB, which state advertising to the public is only allowed for a product which is registered with DCA. No approval shall be given for poisons as specified in the First Schedule of Poisons Act 1952. Acai berry ABC adulterated with sibutramine which considered as poisons in the First Schedule of Poisons Act 1952. Even though acai berry ABC is marketed through internet marketing, it is necessary to display KKLIU number approved by MAB which required in clause 4.14 MAB. The advertiser also needs to clearly state the name, address, and contact number of advertisers on the page. To build trust with the customer, the acai berry ABC advertiser usually displays powerful user's testimonial. However, under clause 5.3 MAB stated that an advertisement may include testimonials, but the individual who gives the testimony must be genuinely exist and responsible as well as accountable to the advertisement and its testimonials must refer to indications approved. Advertisement with a testimonial must be stated with a statement "The effect of the product may vary among individuals." Consent letter of testimony, including name, identification card/passport number, signatures and contact number of the users must be stated in the advertisement.^

Acai berry ABC claimed as a dietary supplement and also have an antioxidant properties. It is a super fruit that can turbo change weight loss to the customer. This statement was against MAB clause 6.7 claims concerning weight management products. Advertisements must have an appropriate balance between the claims of product effectiveness and references to healthy diets and physical activity for products indicated for weight loss, reduction, or management. Quick weight loss results or physiological thermogenic (fat-burning) activity should not be claimed for that product. The advertiser should not state misleading claims on eating such as "eat as much as you like." There should be an emphasis on a well-balanced diet plan and exercise as required under the "warning and cautionary statements" section of these guidelines. According to clause 9.2 MAB, weight loss products should include a statement "this should be taken with a balance diet and regular exercise" but advertiser fail to do so. [5]

METHODOLOGY

An electronic search of Cochrane Library, EMBASE, PubMed and database of abstracts of reviews of effects for studies, trial, and reviews using the following research criteria were carried out:

The following websites were searched for reviews and report for additional information: (MIMS, Micromedex, NICE).

Literature were systematically reviewed using Critical Appraisal Skills Programme tools.

RESULTS

Safety and efficacy

In a double-blind, randomized, placebo-controlled study on the effect of sibutramine on cardiovascular outcomes in overweight and obese subjects (Sibutramine Cardiovascular Outcome Trial [SCOUT]) conducted from January 2003 to March 2009 at 298 centers in 16 countries in Europe, Central America, South America, and Australia. The SCOUT trial showed that long-term use of sibutramine among the subject with cardiovascular disease had a risk of nonfatal myocardial infarction and nonfatal stroke, but not of cardiovascular death or death from any cause. [6]
Search strategies

Key words used                         Sibutramine, obesity, patient
                                       safety, treatment efficacy
Year searched                          2005-2015
Total number of articles reviewed      16
Relevant full-text articles reviewed   7


A randomized, placebo-controlled and double-blind trial in efficacy and safety of sibutramine for weight loss in obese patients with hypertension well controlled by P-adrenergic blocking agent showed that sibutramine is significantly effective in weight loss and does not exacerbate hypertension patient well controlled with medication. [7]

A randomized, placebo-controlled, double-blind, parallel group on the study of sibutramine for weight loss and diabetic control in obesity with Type 2 diabetes was conducted for 12 weeks at two hospital-based obesity/diabetes. Results show that sibutramine 15 mg daily with a customized and reduced calorie diet significantly reduce weight compared to placebo in an obese patient with Type 2 diabetes. [8]

In addition, a randomized, placebo-controlled and double blind trial on the effects of 1 year treatment of sibutramine on insulin resistance (IR) parameters in Type 2 diabetic patients was done in Italy. Findings show that a significant decrease in IR index (homeostatic model assessment-IR), resistin and retinol binding protein 4 with sibutramine comparable to placebo. Sibutramine also gives improvement in hemoglobin A1c, fasting plasma glucose , and postprandial plasma glucose. Besides that sibutramine recorded decrease in fasting plasma insulin total cholesterol, low-density lipoprotein cholesterol, body weight, and body mass index compared to control group. [9]

A meta-analysis of 28 randomized placebo-controlled trial for discontinuation due to adverse events in randomized trials of orlistat, sibutramine, and rimonabant showed that there were no significant risk ratio due to discontinuation for sibutramine (0.98, 0.68-1.41) compare to orlistat and rimonabant. The result also showed that no significant difference in the risk difference between sibutramine (0.2%, -3-4%; NNH 500) and placebo. [10]

A meta-analysis of 21 placebo-controlled, double-blind, randomized trial on the effect of Sibutramine on weight loss and BP showed that even though sibutramine is effective in weight loss, it also may increase slightly in BP. The effect size of sibutramine on weight change was -1.00 (-1.17- -0.84), whereas the effect sizes on systolic blood pressure and diastolic blood pressure changes were 0.16 (0.08-0.24) and 0.26 (0.18-0.33), respectively. Sibutramine should be used cautiously in patients with borderline or high BP. [11]

A case series of three case reports mentioned that panic disorder induced by "herbal" product contains sibutramine. Three cases using an herbal product called "Lida" that claimed to be natural and bought it from internet. This three cases showed that the symptom of panic attack still continues even after discontinued the product and in need of treatment with serotonin-specific reuptake inhibitors. [12]

RISK TO GENERAL POPULATION

According to Ministry of Health, in 2011 about 33.3% from 5.4 million Malaysian adults are included in preobese, whereas 27.2% are under obese category. [13] Because of obesity, Malaysian, especially women prefer to use slimming products rather than exercise and lifestyle modification to look slim. When acai berry ABC widely sold through social media such as Facebook and also webpage, anyone can buy the product without knowing it was an adulterated product. People easily influenced by advertisement and testimonial claimed by users.

A random study about the herbal product available on internet showed that herbal weight loss products available on the internet claimed to be purely herbal contain pharmaceutical substances such as sibutramine or temazepam in high doses. Similarly, they also contain trace toxic metals. Since many people use these products without knowing its real content and without the suggestion or control of a physician, various potentially lethal health problems might occur. The other herbal products used for different purposes, which are not investigated, may also be potentially harmful. [14]

An evaluation of internet websites marketing herbal weight loss supplements to consumers done in 2005 showed that most of the website advertised the herbal weight loss products will provide minimal required labeling information such as product name, contact number, and active ingredients. Others supporting information such as the strength of product, potential interaction and contraindication are infrequently mentioned. [15] Web sites also may provide nonexistent health, safety information or dose recommendation for their products. Consumers may assume that labels of the herbal product are accurately portrayed their safety and efficacy information and that product marketed as "all-natural" are inherently safe. In addition, sellers may use a bombastic word to convince the buyer regarding the benefit of their weight loss products. Misleading information regarding dependent to herbal weight loss products made someone slimmer than before lead to people did not want to exercise and practice a healthy lifestyle.

Furthermore, the study of sibutramine related deaths due to cardiovascular disease and the preliminary results of the SCOUT study, physician, and pharmacist are recommended by the European Medicine Agency to stop selling products containing sibutramine. Malaysia also banned this product since 2010. However, still there is a company selling the herbal weight loss product adulterated with sibutramine such as acai berry ABC. The result from Pharmaceutical Service Division, Ministry of Health of Malaysia stated that acai berry was adulterated with sibutramine and banned this product from marketed in Malaysia. Malaysian are at risk if they are not aware regarding the prohibition of selling this adulterated product with sibutramine and still buying this product, especially for people with a risk of cardiovascular disease.

CONCLUSIONS

Acai berry ABC was an unregistered weight loss product with Ministry of Health of Malaysia. Any products are selling in Malaysia compulsory to register with the Pharmaceutical Division Service, Ministry of Health. Selling product without registration is against the Control Drug and Regulation 1984. However, not everybody in Malaysia is aware of in need of use of registered products. Moreover, not all herbal weight loss products and claimed to be safe and naturally available in Malaysia are genuinely safe. Anyhow, registered product only can be trusted in term of safety and efficacy.

Ministry of Health has banned the selling of acai berry ABC in Malaysia due to adulteration with sibutramine which may risk and harmful to cardiovascular disease patient. As for Malaysian, it is not safe to consume the product that contain with control poison without consultation from physician or pharmacist.

It is a pharmacist responsibility to educate people to consume an only product that registered with Ministry of Health. Malaysian should always consult with a physician or pharmacist if any confusion regarding any product that they have been consumed. Program "know your medicine" under Pharmaceutical Division Services, Ministry of Health are valuable program to introduce and give awareness to Malaysian regarding rational use of medicine and also on how to recognize registered product in the market.

Malaysian especially women, who enthusiastic for weight loss are recommended to change lifestyle in terms of diet modification and have a passion to do an exercise for 30 min/day 5 times in a week. A healthy lifestyle is better than depending on the herbal weight loss product only.

DOI: 10.4103/2045-080X.183031

This is an open access article distributed under the terms of the Creative Commons Attribution-NonCommercial-ShareAlike 3.0 License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical terms.

For reprints contact: reprints@medknow.com

Financial support and sponsorship

This work was supported by LESTARI Grant Scheme: 600RMI/DANA 5/3/LESTARI (42/2015). The authors would like to express their gratitude to Ministry of Higher Education and Universiti Teknologi MARA (UiTM), Malaysia for financial support for this research.

Conflicts of interest

There are no conflicts of interest.

REFERENCES

[1.] Health PSDMO. Adulterated Product; 17 August, 2015. Available from: http://www.pharmacy.gov.my/v2/ms/apps/ adulterated.

[2.] MIMS Gateway Malaysia; 2015. Available from: http:// www.online1.mimsgateway.com.my/.

[3.] Webpage Acai Berry ABC. Available from: http://www. acaiberrymalaysiaoriginal.blogspot.my/.

[4.] Health MO. Sale of Drugs Act 1952; 01 January, 2006.

[5.] 3/2015 MABiM. Guideline on Advertising of Medicines and Medicinal Products to General Public; 1st September, 2015. p. 1-39.

[6.] James WP, Astrup A, Finer N, HilstedJ, Kopelman P, Rossner S, et al. Effect of sibutramine on weight maintenance after weight loss: A randomised trial. STORM Study Group. Sibutramine Trial of Obesity Reduction and Maintenance. Lancet 2000;356:2119-25.

[7.] Sramek JJ, Leibowitz MT, Weinstein SP, Rowe ED, Mendel CM, Levy B, et al. Efficacy and safety of sibutramine for weight loss in obese patients with hypertension well controlled by beta-adrenergic blocking agents: A placebo-controlled, double-blind, randomised trial. J Hum Hypertens 2002;16:13-9.

[8.] Finer N, Bloom SR, Frost GS, Banks LM, Griffiths J. Sibutramine is effective for weight loss and diabetic control in obesity with type 2 diabetes: A randomised, double-blind, placebo-controlled study. Diabetes Obes Metab 2000;2:105-12.

[9.] Derosa G, Maffioli P, Ferrari I, Palumbo I, Randazzo S, D'Angelo A, et al. Effects of one year treatment of sibutramine on insulin resistance parameters in type 2 diabetic patients. J Pharm Pharm Sci 2010;13:378-90.

[10.] Johansson K, Neovius K, DeSantis SM, Rossner S, Neovius M. Discontinuation due to adverse events in randomized trials of orlistat, sibutramine and rimonabant: A meta-analysis. Obes Rev 2009;10:564-75.

[11.] Kim SH, Lee YM, Jee SH, Nam CM. Effect of sibutramine on weight loss and blood pressure: A meta-analysis of controlled trials. Obes Res 2003;11:1116-23.

[12.] Eraslan D, Coban AA, Ertekin E. Panic disorder induced by a "herbal" product containing sibutramine: Case series with review of literature. Klin Psikofarmakol Bul 2015;25:74-7.

[13.] Health Mo. National Health and Morbidity Survey 2011--Ministry of Health; 2011. Available from: http:// www.moh.gov.my/./554756755a584a696158526862693 94859584a70.

[14.] Ozdemir B, Sahin I, Kapucu H, Celbis O, Karakoc Y, Erdogan S, et al. How safe is the use of herbal weight-loss products sold over the internet? Hum Exp Toxicol 2013;32:101-6.

[15.] Jordan MA, Haywood T. Evaluation of internet websites marketing herbal weight-loss supplements to consumers. J Altern Complement Med 2007;13:1035-43.

Saliza Ibrahim (1), June Choon Wai Yee (2), Manish Gupta (2), Muthu Kumar Murugiah (3), Long Chiau Ming (1,4)

(1) Faculty of Pharmacy, Universiti Teknologi MARA, Puncak Alam, (2) School of Pharmacy, Monash University Malaysia, Bandar Sunway, (3) Department of Penang State Health, Pharmaceutical Services Division, Penang, (4) Vector-borne Diseases Research Group (VERDI), Pharmaceutical and Life Sciences CoRe, Universiti Teknologi MARA, Shah Alam, Selangor, Malaysia

Address for correspondence: Saliza Ibrahim, Faculty of Pharmacy, Universiti Teknologi MARA, Puncak Alam, Selangor, Malaysia. E-mail: saliza.ibrahim54@gmail.com
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Author:Ibrahim, Saliza; Yee, June Choon Wai; Gupta, Manish; Murugiah, Muthu Kumar; Ming, Long Chiau
Publication:Archives of Pharmacy Practice
Article Type:Report
Date:Jan 1, 2016
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