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PHA 2nd Summit on Supplements "Heart Supplements: The Facts and Fallacies"
Bayview Hotel, Manila February 26, 2010 The Science, the Hearsay, the Experience and the Evidence Are natural products always safe and effective? The summit tackled only those supplements with purported benefits in clinical conditions related to the heart and blood vessels namely hypertension, heart failure, cholesterol abnormalities, clotting, heart disease, obesity, antioxidants, etc. Supplements are non-food substances that are used to augment the dietary intake of minerals, vitamins, amino acids, etc. Herbal supplements are being hyped as cure-all "breakthroughs" and as effective alternative "medicines". Many people are enticed by the health benefits of food supplements, believing that natural substances are generally safe and can have the same efficacy as drugs. Despite the absence of scientific studies to support their potency and safety, the food supplement is now a P5-billion industry that has posted a 200 percent growth. What is more phenomenal is its unprecedented record growth with an estimated combined market size of 2.1 billion in Northern Luzon, Visayas and Mindanao. SUMMIT OBJECTIVES In his presentation, Javier cited the objectives of the summit which were to provide a venue for discussion of pertinent issues related to heart supplements, to determine sectoral responsibility and accountability among involved stockholders, to present and review available evidence and to define future directions in the various processes related to these supplements. He maintained that the Summit was meant to be an elucidative, elaborative and expository forum. In the multisectoral forum that ensued, various medical experts tackled and presented their perspectives confronting the proliferation and use of heart supplements. The invited panelists included Dr. Ma. Belen Carisma, PHA President, Dr. Santiago del Rosario, chair of the Commission on Ethics of the Philippine Medical Association (PMA), Dr. Fita Guzman, medical specialist IV, Bureau of Food and Drugs and Professor Isidro Sia, director of the National Graduate Office for the Health Sciences, University of the Philippines, Manila. In the panel discussion that followed, Javier, who also acted as moderator, presented the issues concerning the product itself, the various pertinent processes as well as issues on the end-user or the public at large. Emphasis was placed on the efficacy issue of the product, based on the scientific database as well the safety profile. THE AVAILABLE EVIDENCE Javier stated that PHA was compelled to address concerns on the overwhelming proliferation of herbal supplements with 'no therapeutic claims'. He explained that before any drug is launched in the market, it has been rigidly tested in clinical trials which are deemed to be low bias studies (randomized controlled trials or RCT which provide the most robust evidence about a drug or device). Also, he added that such trials involve parameters of clinical outcomes - e.g. death, heart attack, stroke, etc. and they enroll large populations of subjects. In contrast, he stressed that very few health supplements have been evaluated in similar clinical trials. He thereafter presented the collective outputs of the involved PHA committees on the available evidence concerning the safety and efficacy of major heart supplements being promoted in the local market. THE PRODUCT The Summit provided some highlights on some of the popular and widely available products in the market today. Gingko biloba has been cited for possible use in Alzheimer's disease, vascular dementia, peripheral claudication and tinnitus of vascular origin. It is one of the 10 best selling herbal products in the US. For CVA, dementia and memory enhancement, systematic review of eight RCTs concluded that it had modest effect on dementia and cerebral insufficiency. Systematic review of nine studies showed positive and safe effects compared to placebo. Cochrane metaanalysis of 33 trials concluded that gingko is safe with a promising improvement of cognition and function. For claudication, metaanalysis of eight studies concluded that there as statistically significant through modest effect on pain-free walking. Most important clinical problem is bleeding-related and thus makes it important for patients taking warfarin, ASA or others. Systematic review of 15 case reports showed temporal association between gingko and severe bleeding. Hawthorn, Crataegus oxyacantha, has been cited for its inotropic properties and effects on vascular integrity and O2 utilization. Thus, it has been used for hypertension, hyperlipidemia, CHF. Ten RCTs showed no effect on primary endpoint with higher risk of early CHF progression. For CoQ10, two randomized trials on hypertension involving small study populations noted small reduction in blood pressure (BP). The six RCTs on CHF showed inconclusive proof of benefit because of a small population size. The current evidence on ginseng does not support its use in treating cardiovascular disease. Nine RCTs on HPN showed no effect on BP and may even increase it. Grape seed extract has been shown to have no effect on blood pressure and may even increase BP. It has minimal effect on low density lipoprotein. Omega 3-FA may be beneficial in patients with hypertension and hypercholesterolemia but therapeutic doses need to be defined Omega FA is proven for secondary prevention of post-myocardial infaction. Sambong, in one local RCT with 29 patients with mild hypertension, showed no significant reduction in BP. There are herbs that interact with cardiac drugs - UP NDIC Prof. Sia of the UP National Drug Information Center made it clear that not all herbs are safe. He cited that some herbs like mahuang and aristolochia are harmful while gingko and garlic interact with commonly prescribed cardiac drugs. He elaborated that many people use supplements as medicines and regard these as options for treatment and as alternatives to what is studied and backed by evidence and years of research. He opined that this might spring from the inadequacy of knowledge or lack of access to mainstream medicines. Importantly, Sia emphasized - "Registration of a supplement does not entail the evaluation of the efficacy of the product". THE REPONSIBILITY OF BFAD Guzman of BFAD averred that BFAD's recommendation for practitioners it to advise patients to rationally use of supplement with proven efficacy and safety and to discourage use of supplement which have proven to be harmful. She emphasized the need to counsel patients on a wholistic approach to health - feed your body right, exercise, do not smoke, drink moderately, manage stress and feed your soul. Queried on labeling of health supplements, Guzman mentioned that under BFAD memorandum circular no. 25, manufacturers are mandated to strictly adhere to labeling requirements for food supplements: "no approved therapeutic claims". She explained that a health supplement cannot carry a drug claim of therapeutic benefit - or any claim that purports to treat, cure, mitigate, diagnose and prevent disease. ROLE OF PMA According to Del Rosario, the role of monitoring the practices of unscrupulous manufacturers and the quality of their health product is beyond the scope of the PMA. However, in meetings and conventions where PMA acquires information on the practices of manufacturers and the quality of their health products, PHA refers such issues to the Pharmaceutical Healthcare Association of the Philippines (PHAP) Committee on Ethics. The PMA also has a Committee on Drugs that keeps watch over substandard drugs and practices. At one time, Santiago recalled, the PMA Committee on Drugs discovered "kitchen laboratories" which specialized in mixing fake medicines. The PMA helped the authorities in apprehending these culprits. PHA COMMITMENT "What the PHA lacks in terms of funds will be compensated for by information dissemination and the education of the community", Carisma said, adding that "the PHA does not have the funds and leverage to counteract the claims of manufacturers of herbal supplements." Carisma remarked that she would encourage her patients not to spend their hard-earned money on supplements with no therapeutic claims. She also highlighted the need for patients and doctors alike to be knowledgeable about these supplements, including its side-effects and over-all safety and the importance of cascading these information to the patients. Javier stressed that the over-all quality of RCTs including the evidence for the heart supplements is poor; most products are provided without good evidence of benefic; continuing research is necessary to elucidate on the pharmacological activities of the many herbal remedies now being used to treat cardiovascular diseases and most especially, to prove their efficacy and safety in the same manner as how we evaluate conventional medicines. Lastly, Javier lamented that while a doctor-prescribed drug is rigidly tested and evaluated, trial-proven and monitored, a product like a health supplement which is anecdotally proven, testimonial-aided and media promoted, is more widely available and easily obtainable. The irony is that some patients buy the testimonial-driven supplements no matter how expensive they are but complain about the cost and scrimp on budget for medically-proven effective and safe drugs with long-term morbidity and mortality benefits. Guzman remarked that the herbal supplement trade earmarks P3 billion for its media campaign. Summing it up, the unanimous message of the multi-disciplinary experts is that a "natural" product is not necessarily safe. While some herbs are helpful, some are harmful. The Summit on Supplements is envisioned to be the preliminary step in the drafting and finalization of a final position paper by the Philippine Heart Association which shall enlist the support of other medical associations including the PMA and the Philippine College of Physicians. |
