Herbal Medicines: Development, Issues, and Misconceptions

The Philippines is one of the world’s 18 mega-biodiverse countries and hosts up to 80% of the world’s plant and animal species. More than 1500 medicinal plants used by traditional healers have been documented and among those that have been approved for therapeutic use by the Food and Drug Administration (FDA) and the Department of Health (DOH) are lagundi (Vitex negundo), sambong (Blumea balsamifera L.), ampalaya (Momordicac harantia L.), garlic (Allium sativum), guava (Psidium guajava), tsaang-gubat (Carmona cetusa), yerba-buena (Mentha arvensis), niyug-niyogan (Quisaualis indica), acapulco (Cassia alata), and ulasimang-bato (Peperomi apellucida).

The innovation in the discovery of herbal plants as medicines has progressed by leaps and bounds since the establishment of the National Integrated Research Program on Medicinal Plants (NIRPROMP) in 1974, a collective made by the government for local researchers and agencies independently researching herbal medicines. At the time, 75% of market sales in the pharmaceutical industry are from multinational corporations. Annually, the Philippines spend 150 million pesos (around US $22 million at the time) to import medicine. 

In 1997, the Philippine Institute of Traditional and Alternative Health Care (PITAHC) was created through the passing of the Traditional and Alternative Medicine Act in 1997 (RA 8423). The institute is mandated to plan and carry out research and development activities on the indigenous traditional health care practices, formulate standards and guidelines for manufacture, marketing, and quality control of traditional medicine, and provide incentives for manufacturers of traditional and alternative health care products. An important aspect of the law is its definition of herbal medicines as, “finished, labeled, medicinal products that contain as active ingredient/s aerial or underground part/s of plant or other materials or combination thereof, whether in the crude state or as plant preparations.”

According to the Health and Dietary Supplement Association of the Philippines, the consumer health sector is dominated by over-the-counter (OTC) brands with 43% of the market share. Vitamins and supplements and herbal/traditional products account for 34% and 12%, respectively.  

Compared with the international reference prices, generic drugs are sold four times higher and branded innovator products are sold up to 22 times higher, especially in private hospitals and pharmacies. According to the Pharmaceutical and Healthcare Association of the Philippines (PHAP), out-of-pocket expenses for health care costs are about 54% for Filipinos. These expenses are higher compared to our neighboring countries like Thailand at 12%, Malaysia at 38%, and Indonesia at 37%. 

Herbal treatment or folklore medicines were widely used for the treatment of many diseases in both developed and developing countries. It is estimated that around 80% of the world’s population relies on herbal products for primary health care. Herbal medicines are less expensive than synthetic medicines and are widely accessible, especially in populations living in rural areas. 

The scientific validation of the medicinal use of herbal plants adheres to the standards of medical research which involves several tests to confirm safety and efficacy. The documentation of traditional knowledge of the medicinal uses of plants has helped various researchers to subject plants to various bioassay, toxicological, and clinical testing. 

Despite the usefulness of medicinal plants, there is a growing misconception about their use and adverse effects. Consumers most often confuse food supplements and traditionally-used herbal products with herbal medicines. Food or dietary supplements as defined by Administrative Order No. 2014-0029 are processed food products that help supplement the diet. As such, the requirements for registration only include documents to support claims such as scientific reports, market research studies, certificate of analysis, stability study of the finished product, and safety data. The Food and Drug Administration (FDA) has also made it mandatory to reflect the message or phrase, “Mahalagang paalala: Ang (name of product) ay hindi gamot at hindi dapat gamiting panggamot sa anumang uri ng sakit” as the phrase “No Approved Therapeutic Claim” has been used by owners or manufacturers of food supplements with false or misleading claims about their therapeutic value and safety. 

Traditionally-used herbal products, on the other hand, are preparations from plant materials whose claimed applications are based on the traditional experience of long usage of at least five (5) or more decades as documented in medical, historical, and ethnological literature. Like food/dietary supplements, no claim shall be made for the principal treatment of any medical condition and should bear the phrase, “The traditional application/use of this product has not been evaluated by the Bureau of Food and Drugs.”

Herbal medicines, in addition to the definition by PITAHC, are medicinal plant products that have specific therapeutic claims and shall be intended for use in the diagnosis, alleviation, cure or treatment of disease, promotion of health, or intended to affect or modify the structure or any function of the body of humans or animals. They have undergone the tedious process of preclinical, animal, and human studies to prove their safety and efficacy for therapeutic use. 

In spite of their health benefits, herbal medicines should not be considered as the sole method for treating disease. Caution must be exercised especially when prescribing them to adolescents, children, older persons, and pregnant women. Studies on herbal medicines in pregnant women are limited and hard to come by that’s why they are generally avoided during pregnancy.

Due to the preference of some consumers for natural therapies, there is a misconception that herbal medicines are superior to synthetic medicines. It is a common belief that all natural products are not toxic and have no adverse effects. This thinking can lead people to consume natural products to make up for poor diets, to treat chronic conditions instead of seeking trained medical help, or in worse cases can result in severe poisoning and acute health problems.

Healthcare professionals often have little training and understanding of herbal medicines. In a cross-sectional study, about 28.1% of health professionals had training regarding the safety of herbal medicine. Moreover, 41.5% reported that they have encountered patients who have experienced side effects after the concomitant use of a drug and herb but no one reported the suspected adverse reactions of herbal medicine to the national pharmacovigilance center. These findings suggest that adequate knowledge and training are important for the monitoring of the safety of herbal medicines and for better-informed decisions of health professionals

In order to protect public health, regulatory authorities must take measures to ensure the safety of herbal medicines by ensuring that all herbal medicines approved for sale are both safe and of suitable quality. These also include measures to monitor health products that erroneously claim therapeutic benefits despite the lack of evidence. Moreover, regulations should also be in place for the benefit of indigenous populations and sustainable use of natural resources for the growth and production of herbal medicines. By developing our resources, we can not only help develop the pharmaceutical industry but also serve the best interests of public health.

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