Herbal Medicine: Regulation and Marketing

@#Given the expansion of herbal medicine, the overall quality, safety and efficacy must be subjected to critical examination if the intention is to safeguard public health. There are quality concerns on the products already in the market. Adulteration of contents, ingredients differing from label and unsupported or misleading claims are reported in several studies. This article proposes three areas that can be standardized to ensure quality, safety and efficacy of herbal medicines. The first is ensuring good agriculture and harvesting practices for the plant raw materials. Second is good manufacturing practice of producing medicinal preparation (liquid or solid form) from the raw materials. Third, develop a standardized and acceptable clinical trial design to demonstrate safety and efficacy. The regulatory agencies of some developed countries have published guidelines to ensure the quality of herbal medicines. Example of these guidelines are the botanical drug product guidance of the US FDA, the evidence for quality of finished natural health products guidance of the Health Canada and the guideline on quality of herbal medicinal products by the EMA. They specify different registration pathways. Registration pathways in Europe are traditional herbal registration (THR) or conventional marketing authorization (CMA). In the USA, it can be registered as dietary supplement (DS) or botanical drug (BD). In the Philippines herbal medicines taken orally can be registered as herbal medicine (HM), traditional use herbal product (TUHP) and dietary supplement (DS). Requirements for registration in the three regions compared include quality control and good manufacturing practices, evidence of safety and toxicologic studies and evidence of efficacy or clinical trials, but it all depends on the product to be registered or the chosen pathway for registration. After approval for marketing, there must be a methodological approach for post-marketing safety based on sales data and information on adverse drug reactions of newly introduced herbal medicinal products in the market.

Topical herbal preparation with anti-inflammatory and analgesic effects: Qualitative review of evidence

Background@#In the past musculoskeletal complaints were treated with topical preparations from medicinal plants until the advent of NSAIDs. However, because of the side effects of NSAIDs, interest has increased on going back to the use of topical traditional herbal medicines in patients with musculoskeletal pain.@*Objective@#This review was conducted to identify the active substance, its mechanism of action, pre-clinical and clinical studies and propose a topical herbal formulation balancing its analgesic and anti-inflammatory effect with skin care effect among patients with various somatic pain conditions.@*Methods@#This is a qualitative review of both local and international published medical literature to identify and summarize information on the use of topical herbal preparation for the treatment of musculo-skeletal pain.@*Results@#After the initial review, the authors identified six herbal preparations that have been investigated for its analgesic and anti-inflammatory properties in clinical trials. They eventually arrived at a consensus to consider the final combination of ginger, capsaicin, peppermint and virgin coconut oil. Gingerol, a naturally occurring plant phenol, is one of the major components of ginger known to have diverse pharmacologic effects including anti-oxidant, anti-apoptotic, and anti-inflammatory activities in vitro and in vivo. Capsaicin is a highly selective agonist for the transient receptor potential vanilloid 1 receptor expressed in nociceptive sensory nerves. The mechanisms underlying capsaicin-induced analgesia likely involve reversible ablation of nociceptor terminals. Local application of peppermint oil generates a long-lasting cooling effect on the skin and result to muscle relaxation. Ginger, capsicum and peppermint have been shown in clinical trials to relieve musculoskeletal pain and inflammation. Virgin coconut oil on the other hand has no analgesic effect but has been shown in some studies to be favorable for skin conditions and facilitate skin penetration of some substances. @*Conclusion@#Using combined preparation may have the advantage of complementation of its effect i.e. analgesic and anti-inflammatory effect of ginger, warm sensation of capsicum and the cold sensation of peppermint.