Use of Herbs and Clinical Trials, Research Paper Example

There are several pieces of information needed to support clinical trials of herbal products, detailed in the WHO’s operational guidance (2005). Clinical trials are research studies that involve humans, according to the definition of the UK Clinical Research Ombudsman’s detailed review (UK Clinical Research Collaboration, 2006) of the pharmaceutical industry. The research is designed to answer questions regarding a health condition or illness, such as: methods of prevention, treatment effectiveness, improving the quality of life for patients, and diagnosing diseases (UK Clinical Research Collaboration, 2006, p. 5). Dosages are set up based on the trial protocol, which considers previous completed research studies covering the disease, health condition, and the drug (herb). Recommendations of experts and doctors is also considered when creating the dosage to be used during the trial.

Herbal use is regulated by several international agencies. According to Zhang (1998), the main regulator of herbal medicines is the WHO. However, countries also have their national policies that affect the herbal industry. Herbal medicines usually are included in the “Traditional medicine” category by all countries. The World Health Assembly has several resolutions that call for the regulation of traditional medicines the same way as manufactured, pharmaceutical drugs. WHO member states are regulated by the organization’s guidelines. The international helath agency also highlights the fact that “herbal medicines have two special characteristics which distinguish them from chemical drugs; use of crude herbs and prolonged usage” (Zhang, 1998, p. 7). The “Guidelines for the Assessment of Herbal Medicines” created by the WHO provides recommendations for member states to safely assess the effectiveness and safety of herbal products. The WHO is currently in the process of providing more support for countries to develop model guidelines that are easy to implement on the national level.

References

UK Clinical Research Collaboration (2006) Understanding clinical trials. Retrieved from http://www.ukcrc.org/wp-content/uploads/2014/03/iCT_Booklet.pdf

WHO (2005) Operational guidance: Information needed to support clinical trials of herbal products. Retrieved from http://www.who.int/tdr/publications/documents/operational-guidance-eng.pdf

Zhang, X. (1998) Regulatory situation of herbal medicines. A worldwide review. Retrieved from http://apps.who.int/medicinedocs/en/d/Jwhozip57e