Natural Herbs Should Require Scientific Investigation

Category: Medications & Supplementation Published on Wednesday, 25 June 2008 Written by Yong Tsai, MD

Since the pulling Vioxx and Bextra (arthritis), Tysabri (multiple sclerosis) and other medications off the market the public has lost confidence in pharmaceutical companies their medications. The fact is that a numerous people believe that associated side effects will cause them more harm, than the medication will do them good.  Due to this misconception, many people are turning towards "natural" herbal therapy because they believe they are safer than pharmaceutical products.

Recently, I have reviewed several respected resources to find evidence based efficacy and safety data in regards to herbal treatment for my patients.  Yes, there are plenty of natural herbs for arthritis and inflammatory conditions, but are they really effective?  Are they safer?  How do I know?  Can I really recommend their use to my patients?

Natural herbs, promoted to help relieve medical conditions and symptoms, are not subject to the strict testing that pharmaceuticals are required to undergo for FDA approval.  Herbal medicines frequently contain numerous ingredients with unknown pharmacological effects that often interact, sometimes seriously, with other medications.  Ironically, many of these herbs ingredients contain non-steroidal anti-inflammatory drugs and even corticosteroids, popular prescription medications that may have initially deterred a patient towards herbal therapy. And even though some herbs   have undergone investigational research, their scientific efficacy and safety evidence is still not satisfactory. Most herbal medicines are unregulated and poorly or even not studied at all.

Conversely, the FDA requires submission of an investigational new drug (IND) prior to conducting any phases of clinical trials.  Primary objectives in reviewing an IND are, in all phases of the investigation, to ensure the safety and rights of subjects, and, in Phase 2 and 3, to assure that the quality of the scientific evaluation of drugs is adequate to permit an evaluation of the drug's effectiveness and safety."

From the sponsor's submission to the FDA, protocol design, investigator selection, data submission, and adverse event reporting, a new drugs path to FDA approval is by far not an easy task, nor is the process taken lightly.  Even upon approval, post-market studies are required to identify potential long-term side effects.

As a physician and clinical trials investigator, I understand just how stringent all aspects of clinical trials.  I am not against herb or other alternative treatment, as I have no doubt there are some safe and effective natural herbs for my patients.  However, for patient safety, I must follow the same standards when evaluating prescription drugs versus natural herbal therapy.

I believe, as I am sure my patients do too, that natural herbal therapy should be required to undergo scientific investigations to demonstrate their efficacy and safety.  Hopefully, with this, I can, one day, confidently recommend or endorse some natural herbs as treatment for my patients.

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