Evidence to support claims for health benefits

For natural health products evidence is product specific. When people want a health benefit the best proof of this is a clinical trial.

What is a clinical trial?

It is difficult to be sure that a health product actually works, and you wouldn’t have got better on your own. Sometimes we feel better just because we are taking something or talking to a health professional. This is called the placebo effect.

The placebo effect is really great – sometimes as many as 50% of people feel better taking an inactive pill.

This means that the only way to be 100% sure that the medicine you are paying for is really worth taking is to check it against a placebo. If it is more effective than the placebo, without too many side effects, then the medicine is helping your health.

This is even more important with the complexity of natural health products, where evidence is specific to the finished product.

Therefore checking that a natural health product is has a specific clinical trial on it is the place to start. It is also important to check that the results of the trial are really meaningful to health. The Foundation experts check the “efficacy” shown in the trials to ensure that the results are important for health.

Clinical outcomes are only relevant to the specific product that has been trialled and should not be used to support different products. Also to reduce possible bias in the study, clinical study results should be validated by publication in respected peer-reviewed scientific journals.

Is the product you can buy the same as the one that was used in the clinical trial?

It’s not enough to check that the product has a specific clinical trial published on it. Products proven to be effective in clinical studies need to be reproduced with the same medicinal properties year after year. This is really diffficult and needs to be secure to ensure that the product today is essentially the same as the product used in the clinical trial, sometimes many years ago. The Foundation experts call this “quality and equivalence”.

Best Practices

  • Endorse, promote, and assist in development of best practice international research standards and procedures; including research principles, ethics approvals, research applications, government grants.
  • Sustainable research practices such as: Supporting clinical research that leads to the better understanding and hence safe use of herbal medicines.
  • Importance of linking any evidence for efficacy to the exact product featured in any quoted clinical trial.
  • Research and clinical studies on exact product.
  • Research published
  • Practical commitment to scientific laboratory and clinical research activities.
  • Collaboration with universities and consumer organisations.
  • Regulation Compliance : Makes sure that the research parameters meet the standards of respective countries allowing easier and faster transition into marketing stage after the research

For an excellent appraisal, see publication entitled “Standard Operating Procedures for Clinical Trials in Complementary Medicine” published by NICM in August 2013. Click here for information.