Dr. Wei Lu, who holds a Ph.D. degree in Chemistry from Rice University with more than 30 peer-reviewed publications which have been cited over 10, 000 times, started clinicaltrialsofcam.com because he could not find any website that examines the claims on the effectiveness of CAM in clinical studies using the same methodology for developing conventional medicine. While working on oilfield chemicals, he is also passionate about scrutinizing those clinical trial studies on CAM and then giving an effectiveness rating using the probability expressions in general practices 1 since “There is no alternative medicine. There is only scientifically proven, evidence-based medicine supported by solid data or unproven medicine, for which scientific evidence is lacking.”2 Not every study counts! It’s time to follow FDA guidance (Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products3) to examine those trials considering the p value (<0.05 specified by FDA for a statistically significant trial3), the number of participants (≥ 100. The typical number of patients in Phase 2 for checking whether a drug is effective is 100’s4. Thus, 100 is selected as the cut-off point.) and the dropout rate (FDA does not specify the exact number but normally, < 20% is acceptable for a credible trial5-7).
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Level of evidence: the product or the therapy has been reviewed by the FDA (or similar organizations) and it has been found to be effective for a specific condition or disease. (Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, FDA does not have the authority to approve the CAM for safety and effectiveness before they are marketed. However, it will be required to meet the premarket review and approval process by FDA if when it meets the statutory definition of drug, device, biological product, food, etc.,.)8
Level of evidence: two or more randomized, controlled, clinical trials in a group of ≥ 100 participants published in a reputable and peer-reviewed journal on the effectiveness of the product or the therapy for a specific condition or disease. (Normally, FDA requires two adequate and well-controlled positive trials to establish effectiveness3.)
- If the trials are positive, the p value < 0.05 and the dropout rate < 20% are required for a rating of likely effective. It will be downgraded from likely effectively to possibly effective when either the p value or the dropout rate is not met even the trials are positive.
- If the trials are not positive, a rating of probably ineffective will be given.
Level of evidence: one randomized, controlled, clinical trial in a group of ≥ 100 participants published in a reputable and peer-reviewed journal on the effectiveness of the product or the therapy for a specific condition or disease.
- If the trial is positive, P value < 0.05 and dropout rate < 20% are required for a rating of possibly effective. It will be downgraded from possibly effective to Insufficient evidence when either the p value or the dropout rate is not met even if the trial is positive.
- If the trial is not positive, a rating of possibly ineffective will be given.
Level of evidence: one randomized, controlled, clinical trial in a group of <100 participants published in a reputable and peer-reviewed journal on the effectiveness of the product or the therapy for a specific condition or disease.
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