Current trends in medicine, and especially in insurance and governmental coverage of medical treatments, require evidence-based protocols. This is in response to law changes that allow for challenges to medical necessity in coverage. The field of acupuncture, or TCM (Traditional Chinese Medicine), has long been challenged to prove medical efficacy, and today there is a well established documentation with numerous randomized, controlled trials (RCTs). In fact, acupuncture is the most studied of manual therapies, with much positive proof of efficacy, while most manual medicine is still unproven by the standards of randomized, placebo-controlled clinical trials. Since the introduction of evidence-based medicine as a requirement for payment, much evidence has emerged concerning manipulation of this study evidence, though, a cause of concern for patients seeking both efficacy and safety in medical care, as well as a more affordable healthcare system.
Randomized, placebo-controlled, double-blinded clinical trials (RCTs) were set up originally to judge safety and efficacy of pharmaceutical treatments. Applying these standards to manual medicine is problematic, and controversial, especially in terms of devising a true 'placebo', or sham, treatment to compare to real manual therapy, that is blinded to both the patient and the administrator of the therapy (double-blinded), or physician chosen to perform the acupuncture. Obviously, there is a large difference between a sugar pill that does nothing physiologically except stimulate a 'placebo effect' of belief, and an alternate treatment with acupuncture points that still stimulates physiological effect, especially if the difference has to be blinded to the physicians performing the treatment. Use of so-called placebo, or 'sham' acupuncture that compares favorably with the chosen, or 'real' acupuncture sites, to manipulate study data by design, and show little proof of efficacy by comparative value, is a real cause of concern (study design bias). To evaluate evidence fairly, these issues must be addressed in our research, and international research institutions finally called for blinding only the patient in these RCTs for acupuncture (single-blinded), effectively calling into question all prior acupuncture RCTs. In addition, the entire question and definition of the placebo has finally been addressed, and calls to refine the comparative treatment definition when using an alternate treatment for comparison, instead of a sugar pill that is identical to the drug, have finally been voiced. The 'placebo effect' has been thoroughly proven for decades, and is a substantial part of any therapy, both with pills and manual therapies, yet study summaries often imply that this 'placebo effect' has no real treatment value. Scientific evaluation has to set higher standards for assessment, especially in non-allopathic treatments where homeostatic responses are triggered to achieve success, as in acupuncture. Experts have long acknowledged that this 'placebo effect' is a part of the effect of needle stimulation, stimulating a set of responses, some of which are linked to a positive mind-body effect. All of this must be taken into consideration when designing scientific studies to measure safety and efficacy in medical care. In addition, there is very little concern for safety of the standard treatments in the TCM specialty, which have been designed to use the safest treatments known throughout history. This is the core value of Complementary and Integrative Medicine (CIM/TCM), with side effects that are positive, not adverse.
This section of the website addresses these issues, and the worldwide discussion or debate of the fairness of the clinical trials, as well as presenting both documentation of current randomized, controlled trials and links to webpages and studies that further document these RCTs, which are also available in the sections at the end of each article entitled Information Resource and Additional Information. The information on this website is accurate and can be copied in documents regarding medical necessity, and each article has this Additional Information and Links to Studies section with documented evidence. If desired, the information can be easily researched and confirmed as to accuracy. In addition, some historical research of note is added for your enjoyment and elucidation of the science of TCM, a fascinating historical development that involved some of the greatest minds in Chinese history and is still true to its Daoist roots.