Guest guest Posted February 18, 2003 Report Share Posted February 18, 2003 http://pulsemed.org/challengingbody.htm#biomedmech Challenging the Skeptics - The Truth about Acupuncture By Brian Benjamin Carter Chinese herbs and acupuncture are a portion of alternative medicine that has come under fire from skeptics. Skeptics have their own dictionary in which they define acupuncture and chinese medicine in inaccurate terms. Medical research and scientific evidence allow us to speak of and practice evidence based medicine. Here we present most of the acupuncture research and chinese herb research for effectiveness and safety as well as some alternative medicine statistics. This article came out of a dispute I had on the radio with a Christian former new-ager named Marcia Montenegro. Some of the criticisms quoted are hers, others are standard claims made by skeptics. The original criticisms are in italics and marked with 'SKEPTIC.' Some of these are numbered to make the responses more specific and clear. Everything is linked for your convenience. Table of Contents by Topic: The definition of alternative medicine is discussed Research standards and their application to Acupuncture The First RCT faithful to both CM diagnosis and treatment and research standards Acupuncture is proven by research to work for musculoskeletal conditions, such as fibromyalgia, myofascial pain, and tennis elbow, or epicondylitis, acupuncture is efficacious for adult postoperative and chemotherapy nausea and vomiting, postoperative dental pain, menstrual cramps, breech presentation in late pregnancy, irritable bowel syndrome, asthma, immune-system problems, severe vomiting during pregnancy, and cocaine dependence The myth that substantial research evidence supports conventional medical practices is debunked Acupuncture is safe, often safer than standard acceptable medical procedures Fewer malpractice claims are filed against acupuncturists A study of 55,000 acupuncture treatments showed 99.9% safety Some safety issues of biomedicine are reviewed for comparison Explanation of benefit-risk Adverse drug reactions Drug misadventures RCT defined Evidence of the biomedical mechanisms of acupuncture The placebo effect being responsible for acupuncture's success debunked by another RCT Response to inflammatory statements about acupuncturists being irrational, anti-science, conspiracy-oriented, and biased A bad study design reviewed History of TCM Patient Demand, Doctors deceived? Clarification of yin, yang, and qi A possible reason for all the disagreement and confusion, and some perspectives on qi Perspective on Acupuncture from Andrew Fergusson, the General Secretary of Christian Medical Fellowship Is CM a medicine or a metaphysical system? Spiritual aspects of CM, a harmonious-with-the-Bible example Good and evil More about qi More about yin and yang Meridians/channels SKEPTIC: Alternative/Blended/Complementary/Integrated Healing (1) It is called alternative because the technique/drug/herb (1a) has not been or (1a) cannot be adequately tested, or has been found (1c) ineffective or dangerous. (2) If it were a safe, tested treatment, it would not be in the alternative category. RESPONSE:1. This is an inaccurate definition of alternative medicine. " 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. " - Phil B. Fontanarosa, MD; George D. Lundberg, MD, The Journal of the American Medical Association, 1998. The section on RCT's provides the scientific proof, the evidence for acupuncture. * " CAM (Complementary and Alternative Medicine) covers a broad range of healing philosophies (schools of thought), approaches, and therapies that mainstream Western (conventional) medicine does not commonly use, accept, study, understand, or make available. " - from the National Center for Complementary and Alternative Medicine (NCCAM); - What is NCCAM? See the glossary for more info. * Quick Quote: A PCOM professor who is an ER Doc (MD) says western medicine should be called alternative, because oriental medicine is preventive, and if you don't live preventively, the alternative is emergency intervention, often late in life. 1a. NIH Research Standards 1997: " The incorporation of any new clinical intervention into accepted practice faces more scrutiny now than ever before. The demands of evidence-based medicine, outcomes research, managed care systems of health care delivery, and a plethora of therapeutic choices make the acceptance of new treatments an arduous process. The difficulties are accentuated when the treatment is based on theories unfamiliar to Western medicine and its practitioners. It is important, therefore, that the evaluation of acupuncture for the treatment of specific conditions be carried out carefully, using designs that can withstand rigorous scrutiny. " - Bensoussan and others' 1998 IBS RCT was believed to be " the first to incorporate traditional Chinese diagnosis and treatment methods for IBS into a strictly controlled, conventional study model. " 1c. The Effectiveness of Acupuncture (see RCTs below) 2. Is acupuncture safe? * " One of the advantages of acupuncture is that the incidence of adverse effects is substantially lower than that of many drugs or other accepted medical procedures used for the same conditions. As an example, musculoskeletal conditions, such as fibromyalgia, myofascial pain, and tennis elbow, or epicondylitis, are conditions for which acupuncture may be beneficial. These painful conditions are often treated with, among other things, anti-inflammatory medications (aspirin, ibuprofen, etc.) or with steroid injections. Both medical interventions have a potential for deleterious side effects but are still widely used and are considered acceptable treatments. The evidence supporting these therapies is no better than that for acupuncture. In addition, ample clinical experience, supported by some research data, suggests that acupuncture may be a reasonable option for a number of clinical conditions. Examples are postoperative pain and myofascial and low back pain. Examples of disorders for which the research evidence is less convincing but for which there are some positive clinical trials include addiction, stroke rehabilitation, carpal tunnel syndrome, osteoarthritis, and headache. Acupuncture treatment for many conditions such as asthma or addiction should be part of a comprehensive management program. " - National Institutes of Health Consensus Statement on Acupuncture, 1997 * Safety of Acupuncture in terms of Insurance Malpractice Claims, JAMA 1998: " In an analysis of data from malpractice insurers from 1990 through 1996, Studdert and colleagues18 found that claims against chiropractors, massage therapists, and acupuncturists generally occurred less frequently and usually involved less severe injury than claims against medical doctors. " - Phil B. Fontanarosa, MD; George D. Lundberg, MD * Frequency and Types of Adverse Events in 55,291 Acupuncture Treatments: (see table) This means 99.8% of acupuncture is performed with no significant minor adverse events; " During these 5 years, a total of 76 acupuncturists (13 preceptors and 63 interns) participated in the study, and the total number of acupuncture treatments was 55291. A total of 64 adverse events were reported and included 11 types of events... The most frequent adverse event was failure to remove needles after treatment; no sequelae occurred after removal of the needles. The second most common adverse event was dizziness, discomfort, or perspiration probably due to transient hypotension associated with the acupuncture treatment.... We may, therefore, reasonably conclude that serious adverse events in acupuncture treatment are uncommon in the practice of adequately trained acupuncturists... . " - Hitoshi Yamashita, Bac, Hiroshi Tsukayama, BA, Yasuo Tanno, MD, PhD, Kazushi Nishijo, PhD, JAMA * 2 September 2001 Studies of safety of acupuncture in British Medical Journal; Details of 43 minor adverse events associated with 34 407 acupuncture treatments; 91 minor events in 31 822 acupuncture treatments; if combined with the other study above = total of 121,520 treatments with 198 minor adverse events (0.16% incidence), and no pnemuothoraxes (they are concluded to be " extremely rare " ). * The most serious adverse events possible with acupuncture are pneumothorax (puncturing the lung) and septicemia (systemic infection of the blood by bacteria); " Instruction is given by both lectures and practical training and includes information about anatomically risky depth of insertion and use of aseptic procedure for puncturing... Most important, no serious events such as pneumothorax, spinal lesion, or infection were reported (my note: zero out of 55,291! But even just one would have meant only a 0.002% chance of these occurring) " - JAMA The Safety of Acupuncture compared with that of Biomedicine: Antibiotic overuse leads to resistant super-bacteria ( " The prevalence of antibiotic-resistant bacteria in Taiwan is due to the heavy use of antimicrobial agents in both animal husbandry and clinical practice over the past decades " - source) as well as intestinal flora imbalance (diarrhea, vaginal candidiasis) ( " Antibiotic use is a short-term risk factor for symptomatic vulvovaginal candidiasis, either as a first episode or in the form of recurrence. Increasing duration of antibiotic use is directly related with an increased prevalence of Candida vaginal infection. " - source) ( " The spectrum of diarrheal disease associated with antibiotic therapy ranges from antibiotic associated diarrhea and colitis, to the more severe pseudomembranous colitis, which is always associated with Clostridium difficile (CD). " - source) " No drug product is " perfectly " safe. Every single drug that affects the body will have some side effects. Since the FDA considers both the benefits and risks of all medications before approval, side effects are generally not serious. For every drug FDA approves, the benefits are balanced against its risks. In addition, FDA makes sure the labeling (package insert) outlines the benefits and risks reported in the tested population. You and your health-care provider should decide together if the benefits outweigh the risks for YOU. Talking about your medicines with your health-care provider is just as important and good for your health as a complete check-up and taking your medicine as directed. " - FDA/CDER " The benefit-risk ratio weighs the benefits provided by a drug, versus risks or safety problems that may be associated with use of the drug. No drug can be considered to be totally safe. Drugs that are associated with more significant safety problems are expected to have sufficiently greater benefits to justify the increased risk. " - source What does benefit-risk mean to us? A la a discussion of tamoxifen (a breast cancer drug): " there are categories that, from my perspective, clearly fall out where the benefits unequivocally outweigh the risks... I think physicians very frequently discuss risk-benefit ratios for all sorts of treatments, and it ultimately comes down to a decision between the patient and the doctor. " - source ADR's (adverse drug reactions): NSAIDS such as ibuprofen - " Gastrointestinal (GI) Adverse Drug Reactions (ADRs) from the NSAIDs are a major cause of morbidity and mortality in arthritic patients taking these drugs... Clearly, the need to develop newer NSAIDs with lower risks of ulcers and bleeding as well as symptomatic ADRs is still representing a major challenge. " - Jan 2001 high dose steroid use (e.g. in asthma or COPD) leading " high dose of inhaled steroids may lead to adrenocortical suppression and hence estrogen deficiency in postmenopausal women, " " the daily dose, but not the duration, of inhaled steroid therapy may adversely affect bone density " (osteoporosis), " The potential risks of antiasthmatic inhaled steroid therapy are essentially dose-related and include oropharyngeal complications such as thrush and dysphonia, and systemic complications such as hyperactivity, behavioural change, hypothalamic-pituitary-adrenal axis suppression, facial and weight changes characteristic of hypercortisonism, cataracts, increased intraocular pressure, dermal atrophy causing steroid purpura, retarded growth in children and osteoporosis. A few cases of fracture or acute adrenocortical insufficiency have been reported. " Drug Misadventures: " Still, we know from studies published to date that drug misadventures account for: 8-10% of admissions of patients to hospitals, 25% of admissions to hospitals by persons age 65 years of age or older, 10-15% of visits to emergency rooms in some urban settings, 4.5 drug order errors per 1000 drug orders in hospitals, Significant decreases in the quality of life (due to inappropriate prescribing, e.g., of hypnotics for the elderly), 2 in 1000 deaths in hospitals, and Deterioration or destruction of specific organs. " - source SKEPTIC: (3) Many cited studies to support these methods are flawed, short-term, based on anecdotal evidence, (4) conducted by believers in the techniques, & (5) often are not published in a peer-reviewed medical journal. (This section deals with the evidence for the efficacy of acupuncture, and the quality and amount of the research as of November, 2001; many skeptics' criticisms are based on the state of research as of 1997.) RESPONSE: 3. Define RCT - Randomized Controlled Trial. The RCT " is widely regarded as the most powerful and sensitive tool for comparing therapeutic interventions.85 " As for RCTs and acupuncture, even 4 years ago (1997), experts from various fields including MD's, PhD's, and acupuncturists reviewed the evidence and made what was called the National Institutes of Health Consensus Statement on Acupuncture - " There is clear evidence that needle acupuncture is efficacious for adult postoperative and chemotherapy nausea and vomiting and probably for the nausea of pregnancy. Much of the research is on various pain problems. There is evidence of efficacy for postoperative dental pain. There are reasonable studies (although sometimes only single studies) showing relief of pain with acupuncture on diverse pain conditions such as menstrual cramps, tennis elbow, and fibromyalgia. This suggests that acupuncture may have a more general effect on pain. However, there are also studies that do not find efficacy for acupuncture in pain. " * From same source, we see that even biomedicine (drugs and surgery) is not held to the same standards to which skeptics want to hold acupuncture: " While it is often thought that there is substantial research evidence to support conventional medical practices, this is frequently not the case. This does not mean that these treatments are ineffective. " * There was no such thing as RCT's in 4500 year history of CM, and there has only been adequate funding sources for this for 4 or 5 years. Acupuncture RCT's are underway for: Hypertension Chronic diarrhea in HIV patients Fibromyalgia Depression Knee Osteoarthritis Dental pain * 1998: " University of California Irvine professor and physicist Zang-Hee Cho, a member of the highly respected National Academy of Science, the inventor of an early version of the Positron Emission Tomograph, or PET scan, and a pioneer of the MRI scanner, both of which have revolutionized our ability to see into the body and brain, found that stimulation of the vision-related acupoint showed the same reaction in the brain as stimulation of the eye. As the acupuncture signal passes to the brain via nerves, it possibly stimulates the hypothalamus, the " executive center " of the brain, responsible for the production and release of hundreds of neurochemicals, Cho said. " * 1998 research from the Journal of the American Medical Association: " Cardini and Weixin found that moxibustion (stimulation of an acupuncture point by heat generated from burning a specific herb) is helpful for correction of breech presentation in late pregnancy. Bensoussan and colleagues document that a Chinese herbal medicine formulation improves symptoms of irritable bowel syndrome. " * 2000 randomized controlled study showed " asthma patients benefit from acupuncture treatment given in addition to conventional therapy. Furthermore, acupuncture performed in accordance with the principles of TCM showed significant immune-modulating effects. " * " This study suggests that active PC6 acupuncture, in combination with standard treatment, could make women with hyperemesis gravidarum (severe vomiting during pregnancy) better faster than placebo acupuncture. " * " Findings from the current study suggest that acupuncture shows promise for the treatment of cocaine dependence. Further investigation of this treatment modality appears to be warranted. " - * Cytology of acupuncture points * Enkephalins vs endorphins 4. The point of doing RCT's is to eliminate subjectivity- you can't also ask that the studies be performed only by people who think acupuncture doesn't work- generally, the people interested in doing research on something are the ones who are experts about it. Most of the pharaceutical research is done not only by believers in the drug, but by the very corporation who will benefit from its sale, but this fact does not invalidate the conclusions of their RCT's. 5. Actually, this is not true at all. Many studies of various types have been published in peer review journals over the years. We must expand upon what you mean by 'peer' - literally, for acupuncturists, it would mean acupuncturist-reviewed acupuncture journals (for example). But plenty of RCT's have been published in medical journals (such as the Journal of the American Medical Association) as well. The terms complementary, blended, and integrated are now being used as well since alternative treatments are being combined with traditional medicine. This makes it more difficult to test the alternative methods or to know what is really working when the patient improves. This is true clinically just as much for biomedical practitioners as acupuncturists - real patients are affected by many factors including environment, drugs, genetics, supplements, etc. This is another reason for RCT's. The following studies on the biomedical mechanisms of acupuncture may also help you. Continued: Part 2 Gettingwell- / Vitamins, Herbs, Aminos, etc. To , e-mail to: Gettingwell- Or, go to our group site: Gettingwell Send Flowers for Valentine's Day Quote Link to comment Share on other sites More sharing options...
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