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[This sidebar area does not print.] Acupuncture Relieves Pain in Reflex Sympathetic Dystrophy: Pitfalls In The Analysis of Results
Kohler, John P MD, Jin, Ding Lian MD, Mandel, Steven MD John P. Kohler, MD Email: jpmk320@gmail.com Website: Phone: 610-664-6565 Contact 1. Randomized Controlled Trial HTTP://Wikipedia.org/wiki/ Randomized_controlled_trial Page last modified on 27 April 2014. 2. Ni, Maoshing. The Yellow Emperors Classic of Medicine: a new translation of the NeijJing Suwen with commentary: Chapter 5: The Manifestation of Yin and Yang from the Macrocosm to the Microcosm, p. 17: Shambala Publications Inc. Boston Massachusetts, 1995 3. Niemtzow, Richard C. Battlefield acupuncture: Medical Acupuncture. Volume 19, Number 4, 2007
References We performed a small retrospective review of patients with Reflex Sympathetic Dystrophy treated using multiple methods dictated not by set protocol but by the best judgment of the treating acupuncture practitioners. The objective data statistically analyzed was the extremity visual analogue pain levels. The question asked is: Does the objective data collected at the time of acupuncture treatment of a complex chronic pain condition, which is not amenable to simple randomized study design, permit conclusions about the efficacy of treatment? Objective At each treatment time the acupuncture treatment significantly decreased the mean pain level from the value before the treatment to the pain level after the acupuncture treatment. First treatment pre- treatment pain level:7.43+_2.15, Post treatment 3.86_+ 2.76 (P<0.0019). After the initial 15 treatments, the pre treatment pain level did not significantly decline. The pre- treatment average pain level of 6.5+_1.51 was not different from the first treatment average pain level. (P<0.40) Two patient cases illustrate some of the subtle parts of the patient course after beginning acupuncture treatment. . Background All patients were referred for acupuncture treatment. The diagnosis of reflex sympathetic dystrophy was confirmed by the referring/consulting neurologist (SM) and the treating acupuncture providers(JK, JDL). All patients had been treated with other methods (anti- inflammatory medication, opioids, neurotrophic medication, physical therapy, anesthetic nerve block, operation) before starting acupuncture treatment. The patients were treated with multiple acupuncture strategies according to the individual patient as well treating the pathophysiology of the pain anatomically and physiologically. If there was insufficient reduction of pain after an initial treatment the patient was usually given the opportunity of having adjunctive treatment with auricular therapy like Battlefield Acupuncture(3) or directed local treatment. We tried to advance the strategies to more powerful and more extensive treatment methods as tolerated. Methods and Materials Physicians are urged to practice evidence based medicine. Outcomes of clinical trials are used to recommend optimal and unacceptable treatment. Some published trials have very significant deficiencies which does not stop the data from being cited. The vast majority of patients treated with acupuncture are not included in clinical trials. Is the experience of clinicians to be completely disregarded? Some conditions are too rare or too complex to be included in a clinical trial. Chronic pain patients ask their health care provider to improve their pain. Using the patient as their own control avoids some of the problems in controlled study design. This particular study gives a strong conclusion but one that is limited to a short time and the single outcome variable of pain level. Each acupuncture treatment performed in our office reduced the extremity pain levels. This is a good result. Fifteen treatment did not produce a permanent reduction in pain. There are many other parameters which indicate the functional level. We are in the process of collecting and analyzing the vast amount of data from our treated patients. The authors do not consider that this study answers all of the important questions regarding the treatment of these complex and suffering patients. .
Discussion In a small series of patients with reflex sympathetic dystrophy, acupuncture decreased the pain level each and every treatment. The average pre-treatment pain level at the 15 th
treatment was not different than before the first acupuncture treatment. Paired T test using each patient as their own control is statistically appropriate and can be used in clinical studies severe complicated chronic pain conditions. The treatment produced more benefit that simple pain relief. Conclusions Despite clinical experience totaling thousands of years using acupuncture for relief of pain there is controversy whether acupuncture is as efficacious as medications and operations. Some publications have inspired more controversy regarding objective data, study design, adequate controls and avoiding the dreaded placebo effect.
Randomized controlled clinical studies are considered the gold standard for a clinical trial. (1) Many variables are rigidly controlled in the planning of the study. Patients are excluded from inclusion if they do not conform to the study characteristics. In normal clinical treatment settings patients present to the physician with the specific chief complaint and all of their complicating factors. In our practice patients are typically referred for acupuncture treatment after other conventional treatments have failed.
The rigid standardization that is entailed in the randomized controlled study is contrary to the best tradition of Chinese Medicine. In healing, one must grasp the root of the disharmony, which is always subject to the law of yin and yang. Nei Jing: Chapter 5: The Manifestation of Yin and Yang from the Macrocosm to the Microcosm.(2) Results . Patient 1:Comparison of right hand with RSD to left normal hand. 0 1 2 3 4 5 6 7 8 9 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 A V E R A G E P A I N L E V E L TIME (NUMBER OF TREATMENTS) AVERAGE PAIN LEVEL VS. TIME Pre Treatment Pain Level Post Treatment Pain Level Patient 1. 50 yo laborer: Scaffold fell on hand. Swollen, blue, painful hand Ineffective: physical therapy, cast placement, extensive operations, antidepressants, stellate ganglion block Acupuncture: sedation, inverse and contrary, brachial plexus acupuncture, Battlefield acupuncture, 7 internal dragons, Yang wei mai triangular equilibration, SAMe, GABA, Fish oil. With treatment: could workout in gym, (not right arm), care for son and daughter, Normal size and color of hand, Back to work as supervisor (84 treatments over 24 months) Case 2: 34 yo nurse: hand slammed in door. Right hand non-functional, cold and swollen, wakes up 5 times a night. Ineffective: Neurontin, Medrol, Lidoderm, Dilaudid, sympathetic block, physical therapy, spinal stimulator. Acupuncture : sedation, inverse and contrary, brachial plexus, right upper extremity, Battlefield auricular acupuncture , yang wei mai, Moves her fingers, Drives, Takes care of kids, Pink warm hand, sleeps through night Lost to follow up-experimental RSD ketamine treatment