"However, the inter-practitioner variability, the patient's knowledge and experience of acupuncture and the visual impact of needling may be the potential factors when performed in the acupuncture studies (Tsukayama et al., 2006). Because the two criteria of the sham control are to " mimic those aspects of the real treatment " and " not mimic those aspects of treatment that have beneficial effects " (Hammerschlag and Zwickey, 2006), we do not use the sham control to compare with our acupuncture group. PD is a chronic degenerative disease. "
[Show abstract][Hide abstract] ABSTRACT: Complementary therapy with acupuncture for Parkinson's disease (PD) has been studied for quite a long time, but the effectiveness of the treatment still remains unclear. The aim of this study is to evaluate the integrated effects of acupuncture treatment in PD patients who received western medicine. In the short-term acupuncture treatment study, 20 patients received acupuncture therapy twice a week in acupoints DU 20, GB 20, LI 11, LI 10, LI 4, GB 31, ST 32, GB 34 and GB 38 along with western medicine for 18 weeks, and 20 controlled patients received western medicine only. In the long-term acupuncture treatment, 13 patients received acupuncture treatment twice a week for 36 weeks. The outcome parameters include Unified Parkinson's disease rating scale (UPDRS), Beck Anxiety Inventory (BAI), Beck Depression Inventory-Version 2 (BDI-II), and WHO quality of life (WHOQOL). In the short-term clinical trial, a higher percentage of patients in the acupuncture group had score improvement in UPDRS total scores (55% vs. 15%, p = 0.019), sub-score of mind, behavior and mood (85% vs. 25%, p < 0.001), activity of daily living (65% vs. 15%, p = 0.003), mobility (40% vs. 15%, p = 0.155) and complication of treatment (75% vs. 15%, p < 0.001), BDI-II score (85% vs. 35%, p = 0.003), and WHOQOL score (65% vs. 15%, p = 0.003) when compared to control group at the end of the 18 weeks' follow up. After 36 weeks of long-term acupuncture treatment, the mean UPDRS total scores and sub-score of mentation, behavior and mood, sub-score of complications of therapy and BDI-II score decreased significantly when compared to the pretreatment baseline. In conclusion, acupuncture treatment had integrated effects in reducing symptoms and signs of mind, behavior, mood, complications of therapy and depression in PD patients who received Western medicine.
The American Journal of Chinese Medicine 01/2015; 43(3):407-23. DOI:10.1142/S0192415X15500263 · 2.63 Impact Factor
"Preliminary reading on the current status of acupuncture research identified the development of a placebo control as one of the key challenges faced by the acupuncture research community     . Commentaries and papers questioning whether or not these controls should be considered as placebo have for the most part focussed on the potentially meaningful physiological responses that they may induce     . "
[Show abstract][Hide abstract] ABSTRACT: Introduction
Clinical guidelines depend on the analysis of randomised controlled trials in systematic reviews. How to interpret the results of acupuncture vs. sham-placebo procedures is a controversial aspect of the evidence base for acupuncture. Two inferences can be drawn from the acupuncture vs. sham-placebo randomised controlled trials. The first is whether acupuncture has a physiological basis. The second is whether there is any validity in traditional concepts of acupuncture practice. The degree to which sham acupuncture controls can physiologically be considered placebo controls has been challenged. However, whether these procedures should be considered ‘inert’ in terms of Chinese medicine theory has yet to be fully examined.
Therefore this review aims to evaluate the extent to which sham-placebo procedures used in randomised controlled trials should be considered inert, with particular reference to traditional Chinese medicine theories. It also considers sham-placebo controls from a biomedical perspective.
Sham-placebo procedures were identified through reviews examining acupuncture controls.
Four main types of sham-placebo control were identified. The procedures are heterogeneous and should not necessarily be considered as equivalent within systematic reviews.
These procedures cannot be considered as inert controls from either a Chinese medicine or biomedical perspective. There is a need to develop appropriate Acupuncture Control Assessment Guidelines to assess the risk of bias from sham-placebo controls when undertaking systematic reviews. The terminology used to describe control procedures needs to be developed and standardised.
European Journal of Integrative Medicine 04/2014; 6(2). DOI:10.1016/j.eujim.2014.03.004 · 0.65 Impact Factor
"Rational development of a placebo in pharmaceutical trials is based on knowledge of how the test drug is absorbed, metabolized, and recognized by molecular receptors, initiates biochemical and/or physiological events, and is inactivated. The challenge in designing appropriate sham acupuncture is that ignorance of acupuncture mechanism prevents us from knowing what to avoid when inserting a sham acupuncture needle . In particular when numerous sham needles are inserted, there may be a cumulative, beneficial effect resulting from multiple stimulations of superficial sensory nerve endings or connective tissue (two commonly discussed targets of acupuncture needling). "
[Show abstract][Hide abstract] ABSTRACT: In November 2007, the Society for Acupuncture Research (SAR) held an international symposium to mark the 10th anniversary of the 1997 NIH Consensus Development Conference on Acupuncture. The symposium presentations revealed the considerable maturation of the field of acupuncture research, yet two provocative paradoxes emerged. First, a number of well-designed clinical trials have reported that true acupuncture is superior to usual care, but does not significantly outperform sham acupuncture, findings apparently at odds with traditional theories regarding acupuncture point specificity. Second, although many studies using animal and human experimental models have reported physiological effects that vary as a function of needling parameters (e.g., mode of stimulation) the extent to which these parameters influence therapeutic outcomes in clinical trials is unclear. This White Paper, collaboratively written by the SAR Board of Directors, identifies gaps in knowledge underlying the paradoxes and proposes strategies for their resolution through translational research. We recommend that acupuncture treatments should be studied (1) "top down" as multi-component "whole-system" interventions and (2) "bottom up" as mechanistic studies that focus on understanding how individual treatment components interact and translate into clinical and physiological outcomes. Such a strategy, incorporating considerations of efficacy, effectiveness and qualitative measures, will strengthen the evidence base for such complex interventions as acupuncture.
Evidence-based Complementary and Alternative Medicine 01/2011; 2011(1741-427X):180805. DOI:10.1155/2011/180805 · 1.88 Impact Factor
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