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In a lot of publications the reanalysis is impossible or gives different results Data selection Often only report of criteria which are statistically significant. Lack of consideration for results not fitting the initial assumption Data compilation and modification from a previous report[ 30 ].
Consolidated standards of reporting trials; TCM: TCM General considerations TCM comprises various different practices[ 1031 ], including herbal medicine[ 101431 - 37 ], acupuncture[ 1131 - 33 yiai write a song #58, moxibustion as a variant of acupuncture with local heat therapy[ 3133 ], massage[ 3133 ] as Tui Na, the therapeutic massage[ 1013 ], dietary therapy[ 1031 ], physical exercise such as shadow boxing[ 31 ], and Qigong[ 33 ].
According to clinical trials performed in mainland China, the focus of TCM is on herbal remedies TCM has been used by Chinese communities from ancient times[ 2 ] yiai write a song #58 dates back more than years[ 10 ]. A cornerstone of TCM was the introduction of acupuncture in Western countries in the s[ 31 ].
Another major contribution of TCM to general health issues was variolation developed in the 16th century in China as a method to immunize against smallpox[ 31 ]. In the United States, according to the National Health Interview Survey that included a comprehensive survey on the use of complementary health approaches, an estimated 3.
Most of the principles of TCM were derived from the philosophical ideas developed from Taoism and Confucianism[ 1031 ].
Ancient beliefs on which TCM is based include: The TCM philosophy created curiosity and skepticism in Western countries, since transparency is lacking.
A pragmatic approach to successfully transfer TCM philosophy into valid treatment modalities of modern medicine should postulate clear evidence criteria for therapeutic efficiency, prove the absence of major adverse reactions and provide a positive benefit: In a review, the quality of reported randomized controlled trials RCTs of TCM efficiency was considered poor, based on an analysis of trial results published from to [ 33 ].
Among these clinical trials, were initially identified as RCTs, equivalent to Some important methodological components of the RCTs were incompletely reported, such as sample size calculation reported in 1.
Overall, publications of TCM trials are abundant [ 32 ] to [ 33 ] publicationsbut their scientific quality is limited. The poor quality of many TCM RCTs[ 33 ] was continuously discussed in various reports during the last decades[ 13313236 ]; most Cochrane systematic reviews of TCM are inconclusive, due specifically to poor methodology and heterogeneity of the studies reviewed[ 13 ].
This particular situation is difficult to reconcile when evidence for efficiency is a crucial criterion.
It is well recognized that planning and performing RCTs, data analysis and compilation are cumbersome, time consuming, and expensive[ 13 ], with additional efforts to be put into editorial and reviewing work. Unless strict criteria are applied for clinical trials of alternative medicinal systems including TCM, these studies will not be accepted as valid.
For most analyses, including those evaluated in this review, major quality criteria are violated, including primary research hypothesis formulation, clinical inclusion criteria and outcome parameters, and appropriate statistical analysis. Although this design may have its merits for special clinical problems like efficiency of comedications, they do not allow conclusions about the treatment efficiency of the added herbal preparation.
Another major problem is inconsistent reporting. Therefore, results must strictly separate between the effectivity of a treatment shown by changes in parameter s before and after treatment, and indicate the difference between groups.
Current clinical studies are designed either to prove superiority of a new drug, or to show equal effectivity of two different drugs noninferiority design [ 38 ]. Especially for studies comparing herbal preparations with synthetic drugs, it seems prudent to begin with a noninferiority study design; in contrast, nearly all recent Chinese language studies claim superiority of TCM preparations to synthetic drugs.
This peculiarity is highlighted in multiple Cochrane reviews of herbal TCM preparations or acupuncture; these reviews also identify no or a very low number of high quality clinical studies[ 26 - 2939 ].
About herbal preparations are used and are listed in the Chinese Materia Medica CMM and are available in China[ 3438 ], being officially recognized and described in detail by the Chinese Pharmacopeia[ 3437 ], including herbs commonly used, regional variations and folk medicine variants.
The Chinese Materia Medica[ 37 ] is a reference book that also describes details of thousands of plant preparations[ 10 ], including some nonbotanical elements animal parts and minerals [ 10344142 ] that are incorrectly classified as herbal medicines[ 34 ]. Outside of China, only around Chinese herbs are commonly used[ 34 ].
Thousands of medicinal plants in China produce an abundance of different chemicals. With the nature as a potent manufacturer of potential drugs, this treasure has led to the development of some chemically defined drugs including artemisinin and ephedrine. Failure of valid clinical studies based on EBM criteria may have prevented the detection of more pharmacologically active principles and compounds, missing the innovation power of herbal TCM[ 41 ].
This situation is different from other countries and cultures with herbal traditional medicine, where plants were used as a source of drugs and resulted in the development of, e. The use of herbs is considered an essential part of the TCM philosophy and its proposed therapeutic principles to improve or stabilize health conditions[ 10 ]; it takes a holistic view involving activating systems and self-regulating connections enhancing resistance to human diseases[ 43 ].
TCM philosophy classifies the causes of illness as symptoms of diseases from abnormal interactions or imbalances in the human system[ 44 ]; published diagnostic criteria, however, are poorly defined[ 31 ], difficult to ascertain in a Western health care setting and substantially different from the diagnostic approach of Western medicine.
Ideally, the TCM provider is a physician, as in China; qualification requirements may be less strict in other countries such as Germany, where TCM providers commonly are nonmedical healers and only rarely general practitioners[ 42 ].Spring Song, for January h through 28th %A comedy drama.
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