Critical appraisal method of acupuncture safety
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《中华医药杂志》英文版
Critical appraisal method of acupuncture safety(pdf0
1. Graduate Institute of Chinese Medical Science, China Medical University, Taichung City, Taiwan,China
2. Graduate Institute of Integration Chinese and Western Medicine, China Medical University, Taichung City, Taiwan,China
Correspondence to Shih-Liang Chang,MD,PhD, Graduate Institute of Integration Chinese and Western Medicine, China Medical University, Taichung City, Taiwan,China
Tel:+886-4-22053366 ext 1647，Fax:+886-4-8346349 ，E-mail: slchang@mail.cmu.edu.tw
[Abstract] In recent years, more and more importance has been placed on traditional medicine around the world. In May 2002, the World Health Organization (WHO) launched its Traditional Medicine Strategy 2002~2005, suggesting traditional therapies were included in existing national health policy systems, while also providing clinical guidelines to ensure appropriate, safe and effective application of these established treatment modalities. The concept of evidence-based medicine (EBM) proposed by British Professor Archie Cochrane has also gained gradual acceptance and even gained health insurance approval. Given these developments, evidence-based medical study of literature relating to traditional Chinese medicine is both timely and significant.
As acupuncture is an invasive treatment, safety in clinical application should be closely monitored. The safety issue remains largely unresolved, however, and given its rising prominence and acceptance, a resolution is urgently required. Study of the relevant literature may provide a relatively rapid way to evaluate the safety of acupuncture statistically. At the same time, establishing a critical appraisal model will provide a reference for relative intensity study of evidence-based medicine in traditional Chinese medicine.
The PubMed and Medline database search using the terms “acupuncture” and “safety” selected relevant publications. Based on this critical evaluation of the literature and the derivation of these indicators, we conclude that acupuncture safety is supported with certain evidence in research relative to conventional and accepted therapies without evidence.
[Key words] acupuncture safety;evidence-based medicine;critical appraisal method
INTRODUCTION
Over the past two decades, traditional medicine and alternative therapies have increasingly become a focus of attention worldwide. In May 2002, the World Health Organization (WHO) launched its Traditional Medicine Strategy 2002~2005, suggesting that these complementary practices should be included in existing national health policy systems, while also providing clinical guidelines to ensure their appropriate, safe and effective application [1]. Further, the American National Institutes of Health (NIH) has appropriated funds for traditional medicine, establishing the National Center for Complementary and Alternative Medicine (CAM). Traditional Chinese medicine (TCM) is a medical science that is based on experience and the accumulation of the wisdom of ancestors. From the earliest records,human was the object of treatment, and abundant records were handed down as reference for later generations of doctors. The first obstacle encountered in present day Chinese medical policies and systems, however, was the related issues of effectiveness and safety. For thousands of years, the efficacy of TCM has been accepted. With the rapid rise and predominance of medicine based on the Western deterministic paradigm, however, these old-age treatment practices now must be subjected to scientific and medical scrutiny before they can be recognized, while their safety requires even more rigorous verification.
The evidence-based medcine(EBM) concept has evolved since it was first proposed in the 1970's, and has been growing in popularity in recent years. British Professor Archie Cochrane, his book “Effectiveness and Efficiency” won acclaim among health practitioners after its publication in 1972, with later referral to it establishing the concept. Nowadays, evidence-based medicine and health care are regarded as new concepts, replacing authority-based traditional medicine.EBM relies on randomized controlled trials (RCT), systematic review of test series, and meta-analysis. The collection and dissemination of information are also emphasized, so it is comparable to clinical practice, while also incorporating research and practice [2]. In general, EBM consists of five steps: (1) formulation of answerable clinical questions; (2) literature search for the best evidence; (3) critical appraisal of the relevant material; (4) clinical application of the evidence; and, (5) audit of the above [3].
In this study, the EBM concept was applied to literature related to acupuncture safety, and an attempt was made to construct a synthesized model of papers in different EBM levels which allows critical appraisal[4]. The principal aims of the investigation were: to gain an overall understanding of acupuncture safety studies worldwide; to produce a summary of the material and reach a consensus; in-depth study of acupuncture safety; and, to search the literature for the best evidence. Secondarily, the relevant literature was subjected to critical appraisal and a simple, easy-to-use and practicable appraisal model developed for use as a reference in the study of problems related to evidence-based medicine.
MATERIALS AND METHODS
Data Source
The main source for the information used in this study was the PubMed database. This resource is updated weekly and accessible from the National Center for Biotechnology Information (NCBI) of the US National Library Medicine via the Internet, where users may retrieve data without charge. Medline database was also used with the same search strategy for correcting the database bias.
Data Selection
The results of studies relating to acupuncture safety, the findings of systematic reviews, and relevant clinical cases were collected from a PubMed search following a search strategy, for the words “acupuncture” and “safety”, and the search limits as following conditions: publication date to 2004/05/30, only items with abstracts and English. In general, each included paper was reviewed by two members or more of a subgroup in our research team; the conflicts were resolved by discussions among the members of the subgroup.
Data Extraction
Collected data was subjected to critical appraisal, and the five EBM steps applied to the main study results and conclusions. The three main categories of the critical appraisal are: (1) basic informations of included paper: items were defined in Table 1; (2) brief contents of the reference section; and, (3) appraisal index for which a form was designed (Table 1). Through the establishment of an appraisal model and various indexes, insight was gained into the quality and general condition of the reference literature relating to acupuncture safety.
Table 1 Critical Appraisal Form - Reference Literature on Acupuncture and Evidence-based Medicine
Continue(续表)
In the table, the impact factor (IF) is based on latest issue of journal citation report (JCR) available in the library of China Medical University. It is indicated by 0.1 when the issues were unable to find. The supposition of question (SOQ; -3-0-3) is a quantification index given by the appraiser after study of the texts and the described clinical problems. Score of “0” indicates the reference is unrelated to the described clinical problem. The SOQ is divided into 3 positive and 3 negative scores and completed by and according to the appraiser. The scoring method of Evidence (SOE, 5-1) was designed as below [4] :(1)RCTs: reference consists of multiple randomized controlled trials e.g., meta-analysis or systematic review; accredited with a score of 5.(2)RCT/Cohort: reference consists of single randomized controlled trials or cohort studies; a cohort study compares populations exposed to different factors; usually applied for etiology study or to evaluate disease progress e.g., comparison of smoking and non-smoking as causes of lung cancer; accredited with a score of 4.(3)Case control: reference consists of case control studies comparing patients to a control group; historical data was collected to search for between-group differences; accredited with a score of 3.(4)Case series: reference consists of reports of multiple cases; accredited with a score of 2.(5)Experiences/Case report (1): reference consists of a single case; accredited with a score of 1.
Finally, we multiply the indexes, IF, SOQ and SOE as evidence score and rank this score in the name of the quality of evidence.
RESULTS
Seventy four titles were found from the initial search, but only 12 reports exploring the safety and side-effects of acupuncture were selected,and one paper investigating safe needling depth [5] was also included for our analysis and discussed safety of acupuncture, six were systematic reviews [6~11], and five related to clinical testing [12~16], with one evaluating the safety of acupuncture electro-stimulation [17]. On the other hand, we did not include the article that was only appeared in Medline database finally after consideration. After collection and critical appraisal of the reference literature on the safety of clinical acupuncture, a mean value of 2.1 for Supposition of Question (SOQ,-3-0-3) was demonstrated. Additionally, mean post-appraisal Score of Evidence (SOE,5-1) and magazine publication Impact Factor (IF) values of 2.6 and 1.8, respectively, were derived. Each included paper was list in Table 2, that was illustrated the brief summary of each article based on the evidence analyzed in this study. The evidence score and rank of each paper were also derived in Table 2. The mean value of 11.7 for this evidence score was also demonstrated.This score and rank help us to realize the degree of evidence in accordance with the problem of acupuncture safety.
Table 2 Appraisal Indexes of Each Included References
IF = Impact Factor, SOQ = Supposition of Question, SOE = Score of Evidence, Evidence Score = IF×SOQ×SOE
Summarizing the various investigations of safe acupoint depth, the needle depth recorded in the modern reference literature is generally greater than described in the classic medical records, with safe acupoint depth for chest and back areas was not the same for each acupoint. In adults, but not infants, a positive correlation was demonstrated with the length of the second section of the middle finger. Comparing gender, safe acupoint depth in the chest area was greater for females; however, no significant between-gender difference was demonstrated for the back area. This gender variation should be considered, therefore, when deciding on the safe depth for acupoint, and, unless the subject is an infant, the length of the middle section of the second finger may be used as a reference value [5].
Study of the reference literature for side effects found that most researchers deemed the risk of acupuncture causing severe side effects, such as pneumothorax, infectious hepatitis or septicemia, to be extremely low [6~11]. Filshie (2001), however, opines that where palliative treatment is applied for control of tumor pain, and if neither the clinical stage of the disease nor the status of the modern medical treatment thereof is known, acupuncture treatment is not safe [9]. Severe potential side effects include spinal instability, severe coagulation, neutropenia and lymphoedema [8]. Valvular heart disease patients and those who are prone to neutropenia should avoid acupuncture for control and management of pain. Common side effects recorded in the six systematic reviews include epidermal haemorrhage, hypotension, dizziness, and vomitting. (Lao,et al., 2003), needle pain during treatment (1%~45%), fatigue (2%~41%), and haemorrhage (0.03%~38%) (Ernst,et al., 2001) [10]. Summarizing the six reviews, we conclude that acupuncture is safe and has relatively few severe side effects, with five of these indicating that the traditional therapy is safe to a certain degree.
In the studies of clinical evaluation, large samples were used to test whether acupuncture has any side effects. In one investigation, 900 patients were divided into three groups which were assessed using multicenter RCTs [13]. Also, comprehensive evaluation was performed for tens of thousands of patients who had averaged several acupuncture sessions each [12, 14~16]. Ernst,et al. (2003)[14] found that the main side effects of acupuncture were haemorrhage (2.9%), haematoma (2.2%), dizziness (1%) and other systemic symptoms (2.7%). They conclude that although acupuncture, like other therapies, sometimes causes a bad reaction, if it is applied accurately in accordance with set safety standards and with attention to differences in acupoint anatomy, it can be regarded as a safe treatment modality. In their prospective study of 34 407 treatments, MacPherson,et al. (2001) studied the side effects of acupuncture performed by certified members of the British Acupuncture Association and Registration (BAAR), identifying no severe side effects. Some 43 different types of relatively minor side effects were noted, however, giving an occurrence rate of 1.3/1000 treatment sessions (95% CI: 0.9~1.7). These included severe nausea and acute dizziness (n=12), unanticipated symptoms that increased and prolonged the initial feeling of discomfort (n=7), prolonged and unacceptable pain and hematoma (n=5), and emotional and psychological reactions (n=4). The results of the BAAR study were obtained from a survey of one-third of the members. Assuming the accuracy of the proffered annual total of 1.5~2 million acupuncture sessions nationally, this constitutes important evidence for determination of public health and safety policies. Compared to treatments commonly applied during outpatient consultations in conventional medical practice, namely administration of oral agents, acupuncture is a relatively safe method of physical therapy [12]. In their evaluation of 12 172 acupuncture sessions for 1 128 patients treated at an acupuncture research center in a Singapore medical center, Yong,et al. (1999)[15]found that about 70% of these individuals believed that acupuncture was safe, with 54% satisfied with the treatment results, 51% believing it was beneficial, and 54% willing to recommend acupuncture to others with similar problems. In regard to side effects, near-fainting only occurred in two patients (0.18%; 0.02% of treatment sessions), with complications caused by acupuncture not reported [15]. Yamashita,et al. (1999)[16] studied 65 482 sessions performed by 84 specially trained professors and interns at the Institute of Clinical Medicine of the Tsukuba College in Japan, with side effects reported in 94 of these treatments (0.14%). Severe complications, such as pneumothorax, infection or spinal injury, were not observed. It appears reasonable to suggest, therefore, that if acupuncture is performed by well-trained professionals according to standard procedures, the risk of severe complications is extremely low. Further, in the reports that mentioned severe complications after acupuncture, the cause was ascribed to the negligence of the practitioner. In future, complications of this type may be minimized by improved medical education and technical training of acupuncturists.
DISCUSSION AND CONCLUSION
Analysis of the relevant safety-evaluation literature worldwide indicates that acupuncture is a safe treatment modality with certain evidence supported.Although a slight possibility of severe complications such as pneumothorax and infectious hepatitis is mentioned in some of the reports, gradual establishment of standard operating procedures (SOP) for acupuncture, popularization of disinfection practices, enhancement of anatomy training as part of acupuncture education, and increasing the professionalism of acupuncturists have led to reduced incidence of side effects.
Evidence-based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients[18]. Although randomized controlled trials (RCTs) are the gold standard for evidence, it is also important to synthesize the available evidence when there is no or few RCT in interesting area. The main purpose of this study tries to develop a synthesized method of different study designs not only RCT. Through this study, literature based on scientific evidence may be collected and appraisal indexes (IF, SOQ, SOE) developed, also, extended indexes (IF×SOQ×SOE) may also be used to help us to synthesize the degree of evidence in the problem of acupuncture safety. This appraisal model will enhance efforts towards understanding of the degree of evidence among the curative effect of acupuncture treatment in various diseases. For the convenience to abstract data of evidence levels, we change commonly used quality of evidence levels measure in systematic reviews from 5 to 1. The highest quality of evidence levels like meta-analysis in RCT study that was given 5 in SOE. Similarly, the lowest quality of evidence levels like case report that was gave 1 in SOE [4].
We excluded 62 initial searched titles because the focus of each articles was not closely related to acupuncture safety. Excluded titles had been reviewed by a team of research in Chinese Medical College, China Medical University of Taiwan, and though the supposition of question (SOQ) equaled to zero which was defined in Table 1. In order to minimize the bias, Medline database was also used. However, if publications supporting acupuncture safety predominated in PubMed database, we did not include the article that was only appeared in Medline database finally, thus the database bias may have lowered by this consideration. Another important aspect of evidence-based medicine is the collection and dissemination of information to help guide decisions by clinicians, patients and other decision makers.
In their study of acupuncture performed by BAAR members, MacPherson,et al.[12](2001) assumed an annual total of 1.5~2 million sessions, providing an important and substantial body of evidence applicable to public health and safety policies. Compared to treatments commonly applied during outpatient consultations in Western medicine, namely oral administration of pharmaceuticals, acupuncture is a relatively safe therapy. We believe that investigations will be quantitatively and qualitatively improved, and that clinical trials will be conducted in accordance with the principles of multi-center and randomized controlled trials in future. This will allow consensus to be established with respect to the safety and efficacy of acupuncture, allowing this important traditional complementary therapy to keep pace with conventional medical practice and its emergence as a mainstream treatment.
Acknowledgments
We would like to thank the “National Committee of Chinese Medicine” (CCMP93-RD-017 and CCMP94-RD-104) in Taiwan for kindly providing funding for these two-year researches, also to thank Miss Gu and Chen for collecting papers in this article.
REFERENCES
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3. Yamashiro S. Practice and application of evidence-based medicine. Rinsho Byori，2000，48: 1149-1155.
4. Sutherland SE. Evidence-based dentistry: Part IV. Research design and levels of evidence. J Can Dent Assoc，2001，67: 375-378.
5. Lin JG. Studies of needling depth in acupuncture treatment. Chin Med J，1997，110: 154-156.
6. Chung A, Bui L, Mills E. Adverse effects of acupuncture. Which are clinically significant? Can Fam Physician，2003，49: 985-989.
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8. Lao L, Hamilton GR, Fu J, et al. Is acupuncture safe? A systematic review of case reports. Altern Ther Health Med ，2003，9: 72-83.
9. Filshie J. Safety aspects of acupuncture in palliative care. Acupunct Med，2001，19: 117-122.
10. Ernst E, White AR. Prospective studies of the safety of acupuncture: a systematic review. Am J Med，2001，110: 481-485.
11. Jobst KA. A critical analysis of acupuncture in pulmonary disease: efficacy and safety of the acupuncture needle. J Altern Complement Med，1995， 1: 57-85.
12. MacPherson H, Thomas K, Walters S, et al. The York acupuncture safety study: prospective survey of 34 000 treatments by traditional acupuncturists. BMJ， 2001，323: 486-487.
13. Streitberger K, Witte S, Mansmann U, et al. Efficacy and safety of acupuncture for chronic pain caused by gonarthrosis: a study protocol of an ongoing multi-centre randomised controlled clinical trial [ISRCTN27450856]. BMC Complement Altern Med，2004， 4: 6.
14. Ernst G, Strzyz H, Hagmeister H. Incidence of adverse effects during acupuncture therapy-a multicentre survey. Complement Ther Med，2003，11(2): 93-97.
15. Yong D, Lim SH, Zhao CX, et al. Acupuncture treatment at Ang Mo Kio Community Hospital-a report on our initial experience. Singapore Med J， 1999， 40: 260-264.
16. Yamashita H, Tsukayama H, Tanno Y, et al. Adverse events in acupuncture and moxibustion treatment: a six-year survey at a national clinic in Japan. J Altern Complement Med，1999，5: 229-236.
17. Lytle CD, Thomas BM, Gordon EA, et al. Electrostimulators for acupuncture: safety issues. J Altern Complement Med，2000，6: 37-44.
18. Sackett DL. Clinical epidemiology. what, who, and whither. J Clin Epidemiol， 2002， 55: 1161-1166.
(Editor Guo Hui-ling)(Jaung-geng Lin1,Pin-kuei )
1. Graduate Institute of Chinese Medical Science, China Medical University, Taichung City, Taiwan,China
2. Graduate Institute of Integration Chinese and Western Medicine, China Medical University, Taichung City, Taiwan,China
Correspondence to Shih-Liang Chang,MD,PhD, Graduate Institute of Integration Chinese and Western Medicine, China Medical University, Taichung City, Taiwan,China
Tel:+886-4-22053366 ext 1647，Fax:+886-4-8346349 ，E-mail: slchang@mail.cmu.edu.tw
[Abstract] In recent years, more and more importance has been placed on traditional medicine around the world. In May 2002, the World Health Organization (WHO) launched its Traditional Medicine Strategy 2002~2005, suggesting traditional therapies were included in existing national health policy systems, while also providing clinical guidelines to ensure appropriate, safe and effective application of these established treatment modalities. The concept of evidence-based medicine (EBM) proposed by British Professor Archie Cochrane has also gained gradual acceptance and even gained health insurance approval. Given these developments, evidence-based medical study of literature relating to traditional Chinese medicine is both timely and significant.
As acupuncture is an invasive treatment, safety in clinical application should be closely monitored. The safety issue remains largely unresolved, however, and given its rising prominence and acceptance, a resolution is urgently required. Study of the relevant literature may provide a relatively rapid way to evaluate the safety of acupuncture statistically. At the same time, establishing a critical appraisal model will provide a reference for relative intensity study of evidence-based medicine in traditional Chinese medicine.
The PubMed and Medline database search using the terms “acupuncture” and “safety” selected relevant publications. Based on this critical evaluation of the literature and the derivation of these indicators, we conclude that acupuncture safety is supported with certain evidence in research relative to conventional and accepted therapies without evidence.
[Key words] acupuncture safety;evidence-based medicine;critical appraisal method
INTRODUCTION
Over the past two decades, traditional medicine and alternative therapies have increasingly become a focus of attention worldwide. In May 2002, the World Health Organization (WHO) launched its Traditional Medicine Strategy 2002~2005, suggesting that these complementary practices should be included in existing national health policy systems, while also providing clinical guidelines to ensure their appropriate, safe and effective application [1]. Further, the American National Institutes of Health (NIH) has appropriated funds for traditional medicine, establishing the National Center for Complementary and Alternative Medicine (CAM). Traditional Chinese medicine (TCM) is a medical science that is based on experience and the accumulation of the wisdom of ancestors. From the earliest records,human was the object of treatment, and abundant records were handed down as reference for later generations of doctors. The first obstacle encountered in present day Chinese medical policies and systems, however, was the related issues of effectiveness and safety. For thousands of years, the efficacy of TCM has been accepted. With the rapid rise and predominance of medicine based on the Western deterministic paradigm, however, these old-age treatment practices now must be subjected to scientific and medical scrutiny before they can be recognized, while their safety requires even more rigorous verification.
The evidence-based medcine(EBM) concept has evolved since it was first proposed in the 1970's, and has been growing in popularity in recent years. British Professor Archie Cochrane, his book “Effectiveness and Efficiency” won acclaim among health practitioners after its publication in 1972, with later referral to it establishing the concept. Nowadays, evidence-based medicine and health care are regarded as new concepts, replacing authority-based traditional medicine.EBM relies on randomized controlled trials (RCT), systematic review of test series, and meta-analysis. The collection and dissemination of information are also emphasized, so it is comparable to clinical practice, while also incorporating research and practice [2]. In general, EBM consists of five steps: (1) formulation of answerable clinical questions; (2) literature search for the best evidence; (3) critical appraisal of the relevant material; (4) clinical application of the evidence; and, (5) audit of the above [3].
In this study, the EBM concept was applied to literature related to acupuncture safety, and an attempt was made to construct a synthesized model of papers in different EBM levels which allows critical appraisal[4]. The principal aims of the investigation were: to gain an overall understanding of acupuncture safety studies worldwide; to produce a summary of the material and reach a consensus; in-depth study of acupuncture safety; and, to search the literature for the best evidence. Secondarily, the relevant literature was subjected to critical appraisal and a simple, easy-to-use and practicable appraisal model developed for use as a reference in the study of problems related to evidence-based medicine.
MATERIALS AND METHODS
Data Source
The main source for the information used in this study was the PubMed database. This resource is updated weekly and accessible from the National Center for Biotechnology Information (NCBI) of the US National Library Medicine via the Internet, where users may retrieve data without charge. Medline database was also used with the same search strategy for correcting the database bias.
Data Selection
The results of studies relating to acupuncture safety, the findings of systematic reviews, and relevant clinical cases were collected from a PubMed search following a search strategy, for the words “acupuncture” and “safety”, and the search limits as following conditions: publication date to 2004/05/30, only items with abstracts and English. In general, each included paper was reviewed by two members or more of a subgroup in our research team; the conflicts were resolved by discussions among the members of the subgroup.
Data Extraction
Collected data was subjected to critical appraisal, and the five EBM steps applied to the main study results and conclusions. The three main categories of the critical appraisal are: (1) basic informations of included paper: items were defined in Table 1; (2) brief contents of the reference section; and, (3) appraisal index for which a form was designed (Table 1). Through the establishment of an appraisal model and various indexes, insight was gained into the quality and general condition of the reference literature relating to acupuncture safety.
Table 1 Critical Appraisal Form - Reference Literature on Acupuncture and Evidence-based Medicine
Continue(续表)
In the table, the impact factor (IF) is based on latest issue of journal citation report (JCR) available in the library of China Medical University. It is indicated by 0.1 when the issues were unable to find. The supposition of question (SOQ; -3-0-3) is a quantification index given by the appraiser after study of the texts and the described clinical problems. Score of “0” indicates the reference is unrelated to the described clinical problem. The SOQ is divided into 3 positive and 3 negative scores and completed by and according to the appraiser. The scoring method of Evidence (SOE, 5-1) was designed as below [4] :(1)RCTs: reference consists of multiple randomized controlled trials e.g., meta-analysis or systematic review; accredited with a score of 5.(2)RCT/Cohort: reference consists of single randomized controlled trials or cohort studies; a cohort study compares populations exposed to different factors; usually applied for etiology study or to evaluate disease progress e.g., comparison of smoking and non-smoking as causes of lung cancer; accredited with a score of 4.(3)Case control: reference consists of case control studies comparing patients to a control group; historical data was collected to search for between-group differences; accredited with a score of 3.(4)Case series: reference consists of reports of multiple cases; accredited with a score of 2.(5)Experiences/Case report (1): reference consists of a single case; accredited with a score of 1.
Finally, we multiply the indexes, IF, SOQ and SOE as evidence score and rank this score in the name of the quality of evidence.
RESULTS
Seventy four titles were found from the initial search, but only 12 reports exploring the safety and side-effects of acupuncture were selected,and one paper investigating safe needling depth [5] was also included for our analysis and discussed safety of acupuncture, six were systematic reviews [6~11], and five related to clinical testing [12~16], with one evaluating the safety of acupuncture electro-stimulation [17]. On the other hand, we did not include the article that was only appeared in Medline database finally after consideration. After collection and critical appraisal of the reference literature on the safety of clinical acupuncture, a mean value of 2.1 for Supposition of Question (SOQ,-3-0-3) was demonstrated. Additionally, mean post-appraisal Score of Evidence (SOE,5-1) and magazine publication Impact Factor (IF) values of 2.6 and 1.8, respectively, were derived. Each included paper was list in Table 2, that was illustrated the brief summary of each article based on the evidence analyzed in this study. The evidence score and rank of each paper were also derived in Table 2. The mean value of 11.7 for this evidence score was also demonstrated.This score and rank help us to realize the degree of evidence in accordance with the problem of acupuncture safety.
Table 2 Appraisal Indexes of Each Included References
IF = Impact Factor, SOQ = Supposition of Question, SOE = Score of Evidence, Evidence Score = IF×SOQ×SOE
Summarizing the various investigations of safe acupoint depth, the needle depth recorded in the modern reference literature is generally greater than described in the classic medical records, with safe acupoint depth for chest and back areas was not the same for each acupoint. In adults, but not infants, a positive correlation was demonstrated with the length of the second section of the middle finger. Comparing gender, safe acupoint depth in the chest area was greater for females; however, no significant between-gender difference was demonstrated for the back area. This gender variation should be considered, therefore, when deciding on the safe depth for acupoint, and, unless the subject is an infant, the length of the middle section of the second finger may be used as a reference value [5].
Study of the reference literature for side effects found that most researchers deemed the risk of acupuncture causing severe side effects, such as pneumothorax, infectious hepatitis or septicemia, to be extremely low [6~11]. Filshie (2001), however, opines that where palliative treatment is applied for control of tumor pain, and if neither the clinical stage of the disease nor the status of the modern medical treatment thereof is known, acupuncture treatment is not safe [9]. Severe potential side effects include spinal instability, severe coagulation, neutropenia and lymphoedema [8]. Valvular heart disease patients and those who are prone to neutropenia should avoid acupuncture for control and management of pain. Common side effects recorded in the six systematic reviews include epidermal haemorrhage, hypotension, dizziness, and vomitting. (Lao,et al., 2003), needle pain during treatment (1%~45%), fatigue (2%~41%), and haemorrhage (0.03%~38%) (Ernst,et al., 2001) [10]. Summarizing the six reviews, we conclude that acupuncture is safe and has relatively few severe side effects, with five of these indicating that the traditional therapy is safe to a certain degree.
In the studies of clinical evaluation, large samples were used to test whether acupuncture has any side effects. In one investigation, 900 patients were divided into three groups which were assessed using multicenter RCTs [13]. Also, comprehensive evaluation was performed for tens of thousands of patients who had averaged several acupuncture sessions each [12, 14~16]. Ernst,et al. (2003)[14] found that the main side effects of acupuncture were haemorrhage (2.9%), haematoma (2.2%), dizziness (1%) and other systemic symptoms (2.7%). They conclude that although acupuncture, like other therapies, sometimes causes a bad reaction, if it is applied accurately in accordance with set safety standards and with attention to differences in acupoint anatomy, it can be regarded as a safe treatment modality. In their prospective study of 34 407 treatments, MacPherson,et al. (2001) studied the side effects of acupuncture performed by certified members of the British Acupuncture Association and Registration (BAAR), identifying no severe side effects. Some 43 different types of relatively minor side effects were noted, however, giving an occurrence rate of 1.3/1000 treatment sessions (95% CI: 0.9~1.7). These included severe nausea and acute dizziness (n=12), unanticipated symptoms that increased and prolonged the initial feeling of discomfort (n=7), prolonged and unacceptable pain and hematoma (n=5), and emotional and psychological reactions (n=4). The results of the BAAR study were obtained from a survey of one-third of the members. Assuming the accuracy of the proffered annual total of 1.5~2 million acupuncture sessions nationally, this constitutes important evidence for determination of public health and safety policies. Compared to treatments commonly applied during outpatient consultations in conventional medical practice, namely administration of oral agents, acupuncture is a relatively safe method of physical therapy [12]. In their evaluation of 12 172 acupuncture sessions for 1 128 patients treated at an acupuncture research center in a Singapore medical center, Yong,et al. (1999)[15]found that about 70% of these individuals believed that acupuncture was safe, with 54% satisfied with the treatment results, 51% believing it was beneficial, and 54% willing to recommend acupuncture to others with similar problems. In regard to side effects, near-fainting only occurred in two patients (0.18%; 0.02% of treatment sessions), with complications caused by acupuncture not reported [15]. Yamashita,et al. (1999)[16] studied 65 482 sessions performed by 84 specially trained professors and interns at the Institute of Clinical Medicine of the Tsukuba College in Japan, with side effects reported in 94 of these treatments (0.14%). Severe complications, such as pneumothorax, infection or spinal injury, were not observed. It appears reasonable to suggest, therefore, that if acupuncture is performed by well-trained professionals according to standard procedures, the risk of severe complications is extremely low. Further, in the reports that mentioned severe complications after acupuncture, the cause was ascribed to the negligence of the practitioner. In future, complications of this type may be minimized by improved medical education and technical training of acupuncturists.
DISCUSSION AND CONCLUSION
Analysis of the relevant safety-evaluation literature worldwide indicates that acupuncture is a safe treatment modality with certain evidence supported.Although a slight possibility of severe complications such as pneumothorax and infectious hepatitis is mentioned in some of the reports, gradual establishment of standard operating procedures (SOP) for acupuncture, popularization of disinfection practices, enhancement of anatomy training as part of acupuncture education, and increasing the professionalism of acupuncturists have led to reduced incidence of side effects.
Evidence-based medicine is the conscientious, explicit, and judicious use of current best evidence in making decisions about the care of individual patients[18]. Although randomized controlled trials (RCTs) are the gold standard for evidence, it is also important to synthesize the available evidence when there is no or few RCT in interesting area. The main purpose of this study tries to develop a synthesized method of different study designs not only RCT. Through this study, literature based on scientific evidence may be collected and appraisal indexes (IF, SOQ, SOE) developed, also, extended indexes (IF×SOQ×SOE) may also be used to help us to synthesize the degree of evidence in the problem of acupuncture safety. This appraisal model will enhance efforts towards understanding of the degree of evidence among the curative effect of acupuncture treatment in various diseases. For the convenience to abstract data of evidence levels, we change commonly used quality of evidence levels measure in systematic reviews from 5 to 1. The highest quality of evidence levels like meta-analysis in RCT study that was given 5 in SOE. Similarly, the lowest quality of evidence levels like case report that was gave 1 in SOE [4].
We excluded 62 initial searched titles because the focus of each articles was not closely related to acupuncture safety. Excluded titles had been reviewed by a team of research in Chinese Medical College, China Medical University of Taiwan, and though the supposition of question (SOQ) equaled to zero which was defined in Table 1. In order to minimize the bias, Medline database was also used. However, if publications supporting acupuncture safety predominated in PubMed database, we did not include the article that was only appeared in Medline database finally, thus the database bias may have lowered by this consideration. Another important aspect of evidence-based medicine is the collection and dissemination of information to help guide decisions by clinicians, patients and other decision makers.
In their study of acupuncture performed by BAAR members, MacPherson,et al.[12](2001) assumed an annual total of 1.5~2 million sessions, providing an important and substantial body of evidence applicable to public health and safety policies. Compared to treatments commonly applied during outpatient consultations in Western medicine, namely oral administration of pharmaceuticals, acupuncture is a relatively safe therapy. We believe that investigations will be quantitatively and qualitatively improved, and that clinical trials will be conducted in accordance with the principles of multi-center and randomized controlled trials in future. This will allow consensus to be established with respect to the safety and efficacy of acupuncture, allowing this important traditional complementary therapy to keep pace with conventional medical practice and its emergence as a mainstream treatment.
Acknowledgments
We would like to thank the “National Committee of Chinese Medicine” (CCMP93-RD-017 and CCMP94-RD-104) in Taiwan for kindly providing funding for these two-year researches, also to thank Miss Gu and Chen for collecting papers in this article.
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(Editor Guo Hui-ling)(Jaung-geng Lin1,Pin-kuei )