1 Evidence Based Practice Proposal Paper:

2 Acupuncture Treatment and Needle Transmitted Infection

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Acupuncture Treatment and Needle Transmitted Infection

Problem Identification

Acupuncture is a coherent and self-consistent body of knowledge based on a philosophy which differs radically from the conventional Western worldview. Rather than seeing disease as the result of a single causative agent, acupuncture medicine regards illness as a pattern of disharmony, a function of both internal and external phenomena adversely affecting the whole person (Prady et al, 2007). In other words, it describes the universe as a dynamic system, within which all phenomena are interrelated. It has been one of the most popular complementary and alternative therapies for the treatment of pain conditions in developed countries (Barns et al, 2004). The report from a Consensus Development Conference on Acupuncture held at the National Institutes of Health (NIH) in 1997 stated that acupuncture is being widely practiced by thousands of physicians, dentists, acupuncturists, and other practitioners for relief or prevention of pain and for various other health conditions. According to the 2007 National Health Interview Survey (NHIS), which included a comprehensive survey of NCCAM (National Center for Complementary and Alternative Medicine), an estimated 3.1 million U.S. adults and 250,000 children had used acupuncture for pain control in the previous year, and about 8,500 physicians in the major hospitals and 12,000 non-physician acupuncturists use acupuncture in private practice. One of the qualified nurses’ role in the U.S. Army has been extending to practice acupuncture – inserting and withdrawing needles - and appropriately educating the patients about their treatment. However, studies explore that either negligence or insufficient awareness of aseptic procedures before inserting and after withdrawing needles cause needle transmitted infection (White et al., 2005; MacPherson et al., 2005; Yamashita et al., 2008; Witt et al., 2009; Woo et al., 2010). Three studies agree that the incidence of bleeding by inadequate depth of needling and skin disinfection develops the potential hazard of blood-borne infections (White et al., 2005; Yamashita et al., 2008; Witt et al., 2009).

Review of Literature

Witt, Pach, Brinkhaus, et al (2009) Safety of acupuncture: results of a prospective observational Study with 229,230 patients (Witt, Pach, Brinkhaus, et al., 2009) evaluates the safety of acupuncture in a large number of patients receiving conventional health care and, based on these results, to develop a new medical consent form for acupuncture. This study was a quantitative study and implemented quasi-experimental design using observational measurements. The prospective observational study included all out-patients (age > 18 years) from participating health sickness funds who received acupuncture treatment for chronic osteoarthritis pain of the knee or hip, low back pain, neck pain or headache, allergic rhinitis, asthma, or dysmenorrhea between December 2000 and August 2004. A total of 13,579 physicians practicing acupuncture in Germany participated in the study. Acupuncture was provided by physicians with postgraduate acupuncture training of at least 140 hours. 229,230 patients were enrolled and received on average 10.17 acupuncture treatments. The study was approved by the ethics committee of the Acupuncture Safety and Health Economics Study (ASH) and all patients provided written informed consent. At the end of each treatment cycle, all patients were asked to complete a standardized questionnaire and to document adverse events they associated with acupuncture (defined as adverse effects) in free text. SPSS 11.5 (SPSS Inc., Chicago IL, USA) was used for statistical data analysis. The authors used the guidelines of the European Commission for Adverse Effects of Medicinal Products for data analysis and a formula from Hanley and Lippman-Hand. The findings of this study was that all together, 19,726 patients (8.6%) reported experiencing at least one adverse effect and 4,963 patients (2.2%) reported one which required treatment. Common adverse effects were bleeding or hematoma (6.1% of patients, 58% of all adverse effects), pain (1.7%), and vegetative symptoms (0.7%). These bleeding and hematoma developed 681 cases of inflammation at application site (2.9% of all adverse effect) and 31 cases of local infection (0.2% of all adverse effect). There are limitations in this study. Standardized questionnaires only include minor adverse events. Severe or very severe complications were not included in the standardized questionnaire of the guidelines of the European Commission. More detailed standardized questionnaire concerning their most severe adverse effect is need. Another limitation was that adverse events without association to the acupuncture treatment were not documented.
Yamashita & Tsukayama (2008) The second article, Safety of Acupuncture Practice in Japan: Patient Reactions, Therapist Negligence and Error Reduction Strategies(Yamashita & Tsukayama, 2008) focuses on Japanese acupuncture, reviews relevant case reports and prospective surveys on adverse events in Japan, assesses the safety of acupuncture practice, and suggests a strategy for reducing the therapists’ errors. The quantitative study was used to provide an accurate account of acupuncture safety. An adverse event is defined as an unfavorable medical event that occurs during or after the treatment regardless of causal relationship. Quasi-experimental design was used due to no comparison group and non-randomization of the participants. All participants were acupuncture stratified random sampling and retrospective cohort study was used in this quantitative study. Seven acupuncturists meticulously observed the punctured region and general condition of the patients during and immediately after treatment during the period between Aril 2000 and June 2004 at Tsukuba College of Technology Clinic. The patients were asked to report any pain or discomfort caused by needle insertion. Also at the next visit, the acupuncturists asked the patients about any feeling of discomfort after their treatment sessions. Recognized adverse reactions were recorded in a structured case report form. The total number of treatment sessions was 17,332 and the total number of needle insertions was 363,978 (an average of 21 insertions per visit). The actual number of individual patients was 4,691 with ages ranging from 12 to 88 years. The most frequent stimulation method was simple needle during retention: needles were retained for 10–20 min after insertion, and then removed and the second most frequent method was electro acupuncture, followed by manual stimulation of the needle. Finding of this study was that all together, 352 patients (7.5 %) reported experiencing at least one adverse effect and 91 patients were bleedings or hematoma. These bleeding and hematoma developed 16 cases of inflammation at application site (18% of bleeding adverse effect) and 4 cases of local infection (3.8% of bleeding adverse effect). This study resulted in primary importance to educating acupuncturists more about safe depths of insertion, aseptic procedure to prevent adverse effects. It also indicated that Japanese acupuncturists do not frequently access medical journals that carry articles regarding the safety of acupuncture. It is therefore likely that most acupuncturists in Japan do not know what kind of negligence occurs after their treatments. I agree with the authors’ suggestion of the importance of establishing mandatory postgraduate clinical training as well as a continued education system to further improve undergraduate education for acupuncture students (Yamashita & Tsukayama, 2008). Limitation of this study was that there was a recall bias because relevant case studies were retrospective. Since it is difficult to describe the details around an adverse event, it is also difficult to assess the causal relationship between the event and acupuncture treatment.
White, Hayhoe, Hart & Ernst (2005) The third article, Adverse events following acupuncture: prospective survey of 32,000 consultations (White, Hayhoe, Hart & Ernst, 2005) focuses on insufficient awareness of aseptic procedure in acupuncture. The purpose of this study is to assess the incidence of adverse events related to acupuncture treatment, as currently practiced in Britain by acupuncture practitioners including doctors and physiotherapists. This study is a descriptive type of quantitative research for the exploration of phenomena; all of the subjects were acupuncture practitioners. Volunteer acupuncture practitioners were recruited through journals circulated to members of the British Medical Acupuncture Society (BMAS) and the Acupuncture Association of Chartered Physiotherapists (AACP) (approximately 2,750 members). A prospective survey was undertaken using forms for intensive event monitoring that had been piloted previously in 2001. Adverse events were defined as any ill-effect, no matter how small, that is unintended and non-therapeutic, even if expected. These events were reported every month, along with the total number of consultations. Serious events that were considered to be significant- unusual, novel, dangerous, significantly inconvenient, or requiring further information- were reported on separate forms when they occurred. Anonymous reporting was accepted. Simple random sampling was used for the study. In all, 31,822 cases were collected from June 2002 to February 2004 from 78 acupuncturists, 13 of whom chose to remain anonymous. The average age of the acupuncturists was 47 (range 27-71) years, 61% were doctors and 39% physiotherapists, and 71% had practiced for five years or more. Stata version 6.0 with 10,000 replication was used for data analysis. Since the data was skewed, with extreme values present, confidence intervals corrected for bias were calculated using bootstrapping procedure and a total of 2,135 adverse events were reported, giving an incidence of 671 per 10,000 consultation. The adverse effect of bleeding was reported by 277 cases (13% of all adverse effect). Findings in this study were that 17% of bleeding adverse effect developed infection which included local redness, viral infections, bacterial infections abscess, and septicemia. Even though it was informative based on large numbers of survey, the study had limitations. Demographic data suggests that the acupuncturist volunteers were reasonably representative of the members of the two societies (BMAS and AACP), but over-reporting is inherently possible in this study. Another limitation was that the authors did not provide a reliability test in this study, and consequently there was no measure of the amount of random error.
MacPherson, Thomas, Walters & Fitter (2005) The fourth article, The York acupuncture safety study: prospective survey of 34,000 treatments by traditional acupuncturists ( MacPherson, Thomas, Walters & Fitter, 2005) aimed to describe the type and frequency of adverse events after acupuncture and to examine transient reactions associated with acupuncture. The article is of quantitative research. The study of design was descriptive design due to gaining more safety information about the risks associated with acupuncture. Convenience sampling was used for this study. Standardized self report forms were used. The study involved a prospective postal audit of treatments undertaken during a four week period in 2004. Participating practitioners provided information on themselves, including age, sex, length of training, and years of practice. Simple random sampling was used for the study. A total of 574 practitioners participated, 31% of the total population of members. Participating practitioners reported on 34,407 treatments. The mean age of participants was 44.8 years (range 23-79 years), 65% were female, and 62% had been practicing acupuncture for more than five years. Information on sex, training college, and length of practice was available from the British Acupuncture Council's database. Practitioners were asked to give details of any adverse events they considered to be "significant," including any event that was "unusual, novel, dangerous, significantly inconvenient, or requiring further information." Participating practitioners recorded 10,920 transient reactions occurring in 5,136 treatments, 15% of the 34,407 total. The major events in local reactions at the site of needling were bruising and bleeding in 1,122 (11% of all adverse events) cases, and pain in 895 (8.2% of all adverse events) cases. Patients experienced an aggravation of existing symptoms after 966 treatments, 830 of which were followed by an improvement, possibly indicating a positive healing crisis. Even though the study did not provide further infectious implications of bleeding adverse effect, it did indicate that bleeding was the major adverse event in local reactions at the site of needling. This conclusion was based on data collected over a four week period by the British Acupuncture Council. Even given the potential bias of self reporting, this is important evidence on public health and safety as professional acupuncturists deliver approximately two million treatments per year in the United Kingdom. However, further research measuring patients’ experience of adverse events will be merited, such as bacterial, Viral infections, and Hepatitis B.
Woo, Lin, Lau & Yuen (2010) The last study, Acupuncture transmitted infections (Woo, Lin, Lau & Yuen, 2010) explores a high index of suspicion, particularly for viral and mycobacterial infections transmitted by acupuncture and Woo emphasizes the need for enhancing the awareness of its side effects and the need for training and regulating acupuncture practitioners. The article is qualitative research and used typical descriptive design using description of variables and interpretation of meaning. Purpose sampling was used for this study. Data collected from published incidence case studies in the 1970s through1990s shows that most infections associated with acupuncture were sporadic cases involving pyogenic bacteria. The study evaluated 147 sporadic cases involving pyogenic bacteria which have been described globally. In most cases, pyogenic bacteria were transmitted from the patient’s skin flora or the environment because of inadequate skin disinfection before acupuncture. About 70% of patients had musculoskeletal or skin infections, usually in the form of abscesses or septic arthritis, corresponding to the site of insertion of the acupuncture needles. As in musculoskeletal or skin infections, Staphylococcus aureus was the most common bacterium responsible, accounting for more than half of the reported cases. Although most patients recovered, 5-10% died of the infections and at least another 10% had serious consequences such as joint destruction, paraplegia, necrotizing fasciitis, and multiorgan failure. Apart from pyogenic bacterial infections, five outbreaks of hepatitis B virus infection associated with acupuncture, which affected more than 80 patients, have been described globally since the 1970s. In most outbreaks the sources were infected patients, and the virus was transmitted from one patient to another through improperly sterilized or unsterilized reusable acupuncture needles. A new clinical syndrome has emerged in the 21st century- acupuncture mycobacteriosis- which is mainly caused by rapidly growing mycobacteria. These mycobacteria are thought to be transmitted from the environment to patients via contaminated equipment used in acupuncture such as reusable needles, cotton swabs, towels, hot packs, and boiling tanks. All mycobacterial infections associated with acupuncture so far have been characterized by localized meridian specific and acupuncture point specific lesions without dissemination. Patients tended to delay seeking medical advice because of the slow developing and relatively mild symptoms. Furthermore, the first reports of meticillin resistant S aureus (MRSA) transmitted by acupuncture appeared in 2009. The emergence of community associated MRSA infections may aggravate the problem. I agree with Woo and his colleagues that infection control measures should be implemented to the use of disposable needles, skin disinfection procedures, and aseptic techniques, and stricter regulations. Even though reusable needles have been used in China, Hong Kong, and some South Asian countries, reusable needles are not used in all of America and European countries.
Presentation of Evidence

Research shows that the major adverse events in local reactions at the site of needling were bleeding and developed infection at the application site and either negligence or insufficient awareness of aseptic procedures exists in practicing acupuncture (MacPherson et al., 2005; Yamashita et al., 2008; Witt et al., 2009; Woo et al., 2010). Studies also agree the incidence of bleeding indicated that acupuncture has the potential hazard of blood-borne infections (MacPherson et al., 2005; Yamashita et al., 2008; Witt et al., 2009; Woo et al., 2010; White et al., 2005), and Woo, Lin, Lau & Yuen explore cases of meticillin resistant S aureus (MRSA), and hepatitis B virus infection associated with acupuncture (2010). Pyogenic bacteria are transmitted from the patient’s skin flora or the environment because of inadequate aseptic technique and skin disinfection before and after needling in acupuncture procedures (Woo et al, 2010). It is our duty as nurses or practitioners to maximize and maintain asepsis, the absence of pathogenic organisms, and adequately practice skin disinfection before and after needling in acupuncture.

Proposed Solution

Strategies and Implementation

The solution to these problems is that medical practitioners have to be aware of taking responsibility to protect the patient from infection and to prevent the spread of pathogens. Pathogens may introduce infection to the patient through contact with the environment, personnel, or equipment. All patients are potentially vulnerable to infection, although inserting needles under the skin further increases vulnerability. These pyogenic bacteria are transmitted from the environment to patient via contaminated needles used in acupuncture. Furthermore, all mycobacterial infections associated with acupuncture so far have been characterized by localized meridian specific and acupuncture point specific lesions without dissemination (Woo, Lin, Lau & Yuen , 2010). It is important to set up zero tolerance goals of aseptic technique. Often practices that clean (remove dirt and other impurities), sanitize (reduce the number of microorganisms to safe levels), or disinfect (remove most microorganisms but not highly resistant ones) are not sufficient to prevent infection. It is also needed to push for stricter regulation to societies and governing bodies of a acupuncture license to achieve these goals. Studies explored major problems of bleeding in needing were careless needling technique or negligence of safe depth of insertion by practitioners (Yamashita et al., 2008; Witt et al., 2009; Woo et al., 2010; White et al., 2005). It is needed to establish mandatory postgraduate clinical training as well as a continued education system to further improve acupuncture medicinal techniques.

Evaluation Plan Once practitioners or organizations implement these strategies it is required to evaluate that an effective feedback system on the adverse events of acupuncture should be checked and analyzed with relevant data, and assessing solutions, and organizations distribute the updated knowledge for their members then. Summary and Conclusion Acupuncture can make a valuable contribution to the development of a truly modern philosophy of health care treatment of pain conditions without using medications. Despite the dominance of biomedicine in the western medical arena, it has already been demonstrated that acupuncture provides a safe intervention for pain according to the U. S. National Institutes of Health ( Prady et al, 2007). However, current studies explore severe adverse events in practicing acupuncture with negligence of biomedicine, which is preventable by practitioners and nurses. As medical practitioners, we have to be aware of the importance of aseptic techniques including skin disinfection which is the most basic and simple fundamental in biomedicine, and carefully practicing safe depth of insertion in needling techniques. Systemic prevention and advanced clinical trainings are also required as well as pushing for stricter regulations to the societies and governing bodies for prevention of severe adverse events.

References

MacPherson, H., Thomas, K., Walters, S., & Fitter, M. (2005). The York acupuncture safety study: prospective survey of 34,000 treatments by traditional acupuncturists. British Medical Journal, 323, 487-489.

White, A., Hayhoe, S., Hart, A., & Ernst, E. (2005) Adverse events following acupuncture: prospective survey of 32,000 consultations. British Medical Journal, 323, 485–487.

Yamashita, H., & Tsukayama, H. (2007). Safety of acupuncture practice in Japan: patient reactions, therapist negligence and error reduction strategies, Oxford Journals, 5(4), 391- 398.

Witt, C., Pach, D., Brinkhaus, B., Wruck, K., Tag, B., Mank, S., & Willich, S. (2009). Safety of acupuncture: results of a prospective observational study. Research in Complementary Medicine, 16, 91-97.

Woo, P., Lin, A., Lau, S., & Yuen, K. (2010). Acupuncture transmitted infections. British Medical Journal, 340, c1268. doi: 10.1136/bmj.c1268.

Prady, L., Thomas, K., Edmond, L., Crouch, S., MacPherson, H. (2007). The natural history of back pain after a randomized controlled trial of acupuncture and usual care, Acupuncture in Medicine, 25(4), 121-129.