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[Objective]The purpose of this study was to gain a clear understanding of adverse events associated with acupuncture (Acp) and moxibustion (Mox) therapies. Thus, we administered questionnaires to orthopedists in order to understand the clinical experience of patients who suffered adverse events.<BR>[Materials and Methods]For this study, 6,000 orthopedic hospitals and clinics were randomly selected from 13,225 hospitals and clinics listed in the telephone directory iTown Page (http://itp.ne.jp). In October 2011 and July 2012, 3,500 and 2,500 questionnaires, respectively, were sent by mail. The questions addressed the following:(1) the respondent's profile (e.g., years of experience as a licensed orthopedist);(2) adverse events associated with Acp, including electroacupuncture;(3) adverse events associated with Mox;(4) use of Acp and Mox therapies in the orthopedist's hospital or clinic;(5) comments on the safety of Acp and Mox therapies. The identity of respondents remained secret.<BR>[Results]The questionnaire response rate was 10.7%. The respondents were licensed orthopedists for 30 ± 11 years (mean ±standard deviation). Adverse events associated with Acp included retained needles and needle breakage (n ≥148), hemorrhages (n ≥ 64), infections (n ≥ 40), organ injuries (n = 28), and so on. Retained needles (≥ 145 out of 148), subcutaneous hemorrhages (63out of 64), arthritis (17 out of 40), and pneumothorax injuries (27 out of 28) occurred most frequently. The adverse events associated with Mox were burn injuries (n ≥ 121), infections (n ≥ 16), and other adverse events (n = 2). Second-degree burn injuries (n ≥ 48 out of 121) and suppuration infections (11 out of 16) occurred most frequently. These were the most common adverse events associated with Acp and Mox. The usage rate of Acp and Mox therapies in the orthopaedist's hospital or clinic was 18.6%. There were many comments on infection control by acupuncturists (n = 27), education and technical levels of Acp and Mox (n = 13), and retained needles and needle breakages (n = 13). <BR>[Conclusion]These survey results reveal that the occurrence of severe adverse events associated with Acp and Mox was higher than our expectation. In order to improve the safety of Acp and Mox therapies, various educational activities to disseminate information about existing safety measures to acupuncturists are needed. Further studies on new preventive measures, continuous surveys, and feedback to acupuncturists are also required.
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[Objective]The aim of this study was to prevent accidental burns caused by touching a heated needle shaft or by a burning moxa ball falling from a moxa needle. Therefore, we measured the central temperature (Tc) of a burning moxa ball and the temperature at the landing point (Td) of a falling moxa ball.<BR>[Methods]Stainless steel acupuncture needles and unrefined moxa for moxa needles were used. The moxa balls weighed 0.15 g (diameter, 13± 1mm), 0.30 g (diameter, 16 ± 1mm), and 0.60 g (diameter, 24 ± 1mm). To measure the Tc of a moxa ball, a K-type thermocouple temperature probe was inserted into the centre of the ball. The Td of a moxa ball was measured by placing the probe 2 mm directly below the moxa ball. At each point in time, the moxa ball was forced to drop after ignition. Each measurement was repeated 5 times. The data were expressed as mean ±standard deviation.<BR>[Results]The maximum Tc of the 0.15, 0.30, and 0.60 g moxa balls was 569 ± 26°C at 72 ± 8s after ignition, 606 ± 26°C at 109 ± 4s, and 624 ± 48°C at 167 ± 14 s, respectively. Tc of each ball decreased to less than 45°C at 180 ± 8s, 225 ± 4s, and 345 ± 13s after ignition, respectively. When a 0.15 g moxa ball was dropped 30 s after ignition, Td measured 1, 5, and 10 s after the drop was 60 ± 6°C, 97 ± 7°C, and 137 ± 31°C, respectively. Td was less than 45 degrees 120 seconds after ignition. When a 0.30 g moxa ball was dropped 120 s after ignition, Td measured 1, 5, and 10 s after the drop was 66 ± 7°C, 96 ± 6°C, and 129 ± 2°C, respectively. Td was less than 40 degrees 120 seconds after ignition. Td was less than 45 degrees 180 seconds after ignition. When a 0.60 g moxa ball was dropped 180 s after ignition, Td measured 1, 5, and 10 s after the drop was 69 ± 3°C, 96 ± 14°C, and 135 ± 20°C, respectively. Td was less than 45 degrees 270 seconds after ignition.<BR>[Conclusion]For 0.15, 0.30, and 0.60 g moxa balls, if Tc, that is the temperature of the probe, is considered to be the temperature of the needle shaft, burns may be caused by touching the heated shaft up until about 180, 240, and 360 s after ignition, respectively. Furthermore, there is a risk of burns caused by dropping a burning 0.15, 0.30, or 0.60 g moxa ball before 120, 180, or 270 s after ignition, respectively.
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[Objective]The aim of this study was to survey the current status of adverse events (malpractice and side-effects) in clinical practices of acupuncture (Acp) and moxibustion (Mox), to discuss the problems, and to suggest corrective strategies.<BR>[Methods]The survey was sent by mail in October 2009 to 6,000 Acp clinics (including Mox) selected at random from the i-Town-Page telephone directory. The questions addressed the following issues:(1) respondent profile;(2) Acp adverse events;(3) Mox adverse events;(4) complaints and litigation;(5) informed consent regarding these adverse events;(6) subscriptions to publications that address the safety issues of Acp and Mox;and (7) access to free safety resources. Note that we inquired about the experiences of adverse events but did not inquire about their frequency.<BR>[Results]The response rate was 21.6%. The top three adverse events for Acp were subcutaneous hemorrhage (65.8%), micro-hemorrhage (62.0%), and needle pain (52.9%). The top malpractice event was forgotten needles (32.7%). Needle breakage and pneumothorax, which are severe malpractice events, were reported by 2.2%and 2.0%of the clinics, respectively. The top three adverse events for Mox were accidental and unintentional burn injury (24.0%), singed hair (15.5%), and singed clothes (15.0%). The most severe malpractice event was suppuration of the Mox point (10.8%). The top adverse events associated with complaints and litigation were symptom exacerbation (21.8%) and pneumothorax (36.4%). Only 74.8%of respondents obtained informed consent, but of those, 61.0%reported providing adverse affect warnings orally. Subscriptions to books and periodicals on the safety of Acp and Mox were reported by less than 30.0%of the respondents.<BR>[Conclusion]The most common adverse events associated with Acp were side effects caused by excessive stimulation. With Mox adverse events were more commonly attributable to negligence. The low subscription rate to safety periodicals suggests that safety information is not presently widely distributed. It is necessary to transmit safety information via the Internet as well as in books and other periodicals.
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[Objective]The purpose of this study was to investigate the effects of manual acupuncture stimulation (MA) on motor evoked potential (MEP) induced by transcranial magnetic stimulation (TMS).<BR>[Methods]The subjects were 10 healthy volunteers who gave oral and written informed consent. Experiment 1. MEPs were induced from the right abductor digiti minimi muscle (rADM) by TMS with a circular coil to the left cortex motor area and were measured before and after MA to the right LI4 (right Hoku point), left LI4 (left Hoku point), right LR3(right Taichong point) or left LR3(left Taichong point). A sparrow pecking technique (1 Hz for 1 minute) with a stainless steel needle (40 mm long, 0.18 mm in diameter, Seirin co., Inc, Shizuoka) was used for MA. The subjects received the same experiments four times with MA to different acupoints on a different day. Experiment 2. MEPs were measured during imaging of rADM and lADM contraction and immediately after noxious pinch stimulation to the skin on the right LI4 and left LI4 and right LR3and left LR3respectively. Repeated measure two-way ANOVA was used for statistical analysis to compare between all groups. Repeated measure one-way ANOVA and multiple comparison (Dunnett's test) were applied to time point data in each group.<BR>[Results]MA to the left LI4 or right LR3was significantly decreased MEP (P < 0.01, respectively). In the right LI4, there was a tendency to decrease of MEP, but not significantly (P = 0.26). Most subjects answered feeling severe or strong acupuncture needle sensation. MEPs were significantly increased by imaging of contraction and noxious stimulation (P < 0.001 and P < 0.01, respectively).<BR>[Conclusion]These results suggested a possibility that distant acupuncture stimulation would suppress motor activity via several roots and that an acupuncture inhibited effect was compensated by facilitation arising from the concentration to the stimulated hand.
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[Objective]To survey the current situation of infection control in clinical practice of acupuncture and to discuss the problems and strategy.<BR>[Methods]The subjects were 1,000 acupuncture clinics enrolled in iTownPage in the Chubu region. The questionnaire was sent to them by mail in November 2008. The questions were the following; 1) Profile of respondent, 2) Hand hygiene, 3) Preparation of needling sites, 4) Sterilization and storage of needles and equipment and disposable products, 5) Disposable needle, 6) Hand-pressing (Oshi-de), 7) Infectious waste, 8) Awareness, efforts and self-evaluation of practitioner for infection control, and 9) Comments of this survey.<BR>[Results]The collection rate was 22.2%. Washing time for less than 30 sec was 31.1%, Usage rate of a cloth towel was 67.7%, Hand antisepsis by the basin method was 18.9%, Usage rate of 50 %isopropyl alcohol was 19.8%, etc. 26.6%of all respondents answered that the possibility of infection in acupuncture and moxibustion therapy was very low and 50.9%of those responded that it was low. However, only 27.0%of the responders answered that infection control in their own clinics was appropriate. In addition, 72.5%of the responders belonged to the Japan Acupuncture and Moxibustion Association (JAMA) or the Japan Society of Acupuncture and Moxibustion (JSAM).<BR>[Conclusion]Although some infection controls have been improved, many problems became clear. These problems are suggested to be caused by poor acknowledge, previous experience and wishful thinking of practitioners. It is necessary to continue activities to raise practitioner's awareness for infection control.
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We have been utilized acupuncture and moxibustion in our department of internal medicine at Meiji University of Integrative Medicine since its investment in 1987. In the department, various kinds of symptoms in the field of internal medicine have been managed with acupuncture and moxibustion. In this article, I would like to introduce our activities regarding acupuncture treatment in the department of internal medicine and some remarkable results of our clinical studies which evaluated effects of acupuncture and moxibustion as well as relationship between acupuncture therapists and the staff of our department. In the field of respiratory disorders such as COPD or bronchial asthma, usefulness of acupuncture have been proved through a controlled clinical trial which involved COPD patients who had not been able to control with standard care. Also, acupuncture was found to be useful in the management of bronchial asthma in a case series study in which acupuncture treatment was repeatedly applied with intervals without acupuncture. We have also demonstrated that acupuncture was useful for gastrointestinal disorders such as irritable bowel syndrome (IBS). Results of a case series with n-of-1 study design showed significant reduction in the symptoms during acupuncture treatment, while those in the period without acupuncture had been aggravated. Data from studies on diabetic complications such as peripheral neuropathy or gastropathy also showed usefulness of acupuncture. We considered that it is valuable to explore unknown usefulness of acupuncture in the field of internal medicine and prove effectiveness of acupuncture with appropriate scientific manner.
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The purpose of this workshop was to discuss on various issues for the development of a protocol for the Ja pan-Korea research collaboration. An important issue is to select/develop the experimental design of the clinical trial for individualized therapy done in Japan and Korea. Randomizedn-of-1 trial and randomization test were proposed as an possible candidate. A pilot study using randomized n-of-1 trial was done using intradermal acupuncture on pollinosis, and the methodological issues on the generalizability of randomized n-of-1 trial and the need of the selection of target disease were discussed. Onthe other hand, the literature survey has shown that the individualized acupuncture therapy is more effective than those of the standardized' fixed acupuncture therapy in usual RCTs. The diagnosis and selection of acupuncture point and method of manipulation were also shown to be an important factor. Further discussions will be required for the development of the adequate protocol for the individualized therapy.
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The results of multi-center RCT of acupuncture and moxibustion for the prevention of the symptoms of common cold conducted by the financial support of the foundation for training and licensure examination in anma-massage-acupressure, acupuncture and moxibustion were briefly reviewed. Traditional acupuncture manipulation to the throat induced significant positive effects, however, more common indirect moxibustion to the neck for longer period did not induce the significant effect compared with no-treatment control. Several issues to be resolved were discussed and the shortage of duration of intervention was pointed out as one of the major issues. Then four pilot studies with long-lasting intervention of acupuncture or moxibustion were con-ducted. The effects tended to be more positive, however, they were still unclear. The selection of subjects (students in the acupuncture school) will be the next important issue to be examined.