1.A survey of adverse events at acupuncture clinics in Japan
Hisashi SHINBARA ; Chie OGASAWARA ; Shinobu HAYAMA ; Kokoro HINO ; Hiroshi TANIGUCHI ; Eiji SUMIYA
Journal of the Japan Society of Acupuncture and Moxibustion 2012;62(4):315-325
[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.
[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.
[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.
[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.
2.A questionnaire survey for orthopedists on the clinical experience of patients who suffered adverse events associated with acupuncture and moxibustion
Hisashi SHINBARA ; Satomi NAGAOKA ; Chie OGASAWARA ; Kokoro HINO ; Hiroshi TANIGUCHI ; Eiji SUMIYA
Journal of the Japan Society of Acupuncture and Moxibustion 2014;64(1):54-64
[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.
[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.
[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).
[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.
3.Effects of manual acupuncture on motor evoked potentials induced by transcranial magnetic stimulation in human
Chie OGASAWARA ; SHINBARA Hisashi ; Hiroshi TANIGUCHI ; Kokoro HINO ; Shinobu HAYAMA ; Eiji SUMIYA ; Toshikatsu KITADE
Journal of the Japan Society of Acupuncture and Moxibustion 2011;61(2):164-173
[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).
[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.
[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).
[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.