A Multicenter Prospective Survey of Adverse Events Associated with Acupuncture and Moxibustion in Japan

Abstract

There have been only a few prospective surveys on adverse events (AEs) in Japanese-style acupuncture practice, and these surveys were conducted only in a single college acupuncture clinic. The goal of this research was to assess the safety of acupuncture and moxibustion performed in educational facilities in Japan. This was a multicenter prospective survey, using paper reporting forms. It was conducted in eight acupuncture clinics affiliated with educational institutions. The subjects were outpatients attending the clinics. The main outcome measure was the number of reported adverse events. The study was conducted for 5-7 months at each facility between October 2014 and June 2015. Participating acupuncture practitioners were instructed to self-report AEs observed during and after treatment; patients were interviewed upon treatment completion. For returning patients, treatment was preceded by an interview survey regarding the AEs identified after the previous treatment session. A specialized 4-sheet questionnaire was used. Two hundred and thirty-two acupuncture practitioners participated, 2180 patients received treatment, and there were 14,039 sessions, overall. In total, 847 (6.03%) AEs were reported. The most common AEs included subcutaneous bleeding and hematomas (370, 2.64%), followed by discomfort (109, 0.78%) and residual pain at insertion points (94, 0.67%). No infections or serious AEs were reported. Acupuncture and moxibustion performed in educational facilities in Japan were safe because most of the AEs reported were mild and transient. However, the risk cannot be defined definitely because the survey sample size was too small.

Acupuncture-related adverse events: systematic review and meta-analyses of prospective clinical studies

“…33 41 46 49 Three nationwide surveys from the UK (described in four articles), 38–40 48 one in-house surveillance report from Japan, 51 and one summary of AE assessments nested within three Chinese RCTs 52 included 2000–6000 patients receiving over 30 000 treatments, respectively. In three surveys, two from South Korea, 44 45 one from Japan, 35 and one from Brazil, 32 around 1000–2000 patients were included and treated in up to 14 000 acupuncture sessions. One nationwide survey conducted in Sweden assessed the AE risk based on data from over 9000 acupuncture sessions.…”

“…At this, AE reporting by patients or acupuncturists instead of an independent assessor was classified as an unclear risk of social desirability bias. Further possible but unclear sources of detection bias were the sole use of a selection list 35 36 39 44 or the sole use of open questions as AE assessment tool, 49–51 lack of reporting on the AE assessment tool, 43 45 47 and unclear definition of the safety outcome and/or the time point of the AE assessment (only directly after treatment, 32 33 43 47 only after the last treatment initiation, 37 38 41 46 49 and solely on recognition 40 44 48 51 ). Further risk of information bias ( figure 2 , category E) appeared to be unclear due to poor reporting of treatment details in all but seven studies (32%).…”

“…33 38 41 46 51 Four articles reported that none of the AEs observed in a total of 1922 patients undergoing 19 005 treatments required medical treatment, 32 36 47 50 and authors of five articles concluded that none of the AEs observed in 122 699 treatments fulfilled the ICH criteria for SAE. 35 40 44 48 52 Eight articles did not mention SAEs or any AE description that allowed for inferences about SAEs. 31 34 37 39 42 43 45 49 Meta-analyses of the overall risk of an SAE resulted in 1.01 (95% CI 0.23 to 2.33) patients with an SAE in 10 000 patients undergoing an acupuncture series (figure 4A 11 studies, 1 188 930 patients) and 7.98 (95% CI 1.39 to 20.00) SAEs in one million treatments (figure 4B and 4D).…”

A comparison of noninvasive and invasive acupuncture in preventing postoperative nausea and vomiting

“…[ 1 , 15 ] However, the adverse effects like bleeding, discomfort, and residual pain may hamper the successful development of traditional acupuncture therapy. [ 16 ] and otherwise, modern acupuncture therapy such as transcutaneous electric nerve stimulation and acupressure, without piercing skin and feeling pain, is more and more popular and acceptable worldwide. [ 17 ] Thus, we put forward that whether noninvasive regimens are comparison with invasive ones.…”

Development of a survey form through Delphi study about adverse events associated with the miniscalpel needle, for application in prospective observational studies regarding safety of miniscalpel needles

“…[ 16 , 17 ] Similarly, the criteria for reporting needling pain also varied among studies. [ 15 , 17 , 18 ] The incidence of AEs after acupuncture treatment in prospective studies varied from 0.14% to 15%. [ 12 , 18 – 21 ] The heterogeneity of reporting criteria for AEs may be a major reason for this.…”