RESUMEN
Background/Objective: To investigate the patient- and therapist-related factors underlying adverse events (AEs) in acupuncture and moxibustion (A&M). Design: Retrospective study using data from medical records. Subjects: Patients who underwent A&M therapy in 4 clinics providing A&M over a 6-month period and their therapists. Main Outcome Measures: Survey items included the number of patients, age, sex, number of sessions, number and type of AEs, patients' underlying disease, and the therapist's years of clinical experience. The chi-squared test was used for intergroup comparisons. Spearman's rank correlation coefficient was used to analyze the correlations between the number of sessions and AEs. Logistic regression analysis was performed with AEs as the objective variable to investigate the relationships between the various parameters and AEs. Results: The analysis included 615 patients and 113 therapists. A total of 421 AEs occurred in a total of 4,369 sessions (9.6%). The number of sessions and number of AEs were significantly and positively correlated with patients (r = 0.47, P < 0.001) and therapists (r = 0.65, P < 0.001). Logistic analysis identified patient sex (adjusted odds ratio: 1.78, 95% confidence interval: [1.39-2.30]), liver disease (0.40, [0.19-0.84]), and years of clinical experience (to a cutoff of 2 or fewer years, 2-4 years: 0.65, [0.48-0.88], 5-9 years: 0.62, [0.44-0.87], 10 years or more: 0.50, [0.37-0.68]) as significant variables. Conclusions: Female sex and fewer years of clinical experience were factors that increased the risk of AEs, and underlying liver disease was a factor that decreased the risk of AEs.
RESUMEN
Background: 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. Objective: The goal of this research was to assess the safety of acupuncture and moxibustion performed in educational facilities in Japan. Materials and Methods: 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. Results: 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. Conclusions: 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.