Volunteer acupuncture practitioners were recruited through journals circulated to members of the British Medical Acupuncture Society and the Acupuncture Association of Chartered Physiotherapists (approximately 2750 members).2
A prospective survey was undertaken using forms for intensive event monitoring that had been piloted previously.3
Minor adverse events were defined as “any ill-effect, no matter how small, that is unintended and non-therapeutic, even if not unexpected.” These events were reported every month, along with the total number of consultations. Minor or 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. A sample size of 30
000 consultations was necessary to identify with 95% confidence any adverse event with a frequency of 1 in 10
Estimates of incidences per 10
000 population were calculated with the acupuncturist (not the consultation) as the primary sampling unit. Since the data were skewed, with extreme values present, confidence intervals corrected for bias were calculated using bootstrapping procedure “bs” on estimates from the function “svyratio” in intercooled Stata version 6.0 with 10
Data were collected from June 1998 to February 2000 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 practised for five years or more. In all, 31
822 (median 318, range 5-1911) consultations were included.
Altogether, 43 “significant” events were reported (table), giving a rate of 14 per 10
000 (95% confidence interval 8/10
000 to 20/10
000). In addition, 48 apparently similar events were reported on the monthly forms, presumably due to different interpretations of “significant”. All adverse events had cleared within one week, except for one incident of pain that lasted two weeks and one of sensory symptoms that lasted several weeks. According to accepted criteria,3
000 to 1.2/10
000) of these events was serious.
A total of 2135 minor events was reported, giving an incidence of 671 per 10
000 to 1013/10
000) consultations. The most common events were bleeding (310 (160 to 590) per 10
000 consultations) and needling pain (110 (49-247) per 10
000 consultations). Aggravation of symptoms occurred in 96 (43-178) per 10
000 consultations; in 70% of these cases, there was a subsequent improvement in the presenting complaint. The highest rates reported by individual acupuncturists, expressed as a percentage of consultations, were 53% for bleeding, 24% for pain, and 11% for aggravation of symptoms.