Research: MACPHERSON and colleagues

Listed in Issue 71

Abstract

MACPHERSON and colleagues, Foundation for Traditional Chinese Medicine, York YO24 4EY, Medical Care Research Unit, University of Sheffield, and Sheffield Health Economics Group, School of Health and Related Research, University of Sheffield, Sheffield S1 4DA, UK, hugh@ftcm.org.uk, investigated the type and frequency of adverse events (AEs) following acupuncture . Mild transient reactions associated with acupuncture, some of which may indicate a positive response to treatment, were also described.

Background

Recent reports have highlighted the importance of good evidence of safety of acupuncture . However, sound evidence on the risks associated with acupuncture is scarce.

Methodology

The study involved a prospective postal audit of treatments undertaken by 1,848 professional acupuncturists, who were members of the British Acupuncture Council (BAC) and were practising in the UK, during a 4-week period in 2000 . The acupuncturists were invited to record details of AEs and mild transient reactions after treatment using standardized self-report forms. They were asked to give details of any AEs they considered to be 'significant', including any event that was 'unusual, novel, dangerous, significantly inconvenient or requiring further information'. Serious AEs were defined as events requiring hospital admission, leading to permanent disability or resulting in death. Practitioners also provided information on themselves, including age, sex, length of training and years of practice. A sample size of 30,000 treatments was sought in order to fulfil the desired power of the study to reveal a 95% probability that no serious event occurred in the treatments sample.

Results

574 (31%) of the practitioners approached participated. The mean age of the practitioners was 44.8 years (range 23-79); 65% were female; and 62% had been practising acupuncture for more than 5 years. Other information on the practitioners was available from the BAC's database. Participants were sufficiently representative of the population of practitioners for a re-weighting of the primary data to be unnecessary. Participants reported on 34,407 treatments . No serious AEs were reported (95% confidence interval [CI], 0, 1.1 per 10,000 treatments). 43 minor AEs were reported (a rate of 1.3 [95% CI, 0.9, 1.7] per 1,000 treatments). The most common events were severe nausea, fainting and/or related symptoms (n=12). Three avoidable events were caused by practitioners' errors: two patients had needles left in, and one patient had moxibustion burns to the skin. 10,920 mild transient reactions were reported among 5,136 treatments (15% of the total number of treatments). Local reactions at the site of needling included mild bruising (587 cases; 1.7%), pain (422 cases; 1.2%), and bleeding (126 cases; 0.4%). Aggravation of existing symptoms occurred after 966 treatments (2.8%), 830 (86%) of which were followed by an improvement, possibly indicating a positive 'healing crisis' . The most common mild transient reactions were; 'feeling relaxed' (4,098 cases; 11.9%) and 'feeling energized' (2,267 cases; 6.6%), symptoms that often indicate an encouraging response to treatment.

Conclusion

This study reports data collected over a 4-week period by one in three members of the BAC . No serious AEs were reported after 34,407 acupuncture treatments, consistent with an underlying serious AE rate of between 0 and 1.1 per 10,000 treatments . The rate of minor AEs was between 0.9 and 1.7 per 1,000 treatments . The results provide important evidence on public health and safety. Professional acupuncturists deliver approximately 2 million treatments per year in the UK. Comparison of these AE rates for acupuncture with those for drugs routinely prescribed in primary care suggests that acupuncture is a relatively safe form of treatment . Further research measuring patients' experience of AEs is merited.

References

MacPherson H et al. The York acupuncture study: a prospective survey of 34 000 treatments by traditional acupuncturists. British Medical Journal 323: 486-7. Sep 2001.

Comment

Just a reminder of some of the statistics regarding adverse effects of standard and drug treatment include one death per every1200 people taking NSAIDs for at least 2 months. Also, 40,000 people die every year in the UK due to medical mishaps – four times more deaths than from all other types of accident, with a further 280,000 people suffering from non-fatal drug-prescribing errors, overdoses and infections. Contrast this with the safety evidence of acupuncture – no serious adverse events following over 34,000 acupuncture treatment (see Editorial – Issue 50).

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