November 21, 2011 — A systematic review analyzing decades of needle acupuncture therapy in children aged 0 to 17 years reveals an 11.8% incidence of mild adverse events (AEs) and few severe AEs, prompting investigators to characterize the treatment as safe for younger patients, according to research published onlineNovember 21 in Pediatrics.
Led by Denise Adams, PhD, from the CARE program at the Department of Pediatrics, University of Alberta, Edmonton, Canada, investigators documented 279 AEs in patients aged 0 to 17 years. These included AEs cited in reports other than cohort studies and clinical trials. Drawing on guidance from the Common Terminology Criteria for Adverse Events scale, 253 AEs were adjudicated as mild, 1 was categorized as moderate, and 25 were classified as serious.
By restricting their analysis to the randomized controlled trials and cohort studies, Dr. Adams and colleagues were able to calculate the AE incidence.
"What we did was look at all the AEs reported in studies that involved needle acupuncture and found that 170 of 1487 patients equaled 11.4%," Dr. Adams told Medscape Medical News. "These values included patients treated who did not receive needle acupuncture. In order to examine patients treated with only needle acupuncture, we removed numerator (n = 2) and denominator (n = 65) values for the patients in the acupressure and conventional treatment groups, and so the values become 168 AEs for 1422 patients, or 11.8% (95% confidence interval, 10.1 - 13.5)."
The analysis was based on a search of 18 databases and a review of reference lists that identified 37 acupuncture reports meeting prespecified inclusion criteria. Nine of the reports described random controlled trials, 6 described cohort studies, and 22 described case reports or series of cases. Of those, 33 reports focused entirely on pediatric acupuncture patients.
Mild AEs were deemed to be those that generally required no specific medical intervention. These included cases in which the child experienced pain or bruising, transient hemorrhage at the puncture site, numbness, aggravation of an existing condition, or vasovagal reactions such as dizziness, nausea, or vomiting.
In 158 instances, mild AEs occurred while the child was being treated by a certified acupuncturist. In 83 cases the event occurred under the care of a physician trained in the procedure, and in 11 cases, a mild AE was recorded when an unspecified practitioner was involved. Provider credentials were not reported in 1 instance.
Serious AEs included 12 cases of thumb deformity, all occurring in 1 Chinese clinic between 1983 and 1989, and 5 cases of infection. There was also 1 case each of fatal cardiac rupture, pneumothorax, nerve impairment, subarachnoid hemorrhage, intestinal obstruction, hemoptysis, reversible coma, and overnight hospitalization.
Five serious AEs were suspected to have been caused by technical errors, rather than the procedure itself. These may have included improper sterilization or technique, or poor knowledge of anatomy. Numerous errors, including the insertion of needles through clothing and needle punctures in the diaphragm, pericardium, and right ventricular wall, were detected in the cardiac rupture case, which resulted in the death of a 9-year-old boy who suffered from malnutrition, pulmonary tuberculosis, and a severely enlarged heart.
Eighteen of the serious AEs were associated with care provided by an unspecified practitioner, 6 occurred under the care of a certified acupuncturist, and 1 occurred under the care of a physician certified in acupuncture.
Investigators acknowledged that more expansive and uniform research efforts would probably improve the conclusiveness of AE incidence estimates, especially in light of larger-scale surveys that previously have reported similar AEs in adults with incidences as high as 29.5%.
The higher rate of AEs detected in reviews of adult patients may be in part because of the much larger number of patients studied, as well as the prospective design of many of these trials. "In an editorial published a decade ago, MacPherson strongly encouraged the conduct of prospective practice surveys as a way of gathering the strongest safety evidence and overcoming limitations of both retrospective surveys and literature reviews," the authors write.
"The current pediatric acupuncture safety literature is limited to case reports and small studies or the inclusion of small numbers of children in predominantly adult studies. To produce convincing risk estimates for pediatric acupuncture, prospective large-scale pediatric studies and standardized reporting criteria are needed," they conclude.
The work was supported by Alberta Innovates-Health Solutions, which provides salary support to one of the investigators for health scholar activities. The other authors have disclosed no relevant financial relationships.
Pediatrics. Published online November 21, 2011. Abstract