In the latest issue of Annals of Internal medicine, Brinkaus and colleagues (1) evaluated the effectiveness of acupuncture in the treatment of seasonal allergic rhinitis (SAR). They enrolled 422 individuals with SAR and immunoglobulin-E sensitization to birch and grass pollen in a multicenter trial in Germany. Subjects were randomized to receive 12 acupuncture treatments, 12 sham acupuncture procedures, or no acupuncture over a period of 8 weeks between March and July. All subjects were permitted to take the antihistamine medication, cetirizine, as a rescue medication, as well as an oral corticosteroid if SAR symptoms were not adequately controlled. At the primary end point, 8 weeks after randomization, the investigators found that acupuncture was associated with an improvement of 0.7 points on the Rhinitis Quality of Life Questionnaire (RQLQ) and a decrease of 1.5 points on the rescue medication score (RMS) compared with no acupuncture, and an improvement of 0.5 points on the RQLQ and a decrease of 1.1 points on the RMS compared with sham acupuncture. RMS reduction of 1 point is equivalent to reducing cetirizine 10 mg/day or equivalent.
The purpose of the 3-arm RCT design employed by Brinkhaus and colleagues is generally two-fold: 1) to estimate the magnitude of effect (if any) associated with “true” acupuncture relative to what might be expected in the absence of treatment (without consideration of placebo effects); and 2) to determine whether a given course of acupuncture confers greater clinical benefit relative to a sham acupuncture protocol (for the purpose of controlling for placebo effects). The former is of interest to patients, clinicians, or payers who wish to be informed about expected outcomes associated with treatment versus no treatment, while the latter is intended to assess whether placebo effects may account for all of acupuncture’s observed effects. In the case of the study reported in this issue of the Annals, acupuncture was shown to be more effective compared to both no acupuncture and sham acupuncture, but in many other large clinical trials of acupuncture for other clinical conditions, acupuncture was shown to be more effective than no acupuncture, but not more effective than sham acupuncture. In those cases, the answer to the question “is acupuncture effective” depends in large part on whether one considers effectiveness of a procedural-based intervention to be defined as effective relative to the absence of that intervention, or effective relative to an artificial course of treatment that would never be administered in clinical practice and that may not be physiologically inert.
Jongbae Park, a member of NCAAOM and Director of Asian Medicine and Acupuncture Research of the University of North Carolina at Chapel Hill, told MedPage Today he interprets the difference in the use of rescue medication to be clinically important. "By receiving acupuncture, patients could reduce that amount of antihistamine, plus increase the quality of life," Park said.