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Clinical Question
Is acupuncture effective in reducing aromatase inhibitor–related joint pain in women with early-stage breast cancer?
Bottom line
Acupuncture is significantly better than sham acupuncture in reducing aromatase inhibitor–related joint pain and stiffness in women with early-stage breast cancer. However, the difference did not meet the authors' predetermined level of a clinically meaningful difference. 1b-
Reference
Study design: Randomized controlled trial (double-blinded)
Funding: Government
Setting: Outpatient (specialty)
Synopsis
Aromatase inhibitors, including anastrozole (Arimidex), exemestane (Aromasin), and letrozole (Femara), are effective in the treatment of breast cancer. However, joint pain and stiffness occur in nearly half of patients and often leads to nonadherence with therapy. These investigators identified women with breast cancer who were already taking an aromatase inhibitor for more than 30 days with plans to continue for at least one additional year. In addition, inclusion criteria included a baseline pain score of greater than 3 on a previously validated pain evaluation tool (range 0 – 10, with higher scores indicating greater pain) since starting aromatase inhibitor therapy. The 226 patients randomly received (uncertain allocation concealment) assignment to true acupuncture, sham acupuncture, or waitlist control. True and sham acupuncture consisted of twelve 30- to 45-minute sessions twice weekly for 6 weeks, followed by 1 session weekly for 6 additional weeks. The sham acupuncture group received shallow insertion of thin and short needles at nonacupunture points. The waitlist control group received no acupuncture or other intervention for 24 weeks. Individuals who assessed outcomes remained masked to treatment group assignments. A reduction of at least 2 points on the pain scale was predetermined to represent a clinically meaningful difference. Follow-up occurred for 12 weeks. Using intention-to-treat analysis, the difference in mean pain scores was significant (but not clinically meaningful): 0.92 and 0.96 points lower in the true acupuncture group than in the sham acupuncture and waitlist control groups, respectively. Significantly more patients in the true acupuncture group than in the sham group experienced at least a 2-point reduction in mean pain score at 6 weeks, but the difference was no longer significant after 12 weeks.
Reviewer
David C. Slawson, MD
Professor and Vice Chair of Family Medicine for Education and Scholarship
Atrium Health
Professor of Family Medicine, UNC Chapel Hill
Charlotte, NC
Comments
It is important, though more difficult, to study non-pharmacologic treatment for chronic pain. It is less complicated to study medication and so statements like a certain drug helped or does not it usually assessed on an inadequate 3 month trial. A physical treatment is frequently adopted without ever being tested properly. Desperate patients spend their limited money on countless useless treatment.
I find it refreshing to see such a study with clinically insignificant outcomes published. It is an honest attempt to advance Care for suffering patients.
The finding of a difference that is not clinically meaningful implies that the procedure (acupuncture) would not benefit the patient. Applying it may mean a waste of the patient's time and money, if they have to pay for the procedure.
THIS IS A RIDICULOUS STUDY. hOW WOULD REACT TO A STUDY BY AUTOMECHANICS COMPARI9NG THE EFFECTS OF PUTTING NEEDLES INTO A HOOD OF A CAR VERSUS SHAM INSRTIONS OF THE NEEDLES ON THE PERFORMANCE OF THE VEHICLE?
RIDICULOUS
Placebo effect is very important - the authors should have discussed the additive effect of placebo effect to therapeutic effect for a modality that is otherwise not harmful - to determine the *real* value of this treatment. Although evidence-based research is important to disseminate to the masses, too often persons are reliant on sham science. If the additive effects of placebo to the evidence-based effects are significant and the harm is null, then this perhaps should be seen as a suitable treatment. Perhaps this is a differing way to look at evidence(?!?).
Good poem