Clinical Question: Is standardized acupuncture effective in decreasing symptoms for patients with fibromyalgia?

Setting: Outpatient (any)

Study Design: Randomized controlled trial (double-blinded)

Allocation: Concealed

Synopsis: The researchers recruited (by advertisement) 100 patients with a diagnosis of fibromyalgia who had a global pain score of 4 or more (average = 7) on a visual analogue scale of zero (no pain) to 10 (worst pain ever). Patients agreed to maintain current treatment during the study. Using concealed allocation, the patients were randomized to receive traditional Chinese medical acupuncture according to a standardized (i.e., not individualized) protocol (n = 25) or one of three sham acupuncture treatments (n = 25 patients in each group) administered by eight practitioners. The participants were treated twice weekly for 12 weeks with acupuncture only. The study, in its attempt to maintain consistency of the acupuncture treatment, resulted in artificial treatment because acupuncture is just one aspect of traditional Chinese medicine, and the acupuncture practitioner usually adjusts treatment to the specific patient.

Using intention-to-treat analysis, no differences were found in any outcome; pain and fatigue intensity improved similarly in all four groups, as did sleep quality and overall well-being. Scores of general health status, as measured by the 36-item Short Form Health Survey, did not change in any of the four groups.

Bottom Line: A standardized acupuncture protocol is no better than sham acupuncture in relieving pain or improving other symptoms in patients with significant fibromyalgia symptoms. Patients in all groups reported slightly improved scores. Acupuncture is just one aspect of traditional Chinese medicine, however, and this fairly artificial study does not help clarify if this approach is effective. (Level of Evidence: 1b)