Clinical Question: Is acupuncture more effective than placebo for decreasing symptoms in patients with fibromyalgia?

Setting: Outpatient (specialty)

Study Design: Randomized controlled trial (single-blinded)

Allocation: Uncertain

Synopsis: The researchers recruited 50 patients referred by their physician, usually after trying conservative management, to a fibromyalgia treatment program. All patients but one were female, and all but one were white. The patients had their diagnoses confirmed and then participated in a 1.5-day program of education, counseling, and group discussion about pain management. The patients completed the Fibromyalgia Impact Questionnaire, which has scales for physical functioning, depression, anxiety, sleep, pain, stiffness, fatigue, and well-being. They also completed the Multidisciplinary Pain Inventory. Following the intensive intervention, the patients were invited to participate further in this study and were assigned to receive acupuncture or sham acupuncture every two to four days for a total of six sessions.

The investigators blinded patients to treatment by having them sit upright for the treatments and placing a tray under the chin so each patient could see the therapist but not the placement of the needles. Acupuncture treatment was standardized and consisted of 13 needles in strong regulatory points for the first three sessions and 20 needles during the final three sessions. The needles were inserted through a bandage to allow for posttreatment blinding. Some electrical stimulation was used. For sham therapy, the same blinding process was used and, over the same acupuncture points, the skin was pricked with a dull point and then a bandage was placed over the area with an acupuncture needle sticking out of it.

Analysis was by intention to treat. One month after completion of treatment, Fibromyalgia Impact Questionnaire scores dropped from an average of 42.4 (out of a possible 80) to an average of 34.8 in the treatment group; the control group scores declined from 44.0 to 42.2 (P = .007). The reduction is similar to the effect produced in other studies by pharmacologic therapy. Seven months after treatment, scores worsened somewhat in the treatment group (38.1) and were no longer statistically different from scores in the placebo group. Similarly, pain scores were significantly improved in the treated patients at one month after treatment, but not at seven months.

Bottom Line: A six-session acupuncture treatment regimen significantly improves fibromyalgia symptoms in women, at least in the short term. Overall, fibromyalgia scores were significantly improved one month after treatment ended, but not at seven months after treatment ended. (Level of Evidence: 1b)