Individualized acupuncture treatment of fibromyalgia in primary care relieved patients’ pain and enhanced their quality of life for up to a year compared with placebo treatment of sham acupuncture, according to the first trial that studied the efficacy of personalized acupuncture protocols compared with standardized acupuncture treatments.

“We observed a significant improvement in all indicators related to pain perception (pain visual analogue scale score, tender points, pressure pain threshold) in the intervention group compared to the control group, both at the end of treatment and during the follow-up period,” stated the researchers (Acupunct Med 2016 Feb 15. [Epub ahead of print]). “Although both real and sham acupuncture were effective at improving the indicators, the effect of real acupuncture was significantly greater, both at the end of treatment and during the one-year follow-up period.”

The effectiveness seen in the trial of individualized acupuncture treatments in pain reduction, functional capacity and quality of life at six and 12 months for patients with fibromyalgia conflicted with previous studies, which reported negative results. “One fundamental difference between the present study and earlier research is the implementation of individualized treatment that was reassessed throughout the intervention period,” the researchers wrote.

Jorge Vas, MD, of the Pain Treatment Unit, Doña Mercedes Primary Health Centre, Dos Hermanas, Spain, the article’s lead author, explained that individualized acupuncture protocols follow the diagnosis principles for each patient’s symptoms. “In this research, there were three main traditional Chinese medicine syndromes: liver Qi stagnation, spleen and kidney yang deficiency and yin deficiency.” This resulted in acupuncture points individualized to each patient, Dr. Vas said. The researchers said this was the first study of individualized acupuncture treatments, whereas previous studies used a standardized acupuncture treatment. Dr. Vas said the sham acupuncture used the pressure of the needle introducer as the stimulus without the needle actually in it.

“We studied the positive effect of individualized acupuncture on pain among other fibromyalgia symptoms, comparing it with sham acupuncture,” Dr. Vas said. “The [positive] results were significantly shifted toward the first group, not only immediately after the treatment but also 10 weeks, six months and one year after treatment finished.”

Brent A. Bauer, MD, FACP, research director of Mayo Clinic’s Complementary and Integrative Medicine Program in Rochester, Minn., said the findings from the study in Spain are similar to those seen at a study at Mayo Clinic (Mayo Clin Proc2006;81:749-757) that showed symptom relief appeared to extend several months after the acupuncture treatment. “Given the challenges in finding successful treatment strategies for patients with fibromyalgia, as well as the safety of acupuncture in the hands of qualified practitioners, I often incorporate acupuncture as part of my overall treatment approach for my patients with fibromyalgia,” Dr. Bauer said.

The Spanish study was a double-blind, randomized controlled trial. Conducted in three primary care centers in southern Spain, 153 participants over the age of 17 years and diagnosed with fibromyalgia completed the study. Participants, all of whom were women, were randomly assigned to either the real intervention with individualized acupuncture or the sham acupuncture. Both groups underwent one session per week lasting 20 minutes with one-week rest times between each of the nine sessions, in addition to usual pharmacologic treatment.

The primary outcome was a change in pain intensity at 10 weeks. Intention-to-treat analysis revealed that the decrease in pain intensity at 10 weeks was greater (P=0.001) in the individualized acupuncture group (–41.0%; 95% CI,–47.2% to –34.8%) than in the sham acupuncture group (–27.1%; 95% CI, –33.2%to –20.9%). During the follow-up period, significant differences (P<0.01) in favor of the individualized group persisted at 12 months (individualized acupuncture,–19.9%; 95%, CI, –24.6% to –15.1%; sham acupuncture, –6.2%; 95% CI, –11.2%to –1.2%).

Fibromyalgia affects 2% to 5% of the population and has a high economic and social effect, according to the study researchers. It is classified as a functional chronic disease, and is manifested clinically by chronic widespread pain associated with fatigue, sleep disorder and/or depression, among other symptoms. At present, there is no laboratory test or imaging technique to help establish a diagnosis of fibromyalgia, and no structural abnormalities have been observed in the musculoskeletal system of patients with fibromyalgia that could justify its diagnosis.

“One in five patients with fibromyalgia resorts to acupuncture within two years of diagnosis,” according to the researchers. “Most randomized, controlled trials performed to date have not included personalized treatment protocols, which is in contrast to usual clinical practice. Furthermore, acupuncture appears to be beneficial in the treatment of depression, whether or not it is associated with chronic pain.”

“We have been treating fibromyalgia patients for many years with individualized acupuncture, and the results are very good with a very low rate of complications,” Dr. Vas said. “Other studies should follow this road.”

—Thomas Rosenthal

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