Trial of Acupuncture Added to Usual Treatment for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aim of this study was to evaluate the effect of acupuncture as a treatment for this
      condition. Fifty-eight women diagnosed with fibromyalgia were randomly allocated to two
      groups. One group received acupuncture (n=34) twice a week for 20 sessions in addition to
      tricyclic antidepressants and exercises. The control group (n=24) received only tricyclic
      antidepressants and exercises. A blinded assessor evaluated patients' pain using visual
      analog scale (VAS), tender points number (TePsN) and myalgic index (MI). The same assessor
      also evaluated quality of life (QoL) using SF-36. These evaluations were done prior to
      treatments, at the end of the 20 sessions, and again at six months, one year and two years
      after the first evaluation. At the end of the 20 sessions, patients who had received
      acupuncture were significantly better than those who had not in all measures of pain (VAS,
      TePsN, MI) and in five subscales of SF-36. After six months, the acupuncture group was
      significantly better than the control group in some measures of pain (TePsN and MI) and in
      three subscales of SF-36. After one year, the acupuncture group showed significant advantage
      in only one subscale of SF-36; at two years there were no significant differences between the
      two groups on all outcome measures. The addition of acupuncture to usual treatment for
      fibromyalgia is beneficial for pain and quality of life, but only in first six months.
    

Detailed description: 
      Fibromyalgia is a diffuse musculoskeletal pain syndrome with multiple tender points which are
      widely and symmetrically distributed throughout the body. The main symptom is widespread
      musculoskeletal pain, lasting longer than three months, which is associated with chronic
      fatigue, cognitive dysfunction, sleep disorder, morning stiffness, anxiety and depression.
      The etiology of fibromyalgia remains unknown.

      In Brazil, fibromyalgia is estimated to affect two-and-half percent of the population . This
      incidence is similar to other countries .Acupuncture, which involves inserting needles at
      specific points on the patient's skin, is one of the oldest forms of therapy and is widely
      practiced in the United States. Each year about one million Americans undergo acupuncture
      treatments, mainly to relieve pain caused by a variety of ailments . A consensus statement
      from the U.S. National Institutes of Health (NIH) concluded that acupuncture may be useful as
      an adjunct treatment or may be an acceptable alternative treatment in a comprehensive
      management program for fibromyalgia patients (NIH Consensus Conference, 1998.In Brazil, there
      is increased interest in acupuncture; in 1995, a federal law established that the procedure
      can only be performed by physicians.

      Systematic reviews looking at the effectiveness of acupuncture for fibromyalgia have found a
      limited amount of high quality scientific studies. These reviews concluded that acupuncture
      was more effective than sham (placebo) acupuncture in improving symptoms of fibromyalgia.
      There is a need for acupuncture trials that include a large sample size of patients with
      similar and well-defined pain conditions. Such trials should utilize standardized and
      well-described acupuncture stimuli. These should be placed effectively in the skin in
      accordance with classical Chinese experience and utilizing unequivocal primary outcome
      measures for the effect.
    

Intervention name(s): Antidepressants; acupuncture
Intervention type(s): Procedure; Procedure
Intervention MeSH terms: Antidepressive Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Fibromyalgia; Acupuncture; Randomized study