title: Acupuncture for fibromyalgia in primary care: a randomised controlled trial.
abstract: OBJECTIVE
  To evaluate the efficacy of an individualised acupuncture protocol for patients with fibromyalgia.
  
  
  METHODS
  Randomised controlled multicentre trial, blinded to participants and to data analysts. Conducted in three primary care centres in southern Spain. A total of 164 participants aged over 17 years and diagnosed with fibromyalgia were enrolled in this trial; 153 participants completed the study. Participants were randomly assigned to either the real intervention (individualised acupuncture, IA) or the sham intervention (sham acupuncture, SA). In both the IA and SA groups, one session per week (lasting 20 min) was provided, in addition to usual pharmacological treatment. The primary outcome was change in pain intensity at 10 weeks.
  
  
  RESULTS
  Intention-to-treat analysis revealed that the decrease in pain intensity at 10 weeks was greater (p=0.001) in the IA group (-41.0%, 95% CI -47.2% to -34.8%) than in the SA group (-27.1%, 95% CI -33.2% to -20.9%). During the follow-up period, significant differences (p<0.01) in favour of the IA group persisted at 12 months (IA: -19.9%, 95% CI -24.6% to -15.1%; vs SA: -6.2%, 95% CI -11.2% to -1.2%).
  
  
  CONCLUSIONS
  Individualised acupuncture treatment in primary care in patients with fibromyalgia proved efficacious in terms of pain relief, compared with placebo treatment. The effect persisted at 1 year, and its side effects were mild and infrequent. Therefore, the use of individualised acupuncture in patients with fibromyalgia is recommended.
  
  
  BACKGROUND
  ISRCTN60217348.
authors.affiliation: Pain Treatment Unit, Doña Mercedes Primary Health Centre, Dos Hermanas, Spain Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Andalucía, Spain.
authors.forename: Jorge
authors.initials: J
authors.lastname: Vas
authors.affiliation: Pain Treatment Unit, Doña Mercedes Primary Health Centre, Dos Hermanas, Spain.
authors.forename: Koldo
authors.initials: K
authors.lastname: Santos-Rey
authors.affiliation: Mental Health Services, Virgen de Valme University Hospital, Sevilla, Spain.
authors.forename: Reyes
authors.initials: R
authors.lastname: Navarro-Pablo
authors.affiliation: Pain Treatment Unit, Doña Mercedes Primary Health Centre, Dos Hermanas, Spain.
authors.forename: Manuela
authors.initials: M
authors.lastname: Modesto
authors.affiliation: Pain Treatment Unit, Doña Mercedes Primary Health Centre, Dos Hermanas, Spain.
authors.forename: Inmaculada
authors.initials: I
authors.lastname: Aguilar
authors.affiliation: Primary Health Centre Las Cabezas de San Juan, Las Cabezas de San Juan, Spain.
authors.forename: M Ángeles
authors.initials: MÁ
authors.lastname: Campos
authors.affiliation: San Francisco Primary Health Centre, Moron, Spain.
authors.forename: José Francisco
authors.initials: JF
authors.lastname: Aguilar-Velasco
authors.affiliation: Primary Health Centre Las Cabezas de San Juan, Las Cabezas de San Juan, Spain.
authors.forename: Milagrosa
authors.initials: M
authors.lastname: Romero
authors.affiliation: San Francisco Primary Health Centre, Moron, Spain.
authors.forename: Patricia
authors.initials: P
authors.lastname: Párraga
authors.affiliation: Mental Health Services, Virgen de Valme University Hospital, Sevilla, Spain.
authors.forename: Vanesa
authors.initials: V
authors.lastname: Hervás
authors.affiliation: Mental Health Services, Virgen de Valme University Hospital, Sevilla, Spain.
authors.forename: Olalla
authors.initials: O
authors.lastname: Santamaría
authors.affiliation: Pain Treatment Unit, Doña Mercedes Primary Health Centre, Dos Hermanas, Spain.
authors.forename: Carmen
authors.initials: C
authors.lastname: Márquez-Zurita
authors.affiliation: Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Andalucía, Spain Research Unit, Agencia Sanitaria Costa del Sol, Marbella, Spain.
authors.forename: Francisco
authors.initials: F
authors.lastname: Rivas-Ruiz
mesh_terms: D015670:Acupuncture Therapy; D004311:Double-Blind Method; D005260:Female; D005356:Fibromyalgia / Q000628:therapy*; D006801:Humans; D008875:Middle Aged; D059408:Pain Management / Q000379:methods; D011320:Primary Health Care; D011788:Quality of Life; D016896:Treatment Outcome
keywords: ACUPUNCTURE; PAIN MANAGEMENT; PRIMARY CARE; RHEUMATOLOGY