Jorge Vas1, Koldo Santos-Rey2, Reyes Navarro-Pablo3, Manuela Modesto2, Inmaculada Aguilar2, M Ángeles Campos4, José Francisco Aguilar-Velasco5, Milagrosa Romero4, Patricia Párraga5, Vanesa Hervás3, Olalla Santamaría3, Carmen Márquez-Zurita2, Francisco Rivas-Ruiz6. 1. Pain Treatment Unit, Doña Mercedes Primary Health Centre, Dos Hermanas, Spain Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Andalucía, Spain. 2. Pain Treatment Unit, Doña Mercedes Primary Health Centre, Dos Hermanas, Spain. 3. Mental Health Services, Virgen de Valme University Hospital, Sevilla, Spain. 4. Primary Health Centre Las Cabezas de San Juan, Las Cabezas de San Juan, Spain. 5. San Francisco Primary Health Centre, Moron, Spain. 6. Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Andalucía, Spain Research Unit, Agencia Sanitaria Costa del Sol, Marbella, Spain.
Abstract
OBJECTIVES: 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. TRIAL REGISTRATION NUMBER: ISRCTN60217348. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
RCT Entities:
OBJECTIVES: 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. TRIAL REGISTRATION NUMBER: ISRCTN60217348. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Authors: Annika Döhmen; Milan Kock; Alexander Obbarius; Christoph Paul Klapproth; Felix Fischer; Matthias Rose Journal: Qual Life Res Date: 2022-10-01 Impact factor: 3.440
Authors: Stefan J Friedrichsdorf; James Giordano; Kavita Desai Dakoji; Andrew Warmuth; Cyndee Daughtry; Craig A Schulz Journal: Children (Basel) Date: 2016-12-10