Luciano 2011.
| Methods |
Study setting: Europe (Spain). Multicentre, general practitioners, outpatient based Study design: Parallel Duration therapy: 8 weeks Follow‐up: None Analysis: T‐tests and Chi2 to examine baseline differences, repeated measures analysis of variance (factor 1: intervention and control, factor 2: pretreatment and post‐treatment), comparison of baseline differences between responders and non‐responders |
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| Participants |
Patients: Treatment Group: 108 patients; 97% female, race not reported, mean age 55.2 years; years since diagnosis 15.2 (11.7) Control Group: 108 patients; 98% female, race not reported, mean age 55.4 years; years since diagnosis 14.3 (10.6) Inclusion: ACR 1990 criteria for FMS, age 18 to 75 years Exclusion: Diagnosis of FM based on ACR 1990 criteria, cognitive impairment, presence of physical/psychiatric limitations that impeded participation in the study assessments, life expectancy of less than 12 months, absence of schooling |
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| Interventions |
Treatment Group: CBT: information about symptoms, usual course, comorbid medical conditions, potential causes of illness, influence of psychosocial factors on pain, current pharmacological and non‐pharmacological treatments, benefits of regular exercise, autogenic training (2h/week), total: 16h Control Group: TAU: pharmacological treatment and counselling about aerobic exercise Co‐medication allowed: Yes Other Co‐therapies: Not reported |
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| Outcomes |
Primary Outcomes Self reported pain: FIQ pain 0‐10 Self reported negative mood: FIQ depression 0‐10 Self reported disability: FIQ physical impairment 0‐10 Acceptability: Total dropout rate Secondary Outcomes Self reported self efficacy pain: Not assessed Self reported fatigue: FIQ general fatigue 0‐10 Self reported sleep problems: Not assessed Self reported disease‐specific health‐related quality of life: FIQ total 0‐80 |
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| Notes | 1. Reasons for dropout (both groups): 16x not interested in the study, 2x family burden, 2x not able to comply with the treatment schedule, 1x relocation 2. Attendance rates: not reported 3:Responder analysis: 35% of the patients in the CBT groups and 17% of the patients in the TAU group reported a ≥20% reduction of the FIQ total score at final treatment 4. Funding sources and declaration of interest of the primary researchers:The research project and Nuria Martınez’s pre‐doctoral contract were funded by a grant from the “Agencia d’Avaluacio´ de Tecnologia i Recerca Mediques” (AATRM 077/25/06). Juan V. Luciano received a postdoctoral contract from the “Instituto de Salud Carlos III” (Red RD06/0018/0017) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer generated randomisation list |
| Allocation concealment (selection bias) | Unclear risk | No details reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis by baseline carried forward method |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Blinding of outcome assessor | Low risk | Research assistant was not involved in the treatment and was blind to group allocation |