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. 2012 Nov 14;2012(11):CD007407. doi: 10.1002/14651858.CD007407.pub3

Schmidt 2011.

Methods RCT; 3 arms; mindfulness‐based stress reduction, active relaxation control, waiting list; post‐treatment, 2‐month follow‐up
Participants End of treatment n = 148
Start of treatment n = 177
Sex: 177 F; 0 M
Mean age = 52.5 (SD 9.6)
Source = newspapers, GP and specialist referrals, patient self help groups
Diagnosis = fibromyalgia
Mean years of pain: 4.0 (SD 3.9)
Interventions Mindfulness‐based stress reduction; active control (relaxation, support and education); waiting list
Outcomes Primary pain outcome: Pain Perception Scale (sensory)
Primary disability outcome: Fibromyalgia Impact Questionnaire
Primary mood outcome: CES‐D
Catatrophising outcome: none
Pain Perception Scale (Sensory and Affective)
Fibromyalgia Impact Questionnaire
Depression: CES‐D
Anxiety: Trait Sub‐scale STAI
Pittsburgh Sleep Quality Index
Health‐related Quality of Life
Freiburg Mindfulness Inventory
Physical symptoms: Giessen Complaint Questionnaire
Ongoing therapies, medical visits and medication
Medication diary
Goal‐attainment scaling by interview
Notes Active relaxation control versus waiting list; analyses 7.1, 7.2, 7.3
2011 update search
Yates quality scale: total quality = 31/35, design quality = 23/26, treatment quality = 8/9
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk “randomized in blocks by a computer algorithm”
Allocation concealment (selection bias) Low risk Patients and personnel blinded to treatment allocation
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Attrition fully reported; no test for differences
Selective reporting (reporting bias) Low risk Fully reported
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Assessors blinded