Targino 2008.

Methods	Randomised: using "a computer‐generated random sequence of numbers provided by the Hospitals Informatics Departments. The randomization was conducted by one physician who was not involved with the inclusion or exclusion process." Blinding: assessor blind ‐ "participants rated their pain intensity using a VAS. Blinded evaluation of PPT18 and TePsN was carried out by a single physician (HHSK), while blind evaluation of quality of life was conducted by one psychologist (LPMS). Even though the participants knew which group they were in (either the acupuncture treatment group or the standard care group), they were instructed not to communicate this information to the outcome assessors." Setting: not reported, but assume it was the Clinics Hospital Was study aim clear: yes Informed consent: written and informed consent Follow‐up: 3 months (after randomisation and at the end of the treatment), 6 months, 12 months and 24 months Ethics approval: the ethics review committee of the Clinics Hospital WHO clinical trial register: listed and outcomes as per listing Intention‐to‐treat: yes, up to 12 months follow‐up, but not at 24 months follow‐up
Participants	Total number of participants: 58 patients, mean duration of pain (months): acupuncture group 118.8 (117.3), control 93.0 (75.25). Did not describe what they meant by pain duration, whether it was fibromyalgia diagnosis or pain. Assume it refers to fibromyalgia. Gender: 0 male (acupuncture and control) and 58 female Mean age: acupuncture 52.09 SD 10.97 years, control 51.17 SD 11.20 years Diagnosis: ACR: "ACR criteria were applied by one of the physicians (HHSK) to confirm the diagnosis prior to the enrolment to the study." Inclusion: 20 to 70 yrs old, have to have had pain VAC > 4/10; using an antidepressants at an analgesic dose (12.5 to 75 mg/kg). Author did not specify the name of medication Acupuncture‐naive participants: no, patients who had acupuncture in the previous 12 months were excluded. Presumably, this is not an important item because sham acupuncture is not used. Excluded: patients with "severe psychiatric disease, the presence of neurological deficits, cardiac disease or glaucoma, and treatment with acupuncture within one year prior to the start of the study." Recruitment source: "were recruited by physicians from the Clinics Hospital in Sao Paulo. They included doctors practising in the Pain Clinic of the Department of Neurology, those in the Rheumatology Clinic and those in the Division of Physical Medicine of the Institute of Orthopedics and Traumatology." Previous treatments: none reported except for current medication
Interventions	1) Real: acupuncture + standard care (12.5 to 75 mg of tricyclic antidepressants per day), individualised plus exercise, including "oral instruction to walk for 30 min twice a week at their own pace, to breathe deeply and to perform mental relaxation exercises for another 30 min. They were also told to perform twice‐weekly stretching exercises involving the para‐spinalis muscles, glutei, hamstrings, ankle plantar flexors and hip flexors." Patients in the acupuncture group always had their sessions performed by the same physician (RAT). Randomised to this group: 34 2) Control: standard care, tricyclic antidepressant (individualised, ranging from 12.5 to 75 mg/day, most (84.5%) received 50 mg/day) plus exercise. Participants "were seen by a physician at the beginning of the study and during the follow‐up visits. No additional visits were scheduled for the controls to compensate for the extra attention being received by patients in the acupuncture treatment group. Compliance with the use of either exercise or antidepressant drugs was based on participants reports during the outcome evaluation interviews." Randomised to this group: 24 Compliance: 97.1% (33 participants) completed all 20 sessions, with one leaving after 17 sessions due to complete relief from pain Minimum number of treatments needed: not reported Co‐intervention: not reported See STRICTA table for treatment details (Appendix 10)
Outcomes	Primary outcomes: 1) Visual analogue scale (VAS) with 0 = no pain and 10 = worst pain experienced 2) Quality of life: SF‐36 form. Portuguese version of MOS 36‐item short‐form health survey (8‐items), higher scores indicate better quality of life. Secondary outcomes: 3) Number of tender points below 4 kg/cm2 (TePsN). The lower the number, the less the severity of symptoms. 4) Mean pressure pain threshold value, over the 18 fibromyalgia points (PPT18). The higher the values the less severe the symptoms, measured with algometry (not sure if electronic or manual). Assessments: at baseline, 3 months (after randomisation and at the end of the treatment), 6 months, 12 months and 24 months Outcome measure results: The 2 groups were comparable at baseline. Also mentioned in the discussion, the usage of medication was not different between the 2 groups. VAS showed statistically significant improvement in the acupuncture group at 3 months (P < 0.001, however at 6, 12 and 24 months follow‐up, it was not statistically different between the groups (P > 0.05) SF‐36 showed improvement in only 5 sub‐scales of the acupuncture group at 3 months (PF, BP, VT, RE, MH). At 6 months the acupuncture group benefit was for only 1 sub‐scale (GH) and at 12‐month follow‐up only 1 sub‐scale showed improvement (RP). TePsN and PPT18 showed improvement in the acupuncture group at 3 and 6 months There was no statistical difference in the scores of the standard care group at any time (P > 0.05) Withdrawals/drop‐outs: at 24 months, 2 were lost to follow‐up in the acupuncture group (follow‐up rate 94.1%), 1 in the control group (follow‐up rate 95.8%) Complications/adverse events: 2 patients in the acupuncture group reported temporary oedema of the left hand at LI4. There were no reported incidences of discomfort, soreness, vasovagal symptoms, bruising or haematoma at time of treatment or the during the follow‐up period of 24 months. Data extraction method: data were extracted from the published paper using table 2 and medians/ranges were converted by the CMSG statistician. We could not use SF‐36 data as there were no available data for converting median/range to mean. We were waiting for details from the author at the time of publication.
Notes	Other info: 1 author of our review was in contact with the study author who that advised she had a paper awaiting publication which she provided direct. This was outside of our search at the start of review and provided further data. Funding: no funding provided Refunded costs to participants: not reported Language: English Publication: full paper
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated random sequence of numbers
Allocation concealment (selection bias)	High risk	Did not use, as study objective was to evaluate the benefit of the addition of acupuncture to a standard course of tricyclic antidepressants and exercise
Incomplete outcome data (attrition bias) All outcomes	Low risk	No drop‐out was reported during the treatment or in the first 12 months of follow‐up. 3 participants were not contacted at the 24‐month follow‐up and their data were excluded from analysis at that time. This exclusion will not impact on the outcome at the end of treatment or 12‐month follow‐up. Furthermore, the number of drop‐outs at 24 months was comparable between the 2 groups.
Selective reporting (reporting bias)	Low risk	All outcomes reported as per WHO clinical trials register
Blinding of participants and personnel (performance bias) All outcomes	High risk	Participants were restricted to those who not had acupuncture in the last 12 months; care giver was not blinded
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Outcome assessors were blinded and participants were told not to inform them of their group allocation

ACR: American College of Rheumatology 
 CMSG: Cochrane Musculoskeletal Group 
 FIQ: Fibromyalgia Impact Questionnaire 
 MPI: Multidimensional Pain Inventory 
 NCCAM: National Centre for Complementary and Alternative Medicine 
 NIH: National Institutes of Health 
 N/O: non‐traditional acupuncture without stimulation 
 N/S: non‐traditional acupuncture with stimulation 
 PET: positron emission tomography 
 RCT: randomised controlled trial 
 SA: non skin‐penetrating acupuncture 
 SD: standard deviation 
 SE: standard error 
 SF‐MPQ: Short‐Form McGill Pain Questionnaire 
 SNRI: serotonin–norepinephrine reuptake inhibitor 
 S/S: symptoms/signs 
 SSRI: selective serotonin re‐uptake inhibitor 
 STRICTA: Standards for Reporting Interventions in Controlled studies of Acupuncture 
 TA: acupuncture (real) 
 T/O: traditional acupuncture without stimulation 
 T/S: traditional acupuncture with stimulation 
 VAS: visual analogue scale 
 WHO: World Health Organization