| Study characteristics |
| Methods |
Risk of bias:
1. Sequence generation: low ‐ computer generated
2. Allocation concealment: uncertain ‐ not specified (use of clouded vials for immunologic treatment)
3. Blinding: uncertain ‐ double blinding for immunologic treatments (with test of blind); self‐report or physiological measures apart from Karnsofsky scale with blinding unspecified
4. Incomplete outcome data: low ‐ single dropout though reasons not specified; available case analysis
5. Selective outcome reporting: uncertain ‐ no reference to trial protocol
6. Other sources of bias: high ‐ participants also received placebo injections for dialyzable lymphocyte extract; symptomatic improvement correlated with belief that subjects had received active DLE; CBT sessions also sometimes involved other family member and ranged in length from 30‐60 minutes therefore of possibly inconsistent intensity; no manualisation or fidelity testing reported |
| Participants |
Setting: secondary care ‐ exact setting unclear
Sample population: not specified
Sample size: 90 in entire study (including active DLE arms); 44 in placebo arms included in this review
Inclusion criteria: 'Australian' CFS criteria (Lloyd et al 1990)
Exclusion criteria: previous immunologic therapy, non‐ambulatory, incapable of attending clinic every 2 weeks, alternative medical explanation for symptoms assessed by history, physical examination and investigations
Baseline characteristics: comparison groups similar pre‐treatment on demographic and outcome variables |
| Interventions |
1: 'active DLE injections plus cognitive behavioural therapy' (not included in this review)
2: 'active DLE injections only' (not included in this review)
3: 'placebo injections plus cognitive behavioural therapy'; individual (participant could choose to bring close family member); one 60 minute session and five 30‐60 minute sessions over 12 weeks; manualisation not specified; treatment fidelity not specified; therapists were psychiatrists (supervision not specified); subject received booklet with treatment rationale; goal of therapy to shift perceptions of being helpless victim, to re‐establishing social activities; schedule of home based graded exercise; visited clinic every two weeks for 16 weeks for DLE placebo injection.
4: 'placebo injections only'; visited clinic every two weeks for 16 weeks for DLE placebo injection. |
| Outcomes |
1. MEASURES: quality of life visual analogue scales, nonsedentary hours activity/day, Karnofsky score, POMS fatigue scale, POMS confusion scale, POMS depression score, CD4 white cell count, CD8 white cell count, delayed type hypersensitivity skin test
2. FOLLOW‐UP TIMES: 7 months (3 months post‐treatment) |
| Notes |
Mean dutaion of fatigue 66 months |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment (selection bias) |
Unclear risk |
not specified (use of clouded vials for immunologic treatment) |
