| Outcomes | No of Participants (studies*) Follow up | Quality of the evidence (GRADE) | Relative effect (95% CI) | Anticipated absolute effects | |
|---|---|---|---|---|---|
| Risk with Control | Risk difference with Pro-inflammatory cytokine antagonists (anakinra) versus placebo (95% CI) | ||||
| Mortality |
50 (1 study) 24 weeks |
⊕⊕⊕⊝ MODERATE1 due to indirectness | RD 0.00 (−0.07 to 0.07) | 0 per 1000 |
0 more per 1000 (from 70 fewer to 70 more) |
|
Fatigue: Checklist Individual Strength fatigue Scale from: 8 to 56. |
50 (1 study) 24 weeks |
⊕⊝⊝⊝ due to indirectness, imprecision |
The mean fatigue: cis fatigue at 24 weeks in the control groups was 0 |
The mean fatigue: cis fatigue at 24 weeks in the intervention groups was 1.3 higher (5.3 lower to 7.9 higher) | |
|
Physical functioning: SF36 physical function Scale from: 0 to 100. |
50 (1 study) 24 weeks |
⊕⊕⊝⊝ due to indirectness, imprecision |
The mean physical functioning: sf36 physical function at 24 weeks in the control group was 64.8 |
The mean physical functioning: sf36 physical function at 24 weeks in the intervention groups was 4 lower (15.1 lower to 7.1 higher) | |
|
Psychological status: Symptom Checklist 90 Scale from: 90 to 450. |
50 (1 study) 24 weeks |
⊕⊕⊕⊝ due to indirectness |
The mean psychological status: symptom checklist 90 at 24 weeks in the control group was 140.5 |
The mean psychological status: symptom checklist 90 at 24 weeks in the intervention groups was 3 higher (8.6 lower to 14.6 higher) | |
|
Pain: VAS maximum pain score Scale from: 0 to 10. |
50 (1 study) 24 weeks |
⊕⊝⊝⊝ due to indirectness, imprecision |
The mean pain: vas maximum pain score at 24 weeks in the control group was 6.6 |
The mean pain: vas maximum pain score at 24 weeks in the intervention groups was 0.34 higher (1.1 lower to 1.78 higher) | |
| Adverse events |
50 (1 study) 24 weeks |
⊕⊕⊕⊝ MODERATE1 due to indirectness | RR 1.71 (1.2 to 2.45) | 560 per 1000 |
398 more per 1000 (from 112 more to 812 more) |
| Adverse events: withdrawal due to adverse events |
50 (1 study) 24 weeks |
⊕⊝⊝⊝ due to indirectness, imprecision | Peto OR 7.39 (0.15 to 372.38) | 0 per 1000 |
40 more per 1000 (from 60 fewer to 140 more) |
|
Symptom scales: Sickness Impact Profile Scale from: 0 to 5799. |
50 (1 study) 24 weeks |
⊕⊕⊝⊝ due to indirectness, imprecision |
The mean symptom scales: sickness impact profile at 24 weeks in the control groups was 1260.4 |
The mean symptom scales: sickness impact profile at 24 weeks in the intervention groups was 91.2 higher (275.8 lower to 458.2 higher) | |
The majority of the evidence included an indirect population (downgraded by one increment): downgraded if the ME/CFS diagnostic criteria used did not include PEM as a compulsory feature [original analysis]; percentage of participants with PEM unclear [PEM reanalysis – see Appendix G for additional details]
Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs
Studies included: Roerink 2017
From: Pharmacological interventions
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