Table 17Clinical evidence summary: Pro-inflammatory cytokine antagonists (anakinra) versus placebo for ME/CFS

OutcomesNo of Participants (studies*) Follow upQuality of the evidence (GRADE)Relative effect (95% CI)Anticipated absolute effects
Risk with ControlRisk 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

⊕⊝⊝⊝

VERY LOW1,2

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

⊕⊕⊝⊝

LOW1,2

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

⊕⊕⊕⊝

MODERATE1,2

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

⊕⊝⊝⊝

VERY LOW1,2

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

⊕⊝⊝⊝

VERY LOW1,2

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

⊕⊕⊝⊝

LOW1,2

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)

1

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]

2

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

Cover of Pharmacological interventions
Pharmacological interventions: Myalgic encephalomyelitis (or encephalopathy) / chronic fatigue syndrome: diagnosis and management: Evidence review F.
NICE Guideline, No. 206.
National Guideline Centre (UK).
Copyright © NICE 2021.

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