Table 15Clinical evidence summary: Galantamine hydrobromide 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 Galantamine hydrobromide versus placebo (95% CI)

Fatigue: fatigue on VAS

Scale from: 0 to 10.

49

(1 study)

2 weeks

⊕⊝⊝⊝

VERY LOW1,2,3

due to risk of bias, indirectness, imprecision

The mean fatigue: fatigue on vas at 2 weeks in the control groups was

7.11

The mean fatigue: fatigue on vas at 2 weeks in the intervention groups was

0.14 higher

(0.84 lower to 1.12 higher)

Cognitive function: memory on VAS

Scale from: 0 to 10.

49

(1 study)

2 weeks

⊕⊝⊝⊝

VERY LOW1,2,3

due to risk of bias, indirectness, imprecision

The mean cognitive function: memory on vas at 2 weeks in the control groups was

4.72

The mean cognitive function: memory on vas at 2 weeks in the intervention groups was

0.91 higher

(0.67 lower to 2.49 higher)

Pain: myalgia on VAS

Scale from: 0 to 10.

49

(1 study)

2 weeks

⊕⊝⊝⊝

VERY LOW1,2,3

due to risk of bias, indirectness, imprecision

The mean pain: myalgia on vas at 2 weeks in the control groups was

7.99

The mean pain: myalgia on vas at 2 weeks in the intervention groups was

0.47 lower

(1.39 lower to 0.45 higher)

Sleep quality: sleep disturbance on VAS

Scale from: 0 to 10.

49

(1 study)

2 weeks

⊕⊝⊝⊝

VERY LOW1,2,3

due to risk of bias, indirectness, imprecision

The mean sleep quality: sleep disturbance on vas at 2 weeks in the control groups was

6.66

The mean sleep quality: sleep disturbance on vas at 2 weeks in the intervention groups was

0.34 higher

(1.02 lower to 1.7 higher)

Adverse events: AEs dizziness on VAS

Scale from: 0 to 10.

49

(1 study)

2 weeks

⊕⊝⊝⊝

VERY LOW1,2,3

due to risk of bias, indirectness, imprecision

The mean adverse events: aes dizziness on vas at 2 weeks in the control groups was

3.54

The mean adverse events: aes dizziness on vas at 2 weeks in the intervention groups was

0.72 higher

(0.93 lower to 2.37 higher)

Return to school/work: work capacity/satisfaction on VAS

Scale from: 0 to 10.

39

(1 study)

2 weeks

⊕⊝⊝⊝

VERY LOW1,2,3

due to risk of bias, indirectness, imprecision

The mean quality of life: work capacity/satisfaction on vas at 2 weeks in the control groups was

5.09

The mean quality of life: work capacity/satisfaction on vas at 2 weeks in the intervention groups was

0.17 lower

(1.38 lower to 1.04 higher)

Symptom scales: clinical global impression score, no change or worse

347

(1 study)

20 weeks

⊕⊝⊝⊝

VERY LOW2,3

due to risk of bias, indirectness, imprecision

RR 0.86 (0.72 to 1.03)701 per 1000

98 fewer per 1000

(from 196 fewer to 21 more)

1

Downgraded by 1 increment if the majority of the evidence was at high risk of bias, and downgraded by 2 increments if the majority of the evidence was at very high risk of bias

2

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]

3

Downgraded by 1 increment if the confidence interval crossed one MID or by 2 increments if the confidence interval crossed both MIDs

Studies included: Blacker 2004, Snorrason 1996

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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