Table 19Clinical evidence summary: Central antihypertensive drugs (clonidine) versus placebo for ME/CFS (children and young people)

OutcomesNo of Participants (studies*) Follow upQuality of the evidence (GRADE)Relative effect (95% CI)Anticipated absolute effects
Risk withRisk difference with Children and young people: Central antihypertensive drugs (clonidine) versus placebo (95% CI)

Fatigue: Chalder Fatigue Questionnaire (CFQ) total sum score

Scale from: not reported.

103

(1 study)

30 weeks

⊕⊝⊝⊝

VERY LOW1,2,3

due to risk of bias, indirectness, imprecision

The mean fatigue: chalder fatigue questionnaire (cfq) total sum score at 30 weeks in the control group was

13.5

The mean fatigue: chalder fatigue questionnaire (cfq) total sum score at 30 weeks in the intervention groups was

0.5 higher

(14.7 lower to 15.7 higher)

Physical functioning: Fatigue Disability Index (FDI) total sum score

Scale from: not reported.

103

(1 study)

30 weeks

⊕⊝⊝⊝

VERY LOW1,2,3

due to risk of bias, indirectness, imprecision

The mean physical functioning: fatigue disability index (fdi) total sum score at 30 weeks in the control group was

16.8

The mean physical functioning: fatigue disability index (fdi) total sum score at 30 weeks in the intervention groups was

0.2 higher

(13.3 lower to 13.7 higher)

Pain: BPI average pain score

Scale from: 0 to 10.

103

(1 study)

30 weeks

⊕⊝⊝⊝

VERY LOW1,3,4

due to risk of bias, indirectness, imprecision

The mean pain: bpi average pain score at 30 weeks in the control group was

3.3

The mean pain: bpi average pain score at 30 weeks in the intervention groups was

0.4 higher

(0.4 lower to 1.2 higher)

Sleep quality: KSQ insomnia score

Scale from: not reported.

103

(1 study)

30 weeks

⊕⊝⊝⊝

VERY LOW1,2,3

due to risk of bias, indirectness, imprecision

The mean sleep quality: ksq insomnia score at 30 weeks in the control group was

3.6

The mean sleep quality: ksq insomnia score at 30 weeks in the intervention groups was

0.1 higher

(0.3 lower to 0.5 higher)

Adverse effects: various self-reported

108

(1 study)

9 weeks

⊕⊝⊝⊝

VERY LOW1,2,3,4

due to risk of bias, indirectness, imprecision

RR 1.17 (0.91 to 1.5)647 per 1000

110 more per 1000

(from 58 fewer to 324 more)

Activity levels: steps per day (accelerometer)

103

(1 study)

30 weeks

⊕⊕⊝⊝

LOW1,2

due to risk of bias, indirectness

The mean activity levels: steps per day (accelerometer) at 30 weeks in the control group was

4652

The mean activity levels: steps per day (accelerometer) at 30 weeks in the intervention groups was

119 higher

(796 lower to 1034 higher)

Cognitive function: Digit span backward test total

Scale from: not reported

103

(1 study)

30 weeks

⊕⊝⊝⊝

VERY LOW1,2,3

due to risk of bias, indirectness, imprecision

The mean cognitive function: digit span backward test total at 30 weeks in the control group was

6.7

The mean cognitive function: digit span backward test total at 30 weeks in the intervention groups was

0.5 lower

(1.2 lower to 0.2 higher)

Symptom scales: CFS symptom inventory hypersensitivity score

Scale from: not reported

103

(1 study)

30 weeks

⊕⊕⊝⊝

LOW1,2

due to risk of bias, indirectness

The mean symptom scales: cfs symptom inventory hypersensitivity score at 30 weeks in the control group was

2.6

The mean symptom scales: cfs symptom inventory hypersensitivity score at 30 weeks in the intervention groups was

0.03 lower

(0.4 lower to 0.34 higher)

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

4

Outcome indirectness: Some adverse effects are poorly defined, e.g. “unwellness” and “other”

Studies included: Sulheim 2014

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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