Table 14Clinical evidence summary: 5-HT3 antagonists (ondansetron) 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 5-HT3 antagonists (ondansetron) versus placebo (95% CI)

Fatigue: Checklist Individual Strength fatigue

Scale from: 8 to 56.

67

(1 study)

12 weeks

⊕⊝⊝⊝

VERY LOW1,2,3

due to risk of bias, indirectness, imprecision

The mean fatigue: cis fatigue at 12 weeks in the control groups was

45.4

The mean fatigue: cis fatigue at 12 weeks in the intervention groups was

1.4 lower

(6.81 lower to 4.01 higher)

Activity levels: Actometer (objective accelerometer-based method of measuring activity)

67

(1 study)

12 weeks

⊕⊝⊝⊝

VERY LOW1,2,3

due to risk of bias, indirectness, imprecision

The mean activity levels: actometer (objective accelerometer-based method of measuring activity) at 12 weeks in the control groups was

60.6

The mean activity levels: actometer (objective accelerometer-based method of measuring activity) at 12 weeks in the intervention groups was

5.6 lower

(13.61 lower to 2.41 higher)

Adverse events: constipation

67

(1 study)

12 weeks

⊕⊝⊝⊝

VERY LOW1,2,3

due to risk of bias, indirectness, imprecision

Peto OR 7.86 (0.48 to 128.37)0 per 1000

60 more per 1000

(from 40 fewer to 160 more)

Adverse events: malaise

67

(1 study)

12 weeks

⊕⊝⊝⊝

VERY LOW1,2,3

due to risk of bias, indirectness, imprecision

RR 3.09 (0.34 to 28.23)29 per 1000

61 more per 1000

(from 19 fewer to 801 more)

Symptom scales: Sickness Impact Profile (SIP) 8

Scale from: 0 to 5799.

67

(1 study)

12 weeks

⊕⊝⊝⊝

VERY LOW1,2,3

due to risk of bias, indirectness, imprecision

The mean symptom scales: sickness impact profile (sip) 8 at 12 weeks in the control groups was

1172

The mean symptom scales: sickness impact profile (sip) 8 at 12 weeks in the intervention groups was

109 lower

(403.38 lower to 185.38 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

*

Studies included: The 2010

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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