Table 6, Clinical evidence summary: Antidepressants (fluoxetine) versus combined antidepressants (fluoxetine) & graded exercise for ME/CFS - Pharmacological interventions

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Table 6Clinical evidence summary: Antidepressants (fluoxetine) versus combined antidepressants (fluoxetine) & graded exercise for ME/CFS

Outcomes	No of Participants (studies*) Follow up	Quality of the evidence	Anticipated absolute effects
Fatigue: 14-item Chalder fatigue scale Scale from: not reported.	68 (1 study) 26 weeks	⊕⊝⊝⊝ VERY LOW¹^,²^,³ due to risk of bias, indirectness, imprecision	The mean fatigue: 14-item chalder fatigue scale at 26 weeks in the control groups was -6	The mean fatigue: 14-item chalder fatigue scale at 26 weeks in the intervention group was 3 higher (1.47 lower to 7.47 higher)
Psychological status: HADS depression Scale from: 0 to 21.	69 (1 study) 26 weeks	⊕⊝⊝⊝ VERY LOW¹^,²^,³ due to risk of bias, indirectness, imprecision	The mean psychological status: hads depression at 26 weeks in the control groups was -2	The mean psychological status: hads depression at 26 weeks in the intervention group was 0.3 higher (1.51 lower to 2.11 higher)
Exercise performance measure: VO2 max (mL O2/kg/min)	68 (1 study) 26 weeks	⊕⊝⊝⊝ VERY LOW²^,³ due to risk of bias, indirectness, imprecision	The mean change score in exercise performance measure: vo2 max (ml o2/kg/min) at 26 weeks in the control groups was 2	The mean exercise performance measure: vo2 max (ml o2/kg/min) at 26 weeks in the intervention group was 1 lower (3.41 lower to 1.41 higher)

Outcomes

No of Participants (studies*) Follow up

Quality of the evidence

Relative effect (95% CI)

Anticipated absolute effects

Risk with Control

Risk difference with Antidepressants (fluoxetine) versus combined antidepressants (fluoxetine) & graded exercise (95% CI)

Fatigue: 14-item Chalder fatigue scale

Scale from: not reported.

(1 study)

26 weeks

⊕⊝⊝⊝

VERY LOW¹^,²^,³

due to risk of bias, indirectness, imprecision

The mean fatigue: 14-item chalder fatigue scale at 26 weeks in the control groups was

-6

The mean fatigue: 14-item chalder fatigue scale at 26 weeks in the intervention group was

3 higher

(1.47 lower to 7.47 higher)

Psychological status: HADS depression

Scale from: 0 to 21.

(1 study)

26 weeks

⊕⊝⊝⊝

VERY LOW¹^,²^,³

due to risk of bias, indirectness, imprecision

The mean psychological status: hads depression at 26 weeks in the control groups was

-2

The mean psychological status: hads depression at 26 weeks in the intervention group was

0.3 higher

(1.51 lower to 2.11 higher)

Exercise performance measure: VO2 max (mL O2/kg/min)

(1 study)

26 weeks

⊕⊝⊝⊝

VERY LOW²^,³

due to risk of bias, indirectness, imprecision

The mean change score in exercise performance measure: vo2 max (ml o2/kg/min) at 26 weeks in the control groups was

The mean exercise performance measure: vo2 max (ml o2/kg/min) at 26 weeks in the intervention group was

1 lower

(3.41 lower to 1.41 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: Wearden 1998

From: 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).

London: National Institute for Health and Care Excellence (NICE); 2021 Oct.

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