Table 9Clinical evidence summary: Antidepressants (fluoxetine) versus antipsychotics (amisulpride) 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 Antidepressants (fluoxetine) versus antipsychotics (amisulpride) (other) (95% CI)

Quality of Life: SF12

Scale from: 0 to 100.

40

(1 study)

12 weeks

⊕⊝⊝⊝

VERY LOW1,2

due to risk of bias, indirectness

The mean quality of life: sf12 at 12 weeks in the control groups was

53.2

The mean quality of life: sf12 at 12 weeks in the intervention group was

15.6 lower

(18.61 to 12.59 lower)

Fatigue: Fatigue Severity Scale

Scale from: 9 to 63.

40

(1 study)

12 weeks

⊕⊝⊝⊝

VERY LOW1,2

due to risk of bias, indirectness

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

36.3

The mean fatigue: fatigue severity scale at 12 weeks in the intervention group was

12.6 higher

(8.26 to 16.94 higher)

Psychological status: HADS anxiety

Scale from: 0 to 21.

40

(1 study)

12 weeks

⊕⊝⊝⊝

VERY LOW1,2,3

due to risk of bias, indirectness, imprecision

The mean psychological status: hads anxiety at 12 weeks in the control groups was

4.5

The mean psychological status: hads anxiety at 12 weeks in the intervention group was

0.4 higher

(0.22 lower to 1.02 higher)

Psychological status: HADS depression

Scale from: 0 to 21.

40

(1 study)

12 weeks

⊕⊝⊝⊝

VERY LOW1,2,3

due to risk of bias, indirectness, imprecision

The mean psychological status: hads depression at 12 weeks in the control groups was

4.3

The mean psychological status: hads depression at 12 weeks in the intervention group was

0.1 lower

(0.69 lower to 0.49 higher)

Pain: pain on VAS

Scale from: 0 to 100.

40

(1 study)

12 weeks

⊕⊝⊝⊝

VERY LOW1,2

due to risk of bias, indirectness

The mean pain: pain on vas at 12 weeks in the control groups was

40.5

The mean pain: pain on vas at 12 weeks in the intervention group was

12.6 higher

(5.8 to 19.4 to higher)

Adverse events: FIBSER global burden

Scale from: not reported.

40

(1 study)

12 weeks

⊕⊝⊝⊝

VERY LOW1,2,3

due to risk of bias, indirectness, imprecision

The mean adverse events: fibser global burden at 12 weeks in the control groups was

0.8

The mean adverse events: fibser global burden at 12 weeks in the intervention group was

0.2 lower

(0.67 lower to 0.27 higher)

Symptom scales: Clinical Global Impression Severity (CGI-S)

Scale from: 1 to 7.

40

(1 study)

12 weeks

⊕⊝⊝⊝

VERY LOW1,2

due to risk of bias, indirectness

The mean symptom scales: clinical global impression severity (cgi-s) at 12 weeks in the control groups was

2.9

The mean symptom scales: clinical global impression severity (cgi-s) at 12 weeks in the intervention group was

1.3 higher

(0.75 to 1.85 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: Pardini 2011

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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