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Flow diagram.
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Figure 1

Flow diagram.

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'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
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Figure 2

'Risk of bias' graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
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Figure 3

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.

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Forest plot of comparison: 1 Amitriptyline versus placebo, outcome: 1.1 Third‐tier efficacy.
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Figure 4

Forest plot of comparison: 1 Amitriptyline versus placebo, outcome: 1.1 Third‐tier efficacy.

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Third‐tier evidence: substantial pain relief
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Figure 5

Third‐tier evidence: substantial pain relief

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Comparison 1 Amitriptyline versus placebo, Outcome 1 Third‐tier efficacy.
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Analysis 1.1

Comparison 1 Amitriptyline versus placebo, Outcome 1 Third‐tier efficacy.

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Comparison 1 Amitriptyline versus placebo, Outcome 2 At least 1 adverse event.
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Analysis 1.2

Comparison 1 Amitriptyline versus placebo, Outcome 2 At least 1 adverse event.

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Comparison 1 Amitriptyline versus placebo, Outcome 3 All‐cause withdrawal.
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Analysis 1.3

Comparison 1 Amitriptyline versus placebo, Outcome 3 All‐cause withdrawal.

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Comparison 1 Amitriptyline versus placebo, Outcome 4 Adverse event withdrawal.
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Analysis 1.4

Comparison 1 Amitriptyline versus placebo, Outcome 4 Adverse event withdrawal.

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Comparison 1 Amitriptyline versus placebo, Outcome 5 Lack of efficacy withdrawal.
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Analysis 1.5

Comparison 1 Amitriptyline versus placebo, Outcome 5 Lack of efficacy withdrawal.

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Amitriptyline compared with placebo for fibromyalgia

Patient or population: adults with fibromyalgia

Settings: community

Intervention: amitriptyline 25 to 50 mg daily

Comparison: placebo

Outcomes

Probable outcome with intervention

Probable outcome with placebo

NNT or NNH and/or relative effect (95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

At least 50% reduction in pain or equivalent (substantial)

360 in 1000

110 in 1000

RR 2.9 (1.7 to 4.9)

NNT 4.1 (2.9 to 6.7)

4 studies, 275 participants

Very low

Small number of studies and participants

At least 30% reduction in pain or equivalent (moderate)

no data

Adverse event withdrawals

80 in 1000

90 in 1000

RR 1.03 (0.49 to 2.2)

NNTp not calculated

4 studies, 298 participants

Very low

Small number of studies and participants

Serious adverse events

none reported

Death

none reported

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

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Comparison 1. Amitriptyline versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Third‐tier efficacy Show forest plot

4

275

Risk Ratio (M‐H, Fixed, 95% CI)

2.88 [1.69, 4.91]

1.1 Fibromyalgia

4

275

Risk Ratio (M‐H, Fixed, 95% CI)

2.88 [1.69, 4.91]

2 At least 1 adverse event Show forest plot

4

318

Risk Ratio (M‐H, Fixed, 95% CI)

1.54 [1.29, 1.84]

3 All‐cause withdrawal Show forest plot

7

418

Risk Ratio (M‐H, Fixed, 95% CI)

0.77 [0.53, 1.11]

4 Adverse event withdrawal Show forest plot

4

298

Risk Ratio (M‐H, Fixed, 95% CI)

1.03 [0.49, 2.16]

5 Lack of efficacy withdrawal Show forest plot

3

272

Risk Ratio (M‐H, Fixed, 95% CI)

0.42 [0.19, 0.95]
Figuras y tablas -
Comparison 1. Amitriptyline versus placebo
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