Amitriptyline versus placebo for major depressive disorder

Claudia Leucht; Maximilian Huhn; Stefan Leucht

doi:10.1002/14651858.CD009138.pub2

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Figure 1

Study flow diagram.

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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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Figure 3

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

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Figure 4

Forest plot of comparison: 1 Amitriptyline versus placebo, outcome: 1.1 Response.

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Figure 5

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Figure 6

Funnel plot of comparison: 1 Amitriptyline versus placebo, outcome: 1.1 Response.

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Figure 7

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Analysis 1.1

Comparison 1 Amitriptyline versus placebo, Outcome 1 Response.

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Analysis 1.2

Comparison 1 Amitriptyline versus placebo, Outcome 2 Remission.

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Analysis 1.3

Comparison 1 Amitriptyline versus placebo, Outcome 3 Mean severity of depression ‐ change scores.

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Analysis 1.4

Comparison 1 Amitriptyline versus placebo, Outcome 4 Mean severity of depression ‐ endpoint scores.

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Analysis 1.5

Comparison 1 Amitriptyline versus placebo, Outcome 5 Drop‐out: total.

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Analysis 1.6

Comparison 1 Amitriptyline versus placebo, Outcome 6 Drop‐out: due to inefficacy.

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Analysis 1.7

Comparison 1 Amitriptyline versus placebo, Outcome 7 Drop‐out: due to adverse events.

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Analysis 1.8

Comparison 1 Amitriptyline versus placebo, Outcome 8 Side effects ‐ total number of patients experiencing at least one side effect.

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Analysis 1.9

Comparison 1 Amitriptyline versus placebo, Outcome 9 Side effects ‐ anticholinergic: any anticholinergic effects (dry mouth, constipation, visual disturbances).

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Analysis 1.10

Comparison 1 Amitriptyline versus placebo, Outcome 10 Side effects ‐ anticholinergic: constipation.

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Analysis 1.11

Comparison 1 Amitriptyline versus placebo, Outcome 11 Side effects ‐ anticholinergic: dry mouth.

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Analysis 1.12

Comparison 1 Amitriptyline versus placebo, Outcome 12 Side effects ‐ anticholinergic: nasal congestion.

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Analysis 1.13

Comparison 1 Amitriptyline versus placebo, Outcome 13 Side effects ‐ anticholinergic: urination problems.

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Analysis 1.14

Comparison 1 Amitriptyline versus placebo, Outcome 14 Side effects ‐ anticholinergic: vision problems (amblyopia, blurred vision).

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Analysis 1.15

Comparison 1 Amitriptyline versus placebo, Outcome 15 Side effects ‐ cardiovascular: hypertension.

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Analysis 1.16

Comparison 1 Amitriptyline versus placebo, Outcome 16 Side effects ‐ cardiovascular: hypotension.

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Analysis 1.17

Comparison 1 Amitriptyline versus placebo, Outcome 17 Side effects ‐ cardiovascular: lightheadedness.

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Analysis 1.18

Comparison 1 Amitriptyline versus placebo, Outcome 18 Side effects ‐ cardiovascular: palpitations.

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Analysis 1.19

Comparison 1 Amitriptyline versus placebo, Outcome 19 Side effects ‐ cardiovascular: tachycardia.

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Analysis 1.20

Comparison 1 Amitriptyline versus placebo, Outcome 20 Side effects ‐ central nervous: agitation.

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Analysis 1.21

Comparison 1 Amitriptyline versus placebo, Outcome 21 Side effects ‐ central nervous: amnesia.

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Analysis 1.22

Comparison 1 Amitriptyline versus placebo, Outcome 22 Side effects ‐ central nervous: confusion.

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Analysis 1.23

Comparison 1 Amitriptyline versus placebo, Outcome 23 Side effects ‐ central nervous: disco‐ordination.

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Analysis 1.24

Comparison 1 Amitriptyline versus placebo, Outcome 24 Side effects ‐ central nervous: dizziness.

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Analysis 1.25

Comparison 1 Amitriptyline versus placebo, Outcome 25 Side effects ‐ central nervous: headache.

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Analysis 1.26

Comparison 1 Amitriptyline versus placebo, Outcome 26 Side effects ‐ central nervous: increased activity.

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Analysis 1.27

Comparison 1 Amitriptyline versus placebo, Outcome 27 Side effects ‐ central nervous: insomnia.

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Analysis 1.28

Comparison 1 Amitriptyline versus placebo, Outcome 28 Side effects ‐ central nervous: nervousness.

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Analysis 1.29

Comparison 1 Amitriptyline versus placebo, Outcome 29 Side effects ‐ central nervous: sedation/sleepiness/somnolence/drowsiness.

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Analysis 1.30

Comparison 1 Amitriptyline versus placebo, Outcome 30 Side effects ‐ central nervous: tremor.

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Analysis 1.31

Comparison 1 Amitriptyline versus placebo, Outcome 31 Side effects ‐ dermal: rash.

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Analysis 1.32

Comparison 1 Amitriptyline versus placebo, Outcome 32 Side effects ‐ dermal: sweating.

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Analysis 1.33

Comparison 1 Amitriptyline versus placebo, Outcome 33 Side effects ‐ gastrointestinal: anorexia.

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Analysis 1.34

Comparison 1 Amitriptyline versus placebo, Outcome 34 Side effects ‐ gastrointestinal: diarrhoea.

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Analysis 1.35

Comparison 1 Amitriptyline versus placebo, Outcome 35 Side effects ‐ gastrointestinal: dyspepsia.

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Analysis 1.36

Comparison 1 Amitriptyline versus placebo, Outcome 36 Side effects ‐ gastrointestinal: gastralgia.

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Analysis 1.37

Comparison 1 Amitriptyline versus placebo, Outcome 37 Side effects ‐ gastrointestinal: increased appetite.

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Analysis 1.38

Comparison 1 Amitriptyline versus placebo, Outcome 38 Side effects ‐ gastrointestinal: nausea.

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Analysis 1.39

Comparison 1 Amitriptyline versus placebo, Outcome 39 Side effects ‐ gastrointestinal: vomiting.

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Analysis 1.40

Comparison 1 Amitriptyline versus placebo, Outcome 40 Side effects ‐ gastrointestinal: weight gain.

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Analysis 1.41

Comparison 1 Amitriptyline versus placebo, Outcome 41 Side effects ‐ general: fatigue/asthenia/slowed down.

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Analysis 1.42

Comparison 1 Amitriptyline versus placebo, Outcome 42 Side effects ‐ sexual: impotence.

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Analysis 1.43

Comparison 1 Amitriptyline versus placebo, Outcome 43 Side effects ‐ sexual: any sexual dysfunction.

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Analysis 1.44

Comparison 1 Amitriptyline versus placebo, Outcome 44 Subgroup analysis: industry sponsored ‐ response to treatment.

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Analysis 1.45

Comparison 1 Amitriptyline versus placebo, Outcome 45 Subgroup analysis: inpatient versus outpatient studies ‐ response to treatment.

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Analysis 1.46

Comparison 1 Amitriptyline versus placebo, Outcome 46 Subgroup analysis: two‐arms versus three‐arms studies ‐ response to treatment.

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Analysis 1.47

Comparison 1 Amitriptyline versus placebo, Outcome 47 Sensitivity analysis: devoid of studies calculated with imputed statistic methods ‐ response to treatment.

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Analysis 1.48

Comparison 1 Amitriptyline versus placebo, Outcome 48 Sensitivity analysis: fixed instead of random‐effects model ‐ response to treatment.

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Summary of findings for the main comparison. Amitriptyline versus placebo for major depressive disorder

Amitriptyline versus placebo for major depressive disorder
Patient or population: adults with major depressive disorder Settings: inpatients and outpatients Intervention: amitriptyline
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Control	Amitriptyline
Response to treatment At least 50% reduction of a depression scale (mainly Hamilton Depression Rating Scale) Follow‐up: 3 to 12 weeks	313 per 1000	546 per 1000 (509 to 582)	OR 2.64 (2.28 to 3.06)	3228 (31 studies)	⊕⊕⊕⊝ moderate^1,2
Death due to suicide	See comment	See comment	Not estimable³	‐	See comment	No study reported on this outcome
Quality of life	See comment	See comment	Not estimable³	‐	See comment	No study reported on this outcome
Acceptability of treatment Drop‐out for any reason Follow‐up: 3 to 12 weeks	403 per 1000	324 per 1000 (271 to 386)	OR 0.71 (0.55 to 0.93)	2400 (24 studies)	⊕⊝⊝⊝ very low^1,4,5
Overall tolerability Drop‐out due to adverse events Follow‐up: 3 to 12 weeks	45 per 1000	165 per 1000 (114 to 232)	OR 4.15 (2.71 to 6.35)	2174 (19 studies)	⊕⊕⊕⊝ moderate¹
The basis for the assumed risk* (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: confidence interval; OR: odds ratio
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.
¹ The randomisation and allocation methods were usually unclear. Drop‐outs were often not clearly described. ² There was a possibility of publication bias, but according to the trim and fill method the suspected missing studies would not have changed the overall effect size much. ³ Not a single study reported on this outcome. ⁴ There was moderate heterogeneity (I² = 48%). Some studies showed superiority of amitriptyline and others of placebo. ⁵ Acceptability of treatment was measured indirectly by the number of participants leaving the studies prematurely.

Summary of findings for the main comparison. Amitriptyline versus placebo for major depressive disorder

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Comparison 1. Amitriptyline versus placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Response Show forest plot	31	3228	Odds Ratio (M‐H, Random, 95% CI)	2.64 [2.28, 3.06]

1.1 at 1 to 5 weeks	13	1241	Odds Ratio (M‐H, Random, 95% CI)	2.59 [2.03, 3.29]
1.2 at 6 to 12 weeks	18	1987	Odds Ratio (M‐H, Random, 95% CI)	2.67 [2.21, 3.23]
2 Remission Show forest plot	2	120	Odds Ratio (M‐H, Random, 95% CI)	3.29 [1.48, 7.31]

2.1 at 1 to 5 weeks	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
2.2 at 6 to 12 weeks	2	120	Odds Ratio (M‐H, Random, 95% CI)	3.29 [1.48, 7.31]
3 Mean severity of depression ‐ change scores Show forest plot	11	1496	Std. Mean Difference (IV, Random, 95% CI)	‐0.63 [‐0.73, ‐0.52]

3.1 at 1 to 5 weeks	3	498	Std. Mean Difference (IV, Random, 95% CI)	‐0.61 [‐0.83, ‐0.40]
3.2 at 6 to 12 weeks	8	998	Std. Mean Difference (IV, Random, 95% CI)	‐0.63 [‐0.76, ‐0.50]
4 Mean severity of depression ‐ endpoint scores Show forest plot	21	1599	Std. Mean Difference (IV, Random, 95% CI)	‐0.59 [‐0.69, ‐0.49]

4.1 at 1 to 5 weeks	10	720	Std. Mean Difference (IV, Random, 95% CI)	‐0.61 [‐0.77, ‐0.46]
4.2 at 6 to 12 weeks	11	879	Std. Mean Difference (IV, Random, 95% CI)	‐0.57 [‐0.71, ‐0.43]
5 Drop‐out: total Show forest plot	24	2400	Odds Ratio (M‐H, Random, 95% CI)	0.71 [0.55, 0.93]

5.1 at 1 to 5 weeks	9	770	Odds Ratio (M‐H, Random, 95% CI)	0.86 [0.59, 1.25]
5.2 at 6 to 12 weeks	15	1630	Odds Ratio (M‐H, Random, 95% CI)	0.65 [0.46, 0.92]
6 Drop‐out: due to inefficacy Show forest plot	19	2017	Odds Ratio (M‐H, Random, 95% CI)	0.20 [0.14, 0.28]

6.1 at 1 to 5 weeks	7	584	Odds Ratio (M‐H, Random, 95% CI)	0.25 [0.14, 0.43]
6.2 at 6 to 12 weeks	12	1433	Odds Ratio (M‐H, Random, 95% CI)	0.17 [0.10, 0.29]
7 Drop‐out: due to adverse events Show forest plot	19	2174	Odds Ratio (M‐H, Random, 95% CI)	4.15 [2.71, 6.35]

7.1 at 1 to 5 weeks	8	756	Odds Ratio (M‐H, Random, 95% CI)	4.29 [2.19, 8.38]
7.2 at 6 to 12 weeks	11	1418	Odds Ratio (M‐H, Random, 95% CI)	4.15 [2.31, 7.43]
8 Side effects ‐ total number of patients experiencing at least one side effect Show forest plot	7	802	Odds Ratio (M‐H, Random, 95% CI)	4.64 [2.45, 8.78]

8.1 1 to 5 weeks	2	162	Odds Ratio (M‐H, Random, 95% CI)	1.77 [0.33, 9.57]
8.2 at 6 to 12 weeks	5	640	Odds Ratio (M‐H, Random, 95% CI)	6.27 [2.95, 13.29]
9 Side effects ‐ anticholinergic: any anticholinergic effects (dry mouth, constipation, visual disturbances) Show forest plot	2	279	Odds Ratio (M‐H, Random, 95% CI)	6.33 [3.44, 11.65]

9.1 at 1 to 5 weeks	1	143	Odds Ratio (M‐H, Random, 95% CI)	6.5 [2.36, 17.87]
9.2 at 6 to 12 weeks	1	136	Odds Ratio (M‐H, Random, 95% CI)	6.23 [2.90, 13.39]
10 Side effects ‐ anticholinergic: constipation Show forest plot	9	1255	Odds Ratio (M‐H, Random, 95% CI)	3.39 [2.36, 4.88]

10.1 at 1 to 5 weeks	2	251	Odds Ratio (M‐H, Random, 95% CI)	1.56 [0.75, 3.23]
10.2 at 6 to 12 weeks	7	1004	Odds Ratio (M‐H, Random, 95% CI)	4.39 [2.89, 6.68]
11 Side effects ‐ anticholinergic: dry mouth Show forest plot	11	1414	Odds Ratio (M‐H, Random, 95% CI)	13.50 [9.38, 19.42]

11.1 at 1 to 5 weeks	3	311	Odds Ratio (M‐H, Random, 95% CI)	8.76 [4.80, 15.98]
11.2 at 6 to 12 weeks	8	1103	Odds Ratio (M‐H, Random, 95% CI)	15.15 [9.73, 23.61]
12 Side effects ‐ anticholinergic: nasal congestion Show forest plot	1	40	Odds Ratio (M‐H, Random, 95% CI)	0.18 [0.01, 4.01]

12.1 at 1 to 5 weeks	1	40	Odds Ratio (M‐H, Random, 95% CI)	0.18 [0.01, 4.01]
12.2 at 6 to 12 weeks	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
13 Side effects ‐ anticholinergic: urination problems Show forest plot	3	418	Odds Ratio (M‐H, Random, 95% CI)	8.73 [1.95, 39.12]

13.1 at 1 to 5 weeks	1	19	Odds Ratio (M‐H, Random, 95% CI)	1.96 [0.07, 54.67]
13.2 at 6 to 12 weeks	2	399	Odds Ratio (M‐H, Random, 95% CI)	12.77 [2.38, 68.55]
14 Side effects ‐ anticholinergic: vision problems (amblyopia, blurred vision) Show forest plot	10	1055	Odds Ratio (M‐H, Random, 95% CI)	3.73 [2.39, 5.82]

14.1 at 1 5 weeks	4	326	Odds Ratio (M‐H, Random, 95% CI)	2.49 [1.11, 5.57]
14.2 at 6 12 weeks	6	729	Odds Ratio (M‐H, Random, 95% CI)	4.45 [2.61, 7.61]
15 Side effects ‐ cardiovascular: hypertension Show forest plot	1	100	Odds Ratio (M‐H, Random, 95% CI)	2.14 [0.50, 9.07]

15.1 at 1 to 5 weeks	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
15.2 at 6 to 12 weeks	1	100	Odds Ratio (M‐H, Random, 95% CI)	2.14 [0.50, 9.07]
16 Side effects ‐ cardiovascular: hypotension Show forest plot	1	100	Odds Ratio (M‐H, Random, 95% CI)	3.91 [0.77, 19.83]

16.1 at 1 to 5 weeks	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
16.2 at 6 to 12 weeks	1	100	Odds Ratio (M‐H, Random, 95% CI)	3.91 [0.77, 19.83]
17 Side effects ‐ cardiovascular: lightheadedness Show forest plot	1	31	Odds Ratio (M‐H, Random, 95% CI)	3.79 [0.75, 19.04]

17.1 at 1 to 5 weeks	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
17.2 at 6 to 12 weeks	1	31	Odds Ratio (M‐H, Random, 95% CI)	3.79 [0.75, 19.04]
18 Side effects ‐ cardiovascular: palpitations Show forest plot	1	299	Odds Ratio (M‐H, Random, 95% CI)	3.15 [0.84, 11.87]

18.1 at 1 to 5 weeks	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
18.2 at 6 to 12 weeks	1	299	Odds Ratio (M‐H, Random, 95% CI)	3.15 [0.84, 11.87]
19 Side effects ‐ cardiovascular: tachycardia Show forest plot	5	384	Odds Ratio (M‐H, Random, 95% CI)	3.88 [1.71, 8.80]

19.1 at 1 to 5 weeks	1	40	Odds Ratio (M‐H, Random, 95% CI)	3.15 [0.12, 82.16]
19.2 at 6 to 12 weeks	4	344	Odds Ratio (M‐H, Random, 95% CI)	4.32 [1.64, 11.37]
20 Side effects ‐ central nervous: agitation Show forest plot	2	339	Odds Ratio (M‐H, Random, 95% CI)	1.52 [0.79, 2.93]

20.1 at 1 to 5 weeks	1	40	Odds Ratio (M‐H, Random, 95% CI)	5.54 [0.25, 123.08]
20.2 at 6 to 12 weeks	1	299	Odds Ratio (M‐H, Random, 95% CI)	1.43 [0.73, 2.80]
21 Side effects ‐ central nervous: amnesia Show forest plot	1	299	Odds Ratio (M‐H, Random, 95% CI)	13.63 [0.76, 244.23]

21.1 at 1 to 5 weeks	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
21.2 at 6 to 12 weeks	1	299	Odds Ratio (M‐H, Random, 95% CI)	13.63 [0.76, 244.23]
22 Side effects ‐ central nervous: confusion Show forest plot	4	228	Odds Ratio (M‐H, Random, 95% CI)	2.76 [0.50, 15.33]

22.1 at 1 to 5 weeks	2	98	Odds Ratio (M‐H, Random, 95% CI)	0.79 [0.19, 3.32]
22.2 at 6 to 12 weeks	2	130	Odds Ratio (M‐H, Random, 95% CI)	6.06 [0.85, 43.07]
23 Side effects ‐ central nervous: disco‐ordination Show forest plot	1	100	Odds Ratio (M‐H, Random, 95% CI)	6.68 [0.77, 57.70]

23.1 at 1 to 5 weeks	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
23.2 at 6 to 12 weeks	1	100	Odds Ratio (M‐H, Random, 95% CI)	6.68 [0.77, 57.70]
24 Side effects ‐ central nervous: dizziness Show forest plot	8	1246	Odds Ratio (M‐H, Random, 95% CI)	2.92 [2.07, 4.11]

24.1 at 1 to 5 weeks	3	373	Odds Ratio (M‐H, Random, 95% CI)	1.81 [0.93, 3.52]
24.2 at 6 to 12 weeks	5	873	Odds Ratio (M‐H, Random, 95% CI)	3.46 [2.32, 5.17]
25 Side effects ‐ central nervous: headache Show forest plot	9	1173	Odds Ratio (M‐H, Random, 95% CI)	0.84 [0.54, 1.29]

25.1 at 1 to 5 weeks	3	269	Odds Ratio (M‐H, Random, 95% CI)	0.90 [0.29, 2.75]
25.2 at 6 to 12 weeks	6	904	Odds Ratio (M‐H, Random, 95% CI)	0.85 [0.50, 1.43]
26 Side effects ‐ central nervous: increased activity Show forest plot	1	40	Odds Ratio (M‐H, Random, 95% CI)	3.15 [0.12, 82.16]

26.1 at 1 to 5 weeks	1	40	Odds Ratio (M‐H, Random, 95% CI)	3.15 [0.12, 82.16]
26.2 at 6 to 12 weeks	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
27 Side effects ‐ central nervous: insomnia Show forest plot	5	923	Odds Ratio (M‐H, Random, 95% CI)	0.70 [0.39, 1.24]

27.1 at 1 to 5 weeks	2	250	Odds Ratio (M‐H, Random, 95% CI)	0.41 [0.12, 1.36]
27.2 at 6 to 12 weeks	3	673	Odds Ratio (M‐H, Random, 95% CI)	0.81 [0.42, 1.57]
28 Side effects ‐ central nervous: nervousness Show forest plot	4	449	Odds Ratio (M‐H, Random, 95% CI)	2.46 [0.73, 8.35]

28.1 at 1 to 5 weeks	1	58	Odds Ratio (M‐H, Random, 95% CI)	0.63 [0.11, 3.40]
28.2 at 6 to 12 weeks	3	391	Odds Ratio (M‐H, Random, 95% CI)	3.79 [1.06, 13.56]
29 Side effects ‐ central nervous: sedation/sleepiness/somnolence/drowsiness Show forest plot	13	1690	Odds Ratio (M‐H, Random, 95% CI)	5.50 [3.69, 8.20]

29.1 at 1 to 5 weeks	4	451	Odds Ratio (M‐H, Random, 95% CI)	2.36 [0.97, 5.76]
29.2 at 6 to 12 weeks	9	1239	Odds Ratio (M‐H, Random, 95% CI)	7.20 [5.10, 10.17]
30 Side effects ‐ central nervous: tremor Show forest plot	10	1230	Odds Ratio (M‐H, Random, 95% CI)	5.68 [3.19, 10.10]

30.1 at 1 to 5 weeks	3	241	Odds Ratio (M‐H, Random, 95% CI)	2.49 [0.92, 6.71]
30.2 at 6 to 12 weeks	7	989	Odds Ratio (M‐H, Random, 95% CI)	8.38 [4.42, 15.89]
31 Side effects ‐ dermal: rash Show forest plot	2	140	Odds Ratio (M‐H, Random, 95% CI)	7.44 [0.37, 147.92]

31.1 at 1 to 5 weeks	1	40	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
31.2 at 6 to 12 weeks	1	100	Odds Ratio (M‐H, Random, 95% CI)	7.44 [0.37, 147.92]
32 Side effects ‐ dermal: sweating Show forest plot	2	339	Odds Ratio (M‐H, Random, 95% CI)	1.82 [0.28, 12.00]

32.1 at 1 to 5 weeks	1	40	Odds Ratio (M‐H, Random, 95% CI)	8.2 [0.40, 169.90]
32.2 at 6 to 12 weeks	1	299	Odds Ratio (M‐H, Random, 95% CI)	1.01 [0.29, 3.55]
33 Side effects ‐ gastrointestinal: anorexia Show forest plot	1	299	Odds Ratio (M‐H, Random, 95% CI)	0.20 [0.02, 1.70]

33.1 at 1 to 5 weeks	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
33.2 at 6 to 12 weeks	1	299	Odds Ratio (M‐H, Random, 95% CI)	0.20 [0.02, 1.70]
34 Side effects ‐ gastrointestinal: diarrhoea Show forest plot	2	339	Odds Ratio (M‐H, Random, 95% CI)	0.51 [0.21, 1.24]

34.1 at 1 to 5 weeks	1	40	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
34.2 at 6 to 12 weeks	1	299	Odds Ratio (M‐H, Random, 95% CI)	0.51 [0.21, 1.24]
35 Side effects ‐ gastrointestinal: dyspepsia Show forest plot	5	859	Odds Ratio (M‐H, Random, 95% CI)	6.79 [2.49, 18.52]

35.1 at 1 to 5 weeks	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
35.2 at 6 to 12 weeks	5	859	Odds Ratio (M‐H, Random, 95% CI)	6.79 [2.49, 18.52]
36 Side effects ‐ gastrointestinal: gastralgia Show forest plot	2	172	Odds Ratio (M‐H, Random, 95% CI)	1.89 [0.82, 4.35]

36.1 at 1 to 5 weeks	1	58	Odds Ratio (M‐H, Random, 95% CI)	6.71 [0.34, 130.90]
36.2 at 6 to 12 weeks	1	114	Odds Ratio (M‐H, Random, 95% CI)	1.70 [0.71, 4.04]
37 Side effects ‐ gastrointestinal: increased appetite Show forest plot	3	460	Odds Ratio (M‐H, Random, 95% CI)	4.01 [1.95, 8.24]

37.1 at 1 to 5 weeks	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
37.2 at 6 to 12 weeks	3	460	Odds Ratio (M‐H, Random, 95% CI)	4.01 [1.95, 8.24]
38 Side effects ‐ gastrointestinal: nausea Show forest plot	6	749	Odds Ratio (M‐H, Random, 95% CI)	1.22 [0.49, 3.04]

38.1 at 1 to 5 weeks	2	59	Odds Ratio (M‐H, Random, 95% CI)	5.54 [0.25, 123.08]
38.2 at 6 to 12 weeks	4	690	Odds Ratio (M‐H, Random, 95% CI)	1.08 [0.41, 2.84]
39 Side effects ‐ gastrointestinal: vomiting Show forest plot	1	299	Odds Ratio (M‐H, Random, 95% CI)	1.01 [0.14, 7.24]

39.1 at 1 to 5 weeks	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
39.2 at 6 to 12 weeks	1	299	Odds Ratio (M‐H, Random, 95% CI)	1.01 [0.14, 7.24]
40 Side effects ‐ gastrointestinal: weight gain Show forest plot	1	100	Odds Ratio (M‐H, Random, 95% CI)	12.25 [1.50, 99.80]

40.1 at 1 to 5 weeks	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
40.2 at 6 to 12 weeks	1	100	Odds Ratio (M‐H, Random, 95% CI)	12.25 [1.50, 99.80]
41 Side effects ‐ general: fatigue/asthenia/slowed down Show forest plot	6	1051	Odds Ratio (M‐H, Random, 95% CI)	2.44 [1.52, 3.91]

41.1 at 1 to 5 weeks	3	392	Odds Ratio (M‐H, Random, 95% CI)	2.96 [1.06, 8.28]
41.2 at 6 to 12 weeks	3	659	Odds Ratio (M‐H, Random, 95% CI)	2.32 [1.36, 3.94]
42 Side effects ‐ sexual: impotence Show forest plot	1	100	Odds Ratio (M‐H, Random, 95% CI)	9.77 [0.51, 186.52]

42.1 at 1 to 5 weeks	0	0	Odds Ratio (M‐H, Random, 95% CI)	0.0 [0.0, 0.0]
42.2 at 6 to 12 weeks	1	100	Odds Ratio (M‐H, Random, 95% CI)	9.77 [0.51, 186.52]
43 Side effects ‐ sexual: any sexual dysfunction Show forest plot	2	442	Odds Ratio (M‐H, Random, 95% CI)	16.59 [4.54, 60.64]

43.1 at 1 to 5 weeks	1	143	Odds Ratio (M‐H, Random, 95% CI)	7.50 [0.41, 135.98]
43.2 at 6 to 12 weeks	1	299	Odds Ratio (M‐H, Random, 95% CI)	20.24 [4.75, 86.20]
44 Subgroup analysis: industry sponsored ‐ response to treatment Show forest plot	29	2903	Odds Ratio (M‐H, Random, 95% CI)	2.66 [2.28, 3.12]

44.1 industry sponsored	21	2427	Odds Ratio (M‐H, Random, 95% CI)	2.66 [2.25, 3.15]
44.2 not industry sponsored	8	476	Odds Ratio (M‐H, Random, 95% CI)	2.68 [1.77, 4.05]
45 Subgroup analysis: inpatient versus outpatient studies ‐ response to treatment Show forest plot	31	3228	Odds Ratio (M‐H, Random, 95% CI)	2.70 [2.33, 3.13]

45.1 Outpatients	22	2457	Odds Ratio (M‐H, Random, 95% CI)	2.62 [2.21, 3.10]
45.2 Inpatients	3	93	Odds Ratio (M‐H, Random, 95% CI)	7.80 [2.49, 24.49]
45.3 In‐ and outpatients	3	260	Odds Ratio (M‐H, Random, 95% CI)	3.17 [1.90, 5.30]
45.4 Setting unclear	3	418	Odds Ratio (M‐H, Random, 95% CI)	2.51 [1.68, 3.77]
46 Subgroup analysis: two‐arms versus three‐arms studies ‐ response to treatment Show forest plot	31	3228	Odds Ratio (M‐H, Random, 95% CI)	2.70 [2.33, 3.13]

46.1 Two‐arms studies	2	147	Odds Ratio (M‐H, Random, 95% CI)	4.21 [1.17, 15.14]
46.2 Three‐arms studies	29	3081	Odds Ratio (M‐H, Random, 95% CI)	2.67 [2.30, 3.11]
47 Sensitivity analysis: devoid of studies calculated with imputed statistic methods ‐ response to treatment Show forest plot	9	936	Odds Ratio (M‐H, Random, 95% CI)	2.55 [1.93, 3.36]

47.1 1 to 5 weeks	6	495	Odds Ratio (M‐H, Random, 95% CI)	2.43 [1.53, 3.88]
47.2 at 6 to 12 weeks	3	441	Odds Ratio (M‐H, Random, 95% CI)	2.83 [1.92, 4.17]
48 Sensitivity analysis: fixed instead of random‐effects model ‐ response to treatment Show forest plot	31	3228	Odds Ratio (M‐H, Fixed, 95% CI)	2.71 [2.34, 3.14]

48.1 at 1 to 5 weeks	13	1241	Odds Ratio (M‐H, Fixed, 95% CI)	2.62 [2.07, 3.33]
48.2 at 6 to 12 weeks	18	1987	Odds Ratio (M‐H, Fixed, 95% CI)	2.77 [2.30, 3.34]

Comparison 1. Amitriptyline versus placebo

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