Anticonvulsants for fibromyalgia

Nurcan Üçeyler; Claudia Sommer; Brian Walitt; Winfried Häuser

doi:10.1002/14651858.CD010782

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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: 4 Pregabalin versus placebo at end of treatment, outcome: 4.2 50% pain reduction.

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Figure 5

Forest plot of comparison: 4 Pregabalin versus placebo at end of treatment, outcome: 4.3 Fatigue.

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Figure 6

Forest plot of comparison: 4 Pregabalin versus placebo at end of treatment, outcome: 4.4 Sleep problems.

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Analysis 1.1

Comparison 1 Gabapentin flexible 1200 to 2400 mg/day versus placebo at end of treatment, Outcome 1 Pain.

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Analysis 1.2

Comparison 1 Gabapentin flexible 1200 to 2400 mg/day versus placebo at end of treatment, Outcome 2 50% pain reduction.

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Analysis 1.3

Comparison 1 Gabapentin flexible 1200 to 2400 mg/day versus placebo at end of treatment, Outcome 3 Sleep problems.

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Analysis 1.4

Comparison 1 Gabapentin flexible 1200 to 2400 mg/day versus placebo at end of treatment, Outcome 4 Health‐related quality of life.

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Analysis 1.5

Comparison 1 Gabapentin flexible 1200 to 2400 mg/day versus placebo at end of treatment, Outcome 5 Withdrawal due to adverse events.

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Analysis 1.6

Comparison 1 Gabapentin flexible 1200 to 2400 mg/day versus placebo at end of treatment, Outcome 6 Dizziness.

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Analysis 1.7

Comparison 1 Gabapentin flexible 1200 to 2400 mg/day versus placebo at end of treatment, Outcome 7 30% pain reduction.

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Analysis 1.8

Comparison 1 Gabapentin flexible 1200 to 2400 mg/day versus placebo at end of treatment, Outcome 8 Depression.

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Analysis 1.9

Comparison 1 Gabapentin flexible 1200 to 2400 mg/day versus placebo at end of treatment, Outcome 9 Disability.

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Analysis 2.1

Comparison 2 Lacosamide 400 mg/day versus placebo at end of treatment, Outcome 1 Pain.

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Analysis 2.2

Comparison 2 Lacosamide 400 mg/day versus placebo at end of treatment, Outcome 2 Fatigue.

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Analysis 2.3

Comparison 2 Lacosamide 400 mg/day versus placebo at end of treatment, Outcome 3 Sleep problems.

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Analysis 2.4

Comparison 2 Lacosamide 400 mg/day versus placebo at end of treatment, Outcome 4 Health‐related quality of life.

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Analysis 2.5

Comparison 2 Lacosamide 400 mg/day versus placebo at end of treatment, Outcome 5 Serious adverse events.

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Analysis 2.6

Comparison 2 Lacosamide 400 mg/day versus placebo at end of treatment, Outcome 6 Dizziness.

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Analysis 2.7

Comparison 2 Lacosamide 400 mg/day versus placebo at end of treatment, Outcome 7 Anxiety.

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Analysis 2.8

Comparison 2 Lacosamide 400 mg/day versus placebo at end of treatment, Outcome 8 Depression.

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Analysis 2.9

Comparison 2 Lacosamide 400 mg/day versus placebo at end of treatment, Outcome 9 Disability.

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Analysis 2.10

Comparison 2 Lacosamide 400 mg/day versus placebo at end of treatment, Outcome 10 Patient Global Impression of Change 'much' or 'very much' improved.

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Analysis 3.1

Comparison 3 Levetiracetam up to 3000 mg/day versus placebo at end of treatment, Outcome 1 Pain.

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Analysis 3.2

Comparison 3 Levetiracetam up to 3000 mg/day versus placebo at end of treatment, Outcome 2 50% pain reduction.

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Analysis 3.3

Comparison 3 Levetiracetam up to 3000 mg/day versus placebo at end of treatment, Outcome 3 Sleep problems.

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Analysis 3.4

Comparison 3 Levetiracetam up to 3000 mg/day versus placebo at end of treatment, Outcome 4 Health‐related quality of life.

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Analysis 3.5

Comparison 3 Levetiracetam up to 3000 mg/day versus placebo at end of treatment, Outcome 5 Withdrawal due to adverse events.

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Analysis 3.6

Comparison 3 Levetiracetam up to 3000 mg/day versus placebo at end of treatment, Outcome 6 Dizziness.

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Analysis 3.7

Comparison 3 Levetiracetam up to 3000 mg/day versus placebo at end of treatment, Outcome 7 30% pain reduction.

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Analysis 4.1

Comparison 4 Pregabalin versus placebo at end of treatment, Outcome 1 Pain.

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Analysis 4.2

Comparison 4 Pregabalin versus placebo at end of treatment, Outcome 2 50% pain reduction.

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Analysis 4.3

Comparison 4 Pregabalin versus placebo at end of treatment, Outcome 3 Fatigue.

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Analysis 4.4

Comparison 4 Pregabalin versus placebo at end of treatment, Outcome 4 Sleep problems.

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Analysis 4.5

Comparison 4 Pregabalin versus placebo at end of treatment, Outcome 5 Health‐related quality of life.

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Analysis 4.6

Comparison 4 Pregabalin versus placebo at end of treatment, Outcome 6 Withdrawal due to adverse events.

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Analysis 4.7

Comparison 4 Pregabalin versus placebo at end of treatment, Outcome 7 Serious adverse events.

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Analysis 4.8

Comparison 4 Pregabalin versus placebo at end of treatment, Outcome 8 Dizziness.

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Analysis 4.9

Comparison 4 Pregabalin versus placebo at end of treatment, Outcome 9 30% pain reduction.

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Analysis 4.10

Comparison 4 Pregabalin versus placebo at end of treatment, Outcome 10 Anxiety.

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Analysis 4.11

Comparison 4 Pregabalin versus placebo at end of treatment, Outcome 11 Depression.

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Analysis 4.12

Comparison 4 Pregabalin versus placebo at end of treatment, Outcome 12 Disability.

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Analysis 4.13

Comparison 4 Pregabalin versus placebo at end of treatment, Outcome 13 Patient Global Impression of Change 'much' or 'very much' improved.

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Summary of findings for the main comparison. Pregabalin versus placebo at end of treatment for fibromyalgia

Pregabalin versus placebo at final treatment for fibromyalgia
Patient or population: People with fibromyalgia Settings: Research centres Intervention: Pregabalin versus placebo at final treatment
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	Anticonvulsants versus placebo at final treatment
50% pain reduction	137 per 1000	217 per 1000 (182 to 260)	RR 1.59 (1.33 to 1.90)	3256 (5 studies)	⊕⊕⊕⊕ high	Absolute risk difference (fewer pain) 8% (95% CI 6% to 11%) Relative per cent improvement 59% (95% CI 33% to 90%) NNTB 12 (95% CI 9 to 21)
Patient Global Impression of Change of 'much' or 'very much' improved	279 per 1000	385 per 1000 (344 to 432)	RR 1.38 (1.23 to 1.55)	3183 (5 studies)	⊕⊕⊕⊕ high	Absolute risk difference (more global impression of 'much' and 'very much' improved) 12% (95% CI 4% to 20%) Relative per cent improvement 38% (95% CI 23% to 55%) NNTB 9 (95% CI 7 to 15)
Fatigue (1‐50 scale) Higher scores indicate higher fatigue levels	MAF baseline fatigue score control group 35.6 (standard deviation 8.0) **	The mean fatigue in the intervention groups was 0.17 standard deviations lower (0.25 to 0.09 lower)		3195 (5 studies)	⊕⊕⊕⊕ high	SMD ‐0.17 (‐0.25 to ‐0.09) 2.7% (95% CI 1.4% to 4.0%) fewer points on the fatigue scale (absolute improvement) 3.8% (95% CI 2.0% to 5.6%) relative improvement NNTB 13 (95% CI 9 to 25)
Sleep problems (0‐100 scale). Higher scores indicate more sleep problems	MOS baseline overall sleep problem index control group 58.5 (17.8) ***	The mean sleep problems in the intervention groups was 0.35 standard deviations lower (0.43 to 0.27 lower)		3139 (5 studies)	⊕⊕⊕⊕ high	SMD ‐0.35 (‐0.43 to ‐0.27) 6.2% (95% CI 4.8% to 7.7%) fewer points on the sleep problem scale (absolute improvement) 10.6% (95% CI 82.% to 13.1%) relative improvement NNTB 7 (95% CI 5 to 8)
Withdrawal due to adverse events	110 per 1000	185 per 1000 (150 to 229)	RR 1.68 (1.36 to 2.07)	3259 (5 studies)	⊕⊕⊕⊕ high	Absolute risk difference (more withdrawal due to adverse events) 8% (95% CI 5% to 12%) Relative per cent worsening 68% (95% CI 36% to 107%) NNTH 13 (95% CI 9 to 23)
Serious adverse events	41 per 1000	42 per 1000 (29 to 61)	RR 1.03 (0.71 to 1.49)	2729 (4 studies)	⊕⊕⊕⊝ moderate ¹	Absolute risk difference 0 (95% CI ‐1 to 1) Relative per cent change 0 (95% CI ‐1 to 1) Not statistically significant
Dizziness reported to be an adverse event	93 per 1000	350 per 1000 (284 to 429)	RR 3.77 (3.06 to 4.63)	3257 (5 studies)	⊕⊕⊕⊕ high	Absolute risk difference (more dizziness) 28% (95% CI 24% to 32%) Relative per cent worsening 277% (95% CI 206% to 363%) NNTH 4 (95% CI 3 to 5)
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; MAF: Multidimensional Assessment of Fatigue; MOS: Medical Outcomes Study; NNTB: number needed to treat for an additional beneficial outcome; NNTH: number needed to treat for an additional harmful outcome; NRS: numeric rating scale; RR: risk ratio; SMD: standardised mean difference.
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 Frequency of serious adverse events not reported by one study. Arnold 2008: n = 190 participants; MAF (NRS 1‐50). * Arnold 2008: n = 190 participants; MOS Overall Sleep Problems Index (NRS 0‐100).

Summary of findings for the main comparison. Pregabalin versus placebo at end of treatment for fibromyalgia

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Comparison 1. Gabapentin flexible 1200 to 2400 mg/day versus placebo at end of treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain Show forest plot	1	119	Std. Mean Difference (IV, Random, 95% CI)	‐0.49 [‐0.86, ‐0.13]

2 50% pain reduction Show forest plot	1	150	Risk Ratio (IV, Random, 95% CI)	1.6 [1.01, 2.53]

3 Sleep problems Show forest plot	1	119	Std. Mean Difference (IV, Random, 95% CI)	‐0.71 [‐1.08, ‐0.34]

4 Health‐related quality of life Show forest plot	1	119	Std. Mean Difference (IV, Random, 95% CI)	‐0.66 [‐1.03, ‐0.29]

5 Withdrawal due to adverse events Show forest plot	1	150	Risk Ratio (IV, Random, 95% CI)	1.71 [0.71, 4.11]

6 Dizziness Show forest plot	1	150	Risk Ratio (IV, Random, 95% CI)	2.71 [1.21, 6.07]

7 30% pain reduction Show forest plot	1	150	Risk Ratio (M‐H, Random, 95% CI)	1.65 [1.10, 2.48]

8 Depression Show forest plot	1	119	Std. Mean Difference (IV, Random, 95% CI)	‐0.52 [‐0.89, ‐0.16]

9 Disability Show forest plot	1	119	Std. Mean Difference (IV, Random, 95% CI)	‐0.94 [‐1.32, ‐0.56]

Comparison 1. Gabapentin flexible 1200 to 2400 mg/day versus placebo at end of treatment

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Comparison 2. Lacosamide 400 mg/day versus placebo at end of treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain Show forest plot	1	158	Std. Mean Difference (IV, Random, 95% CI)	‐0.25 [‐0.56, 0.07]

2 Fatigue Show forest plot	1	121	Std. Mean Difference (IV, Random, 95% CI)	‐0.07 [‐0.43, 0.28]

3 Sleep problems Show forest plot	1	158	Std. Mean Difference (IV, Random, 95% CI)	‐0.19 [‐0.51, 0.12]

4 Health‐related quality of life Show forest plot	1	157	Std. Mean Difference (IV, Random, 95% CI)	‐0.15 [‐0.47, 0.16]

5 Serious adverse events Show forest plot	1	159	Risk Ratio (IV, Random, 95% CI)	0.15 [0.01, 2.82]

6 Dizziness Show forest plot	1	159	Risk Ratio (IV, Random, 95% CI)	2.34 [1.08, 5.06]

7 Anxiety Show forest plot	1	133	Std. Mean Difference (IV, Random, 95% CI)	0.0 [‐0.34, 0.34]

8 Depression Show forest plot	1	134	Std. Mean Difference (IV, Random, 95% CI)	0.11 [‐0.23, 0.45]

9 Disability Show forest plot	1	158	Std. Mean Difference (IV, Random, 95% CI)	‐0.19 [‐0.51, 0.12]

10 Patient Global Impression of Change 'much' or 'very much' improved Show forest plot	1	134	Risk Ratio (IV, Random, 95% CI)	1.32 [0.85, 2.04]

Comparison 2. Lacosamide 400 mg/day versus placebo at end of treatment

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Comparison 3. Levetiracetam up to 3000 mg/day versus placebo at end of treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain Show forest plot	1	50	Std. Mean Difference (IV, Random, 95% CI)	‐0.21 [‐0.77, 0.36]

2 50% pain reduction Show forest plot	1	66	Risk Ratio (IV, Random, 95% CI)	1.52 [0.43, 5.34]

3 Sleep problems Show forest plot	1	50	Std. Mean Difference (IV, Random, 95% CI)	‐0.16 [‐0.72, 0.40]

4 Health‐related quality of life Show forest plot	1	50	Std. Mean Difference (IV, Random, 95% CI)	0.14 [‐0.42, 0.70]

5 Withdrawal due to adverse events Show forest plot	1	66	Risk Ratio (IV, Random, 95% CI)	0.87 [0.21, 3.56]

6 Dizziness Show forest plot	1	66	Risk Ratio (IV, Random, 95% CI)	1.3 [1.02, 1.66]

7 30% pain reduction Show forest plot	1	66	Risk Ratio (IV, Random, 95% CI)	1.23 [0.65, 2.33]

Comparison 3. Levetiracetam up to 3000 mg/day versus placebo at end of treatment

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Comparison 4. Pregabalin versus placebo at end of treatment

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Pain Show forest plot	5	3252	Std. Mean Difference (IV, Random, 95% CI)	‐0.28 [‐0.35, ‐0.20]

1.1 Pregabalin 150 mg/d	1	175	Std. Mean Difference (IV, Random, 95% CI)	‐0.10 [‐0.45, 0.24]
1.2 Pregabalin 300 mg/d	4	913	Std. Mean Difference (IV, Random, 95% CI)	‐0.24 [‐0.39, ‐0.09]
1.3 Pregabalin 450 mg/d	4	915	Std. Mean Difference (IV, Random, 95% CI)	‐0.36 [‐0.51, ‐0.20]
1.4 Pregabalin 600 mg/d	3	751	Std. Mean Difference (IV, Random, 95% CI)	‐0.30 [‐0.51, ‐0.09]
1.5 Pregabalin flexible 300 or 450 mg/d	1	498	Std. Mean Difference (IV, Random, 95% CI)	‐0.24 [‐0.41, ‐0.06]
2 50% pain reduction Show forest plot	5	3256	Risk Ratio (IV, Random, 95% CI)	1.59 [1.33, 1.90]

2.1 Pregabalin 150 mg/d	1	175	Risk Ratio (IV, Random, 95% CI)	0.92 [0.39, 2.19]
2.2 Pregabalin 300 mg/d	4	915	Risk Ratio (IV, Random, 95% CI)	1.45 [1.03, 2.05]
2.3 Pregabalin 450 mg/d	4	916	Risk Ratio (IV, Random, 95% CI)	1.75 [1.23, 2.49]
2.4 Pregabalin 600 mg/d	3	752	Risk Ratio (IV, Random, 95% CI)	1.51 [1.04, 2.20]
2.5 Pregabalin flexible 300 mg/d or 450 mg/d	1	498	Risk Ratio (IV, Random, 95% CI)	1.88 [1.26, 2.83]
3 Fatigue Show forest plot	5	3195	Std. Mean Difference (IV, Random, 95% CI)	‐0.17 [‐0.25, ‐0.09]

3.1 Pregabalin 150 mg/d	1	165	Std. Mean Difference (IV, Random, 95% CI)	‐0.20 [‐0.56, 0.15]
3.2 Pregabalin 300 mg/d	4	892	Std. Mean Difference (IV, Random, 95% CI)	‐0.16 [‐0.31, ‐0.01]
3.3 Pregabalin 450 mg/d	4	897	Std. Mean Difference (IV, Random, 95% CI)	‐0.15 [‐0.30, 0.01]
3.4 Pregabalin 600 mg/d	3	743	Std. Mean Difference (IV, Random, 95% CI)	‐0.08 [‐0.25, 0.09]
3.5 Pregabalin flexible 300 or 450 mg/d	1	498	Std. Mean Difference (IV, Random, 95% CI)	‐0.31 [‐0.49, ‐0.14]
4 Sleep problems Show forest plot	5	3193	Std. Mean Difference (IV, Random, 95% CI)	‐0.35 [‐0.43, ‐0.27]

4.1 Pregabalin 150 mg/d	1	163	Std. Mean Difference (IV, Random, 95% CI)	‐0.44 [‐0.80, ‐0.08]
4.2 Pregabalin 300 mg/d	4	897	Std. Mean Difference (IV, Random, 95% CI)	‐0.29 [‐0.44, ‐0.14]
4.3 Pregabalin 450 mg/d	4	893	Std. Mean Difference (IV, Random, 95% CI)	‐0.45 [‐0.63, ‐0.27]
4.4 Pregabalin 600 mg/d	3	744	Std. Mean Difference (IV, Random, 95% CI)	‐0.40 [‐0.57, ‐0.23]
4.5 Pregabalin flexible 300 or 450 mg/d	1	496	Std. Mean Difference (IV, Random, 95% CI)	‐0.20 [‐0.37, ‐0.02]
5 Health‐related quality of life Show forest plot	4	2724	Std. Mean Difference (IV, Random, 95% CI)	‐0.17 [‐0.26, ‐0.09]

5.1 Pregabalin 300 mg/d	3	738	Std. Mean Difference (IV, Random, 95% CI)	‐0.12 [‐0.28, 0.05]
5.2 Pregabalin 450 mg/d	3	737	Std. Mean Difference (IV, Random, 95% CI)	‐0.24 [‐0.41, ‐0.07]
5.3 Pregabalin 600 mg/d	3	751	Std. Mean Difference (IV, Random, 95% CI)	‐0.14 [‐0.31, 0.02]
5.4 Pregabalin flexible 300 mg/d or 450 mg/d	1	498	Std. Mean Difference (IV, Random, 95% CI)	‐0.20 [‐0.37, ‐0.02]
6 Withdrawal due to adverse events Show forest plot	5	3259	Risk Ratio (IV, Random, 95% CI)	1.68 [1.36, 2.07]

6.1 Pregabalin 150 mg/d	1	175	Risk Ratio (IV, Random, 95% CI)	1.19 [0.35, 4.08]
6.2 Pregabalin 300 mg/d	4	917	Risk Ratio (IV, Random, 95% CI)	1.54 [1.02, 2.34]
6.3 Pregabalin 450 mg/d	4	917	Risk Ratio (IV, Random, 95% CI)	2.02 [1.32, 3.09]
6.4 Pregabalin 600 mg/d	3	752	Risk Ratio (IV, Random, 95% CI)	2.53 [1.65, 3.86]
6.5 Pregabalin flexible 300 mg/d or 450 mg/d	1	498	Risk Ratio (IV, Random, 95% CI)	1.01 [0.65, 1.57]
7 Serious adverse events Show forest plot	4	2729	Risk Ratio (IV, Random, 95% CI)	1.03 [0.71, 1.49]

7.1 Pregabalin 300 mg/d	3	738	Risk Ratio (IV, Random, 95% CI)	0.96 [0.50, 1.86]
7.2 Pregabalin 450 mg/d	3	741	Risk Ratio (IV, Random, 95% CI)	1.03 [0.52, 2.03]
7.3 Pregabalin 600 mg/d	3	752	Risk Ratio (IV, Random, 95% CI)	1.01 [0.55, 1.87]
7.4 Pregabalin flexible 300 mg/d or 450 mg/d	1	498	Risk Ratio (IV, Random, 95% CI)	2.98 [0.31, 28.42]
8 Dizziness Show forest plot	5	3257	Risk Ratio (IV, Random, 95% CI)	3.77 [3.06, 4.63]

8.1 Pregabalin 150 mg/d	1	175	Risk Ratio (IV, Random, 95% CI)	2.44 [0.91, 6.54]
8.2 Pregabalin 300 mg/d	4	916	Risk Ratio (IV, Random, 95% CI)	3.11 [2.09, 4.65]
8.3 Pregabalin 450 mg/d	4	917	Risk Ratio (IV, Random, 95% CI)	3.95 [2.68, 5.82]
8.4 Pregabalin 600 mg/d	3	751	Risk Ratio (IV, Random, 95% CI)	4.00 [2.65, 6.03]
8.5 Pregabalin flexible 300 mg/d or 450 mg/d	1	498	Risk Ratio (IV, Random, 95% CI)	4.89 [2.89, 8.28]
9 30% pain reduction Show forest plot	5	3259	Risk Ratio (IV, Random, 95% CI)	1.37 [1.22, 1.53]

9.1 Pregabalin 150 mg/d	1	176	Risk Ratio (IV, Random, 95% CI)	1.05 [0.62, 1.77]
9.2 Pregabalin 300 mg/d	4	916	Risk Ratio (IV, Random, 95% CI)	1.35 [1.08, 1.68]
9.3 Pregabalin 450 mg/d	4	917	Risk Ratio (IV, Random, 95% CI)	1.49 [1.20, 1.85]
9.4 Pregabalin 600 mg/d	3	752	Risk Ratio (IV, Random, 95% CI)	1.37 [1.07, 1.76]
9.5 Pregabalin flexible 300 mg/d or 450 mg/d	1	498	Risk Ratio (IV, Random, 95% CI)	1.32 [1.04, 1.68]
10 Anxiety Show forest plot	5	3214	Std. Mean Difference (IV, Random, 95% CI)	‐0.12 [‐0.20, ‐0.04]

10.1 Pregabalin 150 mg/d	1	166	Std. Mean Difference (IV, Random, 95% CI)	0.07 [‐0.28, 0.42]
10.2 Pregabalin 300 mg/d	4	903	Std. Mean Difference (IV, Random, 95% CI)	‐0.05 [‐0.20, 0.10]
10.3 Pregabalin 450 mg/d	4	900	Std. Mean Difference (IV, Random, 95% CI)	‐0.15 [‐0.30, 0.00]
10.4 Pregabalin 600 mg/d	3	749	Std. Mean Difference (IV, Random, 95% CI)	‐0.16 [‐0.32, 0.01]
10.5 Pregabalin flexible 300 mg/d or 450 mg/d	1	496	Std. Mean Difference (IV, Random, 95% CI)	‐0.17 [‐0.35, 0.01]
11 Depression Show forest plot	5	3212	Std. Mean Difference (IV, Random, 95% CI)	‐0.09 [‐0.16, ‐0.01]

11.1 Pregabalin 150 mg/d	1	165	Std. Mean Difference (IV, Random, 95% CI)	‐0.10 [‐0.45, 0.25]
11.2 Pregabalin 300 mg/d	4	902	Std. Mean Difference (IV, Random, 95% CI)	‐0.05 [‐0.20, 0.10]
11.3 Pregabalin 450 mg/d	4	900	Std. Mean Difference (IV, Random, 95% CI)	‐0.13 [‐0.28, 0.02]
11.4 Pregabalin 600 mg/d	3	749	Std. Mean Difference (IV, Random, 95% CI)	‐0.06 [‐0.23, 0.10]
11.5 Pregabalin flexible 300 mg/d or 450 mg/d	1	496	Std. Mean Difference (IV, Random, 95% CI)	‐0.09 [‐0.27, 0.08]
12 Disability Show forest plot	5	3145	Std. Mean Difference (IV, Random, 95% CI)	‐0.01 [‐0.11, 0.09]

12.1 Pregabalin 150 mg/d	1	166	Std. Mean Difference (IV, Random, 95% CI)	0.11 [‐0.24, 0.47]
12.2 Pregabalin 300 mg/d	4	879	Std. Mean Difference (IV, Random, 95% CI)	0.04 [‐0.11, 0.20]
12.3 Pregabalin 450 mg/d	4	888	Std. Mean Difference (IV, Random, 95% CI)	0.00 [‐0.17, 0.18]
12.4 Pregabalin 600 mg/d	3	714	Std. Mean Difference (IV, Random, 95% CI)	0.03 [‐0.14, 0.21]
12.5 Pregabalin flexible 300 mg/d or 450 mg/d	1	498	Std. Mean Difference (IV, Random, 95% CI)	‐0.29 [‐0.47, ‐0.12]
13 Patient Global Impression of Change 'much' or 'very much' improved Show forest plot	5	3183	Risk Ratio (IV, Random, 95% CI)	1.38 [1.23, 1.55]

13.1 Pregabalin 150 mg/d	1	175	Risk Ratio (IV, Random, 95% CI)	1.30 [0.74, 2.29]
13.2 Pregabalin 300 mg/d	4	886	Risk Ratio (IV, Random, 95% CI)	1.25 [0.99, 1.57]
13.3 Pregabalin 450 mg/d	4	892	Risk Ratio (IV, Random, 95% CI)	1.54 [1.15, 2.06]
13.4 Pregabalin 600 mg/d	3	734	Risk Ratio (IV, Random, 95% CI)	1.37 [1.06, 1.76]
13.5 Pregabalin flexible 300 mg/d or 450 mg/d	1	496	Risk Ratio (IV, Random, 95% CI)	1.44 [1.11, 1.87]

Comparison 4. Pregabalin versus placebo at end of treatment

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