Topical capsaicin (high concentration) for chronic neuropathic pain in adults

Sheena Derry; Andrew SC Rice; Peter Cole; Toni Tan; R Andrew Moore

doi:10.1002/14651858.CD007393.pub4

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Figure 1

Study flow diagram.

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Figure 2

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

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Figure 3

Forest plot of comparison: 1 High‐concentration (8%) capsaicin versus control (single dose), outcome: 1.1 Postherpetic neuralgia ‐ at least 50% pain intensity reduction over weeks 2 to 8.

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Figure 4

Forest plot of comparison: 1 High‐concentration (8%) capsaicin versus control (single dose), outcome: 1.5 Postherpetic neuralgia ‐ Patient Global Impression of Change much or very much improved at 8 and 12 weeks.

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Figure 5

Forest plot of comparison: 1 High‐concentration (8%) capsaicin versus control (single dose), outcome: 1.6 HIV‐neuropathy ‐ at least 30% pain intensity reduction over weeks 2 to 12.

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Figure 6

Forest plot of comparison: 1 High‐concentration (8%) capsaicin versus control (single dose), outcome: 1.10 Serious adverse events.

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Analysis 1.1

Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 1: Postherpetic neuralgia (PHN) ‐ at least 50% pain intensity reduction over weeks 2 to 8

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Analysis 1.2

Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 2: PHN ‐ at least 50% pain intensity reduction over 2 to 12 weeks

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Analysis 1.3

Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 3: PHN ‐ at least 30% pain intensity reduction over weeks 2 to 8

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Analysis 1.4

Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 4: PHN ‐ at least 30% pain intensity reduction over weeks 2 to 12

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Analysis 1.5

Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 5: PHN ‐ Patient Global Impression of ChangePGIC much or very much improved at 8 and 12 weeks

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Analysis 1.6

Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 6: HIV‐neuropathy ‐ at least 30% pain intensity reduction over weeks 2 to 12

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Analysis 1.7

Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 7: Local skin reactions ‐ group 1

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Analysis 1.8

Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 8: Local skin reactions ‐ group 2

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Analysis 1.9

Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 9: Patch tolerability

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Analysis 1.10

Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 10: Serious adverse events

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Analysis 1.11

Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 11: Withdrawals

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Summary of findings 1. High‐concentration (8%) capsaicin patch compared with control patch (0.4%) for postherpetic neuralgia

Outcomes	Outcome with intervention	Outcome with comparator	RR, NNT, NNH, NNTp (95% CI)	Number of studies, participants, events	Quality of the evidence (GRADE)	Comments
High‐concentration (8%) capsaicin patch compared with control patch (0.4%) for postherpetic neuralgia
Patient or population: adults with postherpetic neuralgia Settings: community Intervention: high‐concentration (8%) capsaicin patch, single application Comparison: control patch (0.4% capsaicin), single application
Substantial benefit
PGICvery much improved, week 8 and week 12	No data	No data	‐	‐	Very low	No data
Moderate benefit
PGICmuch or very much improved, week 8	360 in 1000	250 in 1000	RR 1.4 (1.1 to 1.8) NNT 8.8 (5.3 to 26)	2 studies, 571 participants, 178 events	Moderate	Downgraded 1 level due to susceptibility to publication bias
PGIC much or very much improved, week 12	390 in 1000	250 in 1000	RR 1.6 (1.2 to 2.0) NNT 7.0 (4.6 to 15)	2 studies, 571 participants, 189 events	Moderate	Downgraded 1 level due to susceptibility to publication bias
Harm ‐ all conditions combined
Withdrawals due to lack of efficacy	15 in 1000	31 in 1000	RR 0.58 (0.32 to 1.04) NNTp 64 (34 to 610)	6 studies, 2073 participants, 44 events	Moderate	Downgraded 1 level due to imprecision (few events, wide CI)
Withdrawals due to adverse events	8.0 in 1000	9.2 in 1000	RR 0.80 (0.36 to 1.8) NNTp not calculated	8 studies, 2487 participants, 21 events	Moderate	Downgraded 1 level due to sparse data (few events)
Serious adverse events	35 in 1000	32 in 1000	RR 1.1 (0.70 to 1.8) NNH not calculated	7 studies, 1993 participants, 67 events	Moderate	Downgraded 1 level due to sparse data (few events)
Death	4 events	2 events	Not calculated	8 studies, 2487 participants	Very low	Downgraded 3 levels as only six events, so no better grading possibleNo death was judged related to study medication by study authors
CI: confidence interval; NNH: number needed to treat for one additional harmful outcome; NNT: number needed to treat for one additional beneficial outcome; NNTp: number needed to treat to prevent one withdrawal event; PGIC: Patient Global Impression of Change; RR: risk ratio.
Descriptors for levels of evidence (EPOC 2015): High quality: This research provides a very good indication of the likely effect. The likelihood that the effect will be substantially different^† is low. Moderate quality: This research provides a good indication of the likely effect. The likelihood that the effect will be substantially different^† is moderate. Low quality: This research provides some indication of the likely effect. However, the likelihood that it will be substantially different^† is high. Very low quality: This research does not provide a reliable indication of the likely effect. The likelihood that the effect will be substantially different^† is very high. ^† Substantially different: a large enough difference that it might affect a decision.

Summary of findings 1. High‐concentration (8%) capsaicin patch compared with control patch (0.4%) for postherpetic neuralgia

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Comparison 1. High‐concentration (8%) capsaicin versus control (single dose)

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1.1 Postherpetic neuralgia (PHN) ‐ at least 50% pain intensity reduction over weeks 2 to 8 Show forest plot	3	870	Risk Ratio (M‐H, Fixed, 95% CI)	1.44 [1.12, 1.86]

1.1.1 Using 30‐minute application	1	97	Risk Ratio (M‐H, Fixed, 95% CI)	2.95 [0.73, 11.88]
1.1.2 Using 60‐minute application	3	674	Risk Ratio (M‐H, Fixed, 95% CI)	1.34 [1.03, 1.75]
1.1.3 Using 90‐minute application	1	99	Risk Ratio (M‐H, Fixed, 95% CI)	2.02 [0.64, 6.33]
1.2 PHN ‐ at least 50% pain intensity reduction over 2 to 12 weeks Show forest plot	2	571	Risk Ratio (M‐H, Fixed, 95% CI)	1.31 [1.00, 1.71]

1.3 PHN ‐ at least 30% pain intensity reduction over weeks 2 to 8 Show forest plot	4	1268	Risk Ratio (M‐H, Fixed, 95% CI)	1.31 [1.13, 1.52]

1.3.1 Using 30‐minute application	1	97	Risk Ratio (M‐H, Fixed, 95% CI)	1.34 [0.67, 2.69]
1.3.2 Using 60‐minute application	4	1072	Risk Ratio (M‐H, Fixed, 95% CI)	1.30 [1.12, 1.52]
1.3.3 Using 90‐minute application	1	99	Risk Ratio (M‐H, Fixed, 95% CI)	1.48 [0.74, 2.95]
1.4 PHN ‐ at least 30% pain intensity reduction over weeks 2 to 12 Show forest plot	3	973	Risk Ratio (M‐H, Fixed, 95% CI)	1.25 [1.07, 1.45]

1.5 PHN ‐ Patient Global Impression of ChangePGIC much or very much improved at 8 and 12 weeks Show forest plot	2		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.5.1 At 8 weeks	2	571	Risk Ratio (M‐H, Fixed, 95% CI)	1.42 [1.10, 1.84]
1.5.2 At 12 weeks	2	571	Risk Ratio (M‐H, Fixed, 95% CI)	1.55 [1.20, 1.99]
1.6 HIV‐neuropathy ‐ at least 30% pain intensity reduction over weeks 2 to 12 Show forest plot	2	801	Risk Ratio (M‐H, Fixed, 95% CI)	1.35 [1.09, 1.68]

1.6.1 Using 30‐minute application	2	340	Risk Ratio (M‐H, Fixed, 95% CI)	1.67 [1.14, 2.46]
1.6.2 Using 60‐minute application	2	359	Risk Ratio (M‐H, Fixed, 95% CI)	1.10 [0.84, 1.44]
1.6.3 Using 90‐minute application	1	102	Risk Ratio (M‐H, Fixed, 95% CI)	1.94 [0.83, 4.53]
1.7 Local skin reactions ‐ group 1 Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.7.1 Erythema	4	1355	Risk Ratio (M‐H, Fixed, 95% CI)	1.42 [1.32, 1.54]
1.7.2 Pain	4	1355	Risk Ratio (M‐H, Fixed, 95% CI)	2.26 [1.98, 2.59]
1.7.3 Papules	3	1312	Risk Ratio (M‐H, Fixed, 95% CI)	3.58 [1.87, 6.85]
1.7.4 Pruritus	3	1312	Risk Ratio (M‐H, Fixed, 95% CI)	1.99 [0.98, 4.03]
1.7.5 Oedema	3	1312	Risk Ratio (M‐H, Fixed, 95% CI)	2.98 [1.44, 6.18]
1.8 Local skin reactions ‐ group 2 Show forest plot	4		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.8.1 Erythema	1	129	Risk Ratio (M‐H, Fixed, 95% CI)	6.31 [0.35, 114.82]
1.8.2 Pain	4	1105	Risk Ratio (M‐H, Fixed, 95% CI)	2.39 [1.41, 4.05]
1.8.3 Papules	3	735	Risk Ratio (M‐H, Fixed, 95% CI)	1.58 [0.59, 4.24]
1.8.4 Pruritus	3	735	Risk Ratio (M‐H, Fixed, 95% CI)	1.57 [0.98, 2.50]
1.8.5 Oedema	3	735	Risk Ratio (M‐H, Fixed, 95% CI)	1.34 [0.75, 2.39]
1.9 Patch tolerability Show forest plot	7		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.9.1 < 90% of application time	6	2074	Risk Ratio (M‐H, Fixed, 95% CI)	3.27 [1.17, 9.15]
1.9.2 Dermal irritation score > 2 at 2 hours	3	1065	Risk Ratio (M‐H, Fixed, 95% CI)	11.80 [4.04, 34.48]
1.9.3 Dermal irritation score > 0 at 2 hours	2	606	Risk Ratio (M‐H, Fixed, 95% CI)	2.28 [1.60, 3.26]
1.9.4 Pain medication 0 to 5 days	7	2442	Risk Ratio (M‐H, Fixed, 95% CI)	2.52 [2.18, 2.92]
1.10 Serious adverse events Show forest plot	7	1993	Risk Ratio (M‐H, Fixed, 95% CI)	1.14 [0.70, 1.86]

1.11 Withdrawals Show forest plot	8		Risk Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.11.1 Adverse events	8	2487	Risk Ratio (M‐H, Fixed, 95% CI)	0.80 [0.36, 1.78]
1.11.2 Lack of efficacy	6	2073	Risk Ratio (M‐H, Fixed, 95% CI)	0.57 [0.32, 1.02]

Comparison 1. High‐concentration (8%) capsaicin versus control (single dose)

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