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Capsaicina tópica (alta concentración) para el dolor neuropático crónico en adultos

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Appendices

Appendix 1. MEDLINE search strategy (via Ovid)

  1. Capsaicin.sh

  2. (capsaicin OR capsaicine OR capsici OR axsain OR capsidol OR capsig OR capsin OR capsina OR capsiplast OR capzasin‐P OR dolorac OR gelcen OR katrum OR "No pain‐HP" OR priltam OR "R‐gel" OR zacin OR zostrix OR capsicum).ti,ab,kw

  3. 1 OR 2

  4. exp Administration, topical.sh

  5. (topical$ OR cutaneous OR dermal OR transcutaneous OR transdermal OR percutaneous OR skin OR massage OR embrocation OR gel OR ointment OR aerosol OR cream OR crème OR lotion OR foam OR liniment OR spray OR rub OR balm OR salve OR emulsion OR oil OR patch OR plaster).ti,ab,kw

  6. 4 OR 5

  7. Diabetic neuropathies.sh OR Peripheral neuropathies.sh OR Polyneuropathies.sh OR Neuralgia.sh

  8. (neuropath$ OR diabet$ post‐herpetic OR neuralgia).ti,ab,kw

  9. 7 OR 8

  10. (pain OR painful OR analgesi$).ti,ab,kw

  11. randomized controlled trial.pt

  12. controlled clinical trial.pt

  13. randomized.ab

  14. placebo.ab

  15. drug therapy.fs

  16. randomly.ab

  17. trial.ab

  18. groups.ab

  19. OR/11‐18

  20. 3 AND 6 AND 9 AND 19

Appendix 2. EMBASE search strategy (via Ovid)

  1. Capsaicin.sh

  2. (capsaicin OR capsaicine OR capsici OR axsain OR capsidol OR capsig OR capsin OR capsina OR capsiplast OR capzasin‐P OR dolorac OR gelcen OR katrum OR "No pain‐HP" OR priltam OR "R‐gel" OR zacin OR zostrix OR capsicum).ti,ab,kw

  3. 1 OR 2

  4. exp Topical Drug Administration.sh

  5. (topical$ OR cutaneous OR dermal OR transcutaneous OR transdermal OR percutaneous OR skin OR massage OR embrocation OR gel OR ointment OR aerosol OR cream OR crème OR lotion OR foam OR liniment OR spray OR rub OR balm OR salve OR emulsion OR oil OR patch OR plaster).ti,ab,kw

  6. 4 OR 5

  7. Diabetic Neuropathy.sh OR Peripheral neuropathy.sh OR Polyneuropathy.sh OR Neuralgia.sh

  8. (neuropath$ OR diabet$ post‐herpetic OR neuralgia).ti,ab,kw

  9. 7 OR 8

  10. (pain OR painful OR analgesi$).ti,ab,kw

  11. clinical trials.sh

  12. controlled clinical trials.sh

  13. randomized controlled trial.sh

  14. double‐blind procedure.sh

  15. (clin$ adj25 trial$).ab

  16. ((doubl$ or trebl$ or tripl$) adj25 (blind$ or mask$)).ab

  17. placebo$.ab

  18. random$.ab

  19. OR/11‐18

  20. 3 AND 6 AND 9 AND 10 AND 19

Appendix 3. CENTRAL search strategy

  1. MeSH descriptor Capsaicin

  2. (capsaicin OR capsaicine OR capsici OR axsain OR capsidol OR capsig OR capsin OR capsina OR capsiplast OR capzasin‐P OR dolorac OR gelcen OR katrum OR "No pain‐HP" OR priltam OR "R‐gel" OR zacin OR zostrix OR capsicum):ti,ab,kw

  3. 1 OR 2

  4. exp MeSH descriptor Administration, topical

  5. (topical* OR cutaneous OR dermal OR transcutaneous OR transdermal OR percutaneous OR skin OR massage OR embrocation OR gel OR ointment OR aerosol OR cream OR crème OR lotion OR foam OR liniment OR spray OR rub OR balm OR salve OR emulsion OR oil OR patch OR plaster):ti,ab,kw

  6. 4 OR 5

  7. MeSH descriptor (Diabetic neuropathies OR Peripheral neuropathies OR Polyneuropathies OR Neuralgia)

  8. (neuropath* OR diabet* post‐herpetic OR neuralgia):ti,ab,kw

  9. 7 OR 8

  10. (pain OR painful OR analgesi*):ti,ab,kw

  11. Randomized Controlled Trial:pt.

  12. MeSH descriptor Double‐Blind Method

  13. (double or treble or triple) NEXT (blind* or mask*)):ti,ab,kw.

  14. random*:ti,ab,kw.

  15. OR/11‐14

  16. 3 AND 6 AND 9 AND 10 AND 15

  17. Limit 16 to Clinical Trials (CENTRAL)

Appendix 4. Summary of outcomes in individual studies: efficacy

Study ID

Treatment

Clinical improvement

Backonja 2008

(1) capsaicin patch 8%, n = 206
(2) control patch, n = 196

At 12 weeks

≥ 30% pain reduction from baseline:

(1) 91/206, (2) 69/196
(Patients with ≥ 50% PR ‐ no significant difference between groups)

≥ 2 points reduction in pain from baseline:
(1) 87/206, (2) 55/196

PGIC (slightly/much/very much improved):
(1) 114/206, (2) 85/196

At 8 weeks

≥ 30% pain reduction from baseline:

(1) 87/206, (2) 63/196

≥ 2 points reduction in pain from baseline:
(1) 82/206, (2) 51/196

PGIC (slightly/much/very much improved):
(1) 109/206, (2) 83/196

Clifford 2012

(1) capsaicin patch 8% 30 min, n = 167
(2) capsaicin patch 8% 60 min, n = 165
(3) control patch 30 min, n = 73
(4) control patch 60 min, n = 89

At 12 weeks

≥ 30% pain reduction from baseline:
(1) 65/167, (2) 79/165, (3) 19/73, (4) 40/89

PGIC (slightly, much, very much improved)
(1) 109/167, (2) 114/165, (3) 33/73, (4) 56/89

Irving 2011

(1) capsaicin patch 8%, n = 212
(2) control patch, n = 204

At 12 weeks

≥ 50% pain reduction from baseline:

(1) 64/212, (2) 43/204

≥ 30% pain reduction from baseline:

(1) 100/212, (2) 71/204

PGIC (much and very much improved):

(1) 83/212, (2) 50/204

≥ 2 points reduction in pain from baseline:

(1) 91/212, (2) 59/204

At 8 weeks

≥ 50% pain reduction from baseline:

(1) 61/212, (2) 41/204

≥ 30% pain reduction from baseline:

(1) 98/212, (2) 69/204

PGIC (much and very much improved):

(1) 71/212, (2) 49/204

≥ 2 points reduction in pain from baseline:

(1) 89/212, (2) 53/204

Simpson 2008

(1) capsaicin patch 8% 30 min, n = 72
(2) capsaicin patch 8% 60 min, n = 78
(3) capsaicin patch 8% 90 min, n = 75
(4) control patch, n = 82

At 12 weeks

≥ 30% pain reduction from baseline:
(1) 30/72, (2) 19/78, (3) 27/75, (4) 15/82

[capsaicin combined 76/225]

PGIC (much and very much improved):

(1) 23/72, (2) 18/78, (3) 20/75, (4) 9/82

[capsaicin combined 61/225]

Webster 2010a

(1) capsaicin patch 8% 30 min, n = 72
(2) capsaicin patch 8% 60 min, n = 77
(3) capsaicin patch 8% 90 min, n = 73
(4) control patch, 30, 60, 90 min pooled for analysis n = 77

At 8 weeks

≥ 50% pain reduction from baseline:

(1) 17/72, (2) 21/77, (3) 17/73, (4) 8/77

≥ 30% pain reduction from baseline:

(1) 27/72, (2) 27/77, (3) 29/73, (4) 22/77

At 12 weeks

PGIC (slight, much and very much improved):

(1) 122/222 [capsaicin combined], (2) 32/77

Webster 2010b

(1) capsaicin patch 8%, n = 102
(2) control patch, n = 53

At 12 weeks

≥ 50% pain reduction from baseline:

(1) 40/102, (2) 19/53

≥ 30% pain reduction from baseline:

(1) 50/102, (2) 26/53

PGIC (much and very much improved):

(1) 41/102, (2) 15/53

At 8 weeks

≥ 50% pain reduction from baseline:

(1) 37/102, (2) 19/53

≥ 30% pain reduction from baseline:

(1) 50/102, (2) 24/53

PGIC (much and very much improved):

(1) 43/102, (2) 14/53

PGIC ‐ patient global impression of change; PR ‐ pain relief

Appendix 5. Summary of outcomes in individual studies: adverse events and withdrawals

Study ID

Treatment

Local AEs

Systemic AEs

Serious AEs

Withdrawals/exclusions

Backonja 2008

(1) capsaicin patch 8%, n = 206
(2) control patch, n = 196

Mostly transient, mild to moderate

Erythema: (1) 193/205, (2) 128/197

Pain: (1) 114/205, (2) 43/197

Papules: (1) 20/205, (2) 6/197

Pruritus: (1) 10/205, (2) 6/197

Oedema: (1) 12/205, (2) 2/197

Nausea, vomiting, nasopharyngitis, sinusitis, back pain, dizziness, headache, worsening of PHN, hypertension ‐ all reported at < 5% per group, with no clear difference between groups

(1) 10/205
(2) 6/197
(1 in capsaicin group judged related to medication)

AE:

(1) 1/205, (2) 0/197

LoE:

(1) 10/205, (2) 9/197

Lost to follow‐up:

(1) 3/205, (2) 2/197

Other:

(1) 5/205, (2) 7/197

Clifford 2012

(1) capsaicin patch 8% 30 min, n = 167
(2) capsaicin patch 8% 60 min, n = 165
(3) control patch 30 min, n = 73
(4) control patch 60 min, n = 89

Generally mild or moderate. Groups combined

Erythema: (1) 176/332, (2) 58/162

Pain: (1) 274/332, (2) 62/162

Papules: (1) 12/332, (2) 0/162

Pruritus: (1) 12/332, (2) 2/162

Oedema: (1) 4/332, (2) 5/162

Diarrhoea, nausea, respiratory tract infection, pain, worsening neuropathy ‐ all reported, generally < 5% per group

Approximately 6% in all groups with "infections and infestations"

1 death in capsaicin 60 min group (judged unrelated)

AE:

(1) 0/167, (2) 2/165 (1 death), (3) 0/72, (4) 1/90
All judged unrelated

Lost to follow‐up:

(1) 3/167, (2) 2/165 (3) 2/73 (4) 0/89

LoE:

(1) 0/167 (2) 1/165 (3) 0/73 (4) 1/89

Other:

(1) 8/167 (2) 6/165 (3) 0/73 (4) 6/89

Irving 2011

(1) capsaicin patch 8%, n = 212
(2) control patch, n = 204

Most mild or moderate.

Erythema: (1) 194/212, (2) 141/204

Pain: (1) 134/212, (2) 57/204

Papules: (1) 15/212 (2) 5/204

Pruritus: (1) 6/212 (2) 3/204

Oedema: (1) 13/212 (2) 0/204

Nausea, vomiting, sinusitis, respiratory tract infection, musculoskeletal disorders, dizziness, headache ‐ all reported, most < 5% per group

(1) 11/212 (1 death)
(2) 8/204
None considered drug‐related

AE:

(1) 4/212 (1 death), (2) 3/304
All SAE and considered not related to treatment

Lost to follow‐up:

(1) 4/212, (2) 5/204

LoE:

(1) 1/212, (2) 5/204

Other:

(1) 11/212, (2) 5/204

Simpson 2008

(1) capsaicin patch 8% 30 min, n = 72
(2) capsaicin patch 8% 60 min, n = 78
(3) capsaicin patch 8% 90 min, n = 75
(4) control patch, n = 82

Self limiting and mild to moderate

Pain: (1) 47/225, (2) 7/82

Papules: (1) 11/225, (2) 1/82

Pruritus: (1) 39/225, (2) 5/82

Swelling: (1) 29/225, (2) 7/82

Diarrhoea, nausea, vomiting, fatigue, infections, musculoskeletal disorders, dizziness, headache, psychiatric disorders ‐ all reported, < 5% per group

(1) 1/225

(2) 2/82

All deaths, judged unrelated to study medication

AE:

(1) 3/225 (1 death), (2) 3/82 (2 deaths)

Lost to follow‐up:

(1) 13/225, (2) 4/82

LoE:

(1) 1/225, (2) 2/82

Other:

(1) 5/225, (2) 2/82

Webster 2010a

(1) capsaicin patch 8% 30 min, n = 72
(2) capsaicin patch 8% 60 min, n = 77
(3) capsaicin patch 8% 90 min, n = 73
(4) control patch, 30, 60, 90 min pooled for analysis n = 77

Transient and mild to moderate

Pain: 1/222, (2) 2/77

Papules: (1) 3/222, (2) 2/77

Pruritus: (1) 17/222, (2) 9/77

Swelling: (1) 3/222, (2) 5/77

Diarrhoea, nausea, vomiting, infections, musculoskeletal disorders, dizziness, headache, cough ‐ all reported, mostly < 5% per group

(1 to 3) 10/222 (1 death)

(4) 3/77

None considered related to study medication

AE:

(1 to 3) 2/222, (4) 1/77 (death)

Lost to follow‐up

(1 to 3) 7/222, (4) 1/77

LoE:

(1 to 3) 4/222, (4) 0/77

Other:

(1 to 3) 9/222, (4) 2/77

Webster 2010b

(1) capsaicin patch 8%, n = 102
(2) control patch, n = 53

Transient and mild to moderate

Erythema: (1) 4/102, (2) 0/53

Pain: (1) 4/102, (2) 2/53

Papules: (1) 4/102, (2) 2/53

Pruritus: (1) 17/102, (2) 6/53

Swelling: (1) 10/102, (2) 1/53

Nausea, infections, musculoskeletal disorders, dizziness, cough, nasopharyngitis, hypertension ‐ all reported, mostly < 5% per group

(1) 7/102
(2) 0/53
None considered related to study medication

AE:

None in either group

Lost to follow‐up:

(1) 5/102, (2) 0/53

LoE:

(1) 3/102, (2) 7/53

Other:

(1) 3/102, (2) 3/53

AE ‐ adverse event; SAE ‐ serious adverse event

Appendix 6. Patch tolerability

Study ID

Treatment

Completed < 90% application time

Dermal irritation score > 2 at 2 h

Rescue medication days 0 to 5

Backonja 2008

(1) capsaicin patch 8%, n = 206
(2) control patch, n = 196

(1) 1/206

(2) 2/196

"common but mild, transient and self‐limited"

(1) 99/206

(2) 32/196

Clifford 2012

(1) capsaicin patch 8% 30 min, n = 167
(2) capsaicin patch 8% 60 min, n = 165
(3) control patch 30 min, n = 73
(4) control patch 60 min, n = 89

(1 to 2) 10/332

(3 to 4) 0/162

(1 to 2) 13/332

(3 to 4) 0/162

(1 to 2) 246/332

(3 to 4) 53/162

Irving 2011

(1) capsaicin patch 8%, n = 212
(2) control patch, n = 204

(1) 4/212

(2) 0/204

(1) 6/212

(2) 1/204

(1) 112/212

(2) 43/204

Simpson 2008

(1) capsaicin patch 8% 30 min, n = 72
(2) capsaicin patch 8% 60 min, n = 78
(3) capsaicin patch 8% 90 min, n = 75
(4) control patch, n = 82

(1) 0/72

(2) 0/78

(3) 2/75

(4) 0/82

> 0 at 2 h

(1 to 3) 92/225

(4) 23/82

(1 to 3) 124/225

(4) 19/82

Webster 2010a

(1) capsaicin patch 8% 30 min, n = 72
(2) capsaicin patch 8% 60 min, n = 77
(3) capsaicin patch 8% 90 min, n = 73
(4) control patch, 30, 60, 90 min pooled for analysis n = 77

(1) 0/73

(2) 1/77

(3) 0/73

(4) 0/77

> 0 at 2 h

(1 to 3) 87/222

(4) 5/77

(1 to 3) 12/222

(4) 3/77

Webster 2010b

(1) capsaicin patch 8%, n = 102
(2) control patch, n = 53

(1) 4/102

(2) 0/53

(1) 53/102
(2) 2/53

(1) 12/102
(2) 1/53

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.
Figuras y tablas -
Figure 1

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

Forest plot of comparison: 1 8% capsaicin versus control (single dose), outcome: 1.1 PGIC much or very much improved at 8 and 12 weeks.
Figuras y tablas -
Figure 2

Forest plot of comparison: 1 8% capsaicin versus control (single dose), outcome: 1.1 PGIC much or very much improved at 8 and 12 weeks.

Forest plot of comparison: 1 8% capsaicin versus control (single dose), outcome: 1.2 PHN ‐ at least 50% pain intensity reduction over weeks 2 to 8.
Figuras y tablas -
Figure 3

Forest plot of comparison: 1 8% capsaicin versus control (single dose), outcome: 1.2 PHN ‐ at least 50% pain intensity reduction over weeks 2 to 8.

Forest plot of comparison: 1 8% capsaicin versus control (single dose), outcome: 1.6 HIVN ‐ at least 30% pain intensity reduction over weeks 2 to 12.
Figuras y tablas -
Figure 4

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

Skin adverse event rates with capsaicin and control. Yellow symbols are studies recording all events (Group 1). Pink symbols are studies specifying that events are not recorded on the first day after treatment (Group 2). The blue symbol did not specify the period over which events were recorded (Group 2). Size of symbol is proportional to the size of the study
Figuras y tablas -
Figure 5

Skin adverse event rates with capsaicin and control. Yellow symbols are studies recording all events (Group 1). Pink symbols are studies specifying that events are not recorded on the first day after treatment (Group 2). The blue symbol did not specify the period over which events were recorded (Group 2). Size of symbol is proportional to the size of the study

Forest plot of comparison: 1 8% capsaicin versus control (single dose), outcome: 1.10 Serious adverse events.
Figuras y tablas -
Figure 6

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

Comparison 1 8% capsaicin versus control (single dose), Outcome 1 PGIC much or very much improved at 8 and 12 weeks.
Figuras y tablas -
Analysis 1.1

Comparison 1 8% capsaicin versus control (single dose), Outcome 1 PGIC much or very much improved at 8 and 12 weeks.

Comparison 1 8% capsaicin versus control (single dose), Outcome 2 PHN ‐ at least 50% pain intensity reduction over weeks 2 to 8.
Figuras y tablas -
Analysis 1.2

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

Comparison 1 8% capsaicin versus control (single dose), Outcome 3 PHN ‐ at least 50% pain intensity reduction over 2 to 12 weeks.
Figuras y tablas -
Analysis 1.3

Comparison 1 8% capsaicin versus control (single dose), Outcome 3 PHN ‐ at least 50% pain intensity reduction over 2 to 12 weeks.

Comparison 1 8% capsaicin versus control (single dose), Outcome 4 PHN ‐ at least 30% pain intensity reduction over weeks 2 to 8.
Figuras y tablas -
Analysis 1.4

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

Comparison 1 8% capsaicin versus control (single dose), Outcome 5 PHN ‐ at least 30% pain intensity reduction over weeks 2 to 12.
Figuras y tablas -
Analysis 1.5

Comparison 1 8% capsaicin versus control (single dose), Outcome 5 PHN ‐ at least 30% pain intensity reduction over weeks 2 to 12.

Comparison 1 8% capsaicin versus control (single dose), Outcome 6 HIVN ‐ at least 30% pain intensity reduction over weeks 2 to 12.
Figuras y tablas -
Analysis 1.6

Comparison 1 8% capsaicin versus control (single dose), Outcome 6 HIVN ‐ at least 30% pain intensity reduction over weeks 2 to 12.

Comparison 1 8% capsaicin versus control (single dose), Outcome 7 Local skin reactions ‐ group 1.
Figuras y tablas -
Analysis 1.7

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

Comparison 1 8% capsaicin versus control (single dose), Outcome 8 Local skin reactions ‐ group 2.
Figuras y tablas -
Analysis 1.8

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

Comparison 1 8% capsaicin versus control (single dose), Outcome 9 Patch tolerability.
Figuras y tablas -
Analysis 1.9

Comparison 1 8% capsaicin versus control (single dose), Outcome 9 Patch tolerability.

Comparison 1 8% capsaicin versus control (single dose), Outcome 10 Serious adverse events.
Figuras y tablas -
Analysis 1.10

Comparison 1 8% capsaicin versus control (single dose), Outcome 10 Serious adverse events.

Comparison 1 8% capsaicin versus control (single dose), Outcome 11 Withdrawals.
Figuras y tablas -
Analysis 1.11

Comparison 1 8% capsaicin versus control (single dose), Outcome 11 Withdrawals.

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

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 PGIC much or very much improved at 8 and 12 weeks Show forest plot

2

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

1.1 8 weeks

2

571

Risk Ratio (M‐H, Fixed, 95% CI)

1.42 [1.10, 1.84]

1.2 12 weeks

2

571

Risk Ratio (M‐H, Fixed, 95% CI)

1.55 [1.20, 1.99]

2 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]

2.1 30‐minute application

1

97

Risk Ratio (M‐H, Fixed, 95% CI)

2.95 [0.73, 11.88]

2.2 60‐minute application

3

674

Risk Ratio (M‐H, Fixed, 95% CI)

1.34 [1.03, 1.75]

2.3 90‐minute application

1

99

Risk Ratio (M‐H, Fixed, 95% CI)

2.02 [0.64, 6.33]

3 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]

4 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]

4.1 30‐minute application

1

97

Risk Ratio (M‐H, Fixed, 95% CI)

1.34 [0.67, 2.69]

4.2 60‐minute application

4

1072

Risk Ratio (M‐H, Fixed, 95% CI)

1.30 [1.12, 1.52]

4.3 90‐minute application

1

99

Risk Ratio (M‐H, Fixed, 95% CI)

1.48 [0.74, 2.95]

5 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]

6 HIVN ‐ 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]

6.1 30‐minute application

2

340

Risk Ratio (M‐H, Fixed, 95% CI)

1.67 [1.14, 2.46]

6.2 60‐minute application

2

359

Risk Ratio (M‐H, Fixed, 95% CI)

1.10 [0.84, 1.44]

6.3 90‐minute application

1

102

Risk Ratio (M‐H, Fixed, 95% CI)

1.94 [0.83, 4.53]

7 Local skin reactions ‐ group 1 Show forest plot

3

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

7.1 Erythema

3

1312

Risk Ratio (M‐H, Fixed, 95% CI)

1.40 [1.30, 1.52]

7.2 Pain

3

1312

Risk Ratio (M‐H, Fixed, 95% CI)

2.28 [1.99, 2.62]

7.3 Papules

3

1312

Risk Ratio (M‐H, Fixed, 95% CI)

3.58 [1.87, 6.85]

7.4 Pruritus

3

1312

Risk Ratio (M‐H, Fixed, 95% CI)

1.99 [0.98, 4.03]

7.5 Oedema

3

1312

Risk Ratio (M‐H, Fixed, 95% CI)

2.98 [1.44, 6.18]

8 Local skin reactions ‐ group 2 Show forest plot

3

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

8.1 Erythema

1

129

Risk Ratio (M‐H, Fixed, 95% CI)

6.31 [0.35, 114.82]

8.2 Pain

3

735

Risk Ratio (M‐H, Fixed, 95% CI)

1.85 [0.99, 3.47]

8.3 Papules

3

735

Risk Ratio (M‐H, Fixed, 95% CI)

1.58 [0.59, 4.24]

8.4 Pruritus

3

735

Risk Ratio (M‐H, Fixed, 95% CI)

1.57 [0.98, 2.50]

8.5 Oedema

3

735

Risk Ratio (M‐H, Fixed, 95% CI)

1.34 [0.75, 2.39]

9 Patch tolerability Show forest plot

6

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

9.1 < 90% of application time

6

2074

Risk Ratio (M‐H, Fixed, 95% CI)

3.27 [1.17, 9.15]

9.2 Dermal irritation score > 2 at 2 h

3

1065

Risk Ratio (M‐H, Fixed, 95% CI)

11.80 [4.04, 34.48]

9.3 Dermal irritation score > 0 at 2 h

2

606

Risk Ratio (M‐H, Fixed, 95% CI)

2.28 [1.60, 3.26]

9.4 Rescue medication 0 to 5 d

6

2073

Risk Ratio (M‐H, Fixed, 95% CI)

2.47 [2.13, 2.87]

10 Serious adverse events Show forest plot

5

1579

Risk Ratio (M‐H, Fixed, 95% CI)

1.41 [0.82, 2.41]

11 Withdrawals Show forest plot

6

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

11.1 Adverse events

6

2073

Risk Ratio (M‐H, Fixed, 95% CI)

0.87 [0.37, 2.00]

11.2 Lack of efficacy

6

2073

Risk Ratio (M‐H, Fixed, 95% CI)

0.57 [0.32, 1.02]

Figuras y tablas -
Comparison 1. 8% capsaicin versus control (single dose)