Capsaicina tópica (alta concentración) para el dolor neuropático crónico en adultos
Información
- DOI:
- https://doi.org/10.1002/14651858.CD007393.pub4Copiar DOI
- Base de datos:
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- Cochrane Database of Systematic Reviews
- Versión publicada:
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- 13 enero 2017see what's new
- Tipo:
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- Intervention
- Etapa:
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- Review
- Grupo Editorial Cochrane:
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Grupo Cochrane de Dolor y cuidados paliativos
- Copyright:
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- Copyright © 2017 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.
Cifras del artículo
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Autores
Contributions of authors
For the original review, SD and RL carried out searches for studies, data extraction, and analyses. RAM was involved with analysis and HJM acted as arbitrator. All authors were involved with writing the review.
For the first update, SD and TT searched for studies and carried out data extraction; RAM checked data extraction. SD and RAM carried out analyses and wrote the initial draft review. All authors were involved with writing the full review.
For this update, SD and RAM searched for studies, carried out data extraction, and revised analyses. All authors were involved with writing the full review.
Sources of support
Internal sources
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The Oxford Pain Relief Trust, UK
External sources
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The National Institute for Health Research (NIHR), UK
NIHR Cochrane Programme Grant: 13/89/29 ‐ Addressing the unmet need of chronic pain: providing the evidence for treatments of pain
Declarations of interest
SD: none known.
ASCR undertakes consultancy and advisory board work for Imperial College Consultants ‐ since June 2013 this has included remunerated work for: Spinifex, Abide, Astellas, Neusentis, Merck, Medivir, Mitsubishi, Aquilas, Asahi Kasei, Relmada, Novartis, and Orion. All consultancy activity relates to consultancy advice on the preclinical/clinical development of drugs for neuropathic pain. Neusentis was a subsidiary of Pfizer. He owned share options in Spinifex Pharmaceuticals which was acquired by Novartis in July 2015. ASCR was a Principal Investigator in the EuroPain consortium. EuroPain has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement number 115007, resources for which are composed of financial contribution from the European Union's Seventh Framework Programme (FP7/20072013) and European Federation of Pharmaceutical Industries and Associations (EFPIA) companies (www.imieuropain.org). Specifically, research funding for ASCR's laboratory has been received by Imperial College from Pfizer (manufacturer of gabapentin) and Astellas ‐ both these grants were for projects related to improving the validity of animal models of neuropathic pain. ASCR is a site investigator for the Neuropain project, funded by Pfizer via Kiel University ‐ Chief Investigator Prof Ralf Baron. He is Vice‐Chair of the International Association for the Study of Pain (IASP) Special Interest Group on Neuropathic Pain (www.neupsig.org) and serves on the Executive Committee of ACTTION (Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks; www.acttion.org).
PC received support from Boston Scientific (2014) for travel and accommodation at a scientific meeting; Boston Scientific does not market drugs. PC is a specialist pain physician and manages patients with chronic pain.
TT: none known.
RAM has received grant support from Grünenthal relating to individual patient level analyses of trial data regarding tapentadol in osteoarthritis and back pain (2015). He has received honoraria for attending boards with Menarini concerning methods of analgesic trial design (2014), with Novartis (2014) about the design of network meta‐analyses, and RB on understanding pharmacokinetics of drug uptake (2015). He has received honoraria from Omega Pharma (2016) and Futura Pharma (2016) for providing advice on trial and data analysis methods.
This review was identified in a 2019 audit as not meeting the current definition of the Cochrane Commercial Sponsorship policy. At the time of its publication it was compliant with the interpretation of the existing policy. As with all reviews, new and updated, at update this review will be revised according to 2020 policy update.
Acknowledgements
Support was provided by the National Health Service) (NHS) Cochrane Collaboration Programme Grant Scheme, and the National Institute for Health Research (NIHR) Biomedical Research Centre Programme. The Oxford Pain Relief Trust provided infrastructure support for this review.
The NIHR is the largest single funder of the Cochrane Pain, Palliative and Supportive Care Review Group.
Disclaimer: the views and opinions expressed herein are those of the review authors and do not necessarily reflect those of the NIHR, NHS, or the Department of Health.
Version history
| Published | Title | Stage | Authors | Version |
| 2017 Jan 13 | Topical capsaicin (high concentration) for chronic neuropathic pain in adults | Review | Sheena Derry, Andrew SC Rice, Peter Cole, Toni Tan, R Andrew Moore | |
| 2013 Feb 28 | Topical capsaicin (high concentration) for chronic neuropathic pain in adults | Review | Sheena Derry, Andrew S C Rice, Peter Cole, Toni Tan, R Andrew Moore | |
| 2009 Oct 07 | Topical capsaicin for chronic neuropathic pain in adults | Review | Sheena Derry, Rosalind Lloyd, R Andrew Moore, Henry J McQuay | |
| 2009 Jul 08 | Topical capsaicin for chronic neuropathic pain in adults | Protocol | Sheena Derry, R Andrew Moore, Henry J McQuay, Rosalind Lloyd | |
Differences between protocol and review
For the first update in 2013, we used revised guidelines for reviews in pain, which took into account our better understanding of potential biases both in studies and in the review process (PaPaS 2012). Moreover, the very different nature of the treatment with high‐concentration capsaicin meant that somewhat different outcomes were used, but those reflect the basic principles outlined in the PaPaS author guide.
For this 2017 update, we included an assessment of the quality of the evidence using GRADE and created a 'Summary of findings' table, in line with current standards for Cochrane Reviews. We have removed tiers of evidence from our analysis since these are largely replaced by GRADE. We also removed the prespecified sensitivity analyses since there were insufficient data to formally examine these issues in the earlier review, and it was thought unlikely that this situation would have changed.
Notes
Assessed for updating in 2019
A new search within two years is not likely to identify any potentially relevant studies likely to change the conclusions. Therefore, following discussion with the authors and editors, this review has now been stabilised until 2021, at which point we will assess the review for updating. If appropriate, we will update the review before this date if new evidence likely to change the conclusions is published, or if standards change substantially which necessitate major revisions.
Assessed for updating in 2021
An updated search did not identify any potentially relevant studies likely to change the conclusions. Therefore, following discussion with the authors and editors, this review has now been stabilised until 2026, at which point we will assess the review for updating. If appropriate, we will update the review before this date if new evidence likely to change the conclusions is published, or if standards change substantially which necessitate major revisions.
Keywords
MeSH
Medical Subject Headings (MeSH) Keywords
- Administration, Topical;
- Analgesics [*administration & dosage, adverse effects];
- Capsaicin [*administration & dosage, adverse effects];
- Chronic Pain [*drug therapy];
- Diabetic Neuropathies [drug therapy];
- HIV Infections [complications];
- Neuralgia [*drug therapy];
- Neuralgia, Postherpetic [drug therapy];
- Numbers Needed To Treat;
- Ointments;
- Pain, Postoperative [drug therapy];
- Randomized Controlled Trials as Topic;
Medical Subject Headings Check Words
Adult; Humans;
PICO
Study flow diagram.
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
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.
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.
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.
Forest plot of comparison: 1 High‐concentration (8%) capsaicin versus control (single dose), outcome: 1.10 Serious adverse events.
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
Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 2: PHN ‐ at least 50% pain intensity reduction over 2 to 12 weeks
Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 3: PHN ‐ at least 30% pain intensity reduction over weeks 2 to 8
Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 4: PHN ‐ at least 30% pain intensity reduction over weeks 2 to 12
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
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
Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 7: Local skin reactions ‐ group 1
Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 8: Local skin reactions ‐ group 2
Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 9: Patch tolerability
Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 10: Serious adverse events
Comparison 1: High‐concentration (8%) capsaicin versus control (single dose), Outcome 11: Withdrawals
| 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 | ||||||
| Outcomes | Outcome with intervention | Outcome with comparator | RR, NNT, NNH, NNTp (95% CI) | Number of | Quality of the evidence | Comments |
|---|---|---|---|---|---|---|
| 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): † Substantially different: a large enough difference that it might affect a decision. | ||||||
| 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] |
