Non-Cochrane · intervention · PM42653103
Capsaicin for Orofacial Pain Management: Systematic Review and Meta-Analysis.
Andrade Ana Claudia de Macedo, Felix Fernanda Aragão, Brauchi Sebastián, et al. · International journal of molecular sciences · 2026 · PubMed · doi:10.3390/ijms27167099
Findings
11 findings
| Population | ||||
|---|---|---|---|---|
| Patients with orofacial pain (temporomandibular disorders, burning mouth syndrome) | Capsaicin (topical 0.025% cream, topical 8%, or systemic 0.25%) | Vehicle (placebo) | Treatment-related adverse events Follow-up 7 days to 30 days | OR 19.84 [4.32, 91.21] 431 [121, 762] more per 1000 Moderate Downgraded: risk of bias 3 studies · 94 participants |
| Patients with orofacial pain (temporomandibular disorders, burning mouth syndrome) | Capsaicin (topical 0.025% cream, topical 8%, or systemic 0.25%) | Vehicle (placebo) | Orofacial pain intensity (VAS 0 to 10) End of treatment (final assessment) · Comparator: vehicle | MD -1.87 [-3.94, 0.19] GRADE not reported 3 studies · 93 participants |
| Patients with orofacial pain (temporomandibular disorders, burning mouth syndrome) | Capsaicin (topical 0.025% cream, topical 8%, or systemic 0.25%) | Vehicle (placebo) | Baseline orofacial pain intensity (VAS 0 to 10; group comparability check) Baseline (before treatment) · Comparator: vehicle | MD 0.03 [-1.08, 1.14] GRADE not reported 3 studies · 93 participants |
| Patients with orofacial pain (temporomandibular disorders, burning mouth syndrome) | Capsaicin (topical 0.025% cream, topical 8%, or systemic 0.25%) | Vehicle (placebo) | Orofacial pain intensity (VAS 0 to 10) 30 days | MD -2.39 [-5.79, 1.01] GRADE not reported 2 studies · 78 participants |
| Patients with burning mouth syndrome | Capsaicin 0.025% topical oral gel | Capsaicin 0.01% topical oral gel (lower dose) | Orofacial pain intensity (VAS 0 to 10) End of treatment (final assessment) · Comparator: lower dose capsaicin | MD 0.46 [-2.67, 3.60] GRADE not reported 1 study · 38 participants |
| Patients with burning mouth syndrome | Capsaicin 0.025% topical oral gel | Capsaicin 0.01% topical oral gel (lower dose) | Baseline orofacial pain intensity (VAS 0 to 10; group comparability check) Baseline (before treatment) · Comparator: lower dose capsaicin | MD 1.59 [-0.07, 3.25] GRADE not reported 1 study · 38 participants |
| Patients with orofacial pain (temporomandibular disorders, burning mouth syndrome) | Capsaicin (topical or systemic) | Vehicle (placebo) or lower-dose capsaicin | Orofacial pain intensity (VAS 0 to 10) End of treatment (final assessment) | MD -1.10 [-2.79, 0.58] -1.1 [-2.79, 0.58] points on VAS 0 to 10 (MD) Very low Downgraded: risk of bias, imprecision, inconsistency 4 studies · 131 participants |
| Patients with orofacial pain (temporomandibular disorders, burning mouth syndrome) | Capsaicin (topical or systemic) | Vehicle (placebo) or lower-dose capsaicin | Baseline orofacial pain intensity (VAS 0 to 10; group comparability check) Baseline (before treatment) | MD 0.48 [-0.59, 1.54] GRADE not reported 4 studies · 131 participants |
| Patients with orofacial pain (trigeminal neuralgia, peripheral neuropathic facial pain, burning mouth syndrome) | Capsaicin (topical 0.025% or 0.05% cream/gel, 8% patch) | Pre-treatment baseline (same patients; uncontrolled single-arm studies) | Orofacial pain intensity (VAS 0 to 10) End of treatment (final assessment) | MD -6.39 [-7.40, -5.38] -6.39 [-7.4, -5.38] points on 0 to 10 scale (MD) Low Downgraded: risk of bias, imprecision 3 studies · 26 participants |
| Patients with orofacial pain (trigeminal neuralgia, peripheral neuropathic facial pain, burning mouth syndrome) | Capsaicin (topical 0.025% or 0.05% cream/gel, 8% patch) | Pre-treatment baseline (same patients; uncontrolled single-arm studies) | Orofacial pain intensity (VAS 0 to 10) 12 weeks | MD -6.10 [-7.49, -4.71] GRADE not reported 2 studies · 14 participants |
| Patients with orofacial pain | Capsaicin | Other (standard) pharmacological interventions | Orofacial pain reduction and tolerability | A systematic review and meta-analysis comparing capsaicin with standard pharmacological treatments was not possible, since no eligible studies made such comparisons. No studies found 0 studies |
Included primary studies 9
Open in Studies| Study | Year | Also included by | Outcomes it informs here | Trial data |
|---|---|---|---|---|
| Berger 1995 Oral capsaicin provides temporary relief for oral mucositis pain secondary to chemotherapy/radiation therapy. PMID:7629418 | 1995 | this review only | not stated | not extracted yet |
| Campbell 2017 Effects of High-Dose Capsaicin on TMD Subjects: A Randomized Clinical Study. PMID:28879245 | 2017 | this review only | Orofacial pain intensity (VAS 0 to 10); Baseline orofacial pain intensity (VAS 0 to 10; group comparability check); PM42653103-P1-O4 | not extracted yet |
| Fusco 1992 Analgesic effect of capsaicin in idiopathic trigeminal neuralgia. PMID:1539818 | 1992 | this review only | Orofacial pain intensity (VAS 0 to 10) | not extracted yet |
| Goncalves 2020 8% Capsaicin Patch in Treatment of Peripheral Neuropathic Pain. PMID:32967405 | 2020 | this review only | Orofacial pain intensity (VAS 0 to 10); PM42653103-P4-O2 | not extracted yet |
| Jorgensen 2016 Analgesic effect of topical oral capsaicin gel in burning mouth syndrome. PMID:28007005 | 2017 | this review only | Orofacial pain intensity (VAS 0 to 10); Baseline orofacial pain intensity (VAS 0 to 10; group comparability check) | not extracted yet |
| Petruzzi 2004 Systemic capsaicin for burning mouth syndrome: short-term results of a pilot study. PMID:14720197 | 2004 | this review only | Orofacial pain intensity (VAS 0 to 10); Baseline orofacial pain intensity (VAS 0 to 10; group comparability check); Treatment-related adverse events; PM42653103-P1-O4 | not extracted yet |
| Ricken 2021 Evaluation of a Protocol For Topical Application of Capsaicine Gel 0.025 % in the Management of Burning Mouth Syndrome Correlating its… DOI:10.4067/s0718-381x2021000200443 | 2021 | this review only | Orofacial pain intensity (VAS 0 to 10); PM42653103-P4-O2 | not extracted yet |
| Wagner 2013 The capsaicin 8% patch for neuropathic pain in clinical practice: a retrospective analysis. PMID:23710678 | 2013 | this review only | not stated | not extracted yet |
| Winocur 2000 Topical application of capsaicin for the treatment of localized pain in the temporomandibular joint area. PMID:11203735 | 2000 | this review only | Orofacial pain intensity (VAS 0 to 10); Baseline orofacial pain intensity (VAS 0 to 10; group comparability check); Treatment-related adverse events; PM42653103-P1-O4 | not extracted yet |
Review question
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Humans with orofacial pain | Orofacial pain: TMD (n=45), burning mouth syndrome (n=90), trigeminal neuralgia (n=16), oral mucositis (n=11), neuropathic facial pain (n=2); 164 participants |
| Intervention | Capsaicin | Topical capsaicin 0.01% to 8% (cream, gel, patch, lozenge) and oral systemic capsaicin |
| Comparison | Placebo or other pharmacological intervention | Placebo or vehicle (n=3 trials); lower dose capsaicin (n=1 crossover trial); no comparator in single-arm studies |
| Outcomes | Efficacy (pain reduction) and tolerability (adverse events) | Pain scale scores; burning sensation; adverse events |
| Study designs | Clinical trials, cross-sectional, cohort and case-control studies | 3 randomized trials, 1 randomized crossover trial, 5 non-randomized studies |
| Timing | Not specified | End of treatment; 30 days; 12 weeks |
AMSTAR 2 items
Two independent extractors rated each item. Their ratings are shown side by side because they have not been reconciled yet. The overall rating follows Shea et al. 2017: one critical flaw gives Low, more than one gives Critically Low.
| Item | Extractor A | Extractor B | Agree |
|---|---|---|---|
| 1Research question includes PICO components | Yes | Yes | yes |
| 2Protocol established before the reviewcritical | Partial Yes | Partial Yes | yes |
| 3Choice of study designs explained | No | No | yes |
| 4Comprehensive literature searchcritical | Partial Yes | Partial Yes | yes |
| 5Study selection in duplicate | Yes | Yes | yes |
| 6Data extraction in duplicate | Yes | Yes | yes |
| 7List of excluded studies with reasonscritical | No | No | yes |
| 8Included studies described in detail | Yes | Yes | yes |
| 9Risk of bias assessed satisfactorilycritical | RCT: Yes · NRSI: Yes | NRSI: Yes · RCT: Yes | no |
| 10Funding of included studies reported | No | No | yes |
| 11Appropriate meta-analysis methodscritical | RCT: No · NRSI: No | NRSI: No · RCT: No | no |
| 12Impact of risk of bias on the pooled results | No | No | yes |
| 13Risk of bias accounted for in interpretationcritical | Yes | Yes | yes |
| 14Heterogeneity explained | Yes | Yes | yes |
| 15Publication bias investigatedcritical | No | No | yes |
| 16Conflicts of interest reported | Yes | Yes | yes |
| Overall | Critically Low | Critically Low | yes |