Cochrane · intervention · CD008092
Interventions for erosive lichen planus affecting mucosal sites
Cheng, S, Kirtschig, G, Cooper, S, et al. · Cochrane Database of Systematic Reviews · 2012 · Cochrane Library
Full textEvery question was extracted from the full review (methods and results), not only its Summary of Findings table.
Questions
55
current version
GRADE rated
0
No studies
6
Included studies
15
as reported
No studies 6 · 10.9%Ungraded 49 · 89.1%Very low 0 · 0%Low 0 · 0%Moderate 0 · 0%High 0 · 0%
Ungraded means an effect was reported without a GRADE rating; it is not a gap. No studies means the review found nothing to answer the question. The six categories are a display order, not a score.
Review question
| Element | Planned (methods) | Found (results) |
|---|---|---|
| Population | Any individual of any age, gender, or race diagnosed by a dermatologist, oral medicine physician, genitourinary physician, or gynaecologist as having ELP affecting the mouth, oesophagus, and/or anogenital regions; idiopathic plaque-like (non-erosive) LP and lichenoid drug eruptions excluded | 473 participants with erosive LP (from 667 with mucosal LP across 15 RCTs); all studies recruited oral - not genital - disease; individual study ELP sizes 8 to 94 |
| Intervention | All types of interventions: topical treatments (potent topical steroids, ciclosporin, retinoids, tacrolimus); oral medications (prednisolone, azathioprine, methotrexate, retinoids, ciclosporin, mycophenolate, anti-malarials); biologics; phototherapy; surgical management | 1% pimecrolimus cream (n=52); Clobetasol propionate 0.025%/0.05% (various vehicles) (n=164); Topical tacrolimus 0.1% (n=29); Ciclosporin gel/rinse (n=56); Fluticasone propionate spray (n=44); Radix tripterygium hypoglaucum tablet (n=47); Tripterygium glucosides tablet (n=47); Aloe vera gel (n=45); Betamethasone oral mini-pulse (n=22); Fluocinonide in adhesive base (n=27) |
| Comparison | Placebo; no treatment; a different intervention; a different dose of the same intervention | Placebo/vehicle (n=133); Conventional clobetasol formulation (n=50); 5% mesalazine gel (n=12); Betamethasone sodium phosphate mouthwash (n=44); 0.1% triamcinolone acetonide (n=37); Clobetasol propionate (as active comparator) (various) |
| Outcomes | Pain reduction (VAS); Physician Global Assessment; Participant global self-assessment; Complete clinical response; Partial response (>=50% improvement); Reduction in severity of flares; Reduction in number of flares; Relapse rate; Dermatology quality of life; Restoration of sexual activity; Eating a normally varied diet; Side-effects reported; Reduction in target/mean lesion size (for oral lesions) | Pain reduction VAS (n=473); Physician Global Assessment (n=473); Participant global self-assessment (n=12); Complete clinical response (n=20); Partial response >=50% (n=473); Relapse rate (n=52); Dermatology quality of life OHQoL16 (n=22); Side-effects reported (n=473); Reduction in target/mean lesion size (n=51) |
| Study designs | Randomised controlled trials (including cross-over; split body-part designs excluded) | 15 RCTs (14 parallel-group, 1 cross-over [Hegarty 2002]); no meta-analysis performed owing to small numbers and clinical heterogeneity |
| Timing | Short-term (less than 6 months) and long-term (6 months or more) from the beginning of treatment | Treatment duration 4 weeks to 6 months; assessment intervals 2 to 4 weeks; 7 studies followed up 1 to 17 months after treatment |
Search date: 2009-09. Databases: Cochrane Skin Group Specialised Register; Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (from 2005); EMBASE (from 2007); LILACS (from 1982)
Questions and results
Current version onlyAny topical or systemic intervention (topical/systemic steroids, ciclosporin, tacrolimus, retinoids, anti-malarials, biologics, phototherapy, surgery) vs Placebo, no treatment, another active intervention, or a different dose of the same intervention
Population: People of any age with erosive lichen planus affecting the oral, anogenital, and/or oesophageal regions
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Restoration of sexual activity | None of the included studies assessed the effectiveness of treatments of genital ELP; thus, this outcome was not reported. | 0 studies | No studies |
Reduction in number of flares | No studies reported this outcome. | 0 studies | No studies |
Eating a normally varied diet | No studies reported this outcome. | 0 studies | No studies |
Reduction in severity of flares | No studies reported this outcome. | 0 studies | No studies |
1% pimecrolimus cream vs Placebo (vehicle cream)
Population: People with erosive oral lichen planus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Side-effects reported | Table 3 (Side-effects). Passeron 2007: 1% pimecrolimus well-tolerated, transient burning (2) during the first 2 weeks. Swift 2005: pimecrolimus - slight burning of the tip of the tongue after applying 1% pimecrolimus… | 3 studies · 52 participants | Ungraded |
Physician Global Assessment (strong improvement) | RR 7.00 [1.04, 46.95] | 1 study · 20 participants | Ungraded |
Relapse rate when medications stopped | In Passeron 2007 (n=12), all participants who improved during treatment relapsed within 1 month of ceasing treatment. | 1 study · 12 participants | Ungraded |
Physician Global Assessment (surface of erosive lesions) | MD -0.50 [-1.39, 0.39] | 1 study · 12 participants | Ungraded |
Participant global self-assessment | One study (Passeron 2007) assessed participant global self-assessment on a 5-point scale: 5/6 participants in the 1% pimecrolimus group rated their improvement as moderate or important versus 1/6 in the placebo group… | 1 study · 12 participants | Ungraded |
Physician Global Assessment (weighted sums of ulceration, erythema, reticulation, mm2) | MD -56.57 [-134.02, 20.88] | 1 study · 20 participants | Ungraded |
Complete clinical response (complete clearance) | RR 3.50 [0.95, 12.90] | 1 study · 20 participants | Ungraded |
Pain reduction (VAS) | MD -3.30 [-20.22, 13.62] | 2 studies · 32 participants | Ungraded |
Clobetasol-17-propionate 0.025% lipid-loaded microspheres vs Conventional 0.025% clobetasol lipophilic ointment in hydrophilic phase
Population: People with erosive oral lichen planus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Side-effects reported | Table 3 (Side-effects). Campisi 2004: oral candidiasis (1 in the lipid-loaded microspheres group, 2 in the conventional ointment group). None serious. | 1 study · 50 participants | Ungraded |
Physician Global Assessment (Thongprasom score) | MD 0.00 [-0.61, 0.61] | 1 study · 45 participants | Ungraded |
Pain reduction (VAS 0-100) | MD -18.30 [-28.57, -8.03] | 1 study · 45 participants | Ungraded |
Topical clobetasol propionate 0.025% vs Topical clobetasol propionate 0.05%
Population: People with erosive oral lichen planus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Physician Global Assessment (Thongprasom score) | MD 0.47 [-0.26, 1.20] | 1 study · 35 participants | Ungraded |
Pain reduction (VAS) | MD -0.26 [-1.42, 0.90] | 1 study · 30 participants | Ungraded |
Partial response (partial or complete response) | RR 1.18 [0.82, 1.70] | 1 study · 35 participants | Ungraded |
Side-effects reported | Table 3 (Side-effects). Carbone 2009: no side-effects. | 1 study · 35 participants | Ungraded |
Clobetasol propionate ointment 0.05% vs 5% topical mesalazine gel in adhesive base
Population: People with erosive oral lichen planus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Pain reduction (VAS 0-10) | MD -0.83 [-4.12, 2.46] | 1 study · 12 participants | Ungraded |
Side-effects reported | Table 3 (Side-effects). Sardella 1998: no side-effects (there were no reported side-effects with topical mesalazine gel). | 1 study · 12 participants | Ungraded |
0.1% triamcinolone acetonide in orabase vs Ciclosporin solution
Population: People with erosive oral lichen planus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Physician Global Assessment (Thongprasom score) | MD 0.61 [-0.79, 2.01] | 1 study · 11 participants | Ungraded |
Pain reduction (VAS 0-100) | MD 45.17 [8.73, 81.61] | 1 study · 11 participants | Ungraded |
Side-effects reported | Table 3 (Side-effects). Yoke 2006: no significant adverse events; transient burning sensation upon initial application with both treatments. | 1 study · 15 participants | Ungraded |
Topical tacrolimus 0.1% ointment vs Topical clobetasol propionate 0.05% ointment
Population: People with erosive oral lichen planus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Side-effects reported | Table 3 (Side-effects). Radfar 2008: burning sensation with topical tacrolimus; transient burning within the first 2 weeks resulted in withdrawal of therapy in 1 participant. | 1 study · 29 participants | Ungraded |
Pain reduction (VAS 0-10) | MD -0.64 [-1.91, 0.63] | 1 study · 29 participants | Ungraded |
Reduction in target/mean lesion size | MD 0.00 [-1.09, 1.10] | 1 study · 29 participants | Ungraded |
Aloe vera gel vs Placebo
Population: People with erosive oral lichen planus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Partial response (>=50% clinical improvement) | RR 19.25 [2.83, 130.85] | 1 study · 45 participants | Ungraded |
Physician Global Assessment (Thongprasom score) | RR 2.64 [0.11, 61.54] | 1 study · 45 participants | Ungraded |
Side-effects reported | Table 3 (Side-effects). Choonhakarn 2008: no serious side-effects; 2 participants receiving aloe vera gel reported stinging and mild itching at lesions within the first week, symptoms spontaneously disappeared with… | 1 study · 45 participants | Ungraded |
Pain (>=50% improvement in symptoms) | RR 6.16 [2.35, 16.13] | 1 study · 45 participants | Ungraded |
Topical ciclosporin 1.5% gel vs Topical clobetasol propionate 0.025% gel
Population: People with erosive oral lichen planus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Physician Global Assessment (Thongprasom score) | RR 3.16 [1.00, 9.93] | 1 study · 40 participants | Ungraded |
Relapse rate when medications stopped | Topical clobetasol gave less stable results than ciclosporin when therapy ended and showed a higher incidence of side-effects (Conrotto 2006, n=40). | 1 study · 40 participants | Ungraded |
Partial response (partial or complete response) | RR 1.46 [1.04, 2.04] | 1 study · 40 participants | Ungraded |
Side-effects reported | Table 3 (Side-effects). Conrotto 2006: ciclosporin - skin rashes (2), parotid swelling (1), and dyspepsia (3); clobetasol - dyspepsia (1). | 1 study · 40 participants | Ungraded |
Pain (>=50% improvement in symptoms) | RR 0.47 [0.17, 1.32] | 1 study · 40 participants | Ungraded |
Ciclosporin rinse vs Placebo (vehicle)
Population: People with erosive oral lichen planus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Side-effects reported | Table 3 (Side-effects). Eisen 1990: no adverse side-effects; transient burning sensation of mucosal surfaces during swishing of medication reported in all participants. | 1 study · 8 participants | Ungraded |
Physician Global Assessment (severity of disease) | MD -1.40 [-1.86, -0.94] | 1 study · 8 participants | Ungraded |
Pain reduction (participant-reported symptoms) | We were unable to extract data on participant-reported symptoms for Eisen 1990 because there was no breakdown of data for the ELP subgroup. | 1 study · 8 participants | Ungraded |
Radix tripterygium hypoglaucum tablet (THT) vs Tripterygium glucosides tablet (TGT)
Population: People with erosive oral lichen planus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Physician Global Assessment (cure of erosive lesions, remarkably effective) Grade II (erosive lesions only) | RR 0.73 [0.42, 1.28] | 1 study · 94 participants | Ungraded |
Partial response (remarkably effective or effective) Grade I (erosive and ulcerative lesions) | RR 0.18 [0.04, 0.82] | 1 study · 94 participants | Ungraded |
Partial response (remarkably effective or effective) Grade II (erosive lesions only) | RR 0.29 [0.07, 1.27] | 1 study · 94 participants | Ungraded |
Side-effects reported | Table 3 (Side-effects). Lin 2005: TGT - menstrual disturbance (6) and leucopenia (1). Tripterygium glucosides are known to be cytotoxic and unsuitable for individuals of child-bearing age. | 1 study · 94 participants | Ungraded |
Physician Global Assessment (cure of erosive lesions, remarkably effective) Grade I (erosive and ulcerative lesions) | RR 0.55 [0.25, 1.20] | 1 study · 94 participants | Ungraded |
Fluocinonide in adhesive base vs Placebo
Population: People with erosive oral lichen planus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Physician Global Assessment (clinical signs, complete response) | RR 4.67 [0.24, 88.96] | 1 study · 27 participants | Ungraded |
Partial response (>33% improvement) | RR 3.00 [0.62, 14.62] | 1 study · 27 participants | Ungraded |
Side-effects reported | Table 3 (Side-effects). Voute 1993: no side-effects during the study and follow-up period. | 1 study · 27 participants | Ungraded |
Betamethasone oral mini-pulse therapy vs Topical triamcinolone acetonide 0.1% paste
Population: People with erosive oral lichen planus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Side-effects reported | Table 3 (Side-effects). Malhotra 2008: betamethasone oral mini-pulse - transient oedema over the face (7), oedema over hands and feet (4), epigastric discomfort (7), weakness/fatigue (5), loose stools (1), headache… | 1 study · 22 participants | Ungraded |
Physician Global Assessment (clinical severity, 0-12 score) 24 weeks | MD 1.78 [0.17, 3.39] | 1 study · 22 participants | Ungraded |
Fluticasone propionate spray vs Betamethasone sodium phosphate mouthwash
Population: People with erosive oral lichen planus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Pain reduction (VAS 0-100) | In the Hegarty 2002 cross-over trial (n=22), no statistical testing of the pain score (VAS 0 to 100) was reported; it is not clear whether the difference is statistically significant (fluticasone mean score 19.8 versus… | 1 study · 22 participants | Ungraded |
Reduction in target/mean lesion size | No statistical testing of the mean surface area of lesions was reported in Hegarty 2002 (fluticasone mean score 547.2 mm2 versus betamethasone mean score 671.9 mm2). | 1 study · 22 participants | Ungraded |
Dermatology quality of life (OHQoL16) | No statistical testing of the Oral Health Quality of Life index (OHQoL16) was reported in Hegarty 2002 (fluticasone mean score 0.7 versus betamethasone mean score -0.8). | 1 study · 22 participants | Ungraded |
Side-effects reported | Table 3 (Side-effects). Hegarty 2002: nausea (4), swollen mouth (1), bad taste and smell (6), difficulty in spray application (7), dry mouth (2), sore throat (1), red painful tongue (1), and pseudomembranous… | 1 study · 44 participants | Ungraded |
Any topical or systemic intervention vs Placebo, no treatment, or another intervention
Population: People with erosive anogenital (genital) lichen planus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | None of the included studies assessed the effectiveness of treatments of genital ELP; no evidence was found for genital ELP. | 0 studies | No studies |
Any topical or systemic intervention vs Placebo, no treatment, or another intervention
Population: People with erosive oesophageal lichen planus
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Outcome NR | None of the studies involved oesophageal disease; hence, no evidence was found for the treatment of oesophageal ELP. | 0 studies | No studies |
Any topical or systemic intervention (topical/systemic steroids, ciclosporin, tacrolimus, retinoids, anti-malarials, biologics, phototherapy, surgery) vs Placebo, no treatment, another active intervention, or a different dose of the same intervention
Population: People of any age with erosive lichen planus affecting the oral, anogenital, and/or oesophageal regions
| Outcome | Effect | Evidence | Status / GRADE |
|---|---|---|---|
Restoration of sexual activity | Protocol (2009): planned outcome; no studies included at protocol stage. | NR | No studies |
Reduction in severity of flares | Protocol (2009): planned outcome; no studies included at protocol stage. | NR | No studies |
Relapse rate when medications stopped or reduced | Protocol (2009): planned outcome; no studies included at protocol stage. | NR | No studies |
Physician Global Assessment | Protocol (2009): planned outcome; no studies included at protocol stage. | NR | No studies |
Participant global self-assessment | Protocol (2009): planned outcome; no studies included at protocol stage. | NR | No studies |
Reduction in number of flares | Protocol (2009): planned outcome; no studies included at protocol stage. | NR | No studies |
Pain reduction (visual analogue scale) | Protocol (2009): planned outcome; no studies included at protocol stage. | NR | No studies |
Complete clinical response | Protocol (2009): planned outcome; no studies included at protocol stage. | NR | No studies |
Partial response (>=50% improvement) | Protocol (2009): planned outcome; no studies included at protocol stage. | NR | No studies |
Eating a normally varied diet | Protocol (2009): planned outcome; no studies included at protocol stage. | NR | No studies |
Dermatology quality of life | Protocol (2009): planned outcome; no studies included at protocol stage. | NR | No studies |