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Analysis of the Efficacy of Two Treatment Protocols for Patients with Symptomatic Oral Lichen Planus: A Randomized Clinical Trial.

ABSTRACT: Oral lichen planus (OLP) is a chronic, inflammatory, immune-mediated disease, which can alter the quality of life of patients. The aim of this randomized clinical trial was to compare the therapeutic efficacy of clobetasol oral gel 0.05% versus an anti-inflammatory in oral solution (mouthwash) in the management of patients suffering from symptomatic OLP. The secondary objective was to analyze which one of the two treatments induced a greater risk of developing side effects. Forty patients were assigned (20 patients for group), through a randomized design, to receive clobetasol gel 0.05% or an anti-inflammatory mouthwash, which contains calcium hydroxide, hyaluronic acid, umbelliferone and oligomeric pro-anthocyanidins) for three months. At baseline (T0) and after 3 months (T1), patients underwent dental and dermatological examinations to assess their symptoms (Numerical Pain Scale (NRS) score) and signs (Thongprasom score). Data were calculated using T-test for the dependent variable, Wilcoxon test and Mann-Whitney u test. Both clobetasol and anti-inflammatory resulted in a statistically significant reduction of signs, (p < 0.001 and p = 0.02, respectively) and symptoms (p < 0.001 for clobetasol and p = 0.02 for anti-inflammatory). In conclusion, the results evidenced that, compared to clobetasol, the anti-inflammatory was less effective in determining the reduction of signs and symptom in OLP patients.

SUBMITTER: Santonocito S

PROVIDER: S-EPMC7794703 | biostudies-literature | 2020 Dec

REPOSITORIES: biostudies-literature

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Analysis of the Efficacy of Two Treatment Protocols for Patients with Symptomatic Oral Lichen Planus: A Randomized Clinical Trial.

Santonocito Simona S Polizzi Alessandro A De Pasquale Rocco R Ronsivalle Vincenzo V Lo Giudice Antonino A Isola Gaetano G

International journal of environmental research and public health 20201223 1

Oral lichen planus (OLP) is a chronic, inflammatory, immune-mediated disease, which can alter the quality of life of patients. The aim of this randomized clinical trial was to compare the therapeutic efficacy of clobetasol oral gel 0.05% versus an anti-inflammatory in oral solution (mouthwash) in the management of patients suffering from symptomatic OLP. The secondary objective was to analyze which one of the two treatments induced a greater risk of developing side effects. Forty patients were a ...[more]

PMID: 33374791

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Project description:ImportanceSymptomatic oral lichen planus (OLP) can be challenging to treat.ObjectiveTo compare the efficacy of oral acitretin plus topical triamcinolone acetonide (TAC), 0.1%, with TAC monotherapy in patients with symptomatic OLP.Design, setting, and participantsThis monocentric, investigator-initiated, placebo-controlled, investigator- and patient-blinded randomized clinical trial was conducted from December 2018 to June 2020 at the Postgraduate Institute of Medical Education and Research, a tertiary referral center in Chandigarh, India. Sixty-four patients 18 years or older with symptomatic OLP were recruited by consecutive sampling. Data were analyzed from July to December 2020.InterventionThe patients were randomized to receive either a combination of oral acitretin (25-35 mg/d) and TAC (treatment group) or TAC in combination with placebo (placebo group) for 28 weeks, with an additional 8 weeks of treatment-free follow-up after the end of treatment (36 weeks of total study duration).Main outcomes and measuresThe disease severity and treatment response were assessed using Oral Disease Severity Score (ODSS), Oral Health Impact Profile 14 (OHIP-14), and visual analog scale (VAS). The primary aim was to assess the number of patients achieving ODSS-75 (75% reduction in ODSS compared with baseline) in both groups at 28 weeks and at the end of 36 weeks.ResultsAmong 64 patients, 31 in the treatment group and 30 in the placebo group completed the study (mean [SD] age, 50.6 [15.2] years vs 49.2 [14.4] years; male-female ratio, 13:19 vs 16:16). Baseline ODSS, visual analog scale, and Oral Health Impact Profile 14 scores were comparable in both groups. In the intention-to-treat analysis, there was a statistically significant higher number of patients achieving 75% or higher reduction in ODSS in the treatment group compared with the placebo group at the end of 28 weeks (28 [88%] vs 15 [47%], a 41 [95% CI, 20-61] percentage point difference between groups; P < .001; Cramér V = 0.47) and 36 weeks (27 [84%] vs 13 [41%], a 43 [95% CI, 23-67] percentage point difference between groups; P < .001; Cramér V = 0.47). Relapses during the posttreatment follow-up of 8 weeks were low among patients in both treatment and placebo groups (1 [3%] vs 2 [6%], a 3 [95% CI, -13 to 7] percentage point difference between groups; P > .99; Cramér V = 0.07).Conclusion and relevanceIn this randomized clinical trial, the combination of oral acitretin and TAC was more effective than TAC monotherapy in patients with symptomatic OLP.Trial registrationClinical Trial Registry of India Identifier: CTRI/2018/11/016448.

Project description:BackgroundOral lichen planus (OLP) is a mucocutaneous autoimmune disease with T-cell mediation. Corticosteroids are considered as a first choice in OLP and should be used for a long period with a subsequent increase in dose since the disease has a chronic and recalcitrant nature. There have been efforts to use alternative therapies due to the Corticosteroid's side effects. Curcumin is a non-toxic natural product with different effects on various oral diseases. It demonstrates antioxidant, anti-inflammatory, antimicrobial, and anticarcinogenic activities. It seems that Curcumin can be used as a proper alternative for Corticosteroid treatments. To overcome limitations in the bioavailability of Curcumin, the therapeutic effect of oral Nano-Curcumin was evaluated for the first time.MethodsSixty OLP patients were included in this double-blinded randomized clinical trial. The patients were randomly divided into two groups and received either 'Nano-Curcumin 80 mg' or 'Prednisolone 10 mg' treatments for 1 month. The patients should take one capsule after having their breakfast. The VAS scale was used to analyze pain severity and burning sensation. To assess lesion size the Thongprasom scale was employed. Repeated measures and independent t-tests, as well as LSD paired-test, were used to analyze the data.ResultsData from 57 patients were analyzed. The level of pain, burning sensation, and OLP lesions decreased in both groups of Curcumin and Prednisolone and no statistically significant difference was observed between the two groups.ConclusionDespite many studies conducted to find an effective approach for managing OLP, the results have often been unsatisfactory. In comparison with previous studies, current results clarify the importance of Nano-Curcumin bioavailability in therapeutic effects. Pain VAS and lesion size were decreased with oral Curcumin. The results have shown that oral Curcumin can be used as an alternative therapy for OLP in patients with the contraindicated Corticosteroids or should be used with caution. Oral Curcumin can be used in preventing the recurrence of OLP lesions after the treatment and initial control. Moreover, the amount of Curcumin dose is more important than its use duration in improving OLP.Trial registrationIRCT, IRCT20100101002950N5. Registered 9 February 2019, https://www.irct.ir/trial/36704 .

Dataset Information

Analysis of the Efficacy of Two Treatment Protocols for Patients with Symptomatic Oral Lichen Planus: A Randomized Clinical Trial.

Publications

Analysis of the Efficacy of Two Treatment Protocols for Patients with Symptomatic Oral Lichen Planus: A Randomized Clinical Trial.

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