Oral lichen planus (OLP) is a common, chronic, inflammatory, mucocutaneous disorder associated with cell-mediated immune system dysfunction. Clinically a number of forms are classified, reticular, papular, plaque-like, erosive, atrophic, and bullous. A wide range of treatments have been used including steroids such as clobetasol, and recently tacrolimus which has demonstrated good results in dermatology being used for oral lesions. The aim of this review was to assess and compare the efficacy of tacrolimus and clobetasol in the treatment of oral lichen planus (OLP).
The Cochrane Central Register of Controlled Trials, PubMed, Scopus, Science Direct, Springer Journals, and Elsevier databases were searched. Two reviewers independently selected studies and study quality was assessed. Studies comparing the use of tacrolimus and/or clobetasol in patients with OLP against patients treated with tacrolimus and/or clobetasol and a control group or cohort of untreated patients were considered. Outcomes included improvement in the subject’s clinical status, including reductions in the duration, size, number, and frequency of lesions. The estimated effect of each treatment or intervention was expressed as the odds ratio (OR).
- 10 RCTs were included, 5 evaluating clobetasol and 5 tacrolimus.
- 3 of the 5 clobetasol studies reported positive clinical outcomes while all 5 of tacrolimus studies did.
- Overall odds ratios (ORs) of recovery in patients with oral lichen planus treated with clobetasol = 1.21 (95% CI; 0.48 – 3.05) [ 5 studies].
- Overall odds ratios (ORs) of recovery in patients with oral lichen planus treated with tacrolimus = 8.09 (95% CI; 3.77 – 17.38) [5 studies].
- 6 of the 10 studies reported no serious adverse events.
The authors concluded:
This review suggests that topical tacrolimus is more efficacious than clobetasol, which is a potent topical corticosteroid and may be considered among the first-line therapies in the management of OLP. Tacrolimus is considered suitable for short-term use in patients who are susceptible to oral candidiasis and for OLP lesions that are resistant to other topical and systemic therapies.
The majority of the studies included in this review were small, with sample sizes ranging from 25-60 patients. They were also of short duration with the maximum being of 8 weeks duration. While study quality was assessed, it would have been preferable if the authors had used the Cochrane risk of bias tool and indicated their findings. The 2011 Cochrane review by Thongprasom et al (Dental Elf – 11th Jul 2012) took at broader look at treatments for OLP. They included 28 RCTs and concluded:-
Although topical steroids are considered to be first line treatment, we identified no RCTs that compared steroids with placebo in patients with symptomatic OLP. From the trials in this review there is no evidence that one steroid is any more effective than another. There is weak evidence that aloe vera may reduce the pain of OLP and improve the clinical signs of disease compared to placebo. There is weak and unreliable evidence that cyclosporin may reduce pain and clinical signs of OLP. There is no evidence that other calcineurin inhibitors reduce pain compared to either steroids or placebo. From the 28 trials included in this systematic review, the wide range of interventions compared means there is insufficient evidence to support the effectiveness of any specific treatment as being superior.
Of the 10 studies included in this new review only 2 have been published since the Cochrane review and only 5 of the studies included in this current review were included in the Thongprasom review.
Another review from the Cochrane Skins Group (Dental Elf – 20th Feb 2012) looked at treatments for erosive lichen planus on mucosal sites highlighting the need for large scale RCTs in populations with OLP.
Chamani G, Rad M, Zarei MR, Lotfi S, Sadeghi M, Ahmadi Z. Efficacy of tacrolimus and clobetasol in the treatment of oral lichen planus: a systematic review and meta-analysis. Int J Dermatol. 2015 Sep;54(9):996-1004. doi: 10.1111/ijd.12925. Epub 2015 Jul 23. PubMed PMID: 26204904.