Effect of Pimecrolimus on Oral Lichen Planus: A Systematic Review_Chinese Journal of Evidence-Based Medicine

Authors：

GONG Zhongcheng ¹ ,  LIN Zhaoquan ¹ , ADILI Moming ¹ , WANG Ling ¹ , XIONG Hui ² , LIAO Feng ³ , LONG Xing ³

1. Department of Oral & Maxillofacial Surgery, First Teaching Hospital of Xinjiang Medical University, Urumqi 830054, China; 2. Department of stomatology, South-centre Hospital of Wuhan University, Wuhan 430079, China 3. Department of Oral & Maxillofacial Surgery, School and Hospital of Stomatology, Wuhan University, Wuhan 430079, China;;

Corresponding author：

LIN Zhaoquan, Email: gump0904@yahoo.com.cn

Keywords：

Pimecrolimus; Oral lichen planus; Systematic review; Randomized controlled trial

DOI：

10.7507/1672-2531.20080056

Video：

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Objective　 To evaluate the efficacy and safety of pimecrolimus for oral lichen planus (OLP).
Methods　 We searched The Cochrane Library, MEDLINE (1990 to 2007), EMBASE (1990 to 2007), and the Chinese Biomedicine Database (1990 to 2007) to collect parallel group randomized controlled trials (RCTs) and cross-over trials comparing pimecrolimus with triamcinolone acctonide or placebo. The Cochrane Collaboration’s RevMan 4.2 software was used for data analyses.
Results　 Three RCTs were included. Meta-analyses showed that pimecrolimus did not improve oral cavity ache measured by VAS (visual analogue scale) (WMD –0.5, 95%CI –9.77 to 8.77), OHIP (oral health impact profile) (WMD 0.9, 95%CI –0.6 to 2.4) and CSS (clinical status score) (WMD 0.00mm2, 95%CI –0.40 to 0.40); compared with triamcinolone acctonide. In comparison to placebo, pimecrolimus did not improve oral cavity ache measured by VAS (WMD –3.30, 95%CI –20.20 to 13.92) or CSS (WMD –56.57, 95%CI -134.02 to 20.88) and did not reduce burning sensations (OR 4.98, 95%CI 0.49 to 50.22) as well.
Conclusion　 Pimecrolimus should not be regarded as a better choice than triamcinolone acctonide or placebo for improving the VAS, OHIP or CSS of patients with oral lichen planus. Since the RCTs available for this systematic review are too small, further high-quality large-scale RCTs with standard clinical evaluation are required to provide more reliable evidence.

Citation： GONG Zhongcheng,LIN Zhaoquan,ADILI Moming,WANG Ling,XIONG Hui,LIAO Feng,LONG Xing. Effect of Pimecrolimus on Oral Lichen Planus: A Systematic Review. Chinese Journal of Evidence-Based Medicine, 2008, 08(4): 261-266. doi: 10.7507/1672-2531.20080056 Copy

1.	Axell T. Occurrence of leukoplakia and some other oral white lesions among 20,333 adult Swedish people. Community Dent Oral Epidemiol, 1987, 15: 46-51.
2.	Altman J, Perry HO. The variations and course of lichen planus. Arch Dermatol, 1961, 84: 179-191.
3.	Eisen D. The clinical features, malignant potential, and systemic associations of oral lichen planus: a study of 723 patients. J Am Acad Dermatol, 2002, 46: 207-214.
4.	Lodi G, Scully C, Carrozzo M, et al. Current controversies in oral lichen planus: report of an international consensus meeting, part 2; clinical management and malignant transformation. Oral Surg Oral Med Oral Pathol Oral Radiol Endod, 2005, 100: 164-178.
5.	Stuetz A, Grassberger M, Meingassner JG. Pimecrolimus (Elidel, SDZ ASM981) -preclinical pharmacologic profile and skin selectivity. Semin Cutan Med Surg, 2001, 20(4): 233.
6.	Gorouhi F, Solhpour A, Beitollahi JM, et al. Randomized trial of pimecrolimus cream versus triamcinolone acetonide paste in the treatment of oral lichen planus. J Am Acad Dermatol, 2007, 57(5): 806-813.
7.	Passeron T, Lacour JP, Fontas E, et al. Treatment of oral erosive lichen planus with 1% pimecrolimus cream: a double-blind, randomized, prospective trial with measurement of pimecrolimus levels in the blood. Arch Dermatol, 2007, 143(4): 472-476.
8.	Scheer M, Kawari-Mahmoodi N, Neugebauer J, et al. Pimecrolimus (Elidel) for therapy of lichen ruber mucosae. Mund Kiefer Gesichtschir, 2006, 10(6): 403-407.
9.	Cedro M, Chaudhry S, Porter S. OC10 Topical pimecrolimus for the treatment of erosive oral lichen planus. Oral Dis, 2006, 12(s1): 11.
10.	Swift JC, Rees TD, Plemons JM. The effectiveness of 1% pimecrolimus cream in the treatment of oral erosive lichen planus. J Periodontol, 2005, 76(4): 627-635.
11.	Thongprasom K, Luangjarmekorn L, Sererat T, et al. Relative efficacy of fluocinolone acetonide compared with triamcinolone acetonide in treatment of oral lichen planus. J Oral Pathol Med, 1992, 21: 456-458.
12.	Scott J, Huskisson EC. Graphic representation of pain. Pain, 1976, 2: 175-184.
13.	Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol, 1997, 25: 284-290.
14.	Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 4.2.4 [updated March 2005]. In: The Cochrane Library, Issue 2, 2005.
15.	Moher D, Pham B, Jones A, et al. Does quality of reports of randomized trials affect estimates of intervention eficacy reported in Meta-analyses. Lancet, 1998, 352(9128): 609-613.
16.	Anon. News: Cream for atopic enzema launched. Pharm J, 2002, 269(7220): 560-563.
17.	Meingassner JG, Kowalsky E, Schwendinger H, et al. Pimecrolimus does not affect Langerhans cells in murine epidermis. Br J Dermatol, 2003, 149: 853-857.
18.	Billich A, Aschauer H, Aszodi A, et al. Percutaneous absorption of drugs used in atopic eczema: pimecrolimus permeates less through skin than corticosteroids and tacrolimus. Int J Pharm, 2004, 269: 29-35.
19.	Gupta AK, Chow M. Pimecrolimus: a review. J Eur Acad Dermatol Venereol, 2003, 17: 493-503.
20.	Dissemond J, Schroter S, Franckson T, et al. Pimecrolimus in an adhesive ointment as a new treatment option for oral lichen planus. Br J Dermatol, 2004, 150: 782-784.
21.	Esquivel-Pedraza L, Fernandez-Cuevas L, Ortiz-Pedroza G, et al. Treatment of oral lichen planus with topical pimecrolimus 1% cream. Br J Dermatol, 2004, 150: 771-773.
22.	Allen BR, Lakhanpaul M, Morris A, et al. Systemic exposure, tolerability, and efficacy of pimecrolimus cream 1% in atopic dermatitis patients. Arch Dis Child, 2003, 88: 969-973.
23.	Rappersberger K, Komar M, Ebelin ME, et al. Pimecrolimus identifies a common genomic anti-inflammatory profile, is clinically highly effective in psoriasis and is well tolerated. J Invest Dermatol, 2002, 119: 876-887.
24.	Lo Muzio L, della Valle A, Mignogna MD, et al. The treatment of oral aphthous ulceration or erosive lichen planus with topical clobetasol propionate in three preparations: a clinical and pilot study on 54 patients. J Oral Pathol Med, 2001, 30: 611-617.
25.	Carbone M, Goss E, Carrozzo M, et al. Systemic and topical corticosteroid treatment of oral lichen planus: a comparative study with long-term follow-up. J Oral Pathol Med, 2003, 32: 323-329.
26.	Berger TG, Duvic M, Van Voorhees AS, et al. The use of topical calcineurin inhibitors in dermatology: safety concerns. Report of the American Academy of Dermatology Association task force. J Am Acad Dermatol, 2006, 54: 818-823.
27.	Spergel JM, Leung DY. Safety of topical calcineurin inhibitors in atopic dermatitis: evaluation of the evidence. Curr Allergy Asthma Rep, 2006, 6: 270-274.

1. Axell T. Occurrence of leukoplakia and some other oral white lesions among 20,333 adult Swedish people. Community Dent Oral Epidemiol, 1987, 15: 46-51.
2. Altman J, Perry HO. The variations and course of lichen planus. Arch Dermatol, 1961, 84: 179-191.
3. Eisen D. The clinical features, malignant potential, and systemic associations of oral lichen planus: a study of 723 patients. J Am Acad Dermatol, 2002, 46: 207-214.
4. Lodi G, Scully C, Carrozzo M, et al. Current controversies in oral lichen planus: report of an international consensus meeting, part 2; clinical management and malignant transformation. Oral Surg Oral Med Oral Pathol Oral Radiol Endod, 2005, 100: 164-178.
5. Stuetz A, Grassberger M, Meingassner JG. Pimecrolimus (Elidel, SDZ ASM981) -preclinical pharmacologic profile and skin selectivity. Semin Cutan Med Surg, 2001, 20(4): 233.
6. Gorouhi F, Solhpour A, Beitollahi JM, et al. Randomized trial of pimecrolimus cream versus triamcinolone acetonide paste in the treatment of oral lichen planus. J Am Acad Dermatol, 2007, 57(5): 806-813.
7. Passeron T, Lacour JP, Fontas E, et al. Treatment of oral erosive lichen planus with 1% pimecrolimus cream: a double-blind, randomized, prospective trial with measurement of pimecrolimus levels in the blood. Arch Dermatol, 2007, 143(4): 472-476.
8. Scheer M, Kawari-Mahmoodi N, Neugebauer J, et al. Pimecrolimus (Elidel) for therapy of lichen ruber mucosae. Mund Kiefer Gesichtschir, 2006, 10(6): 403-407.
9. Cedro M, Chaudhry S, Porter S. OC10 Topical pimecrolimus for the treatment of erosive oral lichen planus. Oral Dis, 2006, 12(s1): 11.
10. Swift JC, Rees TD, Plemons JM. The effectiveness of 1% pimecrolimus cream in the treatment of oral erosive lichen planus. J Periodontol, 2005, 76(4): 627-635.
11. Thongprasom K, Luangjarmekorn L, Sererat T, et al. Relative efficacy of fluocinolone acetonide compared with triamcinolone acetonide in treatment of oral lichen planus. J Oral Pathol Med, 1992, 21: 456-458.
12. Scott J, Huskisson EC. Graphic representation of pain. Pain, 1976, 2: 175-184.
13. Slade GD. Derivation and validation of a short-form oral health impact profile. Community Dent Oral Epidemiol, 1997, 25: 284-290.
14. Higgins JPT, Green S, editors. Cochrane Handbook for Systematic Reviews of Interventions 4.2.4 [updated March 2005]. In: The Cochrane Library, Issue 2, 2005.
15. Moher D, Pham B, Jones A, et al. Does quality of reports of randomized trials affect estimates of intervention eficacy reported in Meta-analyses. Lancet, 1998, 352(9128): 609-613.
16. Anon. News: Cream for atopic enzema launched. Pharm J, 2002, 269(7220): 560-563.
17. Meingassner JG, Kowalsky E, Schwendinger H, et al. Pimecrolimus does not affect Langerhans cells in murine epidermis. Br J Dermatol, 2003, 149: 853-857.
18. Billich A, Aschauer H, Aszodi A, et al. Percutaneous absorption of drugs used in atopic eczema: pimecrolimus permeates less through skin than corticosteroids and tacrolimus. Int J Pharm, 2004, 269: 29-35.
19. Gupta AK, Chow M. Pimecrolimus: a review. J Eur Acad Dermatol Venereol, 2003, 17: 493-503.
20. Dissemond J, Schroter S, Franckson T, et al. Pimecrolimus in an adhesive ointment as a new treatment option for oral lichen planus. Br J Dermatol, 2004, 150: 782-784.
21. Esquivel-Pedraza L, Fernandez-Cuevas L, Ortiz-Pedroza G, et al. Treatment of oral lichen planus with topical pimecrolimus 1% cream. Br J Dermatol, 2004, 150: 771-773.
22. Allen BR, Lakhanpaul M, Morris A, et al. Systemic exposure, tolerability, and efficacy of pimecrolimus cream 1% in atopic dermatitis patients. Arch Dis Child, 2003, 88: 969-973.
23. Rappersberger K, Komar M, Ebelin ME, et al. Pimecrolimus identifies a common genomic anti-inflammatory profile, is clinically highly effective in psoriasis and is well tolerated. J Invest Dermatol, 2002, 119: 876-887.
24. Lo Muzio L, della Valle A, Mignogna MD, et al. The treatment of oral aphthous ulceration or erosive lichen planus with topical clobetasol propionate in three preparations: a clinical and pilot study on 54 patients. J Oral Pathol Med, 2001, 30: 611-617.
25. Carbone M, Goss E, Carrozzo M, et al. Systemic and topical corticosteroid treatment of oral lichen planus: a comparative study with long-term follow-up. J Oral Pathol Med, 2003, 32: 323-329.
26. Berger TG, Duvic M, Van Voorhees AS, et al. The use of topical calcineurin inhibitors in dermatology: safety concerns. Report of the American Academy of Dermatology Association task force. J Am Acad Dermatol, 2006, 54: 818-823.
27. Spergel JM, Leung DY. Safety of topical calcineurin inhibitors in atopic dermatitis: evaluation of the evidence. Curr Allergy Asthma Rep, 2006, 6: 270-274.

Chinese Journal of Evidence-Based Medicine

Effect of Pimecrolimus on Oral Lichen Planus: A Systematic Review

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