| ORIGINAL ARTICLE | ||
| Year : 2014 | Volume : 80 | Issue : 2 | Page : 122-128 | ||
Vinod K Sharma1, Saurabh Singh1, M Ramam1, Mahesh Kumawat1, Rakesh Kumar2
1 Departments of Dermatology, Venereology and Leprology, All India Institute of Medical Sciences (AIIMS), New Delhi, India
2 Centre for Community Medicine, All India Institute of Medical Sciences (AIIMS), New Delhi, India
| Date of Web Publication | 26-Mar-2014 |
Correspondence Address:
Vinod K Sharma
Departments of Dermatology, Venereology, and Leprology, All India Institute of Medical Sciences (AIIMS), New Delhi - 110 029
India
Vinod K Sharma
Departments of Dermatology, Venereology, and Leprology, All India Institute of Medical Sciences (AIIMS), New Delhi - 110 029
India
DOI: 10.4103/0378-6323.129382
PMID: 24685847
| Abstract |
Background: Chronic urticaria not responsive to antihistamines is a difficult disease to manage. Methotrexate has been used in difficult chronic urticarias with some benefit.Objective: To evaluate the efficacy of methotrexate in the treatment of chronic spontaneous urticaria poorly responsive to H1 antihistaminics. Methods: In a randomized double-blind trial at the Department of Dermatology and Venereology of a tertiary care centre, 29 patients with chronic spontaneous urticaria not responding well to H1 antihistaminics were recruited. Patients were randomly allocated to receive either a weekly dose of oral methotrexate 15 mg or placebo (calcium carbonate) for a total duration of 12 weeks, after which treatment was stopped and patients were followed up for relapse of urticaria. Each group also received levocetrizine 5 mg once daily for symptom control. Primary outcome measured was a reduction by >2/3 rd of baseline urticaria scores after 12 week therapy. Secondary outcome was a reduction in antihistamine requirement after stopping therapy. Results:Fourteen patients were randomized to the methotrexate group and fifteen patients to the placebo group. Out of 17 patients who completed therapy, the primary outcome was achieved by 3.5 ± 1.9 (out of 10) patients in the methotrexate group and by 3.67 ± 1.03 (out of 7) patients in the placebo group (P > 0.05). Ten patients followed up, after stopping therapy, for a mean period of 3.5 ± 2.4 months; 3 remained in remission and 7 had relapsed. One patient had uncontrollable nausea and vomiting after taking methotrexate and was withdrawn from the study. The placebo group did not experience any side effects. Conclusions: Methotrexate 15 mg weekly for 3 months did not provide any additional benefit over H1 antihistamines in this study but an adequately powered study with longer follow up is required to assess its utility.
Keywords: Antihistamine resistant urticaria, chronic idiopathic urticaria, chronic spontaneous urticaria, methotrexate in urticaria, randomized controlled trial in chronic urticaria
| In this article | |
| Abstract | |
| Introduction | |
| Methods | |
| Results | |
| Discussion | |
| Acknowledgments | |
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| How to cite this article: Sharma VK, Singh S, Ramam M, Kumawat M, Kumar R. A randomized placebo-controlled double-blind pilot study of methotrexate in the treatment of H1 antihistamine-resistant chronic spontaneous urticaria. Indian J Dermatol Venereol Leprol 2014;80:122-8 |
| How to cite this URL: Sharma VK, Singh S, Ramam M, Kumawat M, Kumar R. A randomized placebo-controlled double-blind pilot study of methotrexate in the treatment of H1 antihistamine-resistant chronic spontaneous urticaria. Indian J Dermatol Venereol Leprol [serial online] 2014 [cited 2014 May 8];80:122-8. Available from: http://www.ijdvl.com/text.asp?2014/80/2/122/129382 |
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