A randomized placebo-controlled double-blind pilot study of methotrexate in the treatment of H1 antihistamine-resistant chronic spontaneous urticaria.

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dc.contributor.authorSharma, Vinod K
dc.contributor.authorSingh, Saurabh
dc.contributor.authorRamam, M
dc.contributor.authorKumawat, Mahesh
dc.contributor.authorKumar, Rakesh
dc.date.accessioned2015-01-07T06:43:59Z
dc.date.available2015-01-07T06:43:59Z
dc.date.issued2014-03
dc.description.abstractBackground: Chronic urticaria not responsive to antihistamines is a diffi cult disease to manage. Methotrexate has been used in diffi cult chronic urticarias with some benefi t. Objective: To evaluate the effi cacy 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 >2/3rd 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 fi fteen 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 One patient had uncontrollable nausea and vomiting after taking methotrexate and was withdrawn from the study.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 benefi t over H1 antihistamines in this study but an adequately powered study with longer follow up is required to assess its utility.en_US
dc.identifier.citationSharma Vinod K, Singh Saurabh, Ramam M, Kumawat Mahesh, Kumar Rakesh. A randomized placebo-controlled double-blind pilot study of methotrexate in the treatment of H1 antihistamine-resistant chronic spontaneous urticaria. Indian Journal of Dermatology, Venereology and Leprology. 2014 Mar-Apr; 80(2): 122-128.en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/154762
dc.language.isoenen_US
dc.source.urihttps://www.ijdvl.com/article.asp?issn=0378-6323;year=2014;volume=80;issue=2;spage=122;epage=128;aulast=Sharmaen_US
dc.subjectAntihistamine resistant urticariaen_US
dc.subjectchronic idiopathic urticariaen_US
dc.subjectchronic spontaneous urticariaen_US
dc.subjectmethotrexate in urticariaen_US
dc.subjectrandomized controlled trial in chronic urticariaen_US
dc.subject.meshAdolescent
dc.subject.meshAdult
dc.subject.meshChronic Disease
dc.subject.meshDermatologic Agents --administration & dosage
dc.subject.meshDouble-Blind Method
dc.subject.meshDrug Resistance
dc.subject.meshFemale
dc.subject.meshFollow-Up Studies
dc.subject.meshHistamine H1 Antagonists --administration & dosage
dc.subject.meshHumans
dc.subject.meshMale
dc.subject.meshMethotrexate --administration & dosage
dc.subject.meshMiddle Aged
dc.subject.meshPilot Projects
dc.subject.meshPlacebos
dc.subject.meshTreatment Outcome
dc.subject.meshUrticaria --drug therapy
dc.subject.meshYoung Adult
dc.titleA randomized placebo-controlled double-blind pilot study of methotrexate in the treatment of H1 antihistamine-resistant chronic spontaneous urticaria.en_US
dc.typeArticleen_US
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