Comparison of Efficacy of Various Treatment Modalities in Patients with Chronic Spontaneous Urticaria

Arul Selvan, M (2020) Comparison of Efficacy of Various Treatment Modalities in Patients with Chronic Spontaneous Urticaria. Masters thesis, Madras Medical College, Chennai.


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BACKGROUND: The term urticaria has been used as descriptive term for recurrent, short lived, itchy wheals, angioedema or both. It is a major health problem in 20% of people at some point during their life time. It is said to be chronic if lesions persist for six or more weeks and at the rate of two or more episodes per week. Proper management of urticaria needs complete understanding of triggers, etiologies and pathogenesis in addition to the most relevant drugs. A significant proportion of patients respond poorly to first line treatment with antihistamines, who may require second line drugs. Considering the autoimmune etiology most of the immunomodulators like cyclosporine, methotrexate, dapsone, azathioprine and mycophenolate mofetil are used, based on clinical experience with good results. OBJECTIVES: The purpose of our study is to compare the efficacy of two of the second line drugs namely methotrexate and dapsone with only second generation antihistamine as control group in the treatment of recalcitrant chronic spontaneous urticaria. The above drugs have been chosen for our study based on the safety profile, cost factor and based on the results shown by previous studies. This will be useful in future management of difficult cases. METHODOLOGY: This is a randomized comparative study conducted from February 2018 to July 2019 at the outpatient department of Dermatology, Madras medical college.150 patients who has been clinically diagnosed as chronic spontaneous urticaria were enrolled into the study and divided into three groups randomly based on inclusion and exclusion criteria. All the patients were explained about the study and informed written consent was obtained from them in the language of their convenience. A thorough history regarding the precipitating factors, nature and course of wheals were obtained and recorded. Complete systemic and dermatological examinations were done on all patients. Complete blood count, ESR, liver and renal function tests were done in all patients. Baseline urticaria total severity scores were calculated in all patients in their first visit. Six parameters namely number and size of wheals, intensity of pruritis, duration of persistence, frequency of appearance and frequency of antihistamines used were used to calculate the score. Patients were randomized into two groups. One group of patients were treated with tablet methotrexate 10mg/week and tablet folic acid 5mg on all other days of the week. The other group was treated with tablet azathioprine 50mg/day. This was continued for a period of twelve weeks. Both the groups were allowed to take cetrizine 10mg tablets as and when required up to a maximum of 4 tablets per day. At end of 12 weeks patients were stopped on all medications and were advised to take tablet cetrizine 10mg when required. Patients were reviewed every 6 weeks and baseline investigations were repeated. In case of any abnormality in blood investigations or any side effect of the drugs were noted, they were treated symptomatically or were excluded from the study, depending on the severity. At the end of 12 weeks and 24 weeks urticarial total severity scores were calculated in all patients to assess the response to treatment. The treatment response was graded as follows based on the total severity scores at baseline and at the end of 12th ad 24th weeks. Good response: Decrease in TSS by greater than 70% Average response: Decrease in TSS by 30 – 70% Poor response: Decrease in TSS by less than 30% Thus, the efficacy of methotrexate and azathioprine in the treatment of chronic urticaria were studied and compared. RESULTS: Our study included 150 patients which included 62 males and 88 females. The youngest patient among the study group was 18 years and the oldest being 60. The duration of urticaria was more common between 1 to 3 years in all three groups. 96% of patients had no specific precipitating factors. Only 9.3% of patients showed minimal tolerable side effects. The most common comorbidity associated with urticaria was hypothyroidism followed by diabetes mellitus. 30% of patients had history of atopy. Total severity score showed significant reduction from baseline to 12 weeks and 24weeks of assessment in all three treatment groups. There was statistically more significant improvement noted in methotrexate with antihistamine group followed by dapsone group and only antihistamine group. Parameters like number of wheals, wheal size, wheal duration, severity of pruritus, frequency of wheals and antihistamine use were assessed separately in all groups of patients. All group of patients showed reduction in score in all the above parameters. There was significant increase in the severity of pruritus and frequency of antihistamine use in both methotrexate group and dapsone group at 24th week of assessment. This could be due to withdrawal of drugs after 12 weeks of treatment. CONCLUSION: Based on the results obtained, we conclude that both methotrexate and dapsone was effective in the management of chronic spontaneous urticaria with good safety profile and prolonged course of treatment was needed to get significant results.

Item Type: Thesis (Masters)
Additional Information: 201730004
Uncontrolled Keywords: Urticaria, wheal, angioedema, methotrexate, dapsone, antihistamine, efficacy, safety.
Subjects: MEDICAL > Dermatology Venereology and Leprosy
Depositing User: Subramani R
Date Deposited: 05 Feb 2021 01:17
Last Modified: 05 Feb 2021 01:17

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