Aims:By virtue of being a specialized field by itself, the science of clinical trials (CTs) may not be well understood by doctors who are not specifically trained in it. A lack of knowledge may translate to a negative perception toward CT. With the idea of getting a situational snapshot, we estimated the knowledge and perception of CTs among doctors from government medical colleges of West Bengal who are not trained on CT in their postgraduate curriculum. Several determinants of knowledge and perception regarding CT were also evaluated.Methods:We have quantified the knowledge and perception of CTs by a structured validated questionnaire. Development and validation of the questionnaire was performed prior to the study.Results:Among 133 participants, 7.5% received focused training on CT and 16.5% participated in CTs as investigators. Majority of the doctors were unfamiliar with the basic terminologies such as, “adverse event” and “good clinical practice.” Encouragingly, 93.3% doctors advised that a detailed discussion of CT methodology should be incorporated in the under graduate medical science curriculum. They had an overall positive attitude toward CTs conducted in India, with a mean score that is 72.6% of the maximum positive score. However, a large number of the doctors were skeptical about the primary motivation and operations of pharmaceutical industry sponsored CTs, with 45% of them believing that patients are exploited in these sponsored CTs.Conclusion:Participant doctors had a basic knowledge of CT methodology. The study has revealed specific areas of deficient knowledge, which might be emphasized while designing focused training on CT methodology.
Objectives:Methotrexate (MTX) is the most commonly used cost-effective disease-modifying antirheumatoid drug (DMARD). Its main dose-limiting adverse effects are hepatic and hematopoietic. This cross-sectional, observational study evaluated the prevalence of hepatic and hematological adverse effects with long-term low-dose MTX therapy.Materials and Methods:Rheumatoid arthritis (RA) patients taking ≤15 mg/week MTX for at least 2 years were enrolled from the rheumatology outpatient department. Demographic, disease, drug treatment profiles, and hematological and hepatic enzyme levels were noted.Results:Of the 204 patients enrolled, the frequency of raised alanine transaminase level (≥3-fold rise above the upper limit of normal) was 6.37% (95% confidence interval of 3.76–10.59) including two biopsy-proven hepatic fibrosis cases. About 5.4% had severe anemia (<8 g/dl) and 4.4% had leukopenia.Conclusion:Long-term low-dose MTX is safe in RA patients in the Indian population. The patterns of adverse effects were similar to those documented in earlier studies. However, our study results suggest that disease duration, cumulative MTX dose, concomitant DMARD intake are not risk factors associated with hepatic or hematological adverse effects.
Context: Melasma is an acquired chronic disorder of hyperpigmentation. Tranexamic acid (TXA) has been shown to be effective in reducing the severity of melasma. Aims: The aim of this study is to compare the efficacy of intralesional TXA with topical Kligman’s regimen in the treatment of facial melasma and to assess their safety profile. Settings and Design: A double arm open-labeled randomized controlled trial was conducted at a tertiary care center in western India. Materials and Methods: Sixty-eight cases of facial melasma of either sex and age ≥ 18 years were randomized into two groups. Group A received intradermal injections of TXA 4 mg/mL, whereas group B received topical Kligman’s therapy. Patients were evaluated at baseline, 4th, 8th, and 12th week semi-objectively using modified melasma area severity index (mMASI) score, physician’s global assessment scale, and patient’s global assessment scale. Statistical Analysis: Data were analyzed using SPSS v16 software. Mann–Whitney U -test, Friedman’s analysis of variance test, and Pearson’s χ 2 test were used. P -value less than 0.05 was considered as statistically significant. Results: Fifty-nine patients completed the study. The decrease in mean mMASI score was statistically significant at 4th, 8th, and 12th week for both groups. On intergroup comparison, a statistically significant difference was observed between both the groups at 12th week ( P < 0.01), with group B showing better response to therapy but no difference at baseline and at 4th and 8th week. Group A showed no significant side effects, whereas group B showed erythema, burning, and hypopigmentation in nine, six, and three patients, respectively. Conclusion: Kligman’s regimen remains the gold standard for melasma but with multiple serious adverse effects. Intralesional TXA is a safe and promising modality in the treatment of melasma. It can be used in non-responding cases and in those who develop side effects of Kligman’s regimen.
Background: Second generation antihistamines are first line therapy for chronic spontaneous urticaria (CSU). Sedation has been always a concern as a side effect of antihistamine for both patients and treating dermatologist. It is always better to prefer non-sedative antihistamine for CSU. Bepotastine is such promising non-sedative agent. Aim and Objectives: The objective of the study was to compare the efficacy and safety of bepotastine and levocetirizine in patients of CSU. Materials and Methods: This is a double arm, open label, randomized, and controlled study. Out of 99 patients, 50 patients belonged to Group A while 49 belonged to Group B. Subjects in Group A received bepotastine 10 mg twice daily while subjects in Group B received levocetirizine 5 mg once daily for 8 weeks. Patients were evaluated at baseline, day 14, day 28, and day 56 using Urticaria Activity Score (UAS) and Urticaria Control Test (UCT) for efficacy; and visual analog scale (VAS) for safety, that is, sedation. Results: The fall in mean UAS scores was statistically significant at day 14, day 28, and day 56 for both Groups A and B (P < 0.05) on intragroup comparison. While comparing the overall improvement between the two groups, there was no significant difference in UAS and UCT score at day 14, day 28, and day 56 between Group A and Group B, respectively (P > 0.05). At day 56, there was significant difference in mean VAS of Group A and B. Only one patient in Group B developed headache. Conclusion: Thus, both levocetirizine and bepotastine are equally effective for the treatment of CSU. Bepotastine has less sedative potential than levocetirizine.
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