Colchicine has shown clinical benefits in the management of COVID‐19 via its anti‐inflammatory effect. However, the exact role of colchicine in COVID‐19 patients is unknown. The current clinical trial was performed on 202 patients with moderate to severe COVID‐19. Patients were randomly assigned in a 1:1 ratio to receive up to a 3‐day course of 0.5 mg colchicine followed by a 12‐day course of 1 mg colchicine in combination with standard care or a 15‐day course of standard care. Among 202 randomized patients, 153 completed the study and received colchicine/standard care or continued standard care (M age, 54.72 [SD, 15.03] years; 93 [63.1%] men). On day 14, patients in the colchicine/standard care group had significantly higher odds of a better clinical status distribution on chest CT evaluation (p = .048). Based on NYHA classification, the percentage change of dyspnea on day 14 between groups was statistically significant (p = .026), indicating a mean of 31.94% change in the intervention group when compared with 19.95% in the control group. According to this study, colchicine can improve clinical outcomes and reduce pulmonary infiltration in COVID‐19 patients if contraindications and precautions are considered and it is prescribed at the right time and in appropriate cases.
Introduction
Radiation therapy is one of the standard methods in the treatment of breast cancer. Radiotherapy-induced dermatitis (RID) is a common complication of radiotherapy (RT) resulting in less tolerance in RT and even discontinuation of treatment. Timolol is a β-adrenergic receptor antagonist that presents the best wound healing effects on both chronic and incurable wound healing. Topical forms of timolol could be effective in the prevention of RID due to the role of β-adrenergic receptors in skin cells and keratinocyte migration, as well as the anti-inflammatory effect of timolol. However, no placebo-controlled randomized trial is available to confirm its role. The current trial aimed to evaluate the efficacy of topical timolol 0.5% (w/w) on the RID severity and patients' quality of life (QOL).
Method
Patients aged older than 18 years with positive histology confirmed the diagnosis of invasive and localized breast cancer were included. Patients were randomized based on the random number table to receive each of the interventions of timolol 0.5% (w/w) or placebo topical gels from the first day of initiation of RT and for 6 weeks, a thin layer of gel twice daily. Patients were asked to use a thin layer of gel for at least two hours before and after radiation therapy. Primary outcomes were acute radiation dermatitis (ARD) grade using Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC) scale and severity of desquamation based on Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. Secondary outcomes were QOL based on Skindex16 (SD-16), maximum grade of ARD, and time of initial RD occurrence.
Results
A total of 64 female patients with an age range of 33 to 79 years were included. The means (SD) of age were 53.88 (11.02) and 54.88 (12.48) in the control and timolol groups, respectively. Considering the RTOG/EORTC and CTCAE scores the difference between groups was insignificant (P-Value = 0.182 and P-Value = 0.182, respectively). In addition, the mean (SD) of time of initial RID occurrence in placebo and timolol groups were 4.09 (0.588) and 4.53 (0.983) weeks, respectively (P-Value = 0.035). The maximum grade of RID over time was significantly lower in the timolol group. During the study period, 75.0% of patients in placebo groups had grade 2 of ARD while in the timolol group it was 31.3% (P-Value = 0.002). QoL was not significantly different between groups (P-Value = 0.148).
Conclusion
Although the topical formulation of timolol, 0.5% (w/w), was found to reduce the average maximum grade of ARD and increase the mean (SD) time of initial RID occurrence, it showed no effect on ARD, severity, and QOL. However, future clinical trials should be performed to assess timolol gel formulation in larger study populations.
Trial registration
https://irct.ir/ IRCT20190810044500N11 (17/03/2021).
AbstractBackground: One of the common side effects of radiotherapy and chemotherapy in patients with head and neck cancer is oral mucositis. This painful complication restricts the ability to eat and drink and increases the risk of oral infections. The aim of this study was to investigate the effect of doxepin oral rinse 0.5% in comparison with persica mouthwash on reducing the pain of oral mucositis in patients with head and neck cancer after radiotherapy and chemotherapy. Methods: This clinical trial was performed on 56 patients admitted in the oncology ward of Shahid Sadoughi Hospital and Shahid Ramezanzadeh radiotherapy center in Yazd, who received more than 45 gray of radiation and had mucositis and their pain score was more than 4 on the basis of the Visual Analogue Scale (VAS). Patients were randomly divided into two groups of persica and doxepin 0.5%. The data collection tool was a questionnaire including visual analogue scale for pain, taste satisfaction and possible complications. Data were analyzed by using SPSS19 software and Chi-square test. Results: There was no significant difference between the mean score of pain in doxepin and persica groups 5,15,30, 120,240 minutes and 24 hours after taking the mouthwash; just in the doxepin group, the mean of pain reduction 60 minute after taking the mouthwash was higher than persica group (P> 0.05). There was no significant difference between the mean score of burning sensation in doxepin and persica groups30,60,120,240 minutes and 24 hours after taking the mouthwash; just in the pesica group, the mean of burning sensation reduction 5,15minutes after taking the mouthwash was lower than doxepin group The level of taste satisfaction and drowsiness in the doxepin group was significantly higher than persica group. (P >0.05) Conclusion: Persica mouthwash, like doxepin mouthwash, was effective in reducing the mucositis pain in patients and just in the doxepin group reduction in pain after 60 minutes was higher than perisca group
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