To compare the efficacy and safety of avanafil as compared with sildenafil in the management of patients with erectile dysfunction. Methods: It was a prospective, randomized, double-blind, two-arm, active-controlled, parallel, multicenter, non-inferiority clinical study carried out in patients with erectile dysfunction for at least 3 months and International Index of Erectile Function -Erectile Function domain score of <26 at enrolment. Results: A total of 220 patients were randomized to receive either avanafil tablets 100 mg or sildenafil tablets 50 mg in 1:1 ratio. After 4 weeks of treatment, 40.0% of patients in the avanafil group and 45.6% of patients in the sildenafil group required dose escalation to a high dose (avanafil 200 mg/sildenafil 100 mg). The difference in the mean change of International Index of Erectile Function -Erectile Function score from baseline in the two groups increased from week 4 (1.1, 95% confidence interval À0.2 to 2.5) to week 8 (1.4, 95% confidence interval 0.1-2.7) and week 12 (2.1, 95% confidence interval 0.8-3.5), showing non-inferiority at week 4, and superiority at week 8 and week 12. Avanafil showed a faster onset of action as shown by a significantly better response to modified Sexual Encounter Profile 1 in the avanafil group (84.8%) as compared with that in the sildenafil group (28.2%; P < 0.001). Both avanafil and sildenafil were well tolerated by all the patients in the study; the most common adverse event reported during the study was headache in both the groups. Conclusion: Avanafil is superior to sildenafil in improving the International Index of Erectile Function -Erectile Function domain score at the end of 12 weeks of treatment with the added advantage of faster onset of action.
CONTEXT:Migraine is the second most common headache disorder. However, prophylactic therapy remains underutilized.AIMS:The objective of the study was to compare the efficacy and safety of low-dose sodium valproate and low-dose propranolol sustained release (SR) in the prophylaxis of common migraine headache.SETTINGS AND DESIGN:The study was conducted in a tertiary care teaching institute. It was a randomized, prospective, parallel, open-label, clinical study.SUBJECTS AND METHODS:The study included 60 patients with common migraine headaches (≥2 attacks/month) treated for 12 weeks. The patients were randomly divided into two treatment groups treated by sodium valproate 500 mg/day and propranolol SR 40 mg/day, respectively. The primary outcome measures were the percentage of responders (i.e., >50% decrease in mean headache frequency) at the end of 12 weeks and decrease in mean headache frequency (per 4 weeks) at the end of 12 weeks. The patients were assessed at 0, 4, 8, and 12 weeks of the study.STATISTICAL ANALYSIS USED:Intention-to-treat analysis was used for all the statistical analysis.RESULTS:Fifty-five patients completed the study. At the end of the treatment, both sodium valproate and propranolol caused a significant (P < 0.0001) reduction in frequency, severity, and duration of migraine headache. Propranolol caused significantly greater reduction in the severity of headache (P = 0.0410) than sodium valproate. The percentage of responders was 60% in sodium valproate group and 70% in propranolol group. Drowsiness was the most common adverse effect noted in both the groups.CONCLUSION:Both sodium valproate and propranolol significantly reduced frequency, severity, and duration of migraine headache, but propranolol caused significantly greater reduction in the severity of headache compared to sodium valproate. Both the medications were well tolerated and did not result in discontinuation.
Background: Psychological distress and depression persist in cancer patients, creating an additional burden during treatment and making it more challenging in terms of management and control. There are few studies on the prevalence of psychological distress and depression among cancer patients in the central India. Hence the present study was undertaken to study the prevalence of psychological distress and depression in the adult cancer patients. Method- A total of 271 patients, age between 18 to 75 years, who have been diagnosed with malignancy and receiving treatment from tertiary health care center were included in the study. They were given the Kessler psychological distress scale (K-10), and their responses were recorded. The Beck depression inventory was utilized to determine the severity of depression. Results- Among 271 patients, 112(41.32%) were males and 159(58.67 %) females. Maximum patients were in the age group of 40–60 years (43.17%). Total number of patients suffering from distress was 254(93%) out of 271, most of them (53.87%) had distress score ranging from 25-29 (Moderate). Among 271 patients, 235 (86.71%) patients had mild to severe depression, most of them had depression score between 10-18 (mild). Out of 87 head, neck cancer patients, 74 (85.05%) had depression. High rate of depression found in head neck cancer as compared to other types of cancer. Using the Kessler and Conclusion- Beck depression inventory, this study indicates the high level of distress and sadness among cancer patients. Screening for psychosocial issues and proper treatments are only the beginning of genuinely integrative cancer care strategy.
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