Comparative Efficacy of Tamsulosin Versus Tamsulosin Plus Finasteride in Patients with Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hypertrophy, a Randomized Open Label Parallel Group Study

Background: Benign prostatic hypertrophy (BPH) is a common entity among elderly men and is responsible for significant disability. Medical treatment for BPH has played a major role in improving the symptoms associated with bladder outlet obstruction. Recent guidelines recommend the combination of an alpha-1 blocker and a 5-ARI as first-line treatment of men with moderate-to-severe LUTS. There is limited study data to support which is the effective therapy for BPH/LUTS in a tertiary care hospital in India. Methods: A randomized, open labelled, double blind, active control parallel group study comparing the safety and efficacy of tamsulosin versus tamsulosin+finasteride in subjects with lower urinary tract symptoms secondary to benign prostatic hypertrophy. The subjects were randomized after obtaining written informed consent. The subjects were recruited from the patient population that was attending the Out-Patient department of Urology, Sri Ramachandra Medical College & Research Institute, Sri Ramachandra University. Results: A total sample of 60 subjects, 30 into each group was enrolled. In the tamsulosin group, according to IPSS score, 11 patients who had moderate symptoms (36.7%) became mild, and among 19 patients who had severe symptoms (63.3%), 12 patients became mild (40%) and 7 patients became moderate (23.3%) with a p value of 0.021 which is statistically significant. In the tamsulosin+ finasteride group, according to IPSS score, 10 patients who had moderate symptoms (33.3%) became mild, and among 20 patients who had severe symptoms (66.7%), 12 patients became mild (40%) and 8 patients became moderate (26.7%) with a p value of 0.020 which is statistically significant. When comparing between the two groups, 76.7% attained mild symptoms in group 1 and 73.3% patients attained mild symptoms in group 2 with a p value of 0.766 which is statistically not significant. Conclusion: To conclude tamsulosin 0.4mg is as effective as the combination therapy of tamsulosin 0.4mg and finasteride 5mg in the treatment of lower urinary tract symptoms secondary to Benign prostatic hypertrophy.

Optimize Initial Freezing Time of Transbronchial Cryobiopsy for the Diagnosis of Interstitial Lung Disease: A Prospective Randomized Parallel Group Study

<b><i>Background:</i></b> Transbronchial cryobiopsy (TBCB) is increasingly being identified as a potential alternative for the diagnosis of interstitial lung disease (ILD). The specimen size of TBCB is positively related to the freezing time. However, the proper initial freezing time for the clinical application of TBCB in ILD remains unknown. <b><i>Methods:</i></b> A prospective randomized parallel group study was employed to investigate ILD patients with unclear diagnosis, who were admitted to the First Affiliated Hospital of Guangzhou Medical University from May 2019 to October 2020 and required TBCB. All patients were randomly divided into 4 groups according to the different freezing times of TBCB: 3 s, 4 s, 5 s, and 6 s groups. All operations were performed under intravenous anesthesia with endotracheal intubation, 60–65 bar pressure of freezing gas source, and 1.9-mm cryoprobe. Compare differences among groups in specimen size, complications, pathological diagnosis efficiency, and multidisciplinary discussion (MDD) diagnostic efficiency. <b><i>Results:</i></b> A total of 100 patients were recruited and randomly assigned into 4 groups (<i>n</i> = 25 each group). The specimen sizes of TBCB in ILD were positively correlated with the freezing time (<i>r</i> = 0.639, <i>p</i> &#x3c; 0.05). None of the patients experienced Grade 3 severe bleeding. Pneumothorax occurred in 1 patient in the 4 s, 5 s, and 6 s groups, respectively. The diagnostic yield of MDD in the 3 s, 4 s, 5 s, and 6 s groups were 64%, 88%, 88%, and 96%, respectively (<i>p</i> &#x3c; 0.05), but showing no significant differences among 4 s, 5 s, and 6 s groups. <b><i>Conclusions:</i></b> The specimen size and diagnostic efficiency of TBCB in ILD increased with a longer freezing time. When the freezing gas pressure is 60–65 bar, we recommended 4 s as the initial freezing time of TBCB, and this time is associated with high diagnostic efficiency and low incidence of complications.

Comparative Effects of Metamizole (Dipyrone) and Naproxen on Renal Function and Prostacyclin Synthesis in Salt-Depleted Healthy Subjects - A Randomized Controlled Parallel Group Study

Aim: The objective was to investigate the effect of metamizole on renal function in healthy, salt-depleted volunteers. In addition, the pharmacokinetics of the four major metamizole metabolites were assessed and correlated with the pharmacodynamic effect using urinary excretion of the prostacyclin metabolite 6-keto-prostaglandin F1α.Methods: Fifteen healthy male volunteers were studied in an open-label randomized controlled parallel group study. Eight subjects received oral metamizole 1,000 mg three times daily and seven subjects naproxen 500 mg twice daily for 7 days. All subjects were on a low sodium diet (50 mmol sodium/day) starting 1 week prior to dosing until the end of the study. Glomerular filtration rate was measured using inulin clearance. Urinary excretion of sodium, potassium, creatinine, 6-keto-prostaglandin F1α, and pharmacokinetic parameters of naproxen and metamizole metabolites were assessed after the first and after repeated dosing.Results: In moderately sodium-depleted healthy subjects, single or multiple dose metamizole or naproxen did not significantly affect inulin and creatinine clearance or sodium excretion. Both drugs reduced renal 6-keto-prostaglandin F1α excretion after single and repeated dosing. The effect started 2 h after intake, persisted for the entire dosing period and correlated with the concentration-profile of naproxen and the active metamizole metabolite 4-methylaminoantipyrine (4-MAA). PKPD modelling indicated less potent COX-inhibition by 4-MAA (EC50 0.69 ± 0.27 µM) compared with naproxen (EC50 0.034 ± 0.033 µM).Conclusions: Short term treatment with metamizole or naproxen has no significant effect on renal function in moderately sodium depleted healthy subjects. At clinically relevant doses, 4-MAA and naproxen both inhibit COX-mediated renal prostacyclin synthesis.

Comparative Efficacy, Safety and Tolerability of Olanzapine and Blonanserin in Patients with Schizophrenia: A Parallel Group Study

Background The antipsychotic olanzapine is a first-line drug in the treatment of schizophrenia while blonanserin is indicated in resistant cases of schizophrenia when the first line antipsychotics have failed. There are very limited studies available world-wide as well as in India that compare blonanserin with other antipsychotics in the setting of schizophrenia. Aims To study the efficacy, safety and tolerability of olanzapine and blonanserin in Schizophrenia. Settings and Design: The study was a prospective, observational, parallel group study done on schizophrenia patients aged between 18-50 years of both sexes at an outpatient Department of Psychiatry, in a tertiary medical college. The study was conducted from February 2015 to October 2016, with follow ups at weeks 4, 8 and 12. Materials and Methods The efficacy parameters were measured by the Brief Psychiatric Rating Scale (BPRS) and the Clinical Global Impression (CGI) rating. The safety parameters included the vital signs, haematological profile, lipid profile, blood sugar monitoring. Adverse drug reactions and compliance to therapy was observed through-out the study period. Appropriate statistical tests were applied to detect any significant within and between group differences using Microsoft Excel 2007 and SPSS version 17. Results There was significant decrease in the mean total score on the BPRS and CGI-S in the blonanserin arm at the 2nd and last follow up visit (p value < 0.001). Compliance was good in both groups (≤ 20% missed pills). Overall, 77 treatment-emergent adverse events were present from 56 patients. Twenty three subjects of the blonanserin arm and 33 subjects in the olanzapine arm at least experienced one adverse event (p = 0.006), metabolic adverse effects were more common with olanzapine, whereas insomnia, headache and somnolence were more often seen with blonanserin. Conclusions In the present study, blonanserin provided significantly better outcomes than olanzapine with respect to BPRS, CGI-S scores.