Clin Ther
Department of Pharmacology, Nil Ratan Sircar Medical College, Kolkata, India.
Published: December 2011
Background: Drug treatment can defer surgical intervention in benign prostatic hyperplasia (BPH), a common disorder in elderly men, and is widely practiced. Various herbal formulations have been used for the treatment of BPH, but few have been compared with established modern medicines in head-to-head clinical trials.
Objective: We compared the effectiveness and tolerability of an oral formulation, comprising standardized extracts of Murraya koenigii and Tribulus terrestris leaves being marketed in India under Ayurvedic license, versus tamsulosin in the treatment of symptomatic BPH.
Methods: A double-blind, double-dummy, parallel-group, randomized controlled trial was conducted with treatment-naive ambulatory patients with BPH aged >50 years. Patients received either the plant drug in a dose of 2 capsules BID or tamsulosin 400 μg once daily for 12 weeks with 2 interim follow-up visits at the end of 4 and 8 weeks. The double-dummy technique was used to ensure double-blinding. The primary effectiveness measure was reduction in the International Prostate Symptom Score (IPSS). Proportion of patients becoming completely or relatively symptom free (IPSS <8), change in prostate volume (assessed by using ultrasonography conducted by a radiologist blinded to the nature or duration of treatment), and peak urinary flow rate (assessed by using uroflowmetry) were secondary measures. Treatment-emergent adverse events, changes in weight, vital signs, and routine laboratory safety parameters were recorded.
Results: Forty-six patients were randomized (23 per group); 19 completed all study visits in the plant drug group and 21 in the tamsulosin group. However, applying modified intention-to-treat criterion, 23 and 21 patients, respectively, were considered for effectiveness analysis. Mean (SD) age and baseline weight were 58.5 (14.0) years and 57.5 (10.5) kg in the plant drug arm, and 62.9 (6.3) years and 59.8 (9.9) kg in the tamsulosin arm, respectively. Median (interquartile range) symptom duration was 12.0 (12.0-24.0) months and 15.0 (12.0-24.0) months, respectively, in the 2 arms. These differences were not statistically significant. IPSS (median [interquartile range]) declined from 17.0 (12.0-19.0) to 9.0 (5.0-13.0) with the plant drug and from 14.0 (11.0-18.0) to 8.0 (6.0-13.0) with tamsulosin after 12 weeks of treatment. The decline was individually significant in both groups (both, P < 0.001), but intergroup values showed no statistically significant difference at any point of time. IPSS <8 at study end was achieved by 10 and 7 patients, respectively, in the 2 arms (P = 0.548). The plant drug reduced prostate volume from 33.5 (26.2-45.9) mL to 31.6 (26.1-37.5) mL (P = 0.040). The corresponding reduction with tamsulosin, from 41.3 (29.4-51.3) mL to 39.9 (32.6-52.3) mL, was not statistically significant. Peak urinary flow rate did not change appreciably. Mild joint pain was the most common adverse event in both arms. No serious events were encountered. Compliance was satisfactory.
Conclusions: These findings suggest that the M koenigii- and T terrestris-based formulation significantly lowered IPSS scores in the initial treatment of symptomatic BPH. Further trials are needed to determine if the beneficial effect is sustained beyond the 12-week observation period of this trial.
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http://dx.doi.org/10.1016/j.clinthera.2011.11.005 | DOI Listing |
Clin Oral Investig
January 2025
Professor, Department of Biology, Faculty of Science, Dokuz Eylul University, Izmir, Tr-35340, Turkey.
Objective: This study investigated the use of oral rinse solutions formulated with boron-containing compounds, known for their antibacterial activity, as an alternative to chlorhexidine (CHX).
Material And Method: Boron nitride (BN), boric acid (BA) and sodium borate (SB) were used in the study. BN was used in nanosuspension (BN-NS) due to its low solubility in water.
J Antimicrob Chemother
January 2025
Infectious Diseases' Specialist Freelance, Fabro, Italy.
Modern ART is evolving, allowing the use of new drug formulations and alternative routes of administration to oral therapy. Long-acting (LA) cabotegravir and rilpivirine, the first fully injectable antiretroviral regimen approved for clinical use, is a test case for this new route of administration, and an innovation with implications for the quality of life of people with HIV (PWH). However, its use requires a reorganization of outpatient clinics and outpatient services, and a number of issues remain to be defined regarding the management of PWH on LA drugs, including the correct selection of people who can be treated with LA cabotegravir and rilpivirine.
View Article and Find Full Text PDFInt J Dent Hyg
January 2025
Unit of Periodontology, Endodontology, and Restorative Dentistry, Department of Medical Biotechnologies, University of Siena, Siena, Italy.
Background: Amidst numerous recent advancements in toothpaste formulations and active ingredients, some clinicians may believe all toothpastes are similar despite differences in their active ingredients and corresponding clinical application.
Aim: This umbrella review aims to provide clinicians with an overview of toothpaste ingredients and evidence of efficacy for a variety of oral conditions, including gum health issues, caries, dentine hypersensitivity, tooth surface loss, oral malodour and tooth whitening (staining).
Methods: The focused question for the review was 'What is the efficacy of common toothpaste active ingredients in preventing or treating oral conditions including gum health issues, caries, dentine hypersensitivity, tooth surface loss, oral malodour and tooth whitening (stain removal)?'.
Assay Drug Dev Technol
January 2025
Department of Pharmaceutics, School of Pharmaceutical Education and Research (SPER), Jamia Hamdard, New Delhi, India.
In vitro In vitro
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