Abstract:
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.
journal_name
Clin Therjournal_title
Clinical therapeuticsauthors
Sengupta G,Hazra A,Kundu A,Ghosh Adoi
10.1016/j.clinthera.2011.11.005subject
Has Abstractpub_date
2011-12-01 00:00:00pages
1943-52issue
12eissn
0149-2918issn
1879-114Xpii
S0149-2918(11)00722-3journal_volume
33pub_type
杂志文章,多中心研究,随机对照试验abstract:BACKGROUND:Numerous studies have shown that plasma exchange (PE) is effective as second-line treatment of severe exacerbations of multiple sclerosis (MS) or other idiopathic inflammatory demyelinating diseases of the central nervous system that are nonresponsive to steroid therapy. OBJECTIVE:The goal of this study was...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2013.02.027
更新日期:2013-04-01 00:00:00
abstract:PURPOSE:This study aimed to review and summarize clinical trial data, updated guidelines, and expert opinions on the recommendations for drug holidays in patients being treated for osteoporosis. METHODS:Three unique PubMed searches using the terms osteoporosis drug holiday, osteoporosis discontinuation, and osteoporos...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2015.03.023
更新日期:2015-07-01 00:00:00
abstract::A 28-day, double-blind study involving 56 outpatients ws initiated to compare the anxiolytic efficacy and safety of ketazolam once a day at bedtime (HS) with diazepam given three times a day (TID) and placebo HS or TID. Ketazolam HS was at least equivalent, and in some respects superior, to diazepam TID with fewer, le...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章
doi:
更新日期:1980-01-01 00:00:00
abstract:BACKGROUND:Risedronate 5 mg/d is approved by the US Food and Drug Administration for the treatment and prevention of postmenopausal osteoporosis. Once-monthly dosing options might increase treatment compliance and persistence. OBJECTIVE:The aim of this study was to compare the tolerability and efficacy of 3 once-month...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.clinthera.2009.02.012
更新日期:2009-02-01 00:00:00
abstract:PURPOSE:Selumetinib (AZD6244, ARRY-142886), an oral, potent, and highly selective mitogen-activated protein kinase 1/2 inhibitor with a short half-life, has shown activity across various tumor types. Before initiation of Phase III trials, the site, scale, and color (hypromellose shell from white [Phase II] to blue [Pha...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2017.08.022
更新日期:2017-11-01 00:00:00
abstract::The safety and efficacy of twice-daily applications of alclometasone dipropionate cream 0.05% were evaluated in 39 children with eczema during a three-week open study. Early-morning plasma cortisol levels were monitored at weekly intervals (visits 1, 2, and 3) for six children. For the remaining 33 children, levels we...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1986-01-01 00:00:00
abstract::The monomeric insulin analogue insulin lispro (Lys B28, Pro B29) is a rapid-acting insulin with a shorter duration of activity than human regular insulin. This compound has the advantage of reducing early postprandial hyperglycemia and the accompanying late hypoglycemia, thereby improving overall blood glucose control...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(98)80040-4
更新日期:1998-01-01 00:00:00
abstract:BACKGROUND:LX4211 is a first-in-class dual inhibitor of sodium-dependent glucose cotransporters 1 and 2 (SGLT1 and SGLT2). SGLT1 is the primary transporter for glucose absorption from the gastrointestinal tract, and SGLT2 is the primary transporter for glucose reabsorption in the kidney. SGLT1 inhibition reduces postpr...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2013.06.011
更新日期:2013-08-01 00:00:00
abstract:OBJECTIVE:The goal of this multicenter, double-blind, randomized, parallel-group study was to compare the effects of losartan potassium (hereafter referred to as losartan), candesartan cilexitil (hereafter referred to as candesartan), and losartan/hydrochlorothiazide (HCTZ) in patients with mild to moderate hypertensio...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
doi:10.1016/s0149-2918(00)83062-3
更新日期:2000-10-01 00:00:00
abstract:PURPOSE:Vitamin D supplementation has been suggested to increase testosterone levels. The primary purpose of this literature review was to critically assess the physiologic effects of vitamin D supplementation on serum testosterone concentrations in men and the secondary purpose was to evaluate the feasibility of vitam...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
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更新日期:2020-06-01 00:00:00
abstract:PURPOSE:Pain in the neonate is often challenging to assess but important to control. Physicians often must balance the need for optimal pain control with the need to minimize oversedation and prolonged opioid use. Both inadequate pain control and overuse of opioids can have long-term consequences, including poor develo...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2019.07.014
更新日期:2019-09-01 00:00:00
abstract::The efficacy and tolerability of a twice-daily dose of 5 mg of nisoldipine versus 40 mg of sustained-release isosorbide dinitrate (ISDN) were compared in a randomized, double-masked study in 91 patients. During the 21-day treatment period, the mean time taken during bicycle ergometry to the appearance of an ST segment...
journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1016/s0149-2918(96)80025-7
更新日期:1996-05-01 00:00:00
abstract:OBJECTIVE:The aim of this study was to evaluate the annhypertensive efficacy and tolerability of the angiotensin-converting enzyme inhibitor imidapril and the angiotensin II type 1 receptor antagonist candesartan in mild to moderate essential hypertension. METHODS:The trial was conducted at 8 centers across Portugal a...
journal_title:Clinical therapeutics
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1016/j.clinthera.2006.12.006
更新日期:2006-12-01 00:00:00
abstract:PURPOSE:This article outlines several important issues regarding the management of patients with gout. The topics discussed include best practices for gout based on the most current guidelines, opportunities for improving gout management, and current and emerging therapies for gout. METHODS:[PubMed and Google Scholar ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2016.12.011
更新日期:2017-02-01 00:00:00
abstract:BACKGROUND:Therapeutic proteins have revolutionized the treatment of many diseases. In the near future, many more therapeutic proteins are likely to become available for an increasingly wide range of indications. OBJECTIVES:This article reviews the incidence, causes, and consequences of formation of antibodies to ther...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/s0149-2918(02)80075-3
更新日期:2002-11-01 00:00:00
abstract:PURPOSE:Despite the availability of numerous pharmacologic and nonpharmacologic antiseizure therapies, a fraction of patients with epilepsy remain refractory to current treatment options, underscoring the need for novel drugs and neuromodulatory therapies. Transcranial magnetic stimulation (TMS), coupled with either el...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2020.05.016
更新日期:2020-07-01 00:00:00
abstract:PURPOSE:ME-401 is a novel selective inhibitor of phosphatidylinositol 3 kinase p110δ, an enzyme often found overexpressed and overactive in B-cell malignancies. The current study was performed to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of single ascending oral doses of ME-401 in healthy ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2018.09.006
更新日期:2018-11-01 00:00:00
abstract:INTRODUCTION:Hemorrhagic cystitis is a potentially life-threatening complication in patients receiving cancer therapy. This urologic emergency is commonly associated with the chemotherapeutic use of oxazaphosphorine alkylating agents. This report describes a case of hemorrhagic cystitis associated with dacarbazine trea...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2007.06.004
更新日期:2007-06-01 00:00:00
abstract::Fifty clinic patients with mild to moderately severe dermatoses were treated for three weeks with bufexamac, a hydroxamic acid compound with anti-inflammatory properties. Half the patients had either contact or seborrheic dermatitis; the remaining 25 were distributed among five other diagnostic categories. Evaluation ...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:
更新日期:1980-01-01 00:00:00
abstract:BACKGROUND:Tetanus-diphtheria-acellular pertussis (Tdap) was licensed in the United States in 2005 to be given in place of tetanus-diphtheria (Td) for single use in adolescents. OBJECTIVES:This analysis was conducted to determine vaccination coverage with Td and Tdap among adolescents in the United States aged 13 to 1...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2010.07.016
更新日期:2010-08-01 00:00:00
abstract::This article reviews the administration, efficacy, and safety of prophylactic intravenous immunoglobulin in patients with secondary immunodeficiency and those undergoing allogeneic bone marrow transplantation. Associated infections in these immunosuppressed patients are examined as they relate to transfusion-associate...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/s0149-2918(96)80204-9
更新日期:1996-01-01 00:00:00
abstract::General health-status questionnaires such as the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) are frequently used to measure health-related quality of life. The SF-36, in its current form, cannot be used to measure individuals' utilities or preferences for their health state. Recently, several inves...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/S0149-2918(00)86747-8
更新日期:1999-11-01 00:00:00
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journal_title:Clinical therapeutics
pub_type: 临床试验,杂志文章,多中心研究,随机对照试验
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更新日期:1997-07-01 00:00:00
abstract:PURPOSE:We applied Multi-Criteria Decision Analysis (MCDA) methods in a structured benefit-risk assessment of cladribine and newer approved disease-modifying drugs (DMDs) for patients with relapsing-remitting multiple sclerosis (RRMS). METHODS:Decision conferencing with clinical neurologists as decision makers was use...
journal_title:Clinical therapeutics
pub_type: 杂志文章
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更新日期:2019-02-01 00:00:00
abstract:BACKGROUND:Numerous reviews and meta-analyses of the antidepressant literature in major depressive disorders (MDD), both acute and maintenance, have been published, some claiming that antidepressants are mostly ineffective and others that they are mostly effective, in either acute or maintenance treatment. OBJECTIVE:T...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:10.1016/j.clinthera.2011.11.019
更新日期:2011-12-01 00:00:00
abstract:BACKGROUND:The efficacy of topiramate (TPM) as an adjunctive treatment for epilepsy has been established in placebo-controlled clinical trials. Clinical trials of antiepileptic monotherapy usually evaluate low and high doses of study drug or compare study drug with another active agent. OBJECTIVE:This article reviews ...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
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更新日期:2008-07-01 00:00:00
abstract::This paper reviews the issues that are critical for the valuation of medical resources in the context of health economic studies. There are several points to consider when undertaking the valuation of medical resources. The perspective of the analysis should be established before determining the valuation process. Fut...
journal_title:Clinical therapeutics
pub_type: 杂志文章,评审
doi:
更新日期:1994-05-01 00:00:00
abstract:BACKGROUND:The effectiveness of a drug is significantly influenced by a patient's adherence to the required regimen. OBJECTIVE:The goal of this retrospective database analysis was to determine the factors affecting adherence over a 12-month follow-up period in adults with type 2 diabetes mellitus (DM) initiating once-...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2013.03.021
更新日期:2013-06-01 00:00:00
abstract:BACKGROUND:Inhibitors of dipeptidyl peptidase (DPP) IV are a class of oral hypoglycemic agents that increase glucagon-like peptide-1 (GLP-1) levels by inhibiting its degradation. OBJECTIVE:This study evaluated the pharmacokinetics, pharmacodynamics, and tolerability of DA-1229, which is a newly developed DPP IV inhibi...
journal_title:Clinical therapeutics
pub_type: 杂志文章,随机对照试验
doi:10.1016/j.clinthera.2012.08.006
更新日期:2012-09-01 00:00:00
abstract:PURPOSE:The objective of this study was to assess the frequency of tablet splitting of psychotropic drugs in a population of older adults with a diagnosis of dementia. METHODS:This retrospective, cross-sectional study examined a sample of geriatric outpatients seen at a public center specializing in the care of elderl...
journal_title:Clinical therapeutics
pub_type: 杂志文章
doi:10.1016/j.clinthera.2015.08.015
更新日期:2015-10-01 00:00:00