Abstract:
INTRODUCTION:Vitamin E is one of the most promising agents for nonalcoholic steatohepatitis (NASH) treatment, and its drug responsiveness may be closely associated with haptoglobin (Hp) genotype. However, its efficacy and safety remain unknown in China. This clinical trial of vitamin E versus placebo for the treatment of nondiabetic patients with nonalcoholic steatohepatitis (VENS) is conducted to evaluate (a) the efficacy and safety of treatment with vitamin E softgel (300 mg/day) determined from standardized histologic scoring of liver biopsies, (b) whether treatment with vitamin E improves biochemical parameters, cytokines, anthropometric parameters, controlled attenuation parameter (CAP), and transient elastography (TE) values determined by Fibroscan and health-related quality of life (SF-36), (c) whether the efficacy of vitamin E treatment is associated with the Hp genotype in nondiabetic adults with NASH. METHODS:VENS is a multicenter, randomized, double-masked, placebo parallel controlled trial to evaluate the efficacy and safety of treatment with vitamin E softgel in nondiabetic adults with NASH versus treatment with placebo in China. Liver biopsies are read by a pathological evaluation committee independently according to the NASH Clinical Research Network (CRN) scoring system. The NAFLD activity score (NAS) represents the sum of scores for steatosis, lobular inflammation, and hepatocyte ballooning. The definition of histologic improvement requires all three of the following criteria to be met: (a) either improvement in NAS by at least 2 points or post-treatment NAS score no higher than 3, (b) at least 1-point improvement in the score for ballooning, and (c) no worsening of fibrosis stages. We plan to recruit 120 biopsy-proven NASH patients from13 centers in China. Participants will be randomly assigned to groups treated with either with vitamin E (100 mg, tid) or placebo for 96 weeks then followed by 24 weeks of post-treatment observation. Biochemical parameters, cytokines, anthropometric parameters, CAP and TE values, Hp genotype, and several questionnaires will be collected as per the schedule. This protocol was approved by the Ethics Committee of Hangzhou Normal University Affiliated Hospital to ensure patients safety, and R&G Pharmastudies Co., Ltd. was established for monitoring the accumulated interim data to review efficacy and quality of data collection and overall study management. RESULTS:As a preliminary study, a mobile phone application (app) for lifestyle modification and database recording ( http://laiyivens.365hy.com ) was exploited for every participant. The percentage of NAFLD patients with Hp 2-2 allele is much higher than that of Western patients (65.71% vs 36%, respectively), which suggests that the Chinese benefit more from vitamin E treatment. CONCLUSION:VENS is the first randomized controlled trial (RCT) to evaluate the efficacy of Vitamin E in treating nondiabetic NASH patients in China. TRIAL REGISTRATION:This study registered at https://clinicaltrials.gov (registration number: NCT02962297). FUNDING:Zhejiang Medicine Co., Ltd.
journal_name
Adv Therjournal_title
Advances in therapyauthors
Zang S,Chen J,Song Y,Bai L,Chen J,Chi X,He F,Sheng H,Wang J,Xie S,Xie W,Yang Y,Zhang J,Zheng M,Zou Z,Wang B,Shi J,Chinese NAFLD Clinical Research Network (CNAFLD CRN).doi
10.1007/s12325-018-0670-8subject
Has Abstractpub_date
2018-02-01 00:00:00pages
218-231issue
2eissn
0741-238Xissn
1865-8652pii
10.1007/s12325-018-0670-8journal_volume
35pub_type
杂志文章,多中心研究,随机对照试验abstract::The lipid-lowering effect of a carob pulp preparation rich in insoluble dietary fiber and polyphenols was investigated in a noncomparative, open-label pilot study. Over 8 weeks, 47 volunteers with moderate hypercholesterolemia (total cholesterol 232-302 mg/dL) consumed 15 g of carob per day in three products (breakfas...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02853169
更新日期:2001-09-01 00:00:00
abstract::With the increasing availability of biosimilars, the practice of switching therapies for non-medical reasons between an originator biologic and an analogous biosimilar has become more common. The evidence to support this practice mostly comes from single-switch randomized controlled trials (RCTs) and real-world (RW) e...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01472-1
更新日期:2020-11-01 00:00:00
abstract::Adenoid cystic carcinoma (AdCC) of the head and neck is a well-recognized pathologic entity that rarely occurs in the larynx. Although the 5-year locoregional control rates are high, distant metastasis has a tendency to appear more than 5 years post treatment. Because AdCC of the larynx is uncommon, it is difficult to...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-016-0311-z
更新日期:2016-04-01 00:00:00
abstract:INTRODUCTION:The purpose of this study was to determine prescribing trends in a specialist glaucoma clinic in the UK. Specifically, the aims were to determine which drugs were prescribed as first-, second-, and third-line treatment, the persistence of first-, second-, and third-line treatment regimens, and the proporti...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-017-0593-9
更新日期:2017-08-01 00:00:00
abstract:INTRODUCTION:The aim of this analysis was to characterize the safety and tolerability of empagliflozin in patients with type 2 diabetes mellitus (T2DM) who were randomized to empagliflozin (10/25 mg) or placebo in clinical trials. METHODS:Pooled data from 20 trials were analyzed for patients with T2DM treated with emp...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01329-7
更新日期:2020-08-01 00:00:00
abstract::This study was undertaken to evaluate the ocular hypotensive efficacy of brimonidine Purite 0.15% (Alphagan P 0.15%; Allergan, Inc., Irvine, Calif) given as adjunctive therapy with latanoprost 0.005% (Xalatan; Pfizer Inc., New York, NY( to patients with open-angle glaucoma or ocular hypertension. In this multicenter, ...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1007/BF02849898
更新日期:2007-03-01 00:00:00
abstract:INTRODUCTION:Rivastigmine is a cholinesterase inhibitor, approved for the treatment of mild-to-moderate dementia of Alzheimer's type. This study assessed the short- and long-term effectiveness and safety of rivastigmine in patients with mild-to-moderate Alzheimer's disease (AD) in a real-world clinical setting in Taiwa...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/s12325-019-00939-0
更新日期:2019-06-01 00:00:00
abstract:INTRODUCTION:Arteriosclerosis obliterans (ASO) causes ischemic symptoms of the lower limbs, reducing quality of life (QOL), and has a poor prognosis. Early diagnosis and treatment are necessary. In this study, the effects of long-term administration of beraprost sodium (beraprost) to treat ASO were investigated. METHO...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-013-0030-7
更新日期:2013-05-01 00:00:00
abstract:OBJECTIVES:Because clinical guidelines do not offer clear recommendations for treatment options after discontinuing a tumor necrosis factor (TNF) blocker, this study evaluated treatment patterns within 360 days after discontinuation of TNF-blocker treatment. METHODS:The IMS LifeLink Health Plan Claims database was use...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-014-0110-3
更新日期:2014-04-01 00:00:00
abstract::Venous leg ulcers (VLUs) are the most severe manifestation of chronic venous disease (CVD). Due to their chronic nature, high recurrence rate and slow healing time, VLUs account for 80% of all leg ulcers seen in patients with CVD. VLUs impose a heavy burden on patients that reduces their quality of life; VLUs also rep...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01219-y
更新日期:2020-02-01 00:00:00
abstract::In an open, controlled study, 44 patients complaining of vertigo, dizziness, or both, caused by vascular vestibular disorders were randomly treated with extract of Ginkgo biloba (EGb 761) 80 mg twice daily or with betahistine dihydrochloride (BI) 16 mg twice daily for 3 months. A complete neuro-otologic and equilibrim...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章
doi:
更新日期:1998-09-01 00:00:00
abstract::The tolerability of brimonidine tartrate 0.15%--referred to as bromonidine-Purite 0.15% in this study--was compared with brimonidine tartrate 0.2% in irritated eyes of healthy volunteers as well as patients with glaucoma or ocular hypertension (N=20) in a 2-week, single-center, randomized, double-masked, crossover stu...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1007/BF02849799
更新日期:2003-11-01 00:00:00
abstract:INTRODUCTION:Pulmonary arterial hypertension (PAH) is associated with poor prognosis despite significant recent advances in its treatment. An intravenous formulation of epoprostenol sodium containing glycine and mannitol (epoprostenol GM; GlaxoSmithKline, London, UK) is widely used to treat PAH. A new formulation of ep...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/s12325-013-0029-0
更新日期:2013-05-01 00:00:00
abstract::In an open, uncontrolled study, 105 patients with locomotor system symptoms were treated twice daily with an ointment containing a Symphytum active substance complex. A clear therapeutic effect was noted on chronic and subacute symptoms that were accompanied mainly by functional disturbances and pain in the musculatur...
journal_title:Advances in therapy
pub_type: 临床试验,杂志文章
doi:10.1007/BF02850297
更新日期:2000-07-01 00:00:00
abstract:BACKGROUND:The OPTIMA© (MSD, Courbevoie, France) questionnaire was developed to promote shared decisions and the set-up of specific micro-objectives in clinical practice by optimizing communication between type 2 diabetes (T2DM) patients and their physicians. The present study aimed to assess OPTIMA in clinical practic...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/s12325-016-0341-6
更新日期:2016-06-01 00:00:00
abstract:INTRODUCTION:This study aims to evaluate the early predictive value for postoperative sepsis and 30-day mortality in liver transplant patients using sequential organ failure assessment (SOFA). METHODS:A total of 96 liver transplant patients were enrolled into this study from February 2015 to June 2018. The general inf...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-019-0889-z
更新日期:2019-03-01 00:00:00
abstract:INTRODUCTION:Rhegmatogenous retinal detachment (RRD) with extensive choroidal detachment (CD), suprachoroidal fluid (SCF), and lower intraocular pressure (IOP) markedly increase the difficulty of pars plana vitrectomy (PPV) because it makes the insertion and placement of the trocar cannulas for PPV time-consuming and t...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-018-0801-2
更新日期:2019-01-01 00:00:00
abstract:INTRODUCTION:Infantile hemangiomas (IH) are the most common benign vascular tumors of childhood, with an incidence of 5-10% during the first year of age. Propranolol is considered the first-line treatment for this condition. Potentially there is a high probability of negative results to therapy, because in many countri...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-016-0391-9
更新日期:2016-10-01 00:00:00
abstract::This study was undertaken to evaluate the effectiveness of prophylactic intranasal mupirocin for peritonitis in patients on continuous ambulatory peritoneal dialysis (CAPD). A total of 49 patients undergoing CAPD for at least 6 mo were followed for 1 year. A nasal smear was obtained from each patient at the beginning ...
journal_title:Advances in therapy
pub_type: 杂志文章,随机对照试验
doi:10.1007/BF02849908
更新日期:2007-03-01 00:00:00
abstract::The prevalence of chronic airways diseases such as chronic obstructive pulmonary disease and asthma is increasing. They lead to symptoms such as a cough and shortness of breath, partially through bronchoconstriction. Inhaled anticholinergics are one of a number of treatments designed to treat bronchoconstriction in ai...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-009-0074-x
更新日期:2009-10-01 00:00:00
abstract::Data from the Framingham Heart Study and risk-appraisal models were used to develop a Coronary Heart Disease (CHD) Risk Factor Calculator for early identification of high-risk individuals. The Calculator was tested at an employee health fair for a large northeastern US corporation. Of the 590 employees who registered ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/BF02850248
更新日期:2001-01-01 00:00:00
abstract:INTRODUCTION:To evaluate the short-term efficacy and safety of intravitreal dexamethasone implant (IDI) in patients with macular oedema associated with diabetic retinopathy (DR) and retinal vein occlusion (RVO) using enhanced-depth image optical coherence tomography (EDI-OCT) and to estimate the effect of dexamethasone...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-018-0848-0
更新日期:2019-02-01 00:00:00
abstract:INTRODUCTION:The objective of this study was to report outcome measures with third-generation pre-attached scrotal port adjustable transobturator male system (ATOMS) for male stress urinary incontinence (SUI) after radical prostatectomy. METHODS:A prospective open study was conducted on consecutive patients. Evaluatio...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-017-0528-5
更新日期:2017-05-01 00:00:00
abstract::Nateglinide is an oral antidiabetic medication that acts through rapid, short-term stimulation of insulin production. This study was undertaken to identify the incidence and nature of adverse effects of nateglinide and to assess its efficacy in clinical practice. Patients (n = 3254) were recruited from 606 centers in ...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/BF02849871
更新日期:2005-09-01 00:00:00
abstract::Traveling through several time zones results in a constellation of symptoms known as jet lag. These include reduced alertness, daytime fatigue, loss of appetite, reduced cognitive skills, and disruption of the sleep/wake cycle. In susceptible air travel passengers, jet lag may exacerbate affective illness and result i...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-010-0065-y
更新日期:2010-11-01 00:00:00
abstract:INTRODUCTION:This study aimed to demonstrate the clinical utility of non-invasive multigene Cxbladder urine tests in reducing the overall number of diagnostic tests and invasive procedures used in the clinical evaluation of patients presenting with microhematuria, a key symptom of urothelial carcinoma (UC). There is a ...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-017-0518-7
更新日期:2017-05-01 00:00:00
abstract::Polycystic ovary syndrome (PCOS) affects 6-10% of women and could be considered one of the most common endocrine alterations in women of reproductive age. The syndrome is characterized by several hormonal and metabolic alterations, including insulin resistance and hyperandrogenism, which play a severe detrimental role...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-018-0810-1
更新日期:2018-11-01 00:00:00
abstract:PURPOSE:A recent successful clinical trial demonstrated that a less invasive cell-injection procedure is a viable medical modality for treating corneal endothelial dystrophy. This medical advance still relies on human corneal endothelial cell (HCEC) sources derived from rare cornea donations. The progenitor of the corn...
journal_title:Advances in therapy
pub_type: 杂志文章,评审
doi:10.1007/s12325-020-01237-w
更新日期:2020-03-01 00:00:00
abstract::Alpha-mannosidosis is a rare lysosomal storage disorder that generally presents in early childhood. It is a progressive, highly heterogeneous disease that is difficult to recognize, and a diagnosis is usually reached after referrals to multiple specialists. It is important to understand the challenges faced by patient...
journal_title:Advances in therapy
pub_type: 杂志文章
doi:10.1007/s12325-020-01574-w
更新日期:2020-11-24 00:00:00
abstract:INTRODUCTION:Acute gastrointestinal bleeding (GIB) is a major cause of death in liver cirrhosis. This multicenter study aims to develop and validate a novel and easy-to-access model for predicting the prognosis of patients with cirrhosis and acute GIB. METHODS:Patients with cirrhosis and acute GIB were enrolled and ra...
journal_title:Advances in therapy
pub_type: 杂志文章,多中心研究
doi:10.1007/s12325-019-01083-5
更新日期:2019-11-01 00:00:00