Abstract：
OBJECTIVE:To assess the potential damage to patients from the inappropriate use of placebo. METHODS:Pivotal clinical trials of new drugs were evaluated for the treatment of multiple sclerosis following effective treatment with beta interferons and glatiramer acetate. The differences in the relapse rate between the experimental arms of the trials with interferons and glatiramer and the placebo groups were calculated. RESULTS:In ten pivotal trials, 2,752 patients were given placebo instead of the best proven treatments. The annualized relapse rate was reported for 2,405 of these patients. Patients receiving placebo suffered 630 more relapses than those treated with interferons or glatiramer. CONCLUSIONS:The inappropriate use of placebo in clinical trials unduly harms patients. The use of standard active comparators would preserve patients' rights and better define the respective clinical value of new medicines.
journal_name
Eur J Clin Pharmacoljournal_title
European journal of clinical pharmacologyauthors
Garattini S,Bertelé V,Banzi Rdoi
10.1007/s00228-012-1383-6subject
Has Abstractpub_date
2013-03-01 00:00:00pages
711-4issue
3eissn
0031-6970issn
1432-1041journal_volume
69pub_type
杂志文章abstract：:As a target group, geriataric patients were selected for pharmacokinetic studies with terodiline (Mictrol), an anticholinergic and calcium antagonist drug effective in the treatment of urinary incontinence. The single-dose kinetics in the geriatric patients (mean age 82 years) differed significantly from that previous...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00540958
更新日期：1988-01-01 00:00:00
abstract：OBJECTIVE:The aim was to develop a model to describe the population pharmacokinetics of nevirapine in South African human immunodeficiency virus (HIV)-infected patients who were taking nevirapine-based antiretroviral therapy concomitantly or in the absence of rifampicin-based tuberculosis therapy. METHODS:Patients wer...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-008-0481-y
更新日期：2009-01-01 00:00:00
abstract：:Plasma renin concentration (PRC) was measured in 46 patients with essential hypertension before and after treatment for 4 weeks with alprenolol 600-1200 mg daily. In 27 of these patients PRC was measured after 4 weeks of combined treatment with alprenolol and hydralizine. During alprenolol treatment PRC and blood pres...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00645128
更新日期：1977-10-14 00:00:00
abstract：:Tolbutamide (1 g/70 kg) was administered as a single intravenous dose to 31 healthy, non-smoking, drug-free males between 23 and 87 years old and the total amounts of hydroxy and carboxytolbutamide excreted in 24 h were measured. There was a significant decrease in the urinary recovery of both metabolites with age. Th...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF02336696
更新日期：1990-01-01 00:00:00
abstract：OBJECTIVE:We investigated whether interindividual differences in the pharmacokinetic disposition of lansoprazole are attributed to the genetic polymorphism of CYP2C19 which occurred by two mutations. CYP2C19m1 and CYP2C19m2, in 20 Japanese subjects. METHODS:Polymerase chain reaction (PCR) restriction fragment length p...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s002280050307
更新日期：1997-01-01 00:00:00
abstract：:We have studied the pharmacodynamic effects of ramipril, propranolol, and their combination, as well as the effect of propranolol on the pharmacokinetics of ramipril in 12 healthy men (age 24 (SD 6) y, weight 72 (7) kg). Propranolol and placebo, ramipril and placebo, or propranolol and ramipril were given orally for f...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1007/BF00315392
更新日期：1993-01-01 00:00:00
abstract：PURPOSE:The Drug Burden Index (DBI) is a tool to quantify the anticholinergic and sedative load of drugs. Establishing functional correlates of the DBI could optimize drug prescribing in patients with dementia. In this cross-sectional study, we determined the relationship between DBI and cognitive and physical function...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-017-2319-y
更新日期：2017-12-01 00:00:00
abstract：OBJECTIVE:As quinine is mainly metabolised by human liver CYP3A4 and grapefruit juice inhibits CYP3A4, the effect of grapefruit juice on the pharmacokinetics of quinine following a single oral dose of 600 mg quinine sulphate was investigated. METHODS:The study was carried out in ten healthy volunteers using a randomis...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1007/s002280050646
更新日期：1999-07-01 00:00:00
abstract：:Enprofylline 1 mg/kg, a new potent antiasthmatic xanthine derivative, which is mainly eliminated by renal excretion, was given intravenously to 6 normal subjects with and without oral pretreatment with 1 g probenecid. The latter caused a drop in the average total body clearance of enprofylline from 21 to 9.8 l/h, and ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00614308
更新日期：1986-01-01 00:00:00
abstract：:The gastric inhibitory effects of CM57755, a new histamine H2 receptor antagonist, have been compared in ten healthy male volunteers with the actions of an equal dose of cimetidine and with placebo. The inhibitory effect of CM57755 was virtually identical with, and not significantly different from the effects of cimet...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章
doi：10.1007/BF00614192
更新日期：1986-01-01 00:00:00
abstract：:The kinetics and dynamics of single doses (5 mg p.o.) of the optical isomers of acenocoumarol (R-AC and S-AC) were followed in healthy subjects and the effect on them of cimetidine 800 mg/day was also investigated. The AC enantiomers differed greatly in their pharmacokinetics. The mean residence time (MRT) of R-AC was...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00542424
更新日期：1986-01-01 00:00:00
abstract：OBJECTIVE:The present study was undertaken to investigate the possible effects of various agents on thiopurine methyltransferase (TPMT) activity in red blood cells (RBCs) from patients with chronic inflammatory bowel disease (IBD). METHODS:In three groups of patients with very high, normal and intermediate TPMT activi...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-005-0950-5
更新日期：2005-07-01 00:00:00
abstract：:All forensic autopsy cases in southern Sweden in 1986-89 in which antidepressant drugs were found in the blood were assessed and the findings related to the sales of antidepressants as expressed as defined daily doses per 1,000 inhabitants per day. There was a total of 272 antidepressant-positive cases, which were div...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00194393
更新日期：1994-01-01 00:00:00
abstract：PURPOSE:The purpose of this study was to systematically review evidence regarding the association between regimen complexity and adherence. METHODS:Articles were searched in MEDLINE, LILACS, Cochrane, CINAHL, PsycINFO and references of included studies. Search terms included medication regimen complexity, medication a...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,评审
doi：10.1007/s00228-017-2315-2
更新日期：2017-11-01 00:00:00
abstract：:The influence of a diet deficient in energy or protein on hepatic oxidation (Phase I reactions) and glucuronidation (Phase II reactions) in man has been examined. Nine healthy volunteers were fed an energy deficient diet (daily energy intake 4.3 MJ; daily protein intake 0.94 g/kg) and a protein deficient diet (daily e...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1007/BF00278583
更新日期：1990-01-01 00:00:00
abstract：:The immediate haemodynamic and metabolic effects of acute dose of diazoxide 300 mg i.v. were studied in six healthy subjects at rest and during dynamic forearm exercise. Control periods of rest, exercise and recovery were compared with corresponding periods after drug administration. Resting forearm blood flow was alm...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00542454
更新日期：1982-01-01 00:00:00
abstract：:Cimetropium bromide is an antimuscarinic compound with antispasmodic properties. Its effect on meal-stimulated sigmoid motor activity in 30 patients with the irritable bowel syndrome, mainly with pain and constipation, has been evaluated. The mechanical activity of the sigmoid colon was recorded with a probe with thre...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1007/BF00542489
更新日期：1988-01-01 00:00:00
abstract：:The effect of the aminoglycosides amikacin, gentamicin, netilmicin sisomicin and tobramycin on the proximal tubule of the human kidney was investigated in 78 healthy subjects. Fifteen adults were each given gentamicin, sisomicin or tobramycin 3 mg/kg bodyweight, 10 subjects received netilmicin 3 mg/kg or amikacin 15 m...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00609758
更新日期：1978-05-17 00:00:00
abstract：PURPOSE:Ultraviolet radiation exposure is the most important exogenous risk factor for cutaneous malignancies. It is possible that phototoxic drugs promote the development of cutaneous melanoma (CM) by intensifying the effect of ultraviolet light on the skin. We investigated the association between the use of common sy...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-013-1476-x
更新日期：2013-07-01 00:00:00
abstract：:The number of marketed non-steroidal anti-inflammatory agents varies widely from one European country to another, partly as a consequence of differing regulatory policies. During a four-year period, nine of 18 applications to market such drugs in the Netherlands failed; the remaining nine compounds were all licenced; ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00558371
更新日期：1981-01-01 00:00:00
abstract：:The influence of isosorbide dinitrate (ISDN) and food ingestion on superior mesenteric artery impedance was investigated in 24 healthy volunteers (age 40 +/- 2.7 years). Superior mesenteric artery circulation was assessed by duplex ultrasound. Pulsatility index (PI) was considered as a parameter of vascular resistance...
journal_title：European journal of clinical pharmacology
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1007/BF00196852
更新日期：1995-01-01 00:00:00
abstract：:We have studied 16 healthy men to evaluate preliminary pharmacodynamics and kinetics of BW443C given by i.v. infusions. Four volunteers received escalating doses at weekly intervals, starting at 0.1 microgram.kg-1 for 60 min and increasing to a maximum of 2.0 micrograms.kg-1.min-1 for 180 min. Subsequently 12 differen...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF01061420
更新日期：1988-01-01 00:00:00
abstract：PURPOSE:The aim of this study was to examine whether educational meetings and group detailing could increase the use of drugs from the ward lists or the drug formulary in hospitals. METHODS:Twelve medical wards from two hospitals were randomized into three groups: control, basic and extended intervention. All wards ha...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章,随机对照试验
doi：10.1007/s00228-013-1589-2
更新日期：2014-01-01 00:00:00
abstract：:The pharmacokinetics of 3H-16-epi-gitoxin have been investigated after oral administration: The peak serum level occurred after 30-60 min, and its subsequent decline was in two phases with half-lives of 3.5 and 19.5 h, respectively. Within 3 days 66-70% of the administered radioactivity were eliminated by renal excret...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00562938
更新日期：1977-07-19 00:00:00
abstract：:Drug utilization was studied in children below 14 years of age in Tenerife, Canary Islands, who were seen as outpatients by 15 paediatricians and 10 general practitioners. Data on diagnosis, previous drug exposure and prescriptions were collected from a random sample of 1327 children. Nose and throat infections (40.1%...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF01046708
更新日期：1988-01-01 00:00:00
abstract：OBJECTIVE:More than 11% of the Caucasian population are heterozygous or homozygous carriers of thiopurine S-methyltransferase (TPMT) mutants and are at risk for toxic side effects when treated with thiopurine drugs. Therefore, screening for TPMT polymorphisms in a patient prior to prescribing these agents is recommende...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-004-0728-1
更新日期：2004-03-01 00:00:00
abstract：:Six women, 13 to 16 weeks pregnant, and 12 women at 38 to 40 weeks gestation, received oral oxazepam about 12 h before legal abortion, by hysterotomy in the former and before elective caesarean section in the latter group. The concentrations of free and conjugated oxazepam in maternal and fetal plasma were determined ...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00625804
更新日期：1980-04-01 00:00:00
abstract：:Protein binding of phenytoin was assesed in one patient with dialysis encephalopathy before and after haemodialysis. Phenytoin concentrations were measured by radioimmunoassay and continuous ultrafiltration was used to assess phenytoin binding. At a serum concentration of 60 micromol.1-1 the percentage of phenytoin bo...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/BF00563560
更新日期：1979-02-19 00:00:00
abstract：PURPOSE:To comparatively assess the prevalence rates of potentially inappropriate medications (PIMs) obtained by the former and latest versions of American Geriatrics Society Beers Criteria (AGS BC) and screening tool of older person's potentially inappropriate prescriptions (STOPP), and analyze the factors of influenc...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-019-02722-0
更新日期：2019-10-01 00:00:00
abstract：OBJECTIVE:To investigate the influence of theophylline on erythropoiesis in chronic obstructive pulmonary disease (COPD) and explore the potential underlying mechanisms. METHODS:We evaluated the haematological parameters and erythropoietin (EPO) values in 38 COPD patients, 18 of which had been treated with theophyllin...
journal_title：European journal of clinical pharmacology
pub_type： 杂志文章
doi：10.1007/s00228-003-0640-0
更新日期：2003-09-01 00:00:00
