A meta-analysis of the placebo response in acute migraine and how this response may be influenced by some of the characteristics of clinical trials.

Abstract:

:Migraine is the most common cause of vascular headache and a highly prevalent illness. In the last 20 years, the discovery of new agents has increased clinical research on migraine. In most of clinical trials that have been conducted, the efficacy was established using a placebo as a control treatment. The objective of the study reported here was to analyse the response rate in patients who received a placebo as well as to determine how a number of the methodological factors may affect the effect of the placebo in clinical trials of acute migraine. Computer-based information searches were conducted on the Medline database. Data analysis included the outcomes 'pain relief', 'pain-free', 'associated symptoms', 'recurrence', 'patients' opinion' about pain relief and 'adverse events'. Administration route, study design and country in which the study was carried out were the methodological factors that were analyzed. Meta-analysis was computed using Mantel-Haenszel, and a total of 98 papers were considered in the final analysis. After 2 h, 28.6% of the patients of the placebo group improved and 8.8% were pain-free. The percentage of pain-free patients was the highest in the placebo and active drug groups in which the placebo or drug had been administered subcutaneously, in parallel design studies (vs. cross-over trials) and in studies performed in Europe (vs. North America). Adverse events in the placebo group were significantly higher in studies performed in North America. These data reinforce the need for knowing the magnitude of the placebo response in each specific situation during the planning of clinical trials on acute migraine.

journal_name

Eur J Clin Pharmacol

authors

Macedo A,Farré M,Baños JE

doi

10.1007/s00228-005-0088-5

subject

Has Abstract

pub_date

2006-03-01 00:00:00

pages

161-72

issue

3

eissn

0031-6970

issn

1432-1041

journal_volume

62

pub_type

杂志文章,meta分析
  • Hydroxyethyl starch for cardiovascular surgery: a systematic review of randomized controlled trials.

    abstract:PURPOSE:The objective of this study was to appraise the safety profiles of HES preparations and to find out which HES preparation was the most acceptable in cardiovascular surgery through a comparison with control solutions. METHODS:Pertinent randomized controlled trials were selected through a search of Pubmed, Embas...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章,meta分析,评审

    doi:10.1007/s00228-011-1008-5

    authors: Shi XY,Zou Z,He XY,Xu HT,Yuan HB,Liu H

    更新日期:2011-08-01 00:00:00

  • Pharmacokinetic model identification and parameter estimation as an ill-posed problem.

    abstract::For model identification and parameter estimation in the framework of linear pharmacokinetics it is most often assumed that the disposition function is a finite sum of exponential functions with time constants lambda i and associated coefficients Ci. Least-square fitting procedures are used to estimate the coefficient...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/BF00315312

    authors: Schwilden H,Honerkamp J,Elster C

    更新日期:1993-01-01 00:00:00

  • Utilization of antihypertensive drugs in certain European countries.

    abstract::The consumption of various groups of antihypertensive drugs in Spain during the period 1977-1981 has been measured by the DDD method. The total consumption of the drugs did not change much during this time. Combinations of thiazides with other hypotensives accounted for more than half the total antihypertensive drugs ...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/BF00542106

    authors: Capellà D,Porta M,Laporte JR

    更新日期:1983-01-01 00:00:00

  • Effect of diuretics and calcium antagonists on circulatory parameters and plasma catecholamines during mental stress.

    abstract::In a model of mental stress the influence of nifedipine and hydrochlorothiazide on stress-induced changes in blood pressure, heart rate, and plasma catecholamines was studied in normal persons. The drugs were used to investigate whether substances with antihypertensive but no particular sympatholytic properties were c...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/BF00544008

    authors: Heidbreder E,Schafferhans K,Kirsten R,Heidland A

    更新日期:1983-01-01 00:00:00

  • The pharmacokinetics of the beta 2-adrenoceptor agonist, tulobuterol, given transdermally and by inhalation.

    abstract::We have studied the pharmacokinetics of tulobuterol given transdermally or by aerosol inhalation in healthy male volunteers. Tulobuterol was rapidly absorbed after inhalation, with a tmax of 0.8-1.5 h. The Cmax and the AUC increased linearly with dose. Tulobuterol was well absorbed after transdermal administration, wi...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/BF00316473

    authors: Uematsu T,Nakano M,Kosuge K,Kanamaru M,Nakashima M

    更新日期:1993-01-01 00:00:00

  • Repolarization effects of multiple-cycle chemotherapy and predictors of QTc prolongation: a prospective female cohort study on >2000 ECGs.

    abstract:PURPOSE:Oncological patients are at increasing risk of QT prolongation, a risk factor for ventricular arrhythmia. We assessed impact and risk factors for corrected QT (QTc) prolongation during multiple-cycle chemotherapy. METHODS:We enrolled 100 outpatients initiating chemotherapy in a university center specializing i...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/s00228-015-1874-3

    authors: Diemberger I,Massaro G,Cubelli M,Rubino D,Quercia S,Martignani C,Ziacchi M,Biffi M,Bernardi A,Cacciari N,Zamagni C,Boriani G

    更新日期:2015-08-01 00:00:00

  • Fluocortolone: pharmacokinetics and effect on ACTH and cortisol secretion during daily and alternate-day administration.

    abstract::The pharmacokinetics of fluocortolone and its effect on the circadian rhythm of plasma cortisol and ACTH have been studied during different schedules of oral administration. Groups of 6 healthy male adults were given a single daily dose of fluocortolone 5, 10 and 20 mg, and another group received 20 mg every second da...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/BF00609249

    authors: Tüber U,Posern U,Bickel U,Matthes H,Voigt K

    更新日期:1988-01-01 00:00:00

  • Modelling circadian variation in the pharmacokinetics of non-steroidal anti-inflammatory drugs.

    abstract::A one-compartment model with first-order absorption has provided good fits to five sets of indomethacin data and four sets of ketoprofen data taken at different times of day. There was substantial variation in the model parameters with time of administration and most of the features of this variation applied equally t...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/BF00265955

    authors: Aronson JK,Chappell MJ,Godfrey KR,Yew MK

    更新日期:1993-01-01 00:00:00

  • Chronopharmacokinetics of theophylline after sustained release and intravenous administration to adults.

    abstract::The influence of time of drug administration on pharmacokinetics of theophylline was studied both after ingestion of a sustained-release tablet, containing choline theophyllinate ( Zy 15061-S. R.; Teovent ; Sabidal ; ZYMA S.A.) and after intravenous infusion of aminophylline to eight healthy volunteers. Both drugs wer...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/BF00630288

    authors: Jonkman JH,van der Boon WJ,Balant LP,Schoenmaker R,Holtkamp A

    更新日期:1984-01-01 00:00:00

  • Lack of acetaminophen ceiling effect on R-III nociceptive flexion reflex.

    abstract:OBJECTIVE:The analgesic efficacy of intravenous doses of acetaminophen (paracetamol) 0.5 g, 1 g and 2 g (administered as propacetamol) was assessed in 11 healthy subjects in a randomised, double-blind, placebo-controlled crossover study. The antinociceptive effect was assessed over 8 h by measurement of the nociceptive...

    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/s002280050386

    authors: Piguet V,Desmeules J,Dayer P

    更新日期:1998-01-01 00:00:00

  • Association between statin-induced creatine kinase elevation and genetic polymorphisms in SLCO1B1, ABCB1 and ABCG2.

    abstract:PURPOSE:Treatment with statins requires close monitoring of serum creatine kinase (CK) levels to prevent myopathy, a common and potentially serious dose-dependent adverse effect of these drugs. We have investigated the correlation between elevated CK levels and polymorphisms in the genes encoding transporters involved ...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/s00228-014-1661-6

    authors: Ferrari M,Guasti L,Maresca A,Mirabile M,Contini S,Grandi AM,Marino F,Cosentino M

    更新日期:2014-05-01 00:00:00

  • Delayed elimination of triamterene and its active metabolite in chronic renal failure.

    abstract::The kinetics of triamterene and its active phase II metabolite were studied in 32 patients with various degrees of impaired renal function; the creatinine clearances ranged from 135 to 10 ml/min. The area under the plasma concentration-time curves (AUC) for triamterene were not influenced by kidney function, but the A...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/BF00609885

    authors: Knauf H,Möhrke W,Mutschler E

    更新日期:1983-01-01 00:00:00

  • Allele and genotype frequencies of polymorphic DCP1, CETP, ADRB2, and HTR2A in the Egyptian population.

    abstract:OBJECTIVE:The goal of this study was to determine the frequencies of important allelic variants of two drug targets, dipeptidyl carboxypeptidase ( DCP1) and cholesteryl ester transfer protein ( CETP), and two other drug receptors, beta-2 adrenergic receptor ( ADRB2) and 5-hydroxy tryptamine 2A receptor ( HTR2A), in the...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/s00228-002-0423-z

    authors: Hamdy SI,Hiratsuka M,Narahara K,El-Enany M,Moursi N,Ahmed MS,Mizugaki M

    更新日期:2002-04-01 00:00:00

  • Hepatic CYP2A6 levels and nicotine metabolism: impact of genetic, physiological, environmental, and epigenetic factors.

    abstract:PURPOSE:We investigated the role of genetic, physiological, environmental, and epigenetic factors in regulating CYP2A6 expression and nicotine metabolism. METHODS:Human livers (n = 67) were genotyped for CYP2A6 alleles and assessed for nicotine metabolism and CYP2A6 expression (mRNA and protein). In addition, a subset...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/s00228-009-0762-0

    authors: Al Koudsi N,Hoffmann EB,Assadzadeh A,Tyndale RF

    更新日期:2010-03-01 00:00:00

  • Pharmacokinetics of TZU-0460, a new H2-receptor antagonist, in patients with impaired renal function.

    abstract::We have studied pharmacokinetics of a new H2-receptor antagonist, TZU-0460, in patients with varying degrees of renal impairment. The apparent volume of distribution at steady-state was 1.70 l/kg, and the plasma protein binding of TZU-0460 or its active metabolite, desacetyl TZU-0460 was less than 10% in normal subjec...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/BF00608220

    authors: Takabatake T,Ohta H,Yamamoto Y,Ishida Y,Hara H,Nakamura S,Ushiogi Y,Satoh S,Hattori N

    更新日期:1986-01-01 00:00:00

  • A population approach to study the influence of nevirapine administration on lopinavir pharmacokinetics in HIV-1 infected patients.

    abstract:OBJECTIVE:The influence of nevirapine (NVP) on lopinavir (LPV) pharmacokinetics was investigated by a population analysis based on a non-linear mixed-effect modelling method. METHODS:In this analysis, 95 HIV-1 infected patients were studied [52 treated with LPV/ritonavir (400/100 mg twice a day) plus nucleoside revers...

    journal_title:European journal of clinical pharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1007/s00228-005-0900-2

    authors: Dailly E,Reliquet V,Raffi F,Jolliet P

    更新日期:2005-04-01 00:00:00

  • Stereoselective distribution of tiaprofenic acid in synovium and cartilage in osteoarthritic patients.

    abstract:OBJECTIVE:In order to document the stereoselective distribution in joints of a chiral nonsteroidal anti-inflammatory drug, the relative affinities of the enantiomers of tiaprofenic acid in synovium and for cartilage were compared. METHODS:The distribution of tiaprofenic acid in synovium and in cartilage was studied 25...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/s002280050109

    authors: Lapicque F,Mainard D,Gillet P,Payan E,Bannwarth B,Netter P

    更新日期:1996-01-01 00:00:00

  • CYP2C19 polymorphism effect on phenobarbitone. Pharmacokinetics in Japanese patients with epilepsy: analysis by population pharmacokinetics.

    abstract:OBJECTIVE:The aim of this study was to clarify the effect of genetic polymorphisms of CYP2C19 on the pharmacokinetics of phenobarbitone (PB) using a nonlinear mixed-effects model (NONMEM) analysis in Japanese adults with epilepsy. METHODS:A total of 144 serum PB concentrations were obtained from 74 subjects treated wi...

    journal_title:European journal of clinical pharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1007/s002280050703

    authors: Mamiya K,Hadama A,Yukawa E,Ieiri I,Otsubo K,Ninomiya H,Tashiro N,Higuchi S

    更新日期:2000-02-01 00:00:00

  • Pharmacodynamics of ticlopidine in man in relation to plasma and blood cell concentration.

    abstract::In 6 normal volunteers given single oral doses of 250,500 and 1000 mg ticlopidine (T), the peak plasma level of unchanged drug was reached after about 2 h. There was no correlation between the plasma T level and its inhibitory effect on platelet function, expressed as % inhibition of ADP-induced aggregation. By means ...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/BF00626364

    authors: DiPerri T,Pasini FL,Frigerio C,Blardi P,Centini F,Messa GL,Ghezzi A,Volpi L

    更新日期:1991-01-01 00:00:00

  • Pharmacokinetics of methadone in human-immunodeficiency-virus-infected patients receiving nevirapine once daily.

    abstract::The effect of nevirapine once-daily dosing on the pharmacokinetics of methadone and its main metabolite, 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, was evaluated in ten HIV positive patients on stable methadone therapy. Nevirapine 200 mg once daily was administered orally from day 1 to day 14. On day 15, nevir...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/s00228-007-0299-z

    authors: Arroyo E,Valenzuela B,Portilla J,Climent-Grana E,Pérez-Ruixo JJ,Merino E

    更新日期:2007-07-01 00:00:00

  • A drug interaction study between cicletanine and tolbutamide in healthy volunteers.

    abstract:OBJECTIVE:To determine the possible interaction between the antihypertensive agent cicletanine and the hypoglycaemic drug tolbutamide. METHODS:Time-courses of glycaemia and serum immunoreactive insulin (IRI) were followed in 10 healthy subjects after two tolbutamide infusions in each volunteer; initially alone and 9 d...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/s002280050127

    authors: Bayés MC,Barbanoj MJ,Vallès J,Torrent J,Obach R,Jané F

    更新日期:1996-01-01 00:00:00

  • Polymorphisms of dopamine receptor genes and risk of visual hallucinations in Parkinson's patients.

    abstract:BACKGROUND:Visual hallucinations (VHs) are frequent non-motor complication of Parkinson's disease (PD), associated to a negative prognosis. Previous studies showed an association between dopamine receptor (DR) gene (DR) variants and psychosis in Alzheimer's disease, addictions, schizophrenia, and bipolar disorder. Howe...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/s00228-016-2111-4

    authors: Ferrari M,Comi C,Marino F,Magistrelli L,De Marchi F,Cantello R,Riboldazzi G,Bono G,Cosentino M

    更新日期:2016-11-01 00:00:00

  • Effects of the Chinese herbal formula "Zuojin Pill" on the pharmacokinetics of dextromethorphan in healthy Chinese volunteers with CYP2D6*10 genotype.

    abstract:OBJECTIVE:Zuojin Pill has been shown to inhibit the cytochrome P450 (CYP) 2D6 isoenzyme in vitro. In Chinese individuals, CYP 2D6*10 is the most common allele with reduced enzyme activity. In this study, we investigated the pharmacokinetic interaction between Zuojin Pill and the sensitive CYP2D6 probe dextromethorphan ...

    journal_title:European journal of clinical pharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1007/s00228-016-2048-7

    authors: Qiu F,Liu S,Miao P,Zeng J,Zhu L,Zhao T,Ye Y,Jiang J

    更新日期:2016-06-01 00:00:00

  • Dose dependence of the 14C-aminopyrine breath test. Intrasubject comparison of tracer and pharmacological doses.

    abstract::Although the aminopyrine breath test has received much attention, the question has not yet been settled whether pharmacological or tracer doses of the drug should be used. Nine volunteers were given 14C-aminopyrine 9 mg/kg or a tracer amount, in a randomized sequence and according to a crossover design. The specific a...

    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/BF00609866

    authors: Gikalov I,Bircher J

    更新日期:1977-11-14 00:00:00

  • Population pharmacokinetics of gentamicin in South African newborns.

    abstract:OBJECTIVE:Gentamicin population pharmacokinetics in newborns were studied with special reference to possible gender effects. METHODS:Steady-state serum levels ( n=139) were obtained from 79 neonates with a mean birth weight of 2.1 kg, mean gestational age of 35.1 weeks and mean age at the time of sampling of 4.2 days....

    journal_title:European journal of clinical pharmacology

    pub_type: 临床试验,杂志文章

    doi:10.1007/s00228-003-0663-6

    authors: Botha JH,du Preez MJ,Adhikari M

    更新日期:2003-12-01 00:00:00

  • Cardiovascular and respiratory effects of the beta-adrenoceptive antagonist sotalol: studies in health, angina pectoris and obstructive lung disease.

    abstract::The cardiovascular and respiratory actions of the adrenergic beta adrenoceptive drug sotalol have been studied in an open, short term trial. Fifteen patients with angina performed standardized orthostatic and exercise tests before and after injection of 20 mg sotalol intravenously. Although there was a significant red...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/BF00562313

    authors: Areskog NH,Cullhed I,Ringqvist I,Ström G

    更新日期:1975-08-14 00:00:00

  • Pharmacokinetics of naproxen in elderly patients.

    abstract::The pharmacokinetics of naproxen have been examined in 13 elderly patients (mean age 84.2 years) and in 9 younger patients (mean age 53.9 years) at the end of a 21 day course of therapy with naproxen 500 mg b.d. The mean pre-dose concentration on days 19, 20 and 21 was significantly higher in the elderly patients than...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/BF00613525

    authors: McVerry RM,Lethbridge J,Martin N,Mukerjee SK,Littler T,Tallis R,Sibeon R,Orme ML

    更新日期:1986-01-01 00:00:00

  • Pharmacokinetic and pharmacodynamic interaction of single doses of valsartan and atenolol.

    abstract:OBJECTIVE:Valsartan (V), a specific inhibitor of the angiotensin II receptor subtype, AT1, has been developed for treatment of hypertension. Combination therapy with a beta-adrenoceptor blocking agent might be considered in cases with insufficient efficacy of V alone. Therefore, an interaction trial was performed to ev...

    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/s002280050318

    authors: Czendlik CH,Sioufi A,Preiswerk G,Howald H

    更新日期:1997-01-01 00:00:00

  • Biperiden effects and plasma levels in volunteers.

    abstract::The pharmacokinetics of biperiden was studied and compared with pharmacodynamics (pupil size, accommodation, self-rating mood scale) in 6 healthy volunteers. A single-blind cross-over design was employed with placebo and biperiden (4 mg as commercially available tablets). After a lag time of 0.5 h, biperiden was rapid...

    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/BF00556903

    authors: Hollmann M,Brode E,Greger G,Müller-Peltzer H,Wetzelsberger N

    更新日期:1984-01-01 00:00:00

  • Effect of the CYP2D6 genotype on the pharmacokinetics of tropisetron in healthy Korean subjects.

    abstract:OBJECTIVE:To evaluate the effect of the CYP2D6 genotype on the pharmacokinetics of tropisetron in healthy Korean subjects. METHODS:A single 5-mg capsule of tropisetron was administered orally to 13 healthy subjects. Plasma concentrations were determined by validated HPLC procedures and data were analyzed by using nonc...

    journal_title:European journal of clinical pharmacology

    pub_type: 杂志文章

    doi:10.1007/s00228-003-0595-1

    authors: Kim MK,Cho JY,Lim HS,Hong KS,Chung JY,Bae KS,Oh DS,Shin SG,Lee SH,Lee DH,Min B,Jang IJ

    更新日期:2003-06-01 00:00:00