Title | Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. |
Comments | Erratum in: Eur Respir J. 2003 May;21(5):912. |
Authors | Szafranski W, Cukier A, Ramirez A, Menga G, Sansores R, Nahabedian S, Peterson S, Olsson H |
Source | The European respiratory journal : official journal of the European Society for Clinical Respiratory Physiology |
Date of publication | 2003 Jan |
Volume | 21 |
Issue | 1 |
Pages | 74-81 |
Abstract | The efficacy and safety of budesonide/formoterol in a single inhaler compared with placebo, budesonide and formoterol were evaluated in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). In a 12-month, randomised, double-blind, placebo-controlled, parallel-group study in 812 adults (mean age 64 yrs, mean forced expiratory volume in one second (FEV1) 36% predicted normal), patients received two inhalations twice daily of either budesonide/formoterol (Symbicort) 160/4.5 microg (delivered dose), budesonide 200 microg (metered dose), formoterol 4.5 microg or placebo. Severe exacerbations and FEV1 (primary variables), peak expiratory flow (PEF), COPD symptoms, health-related quality of life (HRQL), mild exacerbations, use of reliever beta2-agonist and safety variables were recorded. Budesonide/formoterol reduced the mean number of severe exacerbations per patient per year by 24% versus placebo and 23% versus formoterol. FEV1 increased by 15% versus placebo and 9% versus budesonide. Morning PEF improved significantly on day 1 versus placebo and budesonide; after 1 week, morning PEF was improved versus placebo, budesonide and formoterol. Improvements in morning and evening PEF versus comparators were maintained over 12 months. Budesonide/formoterol decreased all symptom scores and use of reliever beta2-agonists significantly versus placebo and budesonide, and improved HRQL versus placebo. All treatments were well tolerated. These results suggest a role for budesonide/formoterol in the long-term management of moderate-to-severe chronic obstructive pulmonary disease. |
Medical Subject Headings (MeSH) | Administration, Inhalation; Adrenal Cortex Hormones[administration & dosage][*therapeutic use]; Adrenergic beta-Agonists[administration & dosage][therapeutic use]; Budesonide[administration & dosage][*therapeutic use]; Double-Blind Method; Drug Combinations; Ethanolamines[administration & dosage][*therapeutic use]; Forced Expiratory Volume; Peak Expiratory Flow Rate; Pulmonary Disease, Chronic Obstructive[*drug therapy]; Time Factors Mesh check words: Female; Humans; Male; Middle Aged |
Correspondence address | Dept Lung Diseases, Voivodeship Specialist Hospital, Radom, Poland. |
Accession number | PUBMED 12570112 |
Publication type | Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov’t |
Cochrane code | SR-AIRWAYS |
ID | CN-00435216 |
CLIB_SPECIFIC___________ | EFFICACY AND SAFETY OF BUDESONIDEFORMOTEROL IN THE MANAGEMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE |
Tag: Colaboracion Cochrane
P.E.A.R.L.S: un simple susurro es efectivo en el diagnostico de dificultad auditiva
A simple whisper test is effective for diagnosing hearing impairment
Clinical Question |
How useful are simple screening tests for diagnosing hearing impairment? |
Bottom Line |
The whispered voice tests and the audio scope are very accurate for ruling out hearing impairment (i.e if patient can hear whisper, they are unlikely to be deaf) |
Context |
Compared to the Weber and Rinne tuning fork tests the whispered voice test is the most accurate and may be better than the expensive audioscope, with pooled positive and negative likelihood ratios of 6.1 and 0.03 respectively. |
Caveat |
There is no single standard method for the whispered voice test but modified Paul Glasziou suggests the following: stand behind the patient at arm’s length (hands on their shoulders), then cover one ear (by rubbing a piece of paper over the external meatus). Exhale fully and whisper letters and numbers with different types of sound. (e.g. b, 6, k, 2, m, 9). Ask the patient to repeat the letters/numbers after each sound. Allow 1-2 errors and repeat each sound once if necessary. |
Reference |
Bagai A, et al. Does this patient have hearing impairment ? JAMA 2006;295:416-28 |
Date (Author) #20 |
January 2007 (Bruce Arroll/Brian McAvoy) |
P.E.A.R.L.S: Inhibidores de la bomba de protones, mas efectivos en la esofagitis
Proton pump inhibitors (PPPIs) most effective treatment for oesophagitis
Clinical Question |
What is the most effective treatment for reflux oesophagitis? |
Bottom Line |
Proton pump inhibitor (PPI) therapy is the most effective treatment for short-term (8wks) management of gastro- oesophageal reflux disease (GORD) – NNT= 1 to 2 (for PPI vs placebo). PPI better than H2 receptor antagonist (H2RA) but both superior to placebo. There is a paucity of evidence on prokinectic therapy but no evidence that it is superior to placebo. |
Context |
GORD is a common problem with an estimated prevalence of 20% in adults. PPIs and H2RAs relieve symptoms by reducing acid secretion in the stomach. |
Caveat |
In equivalent dosage different PPI preparations do not show statistically significant differences in their healing effects. Although there was an apparently higher disease persistence rate at the end of the treatment with double dose PPI compared to standard dose, this difference was not statistically significant. |
Reference |
Mostafizur Khan, Jose Santana, Clare Donnellan, Cathryn Preston, Paul Moayyedi. Medical treatments in the short term management of reflux oesophagitis. Cochrane Database of Systematic Reviews 2007, Issue 2. Art. No.: CD003244. DOI: 10.1002/14651858.CD003244.pub2. This review contains 134 trials with 35978 participants. Cochrane Reviews 2007, Issue 1. |
Date (Author) #19 |
May 2007 (Brian R McAvoy) |
NNT = numbers needed to treat to benefit one person
NNH = numbers needed to harm to benefit one person
Both NNT and NNH are only reported if the studies or pooling of studies is statistically significant
Disclaimer : The P.E.A.R.L.S. are for educational use only and are not meant to guide clinical activity nor are they a clinical guideline.
no recomienda el uso rutinario de la amniotomía durante el manejo y el cuidado del parto normal.
SALUD DE LA MUJER:Romper bolsa: no recomienda el uso rutinario de la amniotomía durante el manejo y el cuidado del parto normal.
La rotura intencional de las membranas amnióticas no aumenta o acelera las contracciones ni reduce el tiempo del trabajo de parto, según una revisión de estudios publicada en la edición online de The Cochrane Library. Aunque esto se realiza, existe poca evidencia que la práctica, llamada también amniotomía, modifique la evolución del parto, señaló el equipo dirigido por la doctora S. Kate Alldred, de University of Liverpool, en Reino Unido.
El equipo buscó en el Registro de Estudios Clínicos del Grupo Cochrane de Embarazo y Nacimientos los ensayos que usaron al azar amniotomía o parto regular.
Los autores identificaron 14 ensayos con 4.893 mujeres.
Observaron que esos estudios tenían altos niveles de variación en casi todos los factores analizados, junto con una amplia variación en los requisitos de selección de las participantes y una “gran falta de información” sobre muchas variables.
El equipo dirigido por Alldred no observó diferencias estadísticamente significativas entre los grupos en los principales resultados analizados, como la duración de la primera etapa del trabajo de parto, la satisfacción materna con el nacimiento, y el riesgo de cesárea y de una baja calificación de Apgar a los 5 minutos.
De todos modos, el equipo registró un pequeño aumento del riesgo de cesárea y una reducida disminución del riesgo de una baja calificación de Apgar en el grupo al que se le practicó la amniotomía.
Este procedimiento tampoco influyó demasiado sobre la duración de la segunda etapa del trabajo de parto, la necesidad de aliviar el dolor, el tratamiento para inducir las contracciones, la hemorragia materna después del alumbramiento, las infecciones o el prolapso del cordón umbilical.
La amniotomía tampoco modificó la condición de los bebés al nacer, incluida la internación en la unidad de terapia intensiva neonatal, la aspiración del meconio o la acidosis.
El equipo consideró que se necesitan estudios más grandes y bien diseñados para evaluar el resultado del procedimiento, pero que “a partir de esta revisión” no recomienda “el uso rutinario de la amniotomía durante el manejo y el cuidado del parto normal”.
The Cochrane Library, online 17 de octubre del 2007.
Fuente Silvia Lenial – Lista de Correo MedFam Argentina.