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Ibuprofen versus mecillinam for uncomplicated cystitis - a randomized controlled trial study protocol

Vik, Ingvild; Bollestad, Marianne; Grude, Nils; Baerheim, Anders; Mölstad, Sigvard LU ; Bjerrum, Lars and Lindbaek, Morten (2014) In BMC Infectious Diseases 14.
Abstract
Background: Although uncomplicated cystitis is often self-limiting, most such patients will be prescribed antibiotic treatment. We are investigating whether treatment of cystitis with an NSAID is as effective as an antibiotic in achieving symptomatic resolution. Methods/Design: This is a randomized, controlled, double blind trial following the principles of Good Clinical Practice. Women between the ages of 18 to 60 presenting with symptoms of uncomplicated cystitis are screened for eligibility. 500 women from four sites in Norway, Sweden and Denmark are allocated to treatment with 600 mg ibuprofen three times a day or 200 mg mecillinam three times a day for three days. Allocation is conducted using block randomization. The primary outcome... (More)
Background: Although uncomplicated cystitis is often self-limiting, most such patients will be prescribed antibiotic treatment. We are investigating whether treatment of cystitis with an NSAID is as effective as an antibiotic in achieving symptomatic resolution. Methods/Design: This is a randomized, controlled, double blind trial following the principles of Good Clinical Practice. Women between the ages of 18 to 60 presenting with symptoms of uncomplicated cystitis are screened for eligibility. 500 women from four sites in Norway, Sweden and Denmark are allocated to treatment with 600 mg ibuprofen three times a day or 200 mg mecillinam three times a day for three days. Allocation is conducted using block randomization. The primary outcome is the number of patients who feel cured by day four as recorded in a diary. Adverse events will be handled and reported in accordance with Good Clinical Practice. Discussion: If treatment of uncomplicated cystitis with ibuprofen is as effective as mecillinam for symptom relief, we can potentially reduce the use of antibiotics on a global scale. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Cystitis, NSAID, Antibiotics, Ibuprofen, Mecillinam, General practice
in
BMC Infectious Diseases
volume
14
publisher
BioMed Central
external identifiers
  • wos:000347126300001
  • scopus:84923922569
ISSN
1471-2334
DOI
10.1186/s12879-014-0693-y
language
English
LU publication?
yes
id
de07b9e3-3aa9-4579-8d0b-f36d8d6918e1 (old id 5085294)
date added to LUP
2015-03-02 07:12:26
date last changed
2017-05-07 03:54:36
@article{de07b9e3-3aa9-4579-8d0b-f36d8d6918e1,
  abstract     = {Background: Although uncomplicated cystitis is often self-limiting, most such patients will be prescribed antibiotic treatment. We are investigating whether treatment of cystitis with an NSAID is as effective as an antibiotic in achieving symptomatic resolution. Methods/Design: This is a randomized, controlled, double blind trial following the principles of Good Clinical Practice. Women between the ages of 18 to 60 presenting with symptoms of uncomplicated cystitis are screened for eligibility. 500 women from four sites in Norway, Sweden and Denmark are allocated to treatment with 600 mg ibuprofen three times a day or 200 mg mecillinam three times a day for three days. Allocation is conducted using block randomization. The primary outcome is the number of patients who feel cured by day four as recorded in a diary. Adverse events will be handled and reported in accordance with Good Clinical Practice. Discussion: If treatment of uncomplicated cystitis with ibuprofen is as effective as mecillinam for symptom relief, we can potentially reduce the use of antibiotics on a global scale.},
  articleno    = {693},
  author       = {Vik, Ingvild and Bollestad, Marianne and Grude, Nils and Baerheim, Anders and Mölstad, Sigvard and Bjerrum, Lars and Lindbaek, Morten},
  issn         = {1471-2334},
  keyword      = {Cystitis,NSAID,Antibiotics,Ibuprofen,Mecillinam,General practice},
  language     = {eng},
  publisher    = {BioMed Central},
  series       = {BMC Infectious Diseases},
  title        = {Ibuprofen versus mecillinam for uncomplicated cystitis - a randomized controlled trial study protocol},
  url          = {http://dx.doi.org/10.1186/s12879-014-0693-y},
  volume       = {14},
  year         = {2014},
}