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Reducing antibiotic use for uncomplicated urinary tract infection in general practice by treatment with uva-ursi (REGATTA) - a double-blind, randomized, controlled comparative effectiveness trial

Reducing antibiotic use for uncomplicated urinary tract infection in general practice by treatment with uva-ursi (REGATTA) - a double-blind, randomized, controlled comparative effectiveness trial
Reducing antibiotic use for uncomplicated urinary tract infection in general practice by treatment with uva-ursi (REGATTA) - a double-blind, randomized, controlled comparative effectiveness trial

Background: Uncomplicated urinary tract infections (UTI) are common in general practice and usually treated with antibiotics. This contributes to increasing resistance rates of uropathogenic bacteria. A previous trial showed a reduction of antibiotic use in women with UTI by initial symptomatic treatment with ibuprofen. However, this treatment strategy is not suitable for all women equally. Arctostaphylos uva-ursi (UU, bearberry extract arbutin) is a potential alternative treatment. This study aims at investigating whether an initial treatment with UU in women with UTI can reduce antibiotic use without significantly increasing the symptom burden or rate of complications. Methods: This is a double-blind, randomized, and controlled comparative effectiveness trial. Women between 18 and 75years with suspected UTI and at least two of the symptoms dysuria, urgency, frequency or lower abdominal pain will be assessed for eligibility in general practice and enrolled into the trial. Participants will receive either a defined daily dose of 3×2 arbutin 105mg for 5 days (intervention) or fosfomycin 3g once (control). Antibiotic therapy will be provided in the intervention group only if needed, i.e. for women with worsening or persistent symptoms. Two co-primary outcomes are the number of all antibiotic courses regardless of the medical indication from day 0-28, and the symptom burden, defined as a weighted sum of the daily total symptom scores from day 0-7. The trial result is considered positive if superiority of initial treatment with UU is demonstrated with reference to the co-primary outcome number of antibiotic courses and non-inferiority of initial treatment with UU with reference to the co-primary outcome symptom burden. Discussion: The trial's aim is to investigate whether initial treatment with UU is a safe and effective alternative treatment strategy in women with UTI. In that case, the results might change the existing treatment strategy in general practice by promoting delayed prescription of antibiotics and a reduction of antibiotic use in primary care.

Antibiotic prescription, Arctostaphylos uva-ursi, Comparative effectiveness design, General practice, Herbal remedy
1472-6882
1-8
Afshar, Kambiz
d5e84c8e-c078-4c2e-b0d5-c7bddb509466
Fleischmann, Nina
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Schmiemann, Guido
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Bleidorn, Jutta
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Hummers-Pradier, Eva
5cdebb96-bf7e-4831-8995-3784967ee742
Friede, Tim
e139f455-c211-4b89-8d93-1103b80b2299
Wegscheider, Karl
ea3efe1d-ac54-4745-9975-b023cc119bc4
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Gágyor, Ildikó
dbcedde8-d7dc-42c0-952b-ae17bd7666d7
Afshar, Kambiz
d5e84c8e-c078-4c2e-b0d5-c7bddb509466
Fleischmann, Nina
decdb550-93ba-4321-ac8d-11807d2dc928
Schmiemann, Guido
a7623ba3-d507-47fe-8310-c53aba3122b7
Bleidorn, Jutta
d014b333-f23e-4fc3-add4-e52415086de7
Hummers-Pradier, Eva
5cdebb96-bf7e-4831-8995-3784967ee742
Friede, Tim
e139f455-c211-4b89-8d93-1103b80b2299
Wegscheider, Karl
ea3efe1d-ac54-4745-9975-b023cc119bc4
Moore, Michael
1be81dad-7120-45f0-bbed-f3b0cc0cfe99
Gágyor, Ildikó
dbcedde8-d7dc-42c0-952b-ae17bd7666d7

Afshar, Kambiz, Fleischmann, Nina, Schmiemann, Guido, Bleidorn, Jutta, Hummers-Pradier, Eva, Friede, Tim, Wegscheider, Karl, Moore, Michael and Gágyor, Ildikó (2018) Reducing antibiotic use for uncomplicated urinary tract infection in general practice by treatment with uva-ursi (REGATTA) - a double-blind, randomized, controlled comparative effectiveness trial. BMC Complementary and Alternative Medicine, 18 (1), 1-8. (doi:10.1186/s12906-018-2266-x).

Record type: Article

Abstract

Background: Uncomplicated urinary tract infections (UTI) are common in general practice and usually treated with antibiotics. This contributes to increasing resistance rates of uropathogenic bacteria. A previous trial showed a reduction of antibiotic use in women with UTI by initial symptomatic treatment with ibuprofen. However, this treatment strategy is not suitable for all women equally. Arctostaphylos uva-ursi (UU, bearberry extract arbutin) is a potential alternative treatment. This study aims at investigating whether an initial treatment with UU in women with UTI can reduce antibiotic use without significantly increasing the symptom burden or rate of complications. Methods: This is a double-blind, randomized, and controlled comparative effectiveness trial. Women between 18 and 75years with suspected UTI and at least two of the symptoms dysuria, urgency, frequency or lower abdominal pain will be assessed for eligibility in general practice and enrolled into the trial. Participants will receive either a defined daily dose of 3×2 arbutin 105mg for 5 days (intervention) or fosfomycin 3g once (control). Antibiotic therapy will be provided in the intervention group only if needed, i.e. for women with worsening or persistent symptoms. Two co-primary outcomes are the number of all antibiotic courses regardless of the medical indication from day 0-28, and the symptom burden, defined as a weighted sum of the daily total symptom scores from day 0-7. The trial result is considered positive if superiority of initial treatment with UU is demonstrated with reference to the co-primary outcome number of antibiotic courses and non-inferiority of initial treatment with UU with reference to the co-primary outcome symptom burden. Discussion: The trial's aim is to investigate whether initial treatment with UU is a safe and effective alternative treatment strategy in women with UTI. In that case, the results might change the existing treatment strategy in general practice by promoting delayed prescription of antibiotics and a reduction of antibiotic use in primary care.

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Accepted/In Press date: 22 June 2018
e-pub ahead of print date: 3 July 2018
Published date: 2018
Keywords: Antibiotic prescription, Arctostaphylos uva-ursi, Comparative effectiveness design, General practice, Herbal remedy

Identifiers

Local EPrints ID: 422434
URI: https://eprints.soton.ac.uk/id/eprint/422434
ISSN: 1472-6882
PURE UUID: ee26e879-6ef8-443f-aabd-d55e1278a434
ORCID for Michael Moore: ORCID iD orcid.org/0000-0002-5127-4509

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Date deposited: 24 Jul 2018 16:30
Last modified: 14 Mar 2019 01:42

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Contributors

Author: Kambiz Afshar
Author: Nina Fleischmann
Author: Guido Schmiemann
Author: Jutta Bleidorn
Author: Eva Hummers-Pradier
Author: Tim Friede
Author: Karl Wegscheider
Author: Michael Moore ORCID iD
Author: Ildikó Gágyor

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