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BMC Complement Altern Med. 2018 Jul 3;18(1):203. doi: 10.1186/s12906-018-2266-x.

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.

Author information

1
Institute for General Practice, Hannover Medical School, Carl-Neuberg-Str. 1, 30625, Hannover, Germany.
2
Department of General Practice, University Medical Center Göttingen, Humboldtallee 38, 37073, Göttingen, Germany.
3
Department for Health Services Research, Institute for Public Health and Nursing Research, University of Bremen, Bremen, Germany.
4
Department of Medical Statistics, University Medical Center Göttingen, Humboldtallee 32, 37073, Göttingen, Germany.
5
Department of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf, Martinistr, 52, 20246, Hamburg, Germany.
6
Primary Care and Population Science, University of Southampton Faculty of Medicine, Aldermoor Health Centre, Southampton, SO16 5ST, UK.
7
Department of General Practice, Universitätsklinikum Wurzburg, Josef-Schneider-Str. 2/D7, 97080, Würzburg, Germany. gagyor_i@ukw.de.

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 75 years 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 105 mg for 5 days (intervention) or fosfomycin 3 g 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.

TRIAL REGISTRATION:

EudraCT: 2016-000477-21 . Clinical trials.gov: NCT03151603 (registered: 10 May 2017).

KEYWORDS:

Antibiotic prescription; Arctostaphylos uva-ursi; Comparative effectiveness design; General practice; Herbal remedy

PMID:
29970072
PMCID:
PMC6029138
DOI:
10.1186/s12906-018-2266-x
[Indexed for MEDLINE]
Free PMC Article

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