Antibiotics vs. placebo in the treatment of women with uncomplicated cystitis: A meta-analysis of randomized controlled trials

Alfa Institute of Biomedical Sciences (AIBS), Athens, Greece.
The Journal of infection (Impact Factor: 4.44). 03/2009; 58(2):91-102. DOI: 10.1016/j.jinf.2008.12.009
Source: PubMed


Acute uncomplicated cystitis is one of the most common bacterial infections in women and is conventionally treated with antibiotics. However, emergence of resistant uropathogens forces physicians to reconsider the prescription of antibiotics for acute uncomplicated cystitis in non-pregnant young women.
To evaluate the effectiveness of antibiotics in the treatment of acute uncomplicated cystitis.
We searched PubMed, the Cochrane Central Register of Controlled Trials and Scopus database.
Five randomized controlled trials (RCTs) involving non-pregnant, non-immunocompromised adult women with clinically and microbiologically documented acute uncomplicated cystitis were included. Clinical success was significantly more likely in women treated with antibiotics versus those treated with placebo [4 RCTs, 1062 patients, random effects model (REM), odds ratio (OR)=4.81, 95% confidence intervals (CI)=2.51-9.21]. Antibiotics were also superior to placebo, regarding cure (4 RCTs, 1062 patients, REM, OR=4.67, 95%CI=2.34-9.35); microbiological eradication at the end of treatment (3 RCTs, 967 patients, REM, OR=10.67, 95%CI=2.96-38.43); after the end of treatment (3 RCTs, 738 patients, REM, OR=5.38, 95%CI=1.63-17.77), and microbiological reinfection or relapse (5 RCTs, 843 patients, REM, OR=0.27, 95%CI=0.13-0.55). However, adverse events were more likely to occur in antibiotic-treated patients versus placebo-treated women (4 RCTs, 1068 patients, REM, OR=1.64, 95%CI=1.10-2.44). No difference was found between the compared treatment arms regarding study withdrawals from adverse events, the development of pyelonephritis and emergence of resistance.
Antibiotics are superior to placebo regarding both clinical and microbiological success in adult non-pregnant women with microbiologically confirmed acute uncomplicated cystitis. However, they are associated with more adverse events.

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    • "PCT cutoffs are derived from data from our recent observational study and after extrapolation from patients with LRTIs and sepsis [36,41,42]. Patients with uncomplicated simple UTIs in the PCT group receive NSAIDs regardless of PCT values for symptom resolution given emerging data [43,44]. In the control group, antibiotic durations are recommended based on guidelines (Figure 2). "
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    ABSTRACT: Urinary tract infections (UTIs) are among the most common infectious diseases and drivers of antibiotic use and in-hospital days. A reduction of antibiotic use potentially lowers the risk of antibiotic resistance. An early and adequate risk assessment combining medical, biopsychosocial and functional risk scores has the potential to optimize site-of-care decisions and thus allocation of limited health-care resources. The aim of this factorial design study is twofold: first, for Intervention A, it investigates antibiotic exposure of patients treated with a protocol based on the type of UTI, procalcitonin (PCT) and pyuria. Second, for Intervention B, it investigates the usefulness of the prognostic biomarker proadrenomedullin (ProADM) integrated into an interdisciplinary assessment bundle for site-of-care decisions. Methods and design This randomized controlled open-label trial has a factorial design (2 × 2). Randomization of patients will be based on a pre-specified computer-generated randomization list and independent for the two interventions. Adults with UTI presenting to the emergency department (ED) will be screened and enrolled after providing informed consent. For our first Intervention (A), we developed a protocol based on previous observational research to recommend initiation and duration of antibiotic use based on the clinical presentation of UTI, pyuria and PCT levels. For our second intervention (B), an algorithm was developed to support site-of care decisions based on the prognostic marker ProADM and distinct nursing factors on days 1 and 3. Both interventions will be compared with a control group conforming to the guidelines. The primary endpoints for the two interventions will be: (A) overall exposure to antibiotics and (B) length of physician-led hospitalization within a follow-up of 30 days. Endpoints are assessed at discharge from hospital, and 30 and 90 days after admission. We plan to screen 300 patients and enroll 250 for an anticipated estimated loss of follow-up of 20%. This will provide adequate power for the two interventions. This trial investigates two strategies for improved individualized medical care in patients with UTI. The minimally effective duration of antibiotic therapy is not known for UTIs, which is important for reducing the selection pressure for antibiotic resistance, costs and drug-related side effects. Triage decisions must be improved to reflect the true medical, biopsychosocial and functional risks in order to allocate patients to the most appropriate care setting and reduce hospital-acquired disability. Trial registration Trial registration number: ISRCTN13663741
    Trials 03/2013; 14(1):84. DOI:10.1186/1745-6215-14-84 · 1.73 Impact Factor
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    • "In a recently published meta-analysis on antibiotic versus placebo treatment of women with uncomplicated cystitis by Falagas and co-workers [7] amongst systematic literature searches in the PubMed database, "
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    ABSTRACT: Uncomplicated urinary tract infections (UTIs) in otherwise healthy premenopausal women are one of the most frequent infections in the community. Therefore any improvement in management will have a high impact not only on the quality of life of the individual patient but also on the health system. In placebo-controlled studies antimicrobial treatment was significantly more effective than placebo, but on the other hand showed more adverse events. The choice of antibiotic depends on the spectrum and susceptibility patterns of the uropathogens, its effectiveness for this indication, its tolerability, its collateral effects and cost. After a systematic literature search, recommendations for empiric treatment of acute uncomplicated cystitis and acute uncomplicated pyelonephritis and for follow-up strategies were developed.
    International journal of antimicrobial agents 12/2011; 38 Suppl:21-35. DOI:10.1016/j.ijantimicag.2011.09.003 · 4.30 Impact Factor
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    ABSTRACT: Kurzfassung: Harnwegsinfektionen gehören zu den häufigsten entzündlichen Erkrankungen im niedergelassenen Bereich. Eine intelligente Therapiestrategie stellt damit nicht nur eine kli- nische Herausforderung dar, sondern ermöglicht rasche Heilung, Vermeidung von Resistenz- bildungen sowie oft unnötiger, teurer diagnosti- scher Schritte. Der erste entscheidende Schritt ist die genaue Klassifizierung des Harnweg- infektes - asymptomatische Bakteriurie bis zur komplizierten Pyelonephritis. Hier entscheiden sich bereits Aggressivität der Behandlung sowie diagnostischer Aufwand. Für die Entwicklung ei- ner empirischen antimikrobiellen Therapie ist die Kenntnis der häufigsten Erreger sowie loka- ler Resistenzmuster wichtig. Bei gezieltem Vorge- hen können die meisten Harnwegsinfekte ohne er- höhten diagnostischen Aufwand therapiert werden. Abstract: Urinary Tract Infection and Therapy. Urinary tract infections are one of the most com- mon infections in primary care. An anticipating strategy for therapy is necessary for a rapid re- covery, avoidance of the development of resistances and unneeded diagnostic tools. The first crucial step is the classification - asympto- matic bacteriuria or complicated pyelonephritis. The decision for the intensity of treatment and diagnostic effort is based on it. For the selection of empiric antibiotic therapy the knowledge about the predominant uropathogens as well as local resistance patterns is important. J Urol Urogynäkol 2010; 17 (1): 5-11.
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