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Symptomatic treatment (ibuprofen) or antibiotics (ciprofloxacin) for uncomplicated urinary tract infection?--results of a randomized controlled pilot trial

BACKGROUND: Uncomplicated lower urinary tract infections (UTI) are usually treated with antibiotics. However, there is little evidence for alternative therapeutic options.This pilot study was set out 1) to make a rough estimate of the equivalence of ibuprofen and ciprofloxacin for uncomplicated urinary tract infection with regard to symptom resolution, and 2) to demonstrate the feasibility of a double-blind, randomized controlled drug trial in German general practices. METHODS: We performed a double-blind, randomized controlled pilot trial in 29 German general practices. Eighty otherwise healthy women aged 18 to 85 years, presenting with at least one of the main UTI symptoms dysuria and frequency and without any complicating factors, were randomly assigned to receive either ibuprofen 3 x 400 mg oral or ciprofloxacin 2 x 250 mg (+1 placebo) oral, both for three days.Intensity of main symptoms--dysuria, frequency, low abdominal pain--was recorded at inclusion and after 4, 7 and 28 days, scoring each symptom from 0 (none) to 4 (very strong). The primary endpoint was symptom resolution on Day 4. Secondary outcomes were the burden of symptoms on Days 4 and 7 (based on the sum score of all symptoms), symptom resolution on Day 7 and frequency of relapses. Equivalence margins for symptom burden on Day 4 were pre-specified as +/- 0.5 sum score points. Data analysis was done by intention to treat and per protocol. Randomization was carried out on patient level by computer programme in blocks of six. RESULTS: Seventy-nine patients were analyzed (ibuprofen n = 40, ciprofloxacin n = 39). On Day 4, 21/36 (58.3%) of patients in the ibuprofen-group were symptom-free versus 17/33 (51.5%) in the ciprofloxacin-group. On Day 4, ibuprofen patients reported fewer symptoms in terms of total sum score (1; SD 1,42) than ciprofloxacin patients (1,3; SD 1,9), difference -0,33 (95% CI (-1,13 to +0,47)), PP (per protocol) analysis. During Days 0 and 9, 12/36 (33%) of patients in the ibuprofen-group received secondary antibiotic treatment due to ongoing or worsening symptoms, compared to 6/33 (18%) in the ciprofloxacin-group (non significant). A total of 58 non-serious adverse events were reported, 32 in the ibuprofen group versus 26 in the ciprofloxacin group (non significant). CONCLUSIONS: Our results support the assumption of non-inferiority of ibuprofen compared to ciprofloxacin for treatment of symptomatic uncomplicated UTI, but need confirmation by further trials.

Trial
Journal Ref. Bleidorn J, Gagyor I, Kochen MM, Wegscheider K, Hummers-Pradier E: BMC Med 2010, 8:30.
Intervention Health services delivery and reconfiguration - GPs use ibuprofen 3 x 400 mg oral in the treatment of uncomplicated urinary tract infection (UTI)
Number of sites 29
Countries involved Germany
Sample size 80
Type of statistical analyses ITT AND per protocol analysis
Risk of bias Overall: Low Risk details
Participant characteristics Age: mean age 44
Condition: Urinary tract infection, otherwise healthy
Baseline severity: at least one of the main UTI symptoms dysuria and frequency and without any complicating factors
Duration of trial 10 months: July 2007 to April 2008
Primary outcome The primary endpoint was symptom resolution on Day 4
Effect Measures
Events Intervention Total Events Control Total Risk Diff.
21 36 17 33 6.82 %
this is pilot study, double blind, RCT. Fullly powered study now started and PRECIS-2 wheel based on that. Inclusion criteria now dont include older women >65
Show Score Ranges

Scores:

(shows median if more than one score was entered)

Elig. Recr. Setting Org. Int. Flex. Del. Flex. Adherence Follow-Up Prim. Out. Prim. An.
4 5 5 4 3 5 4 5 5