BackgroundAlthough uncomplicated urinary tract infections (UTIs) are often self-limiting, most patients will be prescribed antibiotic treatment. We assessed whether treatment with ibuprofen was non-inferior to pivmecillinam in achieving symptomatic resolution by day 4, with a non-inferiority margin of 10%.Methods and findingsThis was a randomized, controlled, double-blind non-inferiority trial. We recruited patients from 16 sites in a general practice setting in Norway, Sweden, and Denmark. Non-pregnant women aged 18–60 years presenting with symptoms of uncomplicated UTI were screened for eligibility from 11 April 2013 to 22 April 2016. Patients with informed consent were randomized (1:1 ratio) to treatment with either 600 mg ibuprofen or 200 mg pivmecillinam 3 times a day for 3 days. The patient, treating physician, and study personnel were blinded to treatment allocation. The primary outcome was the proportion of patients who felt cured by day 4, as assessed from a patient diary. Secondary outcomes included the proportion of patients in need of secondary treatment with antibiotics and cases of pyelonephritis. A total of 383 women were randomly assigned to treatment with either ibuprofen (n = 194, 181 analyzed) or pivmecillinam (n = 189, 178 analyzed). By day 4, 38.7% of the patients in the ibuprofen group felt cured versus 73.6% in the pivmecillinam group. The adjusted risk difference with 90% confidence interval was 35% (27% to 43%) in favor of pivmecillinam, which crossed the prespecified non-inferiority margin. Secondary endpoints were generally in favor of pivmecillinam. After 4 weeks’ follow-up, 53% of patients in the ibuprofen group recovered without antibiotic treatment. Seven cases of pyelonephritis occurred, all in the ibuprofen group, giving a number needed to harm of 26 (95% CI 13 to 103). Five of these patients were hospitalized and classified as having serious adverse events; 2 recovered as outpatients. A limitation of the study was the extensive list of exclusion criteria, eliminating almost half of the patients screened. We did not register symptoms in the screening process; hence, we do not know the symptom burden for those who declined to participate. This might make our results less generalizable.ConclusionsIbuprofen was inferior to pivmecillinam for treating uncomplicated UTIs. More than half of the women in the ibuprofen group recovered without antibiotics. However, pyelonephritis occurred in 7 out of 181 women using ibuprofen. Until we can identify those women who will develop complications, we cannot recommend ibuprofen alone as initial treatment to women with uncomplicated UTIs.Trial registrationClinicalTrials.gov NCT01849926EU Clinical Trials Register (EU-CTR), EudraCT Number 2012-002776-14
This large population study, comprising more than six years of observations, showed the number of primary healthcare patients receiving an RTI diagnosis decreased during the period 1999-2005, but the proportion of patients receiving an antibiotic prescription remained the same. The large seasonal variations indicate a need for further interventions to decrease antibiotic use for RTIs.
The aim of this retrospective study of electronic patient records in primary health care in Kalmar County, Sweden, was to describe consultations for respiratory tract infections (RTIs) in relation to age, choice of antibiotics and the use of rapid diagnostic tests. During the period 1999-2005, 240,445 visits for RTI were recorded. Children aged <2 y and especially those aged 2-16 y with acute otitis media (AOM), showed decreasing consultations between 2000 and 2005. The consultations for sore throat declined during the study period in all age groups and in 65% of these, antibiotics were prescribed, primarily penicillin V (82%). In sore throat, a positive Strep-A test result was followed by antibiotic prescription in about 92% of cases; when negative, the antibiotic prescription rate was 40%. C-reactive protein (CRP) was analyzed in 36% of all consultations for RTI. In common cold and acute bronchitis, the prescription rates of antibiotics rose with rising CRP. The results show that near-patient tests were used extensively, but often not in accordance with the guidelines. Antibiotic use decreased mainly as a consequence of declined visiting frequencies. This indicates that the new guidelines for AOM and sore throat may have influenced patient consultation habits more than physician prescribing habits.
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