STUDY QUESTIONCan treatment of the symptoms of uncomplicated urinary tract infection (UTI) with ibuprofen reduce the rate of antibiotic prescriptions without a significant increase in symptoms, recurrences, or complications? METHODSWomen aged 18-65 with typical symptoms of UTI and without risk factors or complications were recruited in 42 German general practices and randomly assigned to treatment with a single dose of fosfomycin 3 g (n=246; 243 analysed) or ibuprofen 3×400 mg (n=248; 241 analysed) for three days (and the respective placebo dummies in both groups). In both groups additional antibiotic treatment was subsequently prescribed as necessary for persistent, worsening, or recurrent symptoms. The primary endpoints were the number of all courses of antibiotic treatment on days 0-28 (for UTI or other conditions) and burden of symptoms on days 0-7. The symptom score included dysuria, frequency/ urgency, and low abdominal pain.
BackgroundUncomplicated 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.MethodsWe 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 × 400 mg oral or ciprofloxacin 2 × 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.ResultsSeventy-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).ConclusionsOur 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 registrationTrial registration number: ISRCTN00470468See Commentary http://www.biomedcentral.com/1471-2296/11/42
Corticosteroids for Bell's palsy (idiopathic facial paralysis).
Background: Peripheral facial nerve palsy is the most common functional disturbance of a cranial nerve. 60-75% of cases are idiopathic.Methods: This review is based on a selective literature search proceeding from the current, updated German-language guideline on the diagnosis and treatment of idiopathic facial nerve palsy.Results: The recommended drug treatment consists of prednisolone 25 mg bid for 10 days, or 60 mg qd for 5 days followed by a taper to off in decrements of 10 mg per day. This promotes full recovery (number needed to treat [NNT] = 10; 95% confidence interval [6; 20]) and lessens the risk of late sequelae such as synkinesia, autonomic disturbances, and contractures. Virostatic drugs are optional in severe cases (intense pain or suspicion of herpes zoster sine herpete) and mandatory in cases of varicella-zoster virus (VZV) infection. Corneal protection with dexpanthenol ophthalmic ointment, artificial tears, and a nocturnal moistureretaining eye shield has been found useful in practice. In cases of incomplete recovery with residual facial weakness, both static and microsurgical dynamic methods can be used to restore facial nerve function. Conclusion:Because 25-40% of cases of facial nerve palsy are not idiopathic, differential diagnosis is very important; key diagnostic methods include a clinical neurological examination, otoscopy, and a lumbar puncture for cerebrospinal fluid examination. High-level evidence supports corticosteroid treatment for the idiopathic form of the disorder.
Background Antiviral agents against herpes simplex virus are widely used in the treatment of idiopathic facial paralysis (Bell's palsy), but their effectiveness is uncertain. Significant morbidity can be associated with severe cases. Objectives This review addresses the effect of antiviral therapy on Bell's palsy.
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