With the aid of a small number of additional diagnostic criteria, antibiotic treatment for UTI can be provided more specifically and thus more effectively. Differentiating UTI from asymptomatic bacteriuria, which usually requires no treatment, can lower the frequency of unnecessary antibiotic prescriptions.
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.
This older general practice population in Germany is among the top pharmaceutical user group of European study samples. Apart from disease-specific determinants, GPs should be aware that low subjective health and medication disagreement are independent predictors of polypharmacy.
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
What do pri mary care pa tients think about ge neric drugs? Ab stract. Ob jec tive: To ex am ine the at titude of pa tients to wards ge neric drugs and pre scriptions con tain ing ge neric drugs as an al ter na tive to brand-name prod ucts, with a spe cial fo cus on in for ma tion on pa tients at titude to ge neric drugs pro vided by their general prac ti tio ners (GPs). Meth ods: A to tal of 804 pa tients in 31 gen eral prac tices were surveyed us ing a self-ques tion naire. The in fluence of age, sex, ed u ca tion, dis ease, knowledge of ge neric drugs, ex pe ri ence with generic sub sti tu tion and in for ma tion pro vided by the GP on pa tient at ti tudes to wards ge neric drugs and sub sti tu tions were ex am ined. Results: Nearly two thirds of the pa tients (509/804) stated that they knew of the dif ference be tween brand-name drugs and generics; of these, one third were not sat is fied with the in for ma tion given by their GPs and 37% of pa tients ex pressed gen eral skep ti cism to wards ge neric drugs be cause of their lower price. This at ti tude was more fre quent among those who felt that ge neric pre scrib ing was "in vented" to solve the fi nan cial cri sis in the Ger man health in sur ance sys tem at their expense (odds ra tio (OR): 6.2; 95% con fi dence in ter val: 4.0-9.8) and those who had not been con fronted per son ally with a ge neric sub sti tu tion (OR: 1.8; 1.3-3.0). Pa tients who had been skep ti cal when first con fronted with a ge neric sub sti tu tion were more fre quently among those who con sid ered in ex pen sive drugs to be in fe rior (OR: 4.5; 2.0-10.4) and they were fre quently not sat is fied with the infor ma tion on sub sti tu tion pro vided by their GP (OR: 2.7; 1.2-5.9). Con clu sion: GPs are in an ideal po si tion to in form their pa tients ade quately about the equiv a lence of brandname and ge neric drugs. How ever, the pa tient view that in ex pen sive drugs must be in fe rior may be dif fi cult to rec tify in the short term. Key words ge neric drugs-prescriptions-cost-ef fec tive ness-in for ma tion on drug ther apy-fam ily prac tice Re ceived De cem ber 8, 2004; ac cepted
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