Institute of General Practice/Family Medicine, Hanover Medical School, Carl-Neuberg-Str.1, 30625 Hannover, Germany.
BMC Med. 2010 May 26;8:30. doi: 10.1186/1741-7015-8-30.
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.
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.
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).
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.
ISRCTN00470468. See Commentary http://www.biomedcentral.com/1471-2296/11/42.
简单性下尿路感染（UTI）通常采用抗生素治疗。然而，替代治疗方案的证据很少。本初步研究旨在：1）粗略估计布洛芬和环丙沙星在简单性尿路感染症状缓解方面的等效性，以及 2）证明在德国普通诊所进行双盲、随机对照药物试验的可行性。
我们在 29 家德国普通诊所进行了一项双盲、随机对照初步试验。80 名年龄在 18 至 85 岁之间、至少有下尿路刺激症状（尿痛和尿频）之一且无任何并发症的健康女性，随机接受布洛芬 3 x 400mg 口服或环丙沙星 2 x 250mg（+1 个安慰剂）口服，均连续 3 天。在纳入时和第 4、7 和 28 天记录主要症状（尿痛、尿频、下腹痛）的强度，每个症状从 0（无）到 4（非常强烈）进行评分。主要终点为第 4 天症状缓解。次要结局为第 4 天和第 7 天的症状负担（基于所有症状的总和评分）、第 7 天症状缓解和复发频率。第 4 天症状负担的等效性边界预先指定为 +/- 0.5 总和评分点。数据分析采用意向治疗和方案进行。随机化按患者进行，采用计算机程序以 6 个为一组进行分组。
79 名患者进行了分析（布洛芬组 40 名，环丙沙星组 39 名）。第 4 天，布洛芬组 36 名患者中有 21 名（58.3%）无症状，而环丙沙星组 33 名患者中有 17 名（51.5%）。第 4 天，布洛芬组患者的总症状总和评分（1；SD 1.42）低于环丙沙星组患者（1.3；SD 1.9），差值-0.33（95%CI（-1.13 至 0.47）），PP（按方案）分析。在第 0 天和第 9 天，布洛芬组 36 名患者中有 12 名（33%）因持续或恶化的症状接受了二线抗生素治疗，而环丙沙星组 33 名患者中有 6 名（18%）（无统计学意义）。共报告了 58 例非严重不良事件，布洛芬组 32 例，环丙沙星组 26 例（无统计学意义）。
我们的结果支持布洛芬与环丙沙星治疗症状性简单性 UTI 等效性的假设，但需要进一步试验证实。
ISRCTN00470468。请参阅评论文章：http://www.biomedcentral.com/1471-2296/11/42。
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