Nuffield Department of Primary Care Health Sciences, Oxford University, Oxford, England, United Kingdom.
Centre for Academic Primary Care, NIHR School for Primary Care Research, Bristol Medical School: Population Health Sciences, University of Bristol, Bristol, England, United Kingdom.
JAMA Intern Med. 2024 Jun 1;184(6):619-628. doi: 10.1001/jamainternmed.2024.0264.
Recurrent urinary tract infection (UTI) is a common debilitating condition in women, with limited prophylactic options. d-Mannose has shown promise in trials based in secondary care, but effectiveness in placebo-controlled studies and community settings has not been established.
To determine whether d-mannose taken for 6 months reduces the proportion of women with recurrent UTI experiencing a medically attended UTI.
DESIGN, SETTING, AND PARTICIPANTS: This 2-group, double-blind randomized placebo-controlled trial took place across 99 primary care centers in the UK. Participants were recruited between March 28, 2019, and January 31, 2020, with 6 months of follow-up. Participants were female, 18 years or older, living in the community, and had evidence in their primary care record of consultations for at least 2 UTIs in the preceding 6 months or 3 UTIs in 12 months. Invitation to participate was made by their primary care center. A total of 7591 participants were approached, 830 responded, and 232 were ineligible or did not proceed to randomization. Statistical analysis was reported in December 2022.
Two grams daily of d-mannose powder or matched volume of placebo powder.
The primary outcome measure was the proportion of women experiencing at least 1 further episode of clinically suspected UTI for which they contacted ambulatory care within 6 months of study entry. Secondary outcomes included symptom duration, antibiotic use, time to next medically attended UTI, number of suspected UTIs, and UTI-related hospital admissions.
Of 598 women eligible (mean [range] age, 58 [18-93] years), 303 were randomized to d-mannose (50.7%) and 295 to placebo (49.3%). Primary outcome data were available for 583 participants (97.5%). The proportion contacting ambulatory care with a clinically suspected UTI was 150 of 294 (51.0%) in the d-mannose group and 161 of 289 (55.7%) in the placebo group (risk difference, -5%; 95% CI, -13% to 3%; P = .26). Estimates were similar in per protocol analyses, imputation analyses, and preplanned subgroups. There were no statistically significant differences in any secondary outcome measures.
In this randomized clinical trial, daily d-mannose did not reduce the proportion of women with recurrent UTI in primary care who experienced a subsequent clinically suspected UTI. d-Mannose should not be recommended for prophylaxis in this patient group.
isrctn.org Identifier: ISRCTN13283516.
复发性尿路感染 (UTI) 是女性常见的使人虚弱的疾病，预防选择有限。D-甘露糖在二级保健的试验中显示出了前景，但在安慰剂对照研究和社区环境中的有效性尚未得到证实。
确定 D-甘露糖在 6 个月的时间内是否能降低患有复发性 UTI 的女性中出现医疗性 UTI 的比例。
设计、地点和参与者：这是一项 2 组、双盲、随机、安慰剂对照试验，在英国的 99 个初级保健中心进行。参与者于 2019 年 3 月 28 日至 2020 年 1 月 31 日之间招募，随访 6 个月。参与者为女性，年龄 18 岁或以上，居住在社区，其初级保健记录中有证据表明在过去 6 个月中至少有 2 次因 UTI 就诊，或在 12 个月中有 3 次 UTI。邀请是由他们的初级保健中心发出的。共有 7591 名参与者被邀请，830 名做出回应，232 名不符合条件或未进行随机分组。统计分析于 2022 年 12 月进行。
每天 2 克 D-甘露糖粉或等量体积的安慰剂粉。
主要结局指标是在研究入组后 6 个月内，因临床疑似 UTI 而接触门诊护理的女性比例。次要结局包括症状持续时间、抗生素使用、下一次出现医疗性 UTI 的时间、疑似 UTI 的次数和与 UTI 相关的住院治疗。
598 名符合条件的女性（平均[范围]年龄 58 [18-93]岁）中，303 名被随机分配到 D-甘露糖组（50.7%），295 名被分配到安慰剂组（49.3%）。583 名参与者（97.5%）提供了主要结局数据。在 D-甘露糖组中，294 名参与者中有 150 名（51.0%）因临床疑似 UTI 而接触门诊护理，而在安慰剂组中，289 名参与者中有 161 名（55.7%）（风险差异，-5%；95%置信区间，-13%至 3%；P=0.26）。在方案分析、插补分析和预先计划的亚组中，结果相似。在任何次要结局指标上都没有统计学上的显著差异。
在这项随机临床试验中，每日 D-甘露糖并不能降低初级保健中患有复发性 UTI 的女性中随后出现临床疑似 UTI 的比例。甘露糖不应在该患者群体中被推荐用于预防。
isrctn.org 标识符：ISRCTN13283516。
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