Pirotta Marie, Gunn Jane, Chondros Patty, Grover Sonia, Hurley Susan, Garland Suzanne
Department of General Practice, University of Melbourne, 200 Berkeley Street, Carlton, Victoria, Australia, 3053.
BMC Fam Pract. 2004 Mar 28;5:5. doi: 10.1186/1471-2296-5-5.
Complementary and alternative medicines are used by many consumers, and increasingly are being incorporated into the general practitioner's armamentarium. Despite widespread usage, the evidence base for most complementary therapies is weak or non-existent. Post-antibiotic vulvovaginitis is a common problem in general practice, for which complementary therapies are often used. A recent study in Melbourne, Australia, found that 40% of women with a past history of vulvovaginitis had used probiotic Lactobacillus species to prevent or treat post-antibiotic vulvovaginitis. There is no evidence that this therapy is effective. This study aims to test whether oral or vaginal lactobacillus is effective in the prevention of post-antibiotic vulvovaginitis.
METHODS/DESIGN: A randomised placebo-controlled blinded 2 x 2 factorial design is being used. General practitioners or pharmacists approach non-pregnant women, aged 18-50 years, who present with a non-genital infection requiring a short course of oral antibiotics, to participate in the study. Participants are randomised in a four group factorial design either to oral lactobacillus powder or placebo and either vaginal lactobacillus pessaries or placebo. These interventions are taken while on antibiotics and for four days afterwards or until symptoms of vaginitis develop. Women self collect a vaginal swab for culture of Candida species and complete a survey at baseline and again four days after completing their study medications. The sample size (a total of 496--124 in each factorial group) is calculated to identify a reduction of half in post-antibiotic vulvovaginitis from 23%, while allowing for a 25% drop-out. An independent Data Monitoring Committee is supervising the trial. Analysis will be intention-to-treat, with two pre-specified main comparisons: (i) oral lactobacillus versus placebo and (ii) vaginal lactobacillus versus placebo.
许多消费者使用补充和替代医学，并且它们越来越多地被纳入全科医生的治疗手段中。尽管使用广泛，但大多数补充疗法的证据基础薄弱或不存在。抗生素相关性外阴阴道炎是全科医疗中的常见问题，补充疗法常被用于此。澳大利亚墨尔本最近的一项研究发现，有外阴阴道炎病史的女性中有40%曾使用益生菌乳酸杆菌属来预防或治疗抗生素相关性外阴阴道炎。没有证据表明这种疗法有效。本研究旨在测试口服或阴道用乳酸杆菌在预防抗生素相关性外阴阴道炎方面是否有效。
方法/设计：采用随机、安慰剂对照、双盲的2×2析因设计。全科医生或药剂师邀请年龄在18至50岁之间、因非生殖器感染需要短期口服抗生素治疗的非孕妇参与研究。参与者按四组析因设计随机分为口服乳酸杆菌粉或安慰剂组，以及阴道用乳酸杆菌栓剂或安慰剂组。这些干预措施在服用抗生素期间及之后的四天内使用，或直至阴道炎症状出现。女性自行采集阴道拭子用于念珠菌培养，并在基线时以及完成研究用药四天后再次完成一项调查。计算样本量（每个析因组共496人，每组124人），以确定将抗生素相关性外阴阴道炎的发生率从23%降低一半，同时考虑到25%的脱落率。一个独立的数据监测委员会正在监督该试验。分析将采用意向性分析，有两个预先指定的主要比较：（i）口服乳酸杆菌与安慰剂，以及（ii）阴道用乳酸杆菌与安慰剂。
