Supplementation of standard antibiotic therapy with oral probiotics for bacterial vaginosis and aerobic vaginitis: a randomised, double-blind, placebo-controlled trial

Table 2 Baseline characteristics^a of patients in the intent-to-treat (ITT; n = 578) and per-protocol (PP; n = 154) populations

Characteristic	Placebo	Probiotic	p
Hormonal treatment ITT	15	20	0.3388
Hormonal treatment PP	3	5	0.3798
Contraception ITT	89	91	0.6866
Contraception PP	26	20	0.5244
Contraceptive tablets ITT	66	71	0.4999
Contraceptive tablets PP	16	13	0.8095
Transdermal contraception ITT	10	6	0.3380
Transdermal contraception PP	2	0	0.2047
Contraception condom ITT	10	8	0.6750
Contraception condom PP	5	4	0.9480
Contraception other ITT	4	6	0.4951
Contraception other PP	3	3	0.9420
Sexually active ITT	270	266	0.5838
Sexually active PP	76	70	0.5646
More than one sexual partner ITT	1	1	0.9844
More than one sexual partner PP	0	0
Smoking ITT	46	32	0.1120
Smoking PP	14	12	0.8888
Vaginal douching ITT	2	3	0.6310
Vaginal douching PP	1	1	0.9411
Complaints at first visit (PP)
Vaginal itching	7	6	0.9249
Vaginal burning	14	14	0.7301
Vaginal pain	1	1	0.9410
Vaginal discharge	79	70	0.5663
Pelvic pain	2	1	0.6221
Conditions reported by investigators at first visit (PP)
Vaginal erythema	0	3	0.0354
Palpation tenderness	1	1	0.9624
Homogenous vaginal discharge	78	71	0.9260
Clue cell presence	79	71	0.9160
Positive amine test	78	72	0.3632
BV (Amsel’s criteria [13])	80	72	0.2559
Vulvovaginal candidiasis	0	1	0.2206
Microbial species cultured from vaginal swabs collected at first visit ^b(PP)
Gardnerella vaginalis	46	52	0.0628
Streptococcus agalactiae	17	15	0.9465
Escherichia coli	5	3	0.5646
Enterococcus spp.	0	1	0.2206
Candida albicans	2	0	0.1076
Lactobacillus spp.	48	44	0.8980

^aAnalyses were not carried for age, sex, or race, as only Caucasian women aged 18–50 years were included
^bOnly populations exceeding 10⁵ organisms per swab were counted

ISSN: 1472-6874