Intravaginal lactic acid gel versus oral metronidazole for treating women with recurrent bacterial vaginosis: the VITA randomised controlled trial

Table 2 Summary of adherence to and use of study treatment (participant reported)

Participant reported adherence	Oral metronidazole (n = 259)	Intravaginal lactic acid gel (n = 259)	Overall (n = 518)
Number returning questionnaire	157	161	318
Participant took/used any of randomised treatment
Yes	156 (99%)	160 (99%)	316 (99%)
No	1 (1%)	1 (1%)	2 (1%)
Course of study treatment completed^a
Yes	144 (92%)	147 (91%)	291 (92%)
No	13 (8%)	14 (9%)	27 (8%)
Percentage of treatment course received
Mean [SD]	94% [18.4%]	95% [12.9%]	95% [15.8%]
Median [IQR]	100% [100%—100%]	100% [100%—100%]	100% [100%—100%]
Participants receiving at least 85% of treatment course	146 (93%)	148 (92%)	294 (92%)
Reason if treatment course not completed^b
Accidentally missed	10 (48%)	7 (58%)	17 (52%)
Did not like using/taking it	1 (5%)	1 (8%)	2 (6%)
Side-effects of treatment	4 (19%)	0	4 (12%)
Other^c	6 (29%)	4 (33%)	10 (30%)
Ease of taking study treatment
Very easy	63 (40%)	81 (50%)	144 (45%)
Easy	50 (32%)	61 (38%)	111 (35%)
Neither easy not difficult	35 (22%)	16 (10%)	51 (16%)
Difficult	7 (4%)	2 (1%)	9 (3%)
Very difficult	1 (1%)	0	1 (< 0.5%)
Missing	1 (1%)	1 (1%)	2 (1%)
Time from randomisation to treatment start (days)^d
Median [IQR]	0 [0—1]	0 [0—1]	0 [0—1]
Min, max	0, 26	0, 17	0, 26
n	156	156	312
Brand of lactic acid gel used
Balance Activ® (lactic acid 4.5%)	N/A	67 (42%)
Relactagel® (lactic acid 4.5%)	N/A	90 (56%)
Brand unknown	N/A	1 (1%)
Missing	N/A	3 (2%)

IQR interquartile range, SD standard deviation
All data are n (%), mean [SD] or median [IQR]
^aAs reported by the participant. Response was not changed even if contradicted by other data
^bReasons (mutually exclusive) are included even when the participant reported completing the course (8 in the metronidazole group, 2 in the lactic acid gel group). Four in the lactic acid gel group reported not completing the course but did not confirm one of the 4 available options
^cOther reasons are given including some for which the ‘other’ reason was not given as ‘yes’. These were: misplaced treatment, started treatment late due to social engagements, misunderstood how to take treatment, was not prescribed study treatment, unknown in the metronidazole group; period started during treatment (five participants), vaginal itching and bleeding, lower abdominal pain in the lactic acid group
^dTreatment start dates recorded by the participant as being before randomisation dates are assumed to be incorrect and are substituted by the randomisation date: 7 participants in the metronidazole group and 4 participants in the lactic acid gel group gave a treatment start date before the randomisation date. One start date was the same as the Week 2 questionnaire date although they indicated taking all doses

ISSN: 1472-6874