Efficacy and Tolerability of Fitostimoline (Vaginal Cream, Ovules, and Vaginal Washing) and of Benzydamine Hydrochloride (Tantum Rosa Vaginal Cream and Vaginal Washing) in the Topical Treatment of Symptoms of Bacterial Vaginosis
Table 1
Demographic and baseline clinical characteristics (ITT population). If not otherwise stated, entries are mean and 95% CI.
Fitostimoline Cream + vaginal washing
Fitostimoline Ovules + vaginal washing
Pooled Fitostimoline
Tantum Rosa Cream + vaginal washing
Demographics
Age [year]
36.9 34.5–39.4
36.3 33.7–38.9
36.6 34.8–38.4
36.4 34.0–38.7
Weight [kg]
63.6 61.4–65.9
64.0 61.7–66.3
63.8 62.2–65.4
63.2 61.2–65.3
Height [cm]
163 162–164]
162 161–163
163 162–163
163 162–164
BMI [kg/m2]
23.8 23.0–24.7
24.2 23.5–25.1
24.0 23.4–24.6
23.8 23.0–24.5
Caucasian race [%]
92 (96.9%)
95 (97.9%)
187 (97.4%)
98 (99.0%)
Obstetrics and gynaecologic
Days from the last menstrual cycle
10.1 9.4–10.7
9.4 8.7–10.0
9.7 9.2–10.2
9.5 8.8–10.2
Use of oral contraceptives [%]
13 (13.7%)
13 (13.4%)
26 (13.5%)
14 (14.1%)
Years from oral contraceptive start
0.5 0.0–1.0
0.5 0.0–1.0
0.5 0.1–0.9
0.5 0.2–0.7
Previous pregnancies [%]
55 (57.9%)
52 (53.6%)
107 (55.7%)
63 (63.6%)
Number of previous pregnancies
1.4 1.1–1.7
1.5 1.1–1.9
1.5 1.2–1.7
1.6 1.3–2.0
Risk factors for bacterial vaginosis
Regular sexual activity [%]
87 (91.6%)
89 (91.8%)
176 (91.7%)
92 (92.9%)
Exposure to chemicals* and vaginal douching [%]
13 (13.7%)
14 (14.4%)
27 (14.1%)
11 (11.1%)
Use of tight or synthetic clothes [%]
30 (31.6%)
33 (34.0%)
63 (32.8%)
32 (32.3%)
Anxiety and depression [%]
16 (16.8%)
14 (14.4%)
30 (15.6%)
14 (14.1%)
pH and Whiff-test
pH assessment [%]
31 (32.6%)
29 (29.9%)
60 (31.3%)
32 (32.3%)
pH value
5.6 5.4–5.8
5.5 5.3–5.7
5.5 5.4–5.7
5.5 5.3–5.7
Whiff-test performed [%]
30 (31.6%)
32 (33.0%)
62 (32.3%)
31 (31.3%)
Vaginal swab
Swab performed [%]
95 (100.0%)
97 (100.0%)
192 (100.0%)
99 (100.0%)
Specific pathogens growth [%]
51 (53.7%)
52 (53.6%)
103 (53.6%)
54 (54.5%)
Specific treatment [%]
33 (34.7%)
28 (28.9%)
61 (31.8%)
30 (30.3%)
*Scented soaps, feminine hygiene sprays, and cleansers.
