Table 2—

Primary and secondary efficacy outcomes in the two treatment arms in the ITT and PP groups

ParametersITT analysis
PP analysis
Fluconazole (n = 55)Boric acid (n = 56)Odds ratio (95% CI)P valueNagel-kerke-R2Fluconazole (n = 49)Boric acid (n = 50)Odds ratio (95% CI)P valueNagel-kerke R2
Primary outcome
    Mycological cure in C.glabrata VVC10/35 (28.6)21/33 (63.6)4.4 (1.6–12.1)0.0050.15910/30 (33.3)21/29 (72.4)5.3 (1.7–16.0)0.0030.194
    As above (adjusted for A1C)As aboveAs above4.0 (1.4–11.6)0.010.153As aboveAs above4.5 (1.4–14.4)0.010.191
Secondary outcomes
    Mycological cure in C.albicans VVC12 (85.7)11 (61.1)0.3 (0.04–1.5)0.130.11012 (92.3)11 (68.8)0.1 (0.02–1.8)0.140.138
    Overall mycological cure25 (45.4)37 (66.1)2.1 (0.9–4.5)0.070.06925 (51.0)37 (74.0)2.3 (0.97–5.5)0.060.096
    Yeast on direct microscopy21 (38.2)13 (23.2)0.5 (0.2–1.2)0.100.03415 (30.6)7 (14.0)0.4 (0.13–1.1)0.070.053
    Vulval pruritus11 (20.0)7 (12.5)0.5 (0.2–1.4)0.200.0385 (10.2)1 (2.0)0.15 (0.02–1.4)0.090.117
    Vulval edema6 (10.2)7 (12.5)1.1 (0.3–3.4)0.910.0071 (2.0)NA0.89NA
    Vaginal congestion34 (61.8)25 (44.6)0.5 (0.2–1.1)0.090.05928 (57.1)19 (38.0)0.48 (0.2–1.1)0.090.075
  • Data are odds ratio (95% CI) or n (%) in two treatment arms in ITT and PP groups. P values test differences in the proportions observed in the two treatment arms in the ITT and PP groups for primary and secondary outcomes (after adjustment for A1C at baseline). Patients with mixed infection and non-albicans candidiasis other than C. glabrata were excluded in the analysis because of the limited numbers.