Table 4.
Changes in Vaginal Environment Between Baseline and Month 1 and Month 3
| Baseline | Month 1 | Month 3 | Baseline vs. month 3, p* | |
|---|---|---|---|---|
| Changes After Cessation of Intravaginal Practices | ||||
| Mean vaginal pH | 5.28 | 5.08 | 5.15 | 0.486 |
| BV by Nugent score, N (%) | 10/58 (17) | 4/46 (9) | 6/42 (14) | 0.770 |
| Positive Lactobacillus culture | 22/58 (38) | 20/46 (43) | 17/42 (40) | 0.863 |
| H2O2 producing Lactobacillus | 7/58 (12) | 5/46 (11) | 8/42 (19) | 0.228 |
| Vaginal candidiasis | 12/58 (22) | 8/46 (17) | 3/42 (7) | 0.011 |
| Cytokines [mean log10 transformed, pg/ml (SD)] | ||||
| IFN-γ | 1.43 [3.21] | 1.19 [1.62] | 0.60 [1.10] | 0.112 |
| TNF-α | 2.47 [6.10] | 0.87 [1.91] | 0.97 [4.02] | 0.006 |
| IL-10 | 0.62 [1.07] | 0.50 [0.98] | 0.58 [2.06] | 0.172 |
| IL-6 | 41.32 [62] | 24.81 [56] | 24.02 [68] | 0.001 |
| IL-4 | 0.04 [0.25] | 0.22 [0.73] | 0.15 [0.48] | 0.171 |
| IL-2 | 0.58 [0.72] | 0.76 [0.93] | 0.56 [0.69] | 0.913 |
| % CCR5+CD4+ T cells | 65.39 | 66.82 | 65.52 | 0.822 |
| % CCR5+ß7hi+CD4+ T cells | 12.92 | 11.22 | 10.50 | 0.240 |
| Changes Among Women Who Do Not Engage in Intravaginal Practices | ||||
| Mean vaginal pH | 5.5 | 5.6 | 5.6 | 0.628 |
| BV by Nugent score, N (%) | 13/42 (31) | 6/32 (19) | 6/30 (20) | 0.280 |
| Positive Lactobacillus culture | 14/42 (33) | 9/32 (28) | 14/30 (47) | 0.166 |
| H2O2 producing Lactobacillus | 4/42 (10) | 5/32 (16) | 2/30 (7) | 0.308 |
| Vaginal candidiasis | 5/42 (12) | 7/32 (22) | 7/30 (23) | 0.197 |
| Cytokines [mean log10 transformed, pg/ml (SD)] | ||||
| IFN-γ | 1.96 [3.12] | 0.94 [1.57] | 1.15 [0.89] | 0.626 |
| TNF-α | 3.61 [8.82] | 0.97 [1.90] | 0.87 [1.59] | 0.005 |
| IL-10 | 0.85 [1.69] | 0.47 [1.04] | 0.68 [0.92] | 0.856 |
| IL-6 | 91.2 [182] | 21.21 [31] | 16 [19] | 0.041 |
| IL-4 | 0.38 [0.70] | 0.46 [1.68] | 0.27 [0.62] | 0.419 |
| IL-2 | 2.15 [3.57] | 0.81 [0.72] | 1.03 [1.04] | 0.092 |
| % CCR5+CD4+ T cells | 68 [13] | 67 [16] | 71 [14] | 0.114 |
| % CCR5+ß7hi+CD4+ T cells | 10.9 [9.7] | 12.5 [9.8] | 9.65 [4] | 0.254 |
p values from either a binomial generalized estimating equation (GEE) with logit link or a Gaussian GEE analysis.
Figures in bold are statistically significant.
BV, bacterial vaginosis; SD, standard deviation; IFN, interferon; TNF, tumor necrosis factor; IL, interleukin.