From: Management of sexual dysfunction in breast cancer survivors: a systematic review
Vaginal products interventions | ||||||
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Reference | Outcomes | Intervention results | Control results | Comparisons | Quality of evidence (GRADE) | Comments |
Biglia (2010) [24] | 1. Vaginal Symptoms Score | Baseline to 4-week score change (SD) | No control group | Between group comparisons | Very Low | • Dropout: 16 % |
2. Profile of Female Sexual Function (PFSF) | • Estrogens improved all outcomes more than Replens®. | |||||
1. 4 weeks: p = 0.66 | ||||||
1. Replens®: - 6.3 (4.3) | 12 weeks: p = 0.01 | |||||
3. Vaginal Health Index (VHI) | Estrogens: -5.3 (4.7) | 2. 12 weeks: | ||||
2. Not reported | p = 0.19 | • Replens® showed no change in sexual function at 12 weeks. | ||||
3. Replens®: +3.0 (1.6) | 3. 4 weeks: p = 0.05 | |||||
Estrogens: +5.9 (3.0) | 12 weeks: | |||||
Baseline to 12-week score change (SD) | ||||||
p = 0.02 | • Serum estradiol increased 1.4-3.1 pg/mL in Estrogens group (p > 0.05). | |||||
1. Replens®: -1.3 (5.5) | Within group comparisons versus baseline | |||||
Estrogens: -11.6 (5.2) | ||||||
2. Replens®: +2.1 (9.3) | Replens® | |||||
1. 4 weeks: p = 0.01 | ||||||
Estrogens: +7.2 (5.4) | ||||||
3. Replens®: +2.0 (3.4) | 12 weeks: p = 0.72 | |||||
Estrogens: +8.5 (3.6) | 2. 12 weeks: p = 0.70 | |||||
3. 4 weeks: p = 0.07 | ||||||
12 weeks: p = 0.42 | ||||||
Estrogens | ||||||
1. 4 weeks: p < 0.01 | ||||||
12 weeks: p < 0.01 | ||||||
2. 12 weeks: p =0.03 | ||||||
3. 4 weeks: p < 0.01 | ||||||
12 weeks: p < 0.01 | ||||||
Dahir (2014) [27] | 1. Sexual function (FSFI) | Mean (SD) | No control | Within group comparisons versus baseline | Low | • Dropout: 8 % |
1. Pre 8.7 (3.8) | • Significant improvement in all FSFI domains by post-test. | |||||
Post 18.8 (7.1) | 1. p < 0.001 | |||||
Donders (2014) [32] | 1. Serum estradiol, estrone | Baseline, 4-week | No control | Within group comparisons versus baseline | Low | • Dropout: None |
2. Serum estriol | 1. Only 1 estradiol level detectable (1.2 pg/mL) | • 1 of 16 participants with detectable estradiol level (1.2 pg/mL) at day 28. | ||||
3. Vaginal symptoms | 1. Descriptive only | |||||
2. Peak estriol 104.5 pg/mL, 15.8 pg/mL | 2. Descriptive only | |||||
4. Vaginal pH | 3. p < 0.001 for dryness, soreness | |||||
3. Improved dryness, soreness, dyspareunia | ||||||
5. Vaginal maturation index | 4. p < 0.001 | |||||
6. Serum FSH | 4. Mean 6.0, 4.4 | 5. p < 0.001 | ||||
7. Serum LH | 5. 31 %, 72 % | 6. p = 0.03 | ||||
6. Mean 107.9, 98.9 | 7. p > 0.05 | |||||
7. Mean 36.5, 34.0 | ||||||
Gelfand (1994) [25] | 1. Vaginal health index | 1. Mean score (SD) | No control | Within group comparisons versus baseline | Low | • Dropout: None |
2. Vaginal pH | Baseline 10.1 (0.5) | • Vaginal irritation in 12 % of participants. | ||||
3. Patient-reported sexual effects | 1-month 10.8 (0.4) | 1. 1-month | ||||
3-month 19.7 (0.7) | p > 0.05 | |||||
2. Mean pH (SD) | >1 month | |||||
Baseline 6.9 (0.2) | p <0.001 | |||||
1-month 6.8 (0.1) | 2. 1-month | |||||
3-month 4.9 (0.2) | p >0.05 | |||||
3. Pain-free intercourse: | >1 month | |||||
Baseline 36 % | p <0.001 | |||||
4-month 69Â % | 3. Descriptive only | |||||
Sexual satisfaction improved: | ||||||
1-month 0Â % | ||||||
3-month 77Â % | ||||||
Sexual frequency improved: | ||||||
1-month 0Â % | ||||||
3-month 42Â % | ||||||
Juraskova (2013) [26] | 1. Dyspareunia (Visual analog score, 0-10) | Mean (SD) | No control | Within group comparisons versus baseline | Very Low | • Dropout: 36 % |
1. Baseline 7.0 (2.4) | • Maximum gain in sexual satisfaction and dyspareunia occurred by 12 weeks. | |||||
2. Sexual Activity Questionnaire (0-24) | 4-week 4.4 (2.4) | 1. p < 0.001 | ||||
26-week 2.7 (2.3) | 2. p < 0.001 | |||||
3. Sexual satisfaction FSFI subscale (0.8-6) | 2. Baseline 7.2 (3.2) | 3. p < 0.001 | ||||
4-week 12.3 (4.3) | 4. p = 0.01 | |||||
4. Endocrine symptoms (FACT-ES, 0-72) | 26-week 11.6 (4.3) | 5. Descriptive only | ||||
3. Baseline 2.4 (1.4) | ||||||
5. Satisfaction and acceptability | 4-week 3.3 (1.8) | |||||
26-week (3.5 (1.4) | ||||||
4. Baseline 51 (9.2) | ||||||
4-week 51.8 (9.9) | ||||||
26-week 53.8 (8.7) | ||||||
5. Intervention helpful: | ||||||
PFM 92Â % | ||||||
Replens® 88 % | ||||||
Olive oil 76Â % | ||||||
Kendall (2006) [31] | 1. Atrophic vaginitis symptoms (yes/no) | 1. 5 of 6 improved | No control | Descriptive data – no comparisons | Low | • Dropout: None |
2. Serum estradiol, pmol/L | 2. 5 of 6 had estradiol levels > 3 pmol/L | |||||
3. Serum FSH, IU/l | 3. No significant change | |||||
4. Serum LH, IU/l | 4. No significant change | |||||
Lee (2011) [29] | 1. Dryness with pain (Visual analog score 0-10) | Baseline, 12-week mean scores (SD) | Baseline, 12-week mean scores (SD) | Between group comparisons | Moderate | • Dropout: 12 % |
1. p = 0.001 | • All outcomes favor intervention. | |||||
2. Dyspareunia (Visual analog score 0-10) | 1. 8.2 (0.8), | 1. 7.9 (0.9), | 2. p = 0.04 | |||
4.2 (1.4) | 6.5 (1.5) | 3. p = 0.002 | • Vaginal irritation in 50 % participants in first 4 weeks. | |||
3. Vaginal health index | 2. 8.2 (1.0), | 2. 8.1 (1.0), | 4. p < 0.001 | |||
4. Vaginal pH | 5.5 (1.1) | 6.1 (1.4) | 5. p < 0.001 | |||
5. Vaginal maturation index | 3. 15.8 (3.7), 21.0 (3.9) | 3. 14.3 (3.7), 17.0 (3.9) | ||||
4. 6.5 (1.1), | 4. 6.2 (1.1), | |||||
5.0 (0.8) | 5.7 (0.9) | |||||
5. 45.5 (3.5), 51.2 (3.8) | 5. 46.4 (3.7), 47.9 (2.7) | |||||
Loprinzi (1997) [23] | 1. Product preference | 1. 41 % prefer Replens® % score decrease after 4 weeks treatment: | 1. 24 % prefer Placebo % score decrease after 4 weeks treatment: | Between group comparisons | Moderate | • Dropout: 27 % |
2. Vaginal dryness (scale 0-4) | 1. p = 0.68 | • Both groups with improved vaginal dryness by 1 week. | ||||
2. p = 0.3 | ||||||
3. Dyspareunia (scale 0-4) | 2. 64 % | 2. 62 % | 3. p = 0.05 | |||
4. Itching (scale 0-4) | 3. 60 % | 3. 41 % | 4. Not reported | • Vaginal side effects in 42 % participants. | ||
4. Not reported | 4. Not reported | |||||
Pfeiler (2011) [30] | 1. Vaginal dryness (yes/no) | 1. 5/6 reported improvement | No control | Within group comparisons versus baseline | Low | • Dropout: None |
2. Dyspareunia (yes/no) | 2. 3/5 reported improvement | |||||
3. Serum estradiol, pg/mL | 3. All estradiol < 10 pg/mL after treatment | 1. Descriptive only | ||||
4. Serum FSH, mU/mL | 2. Descriptive only | |||||
5. Serum LH, mU/mL | Mean level pre-, post- | 3. Descriptive only | ||||
4. 4. 75.7, 66.0 | 4. p = 0.01 | |||||
5. 5. 32.4, 28.9 | 5. p = 0.02 | |||||
Wills (2012) [33] | 1. Serum estradiol | 1. Median level (95 % CI) pre-, post- | 1. Mean (range) 3.72 pmol/L (3.0-7.7) | Between group comparisons pre-, post- | Low | • Dropout: None |
• Systemic absorption occurs with intravaginal estrogen therapy (ring or tablet). | ||||||
- Vaginal tablet 2.9 pmol/L (2.9-4.9), 45 pmol/L (19-89) | 1. Versus vaginal tablet p = 0.93, p < 0.001; | |||||
- Vaginal ring 15.0 pmol/L (2.9-19), 15 pmol/L (1.9-35) | Versus vaginal ring p < 0.014, p < 0.014 | |||||
Witherby (2011) [28] | 1. Serum estradiol | 1. % < 5 pg/mL | No control | 1. p = 0.91 | Low | • Dropout: 10 % |
2. Vaginal atrophy symptom (Likert scale, 0-12) | Baseline 100 % | 2. p < 0.001 | • Two estradiol levels elevated after testosterone (both <8 pg/mL). | |||
4-week 90 % | 3. p = 0.03 | |||||
3. Vaginal pH | 2. Mean (SD) | 4. p < 0.001 | ||||
4. Vaginal maturation index (VMI) | Baseline 5.9 (1.9) | • Adverse effects: hair growth/acne (n = 3), vaginal irritation (n = 3) | ||||
4 week 2.1 (1.8) | ||||||
3. Median | ||||||
Baseline 5.5 | ||||||
4-week 5.0 | ||||||
4. % VMI ≥ 10 | ||||||
Baseline 20Â % | ||||||
4-week 40Â % |