Skip to main content

Table 4 Summary of findings

From: Management of sexual dysfunction in breast cancer survivors: a systematic review

Vaginal products interventions
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 69 % 3. Descriptive only
Sexual satisfaction improved:
1-month 0 %
3-month 77 %
Sexual frequency improved:
1-month 0 %
3-month 42 %
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 92 %
Replens® 88 %
Olive oil 76 %
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 20 %
4-week 40 %