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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 %