Appendix Table 2.
Summary of Outcome Reporting for Vulvovaginal Discomfort/irritation
| Comparison | # trials Total N |
Follow-up | Measurement tool | Author, year | Intervention | Intervention Mean change |
Comparator Mean change |
Direction of effect*** | Summary COE |
|---|---|---|---|---|---|---|---|---|---|
| Vaginal estrogen vs. placebo | 4 trials N=1,777 | 12 weeks | 4-point severity† | Archer, 2018 (31) | Estradiol cream | No data (reported graphically) | ↔ | Very low ⨁◯◯◯ Uncertain |
|
| Bachmann, 2009 (36) | CEC 0.5g 21/7 CEC 0.5g 2x/wk |
−0.2 −0.3** |
−0.5** −0.2** |
↓ ↔ |
|||||
| Constantine, 2017 (32) | Estradiol tab 4 mcg Estradiol tab 10 mcg |
−0.8 −0.8* |
−0.6* | ↔ ↑ |
|||||
| Freedman, 2009 (37) | CEC 1g 2x/wk | 88.3% improved | 71.7% | ↑ | |||||
| Vaginal estrogen vs. no treatment | 1 trial N=108 | 36 weeks | Patient diary‡ | Eriksen, 1999 (25) | Estradiol ring 2 mg | 80% symptom resolution | 53% | ↔ | Low ⨁⨁◯◯ No difference |
| Vaginal DHEA vs. placebo | 1 trial N=16 | 12 weeks | 4-point severity† | Labrie, 2009 (62) | DHEA 0.25% DHEA 0.5% DHEA 1.0% |
No data (authors stated a statistically significant difference was observed only for 0.5% DHEA vs. placebo) | ↔ ↑ ↔ |
Very low ⨁◯◯◯ Uncertain |
|
| Oral ospemifene vs. placebo | 1 trial N=627 | 12 weeks | 4-point severity† | Archer, 2019 (48) | Ospemifene 60 mg | −1.4 (95% CI −3.4, 0.6) | −1.4 (−3.4, 0.6) | ↔ | High ⨁⨁⨁⨁ No difference |
| OR 1.03 (95% CI 0.65, 1.64) | |||||||||
| Oral raloxifene vs. placebo | 2 trials N=274 | 12 weeks | 4-point severity† | Parsons, 2003 (52) | Raloxifene 60 mg | No data (reported graphically) | ↔ | Low ⨁⨁◯◯ No difference |
|
| 6 months | Pinkerton, 2003 (53) | Raloxifene 60 mg | No data (reported graphically) | ↔ | |||||
| Vaginal oxytocin vs. placebo | 1 trial N=86 | 8 weeks | Study-specific checklist§ | Abedi, 2020 (63) | Oxytocin gel 400 IU | −5.8* | −1.6* | ↑ | Very low ⨁◯◯◯ Uncertain |
Abbreviations: CEC=conjugated estrogens cream; CI=confidence interval; COE=certainty of evidence; DHEA=Dehydroepiandrosterone; IU=international unit; mcg=microgram; mg=milligram; OR=odds ratio; SD=standard deviation; wk=week
Direction of Effect Symbols: Based on statistical comparison between arms; ↑ intervention statistically significantly better than comparator; ↔ no statistically significant difference; ? no statistical comparison
Scale score interpretation:
4-point severity (0=none to 3=severe);
Patient diary (none, mild, moderate, or severe);
Study-specific checklist (lower=better)
Mean difference calculated by review team (trial only reported baseline and follow-up means)
Trial did not provide precision statistics (e.g., SD, SEM, 95% CI)
Direction of effect is based on statistical significance.