Efficacy of Continuous Transdermal Nitroglycerin for Treating Hot Flashes by Inducing Nitrate Cross-tolerance in Perimenopausal and Postmenopausal Women: A Randomized Clinical Trial
Primary result · Change in any hot flash frequencyResult — go to the resultEstimated change −0.9 episodes per day 95% CI −2.1 to 0.3Authors' conclusion
This randomized clinical trial found that continuous use of NTG did not result in sustained improvements in hot flash frequency or severity relative to placebo and was associated with more early but not persistent headache.
Study context
- Population
- Perimenopausal or postmenopausal women reporting ≥7 hot flashes per day, northern California; baseline mean (SD) 10.8 (3.5) hot flashes dailyrandomized
- Participants
- 141 participants
- Comparison
- Uninterrupted transdermal nitroglycerin vs placebo patches
- Nitroglycerin (NTG)n = 70
- Placebon = 71reference
- Primary endpoint
- Change in any hot flash frequency (validated symptom diaries)
- Follow-up
- 5 and 12 weeks
Methodological detailsdouble-blinded, placebo-controlled, single academic center, Randomized July 2017 to December 2021; trial ended April 2022
- Double-blinded
- Placebo-controlled
- Single academic center
- Randomized July 2017 to December 2021; trial ended April 2022
Primary result
Change in any hot flash frequency · 5 weeks
Estimated change
−0.9 episodes per day
95% CI −2.1 to 0.3
P = 0.10
NTGvs Placebo
estimated change −0.9 episodes per day (95% CI −2.1 to 0.3); P = 0.10
As reported in the abstract
- At 12 weeks, NTG did not significantly decrease any hot flash frequency vs placebo
- −0.1 episodes per day (95% CI, −1.2 to 0.4)
- Combined 5- and 12-week data: no significant difference in any hot flash frequency, NTG vs placebo
- −0.5 episodes per day (95% CI, −1.6 to 0.6; P = .25)
Further findings
| Outcome | Change (episodes per day) (95% CI) | P value | |
|---|---|---|---|
| Change in moderate-to-severe hot flash frequency · 5 weeks | −1.1 (−2.2 to 0) | P = 0.05 | |
| −3−2−101Difference, episodes per day (linear scale) |
Completed 12-week follow-up
P = 0.27
| Outcome | Estimate | P value |
|---|---|---|
| Change in moderate-to-severe hot flash frequency · 12 weeksNot significant | −0.5 episodes per day (95% CI −1.6 to 0.7) | |
| Change in moderate-to-severe hot flash frequency, combined 5- and 12-week data | −0.8 episodes per day (95% CI −1.9 to 0.2) | P = 0.12 |
Safety
Headache · 1 week
P < 0.001
Events
| Outcome | NTG | Placebo |
|---|---|---|
| Headache · 12 weeks | 1 | 1 |
Original publication
Efficacy of Continuous Transdermal Nitroglycerin for Treating Hot Flashes by Inducing Nitrate Cross-tolerance in Perimenopausal and Postmenopausal Women: A Randomized Clinical Trial. JAMA Intern Med. Published 1 August 2023. doi:10.
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