Nonhormonal versus non-pharmaceutical

Posted by Liz on Oct 8, 2012 in hot flash | 0 comments

HRT has suffered quite a hit in recent years and as a result, the Menopause Industrial Complex has been scrambling to find a viable replacement. And while I would like to believe in that altruism is driving the train, the cynic in me truly believes that it’s mostly profit motivated. That being said, I do admire the tenacity of industry to attempt to find a reasonable replacement for HRT (and hopefully a safer one) for women who want a fix for troublesome vasomotor symptoms — hot flashes and night sweats — and don’t want to make the effort or don’t understand how to navigate the landscape of alternative strategies.

However, let’s be clear: there is a distinction between nonhormonal treatments and non-pharmaceutical treatments, hence, when you start hearing about ‘nonhormonal’ options, be sure to ask what that means, because it’s likely that it means ‘not HRT,’ such as a new non-hormonal pharmaceutical alternative to HRT: LDMP, better known as low-dose paroxetine. For those of you who are unfamiliar with paroxetine, it is a type of SSRI  used in the treatment of depression, panic disorder and social anxiety disorder; the popular antidepressant Paxil is a form of paroxetine.

Paroxetine is not the first antidepressant to be studied in menopausal women and you may recall that I wrote about the use of Lexapro for hot flashes about a year and a half ago. You can find that post here.  However, paroxetine is the antidepressant that’s all the buzz right now, since Noven Pharmaceuticals presented two studies last week at the North American Menopause Society annual meeting. Note that it’s been reframed as ‘low-dose non-hormonal therapy for menopausal vasomotor symptoms,’ but ya still gotta call a spade a spade and what it is is an antidepressant.

Here’s what you need to know:

In one of two studies, 568 women (40+ years of age) who experienced 7 to 8 moderate or severe hot flashes on a daily basis of 50 to 60 on a weekly basis took either 7.5 mg of LDMP or placebo daily over six months. By the end of the first month (and in contrast to the study’s start), women who were taking LDMP experienced 28.9 fewer hot flashes per week (compared to 19 fewer per week for women taking placebo pills). By the third month, this increased by roughly 10 fewer per week in both groups. The severity of the hot flashes also significantly decreased. Safety wise, women taking LDMP reported nausea and bronchitis.

In the complementary study, which lasted for three months, 606 women in the same demographic took the same dose of LDMP or placebo. Decreases in mean number of flashes per week were pretty much on par with the first study (33 compared to 23.5 for placebo) and similarly, a trend towards maintaining and growing benefits were observed. Severity of hot flashes also declined but by the study’s end, were not significantly different than placebo. This time, women who took LDMP most frequently reported dizziness and fatigue.

Dr. James Simon, one of the studies’ investigators and a professor of ob/gyn at GWU School of Medicine claims that symptoms of menopause often go untreated when women are unable or unwilling to take hormone therapy, which is not entirely true. Another investigator — Dr. Andrew Kaunitz from the University of Florida College of Medicine in Jacksonville notes that if LDMP is approved by the FDA, “it could be the first nonhormonal option available for women.” Again, this statement is not entirely true.  LDMP has the potential to become the first nonhormonal treatment APPROVED by FDA for vasomotor symptoms in menopausal women. There are other options out there but on the most part, they are not embraced by Western practitioners. Take note: while many Western practitioners will argue until they are blue in the face that alternative strategies have no role, are no better than placebo, and do not have evidenced-based trial data to support their use, they are simply incorrect. An unequivocal statement about every alternative strategy available to wo-man is bad medicine at best and at worst? Sheer ignorance.

Back to LDMP…LDMP appears to effectively diminish hot flashes and sweats but it is not without side effects. And while the dosage is considerably lower than full-strength antidepressants, we don’t have enough information to know if it will ultimately mimic its higher dose partner; the most common side effects reported in these trials are the very same that have been reported with Paxil. Another common side effect of Paxil that has not been explored (at least not publicly) in these trials is the effects on libido and it is a well known fact that as many women go through menopause, they experience declines in sex drive, lubrication and the ability to reach orgasm.

I say that the verdict is still out. And that based on the way that communications about this agent are being framed, that it’s about the spin. I guess that time will tell.