A controversial study in JAMA Internal Medicine this week showed that a placebo worked just as well as an estrogen hormone tablet to relieve the most bothersome symptoms of a menopausal condition that used to be called “vulvovaginal atrophy” — that’s before it was renamed to make it more media-friendly.

Now the condition is called GSM or “genitourinary syndrome of menopause.”

“The term vulvovaginal atrophy really was problematic,” said Sheryl Kingsberg, president of the North American Menopause Society, one of two groups that voted to change the name.

She said TV and radio programs are squeamish about saying “vaginal” on the air.

“There are many media stations that will say, ‘You can’t say the word ‘vagina,'” Kingsberg said, adding that women didn’t like the word “atrophy.”

“Menopausal women were really taken aback and offended and bothered by the fact that they were told their vagina was ‘atrophying,'” said Kingsberg.

No matter what it’s called, women are often confused about how to relieve post-menopausal symptoms that can include vaginal dryness and painful sex — called “dyspareunia” in medical literature.

One option is prescription estrogen in the form of a vaginal tablet. On the monograph that comes with the drug, there’s a warning about potential risks of estrogen, although most doctors insist the medication is safe because it is not widely absorbed by the body.

But now there’s evidence that a placebo and an over-the-counter gel worked just as well as the hormone tablets.

“That was a surprise to us,” said study author Dr. Caroline Mitchell from the Massachusetts General Hospital. “These results were a surprise to many people.”

The study randomized 302 women to one of three groups and followed them for three months. One group used a low dose vaginal estrogen pill plus a placebo gel. Another group used a placebo vaginal pill plus an over-the counter nonhormonal gel. A third group used both a placebo vaginal pill and a placebo gel.

The results in all three groups were the same. “Everybody got better, in general,” Mitchell said. The study reported a more than 50 per cent improvement in the most bothersome symptoms which were painful sex and vaginal dryness.

“Our results suggest that neither prescribed vaginal estradiol tablet nor over-the-counter vaginal moisturizer provides additional benefit over placebo vaginal tablet and gel in reducing postmenopausal vulvovaginal symptoms,” the study concluded.

“It’s encouraging because pretty much everyone had some improvement even with a super-cheap intervention,” said Mitchell, adding that the prescription estrogen treatments can be expensive. In Canada the drug costs about $175 for the first three months and $130 every three months after that. It is intended to be taken long term.

But Dr. Jennifer Blake, CEO of the Society of Obstetricians and Gynaecologists of Canada, said the study needed to be longer than three months to test the efficacy of the estrogen pill. “The pill we know it needs three months to be fully effective,” she said adding that she wasn’t surprised that the placebo also showed results. “You would get symptomatic relief from using any kind of cream or lubricant,” she said.

A lot of competition

This study was funded by the U.S. National Institutes of Health. The only other randomized controlled trials of the low-dose estrogen tablet were funded by the company that makes it. The lack of pharmaceutical industry funding in the new study was noted in an accompanying commentary.

“A rigorous side-by-side assessment of hormonal and nonhormonal vaginal treatments arguably has the potential to provide new insights in clinical care, especially when conducted by investigators without any affiliation with the treatment manufacturers,” wrote Allisan Huang in the article “Rethinking the Approach to Managing Postmenopausal Vulvovaginal Symptoms,” also published in JAMA Internal Medicine this week.

“There is definitely a big commercial influence in this field because it is a big market,” said Mitchell.”There are several new agents on the market for post menopausal vaginal discomfort so there’s a lot of competition. The people are at all the meetings trying to encourage physicians  to try these new therapies.”

That’s why independent studies are important, she said.

Some of the controversy about how to treat the condition is caused by the underlying scientific questions about the cause, Mitchell said, adding that the loss of estrogen is not the only answer.

“People have all kinds of theories about what’s going on. But we don’t have the scientific basis to support what we’re saying.”

That’s why she collected tissue samples from the women who improved and from the ones who didn’t, to look for biological clues to the different responses.

In the meantime, the results suggest that women can choose several options to get some relief.

“If women learn there’s something that can be done that they don’t have to suffer, that for me is a win,” said Mitchell.
Photo credit: Shutterstock
Original article at: http://www.cbc.ca/news/health/second-opinion-march24-1.4590454