More data needed on what's effective for hot flashes

A University of Michigan expert on menopause says a new study that indicates placebos work as well as antidepressant drugs to help hot flashes shows how much more research is needed about what gives patients relief.

Nancy Reame, a U-M nursing scientist, was invited by the journal Menopause to evaluate a new study published in today's issue. The study was conducted in Finland, led by Dr. Eila Suvanto-Luukkonen. Reame's editorial, called "The emerging science of hot flash relief: Legitimizing the 'obecalp' effect," is in the same issue. "Obecalp" is placebo spelled backwards.

"These pharmaceutical drugs did work. There was significant improvement in 60 to 70 percent of women who took two popular classes of antidepressants. The problem was the placebo also had the same effect," said Reame, the Rhetaugh Graves Dumas Professor of Nursing at U-M.

Suvanto-Luukkonen conducted a nine-month study of selective serotonin reuptake inhibitor (SSRI) antidepressants—the first study longer than 12 weeks—that showed little difference between placebos and antidepressants for hot flashes.

"We don't pay much attention in a scientific way to why a placebo works," said Reame, also a research scientist with the U-M Reproductive Sciences Program.

Reame suggested it is possible women suffering hot flashes respond to health care professionals who create a caring environment and manage symptoms in a holistic way in collaboration with the patient. If that is the case, she says, the drug itself might be less important than the total package given by a doctor or nurse.

"There is a sense that a placebo is a bad thing," she said. "I want to turn that around and think of it as self healing.

"We need to appreciate the value of providing a therapeutic environment where the patient gets benefits out of the whole health care interaction, apart from any drug effect," Reame said.

Self-healing involves a whole range of activities that reduce anxiety and harness the patient's ability to promote her own wellness. In the case of menopausal women, it means taking control of your own symptoms by getting good education from health care provider, using daily diaries to track hot flashes, monitoring them when they are most bothersome, reflecting on their severity and taking a systematic inventory of behavior in relation to the hot flashes.

All of this happens as part of a scientific study like the one on SSRIs. The process prompts the women to pay careful attention to their experiences with interested people helping them track their data while they are also taking pills that they believe might be working, Reame noted.

Reame said understanding all treatment effects, not just prescription drug impact, is particularly needed in a time when women are worried about potential health risks associated with hormone replacement therapy, a popular way of addressing menopause.

For example, she said, a number of studies show that deep breathing is effective in quelling hot flashes. Similarly, a number of studies on pain show biochemical responses to self-healing—what this study calls the placebo.

To better understand one more holistic approach to menopause treatment, Reame is beginning a small-scale trial of the commonly used herbal supplement black cohosh for hot flashes.

Using a small grant from U-M for the pilot study, Reame and her neuroscience collaborators from the U-M School of Medicine will look at the effects of black cohosh on the brain and on hormone levels. Previous studies have done the same for estrogen therapy, so Reame's team will look for similarities between black cohosh and estrogen's effects in women's bodies.

Reame said she sees two main possibilities for the strong anecdotal evidence that women get relief from black cohosh:

• Black cohosh is working as an estrogen stimulator, generating a similar physical response to taking estrogen supplements.

• Black cohosh triggers the placebo response, reducing hot flashes through something other than an estrogen biochemical route.

Reame will look at chemical receptors in the part of the brain that responds to opiate drugs. In pain studies, these chemicals are often stimulated by placebos in those subjects who get relief from placebos, she said, indicating it is not simply "all in your head" but a physical response just as powerful as that generated by pharmaceuticals.