'Mind Over Matter' for Hot Flushes in Breast Cancer

Placebo Effect?

Nick Mulcahy

February 14, 2012

February 14, 2012 — The vexing problem of hot flushes and night sweats (HFNS) in women treated for breast cancer has an effective treatment — group cognitive behavioral therapy (CBT), according to British researchers. These results from a 96-patient trial were published online February 14 in the Lancet Oncology.

Menopausal symptoms are common in breast cancer patients — about 65% to 85% of these women will have HFNS, say Myra Hunter, PhD, from King's College London, United Kingdom, and her colleagues.

Cancer treatments, including chemotherapy and endocrine therapy, can affect ovarian function, reduce estrogen levels, and induce or exacerbate menopausal symptoms, they write.

Many drugs, herbs, and other modalities have been used to treat HFNS, but some of the most effective treatments, such as antidepressants and hormone replacement therapy, have had problematic adverse effects.

In contrast, group CBT is safe and without adverse effects, the authors report.

The therapy devised by the investigators taught women how to perform "paced breathing" relaxation and to deal with their symptoms using cognitive and emotional techniques (e.g., avoiding negative thoughts).

In the 96-patient trial, the women randomized to group CBT (90 minutes once a week for 6 weeks) were much less affected by their menopausal symptoms than the women randomized to usual care.

Specifically, women in the CBT group reported that their HFNS symptoms were significantly reduced (on a 10-point problem-rating scale), compared with those in the usual-care group (P < .0001 at week 9 and at week 26). These results, which were the primary outcome of the trial, were "substantial and robust," write Dr. Hunter and colleagues.

This study, which consisted of patients from London oncology clinics, "shows the power of the mind over the management of menopausal symptoms in women treated for breast cancer," writes Holly Prigerson, PhD, from the Dana-Farber Cancer Institute in Boston, Massachusetts, in an accompanying comment.

However, the study authors acknowledge that the positive treatment effects "could have been attributable to the placebo effect of additional attention" in the CBT group.

Dr. Prigerson also saw this problem. She told Medscape Medical News that, ideally, the control women would have been in some sort of group to correct for "attention and support." It is a recommendation for future research, she said.

But Dr. Prigerson has doubts about the viability of therapy groups in regular practice settings. Such interventions require "substantial time, effort, and commitment of resources," she writes in her comment.

Using the Internet might be a better way to go, she says.

"An online, CBT-based self-management intervention might be more cost-effective, offer greater flexibility in the timing and location of participation, enhance access, and potentially prove more sustainable," Dr. Prigerson writes.

Would the Web, which is less personal, threaten the sisterhood (and possibly placebo effect) among the group members? Not necessarily. "Online interventions don't preclude social interactions/support," she said.

No Difference in Frequency

On the study's 10-point problem-rating scale, the women receiving group therapy had a decline from a baseline average of 6.5 to 3.5 at 9 weeks (46% reduction) and to 3.1 at 26 weeks (52% reduction); equivalent usual-care scores were 6.1, 5.0, and 4.6.

The frequency of the women's symptoms was also evaluated. At baseline, all 96 had a high frequency of HFNS, and for an extended period of time (average, 69 events/week over an average of 2 years).

Unfortunately, the trial did not show that group CBT reduced the frequency of HFNS, compared with usual care.

Interestingly, both the CBT and usual-care groups had a 38% reduced frequency of symptoms, report the authors.

This is not entirely surprising, suggest Dr. Hunter and her coauthors, because usual care included some of the elements from group CBT; for instance, the usual-care group received instruction in psychoeducation and paced breathing.

Combo Treatment?

As well as having less bothersome menopausal symptoms, women in the CBT group received "additional benefits" — namely, improvements in mood, sleep, and quality of life, report the authors.

Dr. Prigerson thinks that these quality-of-life benefits are important, especially in light of other treatments for menopausal symptoms.

She notes that the selective serotonin reuptake inhibitor (SSRI) escitalopram has been shown to reduce the frequency and severity of menopausal hot flushes more effectively than placebo in healthy women. In other words, at least 1 SSRI can do what group therapy cannot — reduce the frequency of symptoms.

However, "many of these nonhormonal therapies have side effects such as dry mouth, sexual dysfunction, sleep impairment, and nausea," writes Dr. Prigerson about escitalopram and other therapies.

In Dr. Prigerson's mind, the evidence to date suggests that CBT in combination with a nonhormonal therapy could be a winning combination.

"The combination of CBT with an effective nonhormonal treatment might decrease the frequency of and stress associated with HFNS," she writes.

The study authors and Dr. Prigerson have disclosed no relevant financial relationships.

Lancet Oncol. Published online February 14, 2012. Abstract, Comment

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