In contrast with the poorly sourced blog post, this story includes comments from two experts who provide valuable context about the findings of a recent trial. And while the discussion of harms was still inadequate, this story did at least mention the possibility of harm from the treatment and described one of the most common adverse effects. The story also did a good job of describing the design of the study and reporting the benefits in a way that readers can understand and use. It would have benefited from some cost data, a better comparison of antidepressants with hormone therapy, and more emphasis on the short-term nature of the study (8 weeks) considering that hot flash symptoms can last for years.
We need more treatment options for women with disruptive menopausal symptoms. Although hormone treatment is effective, many women are reluctant to take hormones because of the increase in potentially serious adverse effects associated with their use. Emerging research suggests that antidepressants may be an alternate option, but the study discussed in this story found that Lexapro is only slightly more effective than a placebo for reducing hot flashes. In addition, use of antidepressants also may cause a variety of adverse effects which, while less serious than the risks of hormone therapy, can be troublesome enough to cause people to stop taking the medication. Stories should provide this full context to help women make the best possible choice about how to manage their symptoms.
The article did not include information about the cost of this medication. According to recent Consumer Reports data, Lexapro at the dosages studied here would cost about $110 a month. This significant cost is something to bear in mind considering the modest benefit the drug confers compared to a sugar pill.
The story quantifies the benefits of treatment in appropriate absolute terms. It explains that women taking the antidepressant went from about 10 hot flashes per day to 5.26 hot flashes a day, a decline of 47% or about 4.5 fewer hot flashes a day. By comparison, women taking the placebo reported 6.43 hot flashes a day after treatment, a decline of 33% or about 3 fewer a day. The story also quantifies the severity of the hot flashes in terms that are useful to the reader.
The story perhaps could have provided some context regarding the size of the benefit compared with placebo, which was relatively small. It also could have noted noted that symptom reductions were much more modest than those seen with hormone treatment.
The story wasn’t thorough enough in its exploration of potential harms. The only adverse effect noted is the potential loss of libido discussed in the last line of the story. At one point, the story seems to dismiss the potential for harm by noting that “no serious adverse events were reported” in the study. However, minor adverse effects take on greater importance when a drug provides only a modest benefit over placebo — which is the case with this medication. The study should have provided more detail on what harms were observed (even “minor” ones), and how frequently. Lexapro, when used for depression, commonly results in gastrointestinal disturbance such as nausea, vomiting, loose stools, and indigestion. A variety of other adverse effects are possible, including include difficulty sleeping and headaches. It is quite conceivable that an increase in these problems might outweigh the small benefit associated with the reduction in hot flashes, so the story should have provided this information.
Another issue not addressed by the story is the potential for uncomfortable withdrawal symptoms when stopping this medication. This point is particularly relevant to make here because Lexapro hasn’t been extensively studied in women who are healthy and don’t have symptoms of depression. We know that some people with depression experience withdrawal symptoms after they stop taking the drug, but we don’t have much evidence on what happens to healthy non-depressed people when they stop taking it. The risk of a discontinuation syndrome increases the longer antidepressant therapy lasts, so an 8-week study may not capture the problems that women may experience with longer-term use of Lexapro for relief of hot flash symptoms. The story could have mentioned that women should never abruptly stop taking an antidepressant medication like Lexapro, as this can increase the risk of more severe withdrawal symptoms.
The story includes enough details about how the study was conducted and what the researchers observed to earn a satisfactory. It notes that this was a randomized, double-blind, placebo-controlled study — the “gold standard” of medical evidence. It explains that outcomes were based on women’s records of how often and how severe their hot flashes were — a relevant clinical endpoint.
Although the story notes that women in the study took the drug for 8 weeks, it could have explained that 8 weeks isn’t long to meet FDA criteria for a hot flash treatment; the FDA requires that benefits be maintained for 12-weeks. The study also should have explained that we have no idea how well these drugs will work over the longer term (menopause symptoms can last for years) or whether problems might occur with longer use (more on this in the Harms criterion). Lastly, it would have been useful to have some discussion of how the treatment affected general health-related quality of life; this would have helped readers understand the importance of the observed benefit on hot flashes when considering overall health/function.
Menopause has been the subject of considerable disease mongering over the years — see here for some examples. This story, though, confines the discussion to women whose symptoms are severe enough to disrupt their lives and quality of life. That seems to be a fair basis upon which to identify women who might be candidates for some kind of medical treatment of menopause symptoms. The story could have provided data on how many women suffer from moderate to severe hot flash symptoms, to give a better idea of how widespread the problem is.
The story quotes an independent expert who seems generally supportive of antidepressant therapy for hot flashes. While we don’t think it would have been difficult to find someone with a more skeptical take on the results, which would have added value for readers, the story did enough to satisfy this aspect of the criterion.
(UPDATED COMMENT INSERTED ON 2/24/11: We originally but erroneously wrote that this story failed to disclose potential conflicts of interest. But it actually did, when it stated: “The study was funded by the National Institute on Aging and other sources. Freeman reports having received research support from Forest Laboratories Inc., and other pharmaceutical companies that make antidepressants. For this study, Forest, which makes escitalopram, provided the drug and placebo pills but no funding.”)
The story mentions that hormone therapy is another treatment option for hot flashes, but it doesn’t provide enough information to allow the reader to compare the two approaches. The story should have mentioned that hormone therapy seems to be more effective than antidepressants at reducing hot flash symptoms, although the risks may also be greater. It also could have mentioned that complementary and alternative medicine approaches are often used for hot flashes.
The story notes that other antidepressants have been studied for the treatment of hot flashes, with conflicting results. It quotes a doctor who says that antidepressants are sometimes used clinically for hot flashes.
The story included interviews with one of the study researchers and an independent source. It did not rely excessively on a press release.