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Women, depression and Viagra – what you need to know

July 28th, 2008

Dr Petra

JAMA (the Journal of the American Medical Association) have just published a paper called “Sildenafil treatment
of women with anti-depressant-associated sexual dysfunction” which as you may expect has generated a lot of press attention.

You can read the whole paper here.

The media coverage has been predictably uncritical. It has tended to suggest that Viagra is a wonder drug that will save depressed women, and as a subtext suggested it could also help the sex lives of women who weren’t depressed as well.

If you are a woman or the partner of a woman with depression there are several things you need to know about this research before you go asking your doctor for a Viagra script.

The study does rightly state that some anti depressants can lead to sexual problems (usually the inability to have an orgasm through intercourse or masturbation, taking longer than usual to reach orgasm, and/or a lack of lubrication). In order to be an issue, however, women can’t just have these symptoms – they have to be bothered by them too. Meaning if a woman finds it difficult to reach orgasm but isn’t distressed by this then it is not an issue requiring clinical intervention. It’s worth noting depression can lead to women finding it difficult to reach orgasm or have any desire for sex. So it can be worrying for a depressive patient who recieves pharmacological treatment and expects to feel better to then discover their sex life hasn’t returned in the way they wanted.

However, this is not always just down to the side-effects of medication – the underlying causes of the depression may not have gone away and could easily still be contributing to a woman’s sexual problems. For example problems within a relationship, family difficulties, work problems, economic or housing difficulties, issues with childcare, isolation or a lack of support could all be contributing to a woman’s sexual difficulties.

The JAMA study used a randomised, double-blind, placebo controlled trial that ran over 8 weeks and included 98 women (average age 37). The women were randomly assigned to either a treatment or placebo group and neither the participants nor the researchers knew who was having the drug or the placebo. All women in the study were pre-menopausal and had not reported sexual problems before going on anti-depressants. The research took four years to complete and was run across seven centres. The study used questionnaires to assess for sexual dysfunction and on average women reported three sexual problems. Viagra use was found to influence one of the problems (orgasm delay). Headaches, flushing and dyspepsia were noted within the group taking Viagra (although no participant withdrew from the study due to these adverse events).

If you look at the media coverage of this study you’d have thought there was a lot more going on than these results are telling us. This is a very small study – I’d be so bold as to call it a pilot study really. 98 women divided into two groups may not be enough to tell us much about how this drug works. More than this it took the researchers four years to find their 98 participants at over 7 research centres. While we all know research can move slowly this is an incredibly slow recruitment rate with a very small final sample obtained. It is not clear from the paper why this situation arose – or whether it has any bearing on the study outcomes.

Although participants did note a number of sexual problems, Viagra use only seemed to impact on one of them (orgasm delay). Meaning those women who couldn’t reach orgasm, weren’t lubricating enough for sex or weren’t enjoying sex as they had before did not notice any benefits from taking the drug. Numerous side-effects were noted though, with 43% of participants recieving the drug stating they’d had at least one problem with it – but the researchers did not appear to measure whether the side-effects were more or less distressing to the women than their reported sexual problem(s).

The paper does not tell us if the women were recieving or had sought any other form of education, counselling or support for their sexual problems. While women were required to complete numerous sexual diaries and questionnaires for the study a full history does not appear to have been recorded – meaning the factors affecting the women outside the bedroom that may also influence their sexual functioning were not apparently assessed. Whether the women in this study who took Viagra during the trial wanted to continue with it afterwards is not mentioned.

The research was funded by Pfizer who also provided both the treatment drug (Viagra) and the placebo. The paper states the company had no further role in the study. All but one author on the paper has links to one or more drug companies. This is not necessarily sinister, but does raise issues about independence and transparency in research practice.

It would have been nice to see journalists unpacking the research and highlighting some of these issues, since they indicate this is a small scale study that hasn’t proved that Viagra works for all women taking anti depressants. That’s the main outcome but media coverage stated pretty much the opposite. This is probably because most journalists did not read the original research (which is a concern since unusually for a medical journal it is freely available online, and no doubt JAMA’s media office would have supplied the paper to anyone who requested it).

As well as unpacking the study it would also have been good for journalists to think about what this research is really saying. It is telling us that if women are encountering a problem from one drug, then they ought to address this by taking another drug. Although this can happen in medicine we know that it’s not really a good treatment regimen unless there is no other alternative (for example a patient who has to take one lifesaving drug that makes them nauseous may need to take a second drug to combat the nausea). Nowhere in the media coverage or the JAMA paper is it clearly discussed what other options may have been made available to women. I’d have been more convinced by the study if a third arm of the trial was included where women reporting problems were offered education or counselling (particularly a programme that addressed their wider social situation) – that is equally worth testing empirically.

For the record the FDA have never approved Viagra for use in women, and it is not being tested for use in women. There are ethical questions here about why JAMA decided to publish a paper that included an experimental and unapproved drug for women – and why the media didn’t notice this.

It’s also worrying that we’ve recently heard clear evidence that anti-depressants may not be anywhere near as effective as once believed, even though they are routinely over prescribed (particularly in the US). It’s not like journalists didn’t know about this information as it was published in an open access (free) journal and was extensively reported in the media.

This JAMA paper indicates several problems around medical reporting. That journalists do not remember previous health stories (even if they are widely cited), that reporters do not have the time, skills or inclination to critically evaluate a scientific paper, and the public can be misled to thinking there’s a wonder cure out there when the data suggests the opposite.

If you are encountering sexual problems as a result of your depression or medication then you may want to seek professional help. This may include taking anti-depressants, but it should not include taking Viagra at this time since this trial has not fully demonstrated it is completely effective or safe for women taking anti-depressants. You may want to also seek counselling, support and to try and tackle other factors that are causing you problems (for example domestic violence, housing problems, workload issues or stress). Do not be tempted to go online and buy Viagra or similar products – particularly without speaking to your doctor. You could do yourself harm for very little gain in your sex life.

If you want a fair summary of this study, it’s probably best described in the quip of one of my colleagues ‘Taking drugs can help reduce the side effects of other drugs, but you might get headache along the way’.

I certainly got a big headache from the coverage of this research. Who knows what damage may have been caused to women who now incorrectly think a drug could solve their problems – particularly if they decide to self-medicate?

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