Posted by Helen on: 02.28.2008 /
From an article on TIME magazine’s site
Researchers from the U.K., U.S. and Canada analyzed results for fluoxetine (better known by the brand name Prozac), venlafaxine (Effexor), nefazodone (Serzone) and paroxetine (Paxil or Seroxat) - all members of a class of drugs known as selective serotonin reuptake inhibitors (SSRIs). The researchers’ paper, published this week in the journal PLoS Medicine, claims that only patients who are diagnosed “at the upper end of the very severely depressed category” get any meaningful benefit from the widely prescribed drugs. For the others, the paper says, antidepressants are barely more effective than a placebo (although patients suffering from depression, like those suffering from chronic pain, generally do see a substantial placebo benefit).
Not surprisingly:
Drug companies claim the review is still flawed, however.
I hadn’t heard of the distinction between ’statistical significance’ and ‘clinical significance’ before - it makes a lot of sense to me.
There are really two issues at the heart of the controversy. One is the difference between “statistical significance” - a measure of whether the drug’s effects are reliable, and that patient improvement is not just due to chance - and “clinical significance,” whether those effects actually are big enough to make a difference in the life of a patient. The researchers behind this new paper did find that SSRI drugs have a statistically significant impact for most groups of patients: that is, there was some measurable impact on depression compared to the placebo effect. “But a very tiny effect may not have a meaningful difference in a person’s life,” says Irving Kirsch, lead author on the paper and a professor of psychology at the University of Hull in England. As it happens, only for the most severely depressed patients did that measurable difference meet a U.K. standard for clinical relevance - and that was mostly because the very depressed did not respond as much to placebos. The drug trials showed SSRI patients improved, on average, by 1.8 points on the Hamilton Depression Rating Scale, a common tool to rate symptoms such as low mood, insomnia, and lack of appetite. The U.K. authorities use a drug-placebo difference of three points to determine clinical significance.
I agree with the conclusion. Of course drug companies will do whatever they are allowed to (and more in some cases) to sell their product. They are not going to highlight any research which casts any doubt on the effectiveness of it. I think it’s amazing and unfortunate for patients that researchers do not have to hand over all their results once a drug is approved.
The more troubling question concerns what kind of data is appropriate for analyzing a drug’s efficacy. The companies are correct in claiming there is far more data available on SSRI drugs now than there was 10 or 20 years ago. But Kirsch maintains that the results he and colleagues reviewed make up “the only data set we have that is not biased.” He points out that currently, researchers are not compelled to produce all results to an independent body once the drugs have been approved; but until they are, they must hand over all data. For that reason, while the PLoS Medicine paper data may not be perfect, it may still be among the best we’ve got.
Comment by: Amy_Black
1 02/28/08 10:17 AM | Comment Link |There’s a lot of hullabuloo about antidepressants right now and speaking as someone who has been on an SSRI anti-depressant for about 2 years, I think they are very effective.
Even if it’s the placebo effect that makes me feel better, it’s the same result: My emotions are leveled out and I can live my life better when I take it. I <3 antidepressants!
Comment by: pamhogeweide
2 02/28/08 10:27 AM | Comment Link |Zoloft is my best friend and I intend to come out of the closet and blog about it…
Comment by: Shawna R. B. Atteberry
3 02/28/08 11:21 AM | Comment Link |I’m on Paxil and Lexapro, and they make a big difference in my life as well. Just being able to think straight is a nice thing. I’m sure the drug companies do overhype the anti-depressants, buy may be clinical significance isn’t that big of a deal for those of us who got our lives back.
Pam, I would encourage you to blog about your depression. I started to and was surprised how many people came out and said it helped them.
Comment by: Helen
4 02/28/08 12:03 PM | Comment Link |I suppose the title is a bit misleading since the actual findings weren’t so much that ‘anti-depressants hardly help’ as ‘anti-depressants do help; placebos help almost as much’.
That might seem the same to a statistician but as Amy and Shawna said, the point is that you got your life back.
Shawna and Pam I’ve had the same experience that I’m surprised how people open up when I share about the mental health issues I’ve been through.
I don’t know if any of you listened to it - the podcast I did was about mental disorders and the faith community.
Comment by: pamhogeweide
5 02/28/08 4:02 PM | Comment Link |i blogged about. link here
I don’t go into a whole lot of detail about black dog depression (which is my technical term for what had a grip on me) but I do reference some earlier posts to give fill in some blanks.
Yes, being open about it typically inspires others to reveal their own battle with depression and anxiety. This is much different than a case of the blues or having a slump in mood for a few days. Falling into the jaws of that nasty black dog has an affect on everything. Especially thinking. Zoloft is helping me to think clearly without the fog of listlessness and negativity. I can see clearly now, the rain is gone…I love that song…
I don’t understand all the connections between seratonin in the brain and moods and life experiences, etc…but whatever it is, I am glad that Zoloft is available to me. My inner world is more peaceful, and so therefore is my outer…though I must admit that at times I feel a bit flatlined, subdued emotionally. But I will take that anyday over the crazy rollercoaster days of mood swings and intense melancholy.
I’ll have to go listen to the your podcast Helen. Thanks for the link!
Comment by: Randy
6 02/28/08 4:46 PM | Comment Link |One more plug for Zoloft…my 23 year old son finally gave in and started taking this med for his depression. He just told me yesterday that it really seems to help, and that he can actually “feel” when it’s time for his next dose (something about starting to feel anxious and hyper…he often forgets to take it on schedule, but this feeling reminds him). He was suicidally depressed just a couple of months ago. He is happier and more able to connect with others now, and he is the first to say so (which is no small thing, trust me).
That said, it is one of several drugs that are over prescribed to people, partially due to the manufacturers marketing strategies and physician’s willingness to keep looking for the magic bullet. We would do well to be careful with these and all other prescriptive medications.
Thanks for the article, Helen.
Comment by: David H
7 02/28/08 5:05 PM | Comment Link |When my second child was born I was working later at night (until at least 11 p.m.) and already had three years (since the first child) of operating with less than 8 hours of sleep a night except on weekends. My wife was doing a clinical year at a hospital so I was the primary care giver for two small children during the day. I was averaging about 4-5 hours of sleep per night. Needless to say I wasn’t feeling great.
Went to the doctor for a checkup and he asked how I was sleeping. I said I wasn’t getting as much as I needed. He didn’t even ask me why, just handed me a prescription for Paxil. He said it might help me have more normal sleep cycles.
I took it for a few months, but it didn’t help. After that I became far more wary about what doctors prescribed for me and other family members. They seemed a little too eager with that anti-depressant.
None of that is to say I don’t believe such drugs can be useful. I know people who say drugs such as Zoloft, Paxil, et al have helped them reclaim their lives. But those pharmaceuticals aren’t going to add hours to the day so I can sleep more.
Comment by: Traci Cumbay
8 02/28/08 6:00 PM | Comment Link |My pharmacologist husband tells me evidence shows that exercise is “as beneficial as or more beneficial than” SSRIs for cases of mild depression.
Same for restless legs syndrome, by the way, and from what I understand, exercise is much less likely to lead to gambling. Get a tight little ass and save your offsite betting money!
Comment by: Helen
9 02/28/08 6:42 PM | Comment Link |Pam I just read your post - thanks for posting the link. I’m glad Zoloft is helping you.
Randy I’m pleased to hear your son is feeling a little better.
David, I wouldn’t be happy with a doctor like that. I just switched one of my doctors because he didn’t explain anything.
Traci, it’s amazing how wide-ranging the benefits of exercise are. I try to remember that when I don’t feel like doing it :)
Comment by: Randy
10 02/28/08 9:05 PM | Comment Link |Exercise is from the devil…
Comment by: pamhogeweide
11 02/29/08 1:05 AM | Comment Link |AMEN!!!!!!!!!!!
Comment by: Helen
12 02/29/08 5:05 AM | Comment Link |Interesting theory Randy and Pam - but if you’re right how come I’ve never felt tempted to exercise? :)
Comment by: pamhogeweide
13 02/29/08 9:49 AM | Comment Link |cuz you’re such a holy almost christian…:-)
Comment by: karen
14 02/29/08 3:13 PM | Comment Link |One caution for anyone taking SSRIs: Don’t go off them cold turkey.
When my mother moved to an assisted living center, she became quite depressed and withdrawn and her doctor put her on Zoloft, which seemed to help quite a bit.
However, she had surgery a few months later and my sister didn’t think to tell the hospital when she was admitted that mom was on Zoloft (it was a small dose). She was in the hospital about a week, and by the end of that time, she was just about crawling out of her skin! I had never seen her so agitated and upset - she was really manic.
We later learned that she needed to taper off the pills, which she did successfully. But that episode was frightening.
Comment by: Helen
15 03/1/08 5:31 AM | Comment Link |Pam, yes, that must be why :)
Karen thanks for that caution.
Comment by: steve hayes
16 03/2/08 7:43 AM | Comment Link |All of us have different DNA and different metabolisms. Some herbs and vitamins work better than others. The first thing that is needed is proper nutrition and a good physical exam. As the director of Novus Medical Detox, I often see patients who are on alcohol or opioids, central nervous system depressants, also taking antidepressants. When they detox they find they don’t need the antidepressants.
This is good news because a Swedish study showed that 52% of the 2006 suicides by women on antidepressants. Since antidepressants work no better than placebos and are less effective than exercise in dealing with depression.
There is a prescription drug epidemic and these are leaders in the list of terribe abuses.
Steve Hayes
http://novusdetox.com
Comment by: Helen
17 03/2/08 8:05 AM | Comment Link |Thanks for your comment Steve.
I like the holistic approach to wellness, where everything is looked at.
Is your center opposed to all meds? Do you always take people off everything or do you sometimes move people from more to less, rather than to none at all?
Comment by: Eliza
18 03/4/08 9:19 PM | Comment Link |David H, I can’t believe your doctor handed you a Rx for Paxil for “more normal sleep cycles”. Well, actually, I can believe it, but it’s frustrating to hear that he did that. You had 2 small kids & late hours at your job, of course you weren’t getting enough sleep, but no pill would change that. Besides which, the SSRIs don’t help “normalize sleep cycles”, they actually suppress REM sleep (that may be part of how they work to treat depression, as selectively waking people during REM sleep to “REM deprive” them also helps treat depression, in research studies). But paxil can be sedating, maybe he was thinking he was treating insomnia (difficulty sleeping) rather than the condition known as working-parent-of-young-children.
I’ve taken a low dose of Zoloft (12.5 mg, which is 1/2 of the lowest dose tablet strength) daily for several years. I’ve stopped it a few times without any side effects, except for return of “the blues”, so I can only conclude that it is having an actual effect of helping me cope moodwise with modern life. I find it to be quite useful and I do not want it taken away…!
Comment by: Doreen A Mannion
19 03/5/08 2:23 PM | Comment Link |I’m a PPP, proud paxil person.
I’ve tried off & on for the past 20 years to NOT take antidepressants. Studies, smudies, say I. I know how I am when I go off them. (So do those around me.) I know how I am on them.
I’ll keep my low dose of paxil along with my low dose of another antidepressant, thank you very much. (When I sometimes run out of the second, St. Johns Wort does an adequate job of filling in.)
Comment by: Julie Marie
20 03/12/08 5:47 PM | Comment Link |I am tempted to say that antidepressants shouldn’t be precribed w/o concurrent talk therapy. But some folks are so “counselor averse” that they’d never get any help with those restrictions. Antidepressants have helped me, and a loved one. Its hard, sometimes, when you are sufferring clinical depression, to even get up the energy to think about dealing with your problems. But once the fog begins to lift, there is an opportunity for growth and healing.
Comment by: Helen
21 03/12/08 7:50 PM | Comment Link |Eliza, Doreen and Julie Marie, thanks for your comments. I appreciate the openness of each of you in sharing that you take anti-depressants.
Julie Marie, in my experience psychiatrists always recommend talk therapy along with antidepressants. As you say, you need to be enough out of the deep depression for talk therapy and life management approaches to be helpful.