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Dr. Bob is Robert Hsiung, MD,
[email protected]Shown: posts 1 to 25 of 25. This is the beginning of the thread.
Posted by Phillipa on August 24, 2010, at 18:35:55
Seems ad's didn't fare as well as thought on Star D Study. Now much better than placebo. Phillipa
From Medscape Medical News
Broad Review of FDA Trials Suggests Antidepressants Only Marginally Better than Placebo
Deborah BrauserAugust 24, 2010 A new review of 4 meta-analyses of efficacy trials submitted to the US Food and Drug Administration (FDA) suggests that antidepressants are only "marginally efficacious" compared with placebo and "document profound publication bias that inflates their apparent efficacy."
In addition, when the researchers also analyzed the Sequenced Treatment Alternatives to Relieve Depression (STAR*D) trial, "the largest antidepressant effectiveness trial ever conducted," they found that "the effectiveness of antidepressant therapies was probably even lower than the modest one reported...with an apparent progressively increasing dropout rate across each study phase.
"We found that out of the 4041 patients initially started on the SSRI [selective serotonin reuptake inhibitor] citalopram in the STAR*D study, and after 4 trials, only 108 patients had a remission and did not either have a relapse and/or dropped out by the end of 12 months of continuing care," lead study author Ed Pigott, PhD, a psychologist with NeuroAdvantage LLC in Clarksville, Maryland, told Medscape Medical News.
Sustained Benefit "Jaw Dropping"
"In other words, if you're trying to look at sustained benefit, you're only looking at 2.7%, which is a pretty jaw-dropping number," added Dr. Pigott.
Overall, "the reviewed findings argue for a reappraisal of the current recommended standard of care of depression," write the study authors.
"I believe there are likely some people where [antidepressants] are truly beneficial beyond placebo. The problem right now is that we simply have no way of knowing who those people are," noted Dr. Pigott. "My hope is that this kind of analysis creates 'more oxygen' for looking at other kinds of approaches to treatment."
The study was published in the August issue of Psychotherapy and Psychosomatics.
When registering new drug application trials with the FDA, drug companies must prespecify the primary and secondary outcome measures, the investigators report. "Prespecification is essential to ensure the integrity of a trial and enables the discovery of when investigators selectively publish the measures that show the outcome the sponsors prefer following data collection and analysis, a form of researcher bias known as HARKing or 'hypothesizing after the results are known'," they write.
For this article, Dr. Pigott and his team reviewed the following meta-analyses:
1. Rising and colleagues (reviewed all efficacy trials for new drugs between 2001 and 2002)
2. Turner and colleagues (reviewed 74 past trials of 12 antidepressants)
3. Kirsch and colleagues, 2002 (reviewed 47 trials of 6 FDA-approved antidepressants)
4. Kirsch and colleagues, 2008 (reviewed depression severity and efficacy in 35 trials)
The researchers also sought to reevaluate the methods and findings of STAR*D, a randomized, controlled trial of patients with depression. Its prespecified primary outcome measure was the Hamilton Rating Scale for Depression (HRSD), whereas the Inventory of Depressive SymptomatologyClinician-Rated (IDS-C30) was secondary for identifying remitted and responder patients."STAR*D was designed to identify the best next-step treatment for the many patients who fail to get adequate relief from their initial SSRI trial," the study authors write.
"When I first read about STAR*D's step 1 phase, it just seemed biased to me," explained Dr. Pigott. "I thought of it as the 'tag, you're healed' research design. Patients who were scored as having a remission during the first 4 to 6 weeks of up to 14 weeks of acute care treatment were counted as remitted, taken out of the subject pool, and put into the follow-up care phase. In other words, they didn't have the ability to have a relapse. But as most people know, depression ebbs and flows.
"So what made me want to continue to follow this study was that it became clear that the only way that people were really going to be able to evaluate the antidepressants' effectiveness was to wait for the publication of the follow-up findings," he added. "After their major final summary study was published, I felt as though the results weren't really being portrayed in a manner that was consistent with the study's prespecified criteria."
High Dropout, Low Remission Rates
In addition to reporting on low efficacy of antidepressants compared with placebo, the 4 meta-analyses "also document a second form of bias in which researchers fail to report the negative results for the prespecified primary outcome measure submitted to the FDA, while highlighting in published studies positive results from a secondary or even a new measure, as though it was their primary measure of interest," the investigators write.
For example, they note, the meta-analysis from Rising and colleagues found that studies with favorable outcomes were almost 5 times more likely to be published and that over 26% of primary outcome measures were left out of journal articles. Turner and colleagues found that antidepressant studies were 16 times more likely to be published if favorable compared with those with unfavorable outcomes.
In reanalyzing the STAR*D methods, the researchers found that the high dropout rate resulted in frequently missed exit HRSD and IDS-C30 interviews. So the revised statistical analytical plan dropped the IDS-30 for the Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR), which was given at each visit.
"Even with the extraordinary care of STAR*D, only about one fourth of patients achieved remission in step 1 [and] the dropout rate was slightly larger than the success rate," the study authors write. Steps 2 through 4 also each showed increasingly fewer success rates and larger dropout rates.
Of the 4041 patients at the study's initiation, 370 (9.2%) dropped out within 2 weeks, and only 1854 patients (45.9%) obtained remission "using the lenient QIDS-SR criteria." Of these, 670 dropped out within a month of their remission, and only 108 "survived continuing care" and underwent the final assessment.
Dr. Pigott described reanalyzing STAR*D as being "a bit like an onion. Each time we thought we understood the results, we found another layer. It wasn't until about a year and a half ago that we discovered that the secondary outcome measure, the QIDS-SR, was not originally supposed to be used as a research measure. What was particularly disconcerting to me was that in their summary article, they basically used the QIDS-SR to report all of the results, which clearly had an inflationary effect on the outcome."
He also noted that STAR*D did not have a placebo design. "Because the patients knew they were receiving the active medication, I would have expected a higher remission rate than what you'd find normally in a placebo-controlled study.
"The inescapable conclusion from the STAR*D results is that we need to explore more seriously other forms of treatment (and combination thereof) that may be more effective. This effort will require developing new service delivery models to ensure that as treatments are identified, they are widely implemented," the investigators conclude.
Need for Biomarkers
"For STAR*D, we wanted to do a study that other people could then reanalyze and look at. So I'm very glad that these authors reexamined it and saw it slightly differently, which came mainly from ways of analyzing data," Maurizio Fava, MD, STAR*D trial investigator and executive vice chair of the Department of Psychiatry at Massachusetts General Hospital in Boston, told Medscape Medical News.
"I think their analysis is reasonable and not incompatible with what we had reported," added Dr. Fava, who was not involved with this review.
He noted that the review's message for clinicians is that "there's been a failure of the field to demonstrate robust advantages of antidepressants over placebo. It's doesn't mean that clinicians shouldn't use antidepressants, but they should recognize that there's a limitation. On the other hand, we have very plausible, reasonable explanations for such failure, including the fact that patients who don't actually have the disease have often been enrolled in the studies. Therefore, this failure may have to do with imperfect clinical trial design and conduct."
In addition, Dr. Fava said that the review points to a lack of long-term efficacy for antidepressants, although "this may be due to things such as inadequate management of patients without dose adjustments and other things that can increase the likelihood of remaining well.
"Regardless of how you look at it, this study suggests the importance of developing biomarkers to identify patients who really need these antidepressants both in the short and the long term," concluded Dr. Fava. "I'd say there's a real opportunity here for that."
Dr. Pigott reports consulting in the past 3 years for CNS Response, Midwest Center for Stress and Anxiety, and SmartBrain Technologies. Dr. Fava reports several disclosures, which are listed in the original STAR*D papers.
Psychother Psychosom. 2010;79:267-279. Article available online.
Posted by violette on August 25, 2010, at 8:01:54
In reply to Ad follow up of Star D Study Worse Than Before, posted by Phillipa on August 24, 2010, at 18:35:55
"...lead study author Ed Pigott, PhD, a psychologist with NeuroAdvantage LLC"
I wonder if this has anything to do with his motivation to do this study? The guy doesn't have a MD in psychiatry, which to me, sort of impacts his credibility....though I wouldn't be interested in reading it to find out if the study was useful or not for these reasons.
Phillipa, hmmm. maybe you could find us some studies from independent psychiatrists in practice, small studies with different incentives...such as doctors noticing effects on their patients, then wanting to research that effect.
Posted by violette on August 25, 2010, at 8:15:56
In reply to Ad follow up of Star D Study Worse Than Before, posted by Phillipa on August 24, 2010, at 18:35:55
http://www.neuro-advantage.com/
..because then they can post the 'research' (the parts they pick out) on their website, touting the effectiveness of their approaches...
Maybe it's me-maybe I'm just old-fashioned, but marketing mental health care similar to those 'pyramid clubs' hits a nerve...it reminds me of the Blue Algae pyramid-marketed product. I used to have a friend push this on everyone she knows-it was annoying to me. It will change your life she said!! I guess it's annoying because it seems to be a trend for doctors to do this. I can see why they do this though, as medications just don't work that great and people may be responsive to other options when they fail. And sometimes I think psychiatrists lose faith in what they can do when they get out of medical school and see how it really is....it must be disappointing for those who get in the field to help people.
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Posted by MaybeSo on August 25, 2010, at 21:36:40
In reply to Re: Ad follow up of Star D Study Worse Than Before, posted by violette on August 25, 2010, at 8:15:56
Who exactly is enrolled in this study?
Is it mostly adult patients who have never had a depressive episode before?
Short term depression, first time as an adult, may not be at all the same as many of us who struggle lifelong?
My brain changed so drastically when I finally found meds that worked. I can't believe I'm simply getting a placebo effect.
Maybe I'm just misunderstanding the article/study.
Posted by Phillipa on August 25, 2010, at 23:39:35
In reply to Re: Ad follow up of Star D Study Worse Than Before, posted by MaybeSo on August 25, 2010, at 21:36:40
I just get the messages through Medscape. Neither the writer or what not. I'm just interested in what others think. Phillipa
Posted by linkadge on August 26, 2010, at 17:45:17
In reply to Re: Ad follow up of Star D Study Worse Than Before, posted by MaybeSo on August 25, 2010, at 21:36:40
ADs don't work. What else is new?
Linkadge
Posted by Dr. Bob on August 27, 2010, at 22:49:54
In reply to Re: Ad follow up of Star D Study Worse Than Before, posted by linkadge on August 26, 2010, at 17:45:17
> ADs don't work.
Please don't exaggerate.
But please don't take this personally, either, this doesn't mean I don't like you or think you're a bad person, and I'm sorry if this hurts you.
More information about posting policies and tips on alternative ways to express yourself, including a link to a nice post by Dinah on I-statements, are in the FAQ:
http://www.dr-bob.org/babble/faq.html#civil
http://www.dr-bob.org/babble/faq.html#enforceFollow-ups regarding these issues should be redirected to Psycho-Babble Administration. They, as well as replies to the above post, should of course themselves be civil.
Thanks,
Bob
Posted by 49er on August 28, 2010, at 5:09:13
In reply to Re: Ad follow up of Star D Study Worse Than Before » Phillipa, posted by violette on August 25, 2010, at 8:01:54
> "...lead study author Ed Pigott, PhD, a psychologist with NeuroAdvantage LLC"
>
> I wonder if this has anything to do with his motivation to do this study? The guy doesn't have a MD in psychiatry, which to me, sort of impacts his credibility....though I wouldn't be interested in reading it to find out if the study was useful or not for these reasons.
>
> Phillipa, hmmm. maybe you could find us some studies from independent psychiatrists in practice, small studies with different incentives...such as doctors noticing effects on their patients, then wanting to research that effect.Hi Violet,
You make some good points about this guy's background. I don't like to see that at all obviously.
But Bob Whitaker had reached the same conclusion about the Star D study. You might be interested in this article that just came out on his blog:
http://www.psychologytoday.com/blog/mad-in-america/201008/the-stard-scandal-new-paper-sums-it-all
You also might be interested in this exert:
In her article, Medscape Medical News writer Deborah Brauser asked STAR*D investigator Maurizio Fava, who is a prominent psychiatrist from Massachusets General Hospital, whether the published analysis by Pigott and his collaborators was correct. "I think their analysis is reasonable and not incompatible with what we had reported," he said.
Hmm
49er
Posted by SLS on August 28, 2010, at 5:46:34
In reply to Re: Ad follow up of Star D Study Worse Than Before » violette, posted by 49er on August 28, 2010, at 5:09:13
Does anyone know what criteria were used to make one eligible to participate in the STAR*D? What was the minimum depression scored accepted?
- Scott
Posted by SLS on August 28, 2010, at 6:04:45
In reply to Re: Ad follow up of Star D Study Worse Than Before, posted by SLS on August 28, 2010, at 5:46:34
> Does anyone know what criteria were used to make one eligible to participate in the STAR*D? What was the minimum depression scored accepted?
If we are to accept Whitaker's reporting, patients were accepted whose baseline HRSD score was as low as 14. This represents mild depression. It is already established that active compounds separate from placebo by a greater amount when more severe depressions are studied. It is my belief that studies of more mild depressions include too many subjects who don't have the disorder being investigated - major depressive disorder (MDD). It is as if they were treating a bunch of people who have thrush with antibiotics. This is the wrong disease for the treatment chosen. In fact, antibiotics can make thrush worse.
- Scott
Posted by violette on August 28, 2010, at 20:58:01
In reply to Re: Ad follow up of Star D Study Worse Than Before, posted by Phillipa on August 25, 2010, at 23:39:35
Phillipa,
I hope you don't think I was being critical of you for the articles your post..i always welcome your sharing of this information. They are provacative, regardless of whether people agree with the results or not, it promotes useful dialogue either way.
It's interesting to me how some doctors will do a study-then use that one published study to sell products on their website...In just the past 2 weeks, i've seen it twice. Whether or not their research was useful, it is interesting to see how this works.
I don't do much personal research of medication studies, so i do appreciate that you post them here. It sort of lets me be aware of trends and other things going on in the mental health system that i otherwise don't pay as much attention to as i should. It's always a learning experience. So yes, keep sharing them. Thanks
:)
Posted by Phillipa on August 28, 2010, at 21:10:48
In reply to Re: Ad follow up of Star D Study Worse Than Before » Phillipa, posted by violette on August 28, 2010, at 20:58:01
Violette no problem. I get the articles sent to me as I used to be an RN and they cover all medical topics. I can get CME's from them. I found out about them from my internist and subscribed. I have a stack of papers here from the tests I take after some articles I can't post as they are teaching ones but give me credits if decide to nurse again. But age makes it highly unlikely. But at least I know what the doctors and nurses are going by. Phillipa
Posted by linkadge on August 29, 2010, at 16:02:42
In reply to Re: please be civil » linkadge, posted by Dr. Bob on August 27, 2010, at 22:49:54
>> ADs don't work.
>Please don't exaggerate.
Ok sorry, let me clarify. Statistically, ADs don't work (any better than placebo) (in some of the largest and most comprehensive meta-analysis done to date).
Oh, I know, I'm ruining the placebo effect for people right? Sorry.
Linkadge
Posted by morgan miller on August 29, 2010, at 16:11:20
In reply to Re: please be civil » Dr. Bob, posted by linkadge on August 29, 2010, at 16:02:42
Hey linkage, do your really believe placebo is that powerful to be able to sustain someone for years? Also, what about the response people get after being on a antidepressant for 4 or 6 or 8 weeks, is that a placebo? If the side effects of ADs are not placebo and are really coming from the ADS, isn't it likely that the positive responses are coming from the ADs?
The reality is, antidepressants do work for thousands of people, minus any placebo effect.
Posted by linkadge on August 29, 2010, at 16:48:39
In reply to Re: please be civil, posted by morgan miller on August 29, 2010, at 16:11:20
>Hey linkage, do your really believe placebo is >that powerful to be able to sustain someone for >years? Also, what about the response people get >after being on a antidepressant for 4 or 6 or 8 >weeks, is that a placebo?
Depression is a state that has one of the highest rates of spontanious remission. I believe that a lot of people don't necessarily get better because of drugs, they just get better. Some people believe that Jesus, or Mohammed, or other God is responsible for maintaining their health, wealth and prosperity. Is this true? Perhaps. I can't fully discount the antidepressant effect, only question it.
Its not possible to prove that antidepressants don't work for some. On the converse however, if you chose to try and prove that the antidepressants do work (more than an effect that can be reproduced by a placebo) you will be faced with a greater challenge.
The 6-8 week thing is also not exactly set in stone. Some people feel better the next day. Some people don't feel better after 6 months, its highly variable.
When you subject mice to unpredictable stressors, they will recover on their own if you give them time to do so. In some cases, I think the antidepressant gives you something to do while the depression gets better (or doesn't) on its own. Kind of like when you're waiting for the light at the crosswalk to change, you can press the button to make it feel like something is happening. Or those windows messages that come up after an error asking you if you would like to send an error message. It makes you feel as if something is happening, that you have some degree of control. The wheels are in motion so to speak.
>If the side effects of ADs are not placebo and >are really coming from the ADS, isn't it likely >that the positive responses are coming from the >ADs?
Well that logic sounds reasonable, but you cannot really conclude one from the other. That a person starts to feel better while wearing a q-wray ionized braclet, doesn't mean the q-wray caused the recovery. Furthermore, even if the q-wray caused side effects (say a rash on the wrist) this would not conclude that the supposed effect was real.
>The reality is, antidepressants do work for >thousands of people, minus any placebo effect.
Well thats the debate.
Linkadge
Posted by Phillipa on August 29, 2010, at 18:58:21
In reply to Re: please be civil » morgan miller, posted by linkadge on August 29, 2010, at 16:48:39
All I know is I drank and took benzos during the time that l0mg of paxil was deemed to be working but I lay on the couch for three months first. And now they just don't work for me. Now prozac when first out wasn't depressed and still drinking beer with tiny dose of benzo and by day three full panic attack and got off them. Three days to feel normal again. So I feel for me that something in beer with the benzos is all I need. Now that don't drink anymore I'm miserable. Phillipa
Posted by morgan miller on August 29, 2010, at 19:41:34
In reply to Re: please be civil » morgan miller, posted by linkadge on August 29, 2010, at 16:48:39
You make some good points. All I know from my experience, dilated pupils and all, I have had a very intense response to antidepressants. The first time I tried an AD I was on Prozac. Looking back I realize I was in a moderate mixed episode, it was pretty awful. For the first three weeks on Prozac, I really just felt the same-agitated, couldn't stop obsessing over things and regretting things, couldn't get good sleep, couldn't focus, could relax, had constant anxiety, etc. Right around 3 weeks into taking Prozac I took the little pill when I woke up and within the hour I felt like a new person, it was amazing-anxiety was obliterated, sleep was great, no more obsessing or regretting, more focused than ever, and felt about as comfortable as I ever had-and this lasted for 2 years, 9 mths on Prozac and 15 months following being off Prozac. Now, I know of no reports where someone in a mixed bipolar episode just spontaneously got better, better than they were ever in their life, and stayed better without any treatment intervention, it just doesn't happen.
I just think saying antidepressants don't work is like saying that antipsychotics, mood stabilizers, and ADHD drugs don't work.
Morgan
Posted by Dr. Bob on August 29, 2010, at 23:40:27
In reply to Re: please be civil » linkadge, posted by Dr. Bob on August 27, 2010, at 22:49:54
> Follow-ups regarding these issues should be redirected to Psycho-Babble Administration.
Here's a link:
http://www.dr-bob.org/babble/admin/20100714/msgs/960570.html
That'll be considered a new thread, so if you'd like to be notified by email of follow-ups to it, you'll need to request that there. Thanks,
Bob
Posted by Dr. Bob on August 29, 2010, at 23:43:34
In reply to Re: please be civil » Dr. Bob, posted by linkadge on August 29, 2010, at 16:02:42
Posted by SLS on August 30, 2010, at 5:17:32
In reply to Re: please be civil » Dr. Bob, posted by linkadge on August 29, 2010, at 16:02:42
> >> ADs don't work.
>
> >Please don't exaggerate.
>
> Ok sorry, let me clarify. Statistically, ADs don't work (any better than placebo)There was no separation at all? Zero?
> (in some of the largest and most comprehensive meta-analysis done to date).
Which analyses?
Thanks.
- Scott
Posted by Lou Pilder on August 30, 2010, at 7:02:27
In reply to Re: please be civil, posted by SLS on August 30, 2010, at 5:17:32
> > >> ADs don't work.
> >
> > >Please don't exaggerate.
> >
> > Ok sorry, let me clarify. Statistically, ADs don't work (any better than placebo)
>
> There was no separation at all? Zero?
>
> > (in some of the largest and most comprehensive meta-analysis done to date).
>
> Which analyses?
>
> Thanks.
>
>
> - Scott
>
> Friends,
I am requesting that you view the following video if you are considering posting in this thread. If you could, I think that the contents of the video could help in this discussion
Lou
To see this video;
A. pull up google
B. Type in:
[youtube, antidepressants, (fox news)]
You will see a picture of 3 containers of pills. The video is 5 min long and was posted Jan 20, 2008.
Posted by ed_uk2010 on August 30, 2010, at 7:04:48
In reply to Re: please be civil » morgan miller, posted by linkadge on August 29, 2010, at 16:48:39
Hi Link,
What about some of the more 'potent' meds? For example, do you think that clomipramine (Anafranil) is no better than placebo for severe depression?
Posted by Lou Pilder on August 30, 2010, at 7:12:34
In reply to Lou's request-dudhy?, posted by Lou Pilder on August 30, 2010, at 7:02:27
> > > >> ADs don't work.
> > >
> > > >Please don't exaggerate.
> > >
> > > Ok sorry, let me clarify. Statistically, ADs don't work (any better than placebo)
> >
> > There was no separation at all? Zero?
> >
> > > (in some of the largest and most comprehensive meta-analysis done to date).
> >
> > Which analyses?
> >
> > Thanks.
> >
> >
> > - Scott
> >
> > Friends,
> I am requesting that you view the following video if you are considering posting in this thread. If you could, I think that the contents of the video could help in this discussion
> Lou
> To see this video;
> A. pull up google
> B. Type in:
> [youtube, antidepressants, (fox news)]
> You will see a picture of 3 containers of pills. The video is 5 min long and was posted Jan 20, 2008.
>
> Friends,
If you are considering being a discussant here or in parallel threads, I am requesting that uyou view the following.
I think tha there coould be educational aspects here that could have the potential to save your life.
Lou
To view this video,
A. pull up google
B.Type in:
[youtube, mark hyman, why antidepressants]
The picture of Dr Hyman is of him sitting in a dark coat The video is 8 min long and was posted March 2, 2008
Posted by emmanuel98 on August 30, 2010, at 20:45:35
In reply to Re: please be civil » linkadge, posted by ed_uk2010 on August 30, 2010, at 7:04:48
Well, I took several SSRIs and SNRIs and I know I wanted to get better to please my p-doc, but I didn't. Then I took AAPs and got better, but they made me gain weight. We tried two other AAPs and I really, really wanted them to work and they didn't make me gain weight, but they didn't work. Then I took parnate and felt better within days. I had tried Ensam and really,, really wanted that to work, for my own sake and to please my p-doc, but it didn't.
So if the placebo effect is so strong, why does it work for some drugs but not for others? By the way, before I took parnate, I had been in a major depression for nearly two years which was getting worse by the day and not spontaneously remitting.
Posted by morgan miller on August 30, 2010, at 23:40:00
In reply to Re: please be civil » Dr. Bob, posted by linkadge on August 29, 2010, at 16:02:42
Linkage, I feel like your opinion of antidepressants it largely based on your experience with them and reports you read here on PB and the internet. What about the thousands of people out there that feel a significant lasting positive effect on antidepressants? I just find it strange that you so strongly believe that antidepressants flat out don't work.
Morgan
This is the end of the thread.
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