rapid withdrawal made placebo group artificially prone to relapse

[Guest guest]

That trial had several important limitations, according to Tsai and his coauthors. For one, they say, it may have been too short to judge the drug's true effectiveness in preventing mood swings over the long term. The first phase of the trial lasted for 26 weeks, and less than one-fifth of the participants went on to complete the 48-week follow-up phase.

What's more, the study population was limited to people whose mood had already stabilized on Abilify during the preliminary phase of the trial, and the placebo group therefore consisted of patients who were abruptly switched from Abilify to placebo. The potentially harmful effects of rapid drug withdrawal may have made the placebo group appear artificially prone to relapse -- the key finding that made Abilify appear beneficial, Tsai and his colleagues say.

http://edition.cnn.com/2011/HEALTH/05/03/abilify.use.questions/

> >> >> > Long-term use of bipolar drug questioned> >> >> >> > http://edition.cnn.com/2011/HEALTH/05/03/abilify.use.questions/> > <http://edition.cnn.com/2011/HEALTH/05/03/abilify.use.questions/>> >> > [t1larg.abilify.gi.jpg]> >> > Health.com) -- The growing use of a popular drug in the long-term> > treatment of bipolar disorder is based largely on a single, flawed> > clinical trial that may be steering doctors and patients away from> drugs> > with a more established track record, a new review published this week> > in the journal "PLoS Medicine" suggests.> >> > The drug, Abilify (aripiprazole), was initially used to treat> > schizophrenia and acute episodes of mania, the better-than-good> feeling> > that characterizes bipolar disorder. In 2005, the Food and Drug> > Administration also approved it for long-term use in bipolar patients> > whose moods have stabilized (known as "maintenance" therapy).> >> > Since then Abilify sales have more than doubled, according to market> > research cited in the review. And a 2008 survey of doctors found that> it> > had become the first-choice drug for bipolar maintenance therapy among> > 23% of psychiatrists and 16% of primary care physicians.> >> > Health.com: Subtle signs of bipolar disorder> > <http://www.health.com/health/gallery/0,,20436786,00.html>> >> > The medical research does not appear to justify the widespread use of> > Abilify for maintenance therapy, says psychiatrist C. Tsai,> > M.D., one of the lead authors of the review and a visiting researcher> at> > Harvard University. "We failed to find sufficient data to support its> > use."> >> > Tsai emphasizes that individuals taking Abilify for bipolar disorder> > should not abruptly stop the medication. "It may actually be working> for> > some people," he says. "But it's certainly worth talking to your> doctor> > about how it's working for you."> >> > After noticing that a growing number of patients seemed to be asking> for> > Abilify by name, Tsai and his colleagues performed an in-depth search> of> > double-blind, randomized controlled trials -- both published and> > unpublished -- on the use of Abilify for the long-term treatment of> > bipolar disorder. Studies of that design are considered the gold> > standard of medical research.> >> > Health.com: Bipolar celebrities: does it make them more creative?> > <http://www.health.com/health/gallery/0,,20307117,00.html>> >> > Their search turned up just one clinical trial, data from which was> used> > in two published studies. The trial was funded jointly by Otsuka> > Pharmaceutical Co., the Japanese company that developed Abilify, and> > Bristol-Myers Squibb, which markets the drug in the U.S.> >> > That trial had several important limitations, according to Tsai and> his> > coauthors. For one, they say, it may have been too short to judge the> > drug's true effectiveness in preventing mood swings over the long> term.> > The first phase of the trial lasted for 26 weeks, and less than> > one-fifth of the participants went on to complete the 48-week> follow-up> > phase.> >> > What's more, the study population was limited to people whose mood had> > already stabilized on Abilify during the preliminary phase of the> trial,> > and the placebo group therefore consisted of patients who were> abruptly> > switched from Abilify to placebo. The potentially harmful effects of> > rapid drug withdrawal may have made the placebo group appear> > artificially prone to relapse -- the key finding that made Abilify> > appear beneficial, Tsai and his colleagues say.> >> > Health.com: 10 tips for treating bipolar disorder> > <http://www.health.com/health/gallery/0,,20475967,00.html>> >> > Psychiatrists have continued to refer to the results of the trial> > despite these weaknesses, Tsai says. "ly, I think it's an> > embarrassment to the profession that [Abilify] has been accepted so> > uncritically for this indication."> >> > E. Simon, M.D., a psychiatrist at Group Health Research> > Institute, in Seattle, says that the perceived flaws noted in the> review> > are not so clear-cut. "The methods of studying long-term effectiveness> > are complex, and experts disagree regarding the best ways to study> this> > question," he says.> >> > Alternatives within the same class of drugs, known as atypical> > antipsychotics, include Seroquel (quetiapine) and Zyprexa> (olanzapine).> > Older drugs, such as lithium, also remain in popular use.> >> > Evidence for the long-term effectiveness of lithium is far stronger> than> > that for newer medications, including Abilify, Simon says. For that> > reason, lithium remains his first-line treatment for maintenance> therapy> > in bipolar disorder, despite the potentially dangerous side effects> > associated with too-high doses.> >> > Health.com: Must-read books about bipolar disorder> > <http://www.health.com/health/gallery/0,,20447472,00.html>> >> > The increased use of Abilify for maintenance therapy may be leading to> > higher treatment costs for consumers, Tsai says. Abilify runs upwards> of> > $600 for a month's supply and is not yet available in a generic form.> > "But our main concern," he adds, "is that patients are getting> diverted> > from more effective treatments."> >> > Choi, the director of public affairs for Bristol-Myers Squibb,> > said in a statement that the company has conducted five long-term> > studies of Abilify in the maintenance of bipolar disorder, some of> which> > were presented at medical conferences rather than published in> > peer-reviewed journals. (Tsai and his colleagues restricted their> > analysis to peer-reviewed randomized controlled trials.)> >> > Bristol-Myers Squibb and Otsuka are committed to making data from> those> > studies available to physicians, Choi said. "We are confident in the> > Abilify clinical development program and will continue to make> available> > information about the efficacy and safety of Abilify from our studies> in> > this and other indicated uses."> >> > Sandy Walsh, an FDA spokesperson, said the agency will review the new> > study.> >>

[Guest guest]

Withdrawal misdiagnosed as relapse not only contaminates this one study -- it

contaminates EVERY study of psychiatric drug efficacy, particularly

antidepressants.

Although withdrawal symptoms have been found to be very common, affecting 25% to

50% of everyone taken off an antidepressant, not one study of antidepressant

efficacy -- including the STAR*D study, which switched 4,000 people on and off

antidepressants -- has reported a single case of withdrawal syndrome, while

reporting a high incidence of " relapse. "

Coincidence?

>

>

>

>

>

>

>

> That trial had several important limitations, according to Tsai and his

> coauthors. For one, they say, it may have been too short to judge the

> drug's true effectiveness in preventing mood swings over the long term.

> The first phase of the trial lasted for 26 weeks, and less than

> one-fifth of the participants went on to complete the 48-week follow-up

> phase.

>

> What's more, the study population was limited to people whose mood had

> already stabilized on Abilify during the preliminary phase of the trial,

> and the placebo group therefore consisted of patients who were abruptly

> switched from Abilify to placebo. The potentially harmful effects of

> rapid drug withdrawal may have made the placebo group appear

> artificially prone to relapse -- the key finding that made Abilify

> appear beneficial, Tsai and his colleagues say.

>

>

>

> http://edition.cnn.com/2011/HEALTH/05/03/abilify.use.questions/

> <http://edition.cnn.com/2011/HEALTH/05/03/abilify.use.questions/>

>

[Guest guest]

withdrawal symptoms have also been observed during withdrawal of placebo's

equally confounding is the nocebo effect where people experience toxic side effects from inert pills .........both are very real, I'm not being flippant

> >> > > > > > > > > > > > > > That trial had several important limitations, according to Tsai and his> > coauthors. For one, they say, it may have been too short to judge the> > drug's true effectiveness in preventing mood swings over the long term.> > The first phase of the trial lasted for 26 weeks, and less than> > one-fifth of the participants went on to complete the 48-week follow-up> > phase.> > > > What's more, the study population was limited to people whose mood had> > already stabilized on Abilify during the preliminary phase of the trial,> > and the placebo group therefore consisted of patients who were abruptly> > switched from Abilify to placebo. The potentially harmful effects of> > rapid drug withdrawal may have made the placebo group appear> > artificially prone to relapse -- the key finding that made Abilify> > appear beneficial, Tsai and his colleagues say.> > > > > > > > http://edition.cnn.com/2011/HEALTH/05/03/abilify.use.questions/> > <http://edition.cnn.com/2011/HEALTH/05/03/abilify.use.questions/>> >>

[Guest guest]

That depends on what you mean by " withdrawal symptoms, " doesn't it?

I would be surprised if nocebo or placebo " withdrawal symptoms " lasted for more

than a couple of hours, much less a couple of weeks, months, or years.

> > >

> > >

> > >

> > >

> > >

> > >

> > >

> > > That trial had several important limitations, according to Tsai and

> his

> > > coauthors. For one, they say, it may have been too short to judge

> the

> > > drug's true effectiveness in preventing mood swings over the long

> term.

> > > The first phase of the trial lasted for 26 weeks, and less than

> > > one-fifth of the participants went on to complete the 48-week

> follow-up

> > > phase.

> > >

> > > What's more, the study population was limited to people whose mood

> had

> > > already stabilized on Abilify during the preliminary phase of the

> trial,

> > > and the placebo group therefore consisted of patients who were

> abruptly

> > > switched from Abilify to placebo. The potentially harmful effects of

> > > rapid drug withdrawal may have made the placebo group appear

> > > artificially prone to relapse -- the key finding that made Abilify

> > > appear beneficial, Tsai and his colleagues say.

> > >

> > >

> > >

> > > http://edition.cnn.com/2011/HEALTH/05/03/abilify.use.questions/

> > > <http://edition.cnn.com/2011/HEALTH/05/03/abilify.use.questions/>

> > >

> >

>

[Guest guest]

How on earth does my meaning of withdrawal symptoms vary from your

meaning of withdrawal symptoms.?

When people say Paxil is no more effective an antidepressant than a

placebo, which is reasonably accurate, they seem to ignore the fact that

placebo's can be effective antidepressants.

So don't disregard the power of the placebo in suggestive people and

don't disregard the effect of removing the suggestive substance because

the very same people could suffer withdrawal or relapse of their

condition.

as I said in my post I wasn't being flippant

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > >

> > > > That trial had several important limitations, according to Tsai

and

> > his

> > > > coauthors. For one, they say, it may have been too short to

judge

> > the

> > > > drug's true effectiveness in preventing mood swings over the

long

> > term.

> > > > The first phase of the trial lasted for 26 weeks, and less than

> > > > one-fifth of the participants went on to complete the 48-week

> > follow-up

> > > > phase.

> > > >

> > > > What's more, the study population was limited to people whose

mood

> > had

> > > > already stabilized on Abilify during the preliminary phase of

the

> > trial,

> > > > and the placebo group therefore consisted of patients who were

> > abruptly

> > > > switched from Abilify to placebo. The potentially harmful

effects of

> > > > rapid drug withdrawal may have made the placebo group appear

> > > > artificially prone to relapse -- the key finding that made

Abilify

> > > > appear beneficial, Tsai and his colleagues say.

> > > >

> > > >

> > > >

> > > > http://edition.cnn.com/2011/HEALTH/05/03/abilify.use.questions/

> > > >

<http://edition.cnn.com/2011/HEALTH/05/03/abilify.use.questions/>

> > > >

> > >

> >

>