Does Therapy Work?

Currently we are being bombarded by "Big Pharm" companies who are spending millions of dollars to convince us to take powerful drugs to solve our problems of depression, anxiety, insomnia, sexual dysfunction, Etc. Etc.  While music softly plays in the background, a wide range of side effects, some of which are life threatening, are rapidly recited to meet government regulations.  Nobody spends millions of dollars to give us the scientific facts that we need to make informed decisions about our treatment.  Medication is an effective adjunct to therapy in some cases, but it appears that for economic reasons, the cart is often placed before the horse.  Please consider the following information.

Cognitive therapy as good as antidepressants, effects last longer

05 Apr 2005   

Cognitive therapy to treat moderate to severe depression works just as well as antidepressants, according to an authoritative report appearing today in the Archives of General Psychiatry. The study, conducted by researchers at the University of Pennsylvania and Vanderbilt University, challenges the American Psychiatric Association's guidelines that antidepressant medications are the only effective treatment for moderately to severely depressed patients.

Either form of treatment worked significantly better than a placebo, but the researchers demonstrated that cognitive therapy was more effective than medication at preventing relapses after the end of treatment.

"We believe that cognitive therapy might have more lasting effects because it equips patients with the tools they need to learn how to manage their problems and emotions," said Robert DeRubeis, professor and chair of Penn's Department of Psychology. "Pharmaceuticals, while effective, offer no long term cure for the symptoms of depression. For many people, cognitive therapy might prove to be the preferred form of treatment."

The study, which follows years of debate on the relative merits of cognitive therapy versus medication for more severe forms of depression, is the largest trial yet undertaken on the topic; it involved 240 depressed patients. The patients were randomly placed into groups that received cognitive therapy, antidepressant medication or a placebo. Patients in the antidepressant group, which was twice as large as the other two, were treated with paroxetine (Paxil). Lithium or desipramine was also given, as necessary.

After 16 weeks of treatment, patients in both the medication and cognitive therapy groups showed improvement at about the same rate; however, cognitive therapy patients were less likely to relapse in the two years following the end of treatment. According to the researchers, the return of symptoms might demonstrate that the medication may have blunted the appearance of depression but did not affect underlying disease processes.

"Medication is often an appropriate treatment, but drugs have drawbacks, such as side effects or a diminished efficacy over time," DeRubeis said. "Patients with depression are often overwhelmed by other factors in their life that pills simply cannot solve. In many cases, cognitive therapy succeeds because it teaches the skills that help people cope."

The researchers also noted slight differences in the response to treatment between the two testing locations, with cognitive therapy performing better at Penn and medications performing better at Vanderbilt. Researchers surmise that the medication worked so well at the Vanderbilt clinic because more of the patients there were markedly anxious, in addition to being depressed, and the medications used in the research have anti-anxiety properties.

The researchers further believe that cognitive therapy patients might have done better at Penn due to the experience level of the therapists involved. Just as the experience of therapists may be important in cognitive therapy, so, too, can the expertise of prescribing physicians play a role in the success of antidepressant medication treatment. Studies have shown that antidepressant medication dosages are still largely a matter of physicians' discretion.

"Clearly, cognitive therapy is not for everyone, and its success could depend on variables such as the expertise of the therapist and the patient's willingness or ability to take the therapy to heart," DeRubeis said. "The key to establishing any form of treatment is rating its effectiveness in comparison to treatments currently in use, and this study has shown cognitive therapy to be a viable alternative."

Clinical researchers at the Penn School of Medicine's Department of Psychiatry involved in the study were Jay D. Amsterdam, Paula R. Young, John P. O'Reardon and Madeline M. Gladis. Vanderbilt researchers include Steven D. Hollon of the Department of Psychology and Richard C. Shelton, Ronald M. Salomon, Margaret L. Lovett, and Laurel L. Brown of the Department of Psychiatry. Contributing author Robert Gallop is with West Chester University's Department of Mathematics and Applied Statistics.

The work was supported by a grant from the National Institutes of Health. GlaxoSmithKline provided medication and placebos.

Contact: Greg Lester
glester@pobox.upenn.edu
215 573-6604
University of Pennsylvania
http://www.upenn.edu

Study: Therapy as Good as Drugs to Cure Depression

 by Maggie Fox

Reuters

WASHINGTON (May 23, 2002) - Therapy is at least as effective in treating depression as drugs are, and its effects last longer, scientists said on Thursday in a report sure to annoy drug companies that make millions selling antidepressants.

 The cost of therapy is about the same as drugs short-term, and cheaper over the long term, the researchers told a meeting of the American Psychiatric Association. 

Cognitive therapy is a type of talking-out treatment in which patients are helped to question their negative views of themselves.

''By the 16-week post-treatment assessment, response rates were identical (57 percent) for both pharmacotherapy and cognitive therapy,'' the researchers said in their report.

''Thus, these findings suggest that cognitive therapy may work more slowly in effecting change than does pharmacotherapy, but that by the end of a four-month course of treatment, patients who receive cognitive therapy fare as well as those who receive pharmacotherapy.''  

The study is a sharp contrast to dozens of others being presented at the meeting that show the efficacy of one antidepressant over another.

The market for antidepressants is huge -- and profitable. Eli Lilly and Co. earned nearly $2 billion in 2001 from Prozac and Sarafem, two brand names of a drug known generically as fluoxetine used to treat depression and severe premenstrual syndromes.  


   New Hope for Battling Depression  

Study Illuminates Why Benefits of Therapy Are More Lasting Than Medication By SHARON BEGLEY Staff Reporter of THE WALL STREET JOURNAL (January 6, 2004 Wall Street Journal)

For the 18 million American adults who suffer from depression in any given year, the highly effective antidepressant medications come with a dark side: Unless patients continue taking the drugs, they have a considerable risk of suffering a relapse in the year after they stop.

On the other hand, a growing body of research shows that patients completing a course of psychotherapy -- without medication -- relapse far less frequently.

As scientists struggle to explain the gap between the lasting effects of pills and psychotherapy, a new study offers an intriguing clue. Neuroscientists in Canada have found that a form of psychotherapy called cognitive-behavior therapy causes changes in brain activity that are the polar opposite of the changes caused by antidepressants.

The study is the first to show that a depressed brain responds differently to the two kinds of treatment. If the results hold up, they could point the way to combining antidepressants and psychotherapy more effectively to give patients a better chance of loosening the grip of depression for good.

The study found that antidepressants reduce activity in the brain's emotion centers, called the limbic system. Cognitive-behavior therapy quiets overactivity in a different region of the brain -- the cortex, which is the seat of higher thought. The study was published in the January issue of Archives of General Psychiatry.

Cognitive-behavior therapy seems to work by a top-down route, teaching patients not to ruminate endlessly about minor setbacks. Such therapy "gives patients an 'override' capacity," said psychiatrist Richard Shelton of Vanderbilt University, in Nashville, Tenn., who was not involved in the current study, so that when sad feelings bubble up from the brain's emotion centers patients can resist being sucked back into the pit of depression.

Despite the more lasting benefits of therapy, the use of antidepressants is rising steadily. Researchers at Columbia University reported in 2002 that the percentage of depression patients who were treated with antidepressant medication rose to 74.5% from 37.3% from 1987 to 1997. The percentage treated with psychotherapy fell to 60.2% from 71.1% during that time. (Some patients are treated with both.)

The growing preference for pills reflects the push by insurers to have patients treated by primary-care physicians rather than specialists. Primary-care doctors can write prescriptions but are seldom trained in psychotherapy.

The cost of psychotherapy varies by region of the country, but the national average for cognitive-behavior therapy is $100 per session for the standard course of 15-20 sessions, or about $1,500 to $2,000 for the full course of treatment. (In some cities, the price could be as much as twice that.) Branded antidepressants generally cost about $1,000 per year plus the bill for the doctor's appointments needed to continue the prescription.

Unrealistic Pessimism
In the new study, researchers led by neuroscientist Helen Mayberg of the Rotman Research Institute and the University of Toronto had 14 clinically depressed adults undergo 15 to 20 sessions of cognitive-behavior therapy. In this type of therapy, which was developed in the 1960s, patients are taught to identify aberrant beliefs -- "no one will ever love me," "nothing will ever go right for me" -- and their tendency to magnify disappointments into calamities and tragedy. Patients learn to test the accuracy of those beliefs -- by, for example, starting a friendship or applying for a job -- and see that they are often unrealistically pessimistic.

Thirteen other patients were treated with paroxetine (sold as Paxil by GlaxoSmithKline PLC). Both groups had depression of about the same severity, as measured by a standard assessment, and both experienced comparable improvement after their respective treatments. That mirrored the results of the many studies finding that cognitive-behavior therapy and antidepressants are about equally effective in treating mild, moderate and even severe depression.

Using PET (positron emission tomography) imaging, the Toronto scientists scanned the patients' brains before and after the full course of psychotherapy. "Our hypothesis was, if you do well with treatment for depression, your brain will have changed in the same way no matter which treatment you got," says Toronto's Zindel Segal, a co-author of the study. "To our surprise, the treatments operate on different regions of the brain."

"The findings make sense," says Steven Hollon, a psychology professor at Vanderbilt, who wasn't involved in the study. "Antidepressants damp down activity in the lower limbic regions, where stress and negative emotions come from. Cognitive-behavior therapy teaches the brain to respond to those signals in a healthier way, and that has a more enduring effect."

80% vs. 25%
That might explain the chief difference between antidepressants and cognitive- behavior therapy, namely, that pills exert their effect only as long as a patient takes them. A large 2001 study found that the risk of relapse in patients taking antidepressants only, in the year after they stop, is 80%. In contrast, patients receiving only cognitive behavior therapy in that study had a relapse rate of 25% in the year after ending treatment. Relapse and recurrence are measured by whether patients seek treatment again and (because only about half of patients with depression do) by standard psychological assessment of patients previously treated.
The study was funded by the Rotman Research Institute, the University of Toronto and the Canadian Institute for Health Research, a government agency. One weakness of the study is that patients were not randomly assigned to receive cognitive-behavior therapy; they expressed a preference for it over medication. That raises the possibility that the self-selected patients were better candidates for cognitive-behavior therapy than the average person with depression.

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Antidepressants
Reduce activity in the brain's emotion centers Relapse rate of 80% in the year after stopping the drugs, according to one study

Cognitive-Behavior Therapy
Quiets activity in the brain area responsible for conceptual thought, planning, analysis and logic Relapse rate of 25% in year after ending treatment, according to study

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Updated January 6, 2004
Copyright 2004 Dow Jones & Company


Should Children Take Medication?

New report slams antidepressants for children
Sharon Kirkey

CanWest News Service

Saturday, April 10, 2004

OTTAWA -- The benefits of antidepressants prescribed to thousands of Canadian toddlers, children and teens have been exaggerated and the risks downplayed, according to a disturbing new report that's raising concerns about the drugs' potential for harm.

And the researchers who wrote it conclude there is no evidence to justify prescribing these drugs to children.

The Australian team reviewed six published studies of Prozac, Paxil and Zoloft _ drugs known as SSRIs, or selective serotonin reuptake inhibitors _ as well as Effexor.

According to the study, published in today's edition of the British Medical Journal:

- Children who took a placebo showed strong improvement and those who took the real drugs didn't do significantly better. Two small studies found no advantage for the antidepressants over the placebo.

- In one study, 11 of 93 adolescents taking Paxil had a serious adverse event, compared to two of 87 children taking a placebo. The Australian team says that, despite this striking difference, the study's authors concluded Paxil was ''generally well tolerated'' and that most side effects were not serious, even though seven of the youth on Paxil had to be admitted to hospital during treatment. Five were admitted with side effects that have been linked with SSRIs, including suicidal thinking. But ''only one serious event (headache) was judged by the treating investigator to be related to paroxeteine (Paxil) treatment.''

- Drug companies paid for the trials and ''otherwise remunerated'' the authors of at least three of the four bigger studies. Two of the authors of one study testing Paxil in teens were employees of GlaxoSmithKline, which makes the drug. In another study of the Pfizer drug Zoloft, Pfizer paid all the authors, and the study supervisor held stock options in Pfizer. Funding for another study of Prozac was originally attributed to the U.S. National Institute of Mental Health, but U.S. Food and Drug Administration records show Eli Lilly, manufacturer of Prozac, paid for the study.

- The authors of the four larger studies ''exaggerated the benefits, downplayed the harms, or both,'' raising serious concerns over whether the medical journals that published their work bothered to properly scrutinize their data.

- Overall, the numbers of children studied were small, the followup period short and the dropout rates high. The Australian team fears biased reporting and ''overconfident recommendations'' are misleading doctors, patients and their families and that many are overlooking non-drug treatments that are ''probably both safer and more effective.''

The study, led by researchers at the Women and Children's Hospital in North Adelaide, comes on the heels of a U.S. report showing that the number of children and adolescents taking Paxil and other antidepressants increased 49% between 1998 and 2002, with the biggest jump in preschoolers.

None of the drugs has been approved in Canada for anyone under 18, but doctors are prescribing them ''off-label'' -- which they are allowed to do -- to children as young as three for depression, anxiety, social phobia, attention problems and obsessive-compulsive disorder.

In a statement, Pfizer said that it plans to send a detailed response to the British Medical Journal, regarding ''inaccuracies and omissions'' in the report.

Health Canada issued a public advisory in January about the increased risk of suicide in children taking SSRIs. In February, an expert advisory panel asked Health Canada to require drug makers to add new warnings in materials provided to doctors.


Sleep study touts therapy over pills   (from Boston Globe)

A handful of therapy sessions does more to help chronic insomniacs get to sleep than the top-selling sleeping pill, according to a new Harvard Medical School study, suggesting that doctors are relying too heavily on medications to treat Americans' increasingly restless nights.

A quarter of adults take sleeping pills at some point during the year, according to a National Sleep Foundation survey, reflecting the difficulty that more than half of Americans have sleeping at least a few nights a week. But the Harvard study found that among people who chronically struggle with insomnia, advice from a therapist is more likely to produce a normal night's rest than Ambien, the top-selling sleep aid, with sales of $1.5 billion for 2003.

"The first line of treatment should be cognitive behavior therapy, not drugs, and in 75 percent of patients, that is going to be more effective," said Gregg Jacobs of the Sleep Disorders Center at Beth Israel Deaconess Medical Center, lead author of the study.

Jacobs said sleeping pills should be prescribed mainly for people whose insomnia is caused by an event or illness, such as jet lag from a long trip or the side effects of chemotherapy. Other insomniacs, he said, are staying awake in part because of bad sleep habits that a behavior therapist can best help to change.

Therapists' advice typically includes such basics as going to bed only when drowsy and getting up at the same time every day, even after a poor night's sleep. The objective is to get insomniacs to unlearn bad habits such as paying bills in bed, worrying instead of sleeping, and keeping themselves awake at night with coffee and strenuous exercise.

Dr. Carl Hunt, director of the National Center on Sleep Disorders Research, said the new study, one of the first to directly compare the benefits of talk therapy and medication, expands on recent research suggesting that therapy should play a larger role in the battle for a better night's sleep. The most popular prescription medications, Ambien and Sonata, have federal approval only for short-term use, he said, making therapy the preferred treatment for long-term insomnia.

But a sleep specialist for one of the drugmakers said the Harvard study has limited application for doctors who treat sleeplessness, noting that patients in the research had all suffered insomnia for at least six months.

"The vast majority of people have insomnia that is far more short-lived than that," said Dr. Steven James, neuropsychiatry consultant to King Pharmaceuticals , which markets Sonata, the second-leading prescription sleep medication. "About 10 percent of people with acute insomnia will progress to a chronic condition."

National Sleep Foundation surveys indicate that Americans are sleeping less -- and more fitfully -- today than 20 years ago, which sleep specialists say is probably driven by the rise of late-night distractions such as cable television and the Internet, as well as long and irregular workweeks. Nearly a third of adults say they have no set sleeping schedule, for instance, which sleep specialists say makes sleeplessness more likely.

Despite the medical understanding that lifestyle factors contribute heavily to insomnia, Jacobs said doctors still overwhelmingly prescribe medication to treat sleeplessness. And although Sanofi-Aventis, maker of Ambien, emphasizes that the drug should be taken for no more than a month, doctors commonly prescribe it for long-term use, he said.

"It is very disconcerting to see the number of patients who come in for treatment to my office who are not only taking sleeping pills long-term -- meaning years -- but they are on multiple sleeping pills," said Jacobs, author of "Say Goodnight to Insomnia," a book critical of the effectiveness of sleeping pills.

In the new study, published in today's edition of the Archives of Internal Medicine, Jacobs and his colleagues divided 63 chronic insomniacs into four groups receiving either Ambien, five therapy sessions, a combination of the two, or a placebo. The patients kept a sleep diary for eight weeks, recording such factors as how long it took to fall asleep and how long they were awake during the night. Researchers acknowledge that such diaries are subjective, but as long as the patient is consistent, they are useful for comparison purposes.

The researchers found that therapy was most effective for shortening the time it took patients to fall asleep, from 67.9 minutes a night on average to a near-normal 34.1 minutes after eight weeks. The Ambien patients, by contrast, reduced sleep onset time only from 71.5 minutes to 58.7 minutes. Likewise, after therapy patients awoke much less frequently in the night, sleeping 83.5 percent of the time they were in bed compared with 67.2 percent for those taking Ambien.

Sanofi-Aventis issued a statement saying patients should try lifestyle changes before obtaining a prescription.

"We recommend that patients talk to their physician about their sleeping habits and keep a sleep diary to determine if lifestyle or behavioral changes might work for them," the statement said.

Stacia Sailer, codirector of the sleep disorders clinic at UMass Memorial Medical Center in Worcester, said the Harvard research confirms what she and others already champion. She said therapists recommend simple changes such as getting out of bed rather than tossing and turning, or treating the bed as a place only for sleep and sex.

Scott Allen can be reached via e-mail at allen@globe.com 

© Copyright 2004 The New York Times Company
 

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