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Listening to Prozac – Hearing Placebo

I just finished reading The Emperor’s New Drugs: Exploding the Antidepressant Myth by psychologist Dr. Irving Kirsch.

Like his colleagues, Kirsch spent years referring patients to psychiatrists to have their depression treated with drugs.  Because of mixed feedback from his patients on the efficacy of SSRIs (Selective Serotonin Reuptake Inhibitors), eventually however he decided to investigate for himself just how effective the drugs really were.

With fifteen years of investigation on the effectiveness of SSRIs, Kirsch established with solid research and methodology that what everyone “knew” about anti-depressants is wrong – despite what the medical community considered the cornerstone of psychiatric treatment.

According to drug companies more than 80 percent of depressed patients can be treated successfully by anti-depressants (SSRIs).  Obviously, many people believe the drug companies message as SSRIs are one of the most widely prescribed prescription drugs in the world with global sales that make it a $19 – billion dollar a year industry.  The underlying assumption is that depression is a “disease of the brain” that can be cured by medication.

Clinical depression is a serious debilitating condition where people with severe depression can feel unbearably sad and anxious – sometimes to the point of considering suicide.  They may also be racked with feelings of guilt and worthlessness.  Many suffer from insomnia; others sleep too much and find it difficult to get out of bed in the morning.  Some have difficulty concentrating and many lose all interest in activities that brought them pleasure in the past.  Worst of all, they feel hopeless of ever recovering from this terrible state.  I am certain that all of us at some time or other have experienced depression to varying degrees.

Up until several years ago, drug companies submitted to the FDA (Food and Drug Administration) only the research on drug effectiveness that they chose for approval.  Not anymore.  All studies – whether they exhibited a positive outcome for the drug in question or the so-called “file drawer studies” (research that did not support the positive outcome of the drug) and was tucked away in a file drawer hoping no one would look at the negative outcome).

Using the Freedom of Information Act, Kirsch obtained all the studies – positive and “file drawer” by all the pharmaceutical companies in the United States.  He was astonished to discover that 40% of all the clinical trials conducted were withheld from publication because they failed to show a significant benefit from taking the actual drug.  Incidentally, it takes only two successful clinical trials for FDA approval of a drug before the research can be submitted to the various medical journals for publication.

Having access to all the studies, Kirsch employed meta-analysis – a sophisticated statistical procedure that lumps together a large number of studies that are heterogeneous in subject selection, treatments employed and statistical methods used.  He was then able to rank order the effectiveness of SSRIs from one – no effectiveness, to sixty – 100% effective.   I hope you are sitting down.  The effectiveness rating came out at three!  Which means  relatively no effectiveness, or just barely more effective than placebos.  In other words, yes – SSRIs do work but not significantly more so than placebos.  To quote Kirsch –“In fact, most of the clinical trials submitted by the drug companies failed to show any significant benefit of their drugs at all.”

More important theaverage difference in improvement between improvement in the drug groups and improvement in the placebo groups was only 1.8 points on the Hamilton Scale for Depression.  The Hamilton is a 51- point scale, so a difference of less than two points is very small indeed.  For example, one can get a six-point reduction in Hamilton scores merely by sleeping better, even if there is no change in the person’s depressive symptoms.

Over the next three to five years, Kirsch replicated his original work conducting two more major studies utilizing meta-analysis comparing the SSRI’s to placebos.   The results were almost identical to his first study – practically no difference between SSRI’s and placebos in treating depression.  He then hired two consultants considered to be the leading experts on meta-analysis to review his statistics.  Kirsch’s findings held up.

SSRIs do work much better with severely depressed persons, than with mild to moderate depression.  In reviewing the data, Kirsch established that all but one of the studies had been conducted with persons who scored in the severely depressed range.  Again, the drug effect was small even for the severely depressed.

Following the publication of Kirsch’s research, many of his colleagues who had similar reservations about SSRIs came forth with some of their findings which they labeled as “dirty little secrets”

Pharmaceutical companies have used a number of devices to make their products look better than they actually are.  They have:

  • Withheld negative studies from publication
  • Published positive studies multiple times
  • Published data that was different from what they submitted to the FDA
  • Published only some of the results from multi-site studies

Researchers refer to the above as “cherry picking” and in fairness to the drug companies this type of selective reporting goes on in other areas of medical and psychological research.   Perhaps it should be referred to as “salami slicing” or for want of a better word – baloney J

An important consideration for all research involving altering the brain’s chemistry is that no two people in the world have the same biochemical profile or brain chemistry, no two people have the same or identical “brain wiring”, no two people have the same bank of experiences, and no two people have the same hierarchy of beliefs (which influence the placebo response).

I do not want to bore you with more research but in a nutshell, depression can equally be affected by drugs that increase seretonin, by drugs that decrease seretonin and drugs that do not affect if at all.  Perhaps then, perhaps we should be looking at depression as something other than the “chemical imbalance theory”.

What are some of the other choices for treating depression?  Cognitive Behavior Therapy (CBT) has two components – a behavioral and a cognitive component.  By teaching clients how to monitor their self-talk,  ie. drugging their minds with good or bad hypnosis (cognitive) and behaviorally planning activities that provide a sense of pleasure, a sense of mastery and accomplishment!  Research has shown that formerly depressed patients are more likely to relapse after treatment with anti-depressants than they are after psychotherapy.  Some studies have shown that both SSRI’S and psychotherapy combined produce the most ideal outcome.

St. John’s Wort, a yellow flowering plant, is an herbal remedy widely used in Germany for depression.  A study form the University of Munich reviewed 29 clinical trial of St. John’s Wort – involving more than 5,000 depressed patients and concluded that it was more effective than placebos and just as effective as standard anti-depressants in treating depression.

Inositol is an amino acid and in a double blind randomized study, outperformed Prozac in dealing with depression.  It can be obtained at any good health food store.  Incidentally, I take one teaspoon of Inositol every morning with water or juice and I notice a significant improvement in my mental energy and clarity.

In my practice, I have utilized EFT with many of my clients experiencing mild to medium depression – with generally good results.  One of the reasons EFT works is that by tapping or rubbing certain acupoints, it triggers the brain to release beta endorphins – which are the endogenous morphine molecules produced by the brain that are 27 times more powerful than synthetic morphine.  What else releases beta endorphins?  Exercise (which many doctors recommend to depressed patients), laughter, good music  ie. classical music, sex (also known as mother nature’s tranquilizer J) and smoking cigarettes.

The intention of this blog has not been to put down SSRIs – because they do work – but to provide research data so that we can be more discerning in our choice of treatment modalities.

If you are on an SSRI – and it is working- with no side effects – then continue with your treatment regimen.

Perhaps of related interest and good news, Psychologist Ernest Rossi in his book The Psychobiology of Gene Expression reported that three different classes of antidepressant drugs as well as electroconvulsive (ECT) Therapy all lead to the generation of significantly more dividing cells in the hippocampus (the major memory relay station of the brain).  This suggests that increased neurogenesis, or ‘increasing the proliferation and growth of brain cells is at least one mechanism for reversing psychological depression by antidepressant medication as well as ECT.  There is no data for prolonged use of SSRI’s and neurogenesis.

One final thought – while SSRI’s have helped millions of people overcome their depression, I wonder, if in some cases, tranquilizers sometimes cut us off from intuitive breakthroughs by preventing us from coming to grips with the true “darkness of the soul” that can precede such experiences as depressive episodes – by allowing us to accept temporary, objective and artificial solutions.

In my next blog – I will discuss the other side of the coin – placebos.

“Brahms is the best anti-depressant”

Peter Sproston, 2008

* Sweden – also reported a 40% rate of “file drawer” failures

Reference

Kirsch, Irving. (2010). The Emperor’s New Drugs. Exploding the Antidepressant Myth.  Basic Books, New York.

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