Prozac-Type Drugs Proven No Better than Placebo

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Prozac-Type Drugs Proven No Better than Placebo

 

Analysis that included recently uncovered secret trials finds that SSRIs

only match or barely beat the placebo effect

 

by Craig Weatherby

-------------

After the solid one-two punch their products took in recent weeks, the

makers of anti-depressant drugs probably feel like they need a Prozac.

 

Prozac, Zoloft, Paxil, and other members of the newest generation of

anti-depressants are called selective serotonin re-uptake inhibitors or

SSRIs.

SSRI-type drugs work by reducing the amount of serotonin - a

neurotransmitter associated with mood maintenance - that is reabsorbed

by neurons (brain cells) after being used to transmit signals across the

electro-chemical bridges between them (synapses).

 

Thus, SSRIs indirectly increase the amount of serotonin available to

brain cells.

 

Key Points

- British team uncovers hidden studies; Inclusion in new analysis proves

Prozac-type drugs work no better than placebo pills.

- Findings follow recent discovery that drug makers published positive

trials at a far higher rate than negative trials.

- Nutritional factors deserve more research, based on positive

preliminary findings.

 

Prozac and its pharmaceutical competitors take a fatal credibility blow

 

Just last month, we reported on the startling discovery by former FDA

psychiatrist Erick H. Turner, M.D. that 94 percent of anti-depressant

trials with positive outcomes (i.e., effects superior to placebo pills)

had been published, versus disclosure of only 14 percent of trials with

negative or unclear results.

 

And according to the FDA's own study reviewers, the results of many of

the " positive " studies were not as good as their authors claimed.

 

(For more on this, see " Major Heart and Mood Drugs Take Huge Credibility

Hits [

http://newsletter.vitalchoice.com/e_article000995910.cfm?x=bbVV2P3,b7b1jv7h,w

" .)

 

Now the other shoe has dropped hard ... right on the heads of drug

makers, with distressing implications for people suffering from

depression.

 

Hard on the heels of Dr. Turner's discovery, researchers in Britain used

Freedom of Information requests to pry loose even more previously

unpublished studies with primarily negative outcomes.

 

They pooled all of the previously unpublished (and largely negative)

trials of SSRI-class drugs with the previously published (largely

positive) trials.

 

The results were very different from those obtained by prior

" meta-analyses " , which tended to support the efficacy of SSRIs like

Prozac.

 

UK analysis proves devastating to Prozac and similar drugs

 

After including the clinical trials hidden by drug makers, British

researchers at the University of Hull found that for most depression

patients, Prozac-type anti-depressants produce no significant benefits,

when compared with the effects of placebo pills.

 

The only exception to this rule is that minor, marginal benefits were

detected among a small group of the most severely depressed patients.

 

And their analysis indicates that the slight benefits seen in some

severely depressed patients stem from their relatively weak responses to

the placebo effect, rather than any greater efficacy of SSRIs among this

group.

 

Doctors urge cautious response

 

Psychiatrists say that patients taking SSRIs who become aware of this

research should not stop taking their medication before consulting their

doctor. If he or she agrees the pills are a waste, they will likely

recommend a gradual, closely monitored withdrawal.

 

Some psychologists points out that if SSRIs provide a substantial

placebo effect, this should not be discounted. But this advice presumes

that a patient's drugs are cheap or cost free and produce no adverse

side effects.

 

We take no pleasure in the failure of SSRIs drugs to exceed the benefits

of placebo pills.

 

But we deplore the secretive sales strategies practiced by the makers of

some SSRIs.

 

For example, in related news, New Scientist reported last month that US

lawyers claim they've obtained documents suggesting that a skewed

analysis of clinical trial data by GlaxoSmithKline researchers concealed

suicide risks associated with Paxil (paroxetine) - for some 15 years.

 

These deceptions have led to false hopes, adverse effects - including

weight gain, low libido, and mortal risks - and the waste of billions of

dollars for prescriptions of dubious value.

 

Natural mood support

 

Needless to say, no one who feels depressed or shows signs of depression

should self-diagnose or self-medicate without the guidance of a medical

professional. (The signs include chronic anxiety, anger, and negative

thoughts, and/or lack of energy and interest in people and normal

pursuits.)

 

That said, it appears that it may be possible to enhance the brain's

serotonin system, via two dietary approaches:

 

- 5-HTP is the chemical our bodies use to construct serotonin (5-HT).

And supplemental 5-HTP has shown some promise in animal studies and

small, preliminary clinical trials, with fewer adverse effects than

SSRIs (Shaw K et al. 2002). Much more clinical study is needed, however,

to confirm the effects and define which classes of depressed persons may

benefit most from 5-HTP.

 

- Omega-3s are essential to the proper function of brain-cell membranes,

and appear to support the serotonin system (Hibbeln JR et al. 1998).

Among other effects, this could help explain the observed associations

between higher omega-3 intakes and reduced risk of depression, as

affirmed by the American Psychiatric Association's Committee on Research

on Psychiatric Treatments (Freeman MP et al. 2006).

 

We'll keep you posted on developments ... such as the logical but

decidedly unlikely withdrawal of FDA approval for use of SSRIs in

depression.

 

In truth, patients want " magic bullets " , doctors want pills to

prescribe, and US law affords no easy path to approval of non-patentable

nutritional factors as medicines, no matter how much evidence of benefit

may exist.

 

Sources

- Freeman MP, Hibbeln JR, Wisner KL, Davis JM, Mischoulon D, Peet M,

Keck PE Jr, Marangell LB, Richardson AJ, Lake J, Stoll AL. Omega-3 fatty

acids: evidence basis for treatment and future research in psychiatry. J

Clin Psychiatry. 2006 Dec;67(12):1954-67. Review.

- Hibbeln JR, Linnoila M, Umhau JC, Rawlings R, George DT, Salem N Jr.

Essential fatty acids predict metabolites of serotonin and dopamine in

cerebrospinal fluid among healthy control subjects, and early- and

late-onset alcoholics. Biol Psychiatry 1998; 44: 235-242.

- Hibbeln JR. Seafood consumption and homicide mortality. A

cross-national ecological analysis. World Rev Nutr Diet.

2001;88:41-6.Links

- Shaw K, Turner J, Del Mar C.Are tryptophan and 5-hydroxytryptophan

effective treatments for depression? A meta-analysis.Aust N Z J

Psychiatry. 2002 Aug;36(4):488-91.

- Shaw K, Turner J, Del Mar C.Tryptophan and 5-hydroxytryptophan for

depression.Cochrane Database Syst Rev. 2002;(1):CD003198. Review.

- Turner EH, Loftis JM, Blackwell AD. Serotonin a la carte:

supplementation with the serotonin precursor

5-hydroxytryptophan.Pharmacol Ther. 2006 Mar;109(3):325-38. Epub 2005

Jul 14. Review.

- Owen C, Rees AM, Parker G. The role of fatty acids in the development

and treatment of mood disorders. Curr Opin Psychiatry. 2008

Jan;21(1):19-24.

- Virkkunen ME, Horroboin DF, Jenkins DK, Manku MS: Plasma phospholipid

essential fatty acids and prostaglandins in alcoholic, habitually

violent and impulsive offenders. Biol Psychiatry 1987; 22: 1087-1096.