|
 Depression,
anxiety, insomnia,
overeating, PMS, migraine, OCD, aggressive or violent
tendencies, fibromyalgia, alcoholism, and bulimia
are all associated with
relatively low
levels of serotonin. At the same time, treatments like
tryptophan, 5-HTP,
and the SSRIs, which increase
serotonin levels in the
synapse, can alleviate all these disorders.
These two facts have
caused some researchers, led by Dr. Walter Pöldinger, of the
Psychiatrische Universitätsklinik, in Basel, Switzerland, to conclude
that these disorders may each represent a different manifestation of the same
underlying disorder, which they call "serotonin deficiency
syndrome." In other words, when you feel depressed, anxious, etc, you
may not be suffering from "depression" or "anxiety" per
se, but rather from a generalized reduction in serotonin activity.
Depending on your individual physiology, you may experience this as
depression, anxiety, or other symptoms. Pöldinger suggests that this
syndrome can best be treated by restoring normal serotonin levels,
preferably using 5-HTP.
5-HTP:
The Natural Antidepressant
The scientific
realization that depression is often the psychological/emotional
manifestation of a biochemical imbalance has revolutionized the way we
view and treat this disorder. Not only does it remove much of the stigma
traditionally attached to depression -- "It's not me, it's my
serotonin!" -- it has also spurred the development of treatments,
from natural amino acids to high-tech pharmaceuticals to bright lights,
that now allow many people with serious depression to lead normal lives.
The idea that serotonin
was a crucial neurotransmitter in depression was first proposed in the
mid-1970s.15 This conclusion was based partly on the
observation that many people with depression had low levels of a
metabolite of serotonin -- 5-hydroxyindoleacetic acid (5-HIAA) -- in the
fluid that surrounds their brain and spinal cord. Low 5-HIAA suggests that
the brain is not producing -- and therefore not metabolizing -- a normal
amount of serotonin.
Researchers also
discovered that people who had attempted suicide had abnormally low levels
of 5-HIAA in their brains. This finding suggested that a serotonin
deficiency may actually predispose some people to kill themselves.16-18
If low serotonin causes
all these negative effects, does restoring this deficit bring you back to
"normal?" The overwhelming weight of the evidence suggests that
it does.
As we discussed in the
previous chapter, there are two basic ways to normalize serotonergic
functioning in the brain in someone with a serotonin deficiency:
·
Increase the
amount of serotonin nerve cells produce. This is how tryptophan and 5-HTP
work.
·
Slow down the
degradation of serotonin already produced. This is how Prozac and
virtually all other antidepressant pharmaceutical agents work. Even St.
John's wort is thought to relieve depression, at least partly, by blocking
serotonin reuptake.
Accumulating
Evidence
The evidence that 5-HTP
can reduce depression has been accumulating for three decades.*
In preliminary studies dating back to the late 1960s and early 1970s,
5-HTP given to seriously depressed people was reported to produce dramatic
and sudden improvements.19-21 In a 1975 study from Japan,22
24 adults hospitalized with severe depression took 300 mg of 5-HTP
daily for up to 2 weeks. At the conclusion of the study, seven individuals
were showing "marked" improvement, and two were showing
"mild" improvement. Moreover, those who responded did so quite
rapidly -- in 3 to 7 days -- and continued to experience antidepressive
effects for several weeks after they stopped taking the 5-HTP.
* (This clinical
literature is largely unknown among US physicians, because most of it has
been carried out in Europe or Japan, and much of it, especially the early
studies, was not published in English language journals.)
Although improvement by
about one-third of the patients may not seem all that impressive on its
face, we need to consider three important qualifications of these results:
first, the patients were all severely depressed, thus stacking the deck
against any potential treatment. Second, even the best
antidepressants generally have only about a 60 to 80% response rate.
Third, this was a test of a single dose for a fixed -- and relatively
short -- period of time. It is possible that some people may require
higher doses and treatment for longer periods of time. It is typical for
people taking SSRIs and other antidepressant drugs to require at least 2
to 3 weeks before feeling their full effect. The fact that nine patients
taking 5-HTP showed noticeable improvement within only 3 to 7 days is
actually quite remarkable.
Various other small
studies compared 5-HTP with placebo or other active substances thought to
have antidepressant activity (eg, tryptophan, imipramine, l-deprenyl). In
a review of all the early clinical studies, one author concluded that
5-HTP has definite antidepressant properties that are comparable to other
available drugs (the SSRIs were not yet available) and was associated with
fewer adverse effects.23
Since many of these early
studies included relatively few subjects or lacked some important
controls, it is impossible to draw firm conclusions from them. Thus, these
results should be considered suggestive, but far from conclusive. A more
recent, well-controlled, comparative study puts 5-HTP treatment for
depression on far firmer footing, showing it to be equal to or better than
a state-of-the-art SSRI.
The
Key Comparative Study
This important study -- a
head-to-head comparison of 5-HTP and the SSRI drug Luvox7 (fluvoxamine) --
was conducted by a team of researchers headed by Dr. Walter Pöldinger of
the Psychiatrische Universitätsklinik, Bern, Switzerland, and the results
were published in 1991.10 The investigators gave 69 depressed
patients either 5-HTP or fluvoxamine; treatment lasted 6 weeks. The
researchers employed a double-blind design, so that neither the patients
nor the researchers knew which treatment a given patient was getting until
the study was over. The patients' degree of depression was assessed
objectively using standard depression rating scales (Hamilton Rating Scale
for Depression, HRSD), as well as the more subjective global impressions
of investigators and the patients themselves.
As shown in Figure 3,
both the 5-HTP- and the fluvoxamine-treated patients showed a highly
statistically significant reduction in depression scores that gradually
increased at 2, 4, and 6 weeks. By week 6, 22/34 (65%) 5-HTP-treated
patients had improved by more than 50%, compared with 21/29 (72%) of the
patients in the fluvoxamine group, but this difference was not
statistically significant.
Overall, there was
virtually no difference between the two groups in terms of antidepressive
effect, although a closer examination of the data suggested a slight
advantage for 5-HTP. The patients= and investigators= evaluations of the
degree of depression generally paralleled those of the objective tests.
There were more treatment failures in the fluvoxamine group than in the
5-HTP group (17.2% vs 5.9%), but again, this difference was not
statistically significant.
For both groups, the most
common adverse effects encountered were gastrointestinal in nature,
including nausea, heartburn, stomach discomfort, constipation, and reduced
appetite. Most of these occurred within the first few days of treatment.
Although the two
treatments differed little in terms of relative tolerance or safety, 5-HTP
again appeared to come out looking slightly better. Fourteen patients in
the 5-HTP group (39%) reported a total of 43 adverse events, compared with
18 patients (54%) in the fluvoxamine group, who reported a total of 50
adverse events (Fig. 4). For four of these fluvoxamine patients, the
adverse effects were so bad they had to drop out of the study. Only one
5-HTP patient dropped out.
While none of these
differences was statistically significant, one difference was highly
significant. The adverse effects associated with 5-HTP were significantly
milder (Fig. 5).
To sum up the two major
results of this important clinical trial:
·
5-HTP and
fluvoxamine were equally effective in relieving depression.
·
5-HTP was
superior to fluvoxamine in terms of tolerance and safety, because 5-HTP
was associated with fewer adverse side effects that were also
significantly less severe, compared with those caused by the SSRI.
Patentability
and Promotion
If 5-HTP is such a good
antidepressant, why have most physicians never heard of it, while the use
of SSRIs continues to explode? Dr. Pöldinger and his colleagues wondered
why as well. "With all due deference to scientific scepticism,"
they wrote, "the reluctance by some authors of recent textbooks on
the subject and by others to concede 5-HTP its place among acknowledged
pharmacotherapeutics routinely applied against depression does not seem
warranted, neither on empirical nor theoretical grounds."10
The reason 5-HTP has been
largely ignored by most conventional physicians can be summed up in one
word -- patentability. Like all commercial drugs, SSRIs are
patented compounds that can be marketed exclusively by the companies that
own the patent. This gives them an sole right to market the drug until the
patent expires, usually after 17 years. Exclusivity offers pharmaceutical
companies a huge financial incentive to develop patentable products, and
it justifies the enormous expenditures required to gain FDA approval for
the product. Once the patent expires, though, anyone can market the
product generically. The added competition inevitably forces
prices, and consequently profit margins, straight down.
As a naturally occurring
substance -- like water, table salt, or vitamin E -- 5-HTP cannot be
patented. Anyone can market 5-HTP, just as anyone can market vitamins or
generic drugs, provided the product meets accepted standards of quality
and purity.
With no guarantee of
exclusivity, it is rare for a pharmaceutical company to absorb the
hundreds of millions of dollars in development costs involved in years of
laboratory and clinical trials, not to mention millions more for promotion
once the product is "launched.' When faced with a natural product
such as 5-HTP, a pharmaceutical company's typical response is to study how
it works and then try to create/synthesize a brand new -- and patentable
-- molecule that does approximately the same thing. It matters little
whether the synthetic product is as good as or as safe as the natural one.
The only relevant conditions, as far as FDA is concerned, are that the new
product is significantly better than an inactive placebo and that it does
not present an unacceptable risk to the patient. This is an unfortunate
fact of life in the pharmaceutical industry, and we cannot blame
pharmaceutical companies for acting this way. Given the way patent laws
and FDA drug regulations are written, this is the only way they can
maximize profits.
One unfortunate
consequence of this system is that safe, effective, natural products such
as 5-HTP are rarely evaluated in the large, well-controlled clinical
trials required to gain acceptance by the medical/government regulatory
establishment. The fact that drugs are always evaluated this way
makes it easy to dismiss 5-HTP or other such products as having
"insufficient" support to recommend their use, compared with the
Prozacs of the world.
In light of these facts,
the only conclusion we can usually draw about whether the drugs are
actually better than the natural products is, "We don't know,"
because the relevant comparative studies are almost never done. Pöldinger's
comparison of 5-HTP and fluvoxamine was indeed a rare event in
pharmaceutical research.
With the deck stacked
against 5-HTP, it should come as no surprise that few physicians have ever
heard of it, and fewer still are willing to recommend it. Nevertheless, Pöldinger's
results demonstrate that 5-HTP may be every bit as good as the SSRIs and
probably safer and more tolerable. Although it would certainly be useful
to confirm these results in a large-scale US clinical trial, given 5-HTP's
"generic" nature, the enormous costs of such a trial make it
highly unlikely that anyone will ever run one. 
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