: Murray: balanced reflections re Truehope Synergy vitamins for bipolar 7.26.1 rmforall

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: Murray: balanced reflections re Truehope Synergy vitamins for

bipolar 7.26.1 rmforall

Subject: Re: Rich Murray: Ross: Woeckner:

facts re Truehope Synergy hype re pig vitamins for bipolar 7.25.1

rmforall

Date: Thu, 26 Jul 2001 14:41:20 -0700

From: aelewis@...

To: Rich Murray

Rich Murray wrote:

> I want to apologize for my gullibility and carelessness in promoting

> cheap and potentially dangerous PR hype about treating serious mental

> illnesses with simple vitamins.

Now, now, don't be too quick to fall on your sword here, Rich.

Yes, it would seem that Truehope is winging-it, and making claims

(or rather issuing some claimy-sounding verbiage) before they can

properly be made, but let's keep things in perspective. More than

anything else they seem to be suggesting that people with bipolar

disorder (and etc.) should be taking a good, complete

multi-vitamin/mineral -- an obviously sensible idea, and one that

could possibly yield some benefits for some users. An

adequately-formulated multiple would yield goodly amounts of

magnesium and chromium -- elements with some apparent value in

depression or manic-depression (see abstracts below).

> I firmly commit myself to respectfully studying

> points of view that are opposed to mine, for no mortal can

> claim any monopoly on truth. I can hardly demand that others

> listen to me, if I do not listen, really listen, to them!

Now THAT is a great idea!

" The only way in which a human being can make some approach to

knowing the whole of a subject is by hearing what can be said

about it by persons of every variety of opinion and studying all

modes in which it can be looked at by every character of mind. No

wise man ever acquired his wisdom in any mode but this. " --

J S Mill

> I should have known better, as I have studied much false and

> misleading " research " about the safety of aspartame, MSG....

Are you really sure that the Truehope research is " false and

misleading " ?

someone else [ Liz Woeckner ] wrote:

> Scientific conclusions about the efficacy of drugs are drawn

> from double-blind placebo studies published in peer-reviewed

> journals.

Yes. And we cannot forget that prior to those 2x-blind/etc.

studies in peer-reviewed journals come anecdotes, followed by more

anecdotes, followed by more anecdotes, followed by (maybe) someone

getting interested in why there are so many anecdotes regarding

whatever-it-is, and perhaps also developing some hypothesis as to

why whatever-it-is is happening, followed by very informal,

non-blinded clinical trials (scarcely better than anecdotes),

which may or may not be published, along with anecdotal info, in

non-peer-reviewed journals (and/or published as convention

abstracts or presentations, and/or published as letters, etc.,

etc.), followed by...... pant, pant!

See? It is a long path to that golden end of unassailable blinded,

controlled, randomized [blah-blah] trials published in top

journals. *Ignoring* things (or casually dismissing things) that

have not reached that level is about as foolish as becoming wildly

enthusiastic about them. It is important to remember, when it

comes to human health, that the goal (for most of us, at least) is

not clearcut " scientific conclusions " , but rather what works --

and " what works " at any given moment could well be years or

decades away from anything resembling scientific verification.

Vitamin E worked for heart disease no less well back in the days

when JAMA and most of the medical establishment denounced it as

quackery (or was that " dangerous " quackery?); the fact that that

establishment has come around to a mature view does not change the

efficacy of the substance -- nor does it change the beneficial

results that many millions secured even *as* the substance was

denounced.

> But other sorts of studies are possible and if they provided

> suggestive data, interest would support a larger conventional study.

> I've seen studies on a single patient, and I've seen studies on small

> numbers and for limited periods of time.

Absolutely. Truehope should proceed with studies larger and better

than that one little 10-patient one, and post haste... if they are

in fact sincere and committed to scientific verification (which they

may very well NOT be, for all I know).

> These are not the reasons why Truehope has no literature

> to support their claims. These are my objections to Truehope:

> 1] no scientific literature or currently understood biological

> processes or even theoretical paradigms give any evidence that

> the regime of vitamins they sell would have any therapeutic

> benefit in depression, bipolar disorder,

> autism, schizophrenia, ADHD, and TS.

Well, not quite. I cite some literature for chromium and magnesium

effects in depression below. That is not to mention the lit on

vitamin D and brain function, and vitamin D as a mood-elevating

substance. Nor does it mention the role of folic acid and

pyridoxine and B12 in neurotransmitter metabolism, and the

frequency of insufficiency of those vitamins in psychiatric

populations. There is also an interesting literature developing on

calcium therapy for the depression of PMS (and possibly other

depressions? who knows?) Etcetera. Much more could be said, but

time is limiting.

Did Truehope mention schizophrenia or Tourettes? Not on the

literature I have.

The only mention they made of autism was in the context of

mentioning that a study was in the process of being designed to

test their supplement in that condition, and (from their lit):

" The idea is not that the supplement would cure the disorder, but

would allow the child to function better at home or at school. "

Fair enough. Let the trial proceed.

> 2] Inexperience and questionable marketing tactics:

> if Synergy has a bona fide product to test for

> therapeutic benefit they must find an experienced researcher or

> clinician to work with.

Good idea.

> In the same fashion that I do not expect a librarian to

> perform surgery, I do not accept medical and pharmacological

> pronouncements from untrained lay persons.

How about *trained* lay persons? Clinical trials (especially of

harmless vitamin tabs) are not rocket science, nor are they surgery.

> Last November when I visited their web site [the URL you provided

> in your post] Truehope's " protocol " told patients to stop all their

> medications abruptly -- with no warnings to work with their physician

> or taper medication.

Bad idea.

> They have since changed this somewhat, but this points up how

> dangerous inexperience can be: no clinician would ever give

> such potentially lethal advice.

Welllll... as a matter of fact clinicians do much more than just

give " potentially lethal advice " , as the figure for iatrogenic

deaths (around 170,000 per year, if memory serves me) indicates.

[Murray: The news this week is that some experts claim the correct

estimate is about 5,000 to 15,000 iatrogenic deaths in the USA.]

The medical profession as a whole is not in a very good position

to be lecturing about the " dangers " of manifestly innocuous stuff

like low-potency vitamin tabs (like the Truehope formulation).

Now, if said low-potency tabs are dispensed to certain individuals

in, say, a fragile, suicidally-depressed state along with the

advice to abruptly cease whatever antidepressants they may be on,

then... then that is a somewhat different story. But even then,

only somewhat. There appears to be a subpop of SSRI users who

become *more* suicidal when they take SSRIs. So the situation is

hardly clearcut.

> I find it alarming that Truehope would offer their customers the

> support of untrained and uncredentialed company representatives.

> I have corresponded with Stephan, a Synergy principal, and he

> lied to me. This does not bespeak a man who is honestly trying to

> market a beneficial product.

Lies are unprofessional and inexcusable, to be sure, and clueless

company reps are an annoyance. But nothing to get panicked or

alarmed about (provided we are still talking about vitamin tablets).

Sounds like the Truehope people are hucksters... who are

reminding us to do the obvious: provide good, broad-spectrum

nutritional support to people with neuropsychiatric problems,

and do so routinely.

Also sounds like Truehope is charging a semi-ripoff price for what

looks like a conventional multiple: $120 per month, or so; should

probably be 1/4 of that, or thereabouts.

> I am entirely convinced that Truehope is perpetrating

> a dangerous scam.

Dangerous? How?

> As for reaction with psychotropic drugs, if memory serves, at least

> one of the ingredients, inositol, can do nasty things to people

> with bipolar disorders, meds or no.

ONE letter suggested the possibility of manic reactions to inositol.

> Inositol: requires expert clinical management if used by bipolars;

Why?

> some evidence that it causes mania; I would be concerned about

> triggering serotonin syndrome, based on inositol's role in

> serotonin production -- in combination with SSRI meds, frequently

> used in bipolar and depression.

Serotonin syndrome, very doubtful, but possible. Darn near anything

is possible. In the amounts in the Truehope product, probably

impossible. (Amount not specified, but run the numbers, roughly,

on the other ingredients and figure it out, relative to the 10-20

GRAMS/day that have been used in the inositol studies.)

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http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query_old?uid=10699232 & form=6 & db=m\

& Dopt=b

Psychiatry Res 2000 Feb 14;93(1):83-7

Magnesium oxide augmentation of verapamil

maintenance therapy in mania.

Giannini AJ, Nakoneczie AM, Melemis SM, Ventresco J, Condon M

Chemical Abuse Centers Inc.

721 Boardman-Poland Road, Suite 200,

Boardman, OH 44512-5105, USA.

The authors compared the antimanic effects of a

verapamil-magnesium oxide (V-M) combination with a

verapamil-placebo combination (V-P) in patients pretreated with

verapamil. BPRS scores and serum magnesium levels were compared.

The V-M combination was found to be significantly more effective

than V-P in reducing manic symptoms (P=0.015). Serum magnesium

levels were significantly higher in the V-M group (P<0.04). These

data suggest that magnesium may increase antimanic efficacy of

verapamil by mechanisms which may operate at the intracellular

level. The magnesium-verapamil combination may have clinical

application as an adjunct to verapamil in the maintenance therapy

of mania. Publication Types: Clinical trial Randomized controlled

trial PMID: 10699232, UI: 20165007

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http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query_old?uid=2309035 & form=6 & db=m & \

Dopt=b

Prog Neuropsychopharmacol Biol Psychiatry 1990;14(2):171-80

A pilot study of magnesium aspartate hydrochloride (Magnesiocard)

as a mood stabilizer for rapid cycling

bipolar affective disorder patients.

Chouinard G, Beauclair L, Geiser R, Etienne P

Research Centre, Louis-H. Lafontaine Hospital

University of Montreal, Canada.

Nine severe rapid cycling manic-depressive patients were

treated with a magnesium preparation, Magnesiocard 40 mEq/day in

an open label study for a period up to 32 weeks.. Magnesiocard

was found to have clinical results at least equivalent to those of

lithium in about 50% of these patients. These results were

obtained in an exploratory study and should be interpreted with

caution. The possibility that Magnesiocard could replace or

improve the efficacy of lithium as a preventive treatment of

manic-depressive illness merits further clinical investigation.

PMID: 2309035, UI: 90175917

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Chromium Useful in Dysthymia

[Nurses' Drug Alert 23(6):45,46, 1999

.. © 1999 M.J. Powers & Co. Publishers]

Chromium picolinate supplementation was effective in 5 patients

with dysthymia (chronic mild depression, often

treatment-resistant).

A 50-year-old man with a 25-year history of dysthymic disorder,

had only partial response with sertraline. He began taking a

vitamin-mineral supplement, and within days his dysthymia resolved

completely. After informing his psychiatrist, the patient agreed

to stop taking the supplement and undergo separate, single-blind

re-introductions of each of its 5 major ingredients. His symptoms

returned during the supplement washout and disappeared again

during administration of chromium picolinate, 200 mcg/day. The

patient ended the trial prematurely on his own initiative, and

insisted on knowing which supplement ingredient was responsible

for his dramatic remission. He then began taking chromium

picolinate and eventually discontinued sertraline. He switched to

another preparation, chromium polynicotinate, and remained

euthymic after 15 months of chromium monotherapy.

Single-blind trials of chromium were then instituted in 4 other

patients with antidepressant-resistant dysthymia. Each had an

inadequate response to either sertraline, fluoxetine,

nortriptyline, or bupropion with lithium. Chromium was added to

ongoing medication in 3 patients, and was used as monotherapy in

the fourth. In all cases, at least 1 other disguised nutritional

supplement was used as a control; in some cases, chromium was

withdrawn and re-introduced multiple times. Without exception,

mood symptoms resolved during use of chromium and returned upon

its discontinuation. One patient reported side effects of insomnia

and increased dreaming, which resolved when the supplement was

taken in the afternoon. Two other patients also reported increased

dreaming, which resolved spontaneously within 2 weeks in both

cases.

Chromium, which enhances peripheral glucose metabolism, may

improve mood by increasing glucose utilization in the CNS.

Evidence suggests that chromium may also enhance monoaminergic

neurotransmission and serotonin synthesis. Chromium picolinate

supplementation has been studied for 3 decades and appears to be

safe at dosages up to 1 mg/day, higher than the 200-400 mcg

dosages used in these 5 patients. A test for chromium deficiency

does not exist at present.

References

McLeod M, et al: Chromium potentiation of antidepressant

pharmacotherapy for dysthymic disorder in 5 patients. Journal of

Clinical Psychiatry 1999;60 (April):237-240. From the University

of North Carolina School of Medicine, Chapel Hill.

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http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query_old?uid=10221284 & form=6 & db=m\

& Dopt=b

J Clin Psychiatry 1999 Apr;60(4):237-40

Chromium potentiation of antidepressant pharmacotherapy for dysthymic

disorder in 5 patients.

McLeod MN, Gaynes BN, Golden RN

Department of Psychiatry, University of North Carolina School of

Medicine, Chapel Hill 27599-7160, USA.

BACKGROUND: Dysthymic disorder is a relatively common illness that is

often treated with antidepressants. Compared with the study of major

depression, there has been little systematic study of potentiation

strategies for antidepressant-refractory dysthymic disorder. METHOD:

Following a patient's report of dramatic response to the addition of

chromium supplementation to sertraline pharmacotherapy for dysthymic

disorder (DSM-IV), the authors initiated a series of single-blind and

open-label trials of chromium picolinate or chromium polynicotinate

in the treatment of antidepressant-refractory dysthymic disorder.

RESULTS: In a series of 5 patients, chromium supplementation led to

remission of dysthymic symptoms. Single-blind substitution of other

dietary supplements in each of the patients demonstrated specificity

of response to chromium supplementation. CONCLUSION: Preliminary

observations suggest that chromium may potentiate antidepressant

pharmacotherapy for dysthymic disorder. Controlled studies are

indicated to test the validity of these initial observations.

Publication Types: Clinical trial PMID: 10221284, UI: 99236473

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http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query_old?uid=11343609 & form=6 & db=m\

& Dopt=b

Int J Neuropsychopharmacol 2000 Dec;3(4):311-314

Chromium treatment of depression.

McLeod MN, Golden RN

Eight patients with refractory mood disorders received chromium

supplements and described dramatic improvements in their symptoms and

functioning. In several instances, single-blind trials confirmed

specificity of response to chromium. Side-effects were rare and mild,

and most commonly included enhanced dreaming and mild psychomotor

activation. To our knowledge, this is the first case series

describing the response to chromium monotherapy. The putative

antidepressant effects of chromium could be accounted for by

enhancement of insulin utilization and related increases in

tryptophan availability in the central nervous system, and/or by

chromium's effects on norepinephrine release. PMID: 11343609

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