REASONS
TO CONSIDER (OVERVIEW)
- Individuals with
spasmodic
and/or nervous disorders.
- Individuals experiencing
insomnia and common sleep disorders.
- Individuals experiencing
acute stress, anxiety, depression or restlessness in their
daily lives.
- Type A individuals unable
to relax or "enjoy life".
DOSAGE & DIRECTIONS
-
For stress, anxiety, or
depression, take 2
capsules with breakfast and 2 capsules with dinner.
-
For insomnia, take 2
capsules with lunch and 1 with
dinner as needed. Do not take within 3 hours of
bedtime.
- For overall tension
and nervousness, take
1 to 2 capsules with breakfast or lunch as
needed.
- For spasm, take
4 capsules
twice daily for two days, then
one to two capsules daily as
needed. Take with food.
PROTOCOL FOR WEANING YOURSELF
OFF ADDICTIVE AND SIDE-EFFECT LADEN ANTIDEPRESSANTS AND MUSCLE
RELAXANTS.
Synthetic antidepressants and
sedatives are addictive and exhibit
extremely harmful side effects. By far, the SSRI's (Selective
Serotonin Reuptake Inhibitors) are the most commonly used group. They increase
the levels of serotonin in the brain.
The side effects for muscle relaxants are similar to
anti-depressants with the exception that, while they are less addictive, they may
be habit forming. The most common two classes of sedatives
are benzodiazepines and barbiturates.
Some of the more serious
adverse reactions and side effects to these drugs include liver failure,
convulsions, hallucinations, suicide tendencies, nausea, insomnia, psychosis,
mania, sexual dysfunction and weight gain.
Unfortunately, because they are
addictive, anti-depressants and sedatives can induce mild to severe withdrawal
symptoms, called SSRI Discontinuation Syndrome. It is therefore important
to withdraw extremely slowly from SSRI anti-depressant drugs, usually over a
varying time period and under the supervision of a qualified specialist.
SSRI's are split into two
categories - long acting and short acting. Prozac, for example, is a longer
acting SSRI. Paxil, Effexor, Zoloft and Luvox are short-acting. They produce no
metabolites that help the medication stay in the body for an extended period and
withdrawal symptoms are usually more severe.
The shorter acting SSRI's, when
discontinued or when the dosage is lowered, interrupts production of the key
neurotransmitter acetylcholine. (Acetylcholine is the neurotransmitter used more
when a person is under greater stress.) To reduce the interruption of
acetylcholine, in addition to slow titration of the drug, it is necessary to add
supplementation in the diet, in particular choline, lecithin, and B complex.
The B vitamins, especially B-6,
will help sustain your brain's current levels of the neurotransmitter
acetylcholine while the choline and lecithin supplements will help increase the
level of available choline the brain uses to make acetylcholine while the
titration and discontinuation protocol is under way. This is believed to be
somewhat true of sedatives but to a lesser extent.
SSRI
Discontinuation Syndrome is not considered dangerous,
and most people find that it subsides within a few days to a
few weeks.1A
However, the symptoms vary dramatically. In most cases,
symptoms are relatively manageable, and no specific
treatment is needed.
NEITHER
GALENS
GARDEN NOR TITAN LABORATORIES DISPENSE MEDICAL ADVICE.
The protocol developed for weaning the patient off
anti-depressants is intended solely to assist both the
individual and his practitioner in making informed choices:
Month One. Take regular dosage of drug. Also
take 2 capsules twice daily (am & pm
with food) of Factor Six: Sommaserene. Be sure
to space dosages two to three hours apart from the ingestion of synthetic drug.
Consider dietary changes during
this period. Egg yolks are one of the best dietary sources of lecithin/choline.
Other excellent sources of dietary choline are beef steak, liver, organ meat,
spinach, soybeans, cauliflower, wheat germ, peanuts, and brewer's yeast.
Month Two. Reduce dosage of synthetic drug while maintaining the above dosage level of
Factor Six:
Sommaserene.
The individual should ask his
doctor if a special dose is available for the specific purpose of weaning down.
Some pharmaceutical companies are now manufacturing and offering them in sample
form.
Consider adding supplementation to the diet
including choline, lecithin, and B complex tablets/capsules.
Month Three.
Take reduced dosage of drug
every other day while taking 2 capsules twice daily (am and pm with
food) of Factor Six: Sommaserene.
Month Four.
Take reduced
dosage of drug every third day while
maintaining above dosage level of Factor Six:
Sommaserene.
Month Five & Beyond.
Discontinue drug and follow label dosing
directions for Factor Six: Sommaserene.
Since the
beginning of time, human beings have experimented and
utilized various herbs and foods for treating mood problems
to relieve stressful conditions in their lives and maintain
good health. Excellent results were frequently achieved
because the plant kingdom supplies a wealth of building
blocks for calmative, nervine, and muscle relaxant
medicines.
Now, however,
approximately 30 million Americans take anti-depressants at
a cost of over $10 billion a year (National Institute of
Mental Health). Pharmaceutical companies have additional
overall yearly sales of $14.6 billion from anti-psychotics
and $4.8 billion in sales of ADHD drugs.29
Clinical depression (acute stress) ranks second only to advanced
coronary heart disease in the total number of days patients
spent in the hospital or disabled at home, according to Dr.
Frederick Goodwin, director of the National Institute
of Mental Health.
Furthermore, one out of four American
men and one out of two American women have used tranquilizers
and over 20 million Americans take some sort of drug to sleep
at night, asserts Dr. James Fries, medical adviser at Stanford
University.
How did
a country - whose citizens are known the world over for their
outgoing self-confidence - emerge as a leading consumer of
drugs for social anxiety? And how did a nation - famed
for its dedication to the pursuit of happiness - end up as
a fertile market for antidepressant drugs?
The answer lies with the pharmaceutical
industries' clever promotion of these drugs while downplaying
their addictive nature and extremely harmful side effects.
In October of 2003, the FDA finally proposed warning labels
on antidepressants because they may promote suicidal tendencies,
which fact was suppressed by the pharmaceutical industry.
Anti-depressants shown
to be little better than Sugar Pills!
A 2010 study
published in the Journal of the American Medical
Association (JAMA) found that anti-depressants are
basically useless for the vast majority of people who take
them.30
They were only effective on patients with very severe
symptoms.
Psychology
professor Irving Kirsch, Ph.D. analyzed clinical data files
from the FDA on published and unpublished trials and found
no significant differences between anti-depressant drugs and
placebos. What he did find was severe and draconian
differences in side effects.31
Ironically,
far too many anti-depressants precipitate the very
conditions they were prescribed to prevent! In 2003 the FDA
mandated warning labels on anti-depressants because many
were found to promote suicidal tendencies.
After 50
years of prescribing anti-depressants, the results have been
all too frequently the same - drug addiction, mental
impairment, irrational and violent behavior, panic attacks,
suicide, and death.
Stress
is the body's nonspecific response to any demand made upon
it, according to Dr. Hans Selye, one of the pioneers in stress
management. In a very real sense, it's the price we pay for
our increasingly toxic, fast-paced, rapidly changing civilization.
Stress was
programmed into primitive man to provide him with the fight
or flight response. But modern man is usually in situations
where neither fight nor flight are viable options so the
stress point, unless it can be assuaged or channeled, builds
to elevated and anxiety producing levels.
Chronic
stress can raise cortisol levels and weaken the immune
system due to its immunosuppressive action. Problems
related to acute stress include muscle spasm,
atherosclerosis and related heart disease, high blood
pressure, obesity, peptic ulcer, and asthma.32
Anxiety
is the normal response to prolonged or chronic stress.
Anxiety doesn't cause long-term blood pressure
(hypertension). But episodes of anxiety can cause dramatic,
temporary spikes in your blood pressure. (Allopathic
physicians too frequently use this temporary blood pressure
spike to prescribe hypertension drugs).
Anxiety
produces worries and fears which interfere with the
patient's daily life. Chronic anxiety can precipitate panic
attacks.
Chronic Depression
(Dysthymia) affects
about 11 million Americans.
Individuals
with this disorder are unable to enjoy themselves and
exhibit at least four or more of the symptoms listed below
under 'The 10 Warning Signs of Stress, Anxiety and
Depression'.
Because the
onset of depression can be subtle and is rarely
incapacitating, it usually takes a major depressive episode
to call attention to the problem. Chronic depression is
readily treatable with non-narcotic herbal based natural
medicines, lifestyle modifications, and exercises such as
yoga, Tai Chi, and walking.
Chronic Insomnia
is a sleep disorder
that is characterized by difficulty falling and/or staying
asleep. It’s
more accurate to think of insomnia as a symptom of another
problem.
Treatment entails addressing
the underlying conditions or health problems that are
causing the insomnia.
Causes
of chronic insomnia include chronic stress, menopause,
anxiety, and chronic depression. However, medications can
also induce a sleep disorder, such as
antidepressants; cold and flu
medications that contain alcohol; pain relievers that
contain caffeine (Midol, Excedrin); diuretics,
corticosteroids, thyroid hormone, high blood pressure
medications.
Symptoms
of insomnia can include general fatigue, "mental fog,"
irritability, and problems with concentration or memory.
Individuals
taking sedative (hypnotic or tranquilizer)
medications for insomnia (benzodiazepines)
do not have better sleep than chronic insomniacs not
taking medications. In fact, chronic users of hypnotic
medications have more regular nighttime awakenings than
insomniacs not taking hypnotic medications.33
Furthermore,
a review of the literature concluded that these drugs
cause an unjustifiable risk to the individual and to
public health, and lack evidence of long-term
effectiveness.34
The Ten Warning Signs
of Stress, Anxiety and Depression
If you or a
loved one have been experiencing any four
of the following symptoms for a period exceeding two weeks
it's indicative of a potentially harmful psychological
disorder and needs to be addressed immediately:35
1) Feelings
of sadness and/or irritability;
2)
Loss of interest or pleasure in
activities once enjoyed;
3)
Feeling guilty, hopeless or
worthless;
4)
Change in weight and appetite;
5)
Loss of sexual desire and/or
ability to enjoy sex;
6)
Sleep related issues including
trouble falling asleep and difficulty staying asleep;
7)
Inability to concentrate or
remember things;
8) Existing
in a fog-like mental state and unable to focus;
9)
Restlessness or decreased
activity noticed by others;
10)
Fatigue or loss of
energy/constantly feeling tired and worn out.
The following recommendations
are applicable to reduce stress, anxiety, mild depression,
and hyperactivity and should be carefully adhered to:
1)
Take the recommended dosage of Factor
Six: Sommaserene for your
specific psychological disorder. If you are taking
anti-depressants or sedatives the protocol for weaning off
such drugs should be adhered to as previously discussed.
2) An
unbalanced diet can trigger stress, anxiety, and
depression - such as consuming junk food on a regular basis.
When your body doesn't get enough of the necessary minerals
and nutrients it needs, it becomes less able to handle
stress. (Daily calories should be comprised of 20% protein,
20% fat, and 60% complex carbohydrate.)
3)
Avoid the following simple carbohydrates which are mostly
sugar and can cause major swings (a rapid rise followed
by a precipitous fall) in blood sugar, emotions, and body
reactions: cake, candy, cookies, cough drops, doughnuts, fruit
flavored drinks, ice cream, jam and jelly, pastries, pies,
soft drinks, sweet rolls, white bread and white rice.
Scientists at the University of
Berkeley examined the blood glucose curves of various individuals
and a standardized test for mental agility (SST) was given
to each subject. Those subjects whose blood sugar levels were
in the healthy range (60 mg % or above) had average SST scores
of 22, while the low-blood-sugar group had mean scores of
5.36
Simply stated, sugar makes
people stupid and the average American consumes about 130
pounds of it each year!37
4)
Limit the
ingestion of preservatives, such as artificial
colorings, flavorings and nitrites which are used as
preservatives in bacon, ham, sausage, hotdogs, most sandwich
meats, and wines, as well as preserved foods (most
everything packaged in a box, jar, or can). Such food
additives and "foods" are neurotoxic to the brain and
nervous system.38
5)
Do eat a
low-fat, high-fiber, nutrient-dense diet containing a
variety of fruits, vegetables, whole grain breads and
cereals, nuts, low-fat dairy products, and lean meats,
chicken and fish. Drink several glasses of water a day.39
6)
Do exercise at least three times a week for at least 45
minutes per session.
Exercise improves blood sugar
regulation and the receptivity of the cells to insulin.40
Exercise can treat hyperactivity,41
depression, anxiety, and many other mild to moderate mental
problems.42
7)
Avoid the
"stressors" of modern life. TV is a stress inducer. By
watching the violent and stressful situations on TV, you
produce the stress response in your body.
The brain does not know the
difference between what it sees in the environment and what
it imagines. If a person thinks about something stressful or
unpleasant, the body will react accordingly.
8)
Seek support in your life from family, friends, and
your community. This has a big impact on how you experience
stress, and can help you stay healthy. It can be hard to
seek help, but you must understand that doing so is
not an indication of weakness. Social networking and the
extent of an individual's friends and relationships, is a
major predictor of life span.43
9) Rearrange your lifestyle
and rethink your priorities. Weigh the benefits of your
current lifestyle against the potential short-term and
long-term effects on health. Consider setting aside 15
minutes per day of quiet relaxation and consider it as a
daily mini-vacation.
Practice relaxation techniques (stop
and smell the flowers).
The bottom
line is stress, anxiety,
depression, and insomnia are all related to
lifestyle, diet, environmental toxicity,
and how well the body is nourished. It is a sad fact
of life that 90% of Americans show some signs of
malnutrition and environmental poisoning.44
You cannot heal the mind nor the body by
subjecting it to artificial chemicals and poisoning it
further. You cannot poison your way to good health!
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CALCIUM
(AS CALCIUM CITRATE) is essential for normal transmission
of electrical impulses along nerves. When blood calcium levels
drop below normal, nerves become hypersensitive and painful
spasms of the muscles (tetany) can result.1
During a four year study of 115
women, calcium supplements lowered blood pressure in hypertensive
patients more effectively than prescription medication.2
MAGNESIUM (CHELATE) is
important for relaxation of muscles, including those surrounding
the blood vessels. And arteries that are even slightly low
in magnesium are more likely to have spastic contractions.3
Magnesium also has been successful in treating certain rhythm
problems of the heart,4 including eclampsia (sudden
convulsive seizure).5
Calcium and magnesium have long
been known as the sleep minerals.6
INOSITOL, one of the B
vitamins, is a natural tranquilizer that has proven reliable
in helping patients to sleep by combating anxiety.7
VITAMIN B-6 (PYRIDOXINE
HCI) is necessary in the formation of prostaglandins that
regulate blood pressure, muscle contraction, and heart function.
Vitamin B-6 also aids in the formation and maintenance of
the nervous system.8 A diet low in B-6 is associated
with increased risk for developing insomnia, irritability,
and depression. Vitamin B-6 has been used successfully in
treating depression common among women on The Pill, half of
whom responded to B-6 with a dramatic lifting of the depression.9
VALERIAN ROOT FROM EXTRACT
is a primary sedative and is used when sleep disorders are
the result of anxiety, nervousness, exhaustion, headache or
hysteria. In addition, it has been shown to be effective in
treating tachycardia that just precedes going to sleep.10
Valerian has further been shown to help regulate psychosomatic
disorders, and relieve tension and restlessness.11
PASSIFLORA INCARNATA FROM
EXTRACT acts as a natural tranquilizer and can calm hyperactive
people. This herb is used in Italy to treat hyperactive children.12
The pain-killing (analgesic) effect of Passiflora has been
demonstrated in laboratory and clinical tests.13
HOPS STROBILES FROM EXTRACT
is most commonly used for its calming and anti-spasmodic effect
on the nervous system.14 Hops are also fast acting.
A soothing, relaxing calm will be experienced within 20-40
minutes after ingesting the herb.15, 16
RHODIOLA ROSEA EXTRACT (STANDARDIZED TO 3% ROSAVINS AND 1% SALIDROSIDES)
Note: The 3:1 ratio is a proven ratio that matches concentrations used in
clinical trials and is the naturally occurring ratio of the component compounds
in the Rhodiola rosea root.
Rhodiola
rosea has been used for centuries in Russia and Scandinavia
to alleviate anxiety, depress, and insomnia. It is
considered a promising treatment for mild to moderate
depression17
as well as anxiety.18
Rhodiola rosea is also used to improve mood, energy and
mental clarity. It has a powerful ability to increase mental
and physical energy while simultaneously providing calming
effects.19
Use of
Rhodiola herb increases the body's resistance to stress,
anxiety, trauma and fatigue. Classified as an adaptogen,
this herb exhibits the ability to increase resistance to a
variety of chemical, biological, and physical stressors. The
effects of Rhodiola are thought to be related to the
optimization of serotonin and dopamine levels. Rhodiola also
appears to regulate the body's production of cortisol, a
critical "stress hormone."20
Clinical
studies have shown Rhodiola to improve physical and mental
performance, and specifically the ability to concentrate21
as well as reducing both
mental and stress induced physical fatigue.22
Exercise endurance was also shown to be aided by Rhodiola
after a single dose.23
Patients with stress-related
fatigue syndrome were also shown to benefit from Rhodiola.24
A single dose
of Rhodiola extract was shown clinically to improve learning
and memory retention after just 24 hours. A 10 day treatment
period was shown to effect significant improvements in long
term memory.25
Rhodiola
rosea normalizes the immune system by improving T-cell
immunity and has been demonstrated to increase the body's
resistance to toxins that may accumulate during infection
development.26
GOTA KOLA (CENTELLA ASIATICA)
FROM EXTRACT is a neural tonic which is an excellent treatment
for the prevention of nervous breakdown.27 Gota Kola exhibits a sedative
activity similar to meprobamate and chlorpromazine in that
the mode of action appears to be mainly on the cholinergic
mechanism in the central nervous system.28
NOTE: Gota Kola contains no caffeine
at all and should not be confused with Kola nut which contains
more caffeine per gram than coffee beans!
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References
Validation
of Ingredients
1A. Ditto, Kara MD "SSRI
Discontinuation Syndrome.." Awareness as an approach to
prevention", Postgraduate Medicine Online, 114:2, August
2003
1.
Somer, E, The Essential Guide to Vitamins and Minerals, p.77,
1992
2. Johnson, NE, et al., American
Journal of Clinical Nutrition, vol. 42, p. 12, July 1985
3. Altura, BM, Medical Hypotheses,
vol. 5, p. 843, 1979
4. Iseri, Western Journal of Medicine,
vol. 138, p. 1001, 1975
5. Altura, BM, et al., Science,
vol. 221, p. 376, July 22, 1983
6. Goldberg, P, et al., Natural
Sleep (How to Get Your Share), pp. 111 & 249, 1978
7. Cooper, AJ, Psychopharmacology,
vol. 61, pp. 97-102, 1979
8. Somer, E, The Essential Guide
to Vitamins and Minerals, p. 49, 1992
9. Adams, PW, et al., Lancet,
vol. 1, p. 897, April 28, 1973
10. Straube, C, Therapie der Gegenwort,
vol. 107, pp. 555-562, 1968
11. Boeters, V, Muenchener Medizinische
Wochenschrift, vol. 37, pp. 1873-1876, 1969
12. Weiner, M, Weiner's Herbal,
p. 149, 1992
13. Ambuhl, H, "Anatomische
und chemische untersucungen an Passiflor incarnata",
Dissertation Number 3830 ETH, Zurich, 1966
14. Wohlfart, R, et al., Planta
Medica, vol. 48, pp. 120-123, 1983
15. Stocker, H, Schweizer Braverei
Rundschau, vol. 78, p. 80, 1967
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Darbinyan, V, et al, A Clinical trial of Rhodiola rosea
extract in the treatment of mild to moderate depression, Nordic Journal of
Psychiatry, vol 61, issue 5, 2007, pgs 343-348.
18.
Bystritsky, A, et al., A pilot study of Rhodiola rosea for
generalized anxiety disorder (GAD)), Journal Alternative Complementary Med.,
2008 Mar; 14(2): pgs 175-80. Dept. of Psychiatry, University of California, LA.
19.
Brown, RP, Gerbarg, PL, Ramazanov, Z, Rhodiola rosea: a
phytomedicinal overview, Herbalgram 2002: vol 56, pgs 40-52.
20. Gregory,
S, Kelly, ND, Alternative Medicine Review, 6(3) pg 293-302.
21. Shevtsov,
VA, et al, (Mar 2003), "A randomized trial of two different
doses of Rhodiola rosea extract versus placebo and control
of capacity for mental work.", Phytomedicine 10(2-3): pgs
95-105.
22.
Darbinyan, V, et al., (Oct 2000) "Rhodiola rosea in stress
induced fatigue - a double blind cross-over study of a
standardized extract with a repeated low-dose regimen on the
mental performance of healthy physicians during night duty".
Phytomedicine 7(5): pg 365-371.
23. Int
Journal Sports Nutrition Exercise Metab., 2004 June: 14(3):
pg 298-307
24. Olsson,
E, et al., "A randomized double-blind placebo controlled
parallel group study of extract of Rhodiola rosea roots as
treatment for patients with stress related fatigue." Planta
medica vol 75, pg 105-112, 2009
25. Shevisov,
VA et al, (Mar 2003) "A randomized trial of two different
dosed of Rhodiola rosea extract versus placebo and control
of capacity for mental work". Phytomedicine 10(2-3): 95-105
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OA, et al., (1995) "The effect of a Rhodiola rosea extract
on the incidence of recurrences of a superficial bladder
cancer (experimental clinical research)" Urol Nefrol (Mosk)
Mar-Apr, (2) pg 46-47
27. Mowrey, DB, The Scientific
Validation of Herbal Medicine, p. 193, 1986
28. Weiner, M, Weiner's Herbal,
p. 94, 1992
Validation
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29.IMS
Health National Prescription Audit PLUS
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Antidepressant Drug Effects and
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JAMA: 303(1)
pg 47-53, 2010
31.Kirsch,
I, et al. Initial severity and antidepressant benefits: a
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data
submitted to the Food and Drug Administration, PloS Med
2008: 5(2) e45.
32. Christiansen, L, et al., Journal
of Abnormal Psychology, vol. 94, pp. 565-579, 1985
33.
Ohayon MM, Caulet M (1995). "Insomnia and psychotropic drug
consumption". Prog. Neuropsychopharmacol. Biol.
Psychiatry 19 (3): 421–31
34. "What's wrong with
prescribing hypnotics?"
Drug Therapy Bulletin
42 (12): 89–93. 2004
35. Ahmed, SM, et al.
Psychcosocial influences on health, Textbook of Family
Medicine, 8th Ed, Philadelphia,
Pa, Saunders Elsevier; chap 3, 2011
36.
Quillin,
P, Healing Nutrients, p 219, 1987
37.Hale,
F, Biological Psychiatry, vol 17, p 125, 1983
38.
Synergistic Interactions between Commonly
Used Food Additives in a Developmental Neurotoxicity Test,
Toxicology, Science, 90(1), pp 178-187, March 2006
39.O'Hanlon,
P, et al, Amer. J. of Clinical Nutrition, vol 31, p 125,
July 1978
40. Sato, Y, et al.,
International Journal of Sports Medicine, vol. 7, p. 307,
1986
41.Nutrition and Mental Health:
Hearings Before the Select Committee on Nutrition and Human
Needs of the United States Senate, Parker House, Berkely,
Ca, p. 70, 1980
42. Taylor, CB, et al., Public
Health Reports, vol. 100, no. 2, p. 195, 1985
43.
Welin, L, et al, Lancet, p 915,
April 20, 1985
44.Lowenstein, FW, Bibliotheca
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