Weight loss abstract
The present invention is directed to herbal compositions which
reduce weight, maintain weight loss over an extended period of time,
and act as an appetite suppressant. The composition consists of
St. John's Wort with or without caffeine or other appetite suppressants
known in the art, and also a composition comprising St. John's Wart
(Hypericum perforatum) and Mahuang (Ephedra sinica or ephedrine).
Another composition disclosed comprises a combination of the above
herbs with caffeine.
Weight loss claims
What is claimed is:
1. A composition comprising a dosage taken twice a day of St. John's
Wort and Mahuang extract in an amount effective for reducing weight
and maintaining the weight loss for an extended period of time wherein
St. John's Wort is present in an amount ranging from 10 mg per day
to 2500 mg per day.
2. The composition of claim 1 wherein the preferred daily dosage
of St. John's Wort is 400 mg per day to reduce weight and control
appetite.
3. The composition of claim 1 wherein the preferred daily dosage
of St. John's Wort is 800 mg per day to reduce weight and control
appetite.
4. The composition of claim 1 further comprising an effective amount
of caffeine.
5. The composition of claim 1 in unit dosage form.
6. The composition of claim 1, further comprising an agent selected
from the group consisting of electrolytes, buffers, colorants, aromatic
agents, flavoring agents, emulsifying agents, compounding agents,
formulation agents, permeation enhancers, other weight reduction
agents, and bulking agents.
7. The composition of claim 1 in sustained release form.
8. The composition of claim 1 wherein the dosage of Mahuang is
from 5 to 1500 mg per day.
9. The composition of claim 8 wherein Mahuang is present at a preferred
concentration of 250 mg per dose.
10. The composition of claim 8 wherein Mahuang is present at a
preferred concentration of 125 mg per dose.
11. The composition of claim 1 in sustained release form.
12. A method or reducing and controlling weight comprising the
steps of:
administering twice a day to a subject a composition of St. John's
Wort and Mahuang extract in an amount effective for reducing weight
and maintaining the weight loss for an extended period of time wherein
St. John's Wort is present in an amount ranging from 10 mg per day
to 2500 mg per day and after a predetermined weight is attained,
a weight maintaining effective amount of the composition.
13. The composition of claim 1 wherein the preferred dosage comprises
St. John's Wort in a 400 mg dose which is taken twice per day, and
Mahuang in a 250 mg dose which is also taken twice per day.
14. The composition in accordance with claim 13 wherein each 400
mg dose of St. John's Wort is combined with 250 mg dose of Mahuang
two such combined pills being taken per day.
15. The composition in accordance with claim 1 wherein the dosages
are taken before breakfast and before dinner.
16. The composition in accordance with claim 15 wherein the dosages
are taken with a glass of water.
17. The composition in accordance with claim 1 wherein the St.
John's Wort is an extract of St. John's Wort which contains the
active ingredient 0.3% hypericin.
Weight loss description
FIELD OF THE INVENTION
The invention relates to compositions for reducing weight in humans
and/or animals and more particularly to herbal compositions for
achieving the desired result.
BACKGROUND OF THE INVENTION
This invention relates to herbal compositions for reducing weight,
maintaining weight loss over an extended period of time and suppressing
appetite in a human or a domestic animal.
Examples of known appetite reducing agents are ephedrine which
is an extract of the herb Mahuang (Ephreda sinica), phenylpropanolamine
(PPA), amphetamines and fenfluramine alone or in combination with
caffeine. Caffeine functions probably to reduce fatigue as caffeine
has stimulating properties. Phenylpropanolamine (PPA) is a popular
over-the-counter drug for appetite suppression and its side effects
are well documented.
Several herbal compositions have been developed for reducing weight
in humans or domestic animals. U.S. Pat. No. 5,422,352 discloses
a composition of ephedrine and caffeine in a ratio of about 1:12.
U.S. Pat. No. 5,019,594 discloses a method for decreasing appetite
by administering a composition containing ephedrine or other indirect
acting sympathomimetic drugs and tyrosine. U.S. Pat. No. 5,273,754
discloses an appetite suppressant composition comprising a heating
and a cooling carminative substance, which composition may also
include an amino acid and an anxiolytic substance. One of the anxiolytic
substances disclosed is St. John's Wort. U.S. Pat. No. 5,543,405
discloses a weight reduction composition comprising a sympathomimetic
agent and a mineral cation salt or chelate. Preferred is a composition
comprising ephedrine and chromium picolinate. U.S. Pat. No. 5,055,460
discloses a composition for reducing weight comprising ephedrine,
acetylsalicylic acid and caffeine.
However, none of the methods for weight reduction or appetite suppression
disclose a composition comprising St. John's Wort (hypercin) and
Mahuang (Ephedra sinica or ephedrine) which are disclosed in the
present invention. The synergistic effect of St. John's Wort and
Mahuang have been shown to be unexpectedly superior than the effect
of the individual components.
SUMMARY OF THE INVENTION
The present invention discloses herbal compositions effective in
reducing weight, maintaining weight loss and suppressing appetite
comprising St. John's Wort (Hypericum perforatum), and a composition
comprising St. John's Wort and Mahuang (Ephedra sinica or ephedrine).
When taken in combination, St. John's Wort and Mahuang act synergistically
to increase serotonin levels in the brain to effect appetite suppression
and caloric expenditure increase in the body. These weight reduction
and appetite suppressant compositions are presented in a variety
of formulations, with or without other weight reduction active ingredients
such as phenalpropanolamine and caffeine.
Studies conducted by applicant have proven the effectiveness of
the composition.
BRIEF DESCRIPTION OF THE INVENTION
It is a well established fact that overweight and obesity is an
unhealthy condition. It is therefore logical that substances aiding
or resulting in weight reduction would be beneficial to a society
where millions suffer from obesity, as long as the substance is
safe and effective when taken as directed. This condition may be
related to a genetic trait and/or to environmental factors. See,
generally, Ravussin, Lillioja, Knowler, Reduced Rate Of Energy Expenditure
As A Risk factor For Body Weight Gain, New Jr. Eng. of Med., 318,
p. 467, 1988.
Over-weight and obesity are chronic conditions which are highly
prevalent in industrialized society. These conditions are associated
not only with social stigma but are also associated with decreased
longevity and numerous medical problems such as diabetes, reproductive
disorders, dermatological disorders, varicose veins, arthritis,
heart disease, cancer, etc.
Over-weight and obesity is a condition characterized by the excessive
accumulation of fat in the body as a consequence of an energy intake
which is greater than energy expenditure. Over-weight is present
if the body weight exceeds a "desirable weight", whereas
obesity represents a condition where the weight is 20% or more above
the desirable weight. Desirable weight for humans is defined in
the Metropolitan Height And Weight tables as the midpoint of the
range of medium frame individuals. See, JAMA,260, 2547-48, 1988.
Existing therapies for over-weight and obesity basically include
a treatment to establish a negative energy balance. This may be
accomplished by reduction of energy intake, for example, a low calorie
diet; or an increase in energy expenditure, for example, by increased
physical exercise; or by ingestion of a sympathomimetic drug which
stimulates thermogenesis, i.e., increases the metabolic rate of
the body in humans and animals. Known thermogenic drugs are ephedrine,
phenylpropanolamine and caffeine. See, for example, Astrup, A. V.,
Treatment Of Obesity With Thermogenic Agents, Nutrition, 5, p. 70,
1989; Bray, Nutrition Reviews, 49, p. 33, 1991. While energy expenditures
may increase 10-fold during exercise, the thermogenic effect of
pharmacological agents is much more modest. Sympathomimetic compounds
and beta adregenic agonists can increase resting energy expenditure
by 10% to 15% and slightly potentiate the effect of foods. Energy
expenditure may be increased 5% to 10% on a 24-hour basis. See,
generally, Astrup, Breum, Tourbo, Pharmacological And Clinical Studies
Of Ephedrine And Other Thermogenic Agonists, Obesity Research, 3,
p. 537, 1995.
Drugs which are used for reducing weight or obesity suppress appetite
by acting on the noradrenergic neurotransmitter such as mazindol
and derivatives of phenethylamine, for example, phenylpropanolamine,
phentermine, amphetamine, methamphetamine. Also well known in the
art are the use of drugs which act on the serotonin neurotransmitter
such as fenfluramine, tryptophan, fluoxetine and sertraline. However,
all these drugs have side effects.
There is, therefore, a need for a drug which will reduce the weight
of overweight or obese persons without side-effects and which will
also help obese and overweight subjects maintain the reduced weight
level.
OBJECTS OF THE INVENTION
It is therefore an object of the present invention to provide a
regimen that is useful in returning the body weight of overweight
or obese subjects to a lower and preferably normal body weight.
It is another object of the present invention to provide a therapy
for overweight or obesity that results in maintenance of the lowered
body weight over an extended period of time.
BRIEF DESCRIPTION OF THE FIGURES
FIGS. 1-4 are graphs useful in presenting data compiled during
testing of the present invention.
DETAILED DESCRIPTION OF THE INVENTION AND PREFERRED EMBODIMENTS
THEREOF
The present invention is directed to a composition comprising St.
John's Wort (hypercin) and Mahuang (Ephreda sinica, or its extract
ephedrine).
St. John's Wort is a herb of the hypericaceae family which contains
the therapeutically active ingredient hypercin. St. John's Wort
has antidepressant properties for which it is widely used in Europe.
Numerous publications and meta-analysis strongly suggests the antidepressant
efficacy through seratonergic mechanisms. However, it was unexpectedly
found that St. John's Wort also functions to reduce weight and also
acts as an appetite suppressant, most likely by controlling serotonin
levels. See BMJ 1996; 313:253-8 St. John's Wort for Depression--An
Overview and Meta-analysis Of Randomized clinical Trials; K. Linde,
et al.
The dosage form of St. John's medication contains its extract at
a concentration of 0.3% hypercin. For efficacy in providing weight
reduction, St. John's Wort should be present in an amount ranging
from 10 mg to 2500 mg per dose per day, preferably from 100 mg to
800 mg per dose per day, and most preferably at a concentration
of two doses of 400 mg each per day. Other weight reduction compositions
such as caffeine may be taken with St. John's Wort.
Another composition which is effective in reducing weight and suppressing
appetite is a composition comprising St. John's Wort (hypercin)
and Mahuang (Ephedra sinica or ephedrine). Mahuang is also a naturally
occurring herb which aids in weight reduction through its active
ingredient the sympathomimetic compound Ephedra sinica or its extract
ephedrine. When used in combination with St. John's Wort, Mahuang
should be present in an amount ranging from 5 mg to 1500 mg per
dose per day, and most preferably at a concentration of two doses
of 250 mg each per day.
Both St. John's Wort and Mahuang are safe and effective when used
as directed and side effects are minor or none. High doses of Mahuang
are associated with sympathomimetic simulation and attendant side
effects. Accordingly, low doses are recommended in the medication
and subjects who have high blood pressure or cardiac arrhythmias
are not good candidates for this drug regimen.
Mahuang be taken separately in the morning and St. John's Wort
in the afternoon before dinner, or both may be taken in the morning
and before dinner.
Good results were observed in a clinical study conducted at St.
Lukes/Roosevelt Hospital, New York according to the present invention
by using a pharmaceutical tablet composition comprising St. John's
Wort and Mahuang in overweight or obese subjects. The results of
the clinical studies detailed below clearly demonstrate that the
action exerted by the combination of St. John's Wort and Mahuang
is due to an unexpected synergistic effect of the two drugs.
The herbal components (St. John's Wort and Mahuang) may be used
for weight reduction and appetite suppressant without being further
processed, or they may be used as extracts thereof. For example,
St. John's Wort herb may be dried, powdered and used in the powdered
form as the active ingredient in a oral dosage form such as a pill
or a capsule. Alternatively, hypercin, the active ingredient of
St. John's Wort may be extracted from the herb by soaking the crushed
herb in an alcohol/water solution and the extracted active ingredient
dried by spray drying or evaporation.
The composition according to the present invention may be formulated
for administration by any conventional route such as oral, rectal,
nasal, topical (dermal) or parenteral. Thus the composition may
be in the form of tablets, capsules, suspensions, emulsions, solutions,
suppositories, sprays or injectibles. Formulations for oral use
include tablets which contain the active ingredient in admixture
with pharmaceutically acceptable inert excipients. These excipients
may be, for example, inert diluents such as calcium carbonate, sodium
chloride, lactose, calcium phosphate, sodium phosphate, etc.; granulating
and disintegrating agents, for example, potato starch, alginic acid,
etc.; binding agents, for example, starch, gelatin or acacia, etc.;
and lubricating agents for example, magnesium stearate, stearic
acid or talc. Other pharmaceutically acceptable excipients can be
colorants, flavoring agents, plasticizers, humectants, etc. The
tablets may be uncoated or they may be coated by known techniques.
Alternatively, the active ingredients of the weight reduction formulation
may be delivered over an extended time period by delaying disintegration
and absorption in the gastrointestinal tract to provide a sustained
release effect. For example, a time delay material such as glyceral
monostearate or glycerol distearate may be employed. The active
ingredient may be placed in an extended release dosage form by techniques
which are well known in the art. See, for example, Baker, Richard,
Controlled Release Of Biologically Active Agents, John Wiley And
Sons, 1986.
The inactive excipients in a tablet may include calcium carbonate,
dicalcium phosphate, microcrytalline cellulose, croscarmellose sodium,
stearic acid, silica, magnesium stearate and pharmaceutical glaze.
Alternatively, the active ingredient or extract thereof may be delivered
in a soft or hard gel capsule by mixing the active ingredient with
water or an oil medium such as peanut oil, liquid paraffin, or olive
oil and enclosing it within the capsule or gel capsule.
The dosage may also be administered as an oral liquid dosage form
by suspending the active ingredients or extracts thereof in an aqueous
solution in admixture with a dispersing or wetting agent, suspending
agent and one or more preservatives. Suitable dispersing or wetting
agents are, for example, naturally occurring phosphatides, for example,
lecithin, or condensation products of ethylene oxide, fatty acids,
long chain aliphatic acids, or a partial ester derived from fatty
acids and a hexitol or hexitol anhydrides, for example, polyoxyethylene
stearate, polyoxyethylene sorbitol monooleate, polyoxyethylene sorbitan
monooleate, etc. Suitable suspending agents are, for example, sodium
carboxymethylcellulose, methylcellulose, sodium alginate, etc.
The pharmaceutical formulation may also be delivered parenterally
in dosage forms containing conventional pharmaceutically acceptable
carriers and adjuvants. The formulation and preparation of such
compositions is well known to those skilled in the art. For example,
specific formulations can be found in the text Remington's Pharmaceutical
Sciences, Mack Publishing Co., Easton, Pa., 1995. The active ingredients
may be dissolved in vehicles such as water, isotonic sodium hydroxide
solutions, etc. The aqueous formulations may also contain a preservative
such as methyl, ethyl or n-propyl p-hydroxybenzoate.
For rectal applications, suitable dosage forms for a composition
according to the present invention include suppositories (emulsion
or suspension type), and rectal gelatin capsules (solution or suspensions).
In a typical suppository formulation, the active ingredients of
the two herbs are combined with an appropriate pharmaceutically
acceptable suppository base such as cocoa butter, esterified acids,
glycerinated gelatin, and various water soluble or dispersible bases
like polyethylene glycols and polyoxyethylene glycols and polyoxyethylene
sorbitan fatty acid esters.
To prepare the weight loss and appetite suppressant of the present
invention in a tablet form, the extract of the two herbs were combined
with excipients in an appropriate ratio and thereafter tableted
by methods which are well known in the art. See, for example, Remington's
Pharmaceutical Sciences, Mack Publishing Co., Easton, Pa., 1995.
EXAMPLE 1
Overweight and obese patients were placed on a low calorie diet
and a daily dosage of St. John's Wort effective to control appetite
and reduce weight and maintain the weight loss is 10 mg to 2100
mg per day, with and without caffeine. It was found that over a
two month period, over 90% of the subjects lost an average of 4
pounds per month, were able to maintain the weight loss, and reported
a decreased craving for food and a decreased appetite.
EXAMPLE 2
A dose response open-label study of the thermogenic effect of St.
John Wort in combination with Mahuang was conducted under the direction
of Dr. Joseph D. Bartolomeo, Ph.D. The concentration range over
which Mahuang is effective to control appetite, reduce weight and
maintain the weight loss is from 10 mg to 2500 mg per day.
The aim of the study was to assess the effectiveness, tolerability
and safety of oral administration of St. John's Wort at a dosage
of 400 mg twice daily and a Mahuang dosage of 250 mg twice daily
over a 6 week period for the treatment of overweight and appetite
suppression. Changes in weight and body composition measurements
were primary effectiveness variables. The aim of the study was to
determine if fat is preferentially lost when the two herbs are combined
with the diet. Appetite suppression was a secondary effectiveness
variable.
The study was conducted in subjects with a body mass index of 27
to 32 kg/square meter. Fifteen overweight but otherwise healthy
subjects were selected at random for the study. The subjects were
supplied with two weeks supply of 28 caplets and one of three calorie
diet plans. The subjects were directed to swallow a caplet comprising
200 mg St. John's Wort caplet and one 125 mg caplet of Mahuang 30
to 60 minutes before breakfast and to repeat the same dosage before
dinner with a glass of water.
Specifically excluded from this study were subjects who required
or were currently taking any significant medication other than analgesics
on an occasional basis such as drugs containing sympathomimetics
amines, MAO inhibitors and other drugs indicated for weight reduction.
The subjects were instructed to visit the clinic every week to
weigh-in and pick up the necessary St. John's Wort and Mahuang tablets.
On each visit the subjects were also monitored for blood pressure,
temperature, body fat by bioimpendence analysis and anthropometry,
and circumference measurements of the chest, waist and hips.
At the end of the six weeks study, the 12 subjects lost an average
of 8 pounds. The subjects also reported on the effects of the herbal
therapy as it related to appetite control, feeling of fullness and
snack cravings. 87% of the subjects reported a suppression of appetite;
81% reported satisfaction with less food during a meal, and 81%
reported that they were less inclined to snack between meals.
EXAMPLE 3
An open label trial study was conducted in which data was collected,
analyzed, summarized, and presented as a poster at the North American
Association for Study of Obesity in November 1997. The following
data includes the study abstract, weight loss results, and reported
side effects (the results indicate that the subjects placed on the
product on average lose weight over the 8 weeks of follow-up and
reported side effects are, on the whole, minor): OPEN-LABEL WEIGHT
LOSS TRIAL OF COMBINATION HERBAL MA HUANG AND ST. JOHN'S WORT. Steven
B. Heymsfield. Obesity Research Center, St. Luke's/Roosevelt Hospital,
Columbia University, NY, N.Y. 10025.
Objective. Ma Huang and St. John's Wart with active agents ephedra
and hypercin through sympathomimetic and serotonergic actions may
produce appetite suppression and weight loss. This pytothesis was
tested in this first open-label trial and a randomized double blind
study is now in progress (study results of double blind study are
set forth under Example 4 below).
Design. Open label 8 week ongoing safety study in obese adults.
Materials and Methods. Subjects were healthy adults in whom the
herbs (40 mg/d ephedra and 800 mg/d hypericin) were not contraindicated.
Weight loss, blood pressure, and symptoms were monitored over the
8 week treatment period.
Results. 1401 subjects and baseline evaluations; 748 have now completed
4 weeks; and 68 completed 8 weeks of treatment. Weight in subjects
at 4 weeks (mean .DELTA.=1.72 pds/wk) and 8-wks (mean .DELTA.=1.40
pds/wk; plotted in FIG. 1) shows classic exponential weight-decline.
Symptoms for pooled 1401 subjects were minimal (see Table). Blood
pressure was unchanged from baseline for all subjects at last evaluation.
______________________________________ Symptom % ______________________________________
Allergic 0.2 Incr. BP 0.3 Palpitations 0.2 Jittery 1.4 Disturb 0.5
Sleep Headache 0.3 Fatigue 0.2 Dry mouth 1.5 ______________________________________
Conclusion: This ongoing open label trial of an herbal combination
produced weight loss with minimal symptoms. These findings led to
initiation of the double blind phase (Example 4).
METHODS
Subjects
Subjects were healthy adults in whom the herbs were not contraindicated.
Protocol
Open label 8 week safety study in obese adults. Weight loss, blood
pressure, and symptoms were monitored over the 8 week treatment
period.
Results
1401 subjects had baseline evaluations; 748 completed 4 weeks;
and 68 completed 8 weeks of treatment.
Subject age distribution is presented in a Figure.
Weight in subjects at 4 wks (mean change=1.72 pds/wk) and 8-wks
(mean change=1.40 pds/wk; plotted in FIG. 2) shows classic exponential
weight-decline. Symptoms for pooled 1401 subjects were minimal (Table).
Blood pressure was unchanged from baseline for all subjects at
last evaluation (Table).
Reported side effects for the 1401 subjects at the time of analysis
are summarized in the Table below. Side effects were minimal and
similar in profile to previous ephedra reports.
______________________________________ BLOOD PRESSURE Baseline
Final SYSTOLIC DIASTOLIC SYSTOLIC DIASTOLIC ______________________________________
MEAN 117.6 75.2 116.8 74.8 SD 13.7 9.3 32.9 20.1 ______________________________________
REPORTED SIDE EFFECTS SIDE EFFECTS NUMBER ______________________________________
Sleeping Disturbance 8 Gastrointestinal 7 Dry Mouth 17 Lethargy
3 Allergic 3 Nervousness 18 Palpitations 6 Blood Pressure Increase
5 Shortness of Breath 2 Headaches 4 Chest Pains 2 Sun Senstive 1
______________________________________
EXAMPLE 4
A double blind investigation of two numbered products, one active
medication and the other placebo was conducted. The following is
a review of results.
The active product tested was a combination of St. John's Wort
and Ma Huang. St. John's Wort is a naturally occurring herb that
has antidepressant properties and is widely used in Europe. Numerous
publications and a meta-analysis strongly suggests efficacy, most
likely through seratonergic mechanisms.
This study evaluated an extract of St. John's Wort which contains
the active ingredient 0.3% hypercin (Hypericum perforatum herb).
Two pills provide a 400 mg dose and are taken twice per day. Total
dose is 800 mg.
Ma Huang is also an herbal supplement which may aid in weight reduction
through its active ingredient the sympathomimetic compound ephedra
sinica herb. Two pills provide 250 mg and are taken twice per day.
Total dose is 500 mg.
The combined medication (Mahuang and St. John's Wort) is taken
is taken in the morning and in the afternoon before dinner.
The aim of the second study was to assess the tolerability, safety,
and weight loss properties of the above plan (2 caplets of Ma Huang
plus St. John's Wort) in the morning before breakfast and two caplets
in the evening before dinner in the double-blind treatment of overweight
subjects over a 12 week period.
A total of 111 subjects were evaluated at base-line and 81 were
randomized at week 0 within 3 weeks to either product identified
as 325 or identified as 916. Base-line evaluations included medical,
nutritional, and psychological studies. Following randomization
at week 0, subjects returned every two weeks for medication count,
symptom evaluation, blood pressure-vital sign check, and psychological/hunger
studies. On the final week 12 visit subjects had repeat baseline
studies.
A total of 32 subjects were randomized to product 325 and 49 to
916. Of those randomized, 26 in the 325 group and 33 in the 916
group completed 12 weeks of study. Thus 59 subjects or 72.8% completed
the study, 81% in 325 and 67% in 916 groups. The chart set forth
hereinbelow provides a summary of subjects who dropped from study.
Three relevant items are summarized below: Weight; Hunger rating;
and adverse events.
Weight
As the number, weight, and sex distribution of completed subjects
varied between groups, assessing comparative weight change requires
balancing initial weight between groups. The groups were balanced
by matching weights and gender at the screening evaluation. A few
missed-weights were also interpolated so that mean values could
be computed on a per visit basis. The tables give the mean and standard
deviation weight at each visit and FIG. 3 presents a plot of this
information. Weight loss on product 916 exceeded that of product
325 by the final visit. The mean weight losses on 916 and 325 were
0.88 pounds/week and 0.66 pounds/week, respectively. In unmatched
subjects the absolute weight loss was 11.8.+-.9.0 and 7.7.+-.7.8
pounds in the 916 and 325 groups (p=0.05), respectively.
______________________________________ PRODUCT WEEK 0 2.0 4.0 6.0
8.0 10.0 12.0 ______________________________________ 325 mean 179.5
176.5 175.4 173.8 173.0 172.6 171.6 SD 26.3 26.0 26.9 26.6 28.2
27.7 29.0 Change 3.0 4.1 5.7 6.5 6.9 7.9 916 mean 179.8 175.3 173.7
172.4 170.5 169.7 169.2 SD 24.6 24.9 24.3 24.2 22.8 22.8 23.9 Change
4.5 6.1 7.4 9.3 10.1 10.6 ______________________________________
The pulse of the subjects presented above was as follows:
______________________________________ WEEK 0 2.0 4.0 6.0 8.0 10.0
12.0 ______________________________________ 325 mean 71 74 71 70
71 72 71 SD 10 10 8 7 7 8 9 916 mean 71 68 71 69 68 69 70 SD 11
7 8 6 7 8 8 ______________________________________
No pulse trend is evident.
The systolic blood pressure of the subjects presented above was
as follows:
______________________________________ WEEK 0 2.0 4.0 6.0 8.0 10.0
12.0 ______________________________________ 325 mean 120 115 117
116 118 116 118 SD 11 10 10 11 13 9 16 916 mean 113 121 119 116
115 117 117 SD 11 16 11 8 11 12 14 ______________________________________
No blood pressure trends are evident from the chart.
Hunger ratings, by visual analog scale, were as follows for the
above subjects:
______________________________________ WEEK 0 2.0 4.0 6.0 8.0 10.0
12.0 ______________________________________ 325 mean 4.35 3.75 3.56
4.08 3.88 4.88 4.49 SD 2.24 2.49 2.74 2.12 2.62 2.73 2.49 Change
0.60 0.79 0.27 0.47 -0.53 -0.14 916 mean 5.02 3.41 3.14 3.33 3.50
3.74 4.38 SD 1.92 2.00 2.50 2.23 1.68 1.87 1.42 Change 1.61 1.88
1.69 1.52 1.28 0.64 ______________________________________
As can be seen from FIG. 4, product 916 caused a greater hunger
reduction over time than 325. Negative values represent greater
hunger reduction. Hunger tended to return towards baseline over
time for both products with 325 at baseline levels by study end.
Side effects on the whole were minor. They were as follows:
______________________________________ SYMPTOM 325 n(%) 916 n(%)
______________________________________ Allergic 0 0 Incr. BP 0 0
Palpitations 0 2 Jittery 0 1 Disturb Sleep 0 1 Headache 0 0 Fatigue
0 0 Dry Mouth 0 0 Other (misc minor) 11 0 ______________________________________
Two 916 patients dropped from study because of dizziness or jittery
feelings. The reasons for dropping out are shown on the following
chart:
______________________________________ REASON FOR PERSON DROPPED
DROPPING CODE SEX ______________________________________ DA Does
not return 325 F calls - 2 visits AJ did not return 325 F calls
- 3 visits BB felt meds. did 325 F not work - 2 visits KB failed
to come - 325 F 2 visits PR failed to call - 325 F 2 visits BP heard
about bad 325 F side effects - 1 visit EC not interested - 916 F
1 visit DD long vacations - 916 F 3 visits WC no time for study
- 916 F 2 visits MJP nervous about 916 F meds. - 3 visits BB moved
to DC - 4 916 F visits AM unreliable - 1 916 F visit MH unreliable
- 4 916 F visits SG canceled appts. - 916 F 4 visits CR failed to
call - 916 F 1 visit CG car accident - 1 916 F visit TF failed to
call 916 M DY never returned or 916 M phoned - 1 visit ______________________________________
These observations, interpreted within the executed study context,
suggest that: both 325 and 916 are safe over 12 weeks of follow-up;
and product 916 produces both greater weight loss and hunger suppression
than product 325.
______________________________________ Person Reason for Dropped
Dropping Code Sex ______________________________________ DA Does
not re- 325 F turn calls - 2 visits AJ Did not 325 F return calls
- 3 visits BB felt meds. 325 F did not work - 2 visits KB failed
to 325 F call - 2 visits PR failed to 325 F call - 2 visits BP heard
about 325 F bad side effects - 1 visit EC not 916 F interested -
1 visit DD long 916 F vacations - 3 visits WC no time for 916 F
study - 2 visits MJB nervous about 916 F meds. 3 - visits BB moved
to DC - 916 F 4 visits AM unreliable - 916 F 1 visit MH unreliable
- 916 F 4 visits SG cancelled 916 F appts. - 4 visits CR failed
to 916 F call - 1 visit CG car accident - 916 F 1 visit TF failed
to 916 M call DY never returned 916 M or phoned - 1 visit ______________________________________
It will be apparent to one of ordinary skill in the art that many
changes and modifications can be made to the present disclosure
without departing from the spirit and scope of the invention as
set forth herein.
A latitude of modification, change and substitution is intended
in the foregoing disclosure, and in some instances, some features
of the invention will be employed without a corresponding use of
other features. Accordingly, it is appropriate that the appended
claims be construed broadly and in a manner consistent with the
spirit and scope of the invention herein described.
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