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Arthritis
We are committed to continuing research on botanicals and natural
health products that are beneficiary to the health of the people in
our communities.
The Arthritis study was conducted by the Homeopathic College of
Canada, the International Academy of Homeopathy and the Toronto
Homeopathic Clinic and shows the efficacy of the Traditional
Healer's™ Arthritic Formula, Arti-xen™.
COMPARISON OF CLINICAL EFFECTIVENESS OF NON-CONVENTIONAL
THERAPEUTIC REMEDIES IN THE TREATMENT OF ARTHRITIS. PILOT STUDY.
by F. ANIA N.D., A. TYLES, Ph.D., C. POPA, D.H.M.S., M.D.
ABSTRACT
In
this pilot study, homeopathic practitioners from the Homeopathic
College of Canada and The International Academy of Homeopathy
carried out a comparative study of the effectiveness of
non-conventional remedies in the treatment of arthritis. Seventy
(70) arthritic patients participated in the study.
The patients were divided into two groups. Patients in the “remedy
group” (36 patients) were given individually selected homeopathic
remedies. Patients in the “formula group” (34 patients) were given
the Canadian Healer’s™ Arti-xen™.
Although it was found that both homeopathic treatments and
Traditional Healer’s™ Arti-xen™ Formula were equally effective in
(80.55% and 79.41% p>0.05 2=0.016) standardized groups of arthritis
patients (OA and RA). The “formula group” experienced a
significantly greater improvement in treating various symptoms and
signs (1.36 vs. 2.86 symptom/patient improved.)
The Formula was especially effective relieving pain (86.66% of the
patients were relieved) as well it improved stiffness (75.00%) and
swelling (80.00%) and increased the energy level of the patients
(89.33%). Although the Formula showed the greatest improvement for
the varying symptoms. It was also found that higher percentages of
patients were improved with the individually prescribed homeopathic
remedies when patients had the condition for more than 10 years.
It was concluded that the Traditional Healer’s™ Arti-xen™ Formula is
a reliable medicine for the treatment of arthritis, as well as
carefully selected individual homeopathic remedies.
Should you need more information on the arthritis study, please
e-mail The Homeopathic College of Canada at:
info@homeopathy.edu
INTRODUCTION
According to a 1992 study published by the New England Journal of
Medicine1 , 380 million visits were paid to conventional medical
doctors compared to 450 million to alternative practitioners, and
$13.3 billion U.S. were spent in the USA in alternative medicine.
The demand for preventing and managing diseases with less invasive
means has increased considerably during the last ten years and will
continue to do so within the next 10 years due to a general public
who are more aware of health and environmental issues.
Arthritis is the most common cause of long-term disability in
Canada2 and it is one of the three most common chronic conditions in
Canada3. One in every seven Canadians suffers from some form of
arthritis3. A 1991 Health and Welfare Canada study estimates the
nationwide financial impact of the disease at $8 billion per year4.
Today, increasing attention is given to remedies derived from
natural products with analgesic effect as immunostimulants or anti-inflammatories.
Among them are homeopathic and botanical remedies. A formulation for
arthritis, Traditional Healer's™ Arti-xen™ Formula (Fr.)
manufactured by Curanderos Ltd. in Toronto was one of the treatments
used in this study along with homeopathic remedies (Rx.).
Homeopathy is the fastest growing system of medicine in the world,
and after conventional medicine, the most widely used. In the early
nineteenth century, Samuel Hahnemann, a German physician was the
founder of homeopathy. Homeopathic remedies are derived from
vegetable, mineral and animal substances and are used to treat a
wide range of conditions, including acute infections, injuries,
chronic diseases and emotional disorders. Remedies are carefully
selected, according to each individual case, to stimulate the body’s
own defence systems to heal the body, mind and spirit in harmony,
and when properly prescribed, without toxic side effects.5,6
Homeopathy (a Greek word meaning "similar suffering") is a system of
medicine which treats disease by the use of natural substances that,
when administered to a healthy person in a more crude dose, produce
symptoms similar to the condition for which they are being
treated.5,6,7 When a small, often infinitesimal dose of a substance
is administered to a person who exhibits symptoms of illness, that
substance can stimulate the body's own healing abilities to effect a
deep and long lasting cure. Homeopathy is based on the law Similia
Similibus Curantur, or let like be cured by like.6,7 This postulate,
present in the work of Paracelsus, father of chemical medicine, was
foreseen in ancient Greece by Hippocrates. Homeopathy is a
well-established healing system using remedies that have been
carefully researched and selected.
Traditional Healer's™ Arti-xen™ Formula is a specific standardized
formulation of the South American herb Uncaria tomentosa (Willd.
D.C.) and Glucosamine sulphate 24X. The Uncaria species belong to
the Rubinaceae family. The name Uncaria tomentosa was coined in 1830
from the Latin “uncus” - claw and "tomentosa" - fine hair.8 Uncaria
tomentosa (Willd. D.C.) is widely used in Traditional traditional
medicine for inflammatory and cancerous conditions.
Homeopathy has had a substantial body of knowledge in North America,
where there were in the past century, 195 homeopathic hospitals and
over 150 periodicals and journals. Rheumatism has been shown to be
treated successfully by homeopaths.9,10. Experimentally, Uncaria
tomentosa has shown to be anti-inflammatory, anticarcinogenic11 ,
antioxidant, and antileukemic,12 effective against encapsulated RNA
viruses.13 Positive results have been observed in patients with
different pathologies, including AIDS (increasing T4 cell levels and
reducing symptomatology).14 It increases lymphocyte and macrophage
activities,15 antipyretic,16 hypotensive,17 diuretic,18
immunostimulant,19 enhances the immune response of the reticulo-endothelial
system. Clinically promising results have been observed on arthritic
patients, as demonstrated in the following study.
MATERIALS AND METHODS
The main goal of our research was to assess and compare the
effectiveness of standardized Arti-xen™ Formula, manufactured by
Curanderos Ltd., and homeopathic remedies in the treatment of
arthritis.
For participation in the study The International Academy of
Homeopathy recruited seventy (70) arthritic subjects from general
medical clinics, and the community of Toronto and randomly allocated
them into two groups of observation. The subjects of each group
received treatment, either
standardized Arti-xen™ Formula, or individually prescribed
homeopathic remedies.
The first group of 36 patients were treated with homeopathic
remedies. Some of the remedies that were used were: Arnica, Aurum,
Bryonia, Calcarea, Colubrina, Gelsemium, Hypericum, Ignatia,
Lachesis, Lycopodium, Metalicum Album, Natrum Muriaticum,
Phosphorus, Pulsatila, Rhus-tox, Ruta, Sepia, Silicia, Sulphur,
Thuja, in potencies from 12X to 200C.20,21,22,23,24
The second group of 34 patients were treated with the Arti-xen™
Formula, 25 drops three times per day, for 15 days and then 25 drops
twice a day until the end of the study. Ingredients for the Arti-xen™Formula
were prepared by Curanderos Ltd. by alcoholic extraction from
specially chosen parts and vines of Uncaria Tomentosa by traditional
Traditional healers according to their traditional knowledge. The
ingredients were extracted by a double extraction method in alcohol,
standardized at a minimum of 3.0 mg/ml of oxindole alkaloids and
0.50 mg/ml isoptoropodine and Glucosamine Sulphate 24X.
The treatment of both groups lasted 9 weeks and together with the
period of observation the study totaled 4 months, from March 1997 to
June 1997.
A questionnaire was given to people interested in participating in
the study at the time of the first interview. All participants were
asked to answer all items on the questionnaire which included items
such as: age, sex, socioeconomic status, chronic illness, major
symptoms, date diagnosed with arthritis, duration of disease,
dietary habits. All changes in the state of health during the study
were reflected in the same questionnaire completed by researchers
who used objective symptomatalogy as well as subjective feelings of
patients as improvement of symptoms such as pain, inflammation
swelling, stiffness/restricted motion, energy level. Additional
intake of anti-inflammatory, pain killer drugs or alternative
medicine was also noted.
Differences between results in the group treated with homeopathic
remedies and the group treated with Arti-xen™ Formula, were assessed
by means of analysis of variance by Chi-square test. The second method
was used to assess the significance of differences of outcome of
treatment in each group over a study period within 95% confidence
interval.
RESULTS
Download all tables here
Randomization produced two groups with similar characteristics. Both
groups were approximately equivalent by age, sex, duration of
disease (years) and weight (kg). (See Table 1)
Same differences of the indexes were statistically insignificant and
adjustment of co-variants by means of standardization of group was
not necessary. These differences will not affect the final results.
On the other side this is shown by independent distribution of
patients over groups of
observation.
The treatment of patients with arthritis showed high levels of
improvement in both groups during treatment and observation period.
Among patients, who were treated with the Arti-xen™ Formula, 79.41%
of the patients noticed an improvement, compared to 80.55% of the
patients who received
homeopathic remedies. Arthritic symptoms and signs were monitored in
both groups, called: Remedy group (Rx.) and Formula group (Formula
or Fr.) (Table 2)
In the formula group 86.7% of the
patients noticed decreased pain. Restricted motion and stiffness
were reduced in 80.0% of the patients. Swelling was reduced in
75.00% and level of energy and well being was increased in 89.3%
(Table 3). These rates in the Formula group were more significant
than in the remedy group.
In the Formula group, the stiffness was reduced 2.7 times more often
than among patients in the Rx. group; swelling and pain were reduced
1.4 times more often than patients in the Rx. group. Number of
symptoms/patients improved: 1.36 in the Rx. group and 2.86 in the
Formula group.
As shown in Table 4, the results of treatment were better among
patients in the Formula group at any week of observation. Especially
positive results were noticed after the first week of treatment.
Pain relief occurred in 1.5 times more often among patients in the
Formula group than in the Rx. group. Almost the same ratio was
noticed among patients complaining of swelling of the joints. Energy
level in the Formula group was 2.3 times higher than in the Rx.
group. These indexes changed slightly or even lasted almost the same
during observation period. In the Formula group, the stiffness was
reduced 2.7 times more often than among patients in the Rx. group;
swelling and pain were reduced 1.4 times more often than patients in
the Rx. group. Number of symptoms/patients improved: 1.36 in the Rx.
group and 2.86 in the Formula group.
As shown in Table 4, the results of treatment were better among
patients in the Formula group at any week of observation. Especially
positive results were noticed after the first week of treatment.
Pain relief occurred in 1.5 times more often among patients in the
Formula group than in the Rx. group. Almost the same ratio was
noticed among patients complaining of swelling of the joints. Energy
level in the Formula group was 2.3 times higher than in the Rx.
group. These indexes changed slightly or even lasted almost the same
during observation period.
Download
tables here
After 9 weeks of treatment and observation, the patients in the
Formula group noticed a decrease in the level of pain, 1.36 times
more often than patients in the Rx. group. The stiffness and the
restricted motion were reduced 2.7 times compared to the Rx. group.
The pain was relieved 1.36 times more often among patients in the
Formula group than in the Rx. group. The energy level rose 2.45
times more among patients in the Formula group when compared to the
Rx. group.
There is a positive relationship between duration of intake of the
Arti-xen™ Formula, and pain relieved for 9 weeks of treatment
(coefficient of correlation +0.3), and the same positive
relationship between homeopathic treatment and decrease in swelling
of the joints. However, absence of the obvious stable positive trend
during the entire period of treatment, compels to reconsider term of
administration of remedies or to take into consideration other
factors.
In both groups there is a positive correlation between duration of
disease and treatment, either with homeopathic remedies or with the
Arti-xen™ Formula. In the Rx. group coefficient of correlation was
+0.32 (positive medium degree of link). The Formula group has
positive medium degree of link with coefficient of correlation equal
+0.44. According to the results there is a positive correlation
between the shorter disease period of the patient and the
improvement of the patient (Table 5).
The effectiveness of treatment with the Arti-xen™ Formula was higher
than with homeopathic remedies among patients with duration of
disease less than 5 years and between 5-9 years. All 12 patients who
had the disease for 5 years or less and all 10 patients who had the
disease for 5-9 years were improved with the formula; in the Rx.
group, the percentage of patients improved were 85.7% and 83.3%
respectively. The statistical difference of outcome of treatment
among these two groups was significant only among patients with
duration less than 5 years (2 =17.98;p<0.05).
In the Rx. group, 25 people or 69.4% had concomitant disease. The
Formula group has a similar number of patients 70.6%. In spite of
better results of treatment in the Formula group where 60.7% of
patients noted improved state of health after treatment compared to
42.3% such patients of the Rx. group. This difference was
statistically insignificant (?2 =1.235, p>0.05). (See Table 6)
The best results in the treatment of the Rx. group were achieved
among patients with one or more than three concomitant disease - 50%
of patients felt an improvement in health status. Similar results
appear in the Formula group. The greatest success in this group was
noted among patients with 3 or more chronic diseases. However,
statistical difference of outcome among those patients was less
insignificant (2 =0.4; p>0.05). The explanation should certainly lay
in the nature of treatments; the Arti-xen™ Formula is a very
effective anti-oxidant therefore it effects all free-radical related
pathologies; homeopathy treats the whole person rather than symptoms
therefore its effects are not limited to arthritis only.
DISCUSSION
One of the principal medicinal ingredients found in the Formula are
a variety of oxindole alkaloids.25 The presence of three specific oxindole alkaloids is of vital importance to the clinical efficacy
of the Formula. These three are isopteropodine, pteropodine and
mitraphylline. These three oxindole alkaloids ensure maximum
effectiveness during treatment.
The strong anti-inflammatory activity of the extract fractions of
the Arti-xen™ Formula, may be due to the presence of a combination
of compounds. It is possible that some compounds like glycoside 7
have an intrinsic anti-inflammatory effect, while other compounds
may act synergistically or as vehicles enhancing the biological
activity. However, we can't rule out that the activity of the
extracts and fractions could be due to a very minor compound not
isolated yet, or to an isolated compound but at a higher dose (i.e.
oleanolic acid has anti-inflammatory effects).
In the last two decades a great interest has developed in substances
that possess properties that directly or indirectly reduce or
eliminate the mutagenic activity of other chemicals. These
substances are called "antimutagens" and many of these inhibitors
occur naturally in food or elsewhere in nature. The inhibitors
present in food are mainly of plant origin and have diverse chemical
structure. Among antimutagens, anti-oxidants are one of the most
important classes . The involvement of active oxygen and free
radicals has been demonstrated in a variety of pathological events
such as cancer and aging process.
In the present study both treatment groups had significant
improvement over 9 weeks of treatment. In general the treatment with
Arti-xen™ and homeopathic remedies were comparable.
Regarding the correlation between the treatment and the additional
intake of other drugs, the study shows better results among the
Formula group. (See Table 7)
The results in the treatment of the patients with swelling of the
joints can be influenced by unequal groups of patients that took
additional medication. In the Rx. group all 15 patients who
experienced swelling of the joints, took additional medication
(anti-inflammatory or painkiller drugs) during 9 weeks of treatment.
In the Formula group, 60% of the patients stopped or reduced the
medication that they were taking prior to, and throughout the study.
(See Table 7)
CONCLUSION
It can be concluded that the individually prescribed homeopathic
remedies and the Arti-xen™ Formula are significantly effective in
the treatment of arthritis. Both modalities resulted in similar
outcomes when looking at overall improvement of patients. The
Arti-xen™ Formula treatment showed a
significantly greater improvement in treating various symptoms and
signs (Pain, Swelling, Stiffness, Energy). The Formula is not only
the optional remedy for the treatment of separate symptoms, but also
a reliable medicine for the treatment of complex syndromes.
This study is a first step in a series of studies dealing with the
treatment of arthritis using the above two treatments. In this pilot
study, clinical evaluation of therapeutic effectiveness was based on
subjective and objective criteria. The study's purpose was to
observe the efficacy of the two
treatments and compare them on a subjective and objective level. In
the coming year a subsequent study will be done dealing with
arthritis and the same two treatments, homeopathic remedies and
Arti-xen™ Formula. This upcoming study will add to the pilot study
by recording subjective data, as well as other objective parameters.
It will be conducted as a double blind study and it will be
conducted with a larger group of patients.
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2 Arthritis Society of Canada: internet reference: http://arthritis.ca/tv/slides/06b.gif.
1996.
3 Arthritis Society of Canada.: internet reference: http://arthritis.ca/tv/slides/03b.gif.
1996
4 Health and Welfare Canada.: Financial Impact of Arthritis. Medical
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