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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.

References:

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