Primary investigator – Dr Ancy Abraham
Assistant Professor in the Department of Anatomy, Father Muller Homoeopathic Medical College, Mangalore, Karnataka, India, Primary Investigator
1 Dr E S J PrabhuKiran
VicePrincipal and HOD, Department of Anatomy, Father Muller Homoeopathic Medical College, Mangalore, Karnataka, India,
2 Dr Mini. I. V
3Associate Professor in Department of Materia Medica, Father Muller Homoeopathic Medical College, Mangalore, Karnataka, India,
Toxicodendron Pubescens (RhusTox), The Homeopathic medicine frequently used for Osteoarthritis is evaluated with the help of Serum Hyaluronic acid level. For this study out of 70, 44 patients were considered with Primary Osteoarthritis (OA) of knee affection was taken for statistical analysis according to the sample size of the research. Improvements of symptoms of each patient before and after the treatments were analyzed with the help of The Knee injury and Osteoarthritis Outcome Score (KOOS) which was done by case taking and analysis of Serum Hyaluronic Acid is measured through Eliza test which was done under the supervision of a microbiologist and test was done in microbiology lab. The value was evaluated by Biochemist. The drug Rhus tox 200 3 times per day for the entire selected patients was given, Blood samples were collected before and after, administering the drug. Data has taken for statistical analysis to a statistician Serum hyaluronic acid is one of the prognostic criteria for Osteoarthritis; The statistical analysis of data is the drop in the mean value of serum hyaluronic acid from 64.88n/ml to 33.82ng/ml, mean value change in percentage is 47.88
The t value is 8.386with a p-value <0.001 shows high significant in this study it is clear that irrespective of age and duration of treatment there is high significance in changing serum hyaluronic acid with the administration of Rhus tox in Primary Osteo arthritis
KEYWORDS: Primary Osteoarthritis, Toxicodendron Pubescens, RhusTox, Hyaluronic acid, Eliza test, KOOS scale P-value
Osteoarthritis (OA) is a slow, progressive, degenerative disease affecting the articular cartilage of the joints and ultimately causing its destruction leading to disability. The most commonly affected joint is the knee. Pain is a major complaint compelling patient to seek medical advice. Incidence of the joint being disabled is consistent with the period of an individual’s suffering. Primary Osteoarthritis occurs in joints without any previous pathology or any predisposing cause1. Higher levels of Hyaluronic acid (HA) in synovial fluid in comparison with serum were reported in patients with OA, suggesting its local production. Moreover, serum HA levels were shown to be elevated in patients with OA and demonstrated as a possible predictive factor for further development of OA of the knees and hips2.
The Homoeopathic remedy Rhus Tox is prepared from poison ivy, a creeping shrub that is found growing naturally all over North America. Rhus Tox affects fibrous tissue markedly-joints, tendons, sheaths-Apo neurosis, etc., producing pains and stiffness. Worse in, cold, damp weather, at night. A first movement aggravates and a continuous movement reduces the pain Numbness and formication, after overwork and exposure.
1.1 Rhus tox :
Rhus Tox (Toxicodendron pubescens) is found in sandy woods in the eastern United States. The tincture contains Rhoitannic acid (C18H28O13) and Toxicodendric acid, a poisonous, volatile principle3. A peculiarity of the plant is that it is more poisonous during the night, and when bursting into leaves, or at any time in June or July when the sun is not shining upon it. Those who Care for Signatures will not fail to connect the cardinal aggravations of Rhus Tox– at night and from damp – with the increased the virulence of the plant at night and in damp atmosphere4.
The main indication of Rhus tox is-
- Rhus affects fibrous tissues markedly-joints, tendon, sheaths- aponeurosis etc., producing pains and stiffness of muscles and joints3. Rheumatism in cold damp season5.
- The first and the foremost feature of Rhus tox is the amelioration of all symptoms from continual motion
- It has great sensitiveness to open air and to all atmospheric changes6.
- Tearing asunder pains. Parts feel sore bruised and stiff
- Pains are tearing, shooting, stitching, worse at night, cannot rest in any position
- Tenderness about the knee joint.
- Hot painful swelling of joints
- Soreness of condyles of bones.
- The Greatest rigidity and pain is experienced on first moving the joints after rest, and on waking up in the morning. After the joints are moved for a while the pain is lessened3.
Hyaluronan (HA) was formerly called Hyaluronic acid or Hyaluronate. It is found in all extracellular matrixes and in most tissues, its molecules being relatively enormous. Hyaluronic acid forms a very viscous solution which is probably the major lubricants in Synovial joints7.
1.2.Functions of Hyaluronic acid in joints
- Articular cartilage8
- Hyaluronic acid (HA) is crucial for the structural and functional integrity of articular cartilage and responsible for the unique viscoelastic properties of the synovial fluid. The very large aggregates (>108kDa) that are thus formed may be the essential compression –resisting units in cartilage9
- Hyaluronic acid is the most active form of Glycosaminoglycans (GAG)
- The molecular mass of Hyaluron in cartilage is not constant and decreases considerably during maturation and ageing of tissue 9.
1.3. Synovial fluid 10
- It works as a shock absorber.
- Lubricating the fluid in the joint tissues, as well as stabilizing its breakdown.
- It removes the waste products, often acidic in nature, that arise from the destruction of the cartilage matrix and hence eases joint pain.
- As an antioxidant, it further supports joint health by protecting joint destruction due to free radical
1.4. Fibrous Capsule 9
- Anti-inflammatory and anti-edematous properties. The molecular weight (size) of Hyaluron in cartilage decreases with age, but the amount increases. It results in increasing the viscosity of the synovial fluid and leads to stiffness, loss of flexibility, destruction of articular cartilage, inflammation of fibrous capsule, and oedema result in primary Osteoarthritis 9.
1.5. The fundamental idea of Homoeopathy
Homoeopathy implies a particular way of applying drugs to diseases according to a specific Principle: known as ‘Similia similibus curentur’ (‘Let like be treated by likes’) 10, stated by the German physician Samuel Hahnemann (1755–1843) in 1796. This implies that substances capable of causing disorder in healthy subjects are used as medicines to treat similar patterns of disorder experienced by ill people.
In this study, the symptoms of Rhus tox during drug proving have many similarities with the action of Hyaluronic acid in joints like the knee.
1.6 The Similarity of Hyaluronic acid and Rhus tox
|Serial number||Symptoms common to Osteoarthritis and Rhus tox
||Role of Hyaluron in Osteoarthritis and the similarities of Hyaluron and Rhus tox|
1. stiffness (within 4hrs of drug proving)12
1.7. How do Homoeopathic medicines acts
Homoeopathic medicines are aimed to direct and stimulate the body’s self-regulatory mechanisms.
1.8. Selection of potency 14
There are fivefold considerations for choosing the potency of Homoeopathic Drug
1 The Susceptibility of the patient,
2 The seat of disease,
3 The nature and intensity of the disease,
4 The stage and duration of the disease,
5 The previous treatment of the disease,
Repetition of the homoeopathic remedy
According to aphorism 248, the dose of the same medicine may be repeated several times according to the circumstances, but only so long as until either recovery ensures, or the same remedy ceases to do good and the rest of the disease presenting a different group of symptoms demands a different homoeopathic remedy12
It is purely depended on patient14,
1.9. There was a Research Article shows that
Hyaluronic acid levels may have predictive value for the progression of knee osteoarthritis
Open Archive in partnership with OsteoArthritis Society International
Under an Elsevier user license
Hyaluronic acid levels have predictive value for the progression of knee Osteoarthritis. In this Research, it is evaluated that the “Efficacy of Toxicodendron Pubescens in relation with Hyaluronic Acid and its application in Primary osteoarthritis.” The parameter used in this study is the Clinical evaluation of the symptoms according to the KOOS Scale as well as Serum Hyaluronic acid level. Serum Hyaluronic acid is measured before and after the treatment.
2.1. Sample Details
Patients attending the OPD of Father Muller Homoeopathic Hospital Deralakatte were enrolled for the study. A total number of 70 Patients between the age group 40 to 70 were screened to ensure enrollment of 44 patients in the trial. The Diagnosis was made on the basis of clinical presentation. A detailed case study was done and patients were analyzed using the KOOS Scale, before and after the treatment. To get the accurate Serum Hyaluronic acid level the blood has withdrawn on appropriate time before the medicine and after the medicine when the symptoms were better according to the KOOS Scale Score.
2.2. Inclusion criteria
Age 40 to 70, Both sexes are included, Patients selected on the basis of clinical presentation, history and examination with serum hyaluronic acid level, Only primary osteoarthritis cases considered, Only those patients are considered whose complaint indicated for Rhus Tox and change in serum hyaluronic acid
2.3. Exclusion criteria
Cases other than primary osteoarthritis are not considered. Those Patients are not considered, whose symptoms not indicated for Rhus Tox and change in serum hyaluronic acid
2.4. Materials and Method
Approval of the Institutional Ethics Committee of Father Muller Charitable Institution was obtained before the initiation of the project and the procedures followed were in accordance with the ethical guidelines for biomedical research provided by the Indian Council of Medical Research, New Delhi. Informed consent was obtained from each individual before the screening study.
2.5. SOURCE OF DATA
Patients attending the OPD of Father Muller Homoeopathic Hospital Deralakatte were enrolled for the study. A total number of 70 Patients between the age group 40 to 70 were screened to ensure enrollment of 44 patients in the trial. The Diagnosis was made on the basis of clinical presentation. A detailed case study was done and patients were analyzed using the KOOS Scale, before and after the treatment. To get the accurate Serum Hyaluronic acid level the blood has withdrawn on appropriate time before the medicine and after the medicine when the symptoms were better according to the KOOS Scale Score. Purposive sampling, after the collection of blood samples for the pretest. Rhus Tox 200 is administered according to the protocol.
2.6. Research methodology
Criteria for deciding the efficacy of Rhus Tox in Primary Osteoarthritis is based on the intensity of symptoms, change in KOOS Criteria KOOS SCALE is an extension of the WOMAC Osteoarthritis Index with the purpose of evaluating short-term and long-term symptoms and function in subjects with a knee injury and osteoarthritis. The KOOS holds five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL) 16
and Changes in Serum Hyaluronic acid level. Data from the sample were subjected to paired t-test because KOOS criteria are only to see the follow-up improvement and second withdrawal of blood to determine the significance of the efficacy of the drug.
2.7. ASSESSMENT OF EFFECTIVENESS
The data of 44 patients were statistically analyzed. According to Statistical analysis, the effectiveness of RhusTox in Primary Osteoarthritis with the change in Serum Hyaluronic acid is Highly Significant. There was a Statistically High Significant drop in Serum Hyaluronic acid level after the treatment.
2.7.1 Table 1.1 Serum Hyaluronic Acid Value in Elisa Machine
2.7.1 Table 1.2 Serum Hyaluronic Acid Value in Elisa Machine
2.7.1 Table 1.3 Serum Hyaluronic Acid Value in Elisa Machine
2.7.1 Table 1.4 Serum Hyaluronic Acid Value in Elisa Machine
2.7.1 Table 1.5 Serum Hyaluronic Acid Value in Elisa Machine
2.7.1 Table 1.6 Serum Hyaluronic Acid Value in Elisa Machine
2.8 PLAN OF DATA ANALYSIS
The effectiveness of RhusTox in Primary Osteoarthritis with changes in Serum Hyaluronic acid before and after the treatment is shown in table 2 with
Mean value before treatment as 64.88, after treatment 33.82 and
A Standard Deviation of difference 24.57,
The “t” value is 8.386 and
2.7.1. p<0.001 which indicates High Significant
Table .1 Effectiveness and Significant P-Value
|N||Mean||Std. Deviation||Mean difference||S.D of difference||Mean change (%)||t value||p|
Table. 2. Standard Deviation
Chart 1. The significant drop in Serum Hyaluronic Acid level after the administering Rhus Tox
Table.3. Improvement of Osteoarthritis Symptoms in Percentage
Table.4. Improvement of Osteoarthritis Symptoms in Percentage
Chart. 2. Improvement of Osteoarthritis Symptoms According to the Percentage
Table.5. Improvement of Osteoarthritis Symptoms according to Age
|40 – 50||10||22.7|
|51 – 60||24||54.5|
|61 – 70||10||22.7|
Chart. 3.Improvement of Osteoarthritis Symptoms according to Age
Toxicodendron Pubescens (Rhus Tox) is effective for Primary Osteoarthritis by altering Serum Hyaluronic acid level. On the basis of the fundamental principle of Homoeopathy ‘Similia similibus curentur’ the study explains scientifically, that Toxicodendron Pubescens (Rhus Tox) is effective in primary osteoarthritis by correcting Serum Hyaluronic acid level. Its action results in altering the composition of the Hyaluronic acid similar to the changes that occur in Primary Osteoarthritis.
I express my heartfelt Gratitude to Dr. (Prof.) Shivaprasad. K, Principal, Father Muller Homoeopathic Medical College and Hospital and Dr Srinath Rao, HOD of Department of Materia Medica, Father Muller Homoeopathic Medical College and Hospital. I am thankful to Dr Rekha Latha, HOD of Microbiology, Father Muller Charitable Institution, and Dr Shivashankar, HOD of Biochemistry, Father Muller Charitable Institution for providing Lab facilities and Mrs Sucharitha Suresh, Statistician, Father Muller Charitable Institution who has helped in analysing the project.
The Author disclosed the receipt of the following financial support for the research, authorship and or / publication of this article. This work was financially supported by the Rajiv Gandhi University of Health Sciences, Bangalore, Karnataka, India (Grand Number (ORDER No. RGU: adv. Res: Proposal – H- 351:2015-2016) .
Approval of Institutional Ethics Committee of Father Muller Charitable Institution was obtained before the initiation of the project, and the procedures followed were in accordance with the ethical standards provided by Indian Council of Medical Research, New Delhi. Informed consent was obtained from each individual before the screening study. The clinical trial is registered in the Clinicaltrial.gov protocol registration system (CTRI/2015/11/006350 [Registered on: 09/11/2015]).
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