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Controlled trial with R. COMPOUND in certain Orthopaedic disorders

.... Satisfactory response in the form of significant remission in clinical signs in Rheumatoid Arthritis, Osteo-arthritis, Bursitis, Fibrositis and non-specific Joint Pains, was observed in 87.2% of patients.

R. Compound did not produce any untoward side effects, and so it is regarded as a safe drug.

 

CLINICAL EVALUATION of "R. COMPOUND" in RHEUMATOID ARTHRITIS and in certain other ORTHOPAEDIC DISORDERS

by

Dr. RACHHPAL SINGH SANDHU, M.S., Prof. of Orthopaedics

Dr. HARDIP SINGH SOHAL, M.S., Registrar in Orthopaedics

Dr. TEJINDERJIT SINGH, P.G. Student for M.S., (Ortho) Medical College & V. J. Hospital, Amristar

 

- Paper at: 5th Annual Conference of Indian Rheumatic Association Amritsar, 20-21 Dec. 1975.

 

INTRODUCTION:

We had the following objectives for the study of R. Compound in certain orthopaedic disorders: 1) To study the therapeutic efficacy of R. Compound. 2) To study the toxicity, side effects and safety of R. Compound.

 

MATERIALS AND METHODS:

40 patients of Orthopaedic disorders regu­larly attending V.J. Hospital, Amritsar, were in­cluded in the study, There were 12 Male pa­tients and 28 Female patients. Their age ranged from 15 years to 65 years. Children below 15 years were excluded from the study. There was one case of slipped femoral epiphysis, but this case was not fully followed up and so this was not included in the final analysis.

A full history and complete clinical exami­nation were recorded, as also the previous treatment. Routine blood examination and urine examination were done in all the cases. ESR was done in 15 cases out of 23 cases of Rheumatoid Arthritis.

The period of clinical study was upto 12 weeks. If no response to R. Compound was observed within three weeks, the therapy was discontinued.

During the period of the trial, the patient's signs and symptoms were regularly recorded at weekly intervals. Particular attention was given about recording the side effects, if any, and in particular to loss of appetite, nausea, vomiting, bowel motions, uneasiness, giddi­ness, urinary trouble and to any appearance of rash.

 

CONTROL GROUP:

20 cases formed the control group and were investigated and studied as the R. Com­pound Group. Placebo was given for 12 weeks. If no response to placebo was ob­served within three weeks, the placebo was discontinued.

 

CLASSIFICATION OF CASES:

The patients were grouped depending upon the clinical diagnosis. The details are given in Table No. 1, for the study group. They are classified as Acute and Chronic Cases.

 

TABLE 1 - CLASSIFICATION OF CASES

	Acute	Chronic	Total	%
A. Rheumatoid Arthritis:	6	17	23	57.5%
B Osteoarthritis:	-	10	10	25.0%
C. Bursitis & Fibrositis:	1	2	3	7.5%
D. Non-specific Joint Pains:	-	3	3	7.5%
E. Slipped Epiphysis:	-	1	1	2.5%
TOTAL:	7	33	40	100.0%

 

In the R. Compound Group there were 23 cases (57.5%) of Rheumatoid Arthritis: 10 cases (25.0%) of Osteoarthritis; 3 cases (7.5%) of Bursitis & Fibrositis: 3 cases (7.5%) of Non-specific Joint Pains; 1 case (2.5%) of Slipped femoral epiphysis.

 

In the Control Group of 20 patients, the pat­tern of classification follows similarly as in the R. Compound Group and the details are given in Table No. 2.

TABLE 2 - CONTROL GROUP

	Acute	Chronic	Total	%
A. Rheumatoid Arthritis:	3	9	12	60.0%
B.Osteoarthritis:	-	5	5	25.0%
C. Bursitis 8 Fibrositis:	1	1	2	10.0%
0. Non-specific Joint Pains:	-	1	1	5.0%
E. Slipped Epiphysis:	-	-	-	-
TOTAL:	4	16	20	100.0%

 

DOSAGE SCHEDULE:

For the study Group, R. Compound was given 2 tabs, three; times a day for four weeks. Where the. response was satisfactory, the dose was reduced to 2 tabs. twice a day. The treatment was continued upto a period of 12 weeks. If no response was observed after three weeks of threapy, R. Compound was discontinued. In all the six acute cases of Rheumatoid Arthritis, R. Compound was com­bined with some other drug, phenylbutazone, Salicylates or Corticosteroids for 7 to 10 days. Thereafter, only R. Compound was continued for 12 weeks.

The same pattern of therapy was followed with placebo for the 20 cases of the control group.

 

OBSERVATIONS & RESULTS:

Grading of the therapeutic response was done as Good, Fair and Poor depending upon the clinical symptomatology. In our series the results were satisfactory. The overall results were Good in 24 cases (61.6%), Fair in 10 cases (25.6%) and Poor in 5 cases (12.8%).

 

TABLE 3 - ORTHOPAEDIC DISORDERS

	Total Good		%	Fair	%	Poor	%
Rheumatoid Arthritis:	23	16	69.6%	5	21.7%	2	8.7%
Osteoarthritis:	10	6	60 %	2	20 %	2	20 %
Bursitis 8 Fibrositis:	3	-	-	2	66.7%	1	33.3%
Non-specific Joint Pains:	3	2	66.7%	1	33.3%	1	33.3%
Slipped Epiphysis:	-	-	-	-	-	-	-
TOTAL	39	24	61.6%	10	25.6%	5	12.6%

In the Control Group only 2 cases (10.0%) gave satisfactory response arid 18 cases (90.0%) gave poor response.

 

SAFETY & SIDE EFFECTS:

R. Compound can be regarded as safe, as we did not come across with any significant

side effect. We did not come across even minor gastro-intestinal disturbances such as nausea, vomiting etc.

 

CONCLUSION:

The results of our series were satisfactory. In Rhematoid Arthritis, the response was Good in 69.6%, Fair in,21.7%, both totaling 91.3% of satisfactory response. In Osteoar­thritis_ the response was good in 60.0% and Fair in 20.0% thus giving satisfactory re­sponse of 80.0%. In Bursitis & Fibrositis, the response was Fair in 66.7%, which was the satisfactory response. In Non-specific Joint Panis the response was Good in 66.7% and Fair in 33.3%, thus giving 100.0% satisfactory response. Some cases showed improvement in appeitite and a sense of well-being. The overall response is also given in Table No. 4.

TABLE 4 - OVERALL RESPONSE

Disorder	Good	Fair	Total
Rheumatoid Arthritis:	69.6%	21.7%	91.3%
Osteoarthritis:	60.0%	20.0%	80.0%
Bursitis & Fibrositis:	-	66.7%	66.7%
Non specific Joint Pains:	66.7%	33.3%	100.0%
Overall Response	61.6%	25.6%	87.2%

(One case of Slipped epiphysis was dropped)

 

SUMMARY:

40 cases of Orthopaedic disorders, attend­ing regularly the O.P.D. of the V.J. Hospital formed the R. Compound Group and 20 cases formed the Control Group. Satisfactory Re­sponse in the form of significant remission of clinical signs was observed in 87.2%. It was observed .that R. Compound did not produce any untoward effects, and so it is regarded as a safe drug.

 

ACKNOWLEDGEMENTS:

We are thankful to the Principal, Medical College, Amritsar, and the Medical Supdt. V.J. Hospital (Shri Guru Teg Sahadur Hospital), Amritsar for permission to carry out this trail. Our thanks are also due to Shri Jagdish Kang of Alarsin Pharmaceuticals, Bombay, for the supply of R. Compound necessary for the trial.

 

REFERENCES:

1. Ethirajulu, M.S. and Venkata Reddy J. (1972) R. Compound. in Rheumatoid Ar­thritis and other Chronic Arthritics - paper presented at the 4th Annual Conference of the Association of Orthopaedic Surgeons of Andhra Pradesh, Hyderabad.

2. Mohanty B. (1972). R. Compound in Filarial Arthritis -Indian Practitioner 25(9): 417-19.

3. Ramachandra K. and Pari L. (1972) R. Compound in Rheumatoid Arthritis - Mediscope. 15 (6):253-58.

4. Subramanium R. (1972) R. Compound in Osteoarthritis. Madras Clinical Jr. 36: (13)

5. Makhani J.S. (1973) - Paper before 6th Conf. of Tamil Nadu Ortho. Association at C.M.C. Vellore, Dec. 1973.

6. Mrs. Sanghavi, S.M. (1974) -Paper before Joint Conf. of Indian Rheumatism Associa­tion and Indian Association of Physical & Rehabilitation, Bombay. Nov. 1974.

 

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