Dr R.S Kulkarni

COMPARATIVE EFFICACY OF R' COMPOUND,

AN INDEGENOUS FORMULATION AND ASPIRIN IN THE
TREATMENT OF POLY ARTICULAR RHEUMATOID
ARTHRITIS ON 104 PATIENTS
AN OPEN STUDY.

Dr R.S Kulkarni, M.B.B.S., Ortho. , M.S (Bom) F.C.P.S (Ortho)
Medical Supdt., Govt Rural Hospital, Kudal : 416 520, Dist Sindhudurg

 

INTRODUCTION

Rheumatoid arthritis is a crippling disease; with no satisfactory remedy till today and has been known since the times of Hippocrates. The disease has been mentioned in Ayurveda and has been described by Charak, Sushrut¹. It is a common disorder related to varied multi­ple anatomical sites, both articular and extra articular².

Although number of anti-inflammatory drugs are in use unfortunately not a single fits in - from the point of view of efficacy as well as tolerance. Hence the disease continues to be a challenge to the Orthopedic Surgeons. So, there is need for a drug having good effi­cacy with low toxic profile for prolonged use in preventing exacerbations and remissions.

In Ayurveda, large number of herbal drugs having similar therapeutic actions are in clinical use since centuries for the treatment of rheumatoid arthritis and have stood the test of time, especially for long term use  - One such product is - R. Compound, prepared on the basis of Indian medicinal system of Ayurveda.

AIM OF STUDY

Theindigenous drug - R.Compound mainly to be used for a pretty long time in a chronic crippling disease like Poly articular rheumatoid arthritis, as compared to good old timehonored drug - Aspirin. The trial was designed to test anti-inflammatory, analgesicand over all effects including the side effects of an ayurvedic drug - R. COMPOUND and ASPIRIN. And much more so to know their ef­fect on remissions and exacerbations.

R. COMPOUND

R. Compound is an indigenous drug man­ufactured by M/s Alarsin Pharmaceuticals, Bombay containing the following ingredients.

I.              Mahayograj Guggul with gold bhasma - 200 mg. Its chief ingredient is Guggul Balsamodendron Mukul.) It is an oleoresin containing volatile oil, gum resin with a bitter principle.It is prepared from thirty herbo mineral drugs. It has broad spectrum properties - mainly analgesic and anti-inflammatory alongwith that demulscent, carminative, laxative, anti-spasmodic, anti-suppurative, hematinic mode of action.

II.             MaharasnadiQuath - 67 mgs.

It is prepared from twenty five different herbal drugs. Its chief ingredient is Rasna.
It has anti-inflammatory, analgesic, diure­tic, detoxicating properties.

III.            Gold Bhasma.
Gold is reduced to ash form by special ayurvedic processes. It is non-toxic and non- cumulative. It builds up body resis­tance. It is also considered as a metabolic stimulant and activates reticulo endothelial system. It acts as a metabolic catalyst and brings about sense of wellbeing. It also acts as an antiseptic.

IV.           Curcuma longa.
The above three ingredients are proces­sed in Haldi (Curcuma-longa) - which also has got anti-inflammatory and anti-bacte­rial effect. It has also beneficial action over platelet aggregation and vascular prostaglandin synthesis. The activation of adreno hypophyseal axis may be responsi­ble for inhibition of degenerative changes.

MATERIAL AND METHODS

The clinical trial was conducted at Govt. Rural hospital Deogad over a period from 1987 to 1989. Patients were selected from OPD during the above said three years duration. Total no.of patients are 104. The inclusion criteria were morning stiffness, reduced painful movements. Patients having diabetes mellitus, hypertension, renal dis­eases chronic peptic ulcer, drug therapy with SAARDS and NSAIDs, pregnant women were excluded from the study.

 

PLAN OF STUDY

Two qroups were made serially - odd num­bers for R. Compound and even numbers for Aspirin drug. Each patient was given two tab­lets (Aspirin) or R. Compound) three times a day after food for a period of six weeks.
The diagnosis and grading of Polyarticular rheumatoid arthritis was based on the ARA criteria.

TABLE-I

Diagnosis

 

table-v

Duration of disease: (In weeks)

 

ASSESSMENT OF PATIENTS

Once the drugs were started, all the patients were evaluated weekly for the first six weeks, then once in fifteen days (once the drugs were stopped) for a period of four months. There after once in a month. The printed post cards used to be posted on the addresses of the patients on fixed dates for regular follow up to prevent the dropout rate to minimum.

Maximum follow up period in this study was 29 months and the minimum follow up period was 8 months.

The patients were examined on weekly basis in beginning - subjectively and objectively, using clinical parameters like morning stiffness, pain at rest, pain on movement, ten­derness, ESR, joint circumferences and measuring movements of joints, grip strength RA factor. Radiological examina­tion was performed at the beginning and at the last follow up.

 

		R Compound	Aspirin
Peripheral smear done for hypochromic microcytic anaemia	Yes	70.6%	80.9%
	No	29.4%	19.1%
ESR	Average Range	63.6 mm/hr	61.0 mm/hr
R.A Test	+ve	21.6%	23.4%
	-ve	78.4	76.6%
X-ray findings
Osteoporosis		2.9	3.1
Periarticular swelling		2.0	2.4
Joint Intervals		2.3	2.2
Increased Density		0.02	0.02
Irregularity of articular surface		0.73	0.62
Marginal Spurring		1.65	2.7

 

SIDE EFFECTS
It was recorded with every patient at each visit. Four patients were dropped from the study (Aspirin group) due to severe GIT dis­turbances.

 

TOXICITY PROFILE

	R.Compound	Aspirin
Drop out rate (due to severe toxic effects of drugs)	0	4
GIT Symptoms, pain in abdomen vomiting, retrosternal burning sensation	0	36
Antacid therapy started	0	36

 

^RESULTS

Analysis was restricted to patients who completed the study. The data obtained was processed on a computer. Differences bet­ween the groups are compared by Wilcoxon and student's test't'. Data are expressed are as Mean ± SD.

RESULTS:
Comparative Efficacy of R. Compound & Aspirin: (n — 100)

Subject Criteria.

	R Compound	Aspirin
Morning StiffnessBeginning	31.07 ± 9.91	34.12 ±13.15"
End	00.58 ± 2.57	1.25 ± 2.82
Pain at rest                           Beginning	3.96 ± 0.19	4.00 ± 0.00
End	0.03 ± 0.19	0.12 ± 0.39
Pain on movement              Beginning	3.86 ± 0.40	4.00 ± 0.00
End	0.07 ± 0.27	0.10 ± 0.30
Tenderness                           Beginning	3.84 ± 0.61	4.00 ± 0.00
End	0.03 ± 0.19	0.02 ± 0.14

 

 

		OBJECTIVE CRITERIA			R.Compound	Aspirin
1	Joint Circumference	Knee	Beginning	Rt	16.71 ± 0.82	16.58 ± 0.76
				Lt	16.79  ± 1.48	16.85 ± 0.94
			End	Rt	14.33 ± 2.48	15.25 ± 0.73
				Lt	14.79 ± 0.80	15.26 ± 0.80
		Wrist	Beginning	Rt	8.52 ± 1.23	8.34 ± 0.64
				Lt	8.68 ± 0.88	8.53 ± 0.38
			End	Rt	7.28 ± 0.96	7.23 ± 0.48
				Lt	7.23 ± 0.93	7.15 ± 0.50
		Elbow	Beginning	Rt	12.38 ± 1.38	12.44 ± 0.79
				Lt	12.38 ± 0.65	12.23 ± 0.75
			End	Rt	9.88 ± 3.06	10.52 ± 0.69
				Lt	10.01 ± 2.09	10.50 ± 0.66
		Ankle	Beginning	Rt	11.32 ± 0.46	11.34 ± 0.74
				Lt	0.00 ± 0.00	0.00 ± 0.00
			End	Rt	9.82 ± 0.63	10.52 ± 0.69
				Lt	9.82 ± 0.63	10.00  ± 0.54
2	Movements	Knee	Beginning	Rt	87.43 ± 8.49	86.66 ± 7.92
				Lt	86.40 ± 7.09	88.38 ± 5.73
			End	Rt	114.87 ± 10.22	113.47 ± 8.92
				Lt	115.56 ± 8.37	114.35 ± 9.24
		Wrist DF	Beginning	Rt	32.50 ± 9.57	25.00 ± 10.00
				Lt	31.25 ± 8.53	16.66 ± 5.77
			End	Rt	56.25 ± 7.50	40.00 ± 8.16
				Lt	55.00 ± 5.77	36.66 ± 5.77
		Wrist PF	Beginning	Rt	28.00 ± 8.36	21.66 ± 7.63
				Lt	30.00 ± 7.90	17.50 ± 3.53
			End	Rt	50.00 ± 12.24	40.00 ± 10.00
				Lt	50.00 ± 12.24	37.50 ± 3.53
		Elbow	Beginning	Rt	94.44 ± 8.47	94.21 ± 6.92
				Lt	95.18 ± 6.42	93.15 ± 7.49
			End	Rt	123.51± 11.58	121.05 ± 6.57
				Lt	125.74 ± 9.87	121.57 ± 6.02
		Ankle DF	Beginning	Rt	10.00 ± 0.00	10.00  ± 0.00
				Lt	10.62 ± 2.50	11.17 ± 2.18
			End	Rt	15.35 ± 2.37	15.93 ± 2.71
				Lt	15.62 ± 1.70	15.29 ± 1.21
		Ankle PF	Beginning	Rt	21.33 ± 6.11	23.52 ± 4.92
				Lt	22.35 ± 6.15	23.88 ± 5.01
			End	Rt	40.66  ± 8.83	39.11 ± 6.66
				Lt	41.17 ± 9.44	40.27 ± 7.37
		PIP	Beginning	Rt	77.77 ± 6.66	76.92 ± 4.80
				Lt	76.11 ± 4.85	76.53  ± 6.25
			End	Rt	89.44 ± 5.27	89.23 ± 2.77
				Lt	88.33 ± 3.53	90.00 ± 0.00
3	Grip Strength		Beginning	Rt	93.33 ± 5.00	89.23 ± 6.40
				Lt	97.50 ± 10.35	90.76 ± 6.40
			End	Rt	125.55 ± 11.30	120.76 ± 10.37
				Lt	127.50 ± 13.88	120.76 ± 8.62
4	Grasp		Beginning	Rt	2.11 ± 0.33	1.61 ± 0.50
				Lt	1.50 ± 0.53	1.76 ± 0.72
			End	Rt	3.66  ± 0.50	3.38 ± 0.50
				Lt	3.87 ± 0.35	3.46 ± 0.51
5	ESR		Beginning		62.01 ± 24.89	64.91  ± 23.77
			End		15.50 ± 9.18	22.27 ± 11.92
	Final Assessment		Good		92.20%	17.08%
			Satisfactory		7.80%	80.09%
			Slight		0	2.10%