for the use only o/ a registered medical practitioner or a hospital or a laboratory

EFFICACY OF R. COMPOUND - AN AYURVEDIC MEDICINE –

IN INFLAMMATORY AND DEGENERATIVE ARTHRITIS

Dr. U.R.K.RAO, M.D. (Medicine) Consultant Rheumatologist,
Dr. M.U.R.NAIDU, Additional Professor of Pharmacology,
Dr. V. SHANTA RAM, M.D. (Medicine), Professor & Head of Department
Dr. DIRDAUS FATIMA, R.M.O., Dr. P. JAYALAXMI, R.M.O.
Nizam's Institute of Medical Sciences, Hyderabad (A.F)

Indian Journal Of Clinical Practice Vol.5, No.12, PP 29-33 May, 1995

ABSTRACT

R.Compound, an Ayurvedic drug was used in various arthritides with significant clinical relief. Twenty patients with rheumatoid arthritis (RA), 6 with seronegative spondylarthropathy (SSA) and 9 with osteoarthritis (OA) knees were treated. The study period was 6 months for RA and SSA. Patients with RA showed improvement in clinical and laboratory parameters such as morning stiffness, pain and swelling index, grip strength, walking time and ESR (P<0.001). Similar results were obtained in patients with SSA and OA. Two patients had developed dermal allergic reactions. No other serious side effects were noted during the study period.

KEY WORDS

Rheumatoid arthritis, Seronegative spondylarthropathy, Osteoarthritis, Ayurvedic drug, R. compound.

INTRODUCTION

Osteoarthritis (OA), rheumatoid arthritis (RA) and seronegative spondylarthropathy (SSA) are common chronic disorders affecting the joints. Drug therapy forms the mainstay of the treatment for these diseases. The objectives of the treatment are : (i) to suppress inflammation, (ii) to relieve pain and swelling, (iii) to improve function, and if possible, (iv) to retard or reverse the damage to joints especially in RA'. Routinely used non steroidal anti-inflammatory drugs (NSAIDs) and disease modifying antirheumatoid drugs (DMARDs) often produce side effects on prolonged usage 2,3.

The therapeutic agents in arthritis must not only be effective, but also free from side-effects, safe for long term use, and cost-effective. Ayurvedic drugs are claimed to at least partially fulfill these criteria °. R.Compound is one of them and has been in use as an antiarthritic drug for more than three decadess.

Each tablet of R.Compound consists of 3 Ayurvedic preparations: (i) Mahayograj guggul, (ii) Maharasnadi quath, and (iii) Gold in `Bhasma' form. Mahayograj guggul is an oleoresin extracted from the tree Balsamodendron mukul. It has antiinflammatory and antipyretic properties. Maharasnadi quath is prepared by processing 25 different herbal preparations. Its main action is stated to be anti-rheumatic. Gold is reduced to ash form by special processes and is used as a disease modifying drug in rheumatological disorders. The present communication reports the results of a pilot study undertaken to evaluate the therapeutic efficacy of R.Compound in inflammatory and degenerative arthritis.

MATERIAL AND METHODS

The study was conducted at Nizam's Institute of Medical Sciences, Hyderabad with the approval of local ethical committee and with the consent of patients for clinical trial. Twenty consecutive patients with RA, 6 with SSA and 9 with OA were included in the study. The diagnosis of RA was based on ARA criteria6. The disease was staged according to Steinbroker's classification'. Eligible for participation in this study were; seropositive or seronegative RA, with morning stiffness for more than 30 minutes, presence of 3 or more painful swollen joints and erythrocyte sedimentation rate (ESR, Westerngren) of more than 30 mm Hg in one hour. Excluded

were : (i) pregnant or lactating women, (ii) patients with known hypersensitivity to the drug used, (iii) patients taking NSAIDs or DMARDs and (iv) patients with other major systemic disorders. Exclusion criteria were same for the patients with Seronegative spondylarthropathy or Osteo Arthritis.

All patients had thorough clinical, hematological, serological, biochemical and radiological investigations. R.Compound was given-as 2 tab thrice daily to each patient and the study period was six months for RA and SSA, and 2 months for OA. The patients were evaluated at the entry and at the end of each month.

PARAMETERS FOR ASSESSMENT OF EFFICACY OF DRUG

Anatomical stage (I to IV), functional class (I-IV), pain index (at each joint, mild tenderness on deep pressure = 1, winces with mild pressure = 2, winces and withdraws even on touch = 3), swelling index ( at each joint, mild = 1, moderate = 2, severe with loss of bony contours = 3), morning stiffness (minutes), grip strength (mm Hg), walking time (seconds / 15 meters), hemogram, and ESR. Wherever indicated, the following investigations were also carried out: IgM rheumatoid factor (ELISA), and radiographs of chest, knees, hands, pelvis and spine. Before and at the end of the study, liver and renal function tests were also performed. Performas specially designed for the study of RA, SSA and OA were used. All assessments were made by the same observer. At each visit patients were asked about the side effects by direct questioning. Results were statistically analysed, using student T -Test.

RESULTS

Among 35 patients, 20 were suffering from RA, 6 from SSA and 9 from OA. The female to male ratio in RA was 4:1 (Table - 1)

Showing demographic pattern of 20 patients

Female: Male : 16: 4

Seropositive : 8

Mean age (years) : 44.5 ± 14.3

Mean disease duration (Months) : 33.7 ± 22.9

Anatomical stage I/11 : 19

Functional class I/II : 19

Mean ESR (mm/1°) : 53.8 ± 24.6

Except one patient who belonged to anatomical stage III and functional class IV, all others belonged to Stage I or II. The clinical and laboratory parameters have shown statistically significant improvement before and at the end of the study period.

Table - 2

Clinical effects of R. Compound in rheumatoid arthritis (RA)
Variable	Before Mean ± SD	After Mean ± SD
Anatomical stage	1.8 ± 0.5	1.6 ± 0.5
Functional class	1.7 ± 0.8	1.2 ± 0.4*
Pain index	40.2 ± 17.5	12.5 ± 8.2**
Swelling index	4.9 ± 5	1.5 ± 1.8**
Morning stiffness	56.1 ± 43.5	18.4 ± 20.2**
Grip strength	57.4 ± 24.8	82.1 ± 36.4 **
Walking time	39.9 ± 8.64	31.1 ± 5.35 *'
ESR	53.8 ± 24.6	26.7 ± 20.3
P<0.02,*P<0.001

Similar results were seen in the group of SSA; 2 patients had to be withdrawn from the clinical trial due to development of dermal allergic reaction. Four patients required additional drug therapy with NSAIDs, such Ibuprofen for a brief period.

Table - 3

Seronegative Spondylarthropathy (n=6)

Male: Female : 4:2

Mean age (years) : 28.8 ± 6.7

Mean disease duration : 49.7± 34.6

(months)

Morning stiffness (minutes)

- Before : 37.5 ± 21

- After : 13.3 ± 16.6 (p<0.05)

Walking time (seconds)

- Before : 29.2 ± 2.4

- After : 25.5 ± 4.3 (p<0.05)

Table - 4

Osteo Arthritis Knees (n = 9)

Female: Mate : 7:2

Mean age (years) : 57.1 ± 6.5

Mean disease duration : 30.3 ± 29

(months)

Number of patients improved : 5

Pain and mobility index

- Before : 1.83 ± 0.41

- After : 1.17 t 0.75

OSTEOARTHRITIS

Among 9 patients with OA Knees, 3 dropped out with noncompliance and 1 showed no improvement. Five patients showed statistically significant relief of pain and mobility index with R.Compound (Table 4).

DISCUSSION

Ayurvedic preparations containing guggul, Rasna quath and Gold bhasma were shown to be beneficial in rheumatoid arthritis and osteoarthritis in the present study, as well as by several others e-'°. R.Compound with its safety profile is clinically useful in RA, OA and chronic non-specific arthritis.

CONCLUSIONS

R.Compound is beneficial in various inflammatory and degenerative arthritis. It requires further long term studies involving more number of patients to evaluate its sustained efficacy.

REFERENCES

1.Harris ED. Management of Rheumatoid Arthritis. In: Kelly WN, Harris ED, Ruddy S, Sledge CB (ED) Text Book of Rheumatology, WB Saunders Co, Philadelphia 1989:982-92.

2. Pauclus HE. Non steroidal antiinflammatory drugs. In : Text Book of Rheumatology, Kelly WN, Harris ED, Ruddy S, Sledge CB (ED) WB Saunders CO, Philadelphia 1989; 770-71.

3. Hussain Z, Runge LA. Treatment complications of rheumatoid arthritis with gold, hydroxychloroquine, D-penicillamine and levamisole. J Rheum. 1989, 7:825.

4. Yoga Ratnakar, Amavata Chikitsa. Chowkhamba Sanskrit Series Office, PO Box 8, Varanasi 1955; 486 - 492.

5. Variava N.S. Treatment of rheumatic and collagen diseases with an Ayurvedic drug. Current Medical Practice 1965, 91.

6. Arnett FC et al. The American Rheumatism Association (1987). Revised criteria for the classification of rheumatoid arthritis. Arthritis Rheum 1988; 31:315324.

7. Steinbrocker, Trager CH, Batterman RC. Therapeutic criteria in rheumatoid arthritis. J AmMed Assoc 1949, 140-659.

8. U R K Rao, N S Bhatt, M U R Naidu, T R Kumar, U Shobha, K Venubabu Efficacy of Rhumayog and Rhumayog with Gold in rheumatoid arthritis - A double blind study. The Indian Practitioner, 1993 ; 46 : 931 -941.

9. URKRao,NSBhatt,MURNaidu,MA Askar, Noor Ahmed, P Sarada. Comparison of Rhumayog and Ibuprofen in Osteo arthritis - A double blind study. Indian J Int. Medicine 1994 ; 4 : 1-5.

10. Y Mohindra. R.Compound (Alarsin) in Chronic Non specific arthritis. Current Medical Practice 1979 ; 23:33-36.

11. J S Makhani. Experience with R.Compound in Rheumatoid Arthritis, the clinician 196, 40:8:312-317.

12. C J Gaikwad, R C Rallan, A K Gupta. A clinical study with R.Compound. The antiseptic 1968, 64:423.

13. Patnaik B.C. Clinical trial with R.Compound in rheumatoid and other arthritis disorders. Current Medical Practice 1971 ; 15:625.

14. Singh S D, Shrivastava P N, Mehta R K, Ahmed A. Anti-inflammatory and pharmacodynamic studies of R.Compound. Ind J Pharma 1972, 4:135.

for information of ALARSIN products please write to :

ALARSIN , Alarsin House, A/32, Street No. 3, M.I.D.C., Andheri (E), Bombay - 400 093.

Dr. Rao