Objective Evaluation of Rumalaya as an Adjuvant in Rheumatoid Arthritis – A Pilot Study

Seventeen patients suffering from rheumatoid arthritis varying in duration from 5 months to 2 years were included in the study. Anywhere from 5 to 12 joints were involved. They were already on any one or more of the NSAIDs which brought about severe gastric distress and consequent non-compliance of drug intake. But they were asked to continue them along with Rumalaya, 2 tabs. t.i.d. for 8 weeks. Significant reduction in pain intensity and morning stiffness was observed with Rumalaya administration. There was also reduction in 50 ft. walking time and improvement in grip strength. Reduction in dosage of ongoing NSAID treatment resulted in diminished gastric irritation and better drug compliance. Two patients could dispense with NSAIDs and could manage well only with Rumalaya. INTRODUCTION Rheumatoid arthritis is primarily an inflammation of joints in which the synovium is expanded by an infiltrate of cells, the cartilage is destroyed by the advancing edge of the pannus, and the presence of antibodies often detected in the serum and synovial fluid. Altering immunity by pharmacologial or mechanical means provides the most powerful, but at the same time hazardous way of treating rheumatoid arthritis. The drugs include corticosteroids and cytotoxic agents. Control of rheumatoid arthritis is also likely to be achieved eventually by pharmacologial means. Drugs may induce remission; in many they may provide suppression but in a few they achieve less. The non-steroidal, anti-inflammatory drugs (NSAIDs) still form the mainstay of drug therapy for rheumatic diseases. They do not cure or permanently reverse the inflammatory process, but by reducing pain, swelling and stiffness they improve function and give considerable symptomatic relief. But all have adverse effects, which relegate them to a secondary role in the management programme and all demand skilled and careful supervision. Rumalaya (Himalaya), an indigenous herbal remedy, is being used with success in rheumatoid arthritis for many years. Processed in Vitex negundo, Tinospora cordifolia, Ocimum sanctum, Eclipta alba, Withania somnifera, Zingiber officinale, Dashamoola. One of the principal ingredients of Rumalaya tablets is Mahayograj guggul (derived from Commiphora mukul, syn., Balsamodendron mukul (guggul)). The oleo-gum-resin exuded by the tree has been regarded as a sovereign remedy in Each Rumalaya tablet contains: Mahayograj guggul 0.162 g Exts. Maharasnadi quath 65 mg Moringa pterygosperma 16 mg Rubia cordifolia 19 mg Tinospora cordifolia 10 mg Tribulus terrestris 16 mg Shilajeet (Purified) 16 mg Swarnamakshik bhasma 5 mg Shankh bhasma 65 mg Muskdana 10 mg ancient medicine. Scientific investigation of the oleoresin of Commiphora mukul explains why guggul was reputed to be an ancient “broad-spectrum” drug with a wide therapeutic range. It has a significant anti-inflammatory and antiarthritic activity as demonstrated by animal experiments (Gujral et al, 1960; Bhargava, 1962; Bedi and Dwarakanath, 1969). Another important constituent is Maharasnadi quath. Rasna is the main component of this preparation. Because of its analgesic, antiphlogistic and antipyretic properties this drug has long been used for the treatment of rheumatic arthritis. This study was undertaken to objectively evaluate the efficacy of Rumalaya as an adjuvant in the treatment of rheumatoid arthritis. MATERIAL AND METHODS The study was undertaken in 17 cases suffering from rheumatoid arthritis varying from 5 months to 2 years. There was a history of involvement of 5 to 12 joints with severe morning stiffness and pain. These patients were already on one or more of the following NSAIDs – Ibuprofen in the dose of 400 mg, t.i.d. or 600 mg SR, b.i.d., Diclofenac sodium 50 mg, t.i.d., Piroxicam 50 mg, 1 tablet h.s. and Naproxen 2 b.i.d. The patients complained of severe gastric distress and as a result there was noncompliance. Patients were enrolled in the trial with their baseline readings as per the criteria of the American Rheumatic Association (ARA). They were asked to continue their previous treatment and in addition they were given Rumalaya, 2 tablets three times a day for 8 weeks. They were followed up every week and if necessary a reduction was made in the dose of NSAID treatment. Once again they were rated as per ARA at the end of 8 weeks of Rumalaya treatment. The data was analysed for statistical significance by using the Chi Square test. RESULTS Tables I and II show the intensity of pain and the duration of morning stiffness. It was clearly seen that there was significant reduction in both the intensity of pain and duration of morning stiffness following treatment with Rumalaya. Table I: Intensity of pain Before After 2.625 ± 0.125 1.375 ± 0.154 (Rated as No pain = 0; Mild = 1; Moderate = 2; Severe = 3; Very severe = 4) Table II: Duration of morning stiffness (min.) Before After 162.18 ± 25.36 86.87 ± 19.01 There was also reduction in 50 ft walking time (Table III). Patients felt better and the efficiency to work, especially in the morning, improved considerably. Table III: Change in 50 feet walking time after treatment with Rumalaya (Min.) Before After 14.87 ± 0.67 13.50 ± 1.04 The grip strength also improved considerably in both hands and the interphalangeal circumference reduced after 8 weeks of Rumalaya therapy (Table IV). Table IV: Changes in grip strength and interphalangeal circumference Grip strength (mm Hg) Interphalangeal Circumference (mm) Before After Before After Left Hand 35.37 ± 9.84 47.87 ± 9.74 21.75 ± 1.20 20.00 ± 1.26 Right Hand 35.62 ± 9.27 47.75 ± 8.03 23.25 ± 0.97 22.00 ± 1.01 There was also a drop in the ESR, but it was not significant. DISCUSSION Rheumatoid arthritis is a complex and variable condition from the point of view of severity, number of joints involved and duration. It is usually a “painful nuisance” for which treatment needs to be individualised with optimum dosage of analgesic and anti-inflammatory drugs. As usual, treatment is aimed at effective control of symptoms with a minimum of side-effects. A number o patients cannot tolerate high doses of aspirin and other NSAIDs. The most objective finding of this study was the reduction in the dosage of the ongoing NSAID treatment. In most subjects, it was possible to reduce the dosage without causing any deterioration in their disease status and it was possible to reduce the incidence of side effects like gastric irritation. A gradual reduction was attempted after 15 days of starting Rumalaya treatment and the patients were maintained on a lower dosage schedule. In spite of this, a definite improvement was noted and subjectively two patients had a feeling of well-being. In 2 patients the existing therapy was stopped completely and the patients were maintained on Rumalaya alone. The findings on the self-rating 100 mm evaluation scale for pain were also interesting. There was significant reduction in pain when patients evaluated themselves on this rating scale at the end of 8 weeks of treatment with Rumalaya. CONCLUSIONIt can therefore be concluded from the observations in 17 cases that Rumalaya can be a goodadjuvant to the existing therapy with anti-inflammatory agents. No side effects were observed afterRumalaya treatment per se. The search for an ideal compound still continues. In view of theseresults it would be worthwhile to give a trial to Rumalaya to achieve better control of rheumatoidarthritis with no side effects. REFERENCES1. Dutta, N. and Bhattacharya, M.N., “Clinical trial of Rumalaya in some rheumatic conditions.”Probe (1974): 2, 57. 2. Joshi, V.R., Lele, R.D. and Kulkarni, R.D., “Treatment of rheumatoid arthritis withRumalaya.” Probe (1973): 1, 22.3. Mehta, S.H., “Rumalaya in chronic rheumatoid arthritis.” Curr. Med. Pract. (1971): 11, 1024.4. Gujral, M.L. et al. “Antiarthritic and anti-inflammatory activity of gum guggul(Balsamodendron mukul, Hook).” Ind. J. Physiol. Pharmacol. (1960): 4,267.5. Kishore, Prem and Padhi, M.M., “Further clinical evaluation of Sunthi-Guggulu in thetreatment of Amavata-Rheumatoid arthritis.” Jour. Res. Ayur. Siddha (1988): 9, (3-4), 89.6. Bedi, Ramesh and Dwarkanath, C., Natl. med. Gaz. (1969): 1, 10. 7. Hart, F.D. and Huskisson, E.C., “Pain patterns in rheumatic disorders.” Brit. Med. J. (1972b):4, 213.