[Indian Medical Journal, (1984): (78), 6, 82] Management of Chronic Backache by an Indigenous Drug Rumalaya Dubey, G.P., Ph.D., Reader, Incharge Psychosomatic Clinic, Rastogi, V., M.D., D.A., Lecturer in Anaesthesiology and Incharge Pain Clinic, Malviya, P.K., M.D., Research Fellow, and Agrawal, A., Ph.D., Research Fellow, DST Project, Psychosomatic and Pain Clinic, Institute of Medical Sciences, Banaras Hindu University, Varanasi, India. INTRODUCTION Chronic pain is one of the most important clinical symptoms of any morbid condition. There are only a few maladies without a painful sensation. Pain is always a subjective manifestation, not a state to be observed or measured. The nature of chronic pain depends upon the type of pathology present in the body. Chronic pain may be defined as persistent pain of more than six months duration. Senile osteoporosis, ankylosing spondylitis, sacroilitis, fibrositis, prolapsed disc and tuberculosis of the hipjoint are some of the important causes of chronic backache. Spondylolisthesis is another cause of chronic backache, which is always associated with unilateral and bilateral sciatica. Hendler et al. (1979) have described four different phases of chronic pain. In the absence of specific pathological findings, the majority of backache cases are designated as psychogenic. Chronic pain destroys self esteem. Chronic pain not only disturbs the routine functioning of life but also decreases physical and mental performance. Hendler (1952) studied the effect of chronic pain on sexual activity. Due to intense depression such persons develop a suicidal tendency. Chronic back-pain is usually associated with stiffness or limitation of movement or deformity of the lower spine. Fibrositis is generally associated with muscular spasm and localised pain. This clinical condition is mostly painful due to irritation of sensory nerve endings. Ankylosing spondylitis is an inflammatory process of the spine involving the sacroiliac joints. The course of the disease is highly unpredictable. In many cases it is self-limiting and produces chronic backache. Recently the role of autoimmune phenomenon has gained widespread emphasis. Inspite of the tremendous development in the field of diagnostic medicine, no satisfactory method has been evolved to diagnose the exact cause of backache. Radiological examination does not provide satisfactory diagnostic criteria. Similarly immunological changes and blood sedimentation rate also do not reveal any specific morbid condition. In the absence of foolproof diagnostic procedures the management is also unsatisfactory. Till now no satisfactory method of treatment could be evolved. Some of the recent drugs are really effective but due to immense side effects, the applications are limited. Recently attention has been directed by many research workers to find out some suitable remedy from indigenous resources. Rumalaya is an indigenous formulation, which inter alia contains Mahayogaraj Guggul and Shilajeet. Both the indigenous drugs are known to have anti-inflammatory and anti-arthritic properties. Earlier also Agrawal et al. (1970), Banerjee (1976) and Sen et al. (1982) have studied the beneficial effects of Rumalaya in various types of joint disorders. Since chronic backache is one of the common
problems before Clinicians, we decided to conduct a clinical trial of Rumalaya along with Rumalaya cream in selected cases of chronic backache. MATERIAL AND METHODS Sixty two cases of chronic backache were selected for the present clinical trial. After comprehensive clinical and laboratory examinations, the cases wee subdivided into three clinical groups. Out of 62 cases, 17 cases were suffering from chronic fibrositis, 21 cases from sacroilitis and the remaining 24 cases from ankylosing spondylitis. Cases of senile osteoporosis and tuberculosis of the hip-joint were discarded from this series. Before arriving at the final diagnosis, various laboratory investigations like routine blood examination including ESR and total protein including albumin-globulin (AG) ratio and radiological examinations were done in all the cases. Special investigations like plasma cortisol were done in selected cases following Mattingly s technique (1962). The pain threshold was measured by an apparatus specially designed for this purpose. Rumalaya, two tablets b.i.d. were given in all the cases along with local application of Rumalaya Cream wherever tenderness and localised pain were present. Clinical symptomatology like duration and intensity of pain, stiffness of the joints and restriction in movement were recorded following Rumalaya therapy. All the routine and special investigations were repeated after one month of treatment. At least three successive follow-up studies were done in all the three clinical groups of chronic backache. The data obtained were analysed and initial values were compared after three months. RESULTS AND OBSERVATIONS In general, with few exceptions, the subjects reported a feeling of well-being and improvement in clinical symptomatology. From the results it is evident that continuous administration of Rumalaya along with local application of Rumalaya Cream produces more beneficial effects in cases of fibrositis in comparison to ankylosing spondylitis. In cases of fibrositis 94.12 per cent cases showed improvement in intensity of pain and 96.67 percent cases showed improvement in stiffness. Similarly in cases of sacroilitis the intensity of pain, stiffness and restriction in joint movements showed considerable improvement. The drug is comparatively less effective in cases of ankylosing spondylitis than in fibrositis and sacroilitis. Similarly it is more beneficial when used along with local application of Rumalaya cream (Table 1). Table I: Percentage improvement in clinical symptomatology following Rumalaya therapy in cases of chronic backache Clinical symptoms Initial symptoms Ist month IInd months of IIIrd month of (no. of cases) therapy therapy Fibrositis Pain 17 70.59% 88.24% 94.12% Stiffness 15 66.67% 80.00% 86.67% Restriction in movements 14 71.43% 85.71% 92.86% Sacroilitis Pain 21 57.14% 66.76% 58.71% Stiffness 21 47.62% 66.67% 76.19% Restriction in movements 19 52.63% 68.42% 84.21% Spondylitis Pain 24 50.00% 66.67% 83.33% Stiffness 24 41.67% 50.00% 66.67% Restriction in movements 24 41.67% 54.17% 58.33% ESR was measured in all the cases, using the Wintrobe method. Readings were recorded at intervals of one hour. The initial ESR was found elevated in all the three clinical groups of chronic back pain. But the maximum ESR was noticed in cases of spondylitis (45.305 + 7.808). After three months of therapy there was a gradual fall in ESR but maximum decrease was noticed in cases of fibrositis.
When the initial ESR in fibrositis cases was compared after three months, the difference was found significant in this group. But in the remaining group the difference was insignificant. The albumin globulin (AG) ratio was found altered in all the cases, the maximum rise in globulin ration being noticed in spondylitis cases. But after 3 months the globulin level decreased in all the 3 clinical groups. The maximum change was observed in cases of fibrositis and sacroileitis. It indicates the significant effect of Rumalaya in reducing pain, anxiety and stress. Plasma cortisol also showed considerable decrease after 3 months of Rumalaya therapy. When the initial value of plasma cortisol was compared after three months, the difference was found significant in cases of fibrositis and sacroileitis. But in cases of spondylitis the difference was insignificant (Table II). Clinical groups Sample size Table II: Biochemical changes following Rumalaya therapy Initial values Ist month IInd month IIIrd month ESR Level* Fibrositis 17 30.82 ±10.75 32.75 ±9.80 27.80 ±10.75 20.32 ±9.82 Sacroileitis 21 39.80 38.40 34.70 32.80 ±9.80 ±6.28 ±6.68 ±7.80 Spondylitis 24 45.30 40.37 32.70 34.80 ±7.80 8.32 ±8.08 ±8.80 Albumin Globulin Ratio after months of Rumalaya therapy Fibrositis 17 3.6: 3.0 4.0: 2.6 4.2: 2.6 4.4: 2.4 Sacroilitis 18 3.2: 3.6 3.6: 3.2 3.8: 3.2 4.0: 2.8 Spondylitis 20 2.8: 4.1 3.2: 3.7 3.5: 3.2 3.9: 3.0 Plasma cortisol level following three months of Rumalaya therapy Fibrositis 12 28.72 24.30 20.84 18.70 ±6.22 ±7.37 ±6.82 ±8.72 Sacroilitis 13 32.84 26.40 24.37 22.67 ±7.32 ±6.35 ±8.85 Spondylitis 14 42.84 36.70 33.78 ±12.72 ±10.84 ±13.82 * In follow-up cases repeated ESR estimations were done at intervals of one month ±8.45 34.70 ±9.82 Comparison initial vs 3rd month <0.05 <0.01 <0.05 The pain threshold was significantly increased in cases of fibrositis after 3 months of Rumalaya therapy. But in cases of spondylitis, the pain threshold could not show any significant increase following therapy. The anxiety level has been considered an important parameter in the evaluation of the beneficial effect of Rumalaya. We noticed a significant change in the anxiety level in fibrositis and sacroilitis than in spondylitis. In brief Rumalaya tablets when used along with Rumalaya cream, produce more beneficial effects in cases of fibrositis than in the other groups. DISCUSSION The management of chronic pain is one of the most intractable problems in medical practice. Due to the complex pathology and absence of knowledge regarding the specific aetiology, such cases are considered as a separate clinical entity. The present trend of management of chronic pain is directed towards nerve-blocking by neurolytic agents and the use of various anti-inflammatory and analgesic drugs. The use of corticosteroids is very much limited due to many side effects. Due to chronic pain, majority of the cases were suffering from psychological problems including depression. Continuous
use of analgesics produces gastrointestinal disturbances including peptic ulcer. Recently many drugs have been introduced, all of which stop pain for the time being but none of the drugs is able to provide permanent relief from chronic pain. Most of the cases of fibrositis or sacroilitis get converted into spondylitis. Recently the autoimmune concept has gained significant attention in the aetiology of rheumatoid arthritis including spondylitis. Since the autoimmune process is generalised, the involvement of soft parts of the body is equally possible. Holmes et al and Rahe (1967) developed a social re-adjustment rating scale to evaluate the anxiety, stress and coping process. According to Hendler (1982), if one superimposes chronic pain onto a previously disturbed individual, the picture becomes even more complicated. Since pain is a subjective feeling, it is impossible to accurately measure the effect of any drug on the intensity of the pain. In our own observation, we noticed that the majority of the patients suffering from spondylitis and sacroilitis had a lot of psychological problems. They were frustrated due to inadequate diagnosis and unsuitable treatment. The elevated levels of plasma cortisol in all the three clinical groups under trial indicate the level of chronic stress in such patients. Rumalaya, an indigenous formulation, has shown significant clinical improvement in cases of chronic backache. We noticed a significant decrease in duration and intensity of pain, more in fibrositis cases than in sacroilitis and spondylitis. Similarly, stiffness and restriction in movements showed considerable improvement after 3 months. This improvement is more marked in fibrositis in comparison to the other clinical groups. The pain threshold increased after three months. This indicates that Rumalaya reduced the hypersensitivity of pain sensation. The significant rise in albumin in comparison to globulin and significant fall in plasma cortisol levels indicates the marked reduction in anxiety level after Rumalaya therapy. From the results it is evident that Rumalaya is more useful in cases of fibrositis and sacroileitis than in spondylitis. We also noticed a significant improvement in insomnia and functional capability of the individuals. When Rumalaya tablets were used with Rumalaya cream, the improvement in pain was more marked. Fibrositis and sacroilitis are both painful conditions and most of the time associated with stiffness of joints and root pain. In cases of spondylitis, we also observed subjective improvement in pain, gradual improvement in tingling, numbness and root pain. Our observation is in conformity with that of Rao and Gupta (1977). In brief, continuous use of Rumalaya tablets along with local application of Rumalaya cream produces more beneficial effect in the management of chronic backache, especially in cases of fibrositis and sacroilitis. Rumalaya did not cause any side effect even after continuous oral administration. SUMMARY AND CONCLUSION (1) Sixty two cases of chronic backache were selected for our clinical trial with Rumalaya. After clinical and laboratory investigations the cases were given Rumalaya for three months, along with local application of Rumalaya cream. After successive follow-up study, we noticed significant improvements in pain, stiffness and restricted movement of the joints. Majority of the cases reported improvement in insomnia and a feeling of general well-being. (2) Plasma cortisol showed a significant fall in fibrositis cases. The albumin globulin ratio was found altered in all the three clinical groups but after three months of continuous therapy we noticed a marked elevation in albumin level in fibrositis and sacroilitis. The pain threshold showed an increasing trend in almost all the clinical groups but it was found significant in fibrositis cases only. Thus it can be concluded that Rumalaya may be used as a specific drug
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