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Ostolief Tablets showed efficacy for the treatment of Osteoarthritis

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  1. 1. Clinical Study Volume 17, Number 5 October 2006 Special Reprint Evaluation of “Ostolief” (Polyherbal Formulation) in the Management of Osteoarthritis: A Double-blind, Randomized, 12-Week Comparative Study DG Langade* SRSinha** Osteoarthritis is a debilitating disease in AA Hasamnis** geriatric age group. SN Nawale † AS Chandanwale ‡ among the elderly. Since the drug stiffness and immobility, 1 VY Deshpande § therapy of OA involves long-term characteristic of OA. One hundred Abstract medication with drugs such as patients suffering from OA who NSAIDs, it is fraught with unwanted needed drug therapy were divided Osteoarthritis (OA), a adverse effects. In this scenario, into two groups: one group received degenerative form of arthritis, is a plant-based formulations provide tablet Ostolief in a dose of one disease that leads to considerable a unique modality of treatment as tablet twice daily, while the other disability, especially in the they are safe and possibly have a group received tablet valdecoxib geriatric group of patients. In fact, disease-modifying action. The 10 mg twice daily for a period of in certain populations, OA is now present study was conducted to 12 weeks. A total of 94 patients assuming epidemic proportions evaluate the efficacy of completed the trial. In the Ostolief a herbomineral formulation group, the average pain score at *Lecturer, **Resident, “Ostolief” in comparison with rest on visual analog scale Department of Pharmacology, valdecoxib in reducing the pain, decreased from 49.56 ± 10.37 at † Resident, ‡ Professor and Head, Dep. of Orthopedics and Traumatology, § Ex-Professor and Head, With Best Compliments From OCTOBER 2006 Department of Pharmacology, Grant Medical College and Sir J.J. Group of Hospitals, Byculla, Mumbai. M/s. Charak Pharma Pvt. Ltd. INDIAN JOURNAL OF CLINICAL PRACTICE Vol. 17, No. 5
  2. 2. Clinical Study baseline to 26.08 ± 9.77, while in OA has a particularly large novel treatment option of the valdecoxib group, it fell from impact on the health of middle- Ostolief for OA. Ostolief is a 48.02 ± 13.66 to 26.02 ± 8.53. The aged and older women. Before the standardized, multi-ingredient pain on joint use decreased from age 50, men have a higher herbal formulation, which not only 42.97 ± 12.09 to 24.02 ± 11.38 in prevalence of OA, but both the relieves the symptoms of patients on Ostolief, while in prevalence and incidence are osteoarthritis , but is also postulated patients in the valdecoxib group, higher in women after the age of to delay its progression. Ostolief it decreased from 45.30 ± 13.70 to 50.1 The risk of knee, hip and hand contains Shallaki (Boswellia 25.51 ± 10.66. The reduction in OA in women increases s e r r a t a) a n d A s h w a g a n d h a the Western Ontario and McMaster dramatically after menopause2-5. (Withania somnifera), which (WOMAC) score in the Ostolief Older women are more likely to reduce the degradation of group was from 14.13 ± 1.93 at report joint symptoms when glycosaminoglycan and delay the baseline to 9.30 ± 2.83 at 12 weeks. radiographic OA is present, and progression of OA. Gokshur The corresponding reduction in the hip OA atleast appears to progress (Tribulus terrestris) and Guduchi valdecoxib group was 13.91 ± 2.10 more rapidly in older women (Tinospora cordifolia) are powerful antioxidants and thus exhibit anti- at baseline to 8.97 ± 2.99 at compared with older men6. inflammatory action. Bala (Sida 12 weeks. Both the drugs were Numerous studies suggest that cordifolia) and Kupilu (Strychnos well tolerated. It was concluded the prevalence of joint pain rises nux vomica) are potent anti- that Ostolief showed a comparable markedly with age in the general inflammatory and analgesics. efficacy vis-a-vis valdecoxib. On population, but for reasons not fully Moreover, Guduchi (T. cordifolia), all evaluation parameters, Ostolief understood may decline somewhat Bala (S. cordifolia), Gokshur and valdecoxib showed similar after the age of 75 or 80.7 Recent (T. terrestris) and Ashwagandha results. Although patients on data from a variety of sources (W. somnifera) have anti-aging valdecoxib showed slightly greater properties, which have a positive 2 reduction in pain scores, if the across the globe suggest that populations are now experiencing impact on preventing bone safety aspect is considered, an epidemic of knee pain, with degeneration. In this study, we Ostolief definitely has an edge one in 4 or one in 3 persons aged 55 compared the efficacy and while having an equivalent and older having chronic knee tolerability of Ostolief with efficacy. pain8,9. Most studies suggest that valdecoxib during a 12-week knee pain is more common in older treatment in a randomized, Introduction comparative, double-blind trial. women than in older men. OA is a degenerative arthritis The basic pathology in OA is a of chronic progression and is one of the most debilitating diseases thinning of the articular cartilage, Materials and faced by an ever increasing due to a decrease in the synthesis methods of cartilage tissue, relative to the geriatric population. It leads to One hundred patients (50 in wear and tear. Currently available chronic -sometimes severe - pain measures to manage OA include each group), diagnosed as mostly in knees and lower back, NSAIDs, physiotherapy, supportive suffering from chronic OA, who restricted mobility and a markedly belts, etc. Unfortunately, the drug needed drug therapy were reduced quality-of-life. In many therapy of OA involves long-term enrolled after obtaining informed cases, it interferes with normal medication with drugs such as written consent. Each patient NSAIDs, and therefore, is fraught OCTOBER 2006 daytime activities and the joint received either tablet Ostolief pains may keep patients awake at with side effects. or tablet valdecoxib (10 mg). night. In this study, we focus on a The two preparations looked INDIAN JOURNAL OF CLINICAL PRACTICE Vol. 17, No. 5
  3. 3. Clinical Study identical. Patients were provided to each patient leucocyte count, differential randomized according to a for recording symptoms. Compliance leucocyte count, fasting blood computer-generated randomization was checked at every visit. sugar, blood urea, creatinine, bilirubin, alkaline phosphatase chart. The drugs were packed in Evaluation of the patients and X-ray of the affected joint was sealed bottles with patient serial was performed every 3 weeks. performed at baseline on numbers on them. The patients were Patients, who were taking other enrollment and at the end of enrolled and assigned a serial number medications for OA, were given 12 weeks of study period. in a chronological order. Both study a 15-day washout period, treatments were administered in a following which the study drugs Results dose of one tablet twice daily for a were administered. Of the 100 patients period of 12 weeks. A diary was Hemoglobin, ESR, total enrolled in the study, 94 (46 in the Table 1 Radiological findings in the two treatment groups [number of patients] Parameter Ostolief (n = 46) Valdecoxib (n = 48) χ 2-test Marginal lipping 44 41 χ2 = 0.007; 3 Narrowing of joint space 41 47 d.f. Sharpened articular 12 margins p = 0.999 (NS) Sclerosis 34 45 Bone cysts 0 0 3 OCTOBER 2006 Figure 1. Pain on a 0-10 visual analog scale (VAS) during joint use/mobility in two treatment groups at baseline and after 3, 6, 9 and 12 weeks of therapy. INDIAN JOURNAL OF CLINICAL PRACTICE Vol. 17, No. 5
  4. 4. Clinical Study Table 2 Joint tenderness on a four-point rating scale in the two treatment groups (Number of patients) at enrollment and after 3, 6, 9 and 12 weeks Ostolief (n = 46) Valdecoxib (n = 48) Mann-Whitney Nil Mild Moderate Severe Nil Mild Moderate Severe ‘U’ test (p) Baseline 14 29 3 0 24 17 7 0 p > 0.05 (NS) 3 weeks 15 29 2 0 27 14 7 0 p > 0.05 (NS) 6 weeks 19 27 0 0 27 14 7 0 p > 0.05 (NS) 9 weeks 25 21 0 0 37 8 3 0 p < 0.05 (Sig.) 12 weeks 34 12 0 0 36 6 3 0 p < 0.05 (Sig.) p < 0.01 (Sig.) Kruskall-Wallis test p < 0.01 (Sig.) Kruskall-Wallis test - Ostolief group and 48 in the valdecoxib group) completed the study as per the study protocol. Marginal lipping and joint space narrowing were the prominent radiological findings in both groups (Table 1). 4 The pain score on joint use decreased from 42.97 ± 12.09 to 24.02 ± 11.38 in patients on Ostolief after 12 weeks therapy, while for patients in the valdecoxib group, it decreased from 45.30 ± Figure 2. Fall in pain score on 0-100 VAS in the two treatment 13.70 to 25.51 ± 10.66. Here again, groups at 3, 6, 9 and 12 weeks of study period. the reduction in the pain score was significant within both groups (p < 0.0001), while there was no difference in the reduction in pain scores observed between the two groups (Fig. 1). Although the fall in the pain scores were similar in both the groups, the group receiving Ostolief showed a greater fall in the pain score at rest while the group receiving OCTOBER 2006 valdecoxib showed a greater fall Figure 3. Reduction in the mean WOMAC score in the two in the pain scores on joint use/ treatment. mobility (Fig. 2). INDIAN JOURNAL OF CLINICAL PRACTICE Vol. 17, No. 5
  5. 5. Clinical Study Figure 4. Global efficacy assessment by the physician. Joint swelling and Morning stiffness such as hemogram and liver and tenderness In the Ostolief group, only kidney function tests were 11 patients complained of morning performed in all the patients Joint tenderness was also rated on a four-point scale similar to stiffness at the end of the study, compared to 28 at baseline. before and after the therapy. Both the medications were found to be 5 joint swelling. After 12 weeks of However, in patients in the safe and did not lead to any treatment, both the groups valdecoxib group, 12 patients significant alteration in the liver showed significant reduction in complained of morning stiffness and kidney functions. Similarly, the tenderness (Table 2). after 12 weeks treatment, as both the medications were well WOMAC score compared to 21 at baseline. tolerated by the patients. The WOMAC score for OA Global efficacy Discussion showed significant reduction, assessment by the Long-term use of NSAIDs comparable in the two groups. The physician is a common practice in the mean score in the Ostolief group management of mild-to-moderate Overall, physicians rated the reduced from 14.13 ± 1 . 9 3 OA. Patients suffering from OA response as good in all the at baseline to 9.30 ± 2.83 at 12 are also known to consume higher 46 patients in the Ostolief group weeks. The corresponding doses of NSAIDs, and misuse of after 12 weeks therapy. It was reduction in the valdecoxib group NSAIDs is fairly common. observed that as the duration of the was 13.91 ± 2.10 at baseline to therapy increased, the response to Therefore, such patients are 8.97 ± 2.99. Thus, the reduction in therapy improved (Fig. 4). especially vulnerable to the OCTOBER 2006 the mean WOMAC score was distressing side effects of NSAIDs. comparable in both the groups Safety and tolerability The severity and morbidity caused (Fig. 3). Laboratory investigations by the side effects of NSAIDs can INDIAN JOURNAL OF CLINICAL PRACTICE Vol. 17, No. 5
  6. 6. Clinical Study assume grave proportions especially in long-term users. Conclusion NSAID use is a very common From this trial, it can be concluded that the clinical cause of upper gastrointestinal (GI) efficacy of Ostolief tablets is comparable to that of valdecoxib. bleeding. Even cyclooxygenase Ostolief can be prescribed to patients with mild-to-moderate (COX)-2 inhibitors, which are OA. The patients in this trial reported no side effects of Ostolief. believed to have lesser GI side effects compared to other NSAIDs, have been shown to produce gastric ulcers. change the underlying disease Gokshur and Ashwagandha have The recent findings of cardiac process and protect the joint from been used in the Ayurvedic system adverse events with the use of COX- further structural damage. Recent of medicine as rasayanas that 2 inhibitors, especially rofecoxib, studies which have been published have anti-aging properties. Herbs have further highlighted the problem in “The New England Journal of that act as r a s a y a n a s exert of severe side effects that can force Medicine” have demonstrated that their anti-aging effect through discontinuation of therapy. glucosamine and chondroitin rejuvenating/revitalizing all the In addition to these sulfate alone or in combination body tissues (dhatus). Since bones issues, NSAID therapy offers no are one of the seven dhatus (asthi), are similar to placebo and do not advantage in terms of reversing rasayanas also have a positive reduce pain effectively in patients the basic pathological mechanisms impact on preventing bone with OA of the knee10. Therefore, it in OA, namely destruction of intra- degeneration. Rasayanas are also is very important to initiate therapy articular cartilages and progressive powerful antioxidants and thus with drugs that not only manage loss of the articular surfaces of the exhibit anti-inflammatory action. symptoms but also favorably bones. In this study, it was found that affect changes in joint structure Therefore, in the management over long-term treatment periods the study medicine, Ostolief, 6 of OA, it is important to use a therapeutic tool that provides relief and thus slow or arrest disease progression - the so-called showed good efficacy in all the evaluation parameters. The from the disabling symptoms, does disease- or structure-modifying efficacy of Ostolief was not cause distressing side effects treatments. comparable to that of valdecoxib- and also arrests or reverses the Ostolief is one such multi- a COX-2 inhibitor. None of the degenerative changes that ingredient formulation that patients reported any adverse cause OA. contains ingredients like Shallaki effects with the formulation. The (B. serrata), Ashwagandha (W. need for rescue medication was A structure-modifying somnifera), Gokshur (T. terrestris), also low, indicating that patient treatment for OA Guduchi (T. cordifolia), Bala satisfaction with this formulation Nearly all treatments for OA (S . c o r d i f o l i a) a n d K u p i l u was high. in the current therapeutic arsenal (Strychnos nux vomica). Owing to can be considered symptom- this unique combination of drugs References that act on OA through various 1. Nevitt MC and Felson DT. Sex modifying drugs. These include mechanisms, Ostolief emerges as hormones and the risk of aspirin, analgesics and NSAIDs. osteoarthritis in women. Ann. a disease-modifying therapy with Even currently popular potent anti-inflammatory and Rheum. Dis. 1996;55:673-676. nutraceutical treatments, such as analgesic activity. Shallaki 2. Altman R, Asch E, Bloch D, et al. glucosamine sulfate - touted as the Development of criteria for the reduces the degradation of OCTOBER 2006 classification and reporting of “arthritis cure” - may only primarily glycosaminoglycan and delays the osteoarthritis. Classification of modify symptoms rather than progression of OA. Guduchi, Bala, osteoarthritis of the knee. INDIAN JOURNAL OF CLINICAL PRACTICE Vol. 17, No. 5
  7. 7. Clinical Study Diagnostic and Therapeutic 5. Oliveria SA, Felson DT, Reed JI, 8. Peat G, McCarney R and Croft P. Criteria Committee of Cirillo PA and Walker AM. Knee pain and osteoarthritis in the American Rheumatism Incidence of symptomatic hand, older adults: A review of the Association. Arthritis Rheum. hip and knee osteoarthritis community burden and the 1986;29:1039-1049. among patients in a health current use of primary health maintenance organisation. care. Ann. Rheum. Dis. 2001; 3. Felson DT and Zhang Y. Update Arthritis Rheum. 1995;38: 60:91-97. on the epidemiology of knee and 1134-1141. hip OA with a view to prevention. 6. L e d i n g h a m J , D a w s o n S , 9. Woo J, Ho S, Lau J and Leung PC. Arthritis Rheum. 1998;41: Preston B, et al. Radiographic Muculoskeletal complaints and 1343-1355. progression of hospital referred associated consequences in osteoarthritis of the hip. Ann. elderly Chinese age 70 years and 4. van Saase JL, van Romunde LK, Rheum. Dis. 1993;52:63-67. older. J . R h e u m a t o l . 1 9 9 4 ; Cats A, Vandenbroucke JP and 7. Urwin M, Symmons D, Allison T, 21:1927-1931. Valkenburg HA. Epidemiology and et al. estimating the burden of of osteoarthritis: Zoetermeer musculoskeletal disorders in the 10. Clegg DO, Reda DJ, Harris CL, et survey. Comparison of community: The comparative al. Glucosamine, chondroitin radiological osteoarthritis in a prevalence of symptoms at sulfate, and the two in Dutch population with that in 10 different anatomical sites, and the combination for painful knee other populations. Ann. Rheum. relation to social deprivation. Ann. osteoarthritis. N. Engl. J. Med. Dis. 1989;48:271-280. Rheum. Dis. 1998;57:649-655. 2006 Feb. 23;354(8):795-808. 7 Reprinted under permission from IJCP Group of Publications, Daryacha, 39, Hauz Khas Village, New Delhi - 110 016 from Indian Journal of Clinical Practice 2006 October-;17(5):21-26. Published, Printed and Edited by Dr KK Aggarwal, on behalf of IJCP Academy of CME OCTOBER 2006 as part of their social commitment towards upgrading the knowledge of Indian doctors. Website: www.ijcpgroup.com E-mail: editorial@ijcp.com Printed at: Devtech Publishers & Printers Pvt. Ltd., Plot No. 50, Sector-27/C, Faridabad - 121 003. INDIAN JOURNAL OF CLINICAL PRACTICE Vol. 17, No. 5