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|Year : 2007 | Volume
| Issue : 1 | Page : 27--29
Open, randomized, controlled clinical trial of Boswellia serrata extract as compared to valdecoxib in osteoarthritis of knee
S Sontakke1, V Thawani1, S Pimpalkhute1, P Kabra2, S Babhulkar3, L Hingorani4,
1 Government Medical College, Nagpur, India
2 Government Ayurved College, Nagpur, India
3 Indira Gandhi Government Medical College, Nagpur, India
4 Pharmanza (India), GIDC, Kansari, India
Government Medical College, Nagpur
Objective: To compare the efficacy, safety and tolerability of Boswellia serrata extract (BSE) in osteoarthritis (OA) knee with valdecoxib, a selective COX-2 inhibitor.
Materials and Methods: In a randomized, prospective, open-label, comparative study the efficacy, safety and tolerability of BSE was compared with valdecoxib in 66 patients of OA of knee for six months. The patients were assessed by WOMAC scale at baseline and thereafter at monthly interval till 1 month after drug discontinuation. Antero-posterior radiographs of affected knee joint were taken at baseline and after 6 months.
Results: In BSE group the pain, stiffness, difficulty in performing daily activities showed statistically significant improvement with two months of therapy which even lasted till one month after stopping the intervention. In valdecoxib group the statistically significant improvement in all parameters was reported after one month of therapy but the effect persisted only as long as drug therapy continued. Three patients from BSE group and two from valdecoxib group complained of acidity. One patient from BSE group complained of diarrhea and abdominal cramps.
Conclusion: BSE showed a slower onset of action but the effect persisted even after stopping therapy while the action of valdecoxib became evident faster but waned rapidly after stopping the treatment.
|How to cite this article:|
Sontakke S, Thawani V, Pimpalkhute S, Kabra P, Babhulkar S, Hingorani L. Open, randomized, controlled clinical trial of Boswellia serrata extract as compared to valdecoxib in osteoarthritis of knee.Indian J Pharmacol 2007;39:27-29
|How to cite this URL:|
Sontakke S, Thawani V, Pimpalkhute S, Kabra P, Babhulkar S, Hingorani L. Open, randomized, controlled clinical trial of Boswellia serrata extract as compared to valdecoxib in osteoarthritis of knee. Indian J Pharmacol [serial online] 2007 [cited 2019 Nov 22 ];39:27-29
Available from: http://www.ijp-online.com/text.asp?2007/39/1/27/30759
Osteoarthritis (OA) is a common articular disease. The therapy in modern medicine includes the use of NSAIDs and steroids, which are associated with ADRs and do not reverse the pathological process of the disease.
Boswellia serrata (BS) (Family: Bursaraceae) known as Gaja-bhaksha (implying its ingestion by elephants) in Sanskrit and Sallaki Guggul in Ayurveda is widely used in India. BS gum has been mentioned in the ancient Indian Ayurvedic texts., Gum resin extracted from BS possesses good anti-inflammatory, anti-arthritic and analgesic activities. It has been claimed to decrease the degradation of glycosaminoglycans thereby helping to prevent the destruction of articular cartilage. The efficacy and safety of BS in OA knee was studied in a randomized, double blind, placebo-controlled trial where BS was reported to be significantly better than placebo in relieving the symptoms of OA. No comparative clinical trial is yet reported with BS. Hence, this study was planned to compare the efficacy, safety and tolerability of BS in OA knee with valdecoxib, a selective COX-2 inhibitor.
The present study was a randomized, prospective, open-label, comparative trial approved by the Institutional ethics committee. About 66 patients aged between 40 and 70 years of either gender, with primary OA of knee, diagnosed according to the criteria of American College of Rheumatology were recruited from the OPD of Kayachikitsa Government Ayurved College, Nagpur. The diagnosis was based on clinical presentation and X-ray findings and confirmed by the orthopedician. Patients were enrolled between December 2003 and May 2004 and were followed up to 7 months. Patients with history of peptic ulcer, acid peptic disease, concurrent illness, receiving concomitant drug therapy, having history of any drug allergy, having received corticosteroids within four weeks or any anti-inflammatory analgesic three days prior to enrolment, pregnant/lactating women were excluded. Informed, written consent was obtained from those who agreed to participate. Routine hematological investigations were done. The patients were assessed by Western Ontario and McMaster Universities OA index (WOMAC) scale (version VA 3.1) in which decrease in scores suggests improvement and antero-posterior radiographs of affected knee joint in full extension.
The patients were randomly allocated by SAS system for Windows to two groups of 33 each to receive either Boswellia serrata extract (BSE) (Cap WokvelTM, manufactured by Pharmanza India) each containing 333 mg of BSE thrice daily (BSE Group) or valdecoxib 10 mg (Tab Valdone, Cadila Pharmaceuticals Limited) once daily (Valdecoxib Group) for six months. The medicines were given orally and the patients were advised to take them after meals. Asking the patients to bring back the empty blister packs during each visit checked the compliance and the consumed drug count was measured. Consumption of 90% of the drug was considered as adequate compliance. None of the patients became pregnant during the trial period. The age group of study subjects was above 40 years so chances of a patient becoming pregnant were minimal. No advice about contraception was given. The BSE capsule contained the standardized extract of BS gum having minimum 40% total boswellic acids (BA). The main components of BA in BSE used were 11-keto-beta BA - 6.44%, 3-O-Acetyl-beta BA-8.58%, alpha BA -6.93% and 3-O-acetyl alpha BA-1.853%. The patients were assessed by WOMAC scale at monthly intervals and at the end of study. Radiograph of the affected knee joint was repeated at the end of study. The patients were under the assigned intervention for 30 days at a time and permitted to continue physiotherapy they were receiving and advised to report ADRs. The drug intervention was for a period of six months and assessment done with WOMAC scale, was repeated at the end of seventh month to evaluate the residual effect of treatment.
WOMAC scores in each group at monthly interval were compared with the basal scores by repeated measures anova followed by Dunnett's test. Between group comparison was done by unpaired ' t ' test and ' P ' value less than 0.05 was considered statistically significant.
Demographic characteristics of both groups were comparable. Two patients from BSE group and six from valdecoxib group dropped out from the study. From BSE group, one patient dropped due to diarrhea and abdominal cramps and the other due to inadequate control of symptoms. The reason given by all dropouts from valdecoxib group was that symptoms recurred if the patient missed a dose or two.
The basal WOMAC scores for pain, stiffness and difficulty in performing daily activities were compared with the scores at the end of each month. In BSE group, the difference in WOMAC scores was not statistically significant at the end of first month of intervention when compared to baseline ( P >0.05). But from second month onwards the decrease was highly significant ( P P P Department, Government Medical College, Nagpur for internally peer-reviewing the manuscript and Dr. G. Dakhale and Dr. A. Turankar, ex-Lecturers in Pharmacology, Government Medical College Nagpur for helping in statistical analysis.
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