Browse > Article
http://dx.doi.org/10.6116/kjh.2014.29.4.45.

Efficacy and safety of HT008 and glucosamine sulfate in the treatment of knee osteoarthritis : a randomized double-blind trial  

Park, Sangwoug (Korea Institute of Science and Technology for Eastern Medicine, NeuMed Co., Ltd.)
Kim, Young-Sik (Korea Institute of Science and Technology for Eastern Medicine, NeuMed Co., Ltd.)
Lee, Donghun (Dept. of Herbal Pharmacology, College of Korean Medicine, Kyung Hee University)
Kwon, Yongbeom (Korea Institute of Science and Technology for Eastern Medicine, NeuMed Co., Ltd.)
Park, Juyeon (Korea Institute of Science and Technology for Eastern Medicine, NeuMed Co., Ltd.)
Lee, Soh-Young (Dept. of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Kyung Hee University)
Nam, Dong Woo (Dept. of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Kyung Hee University)
Lee, Jae Dong (Dept. of Acupuncture & Moxibustion Medicine, College of Korean Medicine, Kyung Hee University)
Kim, Hocheol (Dept. of Herbal Pharmacology, College of Korean Medicine, Kyung Hee University)
Publication Information
The Korea Journal of Herbology / v.29, no.4, 2014 , pp. 45-52 More about this Journal
Abstract
Objectives : The purpose of this study was to evaluate the efficacy of HT008 on pain relief and functional improvement in participants with mild knee osteoarthritis (OA) in comparison with that of glucosamine sulfate. Methods : This randomized double-blind trial was conducted at Kyung Hee University Medical Center in Seoul where participants with knee pain for more than 6 months and degenerative osteoarthritis were enrolled. The 100 participants were received either HT008 or glucosamine sulfate 750 mg twice daily for 8 weeks and evaluated at baseline, 4 and 8 weeks after the treatment. We primarily evaluated the differences between two groups with respect to changes in the visual analogue score (VAS) for pain, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score from baseline to week 8. Secondarily the difference between and within two groups with respect to changes in WOMAC stiffness and physical function score, and Lequesne Functional Severity Index (LFI) were also evaluated. Results : At week 8, treatment with HT008 resulted in a significant reduction of the VAS for pain and WOMAC pain scores compared to the glucosamine sulfate (both p=0.003). Patients receiving HT008 experienced statistically significantly greater improvements in WOMAC physical function scores and LFI (p = 0.014 and p=0.016, respectively) than glucosamine sulfate-treated group. The within-group change in WOMAC physical function and stiffness, and LFI during the 8-week intervention revealed significant improvements in HT008-treated group. Conclusions : HT008 treatment allows significant pain reduction and functional improvement compared with glucosamine sulfate. These data confirm HT008 as an effective and safe symptomatic drug for knee OA.
Keywords
Citations & Related Records
Times Cited By KSCI : 3  (Citation Analysis)
연도 인용수 순위
1 Clegg DO, Reda DJ, Harris CL, Klein MA, O'Dell JR, Hooper MM, Bradley JD, Bingham CO 3rd, Weisman MH, Jackson CG, Lane NE, Cush JJ, Moreland LW, Schumacher HR Jr, Oddis CV, Wolfe F, Molitor JA, Yocum DE, Schnitzer TJ, Furst DE, Sawitzke AD, Shi H, Brandt KD, Moskowitz RW, Williams HJ. Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis. N Engl J Med, 2006 ; 354(8) : 795-808.   DOI   ScienceOn
2 Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988 ; 15(12) : 1833-40.
3 Bellamy N. WOMAC osteoarthritis user's guide. London (Ontario, Canada) : Victoria Hospital. 1995.
4 Stucki G, Sangha O, Stucki S, Michel BA, Tyndall A, Dick W, Theiler R. Comparison of the WOMAC (Western Ontario and McMaster Universities) osteoarthritis index and a self-report format of the self-administered Lequesne-Algofunctional index in patients with knee and hip osteoarthritis. Osteoarthritis Cartilage. 1998 ; 6(2) : 79-86.   DOI   ScienceOn
5 Weigl M, Cieza A, Harder M, Geyh S, Amann E, Kostanjsek N, Stucki G. Linking osteoarthritis-specific health-status measures to the International Classification of Functioning, Disability, and Health (ICF). Osteoarthritis Cartilage. 2003 ; 11(7) : 519-23.   DOI   ScienceOn
6 Arjmandi BH, Ormsbee LT, Elam ML, Campbell SC, Rahnama N, Payton ME, Brummel-Smith K, Daggy BP. A combination of scutellaria baicalensis and acacia catechu extracts for short-term symptomatic relief of joint discomfort associated with osteoarthritis of the knee. J Med Food. 2014 ; 17(6) : 707-13.   DOI   ScienceOn
7 Mehta K, Gala J, Bhasale S, Naik S, Modak M, Thakur H, Deo N, Miller MJ. Comparison of glucosamine sulfate and a polyherbal supplement, reparagen, for the relief of osteoarthritis of the knee: A randomized controlled trial [ISRCTN25438351]. BMC Complement Altern Med. 2007 ; 7 : 34.   DOI   ScienceOn
8 Sawitzke AD, Shi H, Finco MF, Dunlop DD, Harris CL, Singer NG, Bradley JD, Silver D, Jackson CG, Lane NE, Oddis CV, Wolfe F, Lisse J, Furst DE, Bingham CO, Reda DJ, Moskowitz RW, Williams HJ, Clegg DO. Clinical efficacy and safety of glucosamine, chondroitin sulphate, their combination, celecoxib or placebo taken to treat osteoarthritis of the knee: 2-year results from GAIT. Ann Rheum Dis. 2010 ; 69(8) : 1459-64.   DOI   ScienceOn
9 Rubin BR1, Talent JM, Kongtawelert P, Pertusi RM, Forman MD, Gracy RW. Oral polymeric N-acetyl-D-glucosamine and osteoarthritis. J Am Osteopath Assoc. 2001 ; 101(6) : 339-44.
10 Bee TA, Liew A, Dietary supplements used in osteoarthritis. Proc Singap Healthc. 2010 ; 19(3) : 237-47.   DOI
11 Katz N. The impact of pain management on quality of life. J Pain Symptom Manage. 2002 ; 24(1) : S38-47.   DOI   ScienceOn
12 Ehrich EW, Bolognese JA, Watson DJ, Kong SX. Effect of rofecoxib therapy on measures of health-related quality of life in patients with osteoarthritis. Am J Manag Care. 2001 ; 7(6) : 609-16.
13 Lee DH, Park JH, Bu YM, Kim HC. Effect of new herbal mixture, HT008 on arthritis rat model. Kor J Herbology. 2009 ; 24(4) : 197-204.   과학기술학회마을
14 Jung SM, Schumacher HR, Kim H, Kim M, Lee SH, Pessler F. Reduction of urate crystal-induced inflammation by root extracts from traditional oriental medicinal plants: elevation of prostaglandin D2 levels. Arthritis Res Ther. 2007 ; 9(4) : R64.   DOI   ScienceOn
15 Jia W, Gao WY, Cui NQ, Xiao PG, Anti-inflammatory effects of an herbal medicine (Xuan-ju agent) on carrageenan-and adjuvant-induced paw edema in rats. J Ethnopharmacol. 2003 ; 89 : 139-41.   DOI   ScienceOn
16 Aigner T, Sachse A, Gebhard PM, Roach HI. Osteoarthritis: pathobiology-targets and ways for therapeutic intervention. Adv Drug Deliv Rev. 2006 ; 58(2) : 128-49.   DOI   ScienceOn
17 Zhang DY, Wu J, Ye F, Xue L, Jiang S, Yi J, Zhang W, Wei H, Sung M, Wang W, Li X. Inhibition of cancer cell proliferation and prostaglandin E2 synthesis by Scutellaria baicalensis. Cancer Res. 2003 ; 63(14) : 4037-43.
18 Park SH, Kim SK, Shin IH, Kim HG, Choe JY. Effects of AIF on knee osteoarthritis patients: double-blind, randomized placebo-controlled study. Korean J Physiol Pharmacol. 2009 ; 13(1) : 33-7.   과학기술학회마을   DOI   ScienceOn
19 The Korea Institute for Health and Social Affairs: National Health and Nutrition Survey. 2001.
20 Couture R, Cuello AC. Studies on the trigeminal antidromic vasodilation and plasma extravasation in the rat. J Physiol. 1984 ; 346 : 273-85.   DOI
21 The Korean Orthopaedic Association. Orthopaedics. Seoul : Choisin Euihaksa. 2003 : 1133-5.
22 Cashman JN. The mechanisms of action of NSAIDs in analgesia. Drugs 1996 ; 52 : 801-20.
23 Pascucci RA. Use of nonsteroidal anti-inflammatory drugs and cyclooxygenase-2 (COX-2) inhibitors: indications and complications. J Am Osteopath Assoc. 2002 ; 102 : 487-9.
24 Ignacimuthu S, Prakash BN, Pandikumar P. Antiinflammatory activity of Albizia lebbeck Benth an ethnomedicinal plant in acute and chronic animal models of inflammation. J Ethnopharmacol. 2009 ; 125 : 356-60.   DOI   ScienceOn
25 The Korean Academy of Oriental Rehabilitation Medicine. Oriental Rehabilitation Medicine 2nd edition. Seoul : Gunja. 2005 : 83.
26 Dunlop DD, Manheim LM, Yelin EH, Song J, Chang RW. The costs of arthritis. Arthritis Rheum. 2003 ; 49(1) : 101-13.   DOI   ScienceOn
27 Kim HC. Herbal Pharmocology. Seoul : Jipmoon. 2001.
28 Textbook Compilation Committee of college of Korean Medicine. Herbology. Seoul : Younglim. 1991.
29 Metcalf MH, Larson RV. Painful disorders of the thigh and knee. In Bonica's management of pain. Philadelphia : Lippincott Williams & Wilkins. 2001 : 1593-613.
30 Wandel S, Juni P, Tendal B, Nuesch E, Villiger PM, Welton NJ, Reichenbach S, Trelle S. Effects of glucosamine, chondroitin, or placebo in patients with osteoarthritis of hip or knee: network meta-analysis. BMJ. 2010 ; 341 : c4675.   DOI
31 Corley DA, Kerlikowske K, Verma R, Buffler P. Protective association of aspirin/NSAIDs and esophageal cancer: a systematic review and meta-analysis. Gastroenterol. 2003 ; 124 : 47-56.   DOI   ScienceOn