Effects of AIF on Knee Osteoarthritis Patients: Double-blind, Randomized Placebo-controlled Study

다국어 초록 (Multilingual Abstract)

Anti-inflammatory factor (AIF) is a water soluble extract of three herbs, Panax notoginseng (Burk.) F. H. Chen, Rehmannia glutinosa Libosch and Eleutherococcus senticosus. The present study aimed to investigate the safety and efficacy of herb extracts, AIF, on Korean knee osteoarthritis patients for six weeks. Fifty seven patients with knee osteoarthritis, ranging from 43 to 73 years of age, who fulfilled the “American College of Rheumatology” (ACR) classification of idiopathic osteoarthritis of knee and radiographic criteria were randomly selected and enrolled for the study. After initial screening and resting period, two capsules each of AIF (Each capsule contains; 400 mg) and similar identical placebo were administered twice a day to both groups. Pain intensity at second, fourth, and sixth weeks of study as well as one week after discontinuation of drugs was assessed by using 100 mm visual analogue scale (VAS). Changes in the Korean version of the Western Ontario and McMaster Universities (K-WOMAC) index score were compared at the initiation and completion of the study. VAS assessed by patients were significantly reduced (at visit 2; 54.64±14.72, at visit 4, 37.32±16.58, p＜0.001) after AIF administration. Results showed an improvement in the physical function of K-WOMAC scale which was significantly higher (p=0.013) in AIF than placebo group, and decreases of total K-WOMAC score were also significantly higher (p=0.030) in AIF groups than placebo group. No serious adverse effect was observed, and there was no difference in incidence of adverse effect between AIF and placebo groups. In this population of Korean patients with knee osteoarthritis, AIF was found to be safe, tolerable and effective for symptomatic improvement of pain and physical function.

참고문헌 (Reference)

1 Christensen R, "Symptomatic efficacy of avocado-soybean unsaponifiables (ASU) in osteoarthritis (OA) patients: a meta-analysis of randomized controlled trials" 16 : 399-408, 2008

2 Chang SH, "Suppressive effect of AIF, a water extract from three herbs, on collagen-induced arthritis in mice" 5 : 1365-1372, 2005

3 Kim HM, "Rehmannia glutinosa inhibits tumour necrosis factor-alpha and interleukin-1 secretion from mouse astrocytes" 40 : 171-176, 1999

4 World Medical Association Declaration of Helsinki, "Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects"

5 Kellgren JH, "Radiological assessment of osteo- arthrosis" 16 : 494-502, 1957

6 Martel-Pelletier J, "Pathophysiology of osteoarthritis" 12 (12): S31-S33, 2004

7 Garstang SV, "Osteoarthritis: epidemiology, risk factors, and pathophysiology" 85 : S11-S12, 2006

8 Zhang W, "OARSI Recommendations for the management of hip and knee osteoarthritis. part I: critical appraisal of existing treatment guidelines and systematic review of current research evidence" 15 : 981-1000, 2007

9 Peat G, "Knee pain and osteoarthritis in older adults: a review of community burden and current use of primary health care" 60 : 91-97, 2001

10 Clegg DO, "Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis" 354 : 795-808, 2006

11 McAlindon TE, "Glucosamine and chondroitin for treatment of osteoarthritis: a systematic quality assessment and meta-analysis" 283 : 1469-1475, 2000

12 Lawrence RC, "Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States" 41 : 778-799, 1998

13 Pelletier JP, "Efficacy and safety of diacerein in osteoarthritis of the knee: a double-blind, placebo-controlled trial" The Diacerein Study Group 43 : 2339-2348, 2000

14 Ling S, "Effects of four medicinal herbs on human vascular endothelial cells in culture" 128 : 350-358, 2008

15 Altman R, "Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association" 29 : 1039-1049, 1986

16 Spiker B, "Design issues in a randomized clinical trial of a behavioral intervention: Insights from the infant health and development program" 12 : 386-393, 1992

17 Bae SC, "Cross-cultural adaptation and validation of Korean Western Ontario and McMaster Universities (WOMAC) and Lequesne osteoarthritis indices for clinical research" 9 : 746-750, 2001

18 Chang SH, "Anti-inflammatory effects of BT-201, an n-butanol extract of Panax notoginseng, observed in vitro and in a collagen-induced arthritis model" 26 : 785-791, 2007

19 Ofman JJ, "A metaanalysis of severe upper gastrointestinal complications of nonsteroidal antiinflammatory drugs" 29 : 804-812, 2002