Phellodendron and Citrus extracts benefit joint health in osteoarthritis patients: a pilot, double-blind, placebo-controlled study.
BACKGROUND
The objective of this clinical study was to assess the potential benefit of a dietary supplement, NP 06-1, on joint health in overweight and normal weight adults diagnosed with osteoarthritis.


METHODS
An 8-week placebo-controlled, randomized, double-blind study was conducted with four groups comparing the effects of NP 06-1 to placebo on overweight and normal weight subjects diagnosed with primary osteoarthritis of the knee. NP 06-1 (a combination of two botanical extracts; Phellodendron amurense bark and Citrus sinensis peel) or matching placebo were given in a dose of two capsules (370 mg each) twice daily. The outcome measures were the Lequesne Algofunctional Index (LAI) for joint pain and movement as well as biomarkers of inflammation (C-reactive protein [CRP] and erythrocyte sedimentation rate [ESR]).


RESULTS
Eighty (80) subjects were enrolled and 45 subjects completed the study. No serious adverse events were reported. The mean total LAI scores at baseline for the four groups ranged from 11.4 to 12.4 (SD 1.2 to 2.4). Treatment for 8 weeks resulted in a statistical improvement in the LAI score in the overweight treatment group compared to placebo (6.3 +/- 2.3 vs 11.8 +/- 1.5; p < 0.0001). At 8 weeks, a similar result was observed in the normal weight groups (7.7 +/- 1.4 vs 9.9 +/- 0.9; p < 0.0001). There was a reduction in CRP levels with treatment in the overweight treatment group at 8 weeks (-0.62 +/- 0.2; 49%) compared to baseline (p < 0.001) and to placebo (p < 0.001). For the normal weight participants, there were significant reductions in CRP compared to baseline, but not to the matched placebo group. Both overweight and normal weight treatment groups lost a significant amount of weight compared to their placebo groups. The overweight treatment group lost an average of 5% body weight after 8 weeks. There was no significant change in ESR in any of the groups.


CONCLUSIONS
In this pilot study, NP 06-1 had beneficial effects on symptoms of osteoarthritis of the knee as measured using LAI scores and had anti-inflammatory effects as measured using CRP. Administration of NP 06-1 was also associated with weight loss, which may have been a contributing factor to the other benefits.
Oben
Julius
J
Laboratory of Nutrition & Nutritional Biochemistry, Department of Biochemistry, University of Yaounde I, Cameroon. juliusoben@hotmail.com
Enonchong
Ebangha
E
Kothari
Shil
S
Chambliss
Walter
W
Garrison
Robert
R
Dolnick
Deanne
D
D000328:Adult; D002097:C-Reactive Protein / Q000378:metabolism; D002957:Citrus / Q000737:chemistry*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007596:Joints / Q000187:drug effects; D008297:Male; D008875:Middle Aged; D010003:Osteoarthritis / Q000188:drug therapy*; D050177:Overweight / Q000188:drug therapy*; D032102:Phellodendron / Q000737:chemistry*; D010865:Pilot Projects; D010936:Plant Extracts / Q000008:administration & dosage / Q000627:therapeutic use*
C545281:NP 06-1; D010936:Plant Extracts; D002097:C-Reactive Protein
Int J Immunopharmacol. 1996 Oct;18(10):553-61
9080249
Arthritis Res Ther. 2006;8(4):R127
16859534
J Agric Food Chem. 2004 May 19;52(10):2879-86
15137829
Osteoarthritis Cartilage. 2007 May;15(5):516-23
17157039
Atherosclerosis. 2005 Jan;178(1):25-32
15585197
Best Pract Res Clin Rheumatol. 2007 Feb;21(1):59-76
17350544
Biol Pharm Bull. 1994 Feb;17(2):262-5
7515744
Life Sci. 2003 Aug 1;73(11):1401-12
12850501
Ann Rheum Dis. 2007 Apr;66(4):433-9
17204567
Nutr J. 2008 May 20;7:16
18492265
Diabetes. 2006 Aug;55(8):2256-64
16873688
Exp Mol Med. 2006 Dec 31;38(6):599-605
17202835
Arch Intern Med. 2007 Jan 8;167(1):31-9
17210875
J Rheumatol. 1997 Aug;24(8):1486-8
9263139
Endocr Rev. 2008 Dec;29(7):777-822
18971485
Cancer Lett. 2004 Jan 20;203(2):127-37
14732220
Lipids. 2004 Feb;39(2):143-51
15134141
Arthritis Rheum. 1986 Aug;29(8):1039-49
3741515
Rheumatology (Oxford). 2001 Jul;40(7):779-93
11477283
Life Sci. 2006 Jun 20;79(4):365-73
16497336
J Nat Prod. 1999 Mar;62(3):441-4
10096854
Osteoarthritis Cartilage. 2007 Aug;15(8):966-71
17395501
Immunopharmacol Immunotoxicol. 1999 Nov;21(4):771-86
10584211
J Rheumatol. 1997 Apr;24(4):779-81
9101517