title: Effect of a natural extract of chicken combs with a high content of hyaluronic acid (Hyal-Joint) on pain relief and quality of life in subjects with knee osteoarthritis: a pilot randomized double-blind placebo-controlled trial.
abstract: BACKGROUND
  Intra-articular hyaluronic acid represents a substantive addition to the therapeutic armamentarium in knee osteoarthritis. We examined the effect of dietary supplementation with a natural extract of chicken combs with a high content of hyaluronic acid (60%) (Hyal-Joint) (active test product, AP) on pain and quality of life in subjects with osteoarthritis of the knee.
  
  
  METHODS
  Twenty subjects aged > or =40 years with knee osteoarthritis (pain for at least 15 days in the previous month, symptoms present for > or =6 months, Kellgren/Lawrence score > or =2) participated in a randomized double-blind controlled trial. Ten subjects received AP (80 mg/day) and 10 placebo for 8 weeks. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and quality of life by the Short Form-36 (SF-36v2) were administered at baseline and after 4 and 8 weeks of treatment.
  
  
  RESULTS
  WOMAC pain (primary efficacy variable) was similar in both study groups (mean [SD]) with 6.6 (4.0) points in the AP group and 6.4 (2.7) in the placebo group (P = 0.943). As compared with baseline, subjects in both groups showed statistically significant improvements in WOMAC pain, stiffness, physical function subscales, and in the aggregate score, but the magnitude of changes was higher in the AP group for WOMAC physical function (-13.1 [12.0] vs. -10.1 [8.6], P = 0.575) and total symptoms (-18.6 [16.8] vs. -15.8 [11.4], P = 0.694). At 4 weeks, statistically significant mean changes compared with baseline were observed in the SF-36v2 scales of role-physical, bodily pain, social functioning and role-emotional among subjects in the AP group, and in physical functioning, bodily pain, and social functioning in the placebo group. At 8 weeks, changes were significant for role-physical, bodily pain, and physical component summary in the AP group, and for physical functioning and role-emotional in the placebo arm. Changes in bodily pain and social functioning were of greater magnitude in subjects given AP.
  
  
  CONCLUSIONS
  This pilot clinical trial showed that daily supplementation with oral hyaluronic acid from a natural extract of chicken combs (Hyal-Joint) was useful to enhance several markers of quality of life in adults with osteoarthritis of the knee. The results warrant further study in larger sample sizes.
authors.affiliation: Department of Nutrition, Miami Research Associates, Miami, Florida 33143, USA. dkalman@miamiresearch.com
authors.forename: Douglas S
authors.initials: DS
authors.lastname: Kalman
authors.forename: Maria
authors.initials: M
authors.lastname: Heimer
authors.forename: Anita
authors.initials: A
authors.lastname: Valdeon
authors.forename: Howard
authors.initials: H
authors.lastname: Schwartz
authors.forename: Eric
authors.initials: E
authors.lastname: Sheldon
mesh_terms: D000328:Adult; D000368:Aged; D000698:Analgesia; D000700:Analgesics / Q000008:administration & dosage*; D000818:Animals; D002645:Chickens; D003129:Comb and Wattles / Q000737:chemistry*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D010147:Pain Measurement; D017060:Patient Satisfaction; D010865:Pilot Projects; D010919:Placebos; D011788:Quality of Life; D011795:Surveys and Questionnaires
chemical_list: D000700:Analgesics; D010919:Placebos; D006820:Hyaluronic Acid