Effectiveness of subcutaneous injections of a cartilage preparation in osteoarthritis of the knee--a randomized, placebo controlled phase II study.
OBJECTIVE
Articulatio Genus D5 (AG5), a cartilage preparation, is widely used within anthroposophic medicine to treat osteoarthritis of the knee (OA). To evaluate its efficacy 91 OA patients were randomized to receive either AG5 (46) or placebo (45) following a fully sequential study design. For a period of 4 weeks AG5 or placebo were injected subcutaneously 3 times a week in the predominantly affected knee. Outcome parameters were the Western Ontario and Mc. Masters University Arthritis Index (WOMAC) scores and the use of concomitant pain medication during a follow up period of 2 months.


RESULTS
89 patients completed the study. After 4 weeks of treatment WOMAC pain scores were significantly reduced compared to baseline (mean from 5.1+/-1.8 to 3.2+/-2.2 with AG5 and from 4.3+/-1.5 to 3.0+/-1.8 with placebo, p<0.001) in both groups. This effect was maintained until follow up (mean 3.3+/-2.6 with AG5 and 3.2+/-2.4 with placebo). WOMAC function- and stiffness scores and use of concomitant pain medication were also significantly reduced. There was, however, no significant difference between AG5 and placebo (group difference after 4 weeks: -3.3, CI: -11.8 to 5.3, p=0.46, triangular test). After follow up, WOMAC scores were also not different between AG5 and placebo but the use of pain medication dropped significantly more in the AG5 group (p=0.036). Severe side effects did not occur, minor side effects in 2 patients (1 in each group) were related to the subcutaneous injection.


CONCLUSIONS
For the primary outcome parameter pain AG5 was not superior to placebo after 4 weeks of treatment but the equal reduction of pain in combination with higher reduction of pain medication suggests an effect of the preparation. The long term effect of AG5 on sparing pain medication should be further investigated.
Huber
Roman
R
Department of Environmental Health Sciences, University Hospital Freiburg, Breisacher Str. 115b, D-79106 Freiburg, Germany. roman.huber@uniklinik-freiburg.de
Prestel
Ute
U
Bloss
Isabel
I
Meyer
Ulrich
U
Lüdtke
Rainer
R
D000368:Aged; D000818:Animals; D001688:Biological Products / Q000008:administration & dosage / Q000627:therapeutic use*; D002356:Cartilage; D002417:Cattle; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007279:Injections, Subcutaneous; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000150:complications / Q000188:drug therapy*; D010146:Pain / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome
D001688:Biological Products