An open-label six-month extension study to investigate the safety and efficacy of an extract of Artemisia annua for managing pain, stiffness and functional limitation associated with osteoarthritis of the hip and knee.
OBJECTIVE
This six-month single-centre open-label extension study, conducted at the University of Otago, Dunedin, follows from a previously published 12-week pilot double-blind randomised placebo-controlled study of dietary supplement, Arthrem® (ART) in patients with osteoarthritis (OA) of the hip or knee. The pilot double-blind study showed that treatment with ART 150 mg twice-daily was associated with clinically relevant pain reduction. The extension study aims were to assess longer-term safety and efficacy during six months' treatment following the pilot trial.


METHODS
Patients who completed the pilot double-blind study had the option to continue on open-label treatment with ART for a further six months. Safety was assessed by adverse event monitoring and laboratory tests at three and six months. Efficacy was assessed at three and six months using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®).


RESULTS
Thirty-four patients entered the optional extension and 28 completed six months' treatment. ART was well tolerated when taken for up to nine months. Improvements in WOMAC® efficacy parameters reported in the double-blind phase of the study were maintained over six months.


CONCLUSIONS
ART appears to be a safe and effective alternative for managing the symptoms of OA over an extended period.
Principal Scientist, Promisia Ltd, Wellington.
Sheena
S
Hunt
Associate Professor in Medicine, Rheumatology Research Unit, Department of Medicine, Dunedin School of Medicine, University of Otago, Dunedin.
Simon
S
Stebbings
Research Nurse, Department of Medicine, Rheumatology Research Unit, Dunedin School of Medicine, University of Otago, Dunedin.
Debra
D
McNamara
D000368:Aged; D031172:Artemisia annua / Q000737:chemistry*; D019587:Dietary Supplements; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D015207:Osteoarthritis, Hip / Q000150:complications / Q000188:drug therapy*; D020370:Osteoarthritis, Knee / Q000150:complications / Q000188:drug therapy*; D010146:Pain / Q000188:drug therapy*; D059408:Pain Management; D010147:Pain Measurement; D010936:Plant Extracts / Q000008:administration & dosage*; D012720:Severity of Illness Index; D016896:Treatment Outcome
D010936:Plant Extracts