title: A pilot randomized, placebo-controlled clinical trial to investigate the efficacy and safety of an extract of Artemisia annua administered over 12 weeks, for managing pain, stiffness, and functional limitation associated with osteoarthritis of the hip and knee.
abstract: The objective of this study was to investigate the safety and efficacy of a dietary supplement, Arthrem, containing an extract from the medicinal plant Artemisia annua, on pain, stiffness, and functional limitation in osteoarthritis (OA) of the hip or knee. Forty-two patients were randomized to one of three groups (n = 14 in each group): 150-mg Artemisia annua extract (ART) twice daily (BD) (ART low dose), 300-mg ART BD (ART high dose), or placebo BD administered over 12 weeks. Efficacy was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®) and visual analog scale (VAS) for pain. Participants treated with ART low dose demonstrated significant improvement in WOMAC total scores from baseline to 12 weeks (mean change, -12.2; standard deviation, [SD] 13.84; p = 0.0159); improvement was not shown in the placebo group (mean change, -7.8; SD, 19.80; p = 0.1029). Statistically significant reductions were seen from baseline in the ART low-dose group for individual WOMAC components stiffness and physical function. VAS pain scores were statistically significantly reduced from baseline to 12 weeks in the ART low-dose group (mean change, -21.4 mm; SD, 23.48 mm; p = 0.0082) but not the placebo group (mean change, -11.5 mm; SD, 28.97 mm, p = 0.1757). No statistically significant changes occurred from baseline in the placebo or ART high-dose groups for any parameter. ART low dose was well tolerated. ART has potential as an anti-inflammatory/analgesic in OA. Treatment with ART 150 mg BD is associated with clinically relevant reductions in pain over 12 weeks. Further studies are warranted.
authors.affiliation: Department of Medicine, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand. simon.stebbings@otago.ac.nz.|Rheumatology Research Unit, Dunedin School of Medicine, PO Box 913, Dunedin, 9054, New Zealand. simon.stebbings@otago.ac.nz.
authors.forename: Simon
authors.initials: S
authors.lastname: Stebbings
authors.affiliation: Promisia Ltd, Wellington, New Zealand.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Beattie
authors.affiliation: Department of Medicine, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand.
authors.forename: Debra
authors.initials: D
authors.lastname: McNamara
authors.affiliation: Promisia Ltd, Wellington, New Zealand.
authors.forename: Sheena
authors.initials: S
authors.lastname: Hunt
mesh_terms: D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage* / Q000009:adverse effects; D031172:Artemisia annua / Q000737:chemistry*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009520:New Zealand; D015207:Osteoarthritis, Hip / Q000188:drug therapy*; D020370:Osteoarthritis, Knee / Q000188:drug therapy*; D010146:Pain / Q000188:drug therapy*; D059408:Pain Management; D010147:Pain Measurement; D010936:Plant Extracts / Q000008:administration & dosage* / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D010936:Plant Extracts
keywords: Anti-inflammatory agents; Artemisia annua; Dietary supplements; Herbal medicine; Osteoarthritis; Randomized controlled trial