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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

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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.

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Acknowledgments

The authors thank Liam Harker MSc (Research Scientist, Promisia Ltd) for data management and study monitoring and Liz English (Bellbird Editing) for editorial assistance.

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Authors and Affiliations

  1. Department of Medicine, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand

    Simon Stebbings & Debra McNamara

  2. Promisia Ltd, Wellington, New Zealand

    Elizabeth Beattie & Sheena Hunt

  3. Rheumatology Research Unit, Dunedin School of Medicine, PO Box 913, Dunedin, 9054, New Zealand

    Simon Stebbings

Authors
  1. Simon Stebbings
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  2. Elizabeth Beattie
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  3. Debra McNamara
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  4. Sheena Hunt
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Corresponding author

Correspondence to Simon Stebbings.

Ethics declarations

Compliance with ethical standards

The study was conducted according to the principals of good clinical practice, which protects the rights, safety, and well-being of trial subjects in accordance with the principles of the Declaration of Helsinki. All patients provided written informed consent before any study-related procedures. The study received ethical approval from the Health and Disability Ethics Committee New Zealand (14/NTB/11).

Disclosures and conflict of interest

The study was funded by Promisia Ltd., the manufacturer of the extract of Artemisia used in the study. S Hunt and E Beattie are employees of Promisia Ltd.

Dr Hunt provided assistance in the design of the study. The interpretation of data and writing of the manuscript was performed by Dr Stebbings. Dr Hunt had input into the manuscript. Ms Beattie performed all statistical analysis and randomization. The final decision to publish lay solely with Dr Stebbings.

Dr Stebbings has no financial interests or other conflicts of interest in association with Promisia Ltd, including stock ownership, honoraria, paid expert testimony, or personal relationships, which may inappropriately influence the conduct of the trial.

There are no conflicts of interest for D McNamara.

Additional information

ACTRN12614000259640

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Stebbings, S., Beattie, E., McNamara, D. et al. 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. Clin Rheumatol 35, 1829–1836 (2016). https://doi.org/10.1007/s10067-015-3110-z

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  • DOI: https://doi.org/10.1007/s10067-015-3110-z

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