A randomized double-blind placebo-controlled trial to investigate the effectiveness and safety of a novel green-lipped mussel extract -BioLex® -for managing pain in moderate to severe osteoarthritis of the hip and knee.
|Abstract||Extracts from perna canaliculus, the Green Lipped Mussel (GLM) are widely used as a complimentary therapy by patients with osteoarthritis (OA). The current study investigated the potential of a novel GLM formulation as a treatment for OA. A randomized double-blind placebo-controlled trial was undertaken to assess potential impacts on pain and quality of life following 12 weeks of treatment.|
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.
Combined Treatment With Chondroitin Sulfate and Glucosamine Sulfate Shows No Superiority Over Placebo for Reduction of Joint Pain and Functional Impairment in Patients With Knee Osteoarthritis: A Six-Month Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial.
A 2-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging, phase III trial comparing the efficacy of oxymorphone extended release and placebo in adults with pain associated with osteoarthritis of the hip or knee.
|Journal Title||bmc complementary and alternative medicine|
|Publication Year Start||2017-01-01|
PMID- 28830491 OWN - NLM STAT- MEDLINE DA - 20170823 DCOM- 20170911 LR - 20170911 IS - 1472-6882 (Electronic) IS - 1472-6882 (Linking) VI - 17 IP - 1 DP - 2017 Aug 22 TI - A randomized double-blind placebo-controlled trial to investigate the effectiveness and safety of a novel green-lipped mussel extract -BioLex(R) -for managing pain in moderate to severe osteoarthritis of the hip and knee. PG - 416 LID - 10.1186/s12906-017-1907-9 [doi] AB - BACKGROUND: Extracts from perna canaliculus, the Green Lipped Mussel (GLM) are widely used as a complimentary therapy by patients with osteoarthritis (OA). The current study investigated the potential of a novel GLM formulation as a treatment for OA. A randomized double-blind placebo-controlled trial was undertaken to assess potential impacts on pain and quality of life following 12 weeks of treatment. METHODS: Eighty patients with moderate to severe OA of the hip or knee were randomized to receive either 600 mg of BioLex(R)-GLM daily or placebo for 12 weeks. Entry criteria included a minimum 100 mm Visual Analogue Scale pain score (VAS) of 30 mm at baseline. The primary outcome was patient reported pain, measured by the Western Ontario and McMasters OA Index (WOMAC) pain subscale and VAS pain scale. Secondary outcomes included: quality of life (OAQol), total WOMAC score, WOMAC -20 responder criteria, and change in medication use over the study period. Participants were assessed at baseline, 12 weeks (end of therapy) and 15 weeks (3-weeks post-intervention). RESULTS: At week 12, there were no significant differences in VAS or WOMAC pain subscale between active and placebo groups, nor significant improvement in the WOMAC-20 responder criteria or OAQol. Joint stiffness (measured by WOMAC-B stiffness) in the GLM group improved compared with placebo (p = 0.046). There was a significant difference in paracetamol use between the GLM treated group and the placebo group after week 12 (p = 0.001). CONCLUSIONS: BioLex(R) -GLM extract did not confer clinical benefit in moderate to severe OA over the intervention period, however, a significant difference in paracetamol use in the post-intervention period was observed between the BioLex(R) -GLM group and placebo group. Higher doses and/or longer treatment periods are worthy of future investigation. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Registry: no. ACTRN12611000256976 . FAU - Stebbings, Simon AU - Stebbings S AD - Department of Medicine, Dunedin School of Medicine, University of Otago, Dunedin, New Zealand. [email protected] FAU - Gray, Andrew AU - Gray A AD - Department of Preventive and Social Medicine, University of Otago, Dunedin, New Zealand. FAU - Schneiders, Anthony G AU - Schneiders AG AD - School of Human Health and Social Sciences, Central Queensland University, Branyan, Australia. FAU - Sansom, Andrew AU - Sansom A AD - Seperex Nutritionals, The Centre for Innovation, Dunedin, New Zealand. LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20170822 PL - England TA - BMC Complement Altern Med JT - BMC complementary and alternative medicine JID - 101088661 RN - 0 (Biological Products) RN - 0 (Lipids) SB - IM MH - Aged MH - Animals MH - Arthralgia/*drug therapy MH - Biological Products/*adverse effects/*therapeutic use MH - Blood Pressure MH - Female MH - Humans MH - Lipids/blood MH - Male MH - Middle Aged MH - Osteoarthritis, Hip/*drug therapy MH - Osteoarthritis, Knee/*drug therapy MH - Perna/*chemistry PMC - PMC5568208 OTO - NOTNLM OT - Green lipped mussel extract OT - Osteoarthritis OT - Randomized controlled trial EDAT- 2017/08/24 06:00 MHDA- 2017/09/12 06:00 CRDT- 2017/08/24 06:00 PHST- 2016/02/11 [received] PHST- 2017/08/02 [accepted] AID - 10.1186/s12906-017-1907-9 [doi] AID - 10.1186/s12906-017-1907-9 [pii] PST - epublish SO - BMC Complement Altern Med. 2017 Aug 22;17(1):416. doi: 10.1186/s12906-017-1907-9.