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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.
PMID
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Authors

Mayor MeshTerms
Keywords

Green lipped mussel extract

Osteoarthritis

Randomized controlled trial

Journal Title bmc complementary and alternative medicine
Publication Year Start




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.