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
Bibliographic record
Abstract
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®-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® -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® -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 .
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.004 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.005 | 0.002 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.001 | 0.002 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.004 | 0.003 |
| Insufficient payload (model declined to judge) | 0.013 | 0.002 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".