Efficacy and Safety of Natural Eggshell Membrane (NEM) in Patients with Grade 2/3 Knee Osteoarthritis: A Multi-Center, Randomized, Doubleblind, Placebo-Controlled, Single-crossover Clinical Study
Bibliographic record
Abstract
Objective: To evaluate the efficacy and safety of NEM® (natural eggshell membrane), in patients with grades 2 and 3 knee osteoarthritis (OA) having significant joint pain and stiffness, in a large, multi-center clinical trial. Subjects and methods: This study was a randomized, double-blind, placebo-controlled, multi-center, single-crossover design. One-hundred sixty subjects (male, 32; females, 134; age ≥ 40 years) with grade 2 or 3 knee OA for 1-5 years were randomized to either NEM (n=83) 500 mg once daily or placebo (n=83) for 30 days. Osteoarthritis was evaluated using the Western Ontario and McMaster Universities OA index. NEM and placebo groups were compared at baseline, day 7, and day 30. After 30 days on placebo, the placebo group crossed over while remaining blinded and was provided with NEM (500 mg) for an additional 60 days. Results: In NEM-treated subjects, WOMAC-stiffness was reduced at day 7 (P=0.034 vs. placebo), and WOMAC-total (P=0.004), WOMAC-pain (P=0.023), WOMAC-stiffness (P=0.001), and WOMAC-function (P=0.001) were reduced at day 30 (vs. placebo). The number of subjects experiencing greater decreases (≥ 20%) in WOMAC-pain was significantly greater in the 90-day NEM group (48%, P=0.022), compared to the 60-day NEM group (30%). No serious adverse events (AE) were observed in the NEM group, and there was no significant between-group difference in the total number of AEs reported (NEM, n=8; placebo, n=15). Conclusion: In this large, multi-center study in subjects with grade 2 and 3 knee OA, NEM reduced pain and stiffness within 7-30 days, and these clinically meaningful benefits persisted for 90 days. NEM can be considered as a safe, natural intervention for inclusion as part of a comprehensive clinical protocol in the management of knee OA.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
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 teacher head, 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".