Efficacy and safety of Shexiang Baoxin pill in patients with ischemia with non-obstructive coronary arteries (LESS): a phase 4, multicenter, randomized, double-blind, placebo-controlled clinical trial
Bibliographic record
Abstract
Abstract Background Patients with ischemia with non-obstructive coronary arteries (INOCA) present with ischemic signs and symptoms but no obstructive coronary artery disease (CAD) at coronary angiography. Shexiang Baoxin pill (MUSKARDIA) is effective in reducing angina frequency in patients with stable CAD. Purpose This phase 4 trial was conducted to evaluate the efficacy and safety of MUSKARDIA in INOCA patients. Methods This was a multicenter, randomized, double-blind, placebo-controlled clinical trial (NCT04897126). The enrolled patients with INOCA confirmed as eligible by leading PI were randomly assigned in a 1:1 ratio to receive MUSKARDIA or placebo (oral 4 pills 3 times a day) on the basis of conventional treatment until the end of follow-up. The primary endpoint was the angina-related outcomes based on the Seattle Angina Questionnaire (SAQ) score that assessed by same doctor at week 12. Results 236 INOCA patients were randomized (MUSKARDIA group, n = 117; placebo group, n=119). At week 12, patients in MUSKARDIA group showed higher SAQ scores compared with placebo group (all P<0.0001, Figure 1) indicating MUSKARDIA could significantly relieve symptoms of angina. According to the Canadian Cardiovascular Society (CCS) grading of angina pectoris, the severity of angina pectoris was significantly reduced in MUSKARDIA group compared with placebo group at week 12 (grade Ⅰ [91.09% vs 48.15%]; grade Ⅱ [8.91% vs 25.93%]; grade Ⅲ [0% vs 19.44%]; grade Ⅳ [0% vs 6.48%]; P<0.001). After 12 weeks of treatment with MUSKARDIA, numbers of weekly angina attacks were significantly reduced compared with placebo group (-2.60 vs -0.42; LSM difference: -2.18; P<0.0001). The percentage of patients who did not used nitroglycerin was noticeably higher in MUSKARDIA group than that in placebo group (84.16% vs 58.33%, P<0.001). The incidence of adverse events did not differ meaningfully between two groups. Conclusion MUSKARDIA was confirmed to be an effective, safe and well-tolerated treatment for INOCA patients in clinical settings.
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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 | 0.002 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 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".