Efficacy of Chinese medicine compound Fufang E’jiao Syrupfor symptom burden of cancer-related fatigue in patients with advanced cancer: A randomized clinical trial.
Bibliographic record
Abstract
12070 Background: Cancer-related fatigue ( CRF) is often accompanied by a high symptom burden, significantly impacting the quality of life in patients with advanced cancer. Traditional Chinese medicine compound Fufang E’jiao Syrup (FFEJS) has shown promising potential in alleviating fatigue and reducing the overall burden of cancer-related symptoms. This study aims to investigate the efficacy and safety of FFEJS in reducing symptom burden in patients with advanced cancer. Methods: This multicenter, double-blinded, placebo-controlled trial was conducted across 29 hospitals in China and included 611 patients with advanced non-small cell lung cancer, colorectal cancer, or gastric cancer experiencing moderate-to-severe fatigue (Visual Analogue Fatigue Scale score ≥ 4). Participants were randomized to receive FFEJS (20 mL, 3 times daily) or placebo for six weeks. The primary outcome was the change in symptom burden, assessed via the Edmonton Symptom Assessment Scale (ESAS; score range 0-110, higher scores indicate greater burden). Secondary outcomes included changes in 11 individual symptoms (e.g., tiredness, depression, pain) and the incidence of adverse events. Linear mixed models were used for statistical analysis. Results: Among 611 patients randomized (303 received FFEJS and 308 received placebo; 210 [34.4%] had non-small cell lung cancer, 201 [32.9%] had colorectal cancer, and 200 [32.7%] had gastric cancer; mean [SD] age 62.8 [9.3] years; 413 [68.6%] male; mean [SD] baseline mean total symptom burden 38.96 [15.68] points, 503 (82.3%) completed the primary end point analysis. At week 6, FFEJS demonstrated a significantly greater reduction in total symptom burden compared to placebo (6.67 vs 3.16; adjusted mean difference: 3.51[95% CI 1.21–5.8]; P = .004). Patients in the FFEJS arm showed significant improvements in tiredness (1.68 vs 0.79; adjusted mean difference, 0.89 [95% CI, 0.62-1.18]; P < .001), drowsiness (1.13 vs 0.50; adjusted mean difference, 0.63 [95% CI, 0.32-0.95]; P < .001), pain (0.34 vs 0.01; adjusted mean difference, 0.33 [95% CI, 0.08-0.62]; P = .049), depression (0.41 vs -0.15; adjusted mean difference, 0.56 [95% CI, 0.28-0.86]; P = .003) compared with the placebo arm. Subgroup analysis revealed greater symptom reduction in geriatric patients (≥ 60 years; P < .001) and in non-small cell lung ( P = .044) and colorectal cancer ( P = .047), compared to gastric cancer ( P = .123). Conclusions: FFEJS significantly reduced total symptom burden and improved fatigue-related symptoms in patients with advanced cancer. Subgroup analysis highlighted enhanced efficacy in geriatric populations and certain cancer types. These results highlight the potential of FFEJS as a valuable integrative therapy for improving symptom management and quality of life in advanced cancer care. Clinical trial information: NCT04147312 .
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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 | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.001 |
| Insufficient payload (model declined to judge) | 0.006 | 0.001 |
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".