Long-term results from a randomized blinded sham- and waitlist-controlled trial of acupuncture for joint symptoms related to aromatase inhibitors in early stage breast cancer (S1200).
Bibliographic record
Abstract
12018 Background: Musculoskeletal symptoms are the most common side effect of aromatase inhibitors (AIs) among breast cancer (BC) survivors. We previously reported that true acupuncture (TA) resulted in better pain outcomes than either sham acupuncture (SA) or wait-list controls (WC) at 6 weeks with durable effects through 24 weeks, with minimal toxicity. We now report the 52-week outcomes. Methods: We conducted a SWOG multicenter randomized controlled trial among postmenopausal women with early-stage BC. Patients taking an AI for ≥30 days and reporting a worst pain score of ≥3 out of 10 using the Brief Pain Inventory-Worst Pain (BPI-WP) were eligible. Subjects were randomized 2:1:1 to TA vs. SA vs. WC. Both the TA and SA protocols consisted of a 12-week intervention, with 2 sessions per week for 6 weeks, followed by 1 session per week for 6 additional weeks. At 24 weeks, all subjects remained blinded to intervention arm but were offered 10 sessions of true acupuncture. Endpoints included BPI scores, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for hips and knees, the Modified Score for the Assessment of Chronic Rheumatoid Affections of the Hands (M-SACRAH), PROMIS Pain Inventory Short Form (PI-SF), and Functional Assessment of Cancer therapy Endocrine Symptoms (FACT-ES). Results: Among 226 patients registered, 110 were randomized to TA, 59 to SA and 57 to WC. Baseline characteristics were similar among the arms. At 52 weeks, follow-up assessments were available for 91 (82.7%) TA, 53 (89.8%) SA, and 47 (82.5%) WC patients. In a linear regression adjusting for the baseline score and stratification factors, 52-week mean BPI-WP scores were 1.08 points lower (correlating with less pain) in the TA compared to SA arm (95% CI: 0.24-1.91, p =.01), and were 0.99 points lower in the TA compared to WC arm (95% CI: 0.12-1.86, p =.03). The proportion of patients experiencing a clinically meaningful (>2) reduction (i.e. improvement) in BPI-WP was 64% for TA compared to 45% on SA and 53% on WC. Patients randomized to TA had reduced BPI pain interference at 52 weeks compared to SA (adjusted difference = 0.58, 95% CI: 0.00-1.16, p =.05) but not compared to WC (adjusted difference = 0.33, 95% CI: -0.28-0.93, p =.29). Also, at 52 weeks, patients randomized to TA had improved PROMIS PI-SF T-scores compared to SA (adjusted difference = 2.35, 95% CI: 0.07-4.63, p =.04) but not compared to WC (adjusted difference = 1.28, 95% CI: -1.09-3.66, p =.29). No statistically significant differences were observed in other measures. Conclusions: Women with breast cancer receiving AI therapy and treated with 12 weeks of TA for joint symptoms had reduced levels of worst pain compared to control patients, an effect that was durable through one year despite completion of protocol acupuncture at 12 weeks, and the offering of acupuncture to all participants at 24 weeks. Clinical trial information: NCT01535066.
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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 | 0.003 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.003 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| 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".