Randomized trials are also essential for device therapy
Bibliographic record
Abstract
Dear Sir,We were impressed by the effects of Enhanced External Counter Pulsation (EECP) in the recent study by Loh et al. [1]. However, the study lacked a control group. Therefore, we are surprised by the statement that ‘a major and sustained placebo-response appears unlikely’. We would argue that precisely in refractory angina pectoris a large placebo effect is very likely, as it has been documented in almost every controlled trial in this patient group. For example, in the DIRECT trial [2], the Canadian Cardiovascular Class angina grade improved by at least two classes in 41% of patients, the exercise duration, the time to ST-depression and the time to onset of angina increased by 37, 40 and 48 s respectively (mean values). Furthermore, the quality of life scores increased significantly. All these changes were seen with placebo. Similar effects were seen in the EUROINJECT trial [3]. Even in the only randomized trial of EECP, there was an increase in exercise time both with active and inactive treatment, with no significant difference between groups [4]. As improvements with placebo treatment have been substantial and sustained up to 2 years [5], we think that this is also a main contributor to the effects in the study by Loh. Mechanisms could be a true placebo response or a statistical regression towards the mean effect [6]. Perfusion was not measured in the study by Loh et al. but the authors state that ‘consistent positive treatment effect has been shown in other studies’. They seem to forget that no effect on SPECT perfusion was shown in a recent study [7]. We think that randomized controlled trials are essential to prove treatment effects. As such trials are possible with EECP, they are the only way to prove its efficacy.
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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 | 0.334 | 0.594 |
| Meta-epidemiology (narrow) | 0.003 | 0.002 |
| Meta-epidemiology (broad) | 0.013 | 0.006 |
| Bibliometrics | 0.006 | 0.006 |
| Science and technology studies | 0.002 | 0.009 |
| Scholarly communication | 0.016 | 0.021 |
| Open science | 0.008 | 0.006 |
| Research integrity | 0.024 | 0.034 |
| Insufficient payload (model declined to judge) | 0.059 | 0.029 |
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; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
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".