The DOI matches its Crossref record; 4 of the 4 references it cites were found in a registry or an index.
Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 2: Practical Issues and Specific Cases
Abstract
Placebo controls are commonly used in clinical trials of investigational treatments because they have important advantages. In recent years, some have criticized the use of placebo-controlled trials when effective alternative therapy exists, regardless of the expected effect of the therapy. In part 1 of this paper, ethical arguments are addressed and the interpretive problems inherent in the use of active-control equivalence trials to establish efficacy of a new treatment are clarified. However, uncertainties may complicate decisions about appropriate use of placebo controls in some situations. Part 2 discusses more fully the ethical considerations for using placebo controls in particular medical settings. The value and relevance of placebo-controlled trials of new agents in situations in which proven effective therapy is available are also explored.
Overview
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In the citing paper
“On the other hand, the use of current therapies (active controls) can also be controversial.”
From Understanding Equivalence and Noninferiority Testing (2011) · cites this paper as [12]
In the citing paper
“Another reason is that in many instances the use of placebos is unethical.”
From Understanding Equivalence and Noninferiority Testing (2011) · cites this paper as [12]
In the citing paper
“The issues involved in this decision are discussed by Ellenberg and Temple 12 and Temple and Ellenberg 13 .”
From Understanding Equivalence and Noninferiority Testing (2011) · cites this paper as [12]
Citations
Cites
Tissue Plasminogen Activator for Acute Ischemic Stroke
(1995) · New England Journal of Medicine · doi:10.1056/nejm199512143332401 · Cited by 11,654
The effect of digoxin on mortality and morbidity in patients with heart failure
(1997) · New England Journal of Medicine · doi:10.1056/nejm199702203360801 · Cited by 3,016
Cunningham, D., Pyrhönen, S., James, R. D., Punt, C. J., Hickish, T. F., Heikkila, R., Johannesen, T. B., Starkhammar, H., Topham, C. A., Awad, L., et al. (1998) · The Lancet · doi:10.1016/s0140-6736(98)02309-5 · Cited by 1,259
The Ethics of Clinical Research in the Third World
Angell, M. (1997) · New England Journal of Medicine · doi:10.1056/nejm199709183371209 · Cited by 863
Research works printed but not linked: 35
- 10.1056/NEJM199408113310611 · DOI
- 10.7326/0003-4819-133-6-200009190-00014 · DOI · Paper page
- 10.1111/j.1528-1157.1989.tb05816.x · DOI
- Detre T, 1996, Psychopharmacol Bull, 32, 15
- Friend WC, 1996, J Psychiatry Neurosci, 21, 354
- 10.1136/bmj.303.6804.685 · DOI
- 10.1001/archpsyc.57.4.311 · DOI
- Baldessarini RJ, 1999, J Clin Psychiatry, 60, 117
- Lieberman JA, 1996, Psychopharmacol Bull, 32, 19
- 10.1001/archpsyc.1997.01830170028003 · DOI
- 10.1001/archpsyc.1997.01830170031005 · DOI
- 10.2307/3563910 · DOI
- 10.1001/archpsyc.1997.01830170015002 · DOI
- 10.1007/BF02599912 · DOI
- 10.1016/S0140-6736(98)00039-7 · DOI
- 10.1016/S0140-6736(98)08020-9 · DOI · Paper page
- Sherman DG, 1999, Stroke, 30, 234
- Furlan AJ, 1999, Stroke, 30, 234
- 10.1016/S0140-6736(98)03085-2 · DOI
- 10.1016/S0140-6736(94)90006-X · DOI
- 10.1056/NEJM199004053221401 · DOI
- 10.7326/0003-4819-112-10-727 · DOI
- 10.1056/NEJM199602083340601 · DOI
- 10.1056/NEJM199602083340602 · DOI
- 10.1056/NEJM198908103210629 · DOI
- 10.1056/NEJM199410273311701 · DOI
- 10.1056/NEJM199709183371212 · DOI
- 10.1056/NEJM199710023371411 · DOI
- 10.1016/S0140-6736(98)10414-2 · DOI
- 10.1136/bmj.315.7114.965 · DOI
- 10.2307/3564205 · DOI
- 10.2105/AJPH.88.4.564 · DOI
- 10.1016/S0140-6736(98)01373-7 · DOI
- 10.1016/S0197-2456(97)00006-8 · DOI
- 10.1056/NEJM199908123410713 · DOI
Cited by
Sorted by citations
Understanding Equivalence and Noninferiority Testing
Walker, E., & Nowacki, A. S. (2011) · Journal of General Internal Medicine · doi:10.1007/s11606-010-1513-8 · Cited by 751
Dworkin, R. H., Turk, D. C., Peirce-Sandner, S., Baron, R., Bellamy, N., Burke, L. B., Chappell, A., Chartier, K., Cleeland, C. S., Costello, A., et al. (2010) · Pain · doi:10.1016/j.pain.2010.02.018 · Cited by 381
Self-citationSelf-management program for chronic low back pain: A systematic review and meta-analysis
Du, S., Hu, L., Dong, J., Xu, G., Chen, X., Jin, S., Zhang, H., & Yin, H. (2017) · Patient Education and Counseling · doi:10.1016/j.pec.2016.07.029 · Cited by 199
Magnesium and depression: A systematic review
Derom, M.-L., Sayón-Orea, C., Martínez-Ortega, J. M., & Martínez-González, M. A. (2013) · Nutritional Neuroscience · doi:10.1179/1476830512y.0000000044 · Cited by 108
Metadata
- Authors
- Ellenberg, S. S., & Temple, R.
- Affiliations
- Center for Biologics Evaluation and Research (US)
- Corresponding author
- Ellenberg, Susan S.
- ORCID
- Ellenberg, Susan S.
- Venue
- Annals of Internal Medicine
- Publisher
- American College of Physicians
- Published
- 2000-09-19
- Volume
- 133
- Issue
- 6
- Pages
- 464-470
- ISSN
- 0003-4819 (ISSN-L)
- 1539-3704
- OpenAlex
- W2083976498
- Cited by
- 331
- References
- 4
- Citations by year
- 2026: 2 · 2025: 1 · 2024: 9 · 2023: 2 · 2022: 4 · 2021: 8 · 2020: 5 · 2019: 4 · 2018: 7 · 2017: 7 · 2016: 7 · 2015: 14 · 2014: 8 · 2013: 9 · 2012: 22
- FWCI
- 32.87
- Type
- journal article
- Language
- en
- Open access
- closed
- Locations
- Annals of Internal Medicine (publishedVersion)
- PubMed (publishedVersion)
- DigitalGeorgetown (Georgetown University Library) (submittedVersion)
- Topics
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
- Health Sciences › Nursing › Issues, ethics and legal aspects › Biomedical Ethics and Regulation
- Keywords
- equivalence trials, clinical trial ethics, experimental treatment, efficacy evaluation, complementary and alternative medicine
- MeSH terms
- Decision Making, Ethics, Medical, Humans, Placebos, Treatment Outcome, Risk Assessment, Controlled Clinical Trials as Topic, Ethics, Research
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
How to cite
Cite CoChat for the checks on this page, and the paper for its own findings.
- This page
- CoChat. (2026). Citation check: Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 2: Practical Issues and Specific Cases. https://app.cochat.ai/papers/10.7326/0003-4819-133-6-200009190-00015
- The paper
- Ellenberg, S. S., & Temple, R. (2000). Placebo-Controlled Trials and Active-Control Trials in the Evaluation of New Treatments. Part 2: Practical Issues and Specific Cases. Annals of Internal Medicine. https://doi.org/10.7326/0003-4819-133-6-200009190-00015
