ArticleBMC medical ethics2018
Ethical principles and placebo-controlled trials - interpretation and implementation of the Declaration of Helsinki's placebo paragraph in medical research.
Article in BMC medical ethics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed.
- Trial
- Trial
- Measuring and appraising placebo effects in clinical trials: contemporary challenges and approaches in psychiatry.The lancet. Psychiatry · 2026Review
- Ethical challenges of placebo use in herbal medicine trials: multiple stakeholder perspectives from qualitative interviews.BMC medical ethics · 2026Article
- Intimate partner violence experience, support seeking and coping strategies among pregnant women in Southwestern Uganda.PLOS global public health · 2026Article
- Reference interval for glycated hemoglobin (HbA1c) in non-pregnant, non-diabetic women in Ethiopia: a cross-sectional study.The Pan African medical journal · 2025Article
- A review of ethical considerations for the medical applications of brain-computer interfaces.Cognitive neurodynamics · 2024Review
- Identification of sepsis-associated mitochondrial genes through RNA and single-cell sequencing approaches.BMC medical genomics · 2024Article
- Analgesic Effect of Low-Level Laser Therapy before Heel Lance for Pain Management in Healthy Term Neonates: A Randomized Controlled Trial.Children (Basel, Switzerland) · 2023Article
- Ethical challenges raised by osteoporosis-related clinical trials.Journal of medical ethics and history of medicine · 2023Article
- Effect of blood flow restriction training on pressure pain threshold and hand function among adults with persistent neck pain: A study protocol for a randomized controlled trial.F1000Research · 2023Article
- Article
- The Role of Slit-2 in Gestational Diabetes Mellitus and Its Effect on Pregnancy Outcome.Frontiers in endocrinology · 2022Article
- Alteration of immune profiles is associated with pulmonary function and symptoms in patients with chronic obstructive pulmonary disease.Molecular medicine reports · 2021Article
- Virtual controls as an alternative to randomized controlled trials for assessing efficacy of interventions.BMC medical research methodology · 2021Review
- Maternally Inherited Diabetes Mellitus Associated with a Novel m.15897G>A Mutation in Mitochondrial tRNAJournal of diabetes research · 2020Article
- Clinical Efficacy and Safety of Thai Herbal Formulation-6 in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized-Controlled Trial.Evidence-based complementary and alternative medicine : eCAM · 2020Article
- Evaluation of the 5-fluorouracil plasma level in patients with colorectal cancer undergoing continuous infusion chemotherapy.Molecular and clinical oncology · 2019Article
- Glucocorticoid-induced osteoporosis: from clinical trials to clinical practice.Therapeutic advances in musculoskeletal disease · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn October 2013, the Declaration of Helsinki was revised a seventh time in its 50 year history. While it is the most widely accepted set of ethical principles for the protection of patients participating in medical research, the Declaration of Helsinki has also been subject of constant controversy. In particular, its paragraph on the use of placebo controls in clinical trials divides the research community into active-control and placebo orthodox proponents, both continuously demanding revisions of the Declaration of Helsinki in favour of their position. The goal of the present project is to compare the mainly theoretical controversy with regulatory implementation.
methodsWe distributed a questionnaire to national drug regulatory authorities from different countries to collect information on the authorities' respective approaches to interpretation and implementation of the Declarations' placebo paragraph in the conduct of medical research.
resultsOur findings suggest that the majority of drug regulatory authorities have established a practice of a middle ground, allowing placebo controls in some instances. Various interpretations of "serious harm" and "methodological reasons" are proposed as well as safeguards to avoid abuse of the option to use placebo-controls.
conclusionLeaving the placebo paragraph open to various interpretation is a result of the Declaration of Helsinki's character as a guidance document. With the current version controversy will continue. The Declaration should be continued to be strengthened to enforce the appreciation of conducting medical research with the highest ethical standard.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.