Trial reportBMC clinical pharmacology2003
The safety of over-the-counter niacin. A randomized placebo-controlled trial [ISRCTN18054903].
Trial report in BMC clinical pharmacology, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 14 papers, 1 of them a synthesis that pooled it.
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
14 citing papers in PubMed, 1 synthesis or guideline pooled it, 58 citations in OpenAlex.
- The treatment of migraines and tension-type headaches with intravenous and oral niacin (nicotinic acid): systematic review of the literature.Nutrition journal · 2005Pooled it
- Extended-release niacin/laropiprant significantly improves lipid levels in type 2 diabetes mellitus irrespective of baseline glycemic control.Vascular health and risk management · 2015Trial
- Measuring flushing symptoms with extended-release niacin using the flushing symptom questionnaire: results from a randomised placebo-controlled clinical trial.International journal of clinical practice · 2008Trial
- CONSORT 2025 explanation and elaboration: updated guideline for reporting randomised trials.BMJ (Clinical research ed.) · 2025Article
- Balancing NADCellular and molecular life sciences : CMLS · 2022Review
- Association between Daily Niacin Intake and Glaucoma: National Health and Nutrition Examination Survey.Nutrients · 2021Article
- Apolipoprotein B and Cardiovascular Disease: Biomarker and Potential Therapeutic Target.Metabolites · 2021Review
- Measuring niacin-associated skin toxicity (NASTy) stigmata along with symptoms to aid development of niacin mimetics.Journal of lipid research · 2017Article
- Nicotinamide riboside is uniquely and orally bioavailable in mice and humans.Nature communications · 2016Article
- A comprehensive review on metabolic syndrome.Cardiology research and practice · 2014Review
- Cost-effectiveness of extended-release niacin/laropiprant added to a stable simvastatin dose in secondary prevention patients not at cholesterol goal in Germany.The European journal of health economics : HEPAC : health economics in prevention and care · 2012Article
- A "hot" topic in dyslipidemia management--"how to beat a flush": optimizing niacin tolerability to promote long-term treatment adherence and coronary disease prevention.Mayo Clinic proceedings · 2010Review
- CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials.BMJ (Clinical research ed.) · 2010Article
- The metabolic syndrome.Endocrine reviews · 2008Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundNiacin is widely available over the counter (OTC). We sought to determine the safety of 500 mg immediate release niacin, when healthy individuals use them as directed.
methods51 female and 17 male healthy volunteers (mean age 27 years SD 4.4) participated in a randomized placebo-controlled blinded trial of a single dose of an OTC, immediate-release niacin 500 mg (n = 33), or a single dose of placebo (n = 35) on an empty stomach. The outcomes measured were self-reported incidence of flushing and other adverse effects.
results33 volunteers on niacin (100%) and 1 volunteer on placebo (3%) flushed (relative risk 35, 95% confidence interval (CI) 6.8-194.7). Mean time to flushing on niacin was 18.2 min (95% CI: 12.7-23.6); mean duration of flushing was 75.4 min (95% CI: 62.5-88.2). Other adverse effects occurred commonly in the niacin group: chills (51.5% vs. 0%, P <.0001), generalized pruritus (75% vs. 0%, P = <.001), gastrointestinal upset (30% vs. 3%, P =.005), and cutaneous tingling (30% vs. 0%, P = <.001). Six participants did not tolerate the adverse effects of niacin and 3 required medical attention.
conclusionClinicians counseling patients about niacin should alert patients not only about flushing but also about gastrointestinal symptoms, the most severe in this study. They should not trust that patients would receive information about these side effects or their prevention (with aspirin) from the OTC packet insert.
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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.