Trial reportPloS one2007
A televised, web-based randomised trial of an herbal remedy (valerian) for insomnia.
Trial report in PloS one, 2007. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 4 of them syntheses 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
16 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- A systematic review of methods used to conduct decentralised clinical trials.British journal of clinical pharmacology · 2022Pooled it
- Clinical Practice Guideline for the Pharmacologic Treatment of Chronic Insomnia in Adults: An American Academy of Sleep Medicine Clinical Practice Guideline.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2017Guideline
- Internet-based randomized controlled trials: a systematic review.Journal of the American Medical Informatics Association : JAMIA · 2013Pooled it
- Valerian Root in Treating Sleep Problems and Associated Disorders-A Systematic Review and Meta-Analysis.Journal of evidence-based integrative medicinePooled it
- The Efficacy of Melatonergic Receptor Agonists Used in Clinical Practice in Insomnia Treatment: Melatonin, Tasimelteon, Ramelteon, Agomelatine, and Selected Herbs.Molecules (Basel, Switzerland) · 2025Review
- Mixture ofNutrients · 2024Article
- Review
- The Effects of Valerian on Sleep Quality, Depression, and State Anxiety in Hemodialysis Patients: A Randomized, Double-blind, Crossover Clinical Trial.Oman medical journal · 2021Article
- Sleeping without Prescription: Management of Sleep Disorders in Children with Autism with Non-Pharmacological Interventions and Over-the-Counter Treatments.Brain sciences · 2020Review
- The Norwegian public's ability to assess treatment claims: results of a cross-sectional study of critical health literacy.F1000Research · 2020Article
- Plant Extracts for Sleep Disturbances: A Systematic Review.Evidence-based complementary and alternative medicine : eCAM · 2020Review
- Medicinal Plants for Management of Insomnia: A Systematic Review of Animal and Human Studies.Galen medical journal · 2019Review
- "A waste of time without patients": The views of patient representatives attending a workshop in evidence-based practice.Journal of evidence-based medicine · 2018Article
- Over-the-Counter Agents for the Treatment of Occasional Disturbed Sleep or Transient Insomnia: A Systematic Review of Efficacy and Safety.The primary care companion for CNS disorders · 2015Article
- Updates on Nutraceutical Sleep Therapeutics and Investigational Research.Evidence-based complementary and alternative medicine : eCAM · 2015Review
- Internet trials: participant experiences and perspectives.BMC medical research methodology · 2012Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis trial was conducted as part of a project that aims to enhance public understanding and use of research in decisions about healthcare by enabling viewers to participate in research and to follow the process, through television reports and on the web. Valerian is an herbal over-the-counter drug that is widely used for insomnia. Systematic reviews have found inconsistent and inconclusive results about its effects.
methodsParticipants were recruited through a weekly nationally televised health program in Norway. Enrolment and data collection were over the Internet. 405 participants who were 18 to 75 years old and had insomnia completed a two week diary-keeping run-in period without treatment and were randomised and mailed valerian or placebo tablets for two weeks. All participants and investigators were blind to treatment until after the analysis was completed.
findingsFor the primary outcome of a minimally important improvement in self-reported sleep quality (> or = 0.5 units on a 7 point scale), the difference between the valerian group (29%) and the placebo group (21%) was not statistically significant (difference 7.5%; 95% CI-0.9 to 15.9; p = 0.08). On the global self-assessment question at the end of the treatment period 5.5% (95% CI 0.2 to 10.8) more participants in the valerian group perceived their sleep as better or much better (p = 0.04). There were similar trends favouring the valerian group for night awakenings (difference = 6.0%, 95% CI-0.5 to 12.5) and sleep duration (difference = 7.5%, 95% CI-1.0 to 16.1). There were no serious adverse events and no important or statistically significant differences in minor adverse events.
interpretationBased on this and previous studies, valerian appears to be safe, but with modest beneficial effects at most on insomnia compared to placebo. The combined use of television and the Internet in randomised trials offers opportunities to answer questions about the effects of health care interventions and to improve public understanding and use of randomised trials.
trial registrationControlled-Trials.com ISRCTN72748991.
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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.