A Televised, Web-Based Randomised Trial of an Herbal Remedy (Valerian) for Insomnia

BACKGROUND: This 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. METHODS: Participants 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. FINDINGS: For 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. INTERPRETATION: Based 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 REGISTRATION: Controlled-Trials.com ISRCTN72748991

An exploratory study on the effects of tele-neurofeedback and tele-biofeedback on objective and subjective sleep in patients with primary insomnia

Contains fulltext : 90472.pdf (publisher's version ) (Closed access)Insomnia is a sleeping disorder, usually studied from a behavioural perspective, with a focus on somatic and cognitive arousal. Recent studies have suggested that an impairment of information processes due to the presence of cortical hyperarousal might interfere with normal sleep onset and/or consolidation. As such, a treatment modality focussing on CNS arousal, and thus influencing information processing, might be of interest. Seventien insomnia patients were randomly assigned to either a tele-neurofeedback (n = 9) or an electromyography tele-biofeedback (n = 8) protocol. Twelve healthy controls were used to compare baseline sleep measures. A polysomnography was performed pre and post treatment. Total Sleep Time (TST), was considered as our primary outcome variable. Sleep latency decreased pre to post treatment in both groups, but a significant improvement in TST was found only after the neurofeedback (NFB) protocol. Furthermore, sleep logs at home showed an overall improvement only in the neurofeedback group, whereas the sleep logs in the lab remained the same pre to post training. Only NFB training resulted in an increase in TST. The mixed results concerning perception of sleep might be related to methodological issues, such as the different locations of the training and sleep measurements