A dietary supplement to improve the quality of sleep: a randomized placebo controlled trial

Catherine Cornu, Laurent Remontet, Florence Noel-Baron, Alain Nicolas, Nathalie Feugier-Favier, Pascal Roy, Bruno Claustrat, Mitra Saadatian-Elahi, Behrouz Kassaï, Catherine Cornu, Laurent Remontet, Florence Noel-Baron, Alain Nicolas, Nathalie Feugier-Favier, Pascal Roy, Bruno Claustrat, Mitra Saadatian-Elahi, Behrouz Kassaï

Abstract

Background: To evaluate the effect of a dietary supplement containing polyunsaturated fatty acids, in association with Humulus lupulus extract, on the quality of sleep using the Leeds sleep evaluation questionnaire (LSEQ) in subjects with moderate to severe sleep disorders.

Methods: Randomized placebo-controlled trial, in a Population-based setting. Participants were adult patients 25 to 65 years old with a chronic primary insomnia who volunteered for the study. The tested intervention consisted of two soft gelatine capsules per day, containing either the dietary supplement (active group) or olive oil (placebo group) for a month. Subjects could also volunteer for two ancillary studies on melatonin and actigraphy. Evaluation criteria included i) perception of the quality of sleep at the end of treatment using the LSEQ questionnaire, ii) sleep efficiency measured by one-week actigraphic movement measurement performed before and during the treatment in a subsample of subjects, iii) night melatonin and 6 sulfatoxymelatonin (aMT6S) urine rates in a subsample of subjects.

Results: The average of Leeds score was similar in both groups (p = 0.95). A marked improvement in the quality of sleep was observed in both placebo (62%) and active (65%) group (p = 0.52). The evolution of urinary melatonin, aMT6S, and of the Mel/aMT6S ratio showed no differences between the two groups. Sleep efficiency, as measured by actigraphy, improved similarly in both groups during the treatment period, from 72% to 76% and 75% in the active and placebo group respectively (p = 0.91).

Conclusions: The dietary supplement had neither effect on the perceived quality of sleep, nor on the melatonin metabolism and sleep-wake cycle.

Trial registration: clinical trials.gov:NCT00484497.

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Flow diagram of participants.
Figure 3
Figure 3
Mean score (solid curves and dashed curves) according to age and treatment group for GTS, QOS, AFS and BFW: observed score for each patient are also plotted.

References

    1. Leger D. Public health and insomnia: economic impact. Sleep. 2000;23(Suppl 3):S69–76.
    1. Walsh JK. Clinical and socioeconomic correlates of insomnia. J Clin Psychiatry. 2004;65(Suppl 8):13–9.
    1. Buysse DJ. Clinical diagnoses in 216 insomnia patients using the International Classification of Sleep Disorders (ICSD), DSM-IV and ICD-10 categories: a report from the APA/NIMH DSM-IV Field Trial. Sleep. 1994;17(7):630–7.
    1. Leger D, Levy E, Paillard M. The direct costs of insomnia in France. Sleep. 1999;22(Suppl 2):S394–401.
    1. Glass J. Sedative hypnotics in older people with insomnia: meta-analysis of risks and benefits. BMJ. 2005;331(7526):1169. doi: 10.1136/bmj.38623.768588.47.
    1. Leipzig RM, Cumming RG, Tinetti ME. Drugs and falls in older people: a systematic review and meta-analysis: II. Cardiac and analgesic drugs. J Am Geriatr Soc. 1999;47(1):40–50.
    1. Verster JC. Hypnotics and driving safety: meta-analyses of randomized controlled trials applying the on-the-road driving test. Curr Drug Saf. 2006;1(1):63–71. doi: 10.2174/157488606775252674.
    1. Claustrat B, Brun J, Chazot G. The basic physiology and pathophysiology of melatonin. Sleep Med Rev. 2005;9(1):11–24. doi: 10.1016/j.smrv.2004.08.001.
    1. Butterweck V. Hypothermic effects of hops are antagonized with the competitive melatonin receptor antagonist luzindole in mice. J Pharm Pharmacol. 2007;59(4):549–52. doi: 10.1211/jpp.59.4.0009.
    1. Miranda CL. Prenylflavonoids from hops inhibit the metabolic activation of the carcinogenic heterocyclic amine 2-amino-3-methylimidazo[4, 5-f]quinoline, mediated by cDNA-expressed human CYP1A2. Drug Metab Dispos. 2000;28(11):1297–302.
    1. Wade AG. Efficacy of prolonged release melatonin in insomnia patients aged 55-80 years: quality of sleep and next-day alertness outcomes. Curr Med Res Opin. 2007;23(10):2597–605. doi: 10.1185/030079907X233098.
    1. Lemoine P. Prolonged-release melatonin improves sleep quality and morning alertness in insomnia patients aged 55 years and older and has no withdrawal effects. J Sleep Res. 2007;16(4):372–80. doi: 10.1111/j.1365-2869.2007.00613.x.
    1. Baskett JJ. Does melatonin improve sleep in older people? A randomised crossover trial. Age Ageing. 2003;32(2):164–70. doi: 10.1093/ageing/32.2.164.
    1. Diagnostic and statistical manual of mental disorders, in American Psychiatric Association. Washington DC; 1994. pp. 651–656.
    1. Diagnostic and coding manual. 2. American Academy of Sleep Medicine: Westchester, Illinois; 2005. American Academy of Sleep Medicine. The international classification of sleep disorders; pp. 6–8.
    1. Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001;2(4):297–307. doi: 10.1016/S1389-9457(00)00065-4.
    1. Sheehan DV. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59(Suppl 20):22–33. quiz 34-57.
    1. Beck AT, Rial WY, Rickels K. Short form of depression inventory: cross-validation. Psychol Rep. 1974;34(3):1184–6.
    1. Johns MW. A new method for measuring daytime sleepiness: the Epworth sleepiness scale. Sleep. 1991;14(6):540–5.
    1. Tarrasch R, Laudon M, Zisapel N. Cross-cultural validation of the Leeds sleep evaluation questionnaire (LSEQ) in insomnia patients. Hum Psychopharmacol. 2003;18(8):603–10. doi: 10.1002/hup.534.
    1. Zisapel N, Laudon M. Subjective assessment of the effects of CNS-active drugs on sleep by the Leeds sleep evaluation questionnaire: a review. Hum Psychopharmacol. 2003;18(1):1–20. doi: 10.1002/hup.455.
    1. Horne JA, Ostberg O. A self-assessment questionnaire to determine morningness-eveningness in human circadian rhythms. Int J Chronobiol. 1976;4(2):97–110.
    1. Claustrat B. A chronobiological study of melatonin and cortisol secretion in depressed subjects: plasma melatonin, a biochemical marker in major depression. Biol Psychiatry. 1984;19(8):1215–28.
    1. Harthe C. Direct radioimmunoassay of 6-sulfatoxymelatonin in plasma with use of an iodinated tracer. Clin Chem. 1991;37(4):536–9.
    1. Hindmarch I. A naturalistic investigation of the effects of day-long consumption of tea, coffee and water on alertness, sleep onset and sleep quality. Psychopharmacology (Berl) 2000;149(3):203–16. doi: 10.1007/s002130000383.
    1. H G. Multilevel Statistical Models. London: Arnold; 2003.
    1. McCall WV, D'Agostino R Jr, Dunn A. A meta-analysis of sleep changes associated with placebo in hypnotic clinical trials. Sleep Med. 2003;4(1):57–62. doi: 10.1016/s1389-9457(02)00242-3.
    1. Bent S. Valerian for sleep: a systematic review and meta-analysis. Am J Med. 2006;119(12):1005–12. doi: 10.1016/j.amjmed.2006.02.026.
    1. Morin CM. Valerian-hops combination and diphenhydramine for treating insomnia: a randomized placebo-controlled clinical trial. Sleep. 2005;28(11):1465–71.
    1. Dimpfel W, Suter A. Sleep improving effects of a single dose administration of a valerian/hops fluid extract - a double blind, randomized, placebo-controlled sleep-EEG study in a parallel design using electrohypnograms. Eur J Med Res. 2008;13(5):200–4.
    1. Regestein QR, Monk TH. Delayed sleep phase syndrome: a review of its clinical aspects. Am J Psychiatry. 1995;152(4):602–8.
    1. Prise en charge du patient adulte se plaignant d'insomnie en médecine générale.

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