Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2011 Sep 22;11:78.
doi: 10.1186/1472-6882-11-78.

Preliminary Examination of the Efficacy and Safety of a Standardized Chamomile Extract for Chronic Primary Insomnia: A Randomized Placebo-Controlled Pilot Study

Affiliations
Free PMC article
Randomized Controlled Trial

Preliminary Examination of the Efficacy and Safety of a Standardized Chamomile Extract for Chronic Primary Insomnia: A Randomized Placebo-Controlled Pilot Study

Suzanna M Zick et al. BMC Complement Altern Med. .
Free PMC article

Abstract

Background: Despite being the most commonly used herbal for sleep disorders, chamomile's (Matricaria recutita) efficacy and safety for treating chronic primary insomnia is unknown. We examined the preliminary efficacy and safety of chamomile for improving subjective sleep and daytime symptoms in patients with chronic insomnia.

Methods: We performed a randomized, double-blind, placebo-controlled pilot trial in 34 patients aged 18-65 years with DSM-IV primary insomnia for ≥ 6-months. Patients were randomized to 270 mg of chamomile twice daily or placebo for 28-days. The primary outcomes were sleep diary measures. Secondary outcomes included daytime symptoms, safety assessments, and effect size of these measures.

Results: There were no significant differences between groups in changes in sleep diary measures, including total sleep time (TST), sleep efficiency, sleep latency, wake after sleep onset (WASO), sleep quality, and number of awakenings. Chamomile did show modest advantage on daytime functioning, although these did not reach statistical significance. Effect sizes were generally small to moderate (Cohen's d ≤ 0.20 to < 0.60) with sleep latency, night time awakenings, and Fatigue Severity Scale (FSS), having moderate effect sizes in favor of chamomile. However, TST demonstrated a moderate effect size in favor of placebo. There were no differences in adverse events reported by the chamomile group compared to placebo.

Conclusion: Chamomile could provide modest benefits of daytime functioning and mixed benefits on sleep diary measures relative to placebo in adults with chronic primary insomnia. However, further studies in select insomnia patients would be needed to investigate these conclusions.

Trial registration: ClinicalTrials.gov NCT01286324.

Figures

Figure 1
Figure 1
Participant Flow Through the Study.

Similar articles

See all similar articles

Cited by 12 articles

  • Plant Extracts for Sleep Disturbances: A Systematic Review.
    Guadagna S, Barattini DF, Rosu S, Ferini-Strambi L. Guadagna S, et al. Evid Based Complement Alternat Med. 2020 Apr 21;2020:3792390. doi: 10.1155/2020/3792390. eCollection 2020. Evid Based Complement Alternat Med. 2020. PMID: 32382286 Free PMC article. Review.
  • The Therapeutic Potential of Apigenin.
    Salehi B, Venditti A, Sharifi-Rad M, Kręgiel D, Sharifi-Rad J, Durazzo A, Lucarini M, Santini A, Souto EB, Novellino E, Antolak H, Azzini E, Setzer WN, Martins N. Salehi B, et al. Int J Mol Sci. 2019 Mar 15;20(6):1305. doi: 10.3390/ijms20061305. Int J Mol Sci. 2019. PMID: 30875872 Free PMC article. Review.
  • The effect of herbal tea capsule on menopause hot flashes.
    Kheirkhah M, Naieri SD, Tabari NS. Kheirkhah M, et al. J Family Med Prim Care. 2018 Sep-Oct;7(5):1074-1078. doi: 10.4103/jfmpc.jfmpc_332_17. J Family Med Prim Care. 2018. PMID: 30598960 Free PMC article.
  • Non-pharmacological interventions for sleep and quality of life: a randomized pilot study.
    Santos MAD, Conceição APD, Ferretti-Rebustini REL, Ciol MA, Heithkemper MM, Cruz DALMD. Santos MAD, et al. Rev Lat Am Enfermagem. 2018 Nov 14;26:e3079. doi: 10.1590/1518-8345.2598.3079. Rev Lat Am Enfermagem. 2018. PMID: 30462790 Free PMC article. Clinical Trial.
  • [Herbal medicines for psychiatric disorders].
    Anheyer D, Haller H, Klose P, Cramer H, Dobos G. Anheyer D, et al. Nervenarzt. 2018 Sep;89(9):1009-1013. doi: 10.1007/s00115-018-0539-8. Nervenarzt. 2018. PMID: 29846749 Review. German.
See all "Cited by" articles

References

    1. Alattar M, Harrington JJ, Mitchell CM, Sloane P. Sleep problems in primary care: a North Carolina Family Practice Research Network (NC-FP-RN) study. J Am Board Fam Med. 2007;20(4):365–374. doi: 10.3122/jabfm.2007.04.060153. - DOI - PubMed
    1. Ohayon MM. Epidemiology of insomnia: what we know and what we still need to learn. Sleep Med Rev. 2002;6(2):97–111. doi: 10.1053/smrv.2002.0186. - DOI - PubMed
    1. Breslau N, Roth T, Rosenthal L, Andreski P. Sleep disturbance and psychiatric disorders: a longitudinal epidemiological study of young adults. Biol Psychiatry. 1996;39(6):411–418. doi: 10.1016/0006-3223(95)00188-3. - DOI - PubMed
    1. Katz DA, McHorney CA. The relationship between insomnia and health-related quality of life in patients with chronic illness. J Fam Pract. 2002;51(3):229–235. - PubMed
    1. Taylor DJ, Mallory LJ, Lichstein KL, Durrence HH, Riedel BW, Bush AJ. Comorbidity of chronic insomnia with medical problems. Sleep. 2007;30(2):213–218. - PubMed

Publication types

Associated data

Feedback