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Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: a randomized placebo-controlled pilot study.

Zick SM, Wright BD, Sen A, Arnedt JT - BMC Complement Altern Med (2011)

Bottom Line: Secondary outcomes included daytime symptoms, safety assessments, and effect size of these measures.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: University of Michigan, Department of Family Medicine, 1018 Fuller Street, Ann Arbor, MI 48104-1213, USA. szick@umich.edu

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.

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Related in: MedlinePlus

Participant Flow Through the Study.
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Figure 1: Participant Flow Through the Study.

Mentions: We screened 107 people, of whom 34 met all eligibility criteria and were randomized, 17 to the placebo and 17 to the chamomile group. Figure 1 documents reasons for exclusions. No participants discontinued the intervention. Adherence to study medications was high with 81% of all participants taking greater than 83% of all study medication. Mean intake of tablets was 93% with no significant differences between groups (p = 0.27).


Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: a randomized placebo-controlled pilot study.

Zick SM, Wright BD, Sen A, Arnedt JT - BMC Complement Altern Med (2011)

Participant Flow Through the Study.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3198755&req=5

Figure 1: Participant Flow Through the Study.
Mentions: We screened 107 people, of whom 34 met all eligibility criteria and were randomized, 17 to the placebo and 17 to the chamomile group. Figure 1 documents reasons for exclusions. No participants discontinued the intervention. Adherence to study medications was high with 81% of all participants taking greater than 83% of all study medication. Mean intake of tablets was 93% with no significant differences between groups (p = 0.27).

Bottom Line: Secondary outcomes included daytime symptoms, safety assessments, and effect size of these measures.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.

View Article: PubMed Central - HTML - PubMed

Affiliation: University of Michigan, Department of Family Medicine, 1018 Fuller Street, Ann Arbor, MI 48104-1213, USA. szick@umich.edu

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.

Show MeSH
Related in: MedlinePlus