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Cited by 161Medicinal Plant Extracts EffectsComplementary and Alternative Medicine StudiesAnxiety, Depression, Psychometrics, Treatment, Cognitive Processes

Long-term chamomile (Matricaria chamomilla L.) treatment for generalized anxiety disorder: A randomized clinical trial

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Mao, Jun J., Xie, Sharon X., Keefe, John R., Soeller, Irene, Li, Qing S., Amsterdam, Jay D.·2016·Phytomedicine
DOI 10.1016/j.phymed.2016.10.012PMC PMC5646235
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Abstract

Background Generalized Anxiety Disorder (GAD) is one of the most common anxiety disorders treated in primary care, yet current therapies have limited efficacy and substantial side effects.Purpose To evaluate long-term chamomile (Matricaria chamomilla L.) use for prevention of GAD symptom relapse.Methods Outpatients from primary care practices and local communities with a primary diagnosis of moderate-to-severe GAD were enrolled for this two-phase study at a large US academic medical center. During Phase 1, eligible participants received 12 weeks of open-label therapy with chamomile pharmaceutical grade extract 1500mg (500mg capsule 3 times daily). During Phase 2, treatment responders were randomized to either 26 weeks of continuation chamomile therapy or placebo in a double-blinded, placebo-substitution design. The primary outcome was time to relapse during continuation therapy, analyzed using Cox proportional hazards. Secondary outcomes included the proportion who relapsed, treatment-emergent adverse events, and vital sign changes. This study is registered at ClinicalTrials.gov, identifier NCT01072344.Results Between March 1, 2010, and June 30, 2015, we enrolled 179 participants. Of those, 93 (51.9%) were responders and agreed to continue in the double-blind randomized controlled trial. A numerically greater number of placebo-switched (n=12/47; 25.5%) versus chamomile-continuation (n = 7/46; 15.2%) participants relapsed during follow-up. Mean time to relapse was 11.4 ± 8.4 weeks for chamomile and 6.3 ± 3.9 weeks for placebo. Hazard of relapse was non-significantly lower for chamomile (hazard ratio, 0.52; 95% CI, 0.20-1.33; P = 0.16). During follow-up, chamomile participants maintained significantly lower GAD symptoms than placebo (P = 0.0032), with significant reductions in body weight (P = 0.046) and mean arterial blood pressure (P = 0.0063). Both treatments had similar low adverse event rates.Conclusions Long-term chamomile was safe and significantly reduced moderate-to-severe GAD symptoms, but did not significantly reduce rate of relapse. Our limited sample size and lower than expected rate of placebo group relapse likely contributed to the non-significant primary outcome finding. Possible chamomile superiority over placebo requires further examination in large-scale studies.

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  1. National Institute of Mental Health 1985 Treatment emergent symptoms scale Psychopharmacological Bulletin 21 1069 1073

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Authors
Mao, J. J., Xie, S. X., Keefe, J. R., Soeller, I., Li, Q. S., & Amsterdam, J. D.
Affiliations
  • Memorial Sloan Kettering Cancer Center (US)
  • University of Pennsylvania (US)
Corresponding author
Mao, Jun J.
ORCID
Venue
Phytomedicine
Publisher
Elsevier BV
Published
2016-12
Volume
23
Issue
14
Pages
1735-1742
ISSN
0944-7113 (ISSN-L)
DOI
10.1016/j.phymed.2016.10.012
PMC
PMC5646235
OpenAlex
W2537571917
Cited by
161
References
38
Citations by year
2026: 11 · 2025: 11 · 2024: 17 · 2023: 27 · 2022: 27 · 2021: 25 · 2020: 14 · 2019: 14 · 2018: 8 · 2017: 6 · 2016: 1
FWCI
19.88
Type
journal article
Language
en
Open access
Licence
www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations
  • Phytomedicine (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
  • National Cancer Institute (P30CA008748)
  • National Center for Complementary and Integrative Health (R01AT005074)
Topics
  • Health Sciences › Medicine › Complementary and alternative medicine › Medicinal Plant Extracts Effects
  • Health Sciences › Medicine › Complementary and alternative medicine › Complementary and Alternative Medicine Studies
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
Keywords
chamomile, generalized anxiety disorder, long-term treatment, relapse prevention, herbal medicine, anxiety symptom reduction, body weight, blood pressure, adverse events, primary care outpatients, continuation treatment, time to relapse, treatment-emergent adverse events, vital signs, treatment safety and efficacy comparison
MeSH terms
Adult, Anxiety, Anxiety Disorders, Blood Pressure, Double-Blind Method, Female, Humans, Male, Phytotherapy, Middle Aged, Plant Extracts, Recurrence, Time Factors, Anti-Anxiety Agents, Treatment Outcome, Matricaria, Young Adult

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