| [PMID]: | 27912875 |
| [Au] Autor: | Mao JJ; Xie SX; Keefe JR; Soeller I; Li QS; Amsterdam JD |
| [Ad] Endereço: | Bendheim Center for Integrative Medicine, Memorial Sloan Kettering Cancer Center, 1429 First Avenue, New York, NY 10021, United States. Electronic address: maoj@mskcc.org. |
| [Ti] Título: | Long-term chamomile (Matricaria chamomilla L.) treatment for generalized anxiety disorder: A randomized clinical trial. |
| [So] Source: | Phytomedicine;23(14):1735-1742, 2016 Dec 15. |
| [Is] ISSN: | 1618-095X |
| [Cp] País de publicação: | Germany |
| [La] Idioma: | eng |
| [Ab] Resumo: | 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. |
| [Mh] Termos MeSH primário: |
Ansiolíticos/uso terapêutico
Transtornos de Ansiedade/tratamento farmacológico
Ansiedade/tratamento farmacológico
Matricaria
Fitoterapia
Extratos Vegetais/uso terapêutico
|
| [Mh] Termos MeSH secundário: |
Adulto
Ansiolíticos/farmacologia
Pressão Sanguínea/efeitos dos fármacos
Método Duplo-Cego
Feminino
Seres Humanos
Masculino
Meia-Idade
Extratos Vegetais/farmacologia
Recidiva
Fatores de Tempo
Resultado do Tratamento
Adulto Jovem
|
| [Pt] Tipo de publicação: | JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL |
[Nm] Nome de substância:
| 0 (Anti-Anxiety Agents); 0 (Plant Extracts) |
| [Em] Mês de entrada: | 1705 |
| [Cu] Atualização por classe: | 171019 |
[Lr] Data última revisão:
| 171019 |
| [Sb] Subgrupo de revista: | IM |
| [Da] Data de entrada para processamento: | 161204 |
| [Cl] Clinical Trial: | ClinicalTrial
|
| [St] Status: | MEDLINE |
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