An exploratory study of salivary cortisol changes during chamomile extract therapy of moderate to severe generalized anxiety disorder
Section snippets
Subjects
Subjects were adults (>18 years) with a DSM-IV diagnosis of GAD as a primary disorder recruited from a psychiatric clinic at a major research hospital and from primary care practices. All diagnoses were determined using the MINI-SCID/P structured interview to assess for the presence of specific DSM-IV Axis I disorders (First et al., 2001). Discrepancies in diagnostic assessment for inclusion into the study were resolved by conferencing and consensus between the investigators of the trial.
Demographics and clinical information on subject subsample with CORT measurements
Forty-five subjects were trial completers with pre- and post-treatment measurements of salivary cortisol, and four subjects did not have usable post-treatment cortisol measurements. Of these subjects, two were lost to follow-up, one was withdrawn from the trial due to an unstable preexisting medical condition, and one was withdrawn due to medication non-compliance. The average subject in this subsample experienced a change of 9.4 (SD 5.5) points on the GAD-7, which was the outcome criterion
Discussion
While many researchers hypothesize that stress biology dysregulation is implicated in the etiology of GAD, few data exist to support a relationship between stress biology and clinical response to psychopharmacological drugs (Bandelow et al., 2016, Elnazer and Baldwin, 2014). In this exploratory investigation conducted in the context of a trial of chamomile for patients with GAD, we found that greater symptom improvement was associated with pre-to-post treatment increases in morning cortisol
Disclosures
None of the authors declare any conflicts of interest as regards this manuscript. The parent clinical trial for this study was funded by an NIH/NCCAM R01 grant (AT005074) to Jun J. Mao. This research was also funded in part through the NIH/NCI Cancer Center Support Grant P30 CA008748 and by the Rockefeller Translational and Integrative Medicine Research Fund at the Memorial Sloan-Kettering Cancer Center.
Acknowledgements
We would like to thank Dr. Bernard Carroll for his helpful commentary and review of an earlier version of this manuscript.
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