Abstract
BackgroundAnxiety is a serious personal health condition and represents a substantial burden to overall quality of life. Additionally anxiety disorders represent a significant cost to the health care system as well as employers through benefits coverage and days missed due to incapacity. This study sought to explore the effectiveness of naturopathic care on anxiety symptoms using a randomized trial.MethodsEmployees with moderate to severe anxiety of longer than 6 weeks duration were randomized based on age and gender to receive naturopathic care (NC) (n = 41) or standardized psychotherapy intervention (PT) (n = 40) over a period of 12 weeks. Blinding of investigators and participants during randomization and allocation was maintained. Participants in the NC group received dietary counseling, deep breathing relaxation techniques, a standard multi-vitamin, and the herbal medicine, ashwagandha (Withania somnifera) (300 mg b.i.d. standardized to 1.5% withanolides, prepared from root). The PT intervention received psychotherapy, and matched deep breathing relaxation techniques, and placebo. The primary outcome measure was the Beck Anxiety Inventory (BAI) and secondary outcome measures included the Short Form 36 (SF-36), Fatigue Symptom Inventory (FSI), and Measure Yourself Medical Outcomes Profile (MY-MOP) to measure anxiety, mental health, and quality of life respectively. Participants were blinded to the placebo-controlled intervention.ResultsSeventy-five participants (93%) were followed for 8 or more weeks on the trial. Final BAI scores decreased by 56.5% (p<0.0001) in the NC group and 30.5% (p<0.0001) in the PT group. BAI group scores were significantly decreased in the NC group compared to PT group (p = 0.003). Significant differences between groups were also observed in mental health, concentration, fatigue, social functioning, vitality, and overall quality of life with the NC group exhibiting greater clinical benefit. No serious adverse reactions were observed in either group.RelevanceMany patients seek alternatives and/or complementary care to conventional anxiety treatments. To date, no study has evaluated the potential of a naturopathic treatment protocol to effectively treat anxiety. Knowledge of the efficacy, safety or risk of natural health products, and naturopathic treatments is important for physicians and the public in order to make informed decisions.InterpretationBoth NC and PT led to significant improvements in patients' anxiety. Group comparison demonstrated a significant decrease in anxiety levels in the NC group over the PT group. Significant improvements in secondary quality of life measures were also observed in the NC group as compared to PT. The whole system of naturopathic care for anxiety needs to be investigated further including a closer examination of the individual components within the context of their additive effect.Trial RegistrationControlled-Trials.com ISRCTN78958974
Highlights
Anxiety disorders are among the most prevalent type of psychiatric disorder with an estimated lifetime incidence ranging between 7.9% and 14.5% worldwide [1,2,3]
Anxiety has been associated with increased risk for other disease conditions and plays an important role in overall quality of life, as well as ability to function in normal daily living
Recruitment and Follow-up of Patients Figure 1 describes the flow of participants through the trial. 119 people were screened, with 87 meeting inclusion/exclusion criteria
Summary
Anxiety disorders are among the most prevalent type of psychiatric disorder with an estimated lifetime incidence ranging between 7.9% and 14.5% worldwide [1,2,3]. These disorders are associated with considerable chronicity, morbidity, and disability [3,4,5]. Anxiety disorders impose high individual and social burden, tend to be chronic, and can be as disabling as somatic disorders. This study sought to explore the effectiveness of naturopathic care on anxiety symptoms using a randomized trial
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