Effect of a homeopathic-complex medicine on state and trait anxiety and sleep disorders: a retrospective observational study.
OBJECTIVE
The primary objective of this open-label, retrospective, observational study was to examine change in indicators of anxiety changed after treatment period of at least 1 month with the homeopathic-complex medicine Datif-PC(®). A secondary objective was to describe the quantitative changes in the sleep pattern of the subjects included in the study.


METHODS
The study population consisted of 71 subjects suffering from mild to moderate anxiety, who were treated with a homeopathic-complex medicine. The subjects had attended at least 2 consultations during the year 2010, with the second visit taking place at least 30 days after the first baseline visit. At both visits, subjects were administered the State-Trait Anxiety Inventory (STAI)-Y questionnaire (consisting of trait and state subscales) to assess their level of anxiety. Sleep quality was assessed based on the subjects' self-reported number of hours slept and number of night-time awakenings, before and after treatment.


RESULTS
Compared to baseline, the average (STAI)-state score at visit 2 decreased by more than 6 points, while the STAI-trait score decreased by more than 3 points. This was statistically significant (p < 0.0001) for both subscales. These findings were stable in subgroup analyses (gender, age and anxiety level). The average number of hours slept per night increased significantly at visit 2 compared to baseline (from 5.1 ± 1.1 to 5.56 ± 0.9 h, p < 0.0001). A marked decrease in the average number of night-time awakenings was also observed at the second visit (-42%, p < 0.0001).


CONCLUSIONS
This retrospective observational study suggests that treatment of anxiety and sleep disorders with Datif-PC(®) can produce notable improvements even in a short period of time. Furthermore, the observed effects were not affected by sex, age or baseline anxiety. Further controlled, randomized studies are justified.
Department of Dietary Nutrition and Complementary Medicine, Azienda Ospedaliera G. Rummo, Benevento, Italy. Electronic address: gico61b@gmail.com.
Luigi
L
Coppola
Fabio
F
Montanaro
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001007:Anxiety / Q000150:complications / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D005260:Female; D006705:Homeopathy / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D028321:Plant Preparations / Q000627:therapeutic use*; D012189:Retrospective Studies; D012893:Sleep Wake Disorders / Q000150:complications / Q000188:drug therapy*
D028321:Plant Preparations
Anxiety; Datif-PC(®); Low dose; Retrospective observational study; STAI-Y; Sleep disorders