title: Open-label observational study of the homeopathic medicine Passiflora Compose for anxiety and sleep disorders.
abstract: BACKGROUND
  Anxiety and sleep disorders (SDS) are frequently treated with psychotropic drugs. Health authorities in France have been advised to improve access to alternative treatments such as homeopathic medicines. Our aim was to describe the socio-demographic characteristics and clinical progression of patients prescribed homeopathic medicine Passiflora Compose (PC) for anxiety and/or SDS.
  
  
  METHODS
  This was an open-label, observational study. Randomly selected general practitioners (GPs) known to prescribe homeopathic medicines recruited consecutive patients (≥18-years) prescribed PC. The following data were recorded at inclusion by the GP: socio-demographic data and anxiety severity (Hamilton anxiety rating scale or HAM-A); and by the patients: level of anxiety (STAI Spielberger self-assessment questionnaire) and SDS (Jenkins sleep scale or JSS). Anxiety and SDS were reassessed after 4 weeks of treatment using the same scales.
  
  
  RESULTS
  A total of 639 patients (mean age: 46.3 ± 17.5 years; 78.6% female) were recruited by 98 GPs. Anxiety was present in 85.4% (HAM-A) and 93.3% (Spielberger State) at inclusion (mean scores: 17.8 ± 8.91 and 54.59 ± 11.69, respectively) and SDS was present in 74.0% (mean score: 15.24 ± 5.28). A total of 401 (62.7%) patients received PC alone and 167 (26.1%) PC + psychotropics. After 4 weeks, mean anxiety scores decreased by more than 7, 12 and 6 points (HAM-A, Spielberger State and Trait respectively), and SDS score by more than 4 points (JSS).
  
  
  CONCLUSIONS
  Anxiety and/or SDS improved significantly in patients included on this study. PC could be an alternative to the use of psychotropic drugs for first intention treatment of anxiety and SDS. Further studies are needed to confirm those results.
authors.affiliation: Laboratoires Boiron, 2 Avenue de l'Ouest Lyonnais, 69510 Messimy, France. Electronic address: stephanie.villet@boiron.fr.
authors.forename: Stéphanie
authors.initials: S
authors.lastname: Villet
authors.affiliation: Laboratoires Boiron, 2 Avenue de l'Ouest Lyonnais, 69510 Messimy, France.
authors.forename: Véronique
authors.initials: V
authors.lastname: Vacher
authors.affiliation: Laboratoires Boiron, 2 Avenue de l'Ouest Lyonnais, 69510 Messimy, France.
authors.forename: Aurélie
authors.initials: A
authors.lastname: Colas
authors.affiliation: Laboratoires Boiron, 2 Avenue de l'Ouest Lyonnais, 69510 Messimy, France.
authors.forename: Karine
authors.initials: K
authors.lastname: Danno
authors.affiliation: Laboratoires Boiron, 2 Avenue de l'Ouest Lyonnais, 69510 Messimy, France.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Masson
authors.affiliation: Laboratoires Boiron, 2 Avenue de l'Ouest Lyonnais, 69510 Messimy, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Marijnen
authors.affiliation: Laboratoires Boiron, 2 Avenue de l'Ouest Lyonnais, 69510 Messimy, France.
authors.forename: Marie-France
authors.initials: MF
authors.lastname: Bordet
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001007:Anxiety / Q000188:drug therapy*; D005260:Female; D005602:France; D006705:Homeopathy / Q000379:methods*; D006801:Humans; D008297:Male; D008419:Materia Medica / Q000627:therapeutic use; D008875:Middle Aged; D029598:Passiflora; D010936:Plant Extracts / Q000627:therapeutic use; D012893:Sleep Wake Disorders / Q000188:drug therapy*
chemical_list: D008419:Materia Medica; D010936:Plant Extracts
keywords: Anxiety; Homeopathy; Observational study; Passiflora Compose; Psychotropic drugs; Sleep disorders