Survey on experiences with phytopharmaceuticals via an online based questionnaire (PhytoVIS)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Other
• If ‘other’, further details on the scope of the study:
  Health service research
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective online survey

Population studied

• Short description of the study population:
  The study population was not restricted in any way: any natural person had to be interviewed. The only inclusion criterion was that patients had to have taken an herbal medicinal product during the last eight weeks before the survey.
• Age groups:
  Term newborn infants (0 – 27 days)

  Infants and toddlers (28 days – 23 months)

  Children (2 to < 12 years)

  Adolescents (12 to < 18 years)

  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Pregnant women

  Renal impaired
• Estimated number of subjects:
  20000

Study design details

• Main study objective:
  Information about patients' experience on effectiveness and tolerance of phytopharmaceuticals.
• Data analysis plan:
  For ascertainment of the patients' opinions and experiences on effectiveness and tolerance of phytopharmaca the validated scale of the questionnaire 'Clinical Global Impression Scale - Efficacy' (CGI-E) is utilised. The CGI-E consists of a matrix with 16 fields that builds up the relation between adverse effects and therapeutic effects. The scores range from four (maximum) to 0,25 (minimum). An index of efficacy is calculated, where any values > 1.00 correspond to a predominant therapeutic effect, the value 1.00 means that the effects cancel each other out, any value < 1.00 reflects that adverse effects predominate.The secondary endpoint of the study, health service research on the phytopharmaceuticals' purchase and recommendation are inquired by questions about (1) the source of recommendations, e.g. pharmacist, doctor, family, friends, advertisement etc. and (2) the site of purchase, e.g. pharmacy, drug store, supermarket, organic food store.

Documents

Study results

PhytoVIS_Report_v1.0_final