Assessment report on Lavandula angustifolia Miller, aetheroleum and Lavandula angustifolia Miller, flos

ion made from these limitations and weaknesses, independently from the form administered, lavender oil seems to positively influence anxiety and stress-related restlessness. However, the peroral use of lavender oil cannot be accepted as well-established use, as the essential factors to be taken into account in order to establish a well-established medicinal use (according to Annex I of Directive 2001/83/EC) are not fulfilled. So only for completeness, this assessment report presents also one of the most recent studies (Woelk & Schläfke, 2010), where patients with general anxiety disorder are included. The study is organised according to good clinical practice. Patients are well characterised, capsules with lavender oil are directly compared with lorazepam, and primary and secondary outcomes are clearly distinguished. Before entering, there was a one-week screening phase. Results were calculated using the full analysis set (Intention to treat or ITT) as well as per protocol (PP). However, the number of patients is low and no power calculation is made. Furthermore, no placebo arm was included. Therefore it is not possible to grant a well-established use for lavender. More studies with the same preparation and positive outcome will be necessary to ponder a well-established use. Lavender oil has been studied in special populations like newborn children, children with autistic behaviour, psychogeriatric patients and hospitalised patients with positive outcomes. However the study populations are small and might be too diverse. 5. Clinical Safety/Pharmacovigilance 5.1. Overview of toxicological/safety data from clinical trials in humans In clinical studies involving patients treated orally with a lavender flower tincture (Buchbauer et al. 1993b), and patients or healthy volunteers treated with lavender oil either topically (Dale & Cornwell 1994; Yip & Tse 2004; Dunn et al. 1995) or by inhalation of the odour (Diego et al. 1998; Louis & Kowalski 2002; Kane et al. 2004), only a few mild adverse events have been reported.