Efficacy on Subthreshold Anxiety Disorders of a New Drug Containing Passiflora Incarnata L. Herba in 76 Patients with Anxious Symptoms

With the aim of verifying the anxiolytic and hypnotic effect of Passiflora incarnata L. Herba we conducted a prospective open label study in 76 outpatients who had sought psychiatric consult in private clinical practice for anxiety/ sleep in subthreshold/full blown DSM-IV anxiety spectrum disorders. According to patients’ needs a clinician proposed and prescribed a formulation containing dry extract of Passiflora incarnata L., Herba at a dosage of 1 or 2 tablets daily (200-400 mg/day for six weeks). The comparison of Hamilton-anxiety and insomnia index scales mean scores reported at T0 versus T1 showed a statistically significant decrease (p<0.001). In clinical global impression scale, the 84% of the sample was found to be improved, (60% minimally improved and 24% much improved) while 16% showed no change. The 54% of the sample reported an anxiolytic effect and the 58% reported a pro-hypnotic effect. No side-effects were reported during the treatment with no drop-out. Furthermore, from this study it emerged a double effect, anxiolytic and pro-hypnotic, attributed to Passiflora that misses to antidepressants and benzodiazepines tend to lose overtime. A pharmacological treatment with a new drug containing as active principle Passiflora Incarnata L. Herba could be a valid option in the treatment of anxiety spectrum disorders in monotherapy or in add-on to serotoninergic antidepressants.