A combination of plant extracts in the treatment of outpatients with adjustment disorder with anxious mood: controlled study versus placebo.

Euphytose (EUP) is a combination of six extracts: Crataegus, Ballota, Passiflora and Valeriana, which have mild sedative effects, and Cola and Paullinia, which mainly act as mild stimulants. This multicenter, double-blind, placebo-controlled general practice study was carried outpatients with adjustment disorder with anxious mood. The study was coordinated by psychiatrists. Ninety-one patients were included in the EUP group and 91 patients in the placebo group. They all received two tablets three times a day over 28 days (D). Evaluation using the Hamilton-anxiety (HAM-A) rating scale were carried out on D0, D7, D14 and on D28. Comparing the two groups, 42.9% of the patients (EUP group) had a HAM-A score of less than 10 at D28 versus 25.3% in the placebo group (P = 0.012). Changes in the HAM-A score between D0 and D28 were as follows: D0 (EUP: 26.12 +/- 4.0, placebo: 26.27 +/- 4.5), D7 (EUP: 19.65 +/- 5.7, placebo: 21.37 +/- 5.6), D14 (EUP: 15.36 +/- 5.7, placebo: 17.48 +/- 6.7), D28 (EUP: 12.63 +/- 7.3, placebo: 15.2 +/- 8.1). From D7 to D28 there was a statistically significant difference (P = 0.042) between the two treatments, indicating that EUP is better than placebo in the treatment of adjustment disorder with anxious mood.

RCT Entities:   Population Interventions Outcomes