Double-blind, randomised, placebo-controlled study to evaluate the efficacy and safety of a fixed combination containing two plant extracts (Crataegus oxyacantha and Eschscholtzia californica) and magnesium in mild-to-moderate anxiety disorders

SUMMARY

Objective: To assess the clinical efficacy of a neurotonic component containing fixed quantities of two plant extracts (Crataegus oxyacantha and Eschscholtzia californica) and magnesium versus placebo in mild-to-moderate anxiety disorders with associated functional disturbances, under usual general practice prescription conditions.

Research design and methods: A total of 264 patients (81% female; mean age: 44.6 years) presenting with generalised anxiety (DSM-III-R) of mild-to-moderate intensity (total Hamilton anxiety scale score between 16 and 28) were included in a double-blind, randomised, placebo-controlled trial. Patients were randomly assigned to two groups: 130 received the study drug (Sympathyl), and 134 a placebo (two tablets twice daily for 3 months). Efficacy and safety data were recorded before first administration and 7, 14, 30, 60 and 90 days after start of treatment.

Sympathyl is produced and marketed by Laboratoire Innotech International, Arcueil, France.

Main outcome measures: Efficacy was assessed by (a) change in Hamilton anxiety scale total and somatic scores; (b) change in patient self-assessment; (c) number and percentage of responsive subjects (reduction of at least 50% in Hamilton or self-assessment score); and (d) the physician's clinical global impression. Tolerance was assessed by undesirable events spontaneously reported by the patients over the study period.

Results: Total and somatic Hamilton scale scores and subjective patient-rated anxiety fell during treatment, indicating clinical improvement. The decrease was greater in the study drug than in the placebo group. End of treatment clinical improvement, as measured by the mean difference between final and pre-treatment scores, was, for the study drug and placebo groups respectively: −10.6 and −8.9 on the total anxiety score ( p = 0.005); −6.5 and −5.7 on the somatic score ( p = 0.054); and −38.5 and −29.2 for subjectively assessed anxiety ( p = 0.005). The risk/benefit ratio as judged by the investigating physicians was also significantly greater in the study drug than in the placebo group. In all, 15 patients (11.5%) in the study drug group and 13 patients (9.7%) in the placebo group experienced 22 and 15 adverse events, respectively. Undesirable events were mainly mild or moderate digestive or psychopathological disorders.

Conclusions: The preparation containing fixed quantities of Crataegus oxyacantha, Eschscholtzia californica, and magnesium proved safe and more effective than placebo in treating mild-tomoderate anxiety disorders.

Key words: :

• Anxiety disorder
• Clinical trial
• Crataegus oxyacantha
• Eschscholtzia californica
• General practice
• Magnesium

Notes

Sympathyl is produced and marketed by Laboratoire Innotech International, Arcueil, France.