Jürgen Gromball1, Frank Beschorner2, Christian Wantzen3, Ute Paulsen4, Martin Burkart5. 1. Dombühler Strasse 8, D-90449 Nürnberg, Germany. 2. Spenglersruh 1b, D-36381 Schlüchtern, Germany. 3. Gartenstraße 10, D-54470 Bernkastel-Kues, Germany. 4. Dr. Willmar Schwabe GmbH & Co. KG, Willmar-Schwabe-Str. 4, D-76227 Karlsruhe, Germany. Electronic address: ute.paulsen@schwabe.de. 5. Dr. Willmar Schwabe GmbH & Co. KG, Willmar-Schwabe-Str. 4, D-76227 Karlsruhe, Germany.
Abstract
BACKGROUND: Valerian root and lemon balm extracts have previously shown efficacy and excellent tolerability in children<12 years suffering from restlessness and insomnia. We now examined whether treatment with a fixed combination of both may also improve concentration, hyperactivity and impulsiveness. METHODS: 169 primary school children suffering from hyperactivity and concentration difficulties but not meeting ADHS criteria were treated in an observational study by 27 office based pediatricians with a recommended daily dose of 640 mg valerian root extract WS(®) 1014 and 320 mg lemon balm extract WS(®) 1303 (Sandrin(®)), and evaluated by pediatricians and parents using standardized questionnaires at baseline, weeks 2 and 7. RESULTS: The fraction of children having strong/very strong symptoms of poor ability to focus decreased from 75% to 14%, hyperactivity from 61% to 13%, and impulsiveness from 59% to 22%. Parent rated social behavior, sleep and symptom burden showed highly significant improvements. Only in two children mild transient adverse drug reactions were observed. CONCLUSION: In primary school children with restlessness, concentration difficulties and impulsiveness treatment with WS(®) 1014 and WS(®) 1303 (Sandrin(®)) provides a viable option in addition to counseling and education.
BACKGROUND:Valerian root and lemon balm extracts have previously shown efficacy and excellent tolerability in children<12 years suffering from restlessness and insomnia. We now examined whether treatment with a fixed combination of both may also improve concentration, hyperactivity and impulsiveness. METHODS: 169 primary school children suffering from hyperactivity and concentration difficulties but not meeting ADHS criteria were treated in an observational study by 27 office based pediatricians with a recommended daily dose of 640 mg valerian root extract WS(®) 1014 and 320 mg lemon balm extract WS(®) 1303 (Sandrin(®)), and evaluated by pediatricians and parents using standardized questionnaires at baseline, weeks 2 and 7. RESULTS: The fraction of children having strong/very strong symptoms of poor ability to focus decreased from 75% to 14%, hyperactivity from 61% to 13%, and impulsiveness from 59% to 22%. Parent rated social behavior, sleep and symptom burden showed highly significant improvements. Only in two children mild transient adverse drug reactions were observed. CONCLUSION: In primary school children with restlessness, concentration difficulties and impulsiveness treatment with WS(®) 1014 and WS(®) 1303 (Sandrin(®)) provides a viable option in addition to counseling and education.