Blood Pressure and Cognitive Performance After a Single Administration of a Camphor-Crataegus Combination in Adolescents with Low Blood Pressure

Abstract

Low blood pressure is rather widespread among adolescents and frequently accompanied by complaints. Two single-center, double-blinded, randomized, and placebo-controlled trials were performed with adolescent participants in the age range of 14 – 17 y having a systolic blood pressure below 118 mmHg (boys) or 110 mmHg (girls). They received a single dose of 20 drops of a fixed combination of natural D-camphor and an ethanolic extract from fresh Crataegus berries (CCC) or of an ethanolic placebo. The efficacy of CCC (commercial name Korodin) has proven its efficacy in the treatment of low blood pressure in adults of all ages, although related placebo-controlled, double-blind studies for adolescents following European (EU) pediatric regulations are lacking. Blood pressure and heart rate were assessed during a rest period, prior to substance administration, 1 min thereafter, and after about 5 min. Additionally, performance was assessed by two cognitive tests. After administration of CCC, a significantly greater rise in blood pressure occurred compared to placebo. In the cognitive tasks, no significant differences were observed. No adverse events or subjective complaints were reported at the final examination; thus, the present study provides evidence for the safety and tolerability of CCC after a single administration.

Key words

blood pressure - hypotension - D-camphor - Crataegus laevigata - Crataegus monogyna - Rosaceae - RCT Phase 3 - cognition

• References

• 1 Pilgrim JA, Stansfeld S, Marmot M. Low blood pressure, low mood?. BMJ 1992; 304: 75-78
• 2 Herold G. Innere Medizin. Köln: Verlag Herold; 2008
• 3 Robert Koch Institute, Department of Epidemiology and Health Monitoring. German Health Interview and Examination Survey for Adults (DEGS1). Public Use File 1. Version. 2015
• 4 Neuhauser HK, Thamm M, Ellert U, Hense HW, Rosario AS. Blood pressure percentiles by age and height from non-overweight children and adolescents in Germany. Pediatrics 2011; 127: e978-e988
• 5 de Man SA, Andre JL, Bachmann H, Grobbee DE, Ibsen KK, Laaser U, Lippert P, Hofman A. Blood pressure in childhood: pooled findings of six European studies. J Hypertens 1991; 9: 109-114
• 6 Stewart JM, Clarke D. “Heʼs dizzy when he stands up”: an introduction to initial orthostatic hypotension. J Pediatr 2011; 158: 499-504
• 7 Colman N, Nahm K, Ganzeboom KS, Shen WK, Reitsma J, Linzer M, Wieling W, Kaufmann H. Epidemiology of reflex syncope. Clin Auton Res 2004; 14: 9-17
• 8 Sundstrom J, Neovius M, Tynelius P, Rasmussen F. Association of blood pressure in late adolescence with subsequent mortality: cohort study of Swedish male conscripts. BMJ 2011; 342: d643
• 9 Masaki KH, Schatz IJ, Burchfiel CM, Sharp DS, Chiu D, Foley D, Curb JD. Orthostatic hypotension predicts mortality in elderly men: the Honolulu Heart Program. Circulation 1998; 98: 2290-2295
• 10 Mukai S, Lipsitz LA. Orthostatic hypotension. Clin Geriatr Med 2002; 18: 253-268
• 11 Fedorowski A, Stavenow L, Hedblad B, Berglund G, Nilsson PM, Melander O. Orthostatic hypotension predicts all-cause mortality and coronary events in middle-aged individuals (The Malmo Preventive Project). Eur Heart J 2010; 31: 85-91
• 12 Hildrum B, Mykletun A, Stordal E, Bjelland I, Dahl AA, Holmen J. Association of low blood pressure with anxiety and depression: the Nord-Trondelag Health Study. J Epidemiol Community Health 2007; 61: 53-58
• 13 Duschek S, Hoffmann A, Reyes Del Paso GA, Ettinger U. Autonomic cardiovascular control and executive function in chronic hypotension. Ann Behav Med 2017; 51: 442-453
• 14 Kroll M, Ring C, Gaus W, Hempel B. A randomized trial of Korodin Herz-Kreislauf-Tropfen as add-on treatment in older patients with orthostatic hypotension. Phytomedicine 2005; 12: 395-402
• 15 Schandry R, Duschek S. The effect of camphor-Crataegus berry extract combination on blood pressure and mental functions in chronic hypotension – a randomized placebo controlled double blind design. Phytomedicine 2008; 15: 914-922
• 16 Werner NS, Duschek S, Schandry R. D-camphor-Crataegus berry extract combination increases blood pressure and cognitive functioning in the elderly – a randomized, placebo controlled double blind study. Phytomedicine 2009; 16: 1077-1082
• 17 Erfurt L, Schandry R, Rubenbauer S, Braun U. The effects of repeated administration of camphor-Crataegus berry extract combination on blood pressure and on attentional performance – a randomized, placebo-controlled, double-blind study. Phytomedicine 2014; 21: 1349-1355
• 18 Belz GG, Butzer R, Gaus W, Loew D. Camphor-Crataegus berry extract combination dose-dependently reduces tilt induced fall in blood pressure in orthostatic hypotension. Phytomedicine 2002; 9: 581-588
• 19 Hempel B, Kroll M, Schneider B. [Efficacy and safety of a herbal drug containing hawthorn berries and D-camphor in hypotension and orthostatic circulatory disorders/results of a retrospective epidemiologic cohort study]. Arzneimittelforschung 2005; 55: 443-450
• 20 Belz GG, Loew D. Dose-response related efficacy in orthostatic hypotension of a fixed combination of D-camphor and an extract from fresh Crataegus berries and the contribution of the single components. Phytomedicine 2003; 10: 61-67
• 21 Khoury S, Yarows SA, OʼBrien TK, Sowers JR. Ambulatory blood pressure monitoring in a nonacademic setting. Effects of age and sex. Am J Hypertens 1992; 5: 616-623
• 22 Herrmann R, Butzer R, Roll S, Malerczyk C, Belz GG. Hemodynamic responses to a cumulative dosage of Korodin Herz-Kreislauf-Tropfen. Eur J Clin Pharmacol 1996; 50: 544
• 23 Lagoni N, Mauz M. Hypotone Kreislaufstörungen. Pharmazeutische Zeitung Online 2005; 47 Available at https://www.pharmazeutische-zeitung.de/index.php?id=246 Accessed May 25, 2018
• 24 Pharmacopoea Europaea 9.0 2017: 1400.
• 25 Pharmacopoea Europaea 9.0 2017: 2894.
• 26 Pharmacopoea Europaea 8.3 2015: 1317.
• 27 Pharmacopoea Europaea 9.0 2017: 1220.
• 28 Oswald WD, Roth E. Der Zahlen-Verbindungstest. Göttingen: Hogrefe; 1987
• 29 Wechsler D. Adult Intelligence Scale – Revised. New York: Psychological Corporation; 1981