No Benefit Adding Eleutherococcus senticosus to Stress Management Training in Stress-Related Fatigue/Weakness, Impaired Work or Concentration, A Randomized Controlled Study

K. Schaffler; O. T. Wolf; M. Burkart

doi:10.1055/s-0033-1347178

Pharmacopsychiatry, Inhaltsverzeichnis

Pharmacopsychiatry 2013; 46(05): 181-190
DOI: 10.1055/s-0033-1347178

Original Paper

No Benefit Adding Eleutherococcus senticosus to Stress Management Training in Stress-Related Fatigue/Weakness, Impaired Work or Concentration, A Randomized Controlled Study

K. Schaffler

¹HPR Dr. Schaffler GmbH, Aschheim-Dornach, Germany

,

O. T. Wolf

²Department of Cognitive Psychology, Ruhr-University Bochum, Bochum, Germany

,

M. Burkart

³Dr. Willmar Schwabe GmbH & Co. KG, Karlsruhe, Germany

› Institutsangaben

Abstract

Introduction:

Plant adaptogens are traditionally used for stress-related symptoms, but clinical evidence is inconsistent. This trial explored the effects of 120 mg/day Eleutherococcus senticosus root extract (ES), 2-day professional stress management training (SMT) and a combination of both (COM).

Methods:

144 participants suffering from asthenia and reduced working capacity related to chronic stress were randomized to the treatments. Validated scales and tests were used to investigate cognitive performance; feeling stressed; fatigue and exhaustion; alertness, restlessness and mood; quality of life and sleep; physical complaints and activities; and physiological stress parameters including cortisol awakening response (CAR), at baseline, after 2 and 8 weeks of treatment (German Clinical Trials Register DRKS00000692).

Results:

Almost all parameters improved significantly over time without group differences. Significant differences were found in mental fatigue and restlessness, both in favor of COM vs. ES. COM was not superior to SMT in any parameter at week 8. An attenuation of the CAR was seen at week 2 without group differences. All treatments were well tolerated.

Discussion:

Effects of adding ES to SMT are, if any, negligible.

Key words

adaptogens - Siberian ginseng - Eleutherococcus - asthenia - stress - RCT - fatigue - concentration

Volltext

Referenzen

References
1 Murta SG, Sanderson K, Oldenburg B. Process evaluation in occupational stress management programs: a systematic review. Am J Health Promot 2007; 21: 248-254
2 Chiesa A, Seretti A. Mindfulness-based stress reduction for stress management in healthy people: a review and meta-analysis. J Altern Complement Med 2009; 15: 593-600
3 Li AW, Goldsmith CA. The effects of yoga on anxiety and stress. Altern Med Rev 2012; 17: 21-35
4 Czabała C, Charzyńska K, Mroziak B. Psychosocial interventions in workplace mental health promotion: an overview. Health Promot Int 2011; 26 (Suppl. 01) i70-i84
5 Ratanasiripong P, Ratanasiripong N, Kathalae D. Biofeedback intervention for stress and anxiety among nursing students: a randomized controlled trial. ISRN Nurs 2012; 2012: 827972
6 Panossian A, Wagner H. Stimulating effect of adaptogens: an overview with particular reference to their efficacy following dose administration. Phytother Res 2005; 19: 819-838
7 EMEA/HMPC/102655/2007. Reflection Paper on the Adaptogenic Concept. European Medicines Agency, London, 8 May 2008; Doc. Ref. EMEA/HMPC/102655/2007
8 Committee on herbal medicinal products (HMPC) Eleutherococcus senticosus (Ruppr. et Maxim.) Maxim., radix. Assessment report. London, 8 May 2008; Doc. Ref. EMEA/HMPC/232403/2006
9 Panossian A, Wikman G. Evidence-based efficacy of adaptogens in fatigue, and molecular mechanisms related to their stress-protective activity. Curr Clin Pharmacol 2009; 4: 198-219
10 Smets EMA, Garssen B, Bonke B et al. The multidimensional fatigue inventory (MFI) psychometric qualities of an instrument to assess fatigue. J Psychosomat Res 1995; 39: 315-325
11 Krampen G. Änderungssensitive Symptomliste zu Entspannungserleben, Wohlbefinden, Beschwerden- und Problembelastungen (Manual). Hogrefe Verlag GmbH & Co. KG; 2006
12 Schulz P, Schlotz W, Becker P. Trierer Inventar zum chronischen Stress. Hogrefe-Verlag GmbH & Co. KG; 2004
13 Hautzinger M, Keller F, Kühner C. BDI-II Beck Depression-Inventory – Manual. Pearson Assessment & Information GmbH. 2009 2^nd edition
14 Schellig D, Schächtele B. Visueller und verbaler Merkfähigkeitstest (VVM, visual and verbal memory test) – Manual. Pearson Assessment & Information GmbH, Frankfurt am Main. 2009 2^nd edition
15 Zimmermann P, Fimm B. Testbatterie zur Erfassung von Aufmerksamkeitsstörungen. Freiburg: Psytest; 1993. Version 1.02
16 Zimmermann P, Fimm B. A test battery for attentional performance. In: Leclercq M, Zimmermann P. (eds.). Applied Neuropsychology of Attention. Theory, Diagnosis and Rehabilitation. 2002: 110-151
17 Scholz A. Konzentration im Alltag: Erleben und Leistung (Concentration in everyday life: experience and performance). PhD thesis, Technical University Dresden (Faculty of Mathematics and Natural Sciences); 2006
18 Harnett-Sheehan K, Sheehan DV. Assessing treatment effects in clinical trials with the Discan metric of the Sheehan disability Scale. Int Clin Psychopharmacol 2008; 23: 70-83
19 Steyer R, Schwenkmezger P, Notz P et al. Der mehrdimensionale Befindlichkeitsfragebogen (Multidimensional Mental State Questionnaire, MDBF) Manual. Hogrefe Verlag GmbH & Co. KG; 1997
20 Cheun R, Burkart M, Maier W et al. Internal and external validity of the WHO well-being scale in the elderly general population. Acta Psychiatr Scand 1999; 99: 171-178
21 Parrott AC, Hindmarch I. The Leeds Sleep Evaluation Questionnaire in psychopharmacological investigations – a review. Psychopharmacology 1980; 71: 173-179
22 Frey I, Berg A, Grathwohl D et al. Freiburger Fragebogen zur körperlichen Aktivität – Entwicklung, Prüfung und Anwendung. Soz.-Präventivmed 1999; 44: 55-64
23 Boucsein W, Backs RW. The Psychophysiology of Emotion, Arousal, and Personality: Methods and Models. In: Duffy VG. (ed.). Handbook of Digital Human Modeling. Boca Raton: CRC Press/Taylor & Francis; 2009. 35-1-35-18
24 Boucsein W. Physiologische Grundlagen und Meßmethoden der dermalen Aktivität. In: Rösler F. (ed.). Enzyklopädie der Psychologie, Bereich Psychophysiologie, Band 1: Grundlagen und Methoden der Psychophysiologie (551-623). Göttingen: Hogrefe;
25 Fries E, Dettenborn L, Kirschbaum C. The cortisol awakening response (CAR): Facts and future directions. Int J Psychophysiol 2009; 72: 67-73
26 Chida Y, Steptoe A. Cortisol awakening response and psychosocial factors: A systematic review and meta-analysis. Biol Psychiatry 2008; 80: 265-278
27 Kudielka BM, Wüst S. Human models in acute and chronic stress: assessing determinants of individual hypothalamus-pituitary-adrenal axis activity and reactivity. Stress 2010; 13: 1-14
28 Olsson EMG, von Schéele B, Panossian AG. A randomized, double-blind, placebo-controlled, parallel-group study of the standardized extract SHR-5 of the roots of Rhodiola rosea in the treatment of subjects with stress-related fatigue. Planta Med 2009; 75: 105-112
29 Cooley K, Szczurka O, Perris D et al. Naturopathic Care for Anxiety: A Randomized Controlled Trial ISRCTN78958974. PLoS ONE 2009; 4: e6628
30 Auddy B, Hazra J, Mitra A et al. A standardized Withania Somnifera extract significantly reduces stress-related parameters in chronically stressed humans: A double-blind, randomized, placebo-controlled study. JANA 2008; 11: 50-56
31 Wust S, Wolf J, Hellhammer DH et al. The cortisol awakening response – normal values and confounds. Noise Health 2000; 2: 79-88
32 EMEA ICH, Topic E. 9. Note for Guidance on Statistical Principles for Clinical Trials. European Medicines Agency; London: September 1998. Doc. Ref. EMEA/CPMP/ICH/363/96
33 McCall WV, D’Agostino Jr R, Rosenquist PB et al. Dissection of the factors driving the placebo effect in hypnotic treatment of depressed insomniacs. Sleep Med 2011; 12: 557-564
34 Kuo J, Chen KW, Cheng IS et al. The effect of eight weeks of supplementation with Eleutherococcus senticosus on endurance capacity and metabolism in human. Chin J Physiol 2010; 53: 105-111
35 Facchinetti F, Neri I, Tarabusi M. Eleuterococcus senticosus reduces cardiovascular stress response in healthy subjects: a randomized, placebo-controlled trial. Stress Health 2002; 18: 11-17
36 Cicero AF, Derosa G, Brillante R et al. Effects of Siberian ginseng (Eleutherococcus senticosus maxim.) on elderly quality of life: a randomized clinical trial. Arch Gerontol Geriatr Suppl 2004; 9: 69-73
37 Hartz AJ, Bentler S, Noyes R et al. Randomized controlled trial of Siberian ginseng for chronic fatigue. Psychol Med 2004; 34: 51-61
38 Yarnell E, Abascal K, Rountree R. Chapter 3: Adaptogens. In: Clinical Botanical Medicine. 2^nd edition. Mary Ann Liebert; New Rochelle: 2009. 16-32
39 Committee on herbal medicinal products (HMPC). Assessment report on Rhodiola rosea L., rhizoma et radix. EMA/HMPC/232100/2011, 12 July 2011
40 Ishaque S, Shamseer L, Bukutu C et al. Rhodiola rosea for physical and mental fatigue: a systematic review. BMC Complement Altern Med 2012; 12: 70
41 Hung SK, Perry R, Ernst E. The effectiveness and efficacy of Rhodiola rosea L.: a systematic review of randomized clinical trials. Phytomedicine 2011; 18: 235-244
42 Edwards D, Heufelder A, Zimmermann A. Therapeutic effects and safety of Rhodiola rosea extract WS 1375 in subjects with life-stress symptoms – results of an open-label study. Phytotherapy Res 2012; 26: 1220-1225