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9928 bPhytomedicine, Vol. 7(5), pp. 365–371 Urban & Fischer Verlag 2000http://www.urbanfischer.de/journals/phytomed Rhodiola rosea in stress induced fatigue –
A double blind cross-over study of a standardized
extract SHR-5 with a repeated low-dose regimen
on the mental performance of healthy physicians
during night duty.
V. Darbinyan1, A. Kteyan1, A. Panossian2, E. Gabrielian2, G.Wikman3 and H. Wagner4 1Department of Neurology, Armenian State Medical University, Yerevan, Armenia2Guelbenkian Research Laboratory of Armenian Drug and Medical Technology Agency, Yerevan, Armenia3Swedish Herbal Institute, Gothenburg, Sweden4Institute of Pharmacy, Pharmaceutical Biology, Ludwig Maximilian University, Munich, Germany The aim of this study was to investigate the effect of repeated low-dose treatment with a standardized
extract SHR/5 of rhizome Rhodiola rosea L, (RRE) on fatigue during night duty among a group of 56
young, healthy physicians. The effect was measured as total mental performance calculated as Fatigue
Index. The tests chosen reflect an overall level of mental fatigue, involving complex perceptive and cog-
nitive cerebral functions, such as associative thinking, short-term memory, calculation and ability of con-
centration, and speed of audio-visual perception. These parameters were tested before and after night
duty during three periods of two weeks each: a) a test period of one RRE/placebo tablet daily, b) a wash-
out period and c) a third period of one placebo/RRE tablet daily, in a double-blind cross-over trial. The
perceptive and cognitive cerebral functions mentioned above were investigated using 5 different tests. A
statistically significant improvement in these tests was observed in the treatment group (RRE) during the
first two weeks period. No side-effects were reported for either treatment noted. These results suggest
that RRE can reduce general fatigue under certain stressful conditions.
Key words: Rhodiola rosea L., fatigue, anti-fatigue effect, non-pathological stress, working conditions,
adaptogen, standardized extract SHR/5.
Rhodiola rosea L. is a medicinal plant from the Cras- berg and Hansen, 1998; Sandberg and Bohlin, 1993), sulaceae family, with the main active substance salidro- France (Pharmacopée Française, 1974), Greece and side, a phenylpropanoide (Steinegger-Hänsel, 1992, Russia. Its use in the medicine was reflected already in Saratikov et al., 1968). Rhodiola rosea is grown in dry the first Swedish Pharmacopoeia (Pharmacopoeia Sve- and sandy ground, mainly in the Arctic and Alpine re- cia, 1775) and Materia Medica (Materia Medica, Lin- gions of Europe, Asia and America. The part used in naei, 1749) and appears also more recently in the medicine is the root-stock, while the green aerial part is French Pharmacopoeia (1974) as well as in the Eston- used as a food ingredient. Rhodiola has a long tradition ian (Estonian Ministry of Health, 1998).
as a medicinal plant in several European countries, no- In Europe the use of Rhodiola rosea L. in medicine tably Iceland (Hjaltalin, 1830; Hallgrímsson, 1964), dates back to the ancient Greeks (Mell, 1938).
Norway (Hoeg, 1984), Sweden (Roselli, 1755; Sand- Dioscorides referred to it in the 1st century A.D., under Rhodiola rosea in stress induced fatigue the name of Rodia riza. In England and on the conti- clinical studies as an increased resistance to the harmful nent, the drug became known as lignum rhodium in apothecary shops. It was Linnaeus who gave the plant It has been shown in pharmacological investigations its botanical name Rhodiola and its species name, that Rhodiola rosea extracts (RRE) protect laboratory rosea. The name alludes to the rose-like odor of the animals from the harmful effects of oxygen, cold, radi- rootstock when freshly cut. In France Rhodiola was ation and heavy physical exercise (Saratikov et al., used as „brain tonic“ in the early 19th century (Virey, 1968). The stimulant effect of Rhodiola rosea increases 1811) and in the alpine region of Germany against working capacity, tolerance to anoxia, resistance to mi- crowave irradiation and poisoning by toxins. It de- In Russia, Rhodiola rosea has been used traditionally creases also fatigue and regulates brain function (Azi- and pharmacologically for a long period of time zov and Seifulla, 1998, Saratikov et al., 1968). Rats (Saratikov, 1966). Rhodiola rosea L. (RRE) prepara- treated with Rhodiola rosea extract (RRE) showed im- tions have also been used extensively in traditional Ti- proved learning behavior in a maze model 24 hours af- betan medicine since 300 A.D. for treating lung dis- ter treatment. Significant improvement of long-term eases, particularly lung-heat disorders (Tsarong, 1986; memory has also been established using memory tests Li, 1995). Thus, among the 175 most important Ti- after 10 days’ treatment (Petkov et al., 1986).
betan drugs in the Handbook of Traditional Tibetan Human studies have shown that salidroside, an ac- Drugs, Rhodiola is mentioned in ten formulations, of tive principle of Rhodiola, improved mental ability. In which nine are indicated for lung disorders (Tsarong, correction tests, the error rates were reduced by ap- proximately fifty persent (Wagner et al., 1994). For a It is, however, primarily in Russia and former USSR more detailed discussion see Brekhman, Dardymov and that preparations based on Rhodiola rosea rhizome Nörr (Brekhman and Dardymov, 1969; Nörr, 1993; and the glycoside salidroside (synonym: rhodioloside, rhodosine) have gained an established position and use An overview of the clinical studies of the anti-fatigue within the official medicine (Muravijeva, 1978, effect of Rhodiola rosea preparations shows that a ma- Mashkovskij, 1977, Turova and Sapozhnikova, 1984).
jority are based on single-dose application with a sig- The use in medicine in the former USSR/Russia, goes nificant effect after 1–2 h. This observation was one of back to a number of pharmacological and clinical in- the main motivations for performing a clinical study vestigations in the early 1960, which demonstrated pri- with repeated dose application of a low daily dose. An- marily stimulant and anti-stress actions (Müller-Dietz, other important consideration was to make the investi- 1970; Saratikov, 1974). As a result of these studies, gation in a nearly realistic work situation.
preparations based on Rhodiola rosea became incorpo- The aim of this placebo-controlled, double-blind rated into the officinal medicine by 1969 and are de- cross-over study was to evaluate the efficacy of a Rho- scribed in the last official USSR/Russian Pharma- diola rosea extract (RRE) with standardized content of copoeia and in the current Russian Pharmacopoeia salidroside. The study was performed as treatment of (National Pharmacopoeia of the USSR, 11th Edition, non-specific fatigue, resulting from natural physical fa- 1987; National Pharmacopoeia Committee, 1996).
tigue and using quantitative analysis of speed of audio- The stimulant and anti-stress actions of Rhodiola visual perception and short-term memory as criteria for rosea and its active component salidroside (synonym: fatigue. The study was based on a model reflecting rhodioloside) have been studied extensively in the USSR/Russia (Aksyonova, 1966, Saratikov, 1974,Sokolov, et al., 1985). A bibliography of published sci-entific reports on Rhodiola rosea (and salidroside) Material and Methods
from 1961 to 1987 contains 321 references, of which119 are pharmacological and clinical studies (Sara- The study was performed in compliance with the re- vised declaration of Helsinki and approved by the Ethi- Pharmacologically, Rhodiola rosea and its main ac- cal Review Committee of the Armenian State Medical tive component, salidroside has pronounced and well- documented stimulant and adaptogenic action (Wagner Ȝ Study design: The clinical investigation was carried et al., 1994; Brekhman and Dardymov, 1969; Sara- out as a randomized, placebo-controlled, double-blind, tikov et al., 1968; Nörr, 1993; Petkov et al., 1986). The cross-over study with a wash-out period. The study stimulant effect is a part of the adaptogenic action was intended to investigate the efficacy of a standard- (Saratikov et al., 1965: Zotova, 1966: Saratikov, 1974: ized extract SHR/5 from Rhodiola rosea rhizome Saratikov et al., 1978: Marina and Mikhaleva, 1987).
(RRE) in non-specific fatigue. The primary objective Adaptogenic action is a pharmacological effect seen in was to study the anti-fatigue effect of Rhodiola rosea preparation using repeated low-dose regimen in sons) each received 1 tablet from the Clinical A batch healthy volunteers during work-related fatigue. The per day, while group B (30 volunteers) each received 1 study parameter chosen and considered relevant for as- tablet from the Clinical B batch per day. During the fol- sessment was the degree of fatigue, based on the evalu- lowing two weeks of wash-out period no participants ation of audial and visual short-term memory and abil- received any medication. After that, both groups were ity for mental attention. The level of non-specific fa- again on two weeks of medication with the opposite tigue after the night duties was evaluated using five tests focused on the determination of speed of visual Determination of the level of fatigue after night duty and audial perception, attention capacity and short- was conducted on the basis of test results before and af- term memory. These tests were as follows: ter duty, i.e., with a time difference of 24 hours.
Test 1: the speed of determination of words associated Each volunteer was tested before receiving the prepa- ration or placebo, at the end of the 2-week period of Test 2: the speed of backward spelling of a 6-letter taking the preparation, at the end of the two weeks wash-out period and at the end of the two weeks of Test 3: the speed of subtraction of a given digit se- cross over period. For each test occasion, all the scor- quentially as far as possible from a number be- ings for tests 1–5 were tabulated and used as ranking tween 90 and 99 to 0, scored in seconds.
data for a subsequent statistical analysis of all the tests Test 4: the number of correctly recalled words, irre- spective of sequence and with no time-limit, ten Selection of patients. The patients were recruited ac- of which were presented audially to the subject, cording to specified inclusion and exclusion criteria af- ter having received written and verbal information Test 5: the speed of rearranging digits into an order of about the Department of Neurology, Armenian State decreasing magnitude. The digits were ran- Medical University of Yerevan. The patients were com- domly distributed in a square, scored in sec- prised of young, healthy physicians on night duty, cho- sen by Dr. V. Darbinyan and Dr. A. Kteyan during Jan- For explanation of the rationale for using this test-bat- uary 1998 – March 1999. All participants were resi- tery in the measurement of non-pathological fatigue, dents of Armenia and had a similar socio-cultural A fatigue index was calculated based on these para- meters. As a measure for fatigue, each test was given a Patient inclusion criteria
measure, an index, defined as the following ratio: 1. Age between 24–35, of both genders.
(score of test before night duty divided by score of test 2. Compliance with the study specifications.
after night duty) x 100. Five different measurements 3. All patients were informed about the study and a were assessed collectively, giving a total fatigue. The to- tal effect of taking RRE was assessed according to thetotal fatigue index, FI, which directly gives the level ofperformances after duty on each occasion in percent of Patient exclusion criteria
the performance before duty. Each subject was ran- 1. Mental disease or declared psychological or major domly assigned the medication form two directed sets of jars, containing Clinical A 971106 or Clinical B 2. Somatic disease or complaint with fatigue as a symp- 971106. The volunteers were, according to the assign- ment of test medication, divided into two groups, A and B. During the first two weeks, the group A (26 per- Study medication. The test medication (verum and Rhodiola rosea in stress induced fatigue stearas, silica colloidalis anh.; COATING FOR BOTHVERUM/PLACEBO, Saccharose, calcium carbohy-drate, magnesium silicate, polyvinylpyrrolidone, titandioxide.
Verum and placebo tablets were produced with iden- tical organoleptic appearance, and were indistinguish-able from each other. Each package of tablets con-tained 60 tablets to be taken once daily for 14 days.
Fig. 1. Mean values of Fatigue indices and total index. (Val-
The medications were divided into two sets of plastic jars which were labelled: Clinical A 971106 and Clini-cal B 971106. An identification number was noted in a placebo) was manufactured according to Good Manu- protocol to allow a subsequent identification after the facturing Practice (GMP) by Swedish Herbal Institute completion of the study and statistical analysis. The in- (SHI) in the form of white, sugar-coated tablets, with formation on the placebo and the active substance be- the following composition: VERUM TABLETS, Extr.
came available to the investigators and volunteers only sicc. Rhodiola rosea SHR/5 170 mg (containing ap- after the completion of the study and after the statisti- proximately 4.5 mg salidroside), calcii phosphas diba- sicus, solani amylum, cellulosum microcristallinum,magnesii stearas, silica colloidalis anh.; PLACEBO Anthropometric Data
TABLETS, Lactose 170 mg, calcii phosphas dibasicus, Group A: 26 persons: 14 females, 12 males, age 25.5 ± solani amylum, cellulosum microcristallinum, magnesii Table 3. Test scores: Mean values and standard deviations.
Group B: 30 persons: 19 females, 11 males, age 27.3 ± challenges in the experimental data in clinical practice are the methodological difficulties in measuring such a Statistical analysis. Statistical analysis of the total fa- subjective and complex notion as fatigue. The advan- tigue indices was performed according to the Student‘s tage of the chosen model in a common working situa- T-test, two-tailed. Data management and calculations tion causing fatigue were the similarity of the stress sit- were performed using PRISM Statistical Software Ver- uation for all the participants in an actual and realistic work situation. Regular night duty work is well knownto be stressful and to play a part in causing variouspathological conditions, such as long term disturbances Results and discussion
of sleep and depressions (Czeisler and Richardson,1998).
All the patients completed the study and no adverse ef- Table 3 presents the mean values of the actual score fects or events were observed. As presented in Figure 1 for each test and period. As is seen, the absolute values and Table 2, total fatigue index was significantly im- of the scores vary considerably from test to test.
proved after two weeks of taking the RRE preparation.
To be able to directly compare the tests, Table 4, pre- In different clinical trials with Rhodiola rosea prod- sents the more relevant relative measure called Fatigue ucts, psycho-stimulating, tranquilizing and antidepres- index as defined above. The fatigue index subtracted sive effects have been demonstrated. The preparation is by 100 (FI – 100) gives directly the change in percent of also used for correction of aesthenic conditions the performance before and after duty.
(Mikhailova, 1983). A few clinical studies are also The difference between the tests as a measure of fa- worth noting. Studies have been completed with RRE tigue is directly seen from this table. As an example, ap- in psychiatric practice as an adjuvant anti-depressant pears test 1 to be more sensitively dependent on the (Brichenko et al, 1986) and as an anti-depressant state of fatigue than test 4, as appears directly from the (Brichenko and Skarokhodova, 1987). The anti-hyp- larger magnitude of a fatigue indices. To have a more notic effect of the active substance was assessed by Ak- relevant and also more reliable measure of the degree senova (Aksenova et al., 1968). Komar studied the of fatigue a total fatigue index was calculated, using the stimulating effect in 254 young healthy persons, fatigue indices from each test with equal weight. The demonstrating an increased mental work capacity after result is displayed in Table 2 and in Figure 1. The only intake of a Rhodiola rosea preparation (Komar et al., significant change is seen in the verum group between 1981). Several other similar studies were made by a period I and period II with a change in performance of number of investigators (Saratikov, 1974; Krasik et al., approximately 20 % (p < 0.01). Furthermore this study 1970a; Krasik et al., 1970b; Lapaev, 1982; Metsch- also shows that for the chosen dosage there was no ef- eryakova et al., 1975; Oleinichenko, 1966; Tuzov, ficacy in group B after six weeks of treatment. On the second test occasion however, the subjects had been on The use of adaptogens against common non-patho- night duty for a considerably longer time than for the logical stress under normal conditions of usual work- first occasion. It should therefore be taken into consid- ing activity could be of great practical significance. The eration that the low dosage used was well-adapted for Table 4. Mean values of Fatigue indices and total fatigue index. (Value of scoring before duty = 100)
Rhodiola rosea in stress induced fatigue Table 5. Correlation between before-duty scores on occasion
The size of the study does not allow for further gen- eral conclusions but surely suggests that in a futurestudy of similar design, both higher doses and a larger number of subjects should be used. The present study also indicates that another choice of the test battery, could be more sensitive in assessing a general state of References
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9 Asratyan St., Kanaker Yerevan, Armenia 375000.
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concern the clinical-pharmacological basis of the effi- cacy of HMP (e.g., metabolism of multi-drug-mixtures, Volume I: 198 pp, 1995. ISBN 3-7985-1053-9; analysis and bioequivalence-investigations of HMP), Volume II: 210 pp, 1996. ISBN 3-7985-1066-0; toxicological and safety aspects (mutagenicity and car- Volume III: 215 pp, 1997. ISBN 3-7985-1094-6; cinogenicity studies), the pharmaceutical characteriza- Volume IV: 186 pp, 1998. ISBN 3-7985-1131-4.
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states, gynecological diseases, cardiac insufficiency, im-mune deficiency, cancer, benign prostatic hyperplasia, The five volumes published up to now contain the lec- venous diseases, application of HMP in pediatrics, and tures presented at the annual phytomedicine symposia of the German Society for Clinical Pharmacology. The The scope of herbal drugs which have been subject to aim of these symposia is to review the most current pharmacological and clinical studies includes prepara- therapeutic status of rational herbal medicinal prod- tions from Aesculus hippocastanum, Anthranoid- ucts (HMP). HMPs are subjected to the same scientific Cimicifuga racemosa, Crataegus spp, Cucurbita requirements concerning efficacy, safety and quality as pepo, Ginkgo biloba, Cynara scolymus, Echinacea spp, Harpagophytum procumbens, Hypericum perforatum, Today therapy with HMP is a definite component of Mentha piperita, Piper methysticum, Plantago lanceo- traditional medicine, which is subject to the rules of lata, Sabal serrulata, Senna spp, Silybum marianum, controlled clinical studies according to the guidelines of Urtica spp., Viscum album, Vitex agnus castus as well good clinical practice. It clearly needs to be differenti- as ß-Aescin, volatile oils, silibinin and silymarin.
ated from the numerous methods of so called alterna- The results of pharmacological and clinical trials, presented in the first five volumes of Phytopharmaka, For a number of years HMPs have been placed in an make clear that rational HMP is taking an essential area of conflict between a tradition of several centuries place in medicinal therapy and can meet the require- and a Evidence Based Medicine (EBM). EBM perceives ments of the evidence-based hierarchy from the stand- itself as a quality-orientated but not as a view-orientat- point of quality, clinical trials and meta analyses. The ed implementation of scientific knowledge, and derives books represent an essential basis for all scientists con- concrete therapeutic recommendations from a five-lev- cerned with herbal medicinal products in research, clin- el hierarchy of evidence. Though EBM seems to present itself as a rational and pragmatic procedure for deci-sion-making, from an optimal pharmaco-economically orientated medical support, criticism arises from the Gesellschaft für Phytotherapie e.V.
fact that therapeutic experience and the requirements of daily practice are not considered in EBM.
VASCULAR NEURO-OPHTALMOLOGICAL EMERGENCIES Irene Davidescu, Sanda Nica Neurology Department, “Carol Davila” University of Medicine and Pharmacy, Bucharest, Romania ABSTRACT Neuro-ophtalmology is a borderline specialty, as the eye is not an isolated organ but an extension of the brain. A lot of diseases can cause visual troubles and the vascular ones are quite frequent. The precociou