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Case Study 3: Oralmat and CNS

“The Central Nervous System effects of an extractof the Rye Plant, Secale Cereale (Oralmat): Preliminary indication of anxiolytic /sedatory mode of action” study was conducted by Professor Con Stough of Centre of Neuropsychopharmacology of the Swinburne University of Technology, Melbourne Australia. The purpose of the study was to examine the Human EEG profile of acute doses of an extract of the Rye Plant, Secale Cereale (Oralmat). EEG power at alpha, beta, delta and theta frequencies were measured for placebo, 0.5 and 1.0 ml rye extract in a double blind placebo controlled repeated measures design in 20 healthy human participants.

Previously there had been no studies examining the effects of rye or an extract of rye on the functioning of the human brain so no specific hypotheses were made.

The study concluded that the administration of 1.0mg of Oralmat Drops Solution significantly increases frontal delta and reduced frontal beta activity. Some preliminary evidence showed that Oralmat Drops may be useful in increasing sedation and relaxation.

Following is the complete study

The Central Nervous System effects of an extract of the Rye Plant, Secale Cereale (Oralmat): Preliminary indication of anxiolytic/ sedative mode of action.

Con Stough^1,2*, Jenny Lloyd¹, Jake Ryan¹ and Pradeep J . Nathan^1,2

1 Centre of Neuropsychopharmacology, Swinburne University
2 Brain Sciences Institute, Swinburne University


* To whom correspondence should be addressed
Professor Con Stough
Centre of Neuropsychopharmacology
Swinburne University
PO Box 128 Hawthorn Vic 3122
AUSTRALIA

Tel: + 61 3 9214 8167
Fax; + 61 3 9214 5230
Email: cstough@swin.edu.au
 
Abstract

The purpose of this study was to examine the Human EEG profile of acute doses of an extract of the Rye Plant, Secale Cereale (Oralmat). EEG power at alpha, beta, delta and theta frequencies were measured for placebo, .5, and 1.0 ml rye extract in a double blind placebo controlled repeated measures design in 20 healthy human participants. The results indicated a primarily sedative/hypnotic effect for the rye extract with significant increases in frontal delta and reduction in frontal beta.

 
Introduction

With the ever-increasing number of newly developed drugs the need for early objective and quantitative screening techniques is obvious. Quantitative human electroencephalograph (EEG) methods have a well-documented application in human psychopharmacology. In normal healthy subjects, single dose studies have been conducted to identify drugs which affect the central nervous system (CNS), specify the times of drug activity, compare and classify drugs, predict clinical efficacy, determine dose-response relationships with regard to CNS effects and relate EEG findings to other measured effects (Fink, 1969; Itil et al., 1972; Saletu et al.,1976; 1982; 1988;1992). The effects of psychopharmaceuticals were extensively studied by Fink et al., (1969), and led to the division of psychopharmaceuticals into four classes (neuroleptics, antidepressants, tranquillizers, and psychostimulants) on the basis of EEG characteristics. The classification was based on two hypotheses; (1) that the different therapeutic effects of neuroleptics, antidepressants, tranquillizers, etc. are expressed in the form of different EEG effects in patients as well as in healthy persons; and (2), that it must therefore be possible to allocate new and clinically as yet unknown substances hypothetically to a therapeutic class on the basis of their EEG effects in healthy subjects, and then to confirm this classification in clinical trials.

A recent review by Knott (2000) has further described appropriate EEG methods in discovering whether a new drug is active in the CNS and at what dose and time the drug may be active. Based primarily on work by Saletu (1987), Knott concludes that comparing EEG power at different frequencies due to the administration of a drug relative to placebo reveals a number of consistent EEG profiles for different drug classes. Classification studies have shown that neuroleptics such as chlorpromazine and clozapine show increases in slow frequencies (delta, theta) (1-12 Hz), and decreases in alpha activity (13Hz) and beta activity (14-30Hz) in healthy subjects. An increase in the beta frequencies is typical for the conventional antidepressants, whereas a decrease in alpha and increase in beta activity is typical for tranquillizers and hypnotics. Psychostimulants have been shown to reduce delta and theta activity. Anxiolytic sedatives including hypnotics and tranquillizers increase beta activity and attenuate alpha activity. However, all sedative drugs increase low frequencies such as delta and theta

Oralmat drops, manufactured by Schumacher Pharmaceuticals is based on an extract of the Rye plant, Secale cereale. The extract is composed of natural phytochemicals such as phytoestrogens Genistein, Marairesinol, Coenzyme Q10, Daidzein, Squalene, Beta 1-3 glucan, Sterols and Sterolins. Pharmacological examination of the Schumacher extract has shown that it has antagonistic effects at Substance P, Glycine, AMPA-glutaminergic and α2 receptors (Schumacher Pharmaceuticals Product Information). These pharmacological properties suggest, that in terms of CNS actions, the extract may have antidepressant, anxiolytic, cognitive enhancing and/or neuroprotective effects. There have been no previous studies examining the CNS effects of any rye extract. However a study by Loshen and Ebeling (1991) indicated that a rye extract (in a double blind placebo controlled study) caused inhibitory effects on prostaglandin and leukotrien biosynthesis in vitro. Both on prostaglandins and leukotriens play important roles in inflammatory reactions which may have important consequences for neural and cognitive functioning. Inflammatory processes are thought to be an important indicator of neuronal loss after cerebral injury and in certain disorders of cognitions such as  Dementia of the Alzheimer’s Type. Therefore the effect of a rye extract may have indirect cognitive enhancing effects by reducing neural inflammatory processes. Despite this hypothesis there is little direct evidence to indicate that an extract of rye has direct central nervous system effects rather than peripheral. Clearly this should be the focus of future research.

The aims of the study are to examine the electrophysiological effects of Secale Cereale (Oralmat) utilising EEG to examine whether the extract has direct active effects on the central nervous system. Specifically the aim was to examine the dose-response CNS effects of this rye extract by examining the EEG power at different frequencies. Previous research has documented specific EEG power profiles at different frequencies for different drugs and drug types. To date there have been no studies examining the effects of rye or an extract of rye on the functioning of the human brain so no specific hypotheses are made.
 
Method

The study examined the acute effects of placebo and two doses of Secale Cereale (Oralmat) (0.5ml and 1 ml) on spontaneous EEG using a randomised double blind, placebo controlled design. All subjects provided written informed consent and the research was approved by the Swinburne University Human Research Ethics Committee.

Participants
Twenty healthy human participants (10 males and 10 females) (aged between 18 and 40) were tested. Participants were included in the study after detailed physical examination by a physician. Subjects with history of cardiovascular, hepatic, gastrointestinal, endocrine, neurological conditions (including psychiatric) or glaucoma or are currently taking any drugs use were excluded from the study. Testing was completed in a purpose-built EEG testing room. A repeated measures design was used with each participant acting as his/her own control and undergoing testing in three treatment conditions (placebo, 0.5ml Secale Cereale and 1.0ml Secale Cereale). The .5ml condition comprised 9 drops of the extract and the 1.0 ml comprised 18 drops of the extract. Participants were given their dose sublingually. Each treatment condition was separated by a week washout period. EEG recording was conducted at  0, 60min and 120min after drug administration. The 0 min (baseline) assessment as subtracted from the 60 and 120 min assessments.

Recording
During each of the testing days, an electrode cap was placed on the participants head and a water based gel was used to maintain contact between the electrodes and the scalp.

Electrophysiology
Spontaneous EEG was measured in each subject to determine robust quantitative changes of large-scale neocortical dynamic behaviour due to administration of Secale Cereale. The EEG data was recorded in the "resting state," meaning slowly counting breaths to facilitate relaxation and in "cognitive states," meaning during the performance of a demanding task.

Recording Sequence
During each of the three tests, the following was recorded with the NeuroScanTM EEG
System; 1. Three one-minute periods of eyes-closed spontaneous, resting EEG alternating with; 2. Three one-minute periods of eyes-closed spontaneous, cognitive EEG; 3. Three one-minute periods of eyes-open, resting EEG alternating with;
4. Three one-minute periods of eyes-open, cognitive EEG. EEG power was averaged across all conditions.

Salient aspects of data processing included; 58 scalp sites used, (EOG & EMG to exclude artifact), Signal filtered, FFT of at least 60 sec worth EEG for each condition. Relative Powers calculated for principal EEG frequencies. Frequency bands assessed;
delta – Low (1.5 – 3.5 Hz); theta – (3.5 – 7.5 Hz); alpha – (7.5 – 12.5 Hz); beta – High (13.0 – 17 Hz)

 
Results

All data was averaged into the corresponding EEG frequency bands corresponding to alpha, beta, delta and theta. Power was calculated at each of these frequencies and grouped into specific electrode regions which included left frontal, left temporal, left parietal and left occipital; right frontal, right temporal, right parietal; and all midline sites (Fz, Cz, Pz).

Statistical analyses
To examine whether significant differences in EEG power at alpha, beta, delta, and theta frequencies exist between the three treatment conditions (high and low dose rye extract and placebo) a series of repeated measures ANOVAs were computed. These ANOVAS reflected the 9 different electrode regions, and the 3 treatment conditions. Significant differences were observed for beta and delta frequencies indicating the EEG power at these frequencies were significantly different across the placebo, .5ml and 1.0ml rye extract conditions). Planned comparisons revealed that at frontal sites there were significant differences (p < .05) between the 1.0ml and .5ml conditions and between the 1.0ml and placebo conditions for both beta and delta frequencies. However there were no significant differences between placebo and .5ml conditions (NS). These results indicate a dose response relationship for Secale Cereale (Oralmat) with an increase in theta power and a decrease in beta power with increasing dose.

There were no significant differences between the three conditions at any electrode region at 2 hours post administration.

These relationships are represented figuratively in terms of brain maps in Figures One and Two.


Figure 1: changes in delta power associated with changes in condition. From left of page (placebo) followed by middle (. 5 ml Secale Cereale) and at right of page (1.0 ml Secale Cereale). Changes are most evident at frontal brain sites

Figure 2: changes in beta power associated with changes in condition. From left of page (placebo) followed by middle (. 5 ml Secale Cereale) and at right of page (1.0 ml Secale Cereale). Changes are most evident at frontal brain sites.
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There are three significant findings from the current study. First, the highest strength concentration of Secale Cereale produced the largest effects on both delta and beta power. Second, that the strongest effects were observed up to one hour post-administration and significantly reduced at 2 hours post administration. No changes in alpha or theta were observed across any of the testing times due to the rye extract.


 
Discussion

The brain maps and statistical analyses indicate preliminary dose-related effects of Secale Cereale on the central nervous system. These effects may help explain the behavioural and/or emotional effects reported by consumers of the Secale Cereale. The results indicate the administration of Secale Cereale increased delta activity and reduced beta activity, particularly at frontal electrode sites. Frontal areas of the brain have been implicated in human executive functioning as well as in inhibitory processes that are thought to govern various emotional and behavioural processes collectively underlying subjective states, mood, personality and the experience of emotions (Lexak, 1995). The pattern of results suggest that the Secale Cereale may act similarly to existing drugs that modulate frontal functioning in terms of decreasing beta power and increasing delta power. However existing drugs that change these frequencies also appear to change alpha and theta power, again suggesting a unique profile for Secale Cereale. An alternative explanation is that the concentration of the agent was not sufficient for us to detect changes in alpha and theta activity.
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Table 1 displays the potential overlap of EEG frequencies activated by other drug classes and types that show a similar comparison profile to Secale Cereale 

Table 1: EEG profile of some commonly used drugs