The below 'study' has been used to advertise a Lactium® product...
http://www.rilax.inf.....tudy 2006.pdfSO KEN study:
Efficacy of lactium® on sleep disorders
October2006
Aim :
The target of this clinical investigation was to study the effects of lactium®
intake on sleep disorders.
Protocol
165 Japanese healthy males and females aged between 25 and 40,
but aware of sleep troubles
selection of 44 subjects from self evaluation –inclusion criteria :
PSQI score > 5 and
HAD score < 10
2 homogenous groups : lactium®and placebo
1 capsule a day (150 mg lactium®) during 4 weeks
4 observation periods in addition to initial screening :
during the intake period : weeks 0, 2, 4
after the treatment : week 4+1
evaluation questionnaires : Pittsburg Sleep Quality Index (PSQI)
Epworth Sleepiness Scale (ESS)
Key points
PSQI
PSQI is a suitable index to evaluate the sleep quality of “poor sleepers”
lactium® shows a positive effect on almost all the tested items
in whole population
Nevertheless, some positive results are also observed with placebo.
The placebo effect is a well-known phenomenon especially :
in psychosomatic troubles like sleep disorders,
for “expecting people”with severe symptoms.
It is a short-term effect, as confirmed with the poor placebo results at W4+1.
In whole population, lactium
intake particularly improves :
sleep duration,
sleep efficiency.
Key points
In subjects with a moderate anxiety or depressive profile (HAD-A or HAD-D <7),
the benefits of lactiumare still more noticeable.
Lactiumimproves significantly the :
sleep quality
sleep efficiency
sleep disturbances
daytime dysfunction
Global PSQI score.
it is not the case with placebo.
lactium®decreases sleep troubles, probably via physiologic effects.
Key points
ESS
ESS is a good tool to evaluate alertness or sleepiness during the day
3 key items of ESS are good indicators of alertness and cognitive
performances :
sitting in active public place (meeting…),
sitting and talking to someone
driving and stopped at a traffic light.
the intake of lactium®significantly reduces the diurnal sleepiness for 2 of
them, even one week after the treatment.
lactium®also reduces the sleepiness when being “as a passenger in a car" and “lying down in the afternoon”.
lactium®improves diurnal alterness, probably because it restores night’s quality.
CONCLUSION:
lactium®decreases the sleep disorders, in particular for people with moderate
anxious/depressive profile
lactium®progressively restores a good sleep without being soporific
lactiumhas more a physiological effect, whereas Placebo has a psychological
effect only (especially for expecting people)
For pathological sleep disorders, lactium®could be helpful but it is not a
sedative drug.
GOOD NIGHTS FOR GOOD DAYS :
Do you fall asleep during the day (meeting, car travel…) ? That probably means that the quality of your
night sleep is not good. If you want to have a good day, have first of all a good night.
Take lactium®and you’ll have Good Nights for Good days…