sleep loss and sleep disorders are among the most common health problems , but are frequently overlooked .
it is estimated that about one - third of people in the general population suffer from a chronic disorder of sleep and wakefulness.1 insomnia is a subjective complaint that sleep is difficult to initiate or maintain , or that it is nonrefreshing or of poor quality and quantity.2 insomnia affects approximately 20%40% of older adults at least a few nights per month.3,4 it is an important concern in elderly patients , not only because it is common , but also because it can cause multiple daytime impairments , such as difficulty sustaining attention or alertness , a slowed response time , impaired memory and concentration , and decreased performance .
insomnia is also associated with a shortened lifespan because of an increased risk of heart disease , stroke , cancer , and suicide.5,6 insomnia is mostly treated with benzodiazepine and nonbenzodiazepine hypnotic drugs , which potentiate the central nervous system suppressant activity of gamma aminobutyric acid a receptors in the brain . however , residual daytime effects , development of dependence , and withdrawal symptoms associated with most hypnotic drugs are of considerable concern in public health.7 lactuca sativa ( garden lettuce ) , a member of the compositae family , is a very popular salad herb in egypt.8,9 its seed oil has been in use in folk medicine since ancient times as a sleeping aid , as well as to relieve pain and inflammation.10,11 a crude methanol / petroleum ether extract from l. sativa seeds has demonstrated a time - dependent and dose - dependent analgesic effect in a formalin test and also dose - dependent anti - inflammatory activity in a carrageenan model of inflammation.12 l. sativa seed oil ( sedan , pharco pharmaceutical company , alexandria , egypt ) is marketed as a soft gelatin capsule containing 1000 mg of the purified expressed oil .
gas liquid chromatography shows that the l. sativa seed oil capsule is comprised mainly of oleic acid ( 61.5% ) , stearic acid ( 20.4% ) , palmitic acid ( 9.7% ) , myristic acid ( 2.8% ) , cispalmitoleic ( 1.2% ) , behenic acid ( 0.5% ) , and lignoseric acid ( 0.3% ) , with b - sitosterol and b - amryn also present . despite its
well - known safety over thousands of years of use , l. sativa seed oil has only recently been subjected to extensive pharmacological and toxicological investigation .
it was found to have significant sedative , analgesic , and anti - inflammatory activity in a murine model,13 and in the same study was shown to have significant anticonvulsant activity against convulsions induced by pentylenetetrazole and to potentiate the hypnotic effect of barbiturates .
the oral ld50 was found to be 19.75 ml / kg.13 the scientific data from this animal research in addition to the extensive anecdotal experience of successive generations of traditional egyptian herbalists , prompted our research group , which has a special interest in traditional herbal medicines , to undertake a pilot clinical study to evaluate the sedative and hypnotic effects of l. sativa seed oil in patients complaining of sleeping difficulty with or without anxiety .
this was a prospective single - blind , randomized , placebo - controlled trial performed in two outpatient clinics in alexandria , one at the mamorah psychiatric hospital and the other at the green clinical research center .
sixty consecutive patients presenting with insomnia or sleeping difficulty were recruited for the study after careful medical history - taking and a physical examination .
patients were included if they were aged over 18 years and had a presenting complaint of insomnia , defined as frequently upset sleep quantity / quality or difficulty in initiating or sustaining a normal deep sleep pattern .
dementia of the alzheimer s type was not an exclusion criterion if the patient had a supportive partner / caregiver .
patients with concomitant organic or neuropsychiatric disease necessitating use of tranquilizers , sedatives , anticonvulsants , or psychotropic agents were excluded .
patients who were concomitantly receiving any other conventional or alternative medical intervention which might influence the study outcome , including all other herbal products , hypnotherapy , acupuncture , homeopathy , and yoga , were also excluded .
patients were asked not to use any of these concomitant interventions during the course of the study , and were excluded from the analysis if they did so . critically ill patients with severe heart , renal , or liver dysfunction were excluded , as were patients whose condition precluded verbal communication , unless they were accompanied by a supportive partner / caregiver .
the protocol was approved by the local research ethical committee ( iorg0006902 green clinic and research center irb # 1 ) , and each subject signed a consent form .
group 1 ( n = 30 ) received one sedan capsule every night for 1 week and group 2 ( n = 30 ) received a matching placebo .
randomization was done using a software - generated block randomization technique and the patients were blinded to their allocated drug .
double - blinding was not possible in this pilot study because the baseline examination , supply of medication , and final assessment were all carried out by the same investigator at each clinic .
the effect of sedan vs placebo on both the modified state - trait anxiety inventory ( stai ) score14 and a sleeping difficulty score was assessed at the end of 1 week of treatment .
the modified stai scale comprises 20 questions , each of which is answered on a five - point scale , from 1 ( nil ) to 4 ( very much ) .
the sleeping difficulty scale was a 10-item questionnaire based on the items of the leeds sleep evaluation questionnaire15 and assessed subjective patient estimates of and satisfaction with sleep quality using a three - point rating scale ( 0 = rare / nil , 1 = sometimes , and 2 = often ) . the higher the total score on both scales , the worse the patient s insomnia was deemed to be .
both questionnaires were administered verbally at baseline and at the end of 1 week of treatment .
both instruments were translated into the arabic language by the investigators and had been validated previously in patients with anxiety and insomnia treated at mamorah psychiatric hospital ( unpublished data ) .
clinical global impression of change ( cgi - c ) scores were also recorded by the investigator at baseline after 1 week of treatment .
the cgi - c is a seven - item symptom rating scale ( 0 = not assessed , 1 = very much improved , 2 = much improved , 3 = minimally improved , 4 = no change , 5 = minimally worse , 6 = much worse , 7 = very much worse ) .
data were analyzed using the computer software package spss ( v 14 ; spss , inc , chicago , il ) .
sample size was calculated using sigmastat ( v 3.5 for windows ; systat software , inc , chicago , il ) .
the minimum sample size needed for each treatment group was calculated to be 23 subjects to detect a difference of 3.0 points in mean sleep scale scores with a standard deviation ( sd ) of 3.5 , 80% power , and a 0.05 two - tailed level of significance .
a paired - samples t - test was done to compare the mean scores for each group before and after treatment .
an independent - samples t - test was done to test for a significant difference between any improvements in mean score in each treatment group .
multivariate analysis of covariance with treatment as the main independent factor and the study center as a controlling factor was used in full factorial model testing for main effects plus any possible interaction effects .
baseline pretreatment scores were used as covariates to control for initial group differences potentially affecting the dependent outcome variables , ie , any differences between baseline and posttreatment stai and sleep scores , and their interaction .
parametric statistical methods were utilized after ascertaining the normality of distribution of the dependent variables by kolmogorov 
the effect of sedan vs placebo on both the modified state - trait anxiety inventory ( stai ) score14 and a sleeping difficulty score was assessed at the end of 1 week of treatment .
the modified stai scale comprises 20 questions , each of which is answered on a five - point scale , from 1 ( nil ) to 4 ( very much ) .
the sleeping difficulty scale was a 10-item questionnaire based on the items of the leeds sleep evaluation questionnaire15 and assessed subjective patient estimates of and satisfaction with sleep quality using a three - point rating scale ( 0 = rare / nil , 1 = sometimes , and 2 = often ) . the higher the total score on both scales , the worse the patient s insomnia was deemed to be .
both questionnaires were administered verbally at baseline and at the end of 1 week of treatment .
both instruments were translated into the arabic language by the investigators and had been validated previously in patients with anxiety and insomnia treated at mamorah psychiatric hospital ( unpublished data ) .
clinical global impression of change ( cgi - c ) scores were also recorded by the investigator at baseline after 1 week of treatment .
the cgi - c is a seven - item symptom rating scale ( 0 = not assessed , 1 = very much improved , 2 = much improved , 3 = minimally improved , 4 = no change , 5 = minimally worse , 6 = much worse , 7 = very much worse ) .
data were analyzed using the computer software package spss ( v 14 ; spss , inc , chicago , il ) .
sample size was calculated using sigmastat ( v 3.5 for windows ; systat software , inc , chicago , il ) .
the minimum sample size needed for each treatment group was calculated to be 23 subjects to detect a difference of 3.0 points in mean sleep scale scores with a standard deviation ( sd ) of 3.5 , 80% power , and a 0.05 two - tailed level of significance .
a paired - samples t - test was done to compare the mean scores for each group before and after treatment .
an independent - samples t - test was done to test for a significant difference between any improvements in mean score in each treatment group .
multivariate analysis of covariance with treatment as the main independent factor and the study center as a controlling factor was used in full factorial model testing for main effects plus any possible interaction effects .
baseline pretreatment scores were used as covariates to control for initial group differences potentially affecting the dependent outcome variables , ie , any differences between baseline and posttreatment stai and sleep scores , and their interaction .
parametric statistical methods were utilized after ascertaining the normality of distribution of the dependent variables by kolmogorov  smirnov goodness of fit test .
two patients from group 1 and one from group 2 withdrew from the study after randomization , and three patients in each group were lost to follow - up .
one patient from group 2 was not included in the statistical analysis as a result of recording errors made on the sleep scoring sheet .
twenty - five patients from each group were finally assessed , and their results were subjected to statistical analysis .
the two groups were well matched for age , gender , and baseline sleep scores ( see table 1 ) .
cronbach s alpha coefficients for the 20 items on the modified stai scale and for the ten items of the sleeping difficulty scale were 0.835 and 0.764 , respectively , indicating good reliability .
there was a statistically significant improvement in mean scores for both the modified stai and the sleeping difficulty questionnaires in both groups after treatment ( tables 2 and 3 ) .
however , improvements in both the mean modified stai score and mean sleep score were significantly greater in group 1 than in group 2 by independent - samples t - test ( p < 0.05 ) . multivariate analysis was undertaken using treatment allocation as the main independent factor and the study center as a controlling factor in a full factorial model , with baseline scores as covariates ( tables 4 and 5 ) .
treatment allocation and baseline scores ( covariates ) had statistically significant effects on the outcome variables , while both the study center and its two - way interaction with treatment ( group , center ) did not .
univariate effects of the corrected model and the treatment groups adjusted for baseline severity on both the stai and sleep score showed statistically significant differences , while the study center and its two - way interaction with the groups did not .
eighteen out of the 25 patients who completed the protocol ( 72% ) in group 1 rated their insomnia as  very much or much improved  on the cgic scale , versus 5 ( 20% ) in the control group ( ie , 60% vs 16.7% respectively of the 30 intention - to - treat patients ) ( risk ratio : 3.6 ; 95% confidence interval : 1.588.18 ) .
to our knowledge , this is the first published study of the effect of l. sativa seed oil on a sleeping disorder .
we found that l. sativa seed oil significantly improved both stai and sleep scores , with no apparent side effects at the dose strength used .
being clinicians with a special interest in complementary alternative medicine , we undertook this pilot research on a pragmatic hypothesis - generating basis , rather than as a confirmatory or explanatory study , and hope that our findings will help pave the way for other investigators to join in the attempt to bridge the gap between alternative medicine and evidence - based medicine .
this study has a number of limitations , including a small size , a short follow - up duration , and a single - blind design .
the obvious reason for this is that , unlike patented new chemical entities with research funding from the pharmaceutical industry , quality research involving alternative medicines tends to suffer from financial and logistic constraints . in our opinion , alternative medicines , in particular products already available as over - the - counter dietary supplements , should be subjected to more translational research and clinical trials in human subjects , and the results made available in the scientific literature .
the criteria for publishing such studies would need to be different to those used with the registration trials for new chemical entities .
in conclusion , l. sativa seed oil was found to be a useful sleeping aid and may be a hazard - free line of treatment , especially in geriatric patients suffering mild - to - moderate forms of anxiety and sleeping difficulties .
did you feel in need of frequent naps or a lie - down during the day ?
 background : lactuca sativa ( garden lettuce ) is a popular salad herb . 
 it has been in use in folk medicine since ancient times as both an appetite stimulant and as an aid to sleep . 
 l. sativa seed oil ( sedan ) has demonstrated a pronounced sedative effect and potentiated the hypnotic effect of barbiturates in animal models . 
 it also exhibited significant analgesic and anti - inflammatory activities . in this study 
 , we evaluated the sedative and hypnotic effects of l. sativa in patients suffering from insomnia.methods:sixty patients suffering from insomnia with or without anxiety were randomized to receive capsules containing l. sativa seed oil 1000 mg ( n = 30 ) or placebo ( n = 30 ) . 
 all patients were asked to complete a verbal questionnaire before the start of the trial and 1 week after starting treatment.results:improvements in the modified state - trait anxiety inventory and the sleep rating scale scores were significantly greater in patients receiving l. sativa seed oil compared with those on placebo ( p < 0.05 ) . 
 no side effects were found to be attributable to l. sativa seed oil at the given dosage.conclusion:l . 
 sativa seed oil was found to be a useful sleeping aid and may be a hazard - free line of treatment , especially in geriatric patients suffering from mild - to - moderate forms of anxiety and sleeping difficulties . 
Introduction
Methods
Outcome measures
Statistical analysis
Results
Discussion
Conclusion
Describe your state during the last week, choosing 0 (rare/nil), 1 (sometimes), or 2 (often/always)