human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background Generalised anxiety disorder ( GAD ) is a chronic and pervasive condition that generates high levels of psychological stress , and it is difficult to treat in the long term . Current pharmacotherapeutic options for GAD are in some cases only modestly effective , and may elicit undesirable side effects . Through targeted actions on the gamma-aminobutyric acid ( GABA ) pathway , the South Pacific medicinal plant kava ( Piper methysticum ) is a non-addictive , non-hypnotic anxiolytic with the potential to treat GAD . The evidence for the efficacy of kava for treating anxiety has been affirmed through clinical trials and meta-analyses . Recent research has also served to lessen safety concerns regarding the use of kava due to hepatotoxic risk , which is reflected in a recent German court overturning the previous kava ban in that country ( which may in turn influence a reinstatement by the European Union ) . The aim of current research is to assess the efficacy of an ‘ aqueous noble cultivar rootstock extract ’ of kava in GAD in a larger longer term study . In addition , we plan to investigate the pharmacogenomic influence of GABA transporters on response , effects of kava on gene expression , and for the first time , the neurobiological correlates of treatment response via functional and metabolic imaging . Methods / Design This clinical trial is funded by the Australian National Health and Medical Research Council ( APP1063383 ) and co-funded by MediHerb ( Integria Healthcare ( Australia ) Pty . Ltd ) . The study is a phase III , multi-site , two-arm , 18-week , r and omised , double-blind , placebo-controlled study using an aqueous extract of noble kava cultivar ( st and ardised to 240 mg of kavalactones per day ) versus matching placebo in 210 currently anxious participants with diagnosed GAD who are non-medicated . The study takes place at two sites : the Centre for Human Psychopharmacology ( Swinburne University of Technology ) , Hawthorn , Melbourne , Australia ; and the Academic Discipline of Psychiatry ( The University of Queensl and ) based at the Royal Brisbane and Women ’s Hospital , Herston , Brisbane , Australia . Written informed consent will be obtained from each participant prior to commencement in the study . The primary outcome is the Structured Interview Guide for the Hamilton Anxiety Rating Scale ( SIGH-A ) . The secondary outcomes involve a range of scales that assess affective disorder symptoms and quality of life outcomes , in addition to the study of mediating biomarkers of response ( assessed via genomics and neuroimaging ) . Discussion If this study demonstrates positive findings in support of the superiority of kava over placebo in the treatment of GAD , and also is shown to be safe , then this plant-medicine can be considered a ’ first-line ‘ therapy for GAD . Genomic and neuroimaging data may reveal clinical response patterns and provide more evidence of the neurobiological activity of the plant extract . Trial Registration Information Clinical Trials.gov : NCT02219880 Date : 13 August 2014 Background Anxiety symptoms are frequently observed in dental patients , whether they are undergoing simple or more invasive procedures such as surgery . This research aim ed to compare the effects of Passiflora incarnata and midazolam for the control of anxiety in patients undergoing m and ibular third molar extraction . Material and Methods Forty volunteers underwent bilateral extraction of their m and ibular third molars in a r and omized , controlled , double-blind , crossover clinical trial . Passiflora incarnata ( 260 mg ) or midazolam ( 15 mg ) were orally administered 30 minutes before surgery . The anxiety level of participants was evaluated by question naires and measurement of physical parameters  , including  heart rate ( HR ) , blood pressure ( BP ) , and oxygen saturation ( SpO2 ) . Results Considering each procedure independently , there were no significant differences between the protocol s in BP , HR , and SpO2 . Over 70 % of the volunteers responded that they felt quiet or a little anxious under both protocol s. With midazolam , 20 % of the participants reported amnesia ( not remembering anything at all ) , while Passiflora showed little or no ability to interfere with memory formation . Conclusions Passiflora incarnata showed an anxiolytic effect similar to midazolam , and was safe and effective for conscious sedation in adult patients who underwent extraction of their m and ibular third molars . Key words : Passiflora incarnata , midazolam , anxiety , oral surgery Chronic stress has been associated with a number of illnesses , including obesity . Ashwag and ha is a well-known adaptogen and known for reducing stress and anxiety in humans . The objective of this study was to evaluate the safety and efficacy of a st and ardized root extract of Ashwag and ha through a double-blind , r and omized , placebo-controlled trial . A total of 52 subjects under chronic stress received either Ashwag and ha ( 300 mg ) or placebo twice daily . Primary efficacy measures were Perceived Stress Scale and Food Cravings Question naire . Secondary efficacy measures were Oxford Happiness Question naire , Three-Factor Eating Question naire , serum cortisol , body weight , and body mass index . Each subject was assessed at the start and at 4 and 8 weeks . The treatment with Ashwag and ha result ed in significant improvements in primary and secondary measures . Also , the extract was found to be safe and tolerable . The outcome of this study suggests that Ashwag and ha root extract can be used for body weight management in adults under chronic stress Context : Stress is a state of mental or emotional strain or tension , which can lead to underperformance and adverse clinical conditions . Adaptogens are herbs that help in combating stress . Ayurvedic classical texts , animal studies and clinical studies describe Ashwag and ha as a safe and effective adaptogen . Aims : The aim of the study was to evaluate the safety and efficacy of a high-concentration full-spectrum extract of Ashwag and ha roots in reducing stress and anxiety and in improving the general well-being of adults who were under stress . Setting s and Design : Single center , prospect i ve , double-blind , r and omized , placebo-controlled trial . Material s and Methods : A total of 64 subjects with a history of chronic stress were enrolled into the study after performing relevant clinical examinations and laboratory tests . These included a measurement of serum cortisol , and assessing their scores on st and ard stress- assessment question naires . They were r and omized to either the placebo control group or the study drug treatment group , and were asked to take one capsule twice a day for a period of 60 days . In the study drug treatment group , each capsule contained 300 mg of high-concentration full-spectrum extract from the root of the Ashwag and ha plant . During the treatment period ( on Day 15 , Day 30 and Day 45 ) , a follow-up telephone call was made to all subjects to check for treatment compliance and to note any adverse reactions . Final safety and efficacy assessment s were done on Day 60 . Statistical Analysis : t-test , Mann-Whitney test . Results : The treatment group that was given the high-concentration full-spectrum Ashwag and ha root extract exhibited a significant reduction ( P<0.0001 ) in scores on all the stress- assessment scales on Day 60 , relative to the placebo group . The serum cortisol levels were substantially reduced ( P=0.0006 ) in the Ashwag and ha group , relative to the placebo group . The adverse effects were mild in nature and were comparable in both the groups . No serious adverse events were reported . Conclusion : The findings of this study suggest that a high-concentration full-spectrum Ashwag and ha root extract safely and effectively improves an individual 's resistance towards stress and thereby improves self-assessed quality of life Purpose Patients who undergo regional anesthesia experience anxiety in the preoperative period . Passiflora incarnata Linneaus is a plant that has traditionally been used as an anxiolytic and sedative . We aim ed to investigate the effect of preoperative oral administration of Passiflora incarnata Linneaus on anxiety , psychomotor functions , sedation , and hemodynamics in patients undergoing spinal anesthesia . Methods Under local ethics committee approval , 60 patients who were aged 25–55 years and ASAI – II and who were scheduled for spinal anesthesia were enrolled in this prospect i ve , r and omized , double-blind and placebo-controlled study . Thirty minutes before spinal anesthesia , baseline hemodynamic parameters , State-Trait Anxiety Inventory ( STAI ) score , sedation score , and psychomotor function test results were measured , then patients were r and omly assigned to two groups : oral Passiflora incarnata Linneaus extract or placebo was given to the patients . Tests were repeated just before spinal anesthesia . Hemodynamics , sedation score , sensory-motor block and side effects were assessed during the operation . Psychomotor function tests were repeated at the end of the operation and 60 min after the operation . Results There was a statistically significant difference between the two groups for the increase in State Anxiety Inventory ( STAI-S ) score obtained just before spinal anesthesia when compared to the baseline . There was no statistically significant difference in psychomotor function from the baseline for either group . A significant difference was not found between the two groups in demographics , psychomotor function , sedation score , hemodynamics , and side effects . Conclusion Oral preoperative administration of Passiflora incarnata Linneaus suppresses the increase in anxiety before spinal anesthesia without changing psychomotor function test results , sedation level , or hemodynamics Background Despite being the most commonly used herbal for sleep disorders , chamomile 's ( Matricaria recutita ) efficacy and safety for treating chronic primary insomnia is unknown . We examined the preliminary efficacy and safety of chamomile for improving subjective sleep and daytime symptoms in patients with chronic insomnia . Methods We performed a r and omized , double-blind , placebo-controlled pilot trial in 34 patients aged 18 - 65 years with DSM-IV primary insomnia for ≥ 6-months . Patients were r and omized to 270 mg of chamomile twice daily or placebo for 28-days . The primary outcomes were sleep diary measures . Secondary outcomes included daytime symptoms , safety assessment s , and effect size of these measures . Results There were no significant differences between groups in changes in sleep diary measures , including total sleep time ( TST ) , sleep efficiency , sleep latency , wake after sleep onset ( WASO ) , sleep quality , and number of awakenings  . Chamomile did show modest advantage on daytime functioning , although these did not reach statistical significance . Effect sizes were generally small to moderate ( Cohen 's d ≤ 0.20 to < 0.60 ) with sleep latency , night time awakenings , and Fatigue Severity Scale ( FSS ) , having moderate effect sizes in favor of chamomile . However , TST demonstrated a moderate effect size in favor of placebo . There were no differences in adverse events reported by the chamomile group compared to placebo . Conclusion Chamomile could provide modest benefits of daytime functioning and mixed benefits on sleep diary measures relative to placebo in adults with chronic primary insomnia . However , further studies in select insomnia patients would be needed to investigate these conclusions .Trial Registration Clinical Trials.gov Identifier Scutellaria lateriflora , a traditional herbal remedy for stress and anxiety , was tested on human volunteers for its effects on mood . In a placebo-controlled , double-blind , crossover study , 43 healthy participants were r and omised to a sequence of three times daily S. lateriflora ( 350 mg ) or placebo , each over two weeks . In this relatively non-anxious population ( 81 % were mildly anxious or less , i.e. Beck Anxiety Inventory ( BAI ) scores ≤ 15 ) , there was no significant difference between skullcap and placebo with BAI ( p = 0.191 ) . However , there was a significant group effect ( p = 0.049 ) , suggesting a carryover effect of skullcap . For Total Mood Disturbance measured by the Profile of Mood States , there was a highly significant ( p = < 0.001 ) decrease from pre-test scores with skullcap but not placebo ( p = 0.072 ) . The limitations of carryover effect , generally low anxiety scores and differences in anxiety levels between groups at baseline ( p = 0.022 ) , may have reduced the chances of statistical significance in this study . However , as S. lateriflora significantly enhanced global mood without a reduction in energy or cognition , further study assessing its putative anxiolytic effects in notably anxious subjects with co-morbid depression is warranted Introduction The hop ( Humulus lupulus L. ) , a component of beer , is a sedative plant whose pharmacological activity is principally due to its bitter resins , in particular to the α-acid degradation product 2-methyl-3-buten-2-ol . The mechanism of action of hop resin consists of raising the levels of the neurotransmitter γ-aminobutyric acid ( GABA ) , an inhibitory neurotransmitter acting in the central nervous system ( CNS ) . Objectives To analyze the sedative effect of hops as a component of non-alcoholic beer on the sleep/wake rhythm in a work-stressed population . Methods The experiment was conducted with healthy female nurses ( n = 17 ) working rotating and /or night shifts .  Overnight sleep and chronobiological parameters were assessed by actigraphy ( Actiwatch ® ) after moderate ingestion of non-alcoholic beer containing hops ( 333 ml with 0,0 % alcohol ) 
    Output:
    
agent
Collectively , the literature reveals pre clinical and clinical evidence for various phytomedicines modulating GABA-pathways , with comparative anxiolytic effect to the current array of pharmaceuticals , along with good safety and tolerability profiles
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Background Generalised anxiety disorder ( GAD ) is a chronic and pervasive condition that generates high levels of psychological stress , and it is difficult to treat in the long term . Current pharmacotherapeutic options for GAD are in some cases only modestly effective , and may elicit undesirable side effects . Through targeted actions on the gamma-aminobutyric acid ( GABA ) pathway , the South Pacific medicinal plant kava ( Piper methysticum ) is a non-addictive , non-hypnotic anxiolytic with the potential to treat GAD . The evidence for the efficacy of kava for treating anxiety has been affirmed through clinical trials and meta-analyses . Recent research has also served to lessen safety concerns regarding the use of kava due to hepatotoxic risk , which is reflected in a recent German court overturning the previous kava ban in that country ( which may in turn influence a reinstatement by the European Union ) . The aim of current research is to assess the efficacy of an ‘ aqueous noble cultivar rootstock extract ’ of kava in GAD in a larger longer term study . In addition , we plan to investigate the pharmacogenomic influence of GABA transporters on response , effects of kava on gene expression , and for the first time , the neurobiological correlates of treatment response via functional and metabolic imaging . Methods / Design This clinical trial is funded by the Australian National Health and Medical Research Council ( APP1063383 ) and co-funded by MediHerb ( Integria Healthcare ( Australia ) Pty . Ltd ) . The study is a phase III , multi-site , two-arm , 18-week , r and omised , double-blind , placebo-controlled study using an aqueous extract of noble kava cultivar ( st and ardised to 240 mg of kavalactones per day ) versus matching placebo in 210 currently anxious participants with diagnosed GAD who are non-medicated . The study takes place at two sites : the Centre for Human Psychopharmacology ( Swinburne University of Technology ) , Hawthorn , Melbourne , Australia ; and the Academic Discipline of Psychiatry ( The University of Queensl and ) based at the Royal Brisbane and Women ’s Hospital , Herston , Brisbane , Australia . Written informed consent will be obtained from each participant prior to commencement in the study . The primary outcome is the Structured Interview Guide for the Hamilton Anxiety Rating Scale ( SIGH-A ) . The secondary outcomes involve a range of scales that assess affective disorder symptoms and quality of life outcomes , in addition to the study of mediating biomarkers of response ( assessed via genomics and neuroimaging ) . Discussion If this study demonstrates positive findings in support of the superiority of kava over placebo in the treatment of GAD , and also is shown to be safe , then this plant-medicine can be considered a ’ first-line ‘ therapy for GAD . Genomic and neuroimaging data may reveal clinical response patterns and provide more evidence of the neurobiological activity of the plant extract . Trial Registration Information Clinical Trials.gov : NCT02219880 Date : 13 August 2014 Background Anxiety symptoms are frequently observed in dental patients , whether they are undergoing simple or more invasive procedures such as surgery . This research aim ed to compare the effects of Passiflora incarnata and midazolam for the control of anxiety in patients undergoing m and ibular third molar extraction . Material and Methods Forty volunteers underwent bilateral extraction of their m and ibular third molars in a r and omized , controlled , double-blind , crossover clinical trial . Passiflora incarnata ( 260 mg ) or midazolam ( 15 mg ) were orally administered 30 minutes before surgery . The anxiety level of participants was evaluated by question naires and measurement of physical parameters  , including  heart rate ( HR ) , blood pressure ( BP ) , and oxygen saturation ( SpO2 ) . Results Considering each procedure independently , there were no significant differences between the protocol s in BP , HR , and SpO2 . Over 70 % of the volunteers responded that they felt quiet or a little anxious under both protocol s. With midazolam , 20 % of the participants reported amnesia ( not remembering anything at all ) , while Passiflora showed little or no ability to interfere with memory formation . Conclusions Passiflora incarnata showed an anxiolytic effect similar to midazolam , and was safe and effective for conscious sedation in adult patients who underwent extraction of their m and ibular third molars . Key words : Passiflora incarnata , midazolam , anxiety , oral surgery Chronic stress has been associated with a number of illnesses , including obesity . Ashwag and ha is a well-known adaptogen and known for reducing stress and anxiety in humans . The objective of this study was to evaluate the safety and efficacy of a st and ardized root extract of Ashwag and ha through a double-blind , r and omized , placebo-controlled trial . A total of 52 subjects under chronic stress received either Ashwag and ha ( 300 mg ) or placebo twice daily . Primary efficacy measures were Perceived Stress Scale and Food Cravings Question naire . Secondary efficacy measures were Oxford Happiness Question naire , Three-Factor Eating Question naire , serum cortisol , body weight , and body mass index . Each subject was assessed at the start and at 4 and 8 weeks . The treatment with Ashwag and ha result ed in significant improvements in primary and secondary measures . Also , the extract was found to be safe and tolerable . The outcome of this study suggests that Ashwag and ha root extract can be used for body weight management in adults under chronic stress Context : Stress is a state of mental or emotional strain or tension , which can lead to underperformance and adverse clinical conditions . Adaptogens are herbs that help in combating stress . Ayurvedic classical texts , animal studies and clinical studies describe Ashwag and ha as a safe and effective adaptogen . Aims : The aim of the study was to evaluate the safety and efficacy of a high-concentration full-spectrum extract of Ashwag and ha roots in reducing stress and anxiety and in improving the general well-being of adults who were under stress . Setting s and Design : Single center , prospect i ve , double-blind , r and omized , placebo-controlled trial . Material s and Methods : A total of 64 subjects with a history of chronic stress were enrolled into the study after performing relevant clinical examinations and laboratory tests . These included a measurement of serum cortisol , and assessing their scores on st and ard stress- assessment question naires . They were r and omized to either the placebo control group or the study drug treatment group , and were asked to take one capsule twice a day for a period of 60 days . In the study drug treatment group , each capsule contained 300 mg of high-concentration full-spectrum extract from the root of the Ashwag and ha plant . During the treatment period ( on Day 15 , Day 30 and Day 45 ) , a follow-up telephone call was made to all subjects to check for treatment compliance and to note any adverse reactions . Final safety and efficacy assessment s were done on Day 60 . Statistical Analysis : t-test , Mann-Whitney test . Results : The treatment group that was given the high-concentration full-spectrum Ashwag and ha root extract exhibited a significant reduction ( P<0.0001 ) in scores on all the stress- assessment scales on Day 60 , relative to the placebo group . The serum cortisol levels were substantially reduced ( P=0.0006 ) in the Ashwag and ha group , relative to the placebo group . The adverse effects were mild in nature and were comparable in both the groups . No serious adverse events were reported . Conclusion : The findings of this study suggest that a high-concentration full-spectrum Ashwag and ha root extract safely and effectively improves an individual 's resistance towards stress and thereby improves self-assessed quality of life Purpose Patients who undergo regional anesthesia experience anxiety in the preoperative period . Passiflora incarnata Linneaus is a plant that has traditionally been used as an anxiolytic and sedative . We aim ed to investigate the effect of preoperative oral administration of Passiflora incarnata Linneaus on anxiety , psychomotor functions , sedation , and hemodynamics in patients undergoing spinal anesthesia . Methods Under local ethics committee approval , 60 patients who were aged 25–55 years and ASAI – II and who were scheduled for spinal anesthesia were enrolled in this prospect i ve , r and omized , double-blind and placebo-controlled study . Thirty minutes before spinal anesthesia , baseline hemodynamic parameters , State-Trait Anxiety Inventory ( STAI ) score , sedation score , and psychomotor function test results were measured , then patients were r and omly assigned to two groups : oral Passiflora incarnata Linneaus extract or placebo was given to the patients . Tests were repeated just before spinal anesthesia . Hemodynamics , sedation score , sensory-motor block and side effects were assessed during the operation . Psychomotor function tests were repeated at the end of the operation and 60 min after the operation . Results There was a statistically significant difference between the two groups for the increase in State Anxiety Inventory ( STAI-S ) score obtained just before spinal anesthesia when compared to the baseline . There was no statistically significant difference in psychomotor function from the baseline for either group . A significant difference was not found between the two groups in demographics , psychomotor function , sedation score , hemodynamics , and side effects . Conclusion Oral preoperative administration of Passiflora incarnata Linneaus suppresses the increase in anxiety before spinal anesthesia without changing psychomotor function test results , sedation level , or hemodynamics Background Despite being the most commonly used herbal for sleep disorders , chamomile 's ( Matricaria recutita ) efficacy and safety for treating chronic primary insomnia is unknown . We examined the preliminary efficacy and safety of chamomile for improving subjective sleep and daytime symptoms in patients with chronic insomnia . Methods We performed a r and omized , double-blind , placebo-controlled pilot trial in 34 patients aged 18 - 65 years with DSM-IV primary insomnia for ≥ 6-months . Patients were r and omized to 270 mg of chamomile twice daily or placebo for 28-days . The primary outcomes were sleep diary measures . Secondary outcomes included daytime symptoms , safety assessment s , and effect size of these measures . Results There were no significant differences between groups in changes in sleep diary measures , including total sleep time ( TST ) , sleep efficiency , sleep latency , wake after sleep onset ( WASO ) , sleep quality , and number of awakenings  . Chamomile did show modest advantage on daytime functioning , although these did not reach statistical significance . Effect sizes were generally small to moderate ( Cohen 's d ≤ 0.20 to < 0.60 ) with sleep latency , night time awakenings , and Fatigue Severity Scale ( FSS ) , having moderate effect sizes in favor of chamomile . However , TST demonstrated a moderate effect size in favor of placebo . There were no differences in adverse events reported by the chamomile group compared to placebo . Conclusion Chamomile could provide modest benefits of daytime functioning and mixed benefits on sleep diary measures relative to placebo in adults with chronic primary insomnia . However , further studies in select insomnia patients would be needed to investigate these conclusions .Trial Registration Clinical Trials.gov Identifier Scutellaria lateriflora , a traditional herbal remedy for stress and anxiety , was tested on human volunteers for its effects on mood . In a placebo-controlled , double-blind , crossover study , 43 healthy participants were r and omised to a sequence of three times daily S. lateriflora ( 350 mg ) or placebo , each over two weeks . In this relatively non-anxious population ( 81 % were mildly anxious or less , i.e. Beck Anxiety Inventory ( BAI ) scores ≤ 15 ) , there was no significant difference between skullcap and placebo with BAI ( p = 0.191 ) . However , there was a significant group effect ( p = 0.049 ) , suggesting a carryover effect of skullcap . For Total Mood Disturbance measured by the Profile of Mood States , there was a highly significant ( p = < 0.001 ) decrease from pre-test scores with skullcap but not placebo ( p = 0.072 ) . The limitations of carryover effect , generally low anxiety scores and differences in anxiety levels between groups at baseline ( p = 0.022 ) , may have reduced the chances of statistical significance in this study . However , as S. lateriflora significantly enhanced global mood without a reduction in energy or cognition , further study assessing its putative anxiolytic effects in notably anxious subjects with co-morbid depression is warranted Introduction The hop ( Humulus lupulus L. ) , a component of beer , is a sedative plant whose pharmacological activity is principally due to its bitter resins , in particular to the α-acid degradation product 2-methyl-3-buten-2-ol . The mechanism of action of hop resin consists of raising the levels of the neurotransmitter γ-aminobutyric acid ( GABA ) , an inhibitory neurotransmitter acting in the central nervous system ( CNS ) . Objectives To analyze the sedative effect of hops as a component of non-alcoholic beer on the sleep/wake rhythm in a work-stressed population . Methods The experiment was conducted with healthy female nurses ( n = 17 ) working rotating and /or night shifts .  Overnight sleep and chronobiological parameters were assessed by actigraphy ( Actiwatch ® ) after moderate ingestion of non-alcoholic beer containing hops ( 333 ml with 0,0 % alcohol ) 
    Output:
    