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Article ; Online: Kalium phosphoricum comp. in patients with neurasthenia: a randomized, double-blind, placebo-controlled clinical trial.

Hellhammer, Juliane / Spitznagel-Schminke, Luitgard / Hufnagel, Rebecca

2024 Volume 40, Issue 2, Page(s) 239–251

Abstract: Objective: This Phase IV placebo-controlled clinical trial was designed to demonstrate the efficacy and safety of the product Neurodoron (Kalium phosporicum comp., KPC) in patients with neurasthenia.: Methods: This monocenter, randomized, double- ... ...

Abstract	Objective: This Phase IV placebo-controlled clinical trial was designed to demonstrate the efficacy and safety of the product Neurodoron (Kalium phosporicum comp., KPC) in patients with neurasthenia. Methods: This monocenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial (registration number: DRKS00003261) was conducted in an outpatient German trial site. Women and men aged 18 and above were randomized to receive either KPC or placebo if they reported typical symptoms of neurasthenia and a severe psychiatric disorder could be excluded. The primary objectives were a reduction in characteristic symptoms of nervous exhaustion and perceived stress as well as improvement in general health status after 6 weeks of treatment. Results: In total, 204 patients underwent screening, 78 were randomized in each treatment group, and 77 patients each received treatment (intention-to-treat (ITT) population = 154 patients). For none of the primary efficacy variables, an advantage in favor of KPC could be demonstrated in the pre-specified analysis ( Conclusions: Trial treatment was well tolerated with only a few and minor AEs reported, confirming the markedly good safety of KPC. A significant improvement of neurasthenia was seen for the total study population at the end of the treatment period. Superiority of KPC vs. placebo could not be demonstrated with the pre-specified analysis with regards to a sum score of 12 typical symptoms, perceived stress, or general health status. However, the explorative post-hoc analysis revealed that KPC is superior to placebo in the characteristic symptoms irritability and nervousness. KPC could therefore be a beneficial treatment option for symptomatic relief of neurasthenia.
MeSH term(s)	Adult ; Female ; Humans ; Male ; Double-Blind Method ; Neurasthenia ; Treatment Outcome
Language	English
Publishing date	2024-01-24
Publishing country	England
Document type	Clinical Trial, Phase IV ; Journal Article ; Randomized Controlled Trial
ZDB-ID	80296-7
ISSN	1473-4877 ; 0300-7995
ISSN (online)	1473-4877
ISSN	0300-7995
DOI	10.1080/03007995.2023.2291169
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Zs.A 955: Show issues

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Article ; Online: Efficacy of a fish hydrolysate supplement on sleep quality: A randomized, double-blind, placebo-controlled, crossover clinical trial.

Eckert, Franziska / Meyer, Nadin / Monzel, Elena / Bouvret, Elodie / Chataigner, Mathilde / Hellhammer, Juliane

Clinical nutrition ESPEN

2024 Volume 60, Page(s) 48–58

Abstract: Background & aims: Sleep disturbances are widespread in modern societies and linked to a variety of diseases, creating an urgent need for the development of products that help combat sleep difficulties. One suitable nutritional supplement may be a fish ... ...

Abstract	Background & aims: Sleep disturbances are widespread in modern societies and linked to a variety of diseases, creating an urgent need for the development of products that help combat sleep difficulties. One suitable nutritional supplement may be a fish hydrolysate composed of low molecular weight peptides. Methods: This two-arm, double-blind, randomized, placebo-controlled crossover study investigated the effect of a 4-week fish hydrolysate intervention on sleep in a healthy German population reporting poor sleep quality, assessed with the Pittsburgh Sleep Quality Index (PSQI). Further sleep parameters were measured using an online diary and a wrist wearable device. Additionally, questionnaires related to stress, anxiety, depression, and well-being were evaluated and salivary cortisol and product satisfaction were assessed. Results: The 4-week fish hydrolysate supplementation significantly improved subjective sleep quality measured with the PSQI-score (p = .002). Moreover, individuals reported improvements in sleep efficacy and a reduction in sleep disturbances and daytime sleepiness during fish hydrolysate intake (p = .013, p = .046, p = .004 respectively), but not during placebo phase (all p > .05). No significant intra-individual differences were found between fish hydrolysate and placebo supplementation (p > .05). Conclusions: Although no significant intra-individual differences were found between fish hydrolysate and placebo supplementation, the significant improvement in subjective sleep quality from baseline to treatment phase suggests that fish hydrolysate is a safe nutritional supplement to support individuals with self-reported sleep problems. Clinical trial registration: The study is registered at ClinicalTrials.gov with the Identifier NCT04983355.
MeSH term(s)	Humans ; Sleep Quality ; Cross-Over Studies ; Treatment Outcome ; Sleep ; Sleep Initiation and Maintenance Disorders ; Dietary Supplements
Language	English
Publishing date	2024-01-13
Publishing country	England
Document type	Randomized Controlled Trial ; Journal Article ; Research Support, Non-U.S. Gov't
ISSN	2405-4577
ISSN (online)	2405-4577
DOI	10.1016/j.clnesp.2024.01.002
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Article: Neurodoron® for Stress Impairments: A Prospective, Multicenter Non-Interventional Trial.

Hellhammer, Juliane / Schmidt, Katja / Semaca, Cristina / Hufnagel, Rebecca

Evidence-based complementary and alternative medicine : eCAM

2022 Volume 2022, Page(s) 2626645

Abstract: Introduction: Stress is associated with a multitude of physical and psychological health impairments. To tackle these health disorders, over-the-counter (OTC) products like Neurodoron® are popular since they are considered safe and tolerable. Experience ...

Abstract	Introduction: Stress is associated with a multitude of physical and psychological health impairments. To tackle these health disorders, over-the-counter (OTC) products like Neurodoron® are popular since they are considered safe and tolerable. Experience reports and first studies indicate that Neurodoron® is efficient in the treatment of stress-associated health symptoms. To confirm this, a non-interventional study (NIS) with pharmacies was conducted. Methods: The NIS was planned to enroll female and male patients who suffered from nervous exhaustion with symptoms caused by acute and/or chronic stress. The main outcome measures were characteristic stress symptoms, stress burden, and perceived stress. Further outcome measures included perceived efficacy and tolerability of the product as assessed by the patients and collection of adverse drug reactions (ADRs). A study duration of about 21 days with a recommended daily dose of 3-4 tablets was set. Results: 279 patients were enrolled at 74 German pharmacies. The analyzed set (AS) included 272 patients (mean age 44.8 ± 14.4 years, 73.9% female). 175 patients of the AS completed the NIS. During the study, all stress symptoms declined significantly (total score 18.1 vs. 12.1 (of max. 39 points),
Language	English
Publishing date	2022-02-25
Publishing country	United States
Document type	Journal Article
ZDB-ID	2171158-6
ISSN	1741-4288 ; 1741-427X
ISSN (online)	1741-4288
ISSN	1741-427X
DOI	10.1155/2022/2626645
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Article: Lacticaseibacillus paracasei

Patterson, Elaine / Griffin, Síle M / Ibarra, Alvin / Ellsiepen, Emilia / Hellhammer, Juliane

Neurobiology of stress

2020 Volume 13, Page(s) 100277

Abstract: Chronic stress is a risk-factor for the development of mood and stress-related disorders. Clinical evidence indicates that probiotics can influence the stress response and mood. The Sisu study investigated ... ...

Abstract	Chronic stress is a risk-factor for the development of mood and stress-related disorders. Clinical evidence indicates that probiotics can influence the stress response and mood. The Sisu study investigated whether
Language	English
Publishing date	2020-11-24
Publishing country	United States
Document type	Journal Article
ZDB-ID	2816500-7
ISSN	2352-2895
ISSN	2352-2895
DOI	10.1016/j.ynstr.2020.100277
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Article ; Online: Effects of a homeopathic combination remedy on the acute stress response, well-being, and sleep: a double-blind, randomized clinical trial.

Hellhammer, Juliane / Schubert, Melanie

Journal of alternative and complementary medicine (New York, N.Y.)

2013 Volume 19, Issue 2, Page(s) 161–169

Abstract: Objectives: Stress impacts on health, causing stress-related illness. The aim of this study was to investigate stress dampening effects of the homeopathic combination remedy dysto-loges(®) S on physiological and psychological measures during acute ... ...

Abstract	Objectives: Stress impacts on health, causing stress-related illness. The aim of this study was to investigate stress dampening effects of the homeopathic combination remedy dysto-loges(®) S on physiological and psychological measures during acute stress. Additionally, effects of the substance on sleep and life quality were investigated. Design: This randomized, double-blind, placebo-controlled single center study had a total duration of 15 days for each participant. Setting/location: The study was performed by Daacro, Trier, Germany. Subjects: We included 40 women aged 30-50 years that regularly experienced impaired well-being when feeling stressed. Intervention: Participants took three tablets daily for 14 days. On the final study day, participants took three pills in the morning and upon arrival at the study site. Thereafter, the Trier Social Stress Test (TSST) was performed. Outcome measures: Primary endpoints were saliva cortisol responses to the stress test. Secondary biological endpoints were plasma cortisol, adrenocorticotrophic hormone, epinephrine, and norepinephrine (NE) and heart rates. Psychological secondary endpoints were well-being, anxiety, stress, and insecurity during the stress test as well as sleep and quality of life. Results: Stress-induced cortisol levels did not differ between groups, but verum-treated participants were characterized by lower NE levels. Two weeks of treatment with the homeopathic substance resulted in a better sleep quality. Sleep improvement was associated with a higher hormonal response to the TSST in both groups. In addition, individuals with impaired sleep in the placebo group had higher unstimulated NE levels. Conclusions: This study provides preliminary evidence for beneficial effects of dysto-loges S on sleep quality. Improvement of sleep quality was positively associated with a normalized neuroendocrine stress response during acute stress, whereas an altered hormonal response was observed in participants with impaired sleep. We hypothesize that the test product may possibly reduce NE release.
MeSH term(s)	Acute Disease ; Adrenocorticotropic Hormone/blood ; Adult ; Double-Blind Method ; Female ; Health Status ; Homeopathy ; Humans ; Hydrocortisone/blood ; Hydrocortisone/metabolism ; Materia Medica/therapeutic use ; Norepinephrine/blood ; Saliva/metabolism ; Sleep/drug effects ; Sleep Wake Disorders/drug therapy ; Sleep Wake Disorders/metabolism ; Stress, Psychological/blood ; Stress, Psychological/drug therapy ; Stress, Psychological/metabolism
Chemical Substances	Materia Medica ; Adrenocorticotropic Hormone (9002-60-2) ; Hydrocortisone (WI4X0X7BPJ) ; Norepinephrine (X4W3ENH1CV)
Language	English
Publishing date	2013-02
Publishing country	United States
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ZDB-ID	1237383-7
ISSN	1557-7708 ; 1075-5535
ISSN (online)	1557-7708
ISSN	1075-5535
DOI	10.1089/acm.2010.0636
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Zs.A 4366: Show issues

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Book: Stress

Hellhammer, Dirk / Hellhammer, Juliane

the brain-body connection

(Key issues in mental health, ; v. 174)

2008

Author's details	volume editors, Dirk H. Hellhammer, Juliane Hellhammer
Series title	Key issues in mental health, ; v. 174
MeSH term(s)	Stress, Psychological/physiopathology ; Neurobehavioral Manifestations ; Psychophysiology/methods ; Sympathetic Nervous System/physiopathology
Language	English
Size	viii, 108 p. :, ill.
Publisher	Karger
Publishing place	Basel ; New York
Document type	Book
ISBN	9783805582957 ; 3805582951
Database	Catalogue of the US National Library of Medicine (NLM)

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Article ; Online: The physiological response to Trier Social Stress Test relates to subjective measures of stress during but not before or after the test.

Hellhammer, Juliane / Schubert, Melanie

Psychoneuroendocrinology

2012 Volume 37, Issue 1, Page(s) 119–124

Abstract: The Trier Social Stress Test (TSST) is an effective psychosocial laboratory protocol for inducing stress in humans and has been used in numerous research studies. The stressor leads to a physiological response of the hypothalamus-pituitary-adrenal axis ( ... ...

Abstract	The Trier Social Stress Test (TSST) is an effective psychosocial laboratory protocol for inducing stress in humans and has been used in numerous research studies. The stressor leads to a physiological response of the hypothalamus-pituitary-adrenal axis (HPAA) and the autonomous nervous system (ANS). Common biomarkers are cortisol levels and heart rate. In addition to the physiological stress response, the TSST also triggers a psychological response such as an increase in perceived stress, anxiety and emotional insecurity. Whereas HPA and ANS measures can easily be obtained for the TSST period itself, psychological measures are usually determined prior to (baseline) and after the TSST. This may exclude information of the stressful event itself. In the present study, we assessed perceived stress, anxiety and emotional insecurity before, during and after the TSST using visual analogue scales. In addition, cortisol levels and heart rates were assessed. Data of 260 healthy non-smoking males aged 16-60 yrs were used for analyses. Our results show that stress perception, anxiety and emotional insecurity were significantly higher during the TSST as compared to post-TSST ratings. Furthermore, our results suggest a covariance of the psychological stress response during the TSST and the physiological stress responses (cortisol and heart rate) for stress perception though the explained variance was small. This observation was not found for pre- and post-TSST ratings suggesting that assessing psychological stress measures during the stressor itself present a more informative measure of the stress response.
MeSH term(s)	Adolescent ; Adult ; Anxiety/psychology ; Biomarkers/blood ; Emotions/physiology ; Heart Rate/physiology ; Humans ; Hydrocortisone/blood ; Male ; Middle Aged ; Psychological Tests/statistics & numerical data ; Self Concept ; Stress, Psychological/blood ; Stress, Psychological/physiopathology ; Stress, Psychological/psychology ; Time Factors
Chemical Substances	Biomarkers ; Hydrocortisone (WI4X0X7BPJ)
Language	English
Publishing date	2012-01
Publishing country	England
Document type	Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	197636-9
ISSN	1873-3360 ; 0306-4530
ISSN (online)	1873-3360
ISSN	0306-4530
DOI	10.1016/j.psyneuen.2011.05.012
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Zs.A 1235: Show issues

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Article ; Online: A lecithin phosphatidylserine and phosphatidic acid complex (PAS) reduces symptoms of the premenstrual syndrome (PMS): Results of a randomized, placebo-controlled, double-blind clinical trial.

Schmidt, Katja / Weber, Nicole / Steiner, Meir / Meyer, Nadin / Dubberke, Anne / Rutenberg, David / Hellhammer, Juliane

Clinical nutrition ESPEN

2018 Volume 24, Page(s) 22–30

Abstract: Background & aims: Many women experience emotional and physical symptoms around the time of ovulation and more so before menstruation interfering with their daily normal life also known as premenstrual syndrome (PMS). Recent observational data suggest ... ...

Abstract	Background & aims: Many women experience emotional and physical symptoms around the time of ovulation and more so before menstruation interfering with their daily normal life also known as premenstrual syndrome (PMS). Recent observational data suggest that supplementation with Lipogen's phosphatidylserine (PS) and phosphatidic acid (PA) complex (PAS) alleviates these PMS symptoms. The aim of this study was to confirm these observations on the effects of PAS on PMS symptom severity within a controlled clinical trial setting. Methods: Forty women aged 18-45 years with a diagnosis of PMS were assigned to either take PAS (containing 400 mg PS & 400 mg PA per day) or a matching placebo. The study comprised 5 on-site visits including 1 baseline menstrual cycle followed by 3 treatment cycles. Treatment intake was controlled for by using an electronic device, the Medication Event Monitoring System (MEMS Results: PMS symptoms as assessed by the DRSP Total score showed a significantly better improvement (p = 0.001) over a 3 cycles PAS intake as compared to placebo. In addition, PAS treated women reported a greater improvement in physical (p = 0.002) and depressive symptoms (p = 0.068). They also reported a lower reduction of productivity (p = 0.052) and a stronger decrease in interference with relationships with others (p = 0.099) compared to the placebo group. No other DRSP scale or item showed significant results. Likewise, the reduction in the number of subjects fulfilling PMS or premenstrual dysphoric disorder (PMDD) criteria as classified by the SIPS did not differ between the PAS and the placebo group. For the biomarkers, the salivary cortisol percentage increase of the CAR was significantly less pronounced in the follicular phase of cycle 4 than in the follicular phase of cycle 1 for subjects taking PAS when compared to subjects taking placebo (p = 0.018). Furthermore, the change of serum cortisol levels between visit 1 and visit 5 differed significantly between groups (p = 0.043). While serum cortisol levels of PAS treated females slightly decreased between visit 1 and visit 5, cortisol levels of females treated with placebo increased. For all other biomarkers, no treatment effects were observed over the 4 cycles study period. Overall, this study confirms that a daily intake of PAS, containing 400 mg PS and 400 mg PA, can be considered as safe. Conclusions: Results substantiate the efficacy of PAS in reducing symptoms of PMS. In view of the recent inclusion of severe PMS symptoms (PMDD) in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5), the positive results of this clinical study merits consideration of developing the PAS complex as a botanical drug for treatment of PMDD. Clinical trial registration: The study is registered at Deutsches Register Klinischer Studien with the registration number DRKS00009005.
MeSH term(s)	Adult ; Double-Blind Method ; Female ; Humans ; Lecithins/pharmacology ; Lecithins/therapeutic use ; Phosphatidic Acids/pharmacology ; Phosphatidic Acids/therapeutic use ; Phosphatidylserines/pharmacology ; Phosphatidylserines/therapeutic use ; Premenstrual Syndrome/drug therapy ; Premenstrual Syndrome/physiopathology ; Premenstrual Syndrome/psychology ; Surveys and Questionnaires ; Treatment Outcome ; Young Adult
Chemical Substances	Lecithins ; Phosphatidic Acids ; Phosphatidylserines
Language	English
Publishing date	2018-02-09
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
ISSN	2405-4577
ISSN (online)	2405-4577
DOI	10.1016/j.clnesp.2018.01.067
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Article ; Online: A soy-based phosphatidylserine/ phosphatidic acid complex (PAS) normalizes the stress reactivity of hypothalamus-pituitary-adrenal-axis in chronically stressed male subjects: a randomized, placebo-controlled study.

Hellhammer, Juliane / Vogt, Dominic / Franz, Nadin / Freitas, Ulla / Rutenberg, David

Lipids in health and disease

2014 Volume 13, Page(s) 121

MeSH term(s)	Administration, Oral ; Adrenocorticotropic Hormone/blood ; Adult ; Dietary Supplements ; Humans ; Hydrocortisone/blood ; Hypothalamo-Hypophyseal System/drug effects ; Hypothalamo-Hypophyseal System/metabolism ; Male ; Middle Aged ; Phosphatidic Acids/administration & dosage ; Phosphatidylserines/administration & dosage ; Pituitary-Adrenal System/drug effects ; Pituitary-Adrenal System/metabolism ; Plant Extracts/administration & dosage ; Glycine max/chemistry ; Stress, Psychological/blood ; Stress, Psychological/drug therapy ; Young Adult
Chemical Substances	Phosphatidic Acids ; Phosphatidylserines ; Plant Extracts ; Adrenocorticotropic Hormone (9002-60-2) ; Hydrocortisone (WI4X0X7BPJ)
Language	English
Publishing date	2014-07-31
Publishing country	England
Document type	Journal Article ; Randomized Controlled Trial
ZDB-ID	2091381-3
ISSN	1476-511X ; 1476-511X
ISSN (online)	1476-511X
ISSN	1476-511X
DOI	10.1186/1476-511X-13-121
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Article: Neuropattern

Hellhammer, Dirk / Hellhammer, Juliane

Auf dem Weg zu einer translationalen Verhaltensmedizin

(In: Siegl, Judith; Schmelzer, Dieter; Mackinger, Herbert (Ed.), Horizonte der Klinischen Psychologie und Psychotherapie. Festschrift für Hans Reinecker (S. 112-117). Lengerich: Pabst)

2012

Abstract: Es wird informiert über die Entwicklung von "Neuropattern", einem Diagnosesystem für (niedergelassene) Ärzte, die Patienten mit stressbezogenen Gesundheitsstörungen behandeln. Einleitend wird auf die Notwendigkeit einer frühen Diagnose und Behandlung ... ...

Title translation	Neuropatterns: On the way to a translational behavioral medicine
Series title	In: Siegl, Judith; Schmelzer, Dieter; Mackinger, Herbert (Ed.), Horizonte der Klinischen Psychologie und Psychotherapie. Festschrift für Hans Reinecker (S. 112-117). Lengerich: Pabst
Abstract	Es wird informiert über die Entwicklung von "Neuropattern", einem Diagnosesystem für (niedergelassene) Ärzte, die Patienten mit stressbezogenen Gesundheitsstörungen behandeln. Einleitend wird auf die Notwendigkeit einer frühen Diagnose und Behandlung solcher Störungen hingewiesen. Dann wird das grundsätzliche diagnostische Dilemma besprochen, dass objektive Stressreaktionen und subjektive Stressbelastung nicht miteinander zusammenhängen (müssen). Deshalb müssten psychologische und physiologische Stresseffekte gemessen werden. Ein wesentliches Ziel einer "translationalen und personalisierten" Verhaltensmedizin wird darin gesehen, dem Arzt und Patienten die Möglichkeit zu bieten, über eine geeignete Diagnostik ein psychobiologisches Krankheitsmodell zu bekommen, aus dem sich Therapieindikationen ableiten lassen. Neuropattern, mit dessen Entwicklung vor zehn Jahren begonnen wurde, fokussiert den Aktivitäts- und Reaktivitätsstatus von endokrinen und autonomen Schnittstellen, welche an der Kommunikation zwischen Gehirn und Körperorganen unter Stressbedingungen beteiligt sind. Die erste Version von Neuropattern wurde an über 2200 Patienten und Probanden erprobt. Die zweite evaluierte Version wird derzeit in einer Reihe evidenzbasierter Studien an stationären und ambulanten Patienten getestet. Eine erste abgeschlossene randomisierte Untersuchung in einer Fachklinik zeigte bereits, dass die behandelnden Ärzte ihren Therapieerfolg bei Patienten mit Depression, Angststörungen und somatoformen Erkrankungen beträchtlich steigern können. Neuropattern wird als ein erster Schritt in eine konzeptuell orientierte translationale Verhaltensmedizin angesehen.
Keywords	Behavioral Medicine ; Diagnosis ; Diagnostik ; Physiological Correlates ; Physiological Stress ; Physiologische Korrelate ; Physiologischer Stress ; Psychischer Stress ; Psychological Stress ; Psychophysiologie ; Psychophysiology ; Stress ; Stress Reactions ; Stressreaktionen ; Verhaltensmedizin
Language	German
Document type	Article
Database	PSYNDEX

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