REMfresh® Study (CRA-melatonin™) Advances Use of Melatonin for Sleep Complaints

MedicalResearch.com Interview with:
David C. Brodner, M.D.
Founder and Principle Physician, The Center for Sinus, Allergy, and Sleep Wellness
Double Board-Certified in Otolaryngology (Head and Neck Surgery) and Sleep Medicine
Assistant Clinical Professor, Florida Atlantic University College of Medicine
Medical Director, Good Samaritan Hospital Sleep Laboratory
Senior Medical Advisor, Physician’s Seal, LLC®

MedicalResearch.com: What is the background for this study?

Response: Melatonin is produced by the pineal gland in the brain and is the body’s natural sleep ingredient. Melatonin levels normally begin to rise in the mid-to late evening and remain high for the majority of the night. Levels begin to decline towards early morning, as the body’s wake cycle is triggered. Research shows that as people age, melatonin levels can drop by as much as 70 percent and their bodies may no longer produce enough melatonin to ensure adequate sleep.

Other available products, such as immediate-release melatonin, help initiate the onset of sleep but are usually unable to sustain prolonged sleep maintenance due to an immediate burst of melatonin, which is quickly degraded due to its relatively short half-life (60 minutes). Absorption in the lower digestive tract is limited by melatonin’s limited ability to be absorbed in a low acidity or neutral pH environment.

This post-marketing REMfresh® Patient Reported Outcomes DURation (REMDUR) study was designed to obtain real-world evidence about patients’ sleep patterns, duration of sleep before and after REMfresh® (CRA-melatonin), daily REMfresh® (CRA-melatonin) use, onset of action, sleep maintenance, quality of sleep, and overall satisfaction with REMfresh® (CRA-melatonin). Patients with sleep disturbances in the general population who received a sample of CRA-melatonin (REMfresh®) from their physicians were invited to complete a 12-question survey. Survey responses were received from 500 patients.

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Decreased DNA Repair Links Shift Work and Increased Cancer Risk

MedicalResearch.com Interview with:
Parveen Bhatti, PhD
Associate Member
Fred Hutchinson Cancer Research Center

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Evidence in humans for an association between shift work and cancer has been mixed. This may be due to difficulties in accurately assessing long-term exposures to shift work in studies of cancer risk. We took a different approach that circumvented these difficulties. Rather than look at cancer risk directly, we measured, among actively employed shift workers, a marker of DNA damage that has been linked to cancer.

When repaired by cellular machinery, this particular marker is excreted in urine where it can be measured. We found that, compared to sleeping at night during their night off, shift workers had lower urinary levels of the DNA damage marker during their night work. This effect appears to be driven by reductions in circulating melatonin levels among shift workers during night work relative to night sleep. Given that melatonin has been shown to enhance repair of DNA damage, our results suggest that, during night work, shift workers have reduced ability to repair DNA damage resulting in lower levels being excreted in their urine. Because of this, shift workers likely have higher levels of DNA damage remaining in their cells, which can lead to mutations and cause cancer.

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Continuous Release REMfresh® Mimics Natural Melatonin Release

MedicalResearch.com Interview with:

David C. Brodner, M.D</strong>. Founder and Principle Physician, The Center for Sinus, Allergy, and Sleep Wellness Double Board-Certified in Otolaryngology (Head and Neck Surgery) and Sleep Medicine Assistant Clinical Professor, Florida Atlantic University College of Medicine Medical Director, Good Samaritan Hospital Sleep Laboratory Senior Medical Advisor, Physician’s Seal, LLC®

Dr. Brodner

David C. Brodner, M.D.
Founder and Principle Physician, The Center for Sinus, Allergy, and Sleep Wellness
Double Board-Certified in Otolaryngology (Head and Neck Surgery) and Sleep Medicine
Assistant Clinical Professor
Florida Atlantic University College of Medicine
Medical Director, Good Samaritan Hospital Sleep Laboratory
Senior Medical Advisor, Physician’s Seal, LLC®

MedicalResearch.com: What is the background for this study?

Response: Chronic sleep and wakefulness disorders affect an estimated 50 to 70 million Americans, and long-term sleep deprivation has been associated with negative health consequences, including an increased risk of diabetes, hypertension, heart attack, stroke, obesity and depression.

Sleep/wake cycles are regulated by melatonin, levels of which normally begin to rise in the mid- to late evening and remain high for the majority of the night. Levels begin to decline towards early morning, as the body’s wake cycle in triggered. Melatonin levels typically decline with age, with a significant decrease after age 40.

And as people age, their bodies may no longer produce enough melatonin to ensure adequate sleep. In addition to difficulties falling asleep, sleep in older populations can include fragmented and sustained sleep problems. Melatonin supplementation has been shown to promote and maintain sleep in older populations.

In this study, we compared the pharmacokinetics (PK) profile of REMfresh®, a continuous release and absorption melatonin (CRA-melatonin), with that of a leading immediate-release melatonin (IR-melatonin) formulation.

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Melatonin May Improve Blood Pressure Control Through Circadian Rhythm Regulation

MedicalResearch.com Interview with:
Dr. Denis Gubin
The Tyumen Medical University
Tyumen, Russia

MedicalResearch.com: What is the background for this study? What are the main findings? 

Dr. Gubin: The older we get, the more likely our circadian rhythms are disrupted. For example, blood pressure, BP, not only tends to increase but as well become more irregular.

One of the possible causes is an age-dependent deficit of endogenous melatonin production. We have shown that exogenous melatonin helps to ameliorate both trends – lowers  blood pressure and also stabilizes and synchronizes blood pressure and heart rate variability.
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Could Melatonin Improve Both Sleep and Skin in Atopic Dermatitis?

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Prof. Chiang

MedicalResearch.com Interview with:
Prof. Bor-Luen Chiang
Vice Superintendent, National Taiwan University Hospital
Professor of Graduate Institute of Clinical Medicine and Pediatrics
National Taiwan University
Attending Physician, Department of Medical research
National Taiwan University Hospital and

Yung-Sen Chang, MD MPH
Attending physician, Department of Pediatrics,
Taipei City Hospital Renai Br.
Adjunct Attending Physician, Department of Pediatrics
National Taiwan University Children’s Hospital
Adjunct Instructor, School of Medicine, National Yang-Ming University

Medical Research: What is the background for this study?

Prof. Chang: Sleep disturbance is a common disorder in the children with atopic dermatitis (AD) (reported in 47 to 60%), but no effective way of managing this problem had been established. In our preceding study, we found that lower nocturnal melatonin level was significantly associated with sleep disturbance in the patients with AD. Melatonin is a hormone secreted by the pineal gland which plays an important role in sleep regulation. In addition to sleep-inducing effects, melatonin also has anti-inflammatory and immunomodulatory properties which might be helpful for the management o fatopic dermatitis. Furthermore, melatonin has an excellent safety profile with minimal adverse effects, making it a good choice for children. Therefore, we aimed to evaluate whether melatonin is effective for improving the sleep problems and the dermatitis severity in children with atopic dermatitis.

Medical Research: What are the main findings?

Prof. Chang: From our double-blind, placebo-controlled crossover study, we found that after melatonin treatment, the sleep onset latency shortened by 21.4 minutes compared with placebo (from a mean of 44.9 minutes to 21.6 minutes). The Scoring Atopic Dermatitis Index (higher scores representing more severe dermatitis) also decreased by 9.9 compared with placebo (from a mean of 49.1 to 40.2). No adverse events were reported throughout the study.

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Study Suggests Further Research of Melatonin To Decrease MS Relapses Warranted

MedicalResearch.com Interview with:
Dr.
Mauricio F. Farez
Center for Research on Neuroimmunological Diseases (CIEN)
Raúl Carrea Institute for Neurological Research (FLENI)
Buenos Aires, Argentina

Medical Research: What is the background for this study? What are the main findings?

Dr. Farez: We were intrigued by our initial observation that Multiple Sclerosis (MS) relapses have a clear seasonal occurrence with less relapses during fall and winter. We found that melatonin levels (a hormone secreted by the pineal gland in the absence of light) have an inverse correlation with Multiple Sclerosis relapses. Moreover, melatonin controls the generation of pathogenic Th17 cells, while it boosts the generation of regulatory Tr1 cells. By affecting the immune balance of those cells it may prevents the occurrence of relapse.

Medical Research: What should clinicians and patients take away from your report?

Dr. Farez: Melatonin and drugs alike targeting its pathways may be a future alternative in Multiple Sclerosis  treatment. Until a proper clinical trial is conducted, melatonin SHOULD NOT be used as Multiple Sclerosis therapy. I would like to emphasize this, because melatonin is a complex hormone with receptors present basically in every cell. We do not know yet the dosage and administration form needed to obtain similar effects as the one observed in our in vitro and animal studies.
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Melatonin Did Not Improve Fatigue in Cancer Patients

MedicalResearch.com Interview with:
Charlotte Lund Rasmussen

Research Unit, Department of Palliative Medicine
Bispebjerg Hospital, Copenhagen, Denmark

Medical Research: What is the background for this study? What are the main findings?

Response: We see that patients with advanced cancer often suffer from fatigue, pain, depression, insomnia and other symptoms, which can have a profound impact on quality of life. Melatonin is a neurohormone and its secretion is closely tied to the circadian rhythm making it a regulator of the sleep-cycle.

Studies have shown that cancer patients have lower levels of melatonin than healthy controls, which may contribute to their fatigue and lowered quality of life. Furthermore, previous studies have found a possible effect of melatonin in cancer therapy, and non-clinical trials have shown melatonin to inhibit cell division in tumors.

To our knowledge, no trials to date have investigated the effects of melatonin on fatigue. Given the role of melatonin in the sleep cycle, the lowered levels of melatonin noted among cancer patients, and results from previous studies, we wanted to investigate melatonin’s effect on fatigue among patients with advanced cancer.

The primary objective of our study was to determine whether oral melatonin administered at night would reduce physical fatigue in patients with advanced cancer who were being treated in a palliative care facility. The effect of melatonin on other cancer-related symptoms including mental fatigue, insomnia, pain, emotional function, loss of appetite, and overall QoL were also investigated.

In this trial we tested a dose of 20 mg of melatonin taken orally at night.

However, melatonin did not improve physical fatigue in patients with advanced cancer. Furthermore, we were unable to identify improvements in any other cancer-related symptoms.

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Melatonin Secretion and the Incidence of Type 2 Diabetes

 Dr. Ciaran McMullan MD from Channing Division of Network Medicine in Boston, a research division within the Department of Medicine at Brigham and Women’s Hospital, Boston MassMedicalResearch.com Interview with Dr. Ciaran McMullan MD
from Channing Division of Network Medicine in Boston, a research division within the Department of Medicine at Brigham and Women’s Hospital, Boston Mass

MedicalResearch.com: What are the main findings of the study?

Dr. McMullan: In this observational study performed in non-diabetic women we found that lower nocturnal melatonin secretion predicted future risk of developing type 2 diabetes. When we categorized the individuals by category of nocturnal melatonin secretion we found that those in the lowest category had twice the risk as those in the highest category of nocturnal melatonin secretion. This association remained even after adjusting for other well established risk factors for development of diabetes including body mass index, physical activity, dietary factors, family history of diabetes, smoking and hypertension. This increased risk translates into the lower melatonin secretion group having an additional 5 cases of incident diabetes per 1000 person years than the high melatonin secretion group.
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