Herbal and Dietary supplement Report

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Queens University *

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100

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Medicine

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Dec 6, 2023

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The Natural Health Products (NHP) Regulations govern all natural health products in Canada (Canada, 2023). The NHP regulations offer a distinct regulatory framework appropriate for the low-risk manner of NHP products (Canada, 2023). NHP products include all herbal remedies, vitamins and minerals, homeopathic medicines and traditional medicines(Government of Canada 2023). The regulatory framework of NHP differs from prescription drugs given the decreased risk associated with NHP (Canada, 2023). Although severely decreased compared to prescription drugs NHPs still carry some risk and are used by Canadians to care for their families which is why regulations are crucial (Canada, 2023). Regulations ensure the safety and superior quality of products. Regulations also ensure that companies that manufacture, package, label or import NHPs hold valid product and site licenses and adhere to good manufacturing practices (Canada, 20203). Although the regulations are regulated separately from pharmaceutical drugs, Health Canada still oversees all of the regulations allowing the marketing and sales of all NHP products sold in the country. (Canada,2023). Before January 2004 their NHP did not have their classification so, products were sold and distributed as either drugs or food under the Food and Drug Act (Government of Canada, 2023). The new regulations came into action as they gained popularity and it became apparent that classification as a food would be inaccurate due to their therapeutic uses. They became classified as a subset of drugs due to their unique nature (Government of Canada, 2023). It took 6 years for the Natural Health Products Regulation to be implemented. All natural health products must be approved by the Natural Health Products Regulation before they can be manufactured, packaged or distributed. More than 2000 locations have been granted licenses to produce NHPs, and over 70,000 products have been approved for sale under the NHP Regulations (Smith et al., 2014). Benefits of this regulatory framework include increased government efficiency, industry transparency, support for innovations and improved government market interaction in Canada (Smith et al., 2014). In conclusion, although herbal and dietary supplements carry a reduced risk, Canadian regulations are implemented to guarantee the quality and safety of these Products. Health Canada oversees NHP regulations which offer a specific framework to adhere to the unique nature of natural health products which include herbal remedies, vitamins and minerals, Homeopathic medication and Traditional medicines (Government of Canada, 2023).

Melatonin is a neurohormone that mediates circadian rhythm used in the treatment and prevention of sleep-related disorders including insomnia and circadian rhythm sleep disorder (Erland & Saxena, 2017). Roughly 60 million American adults suffer from sleep-related disorders making it a popular and readily available dietary supplement for treating sleep-related issues like jet lag and difficulty falling asleep (Colten & Altevogt, 2006). Melatonin can be sourced from both natural and synthetic sources (Erland & Saxena, 2017). Melatonin can be found naturally in medical plants and is also produced artificially for use in supplements (Erland & Saxena, 2017). The hormone is the purported active ingredient in melatonin supplements (Colten & Altevogt, 2006). Melatonin is a hormone naturally produced by the pineal gland in the brain which is secreted at night to regulate sleep and wake cycles (Colten & Altevogt, 2006). Once secreted by the pineal gland, melatonin binds to the hormonal receptors throughout the body including the body's internal clock M1 and M2 G-protein receptors causing an inhibitory effect(Gobi & Comai, 2019). Study 1: Efficacy of melatonin with behavioral sleep-wake scheduling for delayed sleep-wake phase disorder: A double-blind, randomized clinical trial Sletten et al. conducted a double-blind, randomized clinical trial for the study. The goal is to investigate the efficacy of melatonin combined with behavioral sleep-wake scheduling for delayed sleep- wake phase disorder (DSWPD). Participants were randomly divided into a melatonin group or a placebo group and the study assessed sleep outcomes using actigraphy and self-reported sleep diaries. Sletten et al. found that in comparison to the placebo, the combination of melatonin and behavioral sleep-wake scheduling significantly increased sleep efficacy and reduced sleep onset latency. The results indicated that melatonin, when used in conjunction with behavioral interventions can be effective in treating DWSPD. The study found that melatonin is a useful treatment for DSWPD when combined with behavioral interventions. The findings support the use of melatonin in managing circadian rhythm sleep disorders, particularly when combined with behavioral strategies. The reliability of the findings is enhanced by the studies of randomized, double-blind design and objective measurements of sleep outcomes using sleep diaries. The study provides valuable insight into the efficacy of melatonin in treating DSWPD. Because the study only focused on one specific sleep disorder limits the generalizability of the findings to the effectiveness of melatonin on other sleep-related disorders. Additionally, the study did not investigate the long-term effects of melatonin treatment.

Study 2: Efficacy and hypnotic effects of melatonin in shift-work nurses: double-blind, placebo-controlled crossover trial To evaluate the effectiveness and hypnotic effects of melatonin in shift-work nurses, Sadeghniiat- Haghighi et al. conducted a double-blind, placebo-controlled crossover trial. The study involved administering melatonin or a placebo drug to shift-work nurses and evaluating its impact on sleep quality and daytime function over time. Although melatonin did not significantly improve sleep quality parameters, it did extend sleep length after night shifts for the nurses. The results suggest that melatonin may have limited efficacy in improving overall sleep quality and daytime function in shift-work nurses. The study concluded that while melatonin may lengthen sleep following night shifts, it had minimal effect on various sleep quality parameters and daytime function in shift work nurses. The findings highlight the necessity for further research into the effects of melatonin on shift workers. The study's placebo design and focus on shift-work nurses provide valuable information about the specific effects of melatonin in a relevant population. The findings of the study were limited to a specific group of shift-work nurses, which affects the generalizability of results on other shift workers or individuals with varying sleep patterns. Study 3: Efficacy of Dietary Supplements on Sleep Quality and Daytime Function of Shift Workers: A Systematic Review and Meta-Analysis Wu et al. completed a systematic review and meta-analysis aimed at evaluating the efficacy of melatonin on the sleep and daytime function of shift workers. The study synthesized findings from various research articles to provide an overview of the effects. The review suggested that melatonin may improve sleep lengths after night shift workers. The evidence supporting its effectiveness on sleep quality and daytime function in shift workers is inconclusive. The study highlighted the absence of high-quality evidence and the need for further research in order to provide more conclusive evidence on the topic. The systematic review and meta-analysis approach provided a comprehensive overview of the existing literature on the efficacy of melatonin for shift workers. Some limitations of the review are the lack of high-quality evidence and the variability of the findings. Lack of evidence leads to difficulty in concluding the matter. Study 1: Prolonged-Release Melatonin for Insomnia - an Open-Label Long-Term Study of Efficacy, Safety, and Withdrawal.

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The study by Lemoine et al. Employed an open-label design to evaluate the long-term effects of prolonged-release melatonin for insomnia. Participants received prolonged-release melatonin and were assessed for safety and withdrawal effects over time. The study found that prolonged-release melatonin improved sleep parameters with favourable safety profiles. Participants experience improvements in sleep durations and with minimal withdrawal symptoms after cessation. The long-term design provided valuable insights into the efficacy and safety of prolonged-release melatonin for insomnia. The open-label design increases the probability of bias and the lack of a control group makes it difficult to compare the outcomes and safety of prolonged-release melatonin. Study 2: Is Melatonin the 'Next Vitamin D'?: A Review of Emerging Science, Clinical Uses, Safety, and Dietary Supplements The study by Minch et al. used a systematic review to summarize scientific evidence, clinical applications and safety considerations of melatonin. The review provided a wide range of articles to provide an overview of the topic. The review addresses the safety concerns about melatonin highlighting the need for further research to fully understand the safety profile. The review concluded that melatonin is a promising neurohormone, although it requires additional research to evaluate the safety of melatonin in the context of dietary supplements. The review's comprehensive approach provided a thorough examination of the safety considerations of melatonin. The review's reliance on existing literature introduces limitations related to the quality of the reviewed studies. Study 3: Chronic Administration of Melatonin: Physiological and Clinical Considerations Givler et al. examined the safety of chronic melatonin administration, particularly at low to moderate dosages. The study also looked at melatonin's potential benefits for certain patient populations. The findings indicated that melatonin at low to moderate dosages ( 5-6 mg or less daily) appears safe. Certain patient populations, such as individuals with autism, appear to benefit from long term. Further research is needed into the long-term effects of exogenous melatonin to draw a definitive conclusion. The study provides valuable insights into the safety and efficacy of melatonin supplements using reliable systematic methods. The study outlines the insufficient research into the long-term effects of melatonin supplements, emphasizing the need for additional investigation to ensure safety. In conclusion, the use of melatonin as a dietary supplement for sleep-related disorders is a topic that has been explored in several studies, ever more research is crucial to fully determine the efficacy and

safety of melatonin. The evidence from the provided research studies provides conflicting evidence on the efficacy of melatonin in treating sleep-related disorders. Most studies outline some benefits to the use of melatonin, and some studies draw attention to the limitations and the crucial need for further research on the matter. The Canadian NHP regulation provides a great regulatory structure guaranteeing the safety and quality of melatonin and all other supplements approved by Health Canada. However the evidence available emphasizes the necessity to conduct more studies to thoroughly evaluate the effectiveness and long-term safety effects of melatonin, particularly in diverse populations and sleep disorders. I would advocate against the use of melatonin for sleep disorders. Despite the Health Canada regulations outlining guaranteeing the safety of the supplement, more evidence and research are needed before we can draw a definitive conclusion on the long-term effects of chronic melatonin use. References Canada, H. (2020, July 30). Government of Canada . Canada.ca. https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-

prescription/frequently-asked-questions/general-questions-regulation.html Canada, H. (2023, October 25). Government of Canada . Canada.ca. https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non- prescription/regulation.html Colten, H. R.; Altevogt, B. M. Sleep Disorders and Sleep Deprivation : An Unmet Public Health Problem ; National Academies Press: Washington, DC, 2006. Erland, L. A. E., & Saxena, P. K. (2017). Melatonin Natural Health Products and supplements: Presence of serotonin and significant variability of melatonin content. Journal of Clinical Sleep Medicine , 13 (02), 275–281. https://doi.org/10.5664/jcsm.6462 Gobbi, G.; Comai, S. Differential Function of Melatonin MT 1 and MT 2 Receptors in REM and NREM Sleep. Frontiers in endocrinology (Lausanne) 2019, 10 , 87-. Khullar, A. The Role of Melatonin in the Circadian Rhythm Sleep-Wake Cycle. The Psychiatric times 2012 , 29 (7), 26–32. Smith, A., Jogalekar, S., & Gibson, A. (2014). Regulation of Natural Health Products in Canada. Journal of Ethnopharmacology , 158 , 507–510. https://doi.org/10.1016/j.jep.2014.06.037

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