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Psychiatria Danubina Sep 2022The features of bipolar affective disorder (BAD) include mood swings, recurring episodes of mania, depression, and mixed states. Numerous studies of people living with...
BACKGROUND
The features of bipolar affective disorder (BAD) include mood swings, recurring episodes of mania, depression, and mixed states. Numerous studies of people living with BAD have found the presence of cognitive impairments that affect patients' daily social functioning and quality of life. Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation technique recommended for the treatment of bipolar depression (BD). The effect of TMS on cognitive function in BD patients remains mostly unclear.
SUBJECTS AND METHODS
We carried out a systematic search in the databases of PubMed and Scopus for the whole publication period until March 30, 2022. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analysis) was used to identify all data published in English language and related to the use of TMS in the treatment of depression in BAD and its impact on cognitive function. Articles related to TMS, cognition, and BD were identified using predefined term search algorithms. Articles on clinical trials and case reports were included, but reviews were excluded. The PICOS (Population Intervention Comparison Outputs Study) formula in our review included: P - patients with bipolar depression, I - TMS treatment, C - patients without TMS treatment / placebo TMS, O - changes in cognitive functions, S - all types of original studies.
RESULTS
Within the primary screening for assessment of full texts, 25 documents met our selection criteria to test the effect of TMS on cognitive functioning in BD. Based on a secondary screening of the full-text analysis, 10 articles (N=259 patients) were included into the current review. Among these, the majority of articles were based on the randomized controlled trials (RCTs, N=6), whereas the remaining four presented a case report, an open unblinded study, an open-label study, and a pilot study, respectively. Most of the studies produced mixed result. However, the limited data strongly suggested that TMS is without detriment to cognition in BD patients and is indeed beneficial in specific domains of cognitive function, namely (i) verbal fluency, (ii) verbal memory, and (iii) executive functioning. Small sample sizes, heterogeneity across the study designs, lack of the control groups data in some of the trials, different TMS protocols parameters and outcome measures represent significant limitations for comparing and analyzing the available results.
CONCLUSIONS
Thus, present data on the effects of TMS in improving cognition in BD patients remains limited. To our mind, in order to evaluate properly the effectiveness of TMS in cognitive functioning improvement in BD, there is need for further randomized controlled trials and the corresponding development of the clinical standards for research recommendations. Such studies could define the appropriate methods for valid assessments of cognitive functions, and guide the selection of optimal TMS protocols when planning RCTs. We suggest that efforts should be expended to organize centralized large-scale clinical trials to determine the optimal parameters of TMS procedures and the range of effects of this treatment on various indicators of cognitive functioning in BD. This applies equally to other socially significant mental disorders marked by perturbations in cognitive functioning.
Topics: Bipolar Disorder; Cognition; Humans; Pilot Projects; Quality of Life; Randomized Controlled Trials as Topic; Transcranial Magnetic Stimulation
PubMed: 36170725
DOI: No ID Found -
Foot (Edinburgh, Scotland) Jun 2024Health specialists suggest a conservative approach comprising non-pharmacological interventions as the initial course of action for individuals with repetitive ankle... (Review)
Review
INTRODUCTION
Health specialists suggest a conservative approach comprising non-pharmacological interventions as the initial course of action for individuals with repetitive ankle sprain due to ankle instability. This systematic review aimed to assess the effectiveness of biomechanical devices (Foot Orthoses, Ankle Orthoses, and Taping) on gait and muscle activity in individuals with ankle instability.
METHODS
A systematic search was performed on electronic databases, including PubMed, EMBASE, Clinical Trials.gov, Web of Science, and Scopus. The PEDro scoring system was used to evaluate the quality of the included studies. We extracted data from population, intervention, and outcome measures.
RESULTS
In the initial search, we found 247 articles. After following the steps of the PRISMA flowchart, only 22 reports met the inclusion criteria of this study. The results show that biomechanical device therapy may increase swing time, stance time, and step. Additionally, studies suggest that these devices can reduce plantar flexion, inversion, and motion variability during gait. Biomechanical devices have the potential to optimize the subtalar valgus moment, push-off, and braking forces exerted during walking, as well as enhance the activity of specific muscles including the peroneus longus, peroneus brevis, tibialis anterior, gluteus medius, lateral gastrocnemius, rectus femoris, and soleus.
CONCLUSION
Biomechanical devices affect gait (spatiotemporal, kinetic, and kinematic variables) and lower limb muscle activity (root mean square, reaction time, amplitude, reflex, and wave) in subjects with ankle instability.
Topics: Humans; Joint Instability; Gait; Biomechanical Phenomena; Muscle, Skeletal; Ankle Joint; Foot Orthoses; Athletic Tape; Ankle Injuries
PubMed: 38513375
DOI: 10.1016/j.foot.2024.102083 -
Frontiers in Psychology 2023Investigation of the psychological impact on soccer athletes during the pandemic is essential given their unique challenges, including training disruptions and...
INTRODUCTION
Investigation of the psychological impact on soccer athletes during the pandemic is essential given their unique challenges, including training disruptions and competition postponements. Understanding these effects will allow the development of specific strategies to preserve the mental health and performance of elite athletes, contributing to effective interventions with both short and long-term benefits.
OBJECTIVE
To analyze the impact of the COVID-19 pandemic on the psychological aspects and mental health of elite soccer athletes.
METHOD
The review adhered to PRISMA criteria, and the study protocol was registered in the International Prospective Register of Systematic Reviews (CRD42022341545). Searches were conducted until July 2023 in databases including Cochrane, PsycINFO, PubMed, Scopus, SPORTDiscus, and Web of Science. Only original, peer-reviewed studies in English, Portuguese, or Spanish assessing the impact of the COVID-19 pandemic on the psychological aspects and mental health of elite soccer athletes were included.
RESULTS
The search identified 1,055 records and 43 studies were included in this review between 2020 and 2023. In total, the sample included 16,321 soccer athletes of different age groups. Anxiety, depression, mood states, and mental well-being were the most investigated variables. Increased levels of anxiety, depression, and worsening mental well-being were observed in elite soccer athletes. Maintaining fitness during the pandemic showed positive results. Other variables, such as coping, resilience, and sleep quality monitoring, were less widely investigated. Evaluating methodological quality was considered regular for observational and experimental studies.
CONCLUSION
The study reveals a negative impact of the COVID-19 pandemic on elite soccer athletes, considering psychological aspects and their mental health, notably heightened anxiety and depression. Observational methods predominated, showing mood swings linked to individual characteristics and fitness maintenance efforts. Studies with better-designed methodological approaches and controlled experimental interventions are recommended in the future to mitigate the negative effects of the pandemic on soccer players.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/display_record.php?, identifier (CRD42022341545).
PubMed: 38333426
DOI: 10.3389/fpsyg.2023.1295652 -
Nephrology, Dialysis, Transplantation :... Sep 2017Decision-making regarding immunosuppression after transplantation relies on robust evidence on the benefits and harms of available drugs. We aimed to evaluate the... (Review)
Review
BACKGROUND
Decision-making regarding immunosuppression after transplantation relies on robust evidence on the benefits and harms of available drugs. We aimed to evaluate the reporting of adverse events (AEs) in trials of maintenance immunosuppression in kidney transplantation.
METHODS
We conducted a systematic review of published randomized controlled trials of maintenance immunosuppression following kidney transplantation in the Cochrane Kidney and Transplant Register (January 2003-December 2015). Appraisal against the 23-item harms extension of the Consolidated Standards of Reporting Trials statement was conducted.
RESULTS
Of 233 trials, 163 (69%) reported at least one AE. Only 17 (10%) provided definitions or justified the AEs, 13 (8%) described methods and 27 (17%) measured severity. Forty AE types were reported, with gastrointestinal being the most common [116 (71%)]. The frequency of reporting did not reflect known drug side-effect profiles. For example, of 90 calcineurin inhibitor trials, only 22% reported tremors, 3% paresthesia and none anxiety, aggression or mood swings. Trials that reported at least one adverse effect were more likely to be industry funded {adjusted odds ratio [OR] 7.6 [95% confidence interval (CI) 3.4-17.1]}, multicenter [OR 5.9 (95% CI 1.7-18.7)] and with follow-up time <24 months [OR 3.7 (95% CI 1.4-10.2)].
CONCLUSIONS
AEs in kidney transplant immunosuppression trials appear to be selectively reported and may be unreliable for clinical decisions. Adherence to the Consolidated Standards of Reporting Trials harms extension should be mandatory to ensure transparent reporting of AEs that are important to patients and clinicians.
Topics: Drug-Related Side Effects and Adverse Reactions; Graft Rejection; Humans; Immunosuppressive Agents; Kidney Transplantation; Maintenance Chemotherapy; Patient Outcome Assessment
PubMed: 29059401
DOI: 10.1093/ndt/gfx216 -
International Journal of Molecular... Oct 2020Bipolar disorder (BD) is a complex neurobiological disorder characterized by a pathologic mood swing. Digital phenotyping, defined as the 'moment-by-moment... (Meta-Analysis)
Meta-Analysis
Bipolar disorder (BD) is a complex neurobiological disorder characterized by a pathologic mood swing. Digital phenotyping, defined as the 'moment-by-moment quantification of the individual-level human phenotype in its own environment', represents a new approach aimed at measuring the human behavior and may theoretically enhance clinicians' capability in early identification, diagnosis, and management of any mental health conditions, including BD. Moreover, a digital phenotyping approach may easily introduce and allow clinicians to perform a more personalized and patient-tailored diagnostic and therapeutic approach, in line with the framework of precision psychiatry. The aim of the present paper is to investigate the role of digital phenotyping in BD. Despite scarce literature published so far, extremely heterogeneous methodological strategies, and limitations, digital phenotyping may represent a grounding research and clinical field in BD, by owning the potentialities to quickly identify, diagnose, longitudinally monitor, and evaluating clinical response and remission to psychotropic drugs. Finally, digital phenotyping might potentially constitute a possible predictive marker for mood disorders.
Topics: Biomarkers; Bipolar Disorder; Endophenotypes; Humans; Mobile Applications; Precision Medicine; Telemedicine
PubMed: 33081393
DOI: 10.3390/ijms21207684 -
Molecular Psychiatry Jan 2020Bipolar disorder (BD) is a chronic affective disorder with extreme mood swings that include mania or hypomania and depression. Though the exact mechanism of BD is...
Bipolar disorder (BD) is a chronic affective disorder with extreme mood swings that include mania or hypomania and depression. Though the exact mechanism of BD is unknown, neuroinflammation is one of the numerous investigated etiopathophysiological causes of BD. This article presents a systematic review of the data regarding brain inflammation evaluating microglia, astrocytes, cytokines, chemokines, adhesion molecules, and other inflammatory markers in postmortem BD brain samples. This systematic review was performed according to PRISMA recommendations, and relevant studies were identified by searching the PubMed/MEDLINE, PsycINFO, EMBASE, LILACS, IBECS, and Web of Science databases for peer-reviewed journal articles published by March 2019. Quality of included studies appraised using the QUADAS-2 tool. Among the 1814 articles included in the primary screening, 51 articles measured inflammatory markers in postmortem BD brain samples. A number of studies have shown evidence of inflammation in BD postmortem brain samples. However, an absolute statement cannot be concluded whether neuroinflammation is present in BD due to the large number of studies did not evaluate the presence of infiltrating peripheral immune cells in the central nervous system (CNS) parenchyma, cytokines levels, and microglia activation in the same postmortem brain sample. For example, out of 15 studies that evaluated microglia cells markers, 8 studies found no effect of BD on these cells. Similarly, 17 out of 51 studies evaluating astrocytes markers, 9 studies did not find any effect of BD on astrocyte cells, whereas 8 studies found a decrease and 2 studies presented both increase and decrease in different brain regions. In addition, multiple factors account for the variability across the studies, including postmortem interval, brain area studied, age at diagnosis, undergoing treatment, and others. Future analyses should rectify these potential sources of heterogeneity and reach a consensus regarding the inflammatory markers in postmortem BD brain samples.
Topics: Astrocytes; Autopsy; Biomarkers; Bipolar Disorder; Brain; Cytokines; Humans; Inflammation; Microglia; Mood Disorders; Neuroimmunomodulation
PubMed: 31249382
DOI: 10.1038/s41380-019-0448-7 -
La Tunisie Medicale Oct 2019During the month of Ramadan, Muslim believers of adult-aged and healthy, restrain themselves from food consumption and liquid intake from dawn to sunset (fasting...
During the month of Ramadan, Muslim believers of adult-aged and healthy, restrain themselves from food consumption and liquid intake from dawn to sunset (fasting duration varying according to the geographical location and time of the year). Differently from other fasting regimens such as caloric restriction, Ramadan fasting is a unique kind of fasting, being total (i.e., absolute abstain from food as well as fluid), time-restricted, intermittent, and circadian (following the circadian rhythm and the human biological clock). As such, the fasting athletes could potentially suffer from hypohydration, altered sleep pattern and architecture, sleep disturbances, mood swings, immunological alterations, impaired psychomotor performance and overall perceived physical and perhaps, mental fatigue, among others. Hence, Muslim athletes who continue to train and compete during Ramadan faced many challenges. Research has shown that depending on the level of effort, Ramadan fasting could have diverse effects on physical performance; from no effect to marked effects. The present review aims to provide practical recommendations based on an updated, evidence-based synthesis of the existing scholarly literature and/or experts opinions on the topic and subsequently, some useful tips for athletes, coaches, medical and scientific support, and sports managers, in order to guide them on how to promote appropriate behavioral, social and psychological strategies to cope with the changes and potential constraints induced by the observance of Ramadan fasting. These recommendations should be adjusted and coped with, utilizing a holistic approach, rather than focusing on the single alterations/perturbations. Moreover, the implemented strategies should not be "one size fits it all" approach, but should rather take into account the variability among athletes and their specific needs (biological, psychological, cognitive-behavioral), and their social and living environment; as it is clearly more challenging when the individual is performing the Ramadan fasting in a predominantly non-Muslim majority country.
Topics: Athletes; Athletic Performance; Circadian Rhythm; Competitive Behavior; Exercise; Fasting; Humans; Islam; Sports
PubMed: 31691937
DOI: No ID Found -
Psychiatria Danubina Oct 2023Depressive disorders are characterized by fluctuating symptom severity, and developing an individual prognostic model for relapse is crucial for effective prevention....
BACKGROUND
Depressive disorders are characterized by fluctuating symptom severity, and developing an individual prognostic model for relapse is crucial for effective prevention. Chronobiological factors are poorly understood in this context.
METHODS
A systematic search was conducted to identify articles related to the prognosis of depression recurrence based on chronobiological factors. Relevant clinical studies were included, while reviews and case reports were excluded. A total of 14 articles were selected for review.
RESULTS
The included articles focused on various chronobiological factors, including circadian biorhythms, individual chronotype, mood swings, seasonal patterns, diurnal cortisol fluctuations, and light therapy. The accuracy of personified prognosis ranged from 22.7% to 93.8%, and the prognostic value of specific predictors in group prognosis varied from 23.9% to 54%. Methodological differences and limitations hindered direct comparison and clinical applicability.
CONCLUSIONS
Developing precise and practical models for depression recurrence prognosis remains limited. Parameters of circadian rhythm showed the highest accuracy for short-term prognosis, and the use of digital technologies, including AI, enhanced prognostic value. Relapse seasonality had limited practical applicability. Integrating other chronobiological factors into prognostic models requires further research. Utilizing digital technologies, including AI, can improve the accuracy and range of personified prognosis. Only a few selected parameters of the human chronobiological system were considered in the examined studies. There are indications of the other chronobiological factors that could be included in the integrated prognostic model of recurrence for its further improvement.
Topics: Humans; Depression; Prognosis; Mood Disorders; Circadian Rhythm; Recurrence
PubMed: 37800204
DOI: No ID Found -
The Cochrane Database of Systematic... Mar 2019This is an update of the original review published in the Cochrane Database of Systematic Reviews 2011, Issue 11, and updated in 2015, Issue 4.Chemotherapy has... (Meta-Analysis)
Meta-Analysis
BACKGROUND
This is an update of the original review published in the Cochrane Database of Systematic Reviews 2011, Issue 11, and updated in 2015, Issue 4.Chemotherapy has significantly improved prognosis for women with malignant and some non-malignant conditions. This treatment, however, is associated with ovarian toxicity. The use of gonadotropin-releasing hormone (GnRH) analogues, both agonists and antagonists, may have a protective effect on the ovaries. The primary mechanism of action of GnRH analogues is to suppress the gonadotropin levels to simulate pre-pubertal hormonal milieu and subsequently prevent primordial follicles from maturation and therefore decrease the number of follicles that are more vulnerable to chemotherapy.
OBJECTIVES
To assess the efficacy and safety of GnRH analogues given before or in parallel to chemotherapy to prevent chemotherapy-related ovarian damage in premenopausal women with malignant or non-malignant conditions.
SEARCH METHODS
The search was run for the original review in July 2011, and for the first update in July 2014. For this update we searched the following databases in November 2018: the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and the Chinese Biomedicine Database (CBM).
SELECTION CRITERIA
Randomised controlled trials (RCTs), in all languages, which examined the effect of GnRH analogues for chemotherapy-induced ovarian failure in premenopausal women, were eligible for inclusion in the review.
DATA COLLECTION AND ANALYSIS
Two review authors independently extracted data and assessed trial quality using the Cochrane 'Risk of bias' tool. We analysed binary data using risk ratios (RRs) with 95% confidence intervals (CI) and for continuous data, we used the standardized mean difference (SMD) to combine trials. We applied the random-effects model in our analyses. We used the GRADE approach to produce a 'Summary of findings' table for our main outcomes of interest.
MAIN RESULTS
We included 12 RCTs involving 1369 women between the ages of 12 and 51.1 years. Participants were diagnosed with breast malignancy, ovarian malignancy, or Hodgkin's lymphoma, and most of them received alkylating, or platinum complexes, based chemotherapy. The included studies were funded by a university (n = 1), research centres (n = 4), and pharmaceutical companies (n = 1). Trials were at high or unclear risk of bias.Comparison 1: GnRH agonist plus chemotherapy versus chemotherapy aloneThe incidence of menstruation recovery or maintenance was 178 of 239 (74.5%) in the GnRH agonist group and 110 of 221 (50.0%) in the control group during a follow-up period no longer than 12 months (RR 1.60, 95% CI 1.14 to 2.24; 5 studies, 460 participants; I = 79%; low-certainty evidence), with an overall effect favouring treatment with GnRH agonist (P = 0.006). However, we observed no difference during a follow-up period longer than 12 months between these two groups (P = 0.24). In the GnRH agonist group, 326 of 447 participants had menstruation recovery or maintenance (72.9%) in comparison to the control group, in which 276 of 422 participants had menstruation recovery or maintenance (65.4%) during a follow-up period longer than 12 months (RR 1.08, 95% CI 0.95 to 1.22; 8 studies, 869 participants; I = 56%; low-certainty evidence).The incidence of premature ovarian failure was 43 of 401 (10.7%) in the GnRH agonist group and 96 of 379 (25.3%) in the control group (RR 0.44, 95% CI 0.31 to 0.61; 4 studies, 780 participants; I = 0%; moderate-certainty evidence), with an overall effect favouring treatment with GnRH agonist (P < 0.00001).The incidence of pregnancy was 32 of 356 (9.0%) in the GnRH agonist group and 22 of 347 (6.3%) in the control group (RR 1.59, 95% CI 0.93 to 2.70; 7 studies, 703 participants; I = 0%; low-certainty evidence), with no difference between groups (P = 0.09). However, we are cautious about this conclusion because there were insufficient data about whether the participants intended to become pregnant.The incidence of ovulation was 29 of 47 (61.7%) in the GnRH agonist group and 12 of 48 (25.0%) in the control group (RR 2.47, 95% CI 1.43 to 4.26; 2 studies, 95 participants; I = 0%; low-certainty evidence) with an overall effect favouring treatment with GnRH (P = 0.001).The most common adverse effects of GnRH analogues included hot flushes, vaginal dryness, urogenital symptoms, and mood swings. The pooled analysis of safety data showed no difference in adverse effects between GnRH agonist group and control group.Comparison 2: GnRH agonist-antagonist cotreatment plus chemotherapy versus chemotherapy aloneOnly one RCT discussed GnRH agonist-antagonist cotreatment. The limited evidence showed the incidence of menstruation recovery or maintenance was 20 of 25 (80%) in both cotreatment group and control group during a 12-month follow-up period (RR 1.00, 95% CI 0.76 to 1.32; 50 participants; very low-certainty evidence), with no difference between groups (P = 1.00). In the cotreatment group, 13 of 25 participants had menstruation recovery or maintenance (52.0%) in comparison to the control group, in which 14 of 25 participants had menstruation recovery or maintenance (56.0%) during a follow-up period longer than 12 months (RR 0.93, 95% CI 0.56 to 1.55; 50 participants; very low-certainty evidence), with no difference between groups (P = 0.78). The incidence of pregnancy was 1 of 25 (4.0%) in the cotreatment group and 0 of 25 (0%) in the control group (RR 3.00, 95% CI 0.13 to 70.30; 50 participants; very low-certainty evidence), with no difference between groups (P = 0.49).
AUTHORS' CONCLUSIONS
GnRH agonist appears to be effective in protecting the ovaries during chemotherapy, in terms of maintenance and resumption of menstruation, treatment-related premature ovarian failure and ovulation. Evidence for protection of fertility was insufficient and needs further investigation. Evidence was also insufficient to assess the effect of GnRH agonist and GnRH antagonist cotreatment on ovarian protection against chemotherapy. The included studies differed in some important aspects of design, and most of these studies had no age-determined subgroup analysis. Large and well-designed RCTs with longer follow-up duration should be conducted to clarify the effects of GnRH analogues in preventing chemotherapy-induced ovarian failure, especially on different age groups or different chemotherapy regimens. Furthermore, studies should address the effects on pregnancy rates and anti-tumour therapy.
Topics: Administration, Intranasal; Adolescent; Adult; Antineoplastic Agents; Child; Female; Gonadotropin-Releasing Hormone; Humans; Injections, Intramuscular; Injections, Subcutaneous; Menstruation; Middle Aged; Ovulation; Pregnancy; Pregnancy Rate; Premenopause; Primary Ovarian Insufficiency; Randomized Controlled Trials as Topic; Recovery of Function; Young Adult
PubMed: 30827035
DOI: 10.1002/14651858.CD008018.pub3 -
CNS Drugs Dec 2019Melatonin is widely available either on prescription for the treatment of sleep disorders or as an over-the-counter dietary supplement. Melatonin has also recently been...
BACKGROUND
Melatonin is widely available either on prescription for the treatment of sleep disorders or as an over-the-counter dietary supplement. Melatonin has also recently been licensed in the UK for the short-term treatment of jetlag. Little is known about the potential for adverse events (AEs), in particular AEs resulting from long-term use. Concern has been raised over the possible risks of exposure in certain populations including pre-adolescent children and patients with epilepsy or asthma.
OBJECTIVES
The aim of this systematic review was to assess the evidence for AEs associated with short-term and longer-term melatonin treatment for sleep disorders.
METHODS
A literature search of the PubMed/Medline database and Google Scholar was conducted to identify randomised, placebo-controlled trials (RCTs) of exogenous melatonin administered for primary or secondary sleep disorders. Studies were included if they reported on both the types and frequencies of AEs. Studies of pre-term infants, studies of < 1 week in duration or involving single doses of melatonin and studies in languages other than English were excluded. Findings from open-label studies that raised concerns relating to AE reports in patients were also examined. Studies were assessed for quality of reporting against the Consolidated Standards of Reporting Trials (CONSORT) checklist and for risk of bias against the Cochrane Collaboration risk-of-bias criteria.
RESULTS
37 RCTs met criteria for inclusion. Daily melatonin doses ranged from 0.15 mg to 12 mg. Subjects were monitored for up to 29 weeks, but most studies were of much shorter duration (4 weeks or less). The most frequently reported AEs were daytime sleepiness (1.66%), headache (0.74%), other sleep-related AEs (0.74%), dizziness (0.74%) and hypothermia (0.62%). Very few AEs considered to be serious or of clinical significance were reported. These included agitation, fatigue, mood swings, nightmares, skin irritation and palpitations. Most AEs either resolved spontaneously within a few days with no adjustment in melatonin, or immediately upon withdrawal of treatment. Melatonin was generally regarded as safe and well tolerated. Many studies predated publication of the CONSORT checklist and consequently did not conform closely to the guidelines. Similarly, only eight studies were judged 'good' overall with respect to the Cochrane risk-of-bias criteria. Of the remaining papers, 16 were considered 'fair' and 13 'poor' but publication of almost half of the papers preceded that of the earliest version of the guidelines.
CONCLUSION
Few, generally mild to moderate, AEs were associated with exogenous melatonin. No AEs that were life threatening or of major clinical significance were identified. The scarcity of evidence from long-term RCTs, however, limits the conclusions regarding the safety of continuous melatonin therapy over extended periods. There are insufficient robust data to allow a meaningful appraisal of concerns that melatonin may result in more clinically significant adverse effects in potentially at-risk populations. Future studies should be designed to comply with appropriate quality standards for RCTs, which most past studies have not.
Topics: Humans; Melatonin; Randomized Controlled Trials as Topic; Sleep; Sleep Wake Disorders
PubMed: 31722088
DOI: 10.1007/s40263-019-00680-w