Role of Melatonin in Body Weight: A Systematic Review and Meta-Analysis

Abstract

Background:
Some trials on animals and human claim that melatonin can influence body weight. So we conducted a systematic review of controlled trials of melatonin effects on weight of human subjects.

Methods:
First we performed a systematic and comprehensive search in June 2015 on MEDLINE/PubMed, Scopus, Google scholar, hand searching in key journals, the list of references of selected articles and gray literature.

Results:
We included 7 clinical trials with a total of 244 patients. All studies were parallel clinical trials conducted at the clinic. Evaluating standardized mean difference (SMD) using Cohen's method shows that none of the included studies have found a strong and significant effect of melatonin on body weight. However, some have reported decreasing or increasing effect of melatonin on body weight. We pooled SMDs using random effects (DerSimonian and Laird). Polled SMD was still not significant SMD (95% CI) = 0.09(-0.17-0.34), with lack of heterogeneity I2=0.0%, p=0.66.

Conclusion:
We concluded that once the standard treatment had increasing effect on body weight, melatonin could be able to slightly diminish this effect and vice versa. Subgroup analysis showed that melatonin was more effective in child and adolescents. According to the results hypothesis of the buffering role of melatonin on body weight fluctuations can be proposed.

Full text

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Current Pharmaceutical Design, 2017, 23, 1-8 1
RESEARCH ARTICLE
1381-6128/17 $58.00+.00 © 2017 Bentham Science Publishers
Role of Melatonin in Body Weight: A Systematic Review and Meta-Analysis
Seyed-Ali Mostafavi1, Shahin Akhondzadeh1, Mohammad Reza Mohammadi1, Abbas-Ali Keshtkar2,
Saeed Hosseini3, Mohammad Reza Eshraghian4, Taranom Ahmadi Motlagh5, Rooya Alipour5 and
Seyed Ali Keshavarz*3
1Psychiatry & Psychology Research Center, Roozbeh Hospital, Tehran University of Medical Sciences, Tehran, Iran; 2Endocrinology
and Metabolism Research Center, Endocrinology and Metabolism Research Institute, Tehran University of Medical Sciences, Tehran,
Iran; 3Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran,
Iran; 4Department of Biostatistics and Epidemiology, School of Public health, Tehran University of Medical Sciences, Tehran, Iran;
5Department of Nutrition, School of Public Health, Iran University of Medical Scien ces, Tehran, Iran
A R T I C L E H I S T O R Y
Received: April 6, 2016
Accepted: July 19, 2016
DOI:
10.2174/1381612822666161129145618
Abstract: Background: Some trials on animals and human claim that melatonin can influence body weight. So
we conducted a systematic review of controlled trials of melatonin effects on weight of human subjects.
Methods: First we performed a systematic and comprehensive search in June 2015 on MEDLINE/Pub Med, Sco-
pus, Google scholar, hand searching in key journals, the list of references of selected articles and gray literature.
Results: We included 7 clinical trials with a total of 244 patients. All studies were parallel clinical trials con-
ducted at the clinic. Evaluating standardized mean difference (SMD) using Cohen’s method shows that none of
the included stud ies have found a stro ng and significant effect of melatonin on body weight. However, some have
reported decreasing or increasing effect of melatonin on body weight. We pooled SMDs using random effects
(DerSimonian and Laird). Polled SMD was still not significant SMD (95% CI) = 0.09(-0.17-0.34), with lack of
heterogeneity I2=0.0%, p=0.66.
Conclusion: We concluded that once the standard treatment had increasing effect on body weight, melatonin
could be able to slightly diminish this effect and vice versa. Subgroup analysis showed that melatonin was more
effective in child and adolescents. According to the results hypothesis of the buffering role of melatonin on body
weight fluctuations can be proposed.
Keywords: Body weight, melatonin, meta-analysis.
INTRODUCTION
Melatonin is a hormone secreted from the pineal gland into the
blood stream. The main role of Melatonin in the body is regulation
of the sleep-wake cycle [1]. Sleep cycles are regulated by neuroen-
docrine system and may adjust metabolic homeostasis and body
weight [2, 3]. It has been shown that disturbed sleep-wake cycles
may lead to metabolic syndrome (MetS) which includes obesity,
diabetes and atherosclerosis [2]. Many studies have confirmed that
melatonin can inhibit fat accumulation in fat tissues of obese animal
models [4]. Also, administration of melatonin in animal studies has
shown to be able to reduce dietary intake, appetite, and body weight
[5]. A nutrition and Lifestyle cohort !study by researchers at West
Washington (n = 15655) after adjustment for confounders found a
strong relationship between melatonin supplements, weight reduc-
tion or weight control [6]. A number of clinical studies on humans
have confirmed effectiveness of melatonin in regulating body
weight and treatment of metabolic problems [7]. In one study, it
was shown that melatonin can physiologically regulate the brown
adipose tissue and metabolic activity in mammals and humans[8].
But in conflict, some studies have reported no or weak effects of
melatonin on body weight. Hence, the present study intends to
evaluate the efficacy of melatonin for weight managem ent in hu-
man subjects by systematic review and meta-analysis of clinical
trials.
*Address correspondence to this author at the Head of Clinical Nutrition
Department, School of Nutritional Sciences and Dietetics, Tehran Univer-
sity of Medical Sciences, Tehran, Iran; E-mail: s_akeshavarz@yahoo.com
Study Question
Is melatonin efficient in body weight management in human
subjects compared with control?!
Objectives
- To evaluate efficacy of melatonin for body weight manage-
ment in human subjects compared with control by systematic
review of literature and meta-analysis of clinical trials
- Describe any possible source for heterogeneity
- Describe any possible publication bias
Materials and Methods
The review protocol was registered in PROSPERO 2015:
CRD42015015803, available from http://www.crd.york.ac.uk/
PROSPERO/display_record.asp?ID=CRD42015015803.
Inclusion criteria for this review includes: clinical trials with
human subjects independent of any special disease, evaluating or
reporting the effect of melatonin on body weight compared to pla-
cebo or standard treatment. Exclusion criteria were: animal studies,
publication date before 1995 (due to lack of accessibility to full
text). No language restriction was set on the searches.
Searching for Studies
To evaluate the efficacy of melatonin for weight management
in human subjects first we performed a systematic and comp rehen-
sive search on June 2015 on MEDLINE/PubMed, Scopus, Google
scholar, hand searching in key journals, list of references of se-
lected articles and gray literature. First, we used mesh keywords to

2 Current Pharmaceutical Design, 2017, Vol. 23, No. 00 Mo stafavi et al.
generate our search syntax on MEDLINE/PubMed and developed
and customized them to other databases (Table 1).
The Process for Selecting Studies
Screening based on the title and then abstract and assessing
eligibility criteria was performed by three independent authors. To
increase the reliability of study selection process, au thors were
needed to review an overlapped set of documents. The level of
agreement between the authors was more than 90%. To resolve
disagreements consensus was used. By presented information on
the title and abstract, we decided whether an article certainly meets
inclusion criteria and study objectives or not. If we doubted that an
article cannot defin itely be rejected (by consensus), then the full
text of the article w as retrieved. If an article was not rejected after
assessing the full text, then its data was extracted. In each level
more than one author (a well-informed author in the area under
review, and the other one not totally an expert in the area, to avoid
biased and pre-formed judgments) assessed eligibility of articles
and in cases of disagreement decision was made by consensus.
Assessment of Study Quality
To help interpretation of results and limit bias of the review, we
assessed the validity and quality of selected articles using CONsoli-
dated Standards Of Reporting Trials (CONSORT) checklist. The
CONSORT Statement consists of a 25-item checklist and a flow
diagram. It can be used by authors and reviewers of articles to en-
sure giving sufficient information in reporting clinical trials. It aims
to lessen the problems arising from inadequate reporting of random-
ized controlled trials. It presents a pattern for authors to organize
compete and precise reports of trial findings. The CONSORT
checklist also can be used as a critical appraisal tool to assess the
quality of reporting clinical trials by scoring. Items related to
method, results and discussion were evaluated. Each article re-
ceived a total quality score, which was used in data synth esis and
interpretation of review results.
Data Extraction
Reviewers extracted necessary data of included articles in
Cochrane’s data collection forms for RCTs. In the cases of missing
data three E-mails in different time points were sent to correspond-
ing authors and more information and addition al statistics were
requested. After that gathered data w ere entered into an excel sh eet
and then entered into STATA ver.11 software. Meta-analysis was
performed using metan command, first with fixed effects (inverse
variance method, Mantel–Haenszel method and Peto’s method) and
then random effects (DerSimonian and Laird).
To assess sources of heterogeneity subgroup analyses was per-
formed by articles quality, by dose category, by age group, and by
adjunction treatments. Results of analyses are presented as forest
plots. Measures of consistency (I2) are presented for each meta-
analysis. To assess publication/language bias funnel plot and Egger
test was performed.
RESULTS
Flowchart of identifying, screening, and assessing process of
included articles is shown in Fig. 1. There w as a very good agree-
ment between raters on the inclusion of studies (k=0.89 (95% CI:
0.61–1). Ten studies included in qualitative synthesis, but three of
them [9-11] lacked necessary effect size measures and SDs to in-
clude in the meta-analy sis. Unfortunately contact with the corre-
sponding authors (three times) was not constructive and we com-
pelled to exclude them. The remained (7) studies included (Table 2)
were all reported in English. Quality assessment of included studies
were done using CONSORT checklist. We used the mean score as a
cutoff for dividing studies into low quality [12, 13] and high quality
[14-17]studies. All studies except reference number [13] used low
dose melatonin (6mg/day or less) and placebo as the control and
were double blinded so they lacked important methodological bias.
Regarding with the interest outcome of weight no selective report-
ing within studies was observed. All studies had ethical approval
and none of them reported conflicts of interest.
The pooled SMD, using a random effects model is 0.09 (-0.17,
0.34). We did not detect significant statistical heterogeneity Overall
(I-squared = 0.0%, p = 0.664) (Fig. 2).
Subgroup analysis of quality (Fig. 3), melatonin dose (Fig. 4),
subjects age group (Fig. 5) and adjunctiv e treatment (Fig. 6) are
shown.
Bias assessment with Funnel plot (Fig. 7), and Egger's test: 2.29
(approximate 95% CI: -1.7 to 6.3, P=0.2) showed no significant
publication bias. Sample size was too small to evaluate Kendall’s
tau.
Table 1. Search syntax in different databases.
Syntax No
SYNTAX
Pubmed
!(melatonin[tiab]! OR “2-methyl-6,7-dichloromelatonin”![tiab]! OR 6-!hydroxymelatonin*[tiab] OR 6-sulfatoxymelatonin![tiab]!" OR ""N-
(4-!chlorobenzoyl)melatonin”[tiab] OR S20098[tiab] OR S-20098[tiab] OR !thymanax[tiab] OR “N-(2-(7-methoxy-1-
naphthyl)ethyl)acetamide”[tiab] !OR valdoxan[tiab] OR “AGO 178”[tiab] OR AGO178[tiab] OR AGO-!!178[tiab] OR agomelati-
ne[tiab]) AND (appeti* OR obes* OR food* OR !weight* OR eat* OR diet OR fat OR BMI OR "body mass index" OR !dietary)
AND dietsuppl[sb] AND (trial[tiab] OR intervention*[tiab] OR !effectiveness[tiab] OR comparative[tiab] OR clinical trial[pt])!.
Scopus
TITLE-ABS-KEY ( melatonin* OR "6-sulfatoxymelatonin" OR agomelatine OR "s 20098" OR !alloxan! ) AND TI TLE-ABS-
KEY ( appeti* OR obes* OR food* OR weight* OR eat* OR diet* OR fat* OR bmi ) AND TITLE-ABS-KEY ( trial*
OR intervention* OR effectiveness OR comparative OR "clinical trial " ! ) AND DOCTYPE ( ar ) AND PUBYEAR > 1997
Google scholar
!(melatonin !OR “2-methyl-6,7-dichloromelatonin”! OR 6-hydroxymelatonin! OR !!6-sulfatoxymelatonin"! OR "!"N-(4-
chlorobenzoyl)melatonin”! OR S20098! OR !thymanax! OR “N-(2-(7-methoxy-1-naphthyl)ethyl)acetamide”! OR valdoxan! !OR “AGO
178”! OR agomelatine)! AND (appetite OR obese OR obesity OR food OR weight OR eat OR diet OR fat !OR BMI OR "body mass
index" OR dietary) AND !!(trial OR intervention OR effectiveness OR !comparative OR clinical trial)!
Conference papers
and gray literature
(Scopus)
TITLE-ABS-KEY ( melatonin* OR "6-sulfatoxymelatonin" OR agomelatine OR "s 20098" OR !alloxan! ) AND TI TLE-ABS-
KEY ( appeti* OR obes* OR food* OR weight* OR eat* OR diet* OR fat* OR bmi ) AND TITLE-ABS-KEY ( trial*
OR intervention* OR effectiveness OR comparative OR "clinical trial " ! ) AND DOCTYPE ( CP ) AND PUBYEA R > 1997

Role of Melatonin in Body Weight: A Systematic Review and Meta-Analysis Current Pharmaceutical Design, 2017, Vol. 23, No. 00 3
Fig. (1). Flowchart of identification, screening, and assessin g process of included articles.
Fig. (2). SMD meta-analysis of 7 RCTs evaluating effects of Melatonin on body weight using the random effects model.

4 Current Pharmaceutical Design, 2017, Vol. 23, No. 00 Mo stafavi et al.
Fig. (3). Subgroup analysis of RCTs evaluating effects of Melatonin on body weight by quality.
Fig. (4). Subgroup analysis of RCTs evaluating effects of Melatonin on body weight by dose.

Role of Melatonin in Body Weight: A Systematic Review and Meta-Analysis Current Pharmaceutical Design, 2017, Vol. 23, No. 00 5
Fig. 5). Subgroup analysis of RCTs evaluating effects of Melatonin on body weight by age group.
Fig. (6). Subgroup analysis of RCTs evaluating effects of Melatonin on body weight by adjunctive treatment.

6 Current Pharmaceutical Design, 2017, Vol. 23, No. 00 Mo stafavi et al.
Fig. (7). Funnel plot, Egger's test: 2.29 (approximate 95% CI: -1.7 to 6.3, P=0.2). Sample size was too small to evaluate Kendall’s tau.
Table 2. Characteristic o f included studies.
Study
Quality
score
study type/
design
subjects
Sample size
Dura-
tion
Interven-
tion
Compari-
son
Adjunction drug/treatment
(effect on weight)
Mostafavi, 2012
(12)
23
RCT/Parallel
children with adhd
(7-12 year)
Interventions:26
Controls:24
8 wk
Melatonin
(3mg)
Placebo
Ritalin (decreasing effect on
weight)
Modabbernia 2013
(16)
27
RCT/Parallel
Adult patients
with Schizophre-
nia !(18-56 y)
Interventions:18
Controls:18
8 wk
Melatonin
(3mg)
Placebo
Olanzapine (increasing effect
on weight)
Alamdari 2013 (15)
25
RCT/Parallel
healthy obese
women (20-50 y)
Interventions:22
Controls:22
6 wk
Melatonin
(6mg)
Placebo
Weight loss diet: -500 kcal of
TEE (deceasing effect on
weight)
Francisco Romo-
Nava 2011 (SGA
medium risk) (14)
24
RCT/Parallel
Adult patients
with Schizophre-
nia !or bipolar (18-
45 y)
Interventions:15
Controls:13
8 wk
Melatonin
(5mg)
Placebo
SGA medium risk (quetiapine
and risperidone) according to
their risk for inducing meta-
bolic disturbances (increasing
effect on weight)
Francisco Romo-
Nava 2011 (SGA
high risk) (14)
24
RCT/Parallel
Adult patients
with Schizophre-
nia !or bipolar (18-
45 y)
Interventions: 5
Controls: 11
8 wk
Melatonin
(5mg)
Placebo
SGA high risk (clozapine and
olanzapine) (increasing effect
on weight)
D.Karaiskos 2012
(13)
15
Clinical
Trial/Parallel
Diabetic patients
with depression
(18-60 y)
Interventions: 20
Controls: 20
16 wk
Agomelati
n (31mg)
Sertralin
standard diabetes treatment
(decreasing effect on weight)
Mostafavi, Gray
literature (ahead of
print 2017) (17)
24
RCT/Parallel
Adult patients
with bipolar (18-
50 y)
Interventions:16
Controls:14
12 wk
Melatonin
(3mg)
Placebo
Olanzapine (increasing effect
on weight)

Role of Melatonin in Body Weight: A Systematic Review and Meta-Analysis Current Pharmaceutical Design, 2017, Vol. 23, No. 00 7
DISCUSSION
Evaluating SMD using Cohen’s method shows that none of
included studies have found significant effects of melatonin on
body weight. Mostafavi [12, 17], and Francisco Romo-Nava [14],
have reported an increasing effect of melatonin on body weight
while Modabernia [16], Alamdari [15], and karaiskos [13] have
found a decreasing effect of melatonin on body weight. W e believe
that this variance in melatonin effect may be due to different meth-
odology and subjects included in each study. So we pooled SMDs
using random effects (DerSimonian and Laird). Polled SMD was
still not significant SMD (95% CI) = 0.09(-0.17-0.34), with lack of
heterogeneity I2=0.0%, p=0.66. Due to different methodologies, we
still were eag er to find for any possible sources of heterogeneity.
Included studies were different in terms of risk of bias (quality),
melatonin dose, age group and risk of bias (quality) (Table 2).
To find whether study quality could influence on the final re-
sult, we divided the studies into high quality or low quality studies
based on the CONSORT check list and with mean quality of in-
cluded studies as a cut off. We performed subgroup analysis and as
it is clear in the fig. 3, low quality studies showed more SMD
(95%CI): 0.16 (-0.25, 0.57) compared with high quality studies
with lower pooled SMD(95%CI): 0.05 (-0.27,0.37).
We divided studies based on melatonin dose into two groups:
low dose (6mg/day or less) and high dose (more than 6mg/day)
(Fig. 4). We performed subgroup analysis by categorised dose. Low
dose studies had SMD (95%CI): 0.11(-0.17, 0.39), high dose stud-
ies showed no significant, but slightly decreasing effect of mela-
tonin on body weight with SMD (95%CI):-0.02 (-0.64, 0.60).
When we divided studies based on age group (fig. 5), we found
that studies performed on child and adolescents showed a moderate
increasing effect of melatonin on body weight with SMD (95%CI):
0.31(-0.14, 0.75), while melatonin in adults had a weak decreasing
effect on body weight SMD (95%CI):-0.02 (-0.33, 0.29).
When we have a deep look at the eligible studies we understand
that the disease or situation under which melatonin has been pre-
scribed is not neutral and can induce potential decreasing or in-
creasing effect on body weight. For example, some medications
such as Olanzapine or Colazapine may increase subject’s weight
while some others such as Ritalin or low calorie diet can reduce
body weight. So we divided included studies into two subgroups
regarding this point of view and performed meta-analysis again. We
found that wherever main treatment had decreased the body weight,
melatonin none significantly increased body weight with SMD
(95%CI): 0.06 (-0.28, 0.40). And once main treatment had a harsh
increasing effect on body weight, melatonin could buffer this effect,
but SMD is still positive, SMD (95%CI): 0.12 (-0.26, 0.51). This
point is far-reaching, especially for clinicians dealing with patients
and researchers who want to design future studies.
There are a number of strengths to our meta-analysis: we con-
ducted a set of comprehensive, systematic searches to seek out all
relevant studies in the field; we evaluated important sources of
heterogeneity which can influence pooled outcomes; and we also
assessed important sources of bias shown to influence pool ed out-
comes. Furthermore, we found no publication bias, database bias or
language bias.
There are a few limitations to be considered in our meta-
analysis. Perhaps the most significant is that three eligible studies
lacked necessary effect size measures and SDs to include in the
met-analysis. Unfortunately contact with the corresponding authors
(three times) was not constructive and we compelled to exclude
them. These three studies were on subjects with cancer cachexia
and may affect on pooled measures.
CONCLUSION
All of the reviewed studies had used melatonin as an adjunctive
treatment to a m edication that had decreased or increased patient’s
body weight. We inferred that once standard treatment had a de-
creasing effect on body weight, melatonin could be able to diminish
this effect and wherever standard treatment had an increasing effect
on body weight, melatonin had buffered this effect. Adjunction of
melatonin with first choice medications may help to diminish their
side effects on body weight. Subgroup analysis showed that this
effect was more in child and adolescent s. According to the results,
hypothesis of the buffering role of m elatonin on body weight fluc-
tuations can be proposed. Future studies should focus on this
interesting effect and m etabolic pathway s involv ed in this process.
CONFLICT OF INTEREST
All authors declare no financial or non-financial conflict of
interest in relation to this work.
ACKNOWLEDGEMENTS
We acknowledge the Psychiatry & Psychology Research Cen-
ter, Roozbeh Hospital, Tehran University of Medical Sciences, for
their help and facilities to perform this review.
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