Finasteride in hospitalized adult males with COVID-19: A risk factor for severity of the disease or an adjunct treatment: A randomized controlled clinical trial

Abstract

Background: There is controversy about the efficacy of 5-alpha-reductase inhibitors in COVID-19 patients. Some assumed that finasteride might be a risk factor for deterioration and others proposed it as a possible adjunct treatment for moderate to severe COVID-19 infection in the elderly.
Methods: We performed a randomized controlled clinical trial (registration ID IRCT20200505047318N1) on 80 hospitalized male patients aged ≥50 years diagnosed with COVID-19 pneumonia in a tertiary hospital in Qazvin (Iran) from April to July 2020. The patients were randomized into one of the 2 treatment groups using simple randomization. Treatment group patients underwent routine drug therapy and 5 mg finasteride once daily for 7 days. The primary endpoint was mortality rate and length of hospital stay (LOS), and secondary endpoints were peripheral capillary oxygen saturation, respiratory rate, and inflammatory markers changes. The study protocol was approved by the medical ethics committee of Qazvin University of Medical Sciences (registration ID IR.QUMS.REC.1399.080). Data were analyzed by statistical tests and SPSS version 25. Also, p<0.05 was considered to be statistically significant.
Results: We found a significant difference on O2 saturation among the 2 study groups on fifth day compared with the admission time (p= 0.018). The results did not show significant differences in mortality rate (2.5% vs 10%; p= 0.166) and LOS (p= 0.866) between patients in the finasteride and the control group.
Conclusion: A short course of finasteride administration partially improves O2 saturation but does not influence other outcomes in hospitalized male patients aged ≥50 years with COVID-19 pneumonia. Further research in a large scale with longer follow-up is required to help clarify the role of finasteride in this setting.

Full text

Original Article
http://mjiri.iums.ac.ir
Medical Journal of the Islamic Republic of Iran (MJIRI)
Med J Islam Repub Iran. 2021(3 Mar);35.30. https://doi.org/10.47176/mjiri.35.30
______________________________
Corresponding author: Dr Abbas Allami, allami9@yahoo.com
1.
Department of Infectious Diseases, Clinical Research Development Unit, BouAli Sina
Hospital, Qazvin University of Medical of Sciences, Qazvin, Iran
2.
Qazvin Blood Transfusion Organization, Qazvin, Iran
3.
Children Growth Research Center, Research Institute for Prevention of N on-
Communicable Diseases, Qazvin University of Medical Sciences, Qazv in, Iran
4.
Canada Optimax Access Consultation, Ottawa, Canada
↑What is “already known” in this topic:
There is controversy about the efficacy of 5α-reductase
inhibitors in COVID-19 patients. Some assumed they might be
a risk factor for deterioration and others proposed it as a
possible adjunct treatment for moderate to severe COVID-19
infection in the elderly.
→What this article adds:
This study is the first and only interventional research on
COVID-19 pneumonia outcome in hospitalized male patients
aged ≥50 years. A short course of finasteride administration
partially improves peripheral capillary O
2
saturation.
Finasteride in hospitalized adult males with COVID-19: A risk factor for
severity of the disease or an adjunct treatment: A randomized controlled
clinical trial
Elham Zarehoseinzade1, Abbas Allami1* , Mehrnoosh Ahmadi2, Behzad Bijani1, Navid Mohammadi3,4
Received: 29 Sep 2020 Published: 3 Mar 2021
Abstract
Background: There is controversy about the efficacy of 5-alpha-reductase inhibitors in COVID-19 patients. Some assumed that
finasteride might be a risk factor for deterioration and others proposed it as a possible adjunct treatment for moderate to severe
COVID-19 infection in the elderly.
Methods: We performed a randomized controlled clinical trial (registration ID IRCT20200505047318N1) on 80 hospitalized male
patients aged ≥50 years diagnosed with COVID-19 pneumonia in a tertiary hospital in Qazvin (Iran) from April to July 2020. The
patients were randomized into one of the 2 treatment groups using simple randomization. Treatment group patients underwent routine
drug therapy and 5 mg finasteride once daily for 7 days. The primary endpoint was mortality rate and length of hospital stay (LOS),
and secondary endpoints were peripheral capillary oxygen saturation, respiratory rate, and inflammatory markers changes. The study
protocol was approved by the medical ethics committee of Qazvin University of Medical Sciences (registration ID
IR.QUMS.REC.1399.080). Data were analyzed by statistical tests and SPSS version 25. Also, p<0.05 was considered to be statistically
significant.
Results: We found a significant difference on O
2
saturation among the 2 study groups on fifth day compared with the admission time
(p= 0.018). The results did not show significant differences in mortality rate (2.5% vs 10%; p= 0.166) and LOS (p= 0.866) between
patients in the finasteride and the control group.
Conclusion: A short course of finasteride administration partially improves O2 saturation but does not influence other outcomes in
hospitalized male patients aged ≥50 years with COVID-19 pneumonia. Further research in a large scale with longer follow-up is
required to help clarify the role of finasteride in this setting.
Keywords: Finasteride, Adult, Male, Therapy, COVID-19 Infection
Conflicts of Interest: None declared
Funding: Qazvin University of Medical Sciences (project number: 14004290).
*This work has been published under CC BY-NC-SA 1.0 license.
Copyright© Iran University of Medical Sciences
Cite this article as: Zarehoseinzade E, Allami A, Ahmadi M, Bijani B, Mohammadi N. Finasteride in hospitalized adult males with COVID-19: A
risk factor for severity of the disease or an adjunct treatment: A randomized controlled clinical trial. Med J Islam Repub Iran. 2021 (3 Mar);35:30.
https://doi.org/10.47176/mjiri.35.30
Introduction
In 2020, COVID-19 pneumonia has become a leading
cause of morbidity and mortality in many countries
worldwide, particularly among the elderly (1). Since
COVID-19 was first reported, a worldwide pandemic has
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ensued affecting more than 24 000 000 people as of Sep-
tember 2020. Only oxygen and other supportive care may
help improve outcomes in patients with COVID-19 pneu-
monia and rare pro
gress has been made in the treatment
of COVID patients (2).
During the Covid-19
pandemic, epidemiological reports
unveiled a disproportionate high rate of severe cases and
disease outcomes among adult males compared to adult
females (with short-term follow-up, males have 65%
higher mortality). Also, convalescence from COVID-19
among the elderly takes longer, and complications and
death are also more frequent than in younger adults (3, 4).
Research to date has not yet clearly determined the rea-
son for differences of COVID-19 infection severity and
outcome between adult females and males. This issue was
discussed theoretically in 4 earlier studies (5-8). These
studies have introduced the hypothesis that finasteride has
a beneficial or harm effect on clinical outcomes in adults
with COVID-19 pneumonia. Hoffmann et al propose that
the lower rate of severe COVID-19 infection in female
patients may be attributed to the molecular mechanism
required for SARS-CoV-2 infectivity (ie, lower androgen
receptor (AR) expression in females). SARS-CoV-2 cell
entry depends on priming of a viral spike surface protein
by transmembrane protease serine 2 (TMPRSS2) present
in type II pneumocytes (9). TMPRSS2 expression is asso-
ciated with an increase in AR expression, specifically
connecting AR expression to SARSCoV-2 due to AR-
regulated TMPRSS2 gene promoter (7, 10). Angiotensin-
converting enzyme 2 (ACE2) is the attachment molecule
to the viral spike surface protein “receptor of SARS-CoV-
2”. ACE2 activity has been shown to be reduced by the
decrease of androgen hormones, possibly due to decreased
expression of ACE2 (6). The US Food and Drug Admin-
istration (FDA) approved that 5-alpha reductase inhibitor
(finasteride) demonstrated reduction of activation of AR
in multiple tissues.
In another paper, authors assumed finasteride might in-
crease androgen concentration in lungs hampering their
regeneration. It might result in impairment of spontaneous
regeneration capacity and prolonged or deteriorated re-
covery prognosis. According to the presented hypothesis,
patients receiving 5-alpha-reductase inhibitors (5-ARIs)
might be vulnerable to COVID-19 infection with poorer
prognosis (5).
However, no observational or interventional studies on
the effect of finasteride on the treatment of COVID pneu-
monia was found in our literature review. Taken together,
the evidence warrants further studies to elucidate the role,
if any, of the AR on the severity of COVID-19 infection.
The study aim was to assess the influence of adjunctive
treatment with finasteride on the outcomes of hospitalized
adult male patients with COVID-19 pneumonia.
Methods
Study Design
We conducted a clinical randomized controlled trial in
hospitalized male patients aged 50 years or older, who are
predisposed to higher AR expression and may also be
suffering from benign prostatic hyperplasia (BPH), with
COVID-19 pneumonia. Patients were prospectively en-
rolled between May and June 2020 at BouAli Sina hospi-
tal (a tertiary referral center during the COVID‐19 out-
break), Qazvin, Iran. Patients were considered eligible if
they met the following criteria: (1) provided informed
consent; (2) had clinical symptoms suggestive of COVID-
19 pneumonia, including cough (with or without sputum),
fever, pleuritic chest pain, or dyspnea; (3) chest computed
tomography (CT) scan findings compatible with COVID-
19 or positive real time reverse transcription polymerase
chain reaction RT-PCR of COVID-19; (4) male patients
aged 50 years and older; and (5) moderate and sever dis-
ease.
Patients were excluded from the study if one of the fol-
lowing criteria applied: the presence of severe immuno-
suppression (eg, use of immunosuppressants); malignan-
cy; any likely infection other than COVID-19 pneumonia;
and indications that the patient was unable and/or unlikely
to comprehend and/or follow the protocol; liver function
abnormalities (as finasteride is metabolized extensively in
the liver); and a positive drug history of finasteride medi-
cation or hypersensitivity to any component of this medi-
cation. If there was any violation of the protocol, the pa-
tient was excluded from the final analysis.
We calculated that 40 patients were needed in both
groups to detect a mean difference of 2 days LOS (5±1.7
vs 7±1.7 days) between finasteride and control groups,
with a power of 80% and an alpha level of 0.05 (by statis-
tics and sample size calculator). Formula:
()
22
22
11
12
2
12
r
n
αβ
σ
σ
μμ
−
−


Ζ+Ζ +




≥−
Patients were randomly allocated into 2 therapeutic
groups in a 1:1 ratio to receive either only common care
based on “Iranian Guideline of Hospitalized COVID-19
Patients’ Management (V 5)” or common care plus finas-
teride (as adjuvant). The randomization sequence was
generated using Statistics and Sample Size application
version 1.0. A simple randomized list was produced for a
sample size of 80 and the participants were placed into 2
groups of case and control with numeric sequential unique
identifiers (simple or unrestricted randomization). Forty
patients in case group received a film coated tablet con-
taining 5 mg finasteride (Aburaihan pharmaceutical Co,
Iran) once daily for 7 days.
This study was a partial double-blind study. During the
treatment phase, the investigators could ascertain the pa-
tients’ study-drug assignment (only in the event of an
emergency). During the study, to minimize possible
sources of bias (ie, report more favorable outcomes or
even reporting subjective efficacy endpoints or adverse
effects in patients with previous experience of finasteride
and reporting treatment responses or adverse events by the
observer), patients and health care professionals who were
undertaking the outcome assessment of the primary out-
come were blinded to the group to which the subject was
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assigned.
Clinical data were measured at enrolment. Hypertension
was defined as an average systolic blood pressure (SBP)
greater than or equal to 140 mmHg or an average diastolic
blood pressure (DBP) greater than or equal to 90 mmHg,
or currently using blood pressure (BP)-lowering medica-
tion. A generalized formula of the mean arterial pressure
(MAP) is as follows:
MAP = DP+0.01x exp (4.14-40.74/HR) (SP-DP), where
HR is the heart rate (11).
All patients were treated according to “Iranian Guide-
line of Hospitalized COVID-19 Patients Management
(version 5)”. This comprised a heparin prophylaxis in
combination with a supplemental oxygen and intravenous
or oral fluid therapy. To avoid exaggerated estimates of
treatment effect, baseline and follow-up clinical and para-
clinical data measurement and recording were performed
by nurses with adequate experience. The investigators did
not influence decisions concerning discharge.
The primary endpoint was death/alive status and length
of hospital stay (LOS) and secondary endpoints were pe-
ripheral capillary oxygen saturation, respiratory rate, and
inflammatory markers changes. A CURB-65 severity
score was calculated, and 1 point was given for each fea-
ture present (range, 0–4 points) (12, 13). All patients were
observed and subsequently asked about adverse events.
Renal function assessment was performed on presentation.
Assessment of gas exchange requires knowledge of
fractional inspired oxygen tension (FiO2) unless the pa-
tient is breathing room air. Hence, all peripheral capillary
oxygen saturation was measured in breathing room air at
rest.
This trial was registered with the Iranian Registry of
Clinical Trials website (registration ID
IRCT20200505047318N1). The study protocol was ap-
proved by the medical ethics committee of Qazvin Uni-
versity of Medical Sciences (registration ID
IR.QUMS.REC.1399.080). All participants were provided
with information about the study’s purpose and gave in-
formed consent to participate in the study, according to
the principles of medical ethics of the World Health Or-
ganization and the seventh revision of the Declaration of
Helsinki 2008.
Statistical Analysis
The data were summarized as frequencies or percent-
ages for categorical variables and as medians and inter-
quartile ranges (IQR) (all the variable distributions were
skewed). We compared continuous variables using the
Mann-Whitney test and proportions using the χ2 test or
Fisher’s exact test. Moderation analyses were conducted
using the SPSS macro–PROCESS V 3.5. The PROCESS
macro produces bootstrapped unstandardized regression
output as well as estimates of the effect of the focal pre-
dictor variables (LOS and death/alive status) at values of
the moderator variables (ie, diabetes melitus) (14). P≤0.05
was considered statistically significant. The Statistical
Package for Social Sciences software, version 25.0
(SPSS®, Armonk, NY, USA) was used for data manage-
ment and statistical analysis.
Results
In this study, of the 90 hospitalized male patients diag-
nosed with COVID-19 pneumonia who met the inclusion
Fig. 1. Design Trial
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Finasteride and in-hospital outcome of COVID-19
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criteria, 8 were unwilling to continue the study. The re-
maining 82 patients were randomized, and 2 patients, one
in each group, were excluded due to a positive drug histo-
ry of finasteride. Data from the final 80 randomized pa-
tients were analyzed (Fig. 1). Demographic Information is
presented in Table 1.
Patients were evenly distributed in the 2 groups, except
those with diabetes mellites history; (5 [12.5%] vs 15
[37.5%] patients; p=0.020). Other clinical and paraclinical
features, such as Glasgow coma scale, peripheral capillary
oxygen saturation, white blood cell and platelet count, and
erythrocyte sedimentation rate, were not significantly dif-
ferent between the 2 groups (Table 1).
The results did not show significant differences in mor-
tality rate (1 [2.5%] vs 4 [10.0%]; p=0.166) and LOS
(p=0.866) between patients in the finasteride and the con-
trol groups (Table 2).
We found a significant difference in peripheral capillary
O2 saturation on the fifth day among the 2 study groups
(p=0.016) (Fig. 2).
The results of the binary logistic regression analysis and
linear regression analysis showed diabetes is not a signifi-
cant predictor of the outcome variables (for death/alive
status [model 1 Hayes: Y= death/alive status, X = group
and W = DM; p=0.989] and for LOS [model 1 Hayes: Y=
LOS, X = group and W = DM; p=0.398]).
Two patients developed hospital-acquired pneumonia
and were treated in the intensive care unit (one patient in
each group). Other patients in the finasteride group and in
the control group did not have any treatment-related ad-
verse events.
Discussion
To the best of our knowledge, this clinical trial study
was the first to examine the effects of finasteride as ad-
junctive therapy on outcome, hypoxia, and inflammatory
biomarkers in hospitalized adult male patients with
COVID-19 by assessing clinical and paraclinical parame-
ters. This study may help clinicians to optimize the
COVID infection management to decrease its mortality
and morbidity.
Only patient peripheral capillary O2 saturation on the
fifth day was significantly higher in the finasteride com-
pared with the control group. Finasteride could reduce
hypoxia-inducible factor-1alpha (HIF-1α), which reduces
vascular endothelial growth factor (VEGF), which in turn
reduces micro vessel density (MVD). Finasteride admin-
istration in BPH results in a statistically significant sup-
pression of hypoxia marker in BPH (HIF-1α expression)
(15).
Although a trend towards improved clinical outcomes
was observed in the finasteride group, these differences
were not statistically significant at day 5. Reduction in
LOS is an important goal in the treatment of patients with
COVID-19 pneumonia. In our study, the finasteride group
patients had not shorter LOS than control patients.
One hypothetical study assumed finasteride might be a
risk factor for deterioration of COVID-19 pneumonia in
the elderly (5) and 2 others proposed finasteride admin-
istration as a possible adjunctive treatment (6, 16). Based
Table 1. Baseline Characteristics and Severity Score in the Study Groups
Group
Characteristics Finasteride + Common
regimen (n=40)
Common regimen
(n=40)
Total (n=80) p
Age (year) 71 [62- 81] 72 [65- 77] 72 [64- 78] 0.904
Diabetes mellitus (%) 5 (12.5) 15 (37.5) 20 (25.0) 0.020*
Hypertension (%) 24 (60.0) 29 (72.5) 53 (66.3) 0.344
Cardiac disease (%) 17 (42.5) 14 (35.0) 31 (38.8) 0.646
Chronic obstructive pulmonary disease 3 (7.5) 7 (17.5) 10 (12.5) 0.310
Respiratory rate (breath/min) 18 [18- 20] 19 [18- 20] 19 [18- 20] 0.189
Systolic blood pressure (mmHg) 120 [120- 135] 130 [120- 140] 128 [120- 140] 0.265
Diastolic blood pressure (mmHg) 80 [70- 80] 80 [70- 90] 80 [70- 90] 0.426
Mean Arterial Pressure (mmHg) 96 [92- 103] 97 [91- 109] 96 [91- 106] 0.453
Pulse rate (beats/min) 90 [78- 100] 85 [81- 90] 88 [80- 95] 0.205
Temperature (°C) 36.8 [36.5- 37.8] 36.9 [36.5- 37.2] 36.8 [36.5- 37.4] 0.877
Peripheral capillary O
2
saturation 90 [84- 92] 89 [86- 92] 90 [85- 92] 0.806
Glasgow Coma Scale (GCS) ≤10 3 (7.5) 0 (0.0) 3 (3.9) 0.136
11-12 3 (7.5) 1 (2.5) 4 (5.1)
13-14 4 (10.0) 8 (20.0) 12 (15.0)
15 30 (75.0) 31 (77.5) 61 (76.3)
White blood cells (per mL) 8.0 [4.6- 11.4] 8.9 [6.8- 11.7] 8.4 [6.3- 11.6] 0.187
Absolute Lymphocyte count per μl) 1063 [797- 1441] 1144 [851- 1455] 1116 [821- 1455] 0.498
Platelets count (per ml) 159 [117- 234] 183 [134- 211] 162 [130- 223] 0.557
Erythrocyte sedimentation rate (mm/h) 29 [9- 45] 28 [15- 44] 28 [14- 44] 0.952
C-Reactive Protein (mg/dL) 23 [10- 40] 22 [6- 43] 23 [7- 42] 0.704
Blood Urea Nitrogen (mg/dL) 22 [17- 29] 23 [19- 29] 22 [18- 29] 0.512
Creatinine (mg/dL) 1.0 [0.9- 1.3] 1.1 [0.9- 1.3] 1.1 [0.9- 1.3] 0.615
Risk class (CURB-65) 0 7 (17.5) 1 (2.5) 8 (10.0) 0.443
1 12 (30.0) 16 (40.0) 28 (35.0)
2 18 (45.0) 23 (57.5) 41 (51.2)
3 3 (7.5) 0 (0.0) 3 (3.8)
n (%) or median [IQR]; IQR = Interquartile Range; CURB-65 = Mental Confusion; Urea >20 mg/dL; Respiratory Rate ≥30/min; Low Blood Pressure (diastolic blood
pressure ≤60 mm Hg or systolic blood pressure >90 mm Hg); Age ≥65 years; COVID-19 Pneumonia.
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on our result, a short course administration of finasteride
does not seem to deteriorate outcomes of COVID-19
pneumonia in male adults but even improves peripheral
capillary O2 saturation. Two recent reports are compatible
with our study. In a recent retrospective cohort analysis on
male participants with laboratory confirmed SARS‐CoV‐2
infection, it was demonstrated that males using the 5-ARIs
display drastically reduced symptoms of COVID‐19 dis-
ease in an outpatient setting (17). Another prospective
cohort study was conducted from the data of men hospital-
ized due to COVID-19. The participants were categorized
into 2 cohorts: those taking antiandrogens for at least 6
months or those not taking antiandrogens prior to hospital-
ization. The participants were followed for a period of 60
days from the date of hospitalization. The relative risk for
ICU admission for those taking antiandrogens compared
with the age-matched group was RR 0.19 (16).
Adverse events related to treatment with finasteride in
our study were low and did not differ from the control
group. Adverse effects such as decrease in sexual and gen-
itourinary complications were reported with long-term
finasteride consumption; however, at recommended dos-
ages and duration, finasteride is well-tolerated. Finasteride
is generally well tolerated; adverse reactions are usually
mild and transient (18).
There are a number of limitations in the present study.
Table 2. Length of Hospital Stay, Outcome and Parameters of Disease Severity in Fifth Day Admission Among Male Adults With COVID-19 Pneu-
monia.
Group
n (%) or median [IQR]
Characteristics Finasteride Plus Common regime (n = 40) Common Regimen (n = 40) p
Respiratory rate (breath/min) 18 [17– 18] 18 [17– 18] 0.940*
Systolic blood pressure (mmHg) 115 [103– 120] 120 [110– 130] 0.090*
Diastolic blood pressure (mmHg) 70 [70– 80] 80 [70– 80] 0.074*
Pulse rate (beats/min) 79 [69– 84] 73 [66– 80] 0.126*
Temperature (°C) 36.7 [36.5– 36.8] 36.7 [36.5– 36.9] 0.731*
Peripheral capillary O
2
saturation 92 [89– 94] 89 [86– 92] 0.016*†
White blood cells (per μl) 7100 [5000– 9900] 6900 [5900– 8950] 0.773*
Absolute lymphocyte count (per μl) 1057 [630– 1491] 1312 [1062– 1440] 0.229*
Platelets count (per μl) 200 [165– 254] 195 [157– 237] 0.625*
Erythrocyte sedimentation rate (mm/h) 29 [13– 40] 28 [20– 44] 0.676*
C-Reactive Protein (mg/dL) 18 [5– 50] 28 [20– 40] 0.255*
Blood Urea Nitrogen (mg/dL) 18 [15– 31] 21 [15– 29] 0.602*
Creatinine (mg/dL) 1 [1– 1] 1 [1– 1] 0.670*
Length of hospital stay (day) 10 [6– 16] 10 [6– 14] 0.866*
Length of ICU stay (day) 0 [0– 0] 0 [0– 0] 0.902*
Length of intubation (day) 0 [0– 0] 0 [0– 0] 0.539*
Glasgow Coma Scale (GCS) ≤8 2 (5) 2 (5) 0.730**
9 to 14 8 (17.5) 7 (17.5)
15 31 (77.5) 31 (77.5)
Outcome discharge 39 (97.5) 36 (90) 0.166***
expire 1 (2.5) 4 (10)
* Mann-Whitney U test, ** χ
2
for linear trend, *** χ
2
test, † Significant, IQR = interquartile range.
Fig. 1. Box Plot of the peripheral capillary O
2
saturation trends during hospital admission for the 2 study groups
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Finasteride and in-hospital outcome of COVID-19
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A limitation of the present study was that the finasteride
and dihydrotestosterone levels in our study population was
not directly assessed. The lack of a placebo group necessi-
tated a single-blind design, which may have influenced the
study outcomes. To prevent bias in parameter estimates,
health care professionals who were undertaking primary
outcome assessment did not have a priori knowledge of
group assignment (ie, partially blinded). In addition to,
patients took numerous medications. Also, the follow-up
period was short and in conditions such as COVID-19,
much longer periods are warranted to evaluate lasting
treatment effects. Furthermore, the follow-up period
lacked a control group because of funding constraints.
Additionally, although patients were usually discharged
when they reached the discharge criteria listed in the na-
tional COVID-19 guidelines, various comorbid disease of
patients and their socioeconomic status might influence
the decision-making of physicians.
Conclusion
A
short course of finasteride administration partially
improves peripheral capillary O
2
saturation but does not
influence other outcomes in hospitalized male patients
aged 50 years and older with COVID-19 pneumonia.
Further research in a large scale with longer follow-up is
required to help clarify the role of finasteride in the treat-
ment of COVID-19 pneumonia. Until then, we should be
cautious and not recommend routine administration of
finasteride for COVID-19 treatment.
Acknowledgements
The authors would like to thank the medical and nursing
staff at the BouAli Sina Medical Centre who participated
in the study.
Conflict of Interests
The authors declare that they have no competing interests.
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