Hypothesis
On
January 30, 2020, the World Health Organization (WHO) announced a
global public health emergency of severe acute respiratory
syndrome-coronavirus-2 (SARS-CoV-2) causing illness of coronavirus
disease-2019 (COVID-19) [3].
As of October 1, 2020, worldwide 34,166,633 cases were reported and
1,018,876 have died with virus diagnosis. Interestingly, 99% of the
detected cases with SARS-CoV-2 are asymptomatic or have mild condition,
which contradicts with the virus name (severe acute respiratory syndrome-coronavirus-2) [4].
Although infection fatality rate (number of death cases divided by
number of reported cases) initially seems quite high 0.029 (2.9%) [4],
this overestimation related to limited number of COVID-19 tests
performed which biases towards higher rates. Given the fact that
asymptomatic or minimally symptomatic cases is several times higher than
the number of reported cases, the case fatality rate is considerably
less than 1% [5].
This was confirmed by the head of National Institute of Allergy and
Infectious Diseases from US stating, “the overall clinical consequences
of COVID-19 are similar to those of severe seasonal influenza” [5], having a case fatality rate of approximately 0.1% [5], [6], [7], [8].
In addition, data from hospitalized patients with COVID-19 and general
public indicate that the majority of deaths were among older and
chronically ill individuals, supporting the possibility that the virus
may exacerbates existing conditions but rarely causes death by itself [9], [10].
SARS-CoV-2 primarily affects respiratory system and can cause
complications such as acute respiratory distress syndrome (ARDS),
respiratory failure and death [3], [9].
It is not clear however, what the scientific and clinical basis for
wearing facemasks as protective strategy, given the fact that facemasks
restrict breathing, causing hypoxemia and hypercapnia and increase the
risk for respiratory complications, self-contamination and exacerbation
of existing chronic conditions [2], [11], [12], [13], [14].
Of note, hyperoxia or oxygen supplementation (breathing air with high partial O2
pressures that above the sea levels) has been well established as
therapeutic and curative practice for variety acute and chronic
conditions including respiratory complications [11], [15]. It fact, the current standard of care practice for treating hospitalized patients with COVID-19 is breathing 100% oxygen [16], [17], [18].
Although several countries mandated wearing facemask in health care
settings and public areas, scientific evidences are lacking supporting
their efficacy for reducing morbidity or mortality associated with
infectious or viral diseases [2], [14], [19].
Therefore, it has been hypothesized: 1) the practice of wearing
facemasks has compromised safety and efficacy profile, 2) Both medical
and non-medical facemasks are ineffective to reduce human-to-human
transmission and infectivity of SARS-CoV-2 and COVID-19, 3) Wearing
facemasks has adverse physiological and psychological effects, 4)
Long-term consequences of wearing facemasks on health are detrimental.
Evolution of hypothesis
Breathing Physiology
Breathing
is one of the most important physiological functions to sustain life
and health. Human body requires a continuous and adequate oxygen (O2)
supply to all organs and cells for normal function and survival.
Breathing is also an essential process for removing metabolic byproducts
[carbon dioxide (CO2)] occurring during cell respiration [12], [13]. It is well established that acute significant deficit in O2 (hypoxemia) and increased levels of CO2
(hypercapnia) even for few minutes can be severely harmful and lethal,
while chronic hypoxemia and hypercapnia cause health deterioration,
exacerbation of existing conditions, morbidity and ultimately mortality [11], [20], [21], [22].
Emergency medicine demonstrates that 5–6 min of severe hypoxemia during
cardiac arrest will cause brain death with extremely poor survival
rates [20], [21], [22], [23].
On the other hand, chronic mild or moderate hypoxemia and hypercapnia
such as from wearing facemasks resulting in shifting to higher
contribution of anaerobic energy metabolism, decrease in pH levels and
increase in cells and blood acidity, toxicity, oxidative stress, chronic
inflammation, immunosuppression and health deterioration [24], [11], [12], [13].
Efficacy of facemasks
The
physical properties of medical and non-medical facemasks suggest that
facemasks are ineffective to block viral particles due to their
difference in scales [16], [17], [25].
According to the current knowledge, the virus SARS-CoV-2 has a diameter
of 60 nm to 140 nm [nanometers (billionth of a meter)] [16], [17],
while medical and non-medical facemasks’ thread diameter ranges from
55 µm to 440 µm [micrometers (one millionth of a meter), which is more
than 1000 times larger [25].
Due to the difference in sizes between SARS-CoV-2 diameter and
facemasks thread diameter (the virus is 1000 times smaller), SARS-CoV-2
can easily pass through any facemask [25].
In addition, the efficiency filtration rate of facemasks is poor,
ranging from 0.7% in non-surgical, cotton-gauze woven mask to 26% in
cotton sweeter material [2].
With respect to surgical and N95 medical facemasks, the efficiency
filtration rate falls to 15% and 58%, respectively when even small gap
between the mask and the face exists [25].
Clinical
scientific evidence challenges further the efficacy of facemasks to
block human-to-human transmission or infectivity. A randomized
controlled trial (RCT) of 246 participants [123 (50%) symptomatic)] who
were allocated to either wearing or not wearing surgical facemask,
assessing viruses transmission including coronavirus [26].
The results of this study showed that among symptomatic individuals
(those with fever, cough, sore throat, runny nose ect…) there was no
difference between wearing and not wearing facemask for coronavirus
droplets transmission of particles of >5 µm. Among asymptomatic
individuals, there was no droplets or aerosols coronavirus detected from
any participant with or without the mask, suggesting that asymptomatic
individuals do not transmit or infect other people [26].
This was further supported by a study on infectivity where 445
asymptomatic individuals were exposed to asymptomatic SARS-CoV-2 carrier
(been positive for SARS-CoV-2) using close contact (shared quarantine
space) for a median of 4 to 5 days. The study found that none of the 445
individuals was infected with SARS-CoV-2 confirmed by real-time reverse
transcription polymerase [27].
A meta-analysis
among health care workers found that compared to no masks, surgical
mask and N95 respirators were not effective against transmission of
viral infections or influenza-like illness based on six RCTs [28]. Using separate analysis of 23 observational studies, this meta-analysis found no protective effect of medical mask or N95 respirators against SARS virus [28].
A recent systematic review of 39 studies including 33,867 participants
in community settings (self-report illness), found no difference between
N95 respirators versus surgical masks and surgical mask versus no masks
in the risk for developing influenza or influenza-like illness,
suggesting their ineffectiveness of blocking viral transmissions in
community settings [29].
Another meta-analysis
of 44 non-RCT studies (n = 25,697 participants) examining the potential
risk reduction of facemasks against SARS, middle east respiratory
syndrome (MERS) and COVID-19 transmissions [30]. The meta-analysis
included four specific studies on COVID-19 transmission (5,929
participants, primarily health-care workers used N95 masks). Although
the overall findings showed reduced risk of virus transmission with
facemasks, the analysis had severe limitations to draw conclusions. One
of the four COVID-19 studies had zero infected cases in both arms, and
was excluded from meta-analytic calculation. Other two COVID-19 studies had unadjusted models, and were also excluded from the overall analysis. The meta-analytic
results were based on only one COVID-19, one MERS and 8 SARS studies,
resulting in high selection bias of the studies and contamination of the
results between different viruses. Based on four COVID-19 studies, the meta-analysis
failed to demonstrate risk reduction of facemasks for COVID-19
transmission, where the authors reported that the results of meta-analysis have low certainty and are inconclusive [30].
In
early publication the WHO stated that “facemasks are not required, as
no evidence is available on its usefulness to protect non-sick persons” [14].
In the same publication, the WHO declared that “cloth (e.g. cotton or
gauze) masks are not recommended under any circumstance” [14].
Conversely, in later publication the WHO stated that the usage of
fabric-made facemasks (Polypropylene, Cotton, Polyester, Cellulose,
Gauze and Silk) is a general community practice for “preventing the
infected wearer transmitting the virus to others and/or to offer
protection to the healthy wearer against infection (prevention)” [2].
The same publication further conflicted itself by stating that due to
the lower filtration, breathability and overall performance of fabric
facemasks, the usage of woven fabric mask such as cloth, and/or
non-woven fabrics, should only be considered for infected persons and
not for prevention practice in asymptomatic individuals [2].
The Central for Disease Control and Prevention (CDC) made similar
recommendation, stating that only symptomatic persons should consider
wearing facemask, while for asymptomatic individuals this practice is
not recommended [31].
Consistent with the CDC, clinical scientists from Departments of
Infectious Diseases and Microbiology in Australia counsel against
facemasks usage for health-care workers, arguing that there is no
justification for such practice while normal caring relationship between
patients and medical staff could be compromised [32].
Moreover, the WHO repeatedly announced that “at present, there is no
direct evidence (from studies on COVID-19) on the effectiveness face
masking of healthy people in the community to prevent infection of
respiratory viruses, including COVID-19”[2].
Despite these controversies, the potential harms and risks of wearing
facemasks were clearly acknowledged. These including self-contamination
due to hand practice or non-replaced when the mask is wet, soiled or
damaged, development of facial skin lesions, irritant dermatitis or
worsening acne and psychological discomfort. Vulnerable populations such
as people with mental health disorders, developmental disabilities,
hearing problems, those living in hot and humid environments, children
and patients with respiratory conditions are at significant health risk
for complications and harm [2].
Physiological effects of wearing facemasks
Wearing
facemask mechanically restricts breathing by increasing the resistance
of air movement during both inhalation and exhalation process [12], [13].
Although, intermittent (several times a week) and repetitive (10–15
breaths for 2–4 sets) increase in respiration resistance may be adaptive
for strengthening respiratory muscles [33], [34], prolonged and continues effect of wearing facemask is maladaptive and could be detrimental for health [11], [12], [13]. In normal conditions at the sea level, air contains 20.93% O2 and 0.03% CO2,
providing partial pressures of 100 mmHg and 40 mmHg for these gases in
the arterial blood, respectively. These gas concentrations significantly
altered when breathing occurs through facemask. A trapped air remaining
between the mouth, nose and the facemask is rebreathed repeatedly in
and out of the body, containing low O2 and high CO2 concentrations, causing hypoxemia and hypercapnia [35], [36], [11], [12], [13].
Severe hypoxemia may also provoke cardiopulmonary and neurological
complications and is considered an important clinical sign in
cardiopulmonary medicine [37], [38], [39], [40], [41], [42].
Low oxygen content in the arterial blood can cause myocardial ischemia,
serious arrhythmias, right or left ventricular dysfunction, dizziness,
hypotension, syncope and pulmonary hypertension [43].
Chronic low-grade hypoxemia and hypercapnia as result of using facemask
can cause exacerbation of existing cardiopulmonary, metabolic, vascular
and neurological conditions [37], [38], [39], [40], [41], [42].
summarizes the physiological, psychological effects of wearing facemask and their potential long-term consequences for health.
Table 1
Physiological and Psychological Effects of Wearing Facemask and Their Potential Health Consequences.
Physiological Effects |
Psychological Effect |
Health Consequences |
- • Hypoxemia
- • Hypercapnia
- • Shortness of breath
- • Increase lactate concentration
- • Decline in pH levels
- • Acidosis
- • Toxicity
- • Inflammation
- • Self-contamination
- • Increase in stress hormones level (adrenaline, noradrenaline and cortisol)
- • Increased muscle tension
- • Immunosuppression
|
- • Activation of “fight or flight” stress response
- • Chronic stress condition
- • Fear
- • Mood disturbances
- • Insomnia
- • Fatigue
- • Compromised cognitive performance
|
- • Increased predisposition for viral and infection illnesses
- • Headaches
- • Anxiety
- • Depression
- • Hypertension
- • Cardiovascular disease
- • Cancer
- • Diabetes
- • Alzheimer disease
- • Exacerbation of existing conditions and diseases
- • Accelerated aging process
- • Health deterioration
- • Premature mortality
|
In
addition to hypoxia and hypercapnia, breathing through facemask
residues bacterial and germs components on the inner and outside layer
of the facemask. These toxic components are repeatedly rebreathed back
into the body, causing self-contamination. Breathing through facemasks
also increases temperature and humidity in the space between the mouth
and the mask, resulting a release of toxic particles from the mask’s
materials [1], [2], [19], [26], [35], [36].
A systematic literature review estimated that aerosol contamination
levels of facemasks including 13 to 202,549 different viruses [1]. Rebreathing contaminated air with high bacterial and toxic particle concentrations along with low O2 and high CO2 levels continuously challenge the body homeostasis, causing self-toxicity and immunosuppression [1], [2], [19], [26], [35], [36].
A
study on 39 patients with renal disease found that wearing N95 facemask
during hemodialysis significantly reduced arterial partial oxygen
pressure (from PaO2 101.7 to 92.7 mm Hg), increased
respiratory rate (from 16.8 to 18.8 breaths/min), and increased the
occurrence of chest discomfort and respiratory distress [35].
Respiratory Protection Standards from Occupational Safety and Health
Administration, US Department of Labor states that breathing air with O2
concentration below 19.5% is considered oxygen-deficiency, causing
physiological and health adverse effects. These include increased
breathing frequency, accelerated heartrate and cognitive impairments
related to thinking and coordination [36].
A chronic state of mild hypoxia and hypercapnia has been shown as
primarily mechanism for developing cognitive dysfunction based on animal
studies and studies in patients with chronic obstructive pulmonary
disease [44].
The
adverse physiological effects were confirmed in a study of 53 surgeons
where surgical facemask were used during a major operation. After 60 min
of facemask wearing the oxygen saturation dropped by more than 1% and
heart rate increased by approximately five beats/min [45].
Another study among 158 health-care workers using protective personal
equipment primarily N95 facemasks reported that 81% (128 workers)
developed new headaches during their work shifts as these become
mandatory due to COVID-19 outbreak. For those who used the N95
facemask greater than 4 h per day, the likelihood for developing a
headache during the work shift was approximately four times higher [Odds
ratio = 3.91, 95% CI (1.35–11.31) p = 0.012], while 82.2% of the N95
wearers developed the headache already within ≤10 to 50 min [46].
With
respect to cloth facemask, a RCT using four weeks follow up compared
the effect of cloth facemask to medical masks and to no masks on the
incidence of clinical respiratory illness, influenza-like illness and
laboratory-confirmed respiratory virus infections among 1607
participants from 14 hospitals [19].
The results showed that there were no difference between wearing cloth
masks, medical masks and no masks for incidence of clinical respiratory
illness and laboratory-confirmed respiratory virus infections. However, a
large harmful effect with more than 13 times higher risk [Relative
Risk = 13.25 95% CI (1.74 to 100.97) was observed for influenza-like
illness among those who were wearing cloth masks [19].
The study concluded that cloth masks have significant health and safety
issues including moisture retention, reuse, poor filtration and
increased risk for infection, providing recommendation against the use
of cloth masks [19].
Psychological effects of wearing facemasks
Psychologically,
wearing facemask fundamentally has negative effects on the wearer and
the nearby person. Basic human-to-human connectivity through face
expression is compromised and self-identity is somewhat eliminated [47], [48], [49].
These dehumanizing movements partially delete the uniqueness and
individuality of person who wearing the facemask as well as the
connected person [49].
Social connections and relationships are basic human needs, which
innately inherited in all people, whereas reduced human-to-human
connections are associated with poor mental and physical health [50], [51].
Despite escalation in technology and globalization that would
presumably foster social connections, scientific findings show that
people are becoming increasingly more socially isolated, and the
prevalence of loneliness is increasing in last few decades [50], [52]. Poor social connections are closely related to isolation and loneliness, considered significant health related risk factors [50], [51], [52], [53].
A meta-analysis
of 91 studies of about 400,000 people showed a 13% increased morality
risk among people with low compare to high contact frequency [53]. Another meta-analysis
of 148 prospective studies (308,849 participants) found that poor
social relationships was associated with 50% increased mortality risk.
People who were socially isolated or fell lonely had 45% and 40%
increased mortality risk, respectively. These findings were consistent
across ages, sex, initial health status, cause of death and follow-up
periods [52].
Importantly, the increased risk for mortality was found comparable to
smoking and exceeding well-established risk factors such as obesity and
physical inactivity [52]. An umbrella review of 40 systematic reviews including 10 meta-analyses
demonstrated that compromised social relationships were associated with
increased risk of all-cause mortality, depression, anxiety suicide,
cancer and overall physical illness [51].
As
described earlier, wearing facemasks causing hypoxic and hypercapnic
state that constantly challenges the normal homeostasis, and activates
“fight or flight” stress response, an important survival mechanism in
the human body [11], [12], [13]. The acute stress response includes activation of nervous, endocrine, cardiovascular, and the immune systems [47], [54], [55], [56].
These include activation of the limbic part of the brain, release
stress hormones (adrenalin, neuro-adrenalin and cortisol), changes in
blood flow distribution (vasodilation of peripheral blood vessels and
vasoconstriction of visceral blood vessels) and activation of the immune
system response (secretion of macrophages and natural killer cells) [47], [48].
Encountering people who wearing facemasks activates innate stress-fear
emotion, which is fundamental to all humans in danger or life threating
situations, such as death or unknown, unpredictable outcome. While acute
stress response (seconds to minutes) is adaptive reaction to challenges
and part of the survival mechanism, chronic and prolonged state of
stress-fear is maladaptive and has detrimental effects on physical and
mental health. The repeatedly or continuously activated stress-fear
response causes the body to operate on survival mode, having sustain
increase in blood pressure, pro-inflammatory state and immunosuppression
[47], [48].
Long-Term health consequences of wearing facemasks
Long-term
practice of wearing facemasks has strong potential for devastating
health consequences. Prolonged hypoxic-hypercapnic state compromises
normal physiological and psychological balance, deteriorating health and
promotes the developing and progression of existing chronic diseases [23], [38], [39], [43], [47], [48], [57], [11], [12], [13].
For instance, ischemic heart disease caused by hypoxic damage to the
myocardium is the most common form of cardiovascular disease and is a
number one cause of death worldwide (44% of all non-communicable
diseases) with 17.9 million deaths occurred in 2016 [57]. Hypoxia also playing an important role in cancer burden [58].
Cellular hypoxia has strong mechanistic feature in promoting cancer
initiation, progression, metastasis, predicting clinical outcomes and
usually presents a poorer survival in patients with cancer. Most solid
tumors present some degree of hypoxia, which is independent predictor of
more aggressive disease, resistance to cancer therapies and poorer
clinical outcomes [59], [60].
Worth note, cancer is one of the leading causes of death worldwide,
with an estimate of more than 18 million new diagnosed cases and 9.6
million cancer-related deaths occurred in 2018 [61].
With
respect to mental health, global estimates showing that COVID-19 will
cause a catastrophe due to collateral psychological damage such as
quarantine, lockdowns, unemployment, economic collapse, social
isolation, violence and suicides [62], [63], [64].
Chronic stress along with hypoxic and hypercapnic conditions knocks the
body out of balance, and can cause headaches, fatigue, stomach issues,
muscle tension, mood disturbances, insomnia and accelerated aging [47], [48], [65], [66], [67].
This state suppressing the immune system to protect the body from
viruses and bacteria, decreasing cognitive function, promoting the
developing and exacerbating the major health issues including
hypertension, cardiovascular disease, diabetes, cancer, Alzheimer
disease, rising anxiety and depression states, causes social isolation
and loneliness and increasing the risk for prematurely mortality [47], [48], [51], [56], [66].