Wang y Cols
Wang y Cols
  Abstract
  Background: The importance of breastfeeding for maternal and child health is agreed upon worldwide. However,
  lactation-related nipple problems are common and are important factors affecting breastfeeding. Multiple studies
  recommended laid-back breastfeeding, but they are of various levels of quality, and the results are inconclusive.
  Methods: We systematically searched the following twelve databases from inception to January 28,2020: Cochrane
  Library, EMBASE, Medline, Ovid, PubMed, Web of Science, CINAHL, Scopus, Chinese National Knowledge
  Infrastructure (CNKI), China Biology Medicine disc (CBM), WanFang, and VIP. All studies regarding laid-back
  breastfeeding or biological nurturing were considered, regardless of whether they were randomized controlled
  trials. Two trained investigators independently evaluated the quality of the selected articles and screened the data.
  All the data were analysed separately using Review Manager Version 5.3 and STATA/SE Version 15.1.
  Results: A total of 12 studies involving 1936 groups of postpartum women and their newborns were included. The
  results of the meta-analysis showed that nipple pain (RR = 0.24; 95% CI 0.14, 0.40; p < 0.00001), nipple trauma (RR =
  0.47; 95% CI 0.29, 0.75; p = 0.002) and correct latching position (RR = 1.22; 95% CI 1.11, 1.33; p < 0.0001) in the
  experimental groups were all better than those of the control groups, and the differences were statistically
  significant (p < 0.05), which indicates that the laid-back position has a positive effect on maternal breastfeeding.
  However, the results of position comfort showed that there was no statistical significance between the two groups
  (ES = 0.09; 95% CI -0.63, 0.81; p = 0.798).
  Conclusion: Compared with traditional breastfeeding positions, the laid-back position has been proven to be
  related to a decreased incidence of nipple pain and nipple trauma and is seemingly conducive to the use of the
  correct latching position. It is suggested that the laid-back position is helpful in solving lactation-related nipple
  problems and can be recommended as a position for breastfeeding. However, no significant difference in position
  comfort was found between the two groups based on the current evidence, and further studies are still needed to
  validate these results due to the limitations of the included studies.
  Keywords: Breastfeeding, Biological nurturing, Laid-back breastfeeding, Meta-analysis
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Wang et al. BMC Pregnancy and Childbirth   (2021) 21:248                                                       Page 2 of 14
position, including the cradle, cross-cradle, side-lying      Disagreements were resolved by discussion with all
and football positions, were used; (2) the effects of the     members of the research team until a consensus was
intervention were assessed as the incidence of nipple         reached.
pain, nipple trauma, correct latching position and pos-
ition comfort; and (3) a clinical study design, including     Quality assessment
randomized controlled trials (RCTs) and quasi-                The risk of bias (RoB) of each RCT was evaluated inde-
randomized controlled trials (Q-RCTs), was used.              pendently by two investigators using the RoB 2.0 tool ob-
    Studies were excluded if they (1) were not focused on     tained from the Cochrane Handbook for Systematic
the effectiveness of the laid-back position on lactation-     Reviews of Interventions (Version 62,019) [23], which in-
related nipple problems and comfort; (2) had no full text     cluded the following domains: bias arising from the
available; (3) reported unextractable or unrelated raw        randomization process, bias due to deviations from
data and the authors could not be contacted; (4) were         intended interventions, bias due to missing outcome data,
published other than in English or Chinese; and (5) were      bias in measurement of the outcome, and bias in selection
reviews, editorials, books, theses, news, etc.                of the reported result. For each domain, the tool com-
                                                              prises a series of “signalling questions”, and once they
Search strategy                                               were answered, the next step was to reach a risk-of-bias
We systematically searched the following twelve data-         judgement and assign one of three levels to each domain
bases from inception to January 28,2020: Cochrane Li-         [23, 24]: “low risk of bias”, “some concerns”, or “high risk
brary, EMBASE, Medline, Ovid, PubMed, Web of                  of bias”. Finally, risk-of-bias judgements within domains
Science, CINAHL, Scopus, Chinese National Knowledge           were mapped to an overall judgement for the outcome.
Infrastructure (CNKI), China Biology Medicine disc            The risk of bias of each quasi-randomized controlled trial
(CBM), WanFang and VIP. The search was carried out            was evaluated independently by two investigators using
using the following keywords or medical subject head-         the JBI Critical Appraisal Checklist for Quasi-
ings: [“breast-feed” OR “Feeding, Breast” OR “Breast-         Experimental Studies (JBI, 2016) [25] by assigning “Yes”,
feeding” OR “Breast Feeding, Exclusive” OR “Exclusive         “No”, “Unclear” or “Not applicable” for each of the 9
Breast Feeding” OR “Breastfeeding, Exclusive” OR “Ex-         items. Any disagreements regarding the inclusion of stud-
clusive Breastfeeding” OR “Breast-feeding”] AND [“Laid-       ies were resolved through discussion; if a consensus could
back” OR “Half lay” OR “Semi recumbent position” OR           not be reached, a senior reviewer served as the final
“Semi-reclining position” OR “semirecumbent” OR “Half         arbiter.
lying type” OR “semi supine position” OR “semiprone
position”] OR [“Biological Nurturing” OR “recommend-          Statistical analysis
ing biological breeding” OR “Laid-back Breastfeeding”         Statistical analyses were performed with Review Man-
OR “Laid-back breast feeding” OR “Half lay breast-            ager Version 5.3 and STATA/SE Version 15.1 (Stata-
feeding”]. To obtain a full understanding of this topic,      Corp, College Station, TX, USA). To eliminate man-
we also manually tracked the references in the included       made errors and combine the functions of the different
articles and contacted investigators in the field to locate   software programs, all the data were analysed separately
unpublished studies, but none were available. The search      by two investigators using different programs (ZW:
strategies are listed in Additional file 2.                   STATA/SE and QL: RevMan). Dichotomous outcome
                                                              data were pooled using the risk ratio (RR) and presented
Data extraction and synthesis                                 as the 95% confidence interval (CI), and continuous out-
Two reviewers independently assessed the studies for eli-     come data are presented as the mean ± standard devi-
gibility and extracted the data using a standardized data     ation (SD) and were pooled using the mean difference
extraction form, which was then checked by the third re-      (MD) and 95% CI. For data for the same outcome pre-
viewer. Disagreements were resolved via discussion with       sented in some studies as dichotomous data and in other
the third author. Studies selected for inclusion were         studies as continuous data (for example, position com-
transferred to a Microsoft Excel spreadsheet for extrac-      fort), we re-expressed the odds ratios as standard mean
tion of data items of: basic information from the in-         differences (SMDs) according to the simple formula
cluded literature (first author, year of publication, study   SMD = logor×(√3/π = 0.5513), computing them (or the
design), baseline characteristics (sample size, inclusion     log odds ratios) and their standard errors for all studies
and exclusion criteria, delivery mode, maternal category,     in the meta-analysis and allowing dichotomous and con-
gestational weeks, age mothers) and analysis indexes (in-     tinuous data to be combined by using the generic
terventions, intervention time, outcomes). When infor-        inverse-variance method [26, 27].
mation regarding the study methods and results was              Heterogeneity was assessed statistically by using the
unclear, we contacted the authors for further details.        Chi2 (χ2, or chi-squared) test and the I2 statistic. When
Wang et al. BMC Pregnancy and Childbirth   (2021) 21:248                                                        Page 4 of 14
p > 0.10 or I2 ≤ 50%, the results of the associated studies      included studies were reported in English (one trial) and
were said to be homogenous or to have acceptable het-            Chinese (eleven trials). No significant difference was ob-
erogeneity, and a fixed-effects model was utilized. When         served between the two groups in terms of the studied
p ≤ 0.10 or I2 > 50%, it was considered that there was           variables. All the included studies were published from
heterogeneity in the results of the multiple included            2017 to 2019. The intervention period of the included
studies, and subgroup analysis or sensitivity analysis was       studies lasted from 3 days to 8 weeks. The age of the in-
performed to identify the sources of heterogeneity.              fants was estimated to be 0–3 days according to the
Then, the selected studies were removed one by one,              starting time of the intervention. The outcomes included
and the overall correlation results and I2 were recalcu-         nipple trauma (n = 7), nipple pain (n = 8), correct latch-
lated. A random-effects model was selected if the hetero-        ing position (n = 3) and position comfort (n = 4). We
geneity could not be eliminated. To assess the effects of        established three subgroups based on intervention, deliv-
covariates on the pooled estimates, subgroup analysis            ery mode and maternal category. Studies were divided
and meta-regression analysis were conducted [28, 29]. If         into two groups according to whether they implemented
there was considerable variation in the results that could       skin-to-skin care (SSC) [36]; in other words, whether the
not be removed, the meta-analysis was abandoned, and             mother and baby had direct skin contact. In the sub-
the evidence was presented in a narrative form only.             grouping based on intervention, the studies were divided
  Publication bias was detected using Egger’s linear re-         into the “LBBF” group and the “LBBF+SSC” group ac-
gression test [30] since no more than 10 original articles       cording to whether the skin-to-skin care was performed
were enrolled in any analysis. p-values (two–tailed) <           on the basis of laid-back breastfeeding. In the subgroup-
0.05 were considered statistically significant. For studies      ing based on maternal delivery mode, the studies were
with publication bias, we conducted sensitivity analyses         divided into the “vaginal delivery” group and the “vaginal
(trim and fill method) to explore the publication bias           delivery & caesarean” group. In the subgrouping based
and the robustness of the meta-analysis conclusions to           on maternal category, the studies were divided into the
different assumptions about the causes of the funnel plot        “primipara” group and the “primipara & multipara”
asymmetry [31–35].                                               group according to whether the delivery times were re-
                                                                 stricted. Further details about the included studies are
Results                                                          shown in Table 1.
Search results
The literature selection process is shown in the PRISMA          Risk of bias assessment
flow diagram [22] (Fig. 1), including the reasons for exclu-     The quality of all included RCT studies is shown in
sion. Initially, a total of 296 publications were retrieved      Table 2 and Fig. 2. For the judgement of “bias arising
from the following 12 electronic databases: Cochrane Li-         from the randomization process”, five [37–41] of the 11
brary (n = 7), EMBASE (n = 13), Medline (n = 14), Ovid           included RCTs did not show detailed information on the
(n = 122), PubMed (n = 12), Web of Science (n = 31),             random components in the sequence generation process,
CINAHL (n = 22), Scopus (n = 11), CNKI (n = 18), CBM             eight studies [37–44] were judged to raise some con-
(n = 13), WanFang (n = 17) and VIP (n = 16). A search of         cerns, and three studies [45–47] were judged to have a
the reference lists of the included studies yielded no add-      low risk of bias. They concealed the allocation sequence
itional studies. After eliminating duplicates, 214 references    with opaque envelopes that were sequentially numbered
were included. Then, the remaining 214 studies were              and sealed with a tamper-proof seal. With regard to the
screened through their titles and abstracts, excluding an        judgement of “bias due to deviations from intended in-
additional 179 articles. The remaining 35 articles were          terventions”, only two studies [46, 47] reported compli-
screened through their full texts, of which 22 were ex-          ance with the intervention, and they were judged to have
cluded because they were not appropriate study designs           a low risk of bias. All included studies were judged to be
(n = 18) or interventions (n = 4). Moreover, one article was     at low risk of bias in the judgement of “bias due to miss-
excluded because the data were difficult to extract, and we      ing outcome data”. For the judgement of “bias in meas-
were unable to contact the author. Finally, 12 articles ful-     urement of the outcome”, three studies [39, 41, 45] were
filled the eligibility criteria and were included in the meta-   judged to raise some concerns, and the others [37, 38,
analysis.                                                        40, 42–44, 46, 47] were judged to have a low risk of bias.
                                                                 For the judgement of “bias in selection of the reported
Characteristics of the included studies                          result”, one study [45] was judged to have raised some
Twelve studies met the inclusion criteria, including             concerns because the trial did not perform the analysis
eleven RCTs and one quasi-randomized controlled trial            in accordance with a pre-specified plan, and ten studies
and consisting of 1936 participants (970 in the experi-          [37–44, 46, 47] were judged to have a low risk of bias.
mental groups and 966 in the control groups). The                Overall, three RCTs (27%) had a high RoB, six (55%)
Wang et al. BMC Pregnancy and Childbirth       (2021) 21:248                                                                          Page 5 of 14
 Fig. 1 PRISMA flow diagram of the literature search and study selection. *Twelve papers were included in meta-analysis. #Eleven studies were
 included in RCTs, and one study was a Q-RCT
showed some concerns, and two (18%) had a low RoB                          source of the heterogeneity. After removing it, the result
for their outcomes. The quality of the one quasi-                          of the heterogeneity test with the remaining 7 studies
randomized controlled trial included is presented in                       decreased I2 to 73% (χ2 = 22.46, p = 0.001, I2 = 73%).
Table 3.                                                                   Therefore, a random-effects model was utilized for the
                                                                           meta-analysis, and the results showed that the experi-
Synthesis of results                                                       mental group had a lower incidence of nipple pain than
Nipple pain                                                                the control group (RR = 0.24; 95% CI 0.14, 0.40; p <
Eight studies [37–39, 41–44, 46], with a total of 1076                     0.00001) (Fig. 3). It is worth mentioning that the result
pairs of postpartum women and their newborns, com-                         of the heterogeneity test decreased I2 to 0% (χ2 = 2.02,
pared traditional breastfeeding positions vs. laid-back                    p = 0.85, I2 = 0%) after removing the two studies [43, 46],
breastfeeding in terms of nipple pain. There was sub-                      probably because of the different measurement tools
stantial heterogeneity among these studies (χ2 = 125.27,                   used in the included studies.
p < 0.00001, I2 = 94%) according to the heterogeneity
test. It seems that one outlier [43] had a substantial in-                 Nipple trauma
fluence on the results of the overall meta-analysis ac-                    Seven studies [37–41, 45, 48], which included 1274 pairs
cording to sensitivity analyses and was thus a major                       of postpartum women and their newborns, reported
Wang et al. BMC Pregnancy and Childbirth      (2021) 21:248                                                                     Page 6 of 14
nipple trauma. The results of the heterogeneity test for                        incidence of nipple trauma than the control group (RR =
these studies showed that there was substantial hetero-                         0.47; 95% CI 0.29, 0.75; p = 0.002) (Fig. 4).
geneity (χ2 = 40.95, p < 0.00001; I2 = 85%), probably be-
cause of the different interventions used. However, the                         Correct latching position
sensitivity analyses did not show any study to substan-                         Three studies [38, 46, 48], which included 452 pairs of
tially influence the heterogeneity. Thus, a random-effects                      postpartum women and their newborns, reported on the
model was utilized for the meta-analysis, and the results                       correct latching position. The incidence of using the cor-
showed that the experimental group had a lower                                  rect position for latching did not significantly differ
Table 2 Results of critical appraisal for Randomized Controlled Trials (Cochrane, 2019)
Study (year)       Bias arising from the     Bias due to deviations          Bias due to     Bias in                    Bias in selection of   Overall
                   randomization             from intended                   missing outcome measurement of             the reported result    risk-of-
                   process                   interventions                   data            the outcome                                       bias
Zhuang (2019)      Some concerns             Some concerns                   Low risk               Low risk            Low risk               Some
[37]                                                                                                                                           concerns
Shi et al. (2017) Some concerns              Some concerns                   Low risk               Some concerns       Low risk               High risk
[38]
Li et al. (2017)   Some concerns             Some concerns                   Low risk               Low risk            Low risk               Some
[39]                                                                                                                                           concerns
Yu et al. (2019)   Some concerns             Some concerns                   Low risk               Low risk            Low risk               Some
[40]                                                                                                                                           concerns
Zeng et al.        Some concerns             Some concerns                   Low risk               Low risk            Low risk               Some
(2019) [41]                                                                                                                                    concerns
Puapornpong        Low risk                  Low risk                        Low risk               Low risk            Low risk               Low risk
et al. (2017)
[42]
Liu et al. (2019) Some concerns              Some concerns                   Low risk               Low risk            Low risk               Some
[43]                                                                                                                                           concerns
Zhang (2019)       Low risk                  Low risk                        Low risk               Low risk            Low risk               Low risk
[44]
Zhao (2019)        Some concerns             Some concerns                   Low risk               Low risk            Low risk               Some
[45]                                                                                                                                           concerns
Liang et al.       Low risk                  Some concerns                   Low risk               Some concerns       Some concerns          High risk
(2017) [46]
Wang (2019)        Some concerns             Some concerns                   Low risk               Some concerns       Low risk               High risk
[47]
Wang et al. BMC Pregnancy and Childbirth   (2021) 21:248                                                  Page 8 of 14
between the two groups (χ2 = 0.09, p = 0.95, I2 = 0%), so   Position comfort
we used a fixed-effect model to pool the summary out-       Four studies [38, 40, 47, 48] reported data on position
come. The results showed that the experimental group        comfort, and these studies included 660 pairs of postpar-
had a higher incidence of using the correct position for    tum women and their newborns. There were two dichot-
latching than the control group (RR = 1.22; 95% CI 1.11,    omous data [38, 48] and two continuous data [40, 47]
1.33; p < 0.0001) (Fig. 5).                                 among them. The results of the heterogeneity test
Wang et al. BMC Pregnancy and Childbirth           (2021) 21:248                                                                    Page 9 of 14
 Fig. 3 Forest plot for the incidence of nipple pain between the laid-back position and the traditional position in breastfeeding
Wang et al. BMC Pregnancy and Childbirth        (2021) 21:248                                                                         Page 10 of 14
Fig. 4 Forest plot for the incidence of nipple trauma between the laid-back position and the traditional position in breastfeeding
quantitatively because concern remains that visual inter-                      Nipple pain is reported as one of the main causes of
pretation of the funnel plots is inherently subjective. The                  abandoning breastfeeding prematurely [49, 50]. Most
p-values for the correct latching position (p = 0.152) and                   women experience some degree of pain during breast-
position comfort (p = 0.138) were greater than 0.05,                         feeding, ranging from mild to severe, which may be ac-
which indicates that there is no significant publication                     companied by nipple trauma. Our meta-analysis showed
bias. Although the p-values for nipple pain (p = 0.008)                      that the experimental group had a lower incidence of
and nipple trauma (p = 0.013) were less than 0.05, there                     nipple pain than the control group (13.8% vs. 55.1%,
were no missing ‘counterparts’ to fill after the data were                   RR = 0.24; 95% CI 0.14, 0.40; p < 0.00001). This result is
analysed by the trim and fill method. This indicates that                    similar to a study carried out in Italy [51], which re-
the results of the two outcomes are stable and that the                      ported that biological nurturing significantly reduced the
effect of publication biases is negligible. In summary, the                  risk of sore nipples from 46.9 to 27.8% (RR 0.59, 95% CI
results showed no significant risk of publication bias                       0.40, 0.88). These results may be explained by a higher
among the included studies.                                                  proportion of successful latching and self-attachment
                                                                             with the laid-back position [51]. Nipple pain was mea-
                                                                             sured on a rating scale that was developed based on the
Discussion                                                                   characteristics of the general population. No unified and
This meta-analysis was conducted to estimate the effect                      specialized comprehensive assessment scale for nipple
of the laid-back position on lactation-related nipple                        pain has been formed.
problems. The results of this study showed that the ex-                        Nipple trauma is the main cause of nipple pain, and it
perimental group had a lower incidence of nipple                             is a well-recognized risk factor for breastfeeding cessa-
trauma (22.4% vs. 38.5%) and nipple pain (13.8% vs.                          tion [50]. Our results suggest that BN reduced the inci-
55.1%) than the control group. This suggests that the                        dence of nipple trauma by 16.1% (RR = 0.47; 95% CI
laid-back position has a positive effect on maternal                         0.29, 0.75; p = 0.002). Nipple trauma includes nipple red-
breastfeeding with regard nipple pain, nipple trauma and                     ness and swelling, cracks, blisters, ulcers, keratinization
the correct position of latching. Further study regarding                    and defects [46]. Nipple cracks were the most common
position comfort remains to be conducted.                                    type of nipple trauma in this study, and 4 studies [37,
 Fig. 5 Forest plot for the correct latching position between the laid-back position and the traditional position in breastfeeding
Wang et al. BMC Pregnancy and Childbirth        (2021) 21:248                                                                             Page 11 of 14
Fig. 6 Forest plot for the position comfort between the laid-back position and the traditional position in breastfeeding
40, 41, 45] showed that the laid-back position could help                   mother’s perception of an inadequate milk supply and
to reduce the incidence of nipple cracks compared with                      difficulty with latching [54]. This study indicated that
the traditional position (4.2% vs. 19.8%). Nipple trauma                    BN increased the success rate of “establishing the correct
causes pain and discomfort, which render it difficult for                   latching position” with an RR of 1.22 (95% CI 1.11, 1.33;
the mother to continue breastfeeding [52]. Nipple pain                      p < 0.00001). The laid-back position is conducive to
and nipple trauma exert an influence on each other. An                      obtaining the correct position of latching (89.5% in the
improper feeding position can interfere with the tissue                     intervention group and 73.7% in the control group),
repair process and can lead to further damage [12]. We                      which may contribute to successful breastfeeding. How-
should pay greater attention to the evaluation of these                     ever, this conclusion should be treated with caution be-
two aspects of breastfeeding.                                               cause only three trials [38, 46, 48] were included.
  Correction of positioning and latching is the most                           Position comfort in this study is regarded theoretically
common experience-based recommendation for the                              as a state of strengthening by having the needs of human
treatment of nipple pain [53]. A qualitative analysis to                    experience met, which causes mothers to be happy with
identify breastfeeding barriers in the early postpartum                     their health care in the process of breastfeeding [55]. It
period found that the most common barrier was the                           is unclear from this study whether the laid-back position
is superior to the traditional position regarding comfort                     the whole process. Thus, we should focus on this issue
in the period of breastfeeding, because the available                         in future studies and take measures to ensure compli-
current evidence did not reveal a significant difference                      ance, such as videotaping with informed consent.
in position comfort between the two groups. This could                          All the data were analysed separately by two investiga-
be due to the small sample size of the included studies                       tors using different software programs. The results show
or the different types of data, which weakens the assess-                     that this method can effectively avoid human errors such
ment of the results of the meta-analysis. Thus, additional                    as data entry errors and improper operation, and it also
research about the effect of the laid-back position on                        combines the functions of the different programs. We
position comfort should be conducted in the future.                           found that, in practice, the I2 and Z values of the con-
  Breastfeeding is a biology-based nurturing method                           tinuous variables obtained by the two software programs
rooted in human instinct [21]. Laid-back breastfeeding                        were slightly different, but this did not affect the out-
can be adopted even if there is early separation after birth                  comes, which is probably related to the algorithms used
or the mother is suffering from problems with breastfeed-                     by the software; all other results from the programs were
ing. The National Childbirth Trust (NCT) breastfeeding                        identical.
counsellor Ros Vinall [56] considers that biological nurt-
uring or “laid-back breastfeeding” taps into the mothers’                     Limitation
and babies’ own instincts to successfully perform breast-                     The present meta-analysis has some potential limita-
feeding. She also highlighted that BN approach can re-                        tions: (1) We considered all RCTs and quasi-randomized
move breastfeeding from the medical model, with its need                      controlled trials published in English and Chinese; stud-
for instruction and prescriptive rules. Colson’s research                     ies published in other language were not included, lead-
emphasizes the biological underpinnings of breastfeeding,                     ing to potential selection bias; (2) The heterogeneity for
empowering parents to be active participants in feeding                       certain comparations was significant, which may have
rather than merely relying on the instincts of the infant                     influenced the pooled results, despite our using a
[21]. Laid-back breastfeeding is a revelation for human be-                   random-effects model; (3) Three subgroups analyses
ings, as it accords with our humanist, non-interventionist                    were performed according to intervention, delivery mode
and back-to-biological spirit.                                                and maternal category, but other factors that could in-
  The quality of the included studies was moderate, and                       fluence the outcomes might be present; and (4) In this
the results should be interpreted with caution. Many of                       study, only quantitative indicators were analysed, and
the original studies implemented a single-blind design.                       the vast majority of the included studies were published
The nurses who followed up with the breastfeeding out-                        in Chinese, because most of the studies obtained from
comes did not know the breastfeeding position groups,                         the search were qualitative reports written in other
and none of the included studies reported whether the                         countries.
researchers who analysed data knew which was the ex-
perimental group. Few of the original studies reported                        Conclusions
compliance with the intervention. The reason might be                         The results of this meta-analysis suggest that the laid-
that breastfeeding is a private activity, and researchers                     back position is helpful for solving lactation-related nip-
can only provide guidance, making it difficult to monitor                     ple problems and can be used as a recommended
Wang et al. BMC Pregnancy and Childbirth            (2021) 21:248                                                                                  Page 13 of 14
based on the current evidence. Further high-quality and                          Received: 6 July 2020 Accepted: 15 March 2021
large-scale studies are needed to validate these results
due to the limitations of the included studies.
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