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Lack of association between endocrine disrupting chemicals and male fertility: A systematic review and meta-analysis.
Martínez, MÁ, Marquès, M, Salas-Huetos, A, Babio, N, Domingo, JL, Salas-Salvadó, J
Environmental research. 2023;217:114942
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Exposure to natural or synthetic chemicals is directly related to environmental conditions, dietary and other lifestyle factors. Some of these chemicals are named endocrine disrupting chemicals (EDCs) because of their capability to interfere with the endocrine system. The aim of this study was to summarise and explore the association between exposure to EDCs and human male fertility indicators. This study is a systematic review and meta-analysis of seven studies; 4 assessed bisphenol A (BPA) in urine and sperm quality parameters, while 3 articles evaluated PCB153 [polychlorinated biphenyls] in serum and sperm quality parameters. Results show that there weren’t any positive or inverse associations between BPA or PCB153 and the sperm parameters analysed. Authors conclude that the systematic review showed a high disparity between studies, making difficult a consensus on the possible detrimental effect of the 12 groups of EDCs on male fertility. Thus, no conclusive statements can be drawn. Further studies are needed in order to provide more robust data.
Abstract
The incidence of infertility currently affects about 15% of the world's population. Male factors are estimated to be responsible for up to 40-50% of these cases. While the cause of these reproductive disorders is still unclear, the exposure to a family of ubiquitous compounds in our daily life, named endocrine disrupting chemicals (EDCs) could be involved. This paper was aimed at performing a systematic review and meta-analysis of population studies exploring whether human male exposure to EDCs affects male fertility. Clinical and observational studies assessing the exposure to EDCs along with sperm quality, the most common reproductive disorders, sperm DNA damage, sperm oxidative stress, fertilization rate, implantation rate, clinical pregnancy rate, live birth rate, and miscarriage rate were included. The quality assessment tool from the NHLBI-NIH was used to assure that studies met standardized quality criteria. Sensitivity analysis and heterogeneity among studies was assessed. Overall, the 32 selected articles, including 7825 individuals in the systematic review, explored 12 families of EDCs. The results revealed a high heterogeneity among studies in relation to the association between exposure to EDCs and the endpoints analyzed. Meta-analyses were performed with data from 7 articles including 479 individuals, 4 articles assessing the association between BPA in urine and sperm quality, and 3 articles evaluating PCB153 in serum and sperm quality. In the meta-analysis, we identified an unpredicted significant positive association between PCB153 exposure and sperm concentration. However, it would not be clinically relevant. No positive or inverse associations were found neither for BPA, nor for PCB153 and the rest of sperm parameters analyzed. The high disparity between studies made difficult to draw conclusions on the potential harmful effects of EDCs on male fertility. Consequently, to delineate the potential relationship that EDCs can have on male fertility, an important condition stressing the health system, further investigations are required.
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Lifestyle-, environmental-, and additional health factors associated with an increased sperm DNA fragmentation: a systematic review and meta-analysis.
Szabó, A, Váncsa, S, Hegyi, P, Váradi, A, Forintos, A, Filipov, T, Ács, J, Ács, N, Szarvas, T, Nyirády, P, et al
Reproductive biology and endocrinology : RB&E. 2023;21(1):5
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The World Health Organization defines infertility as regular unprotected sexual intercourse without achieving conception within a year. In recent years, there has been a growing demand for functional, objective parameters reflecting fertility status more clearly than classical parameters. Of these, sperm DNA fragmentation (SDF) and the DNA fragmentation index – denoting the percentage of sperm with damaged DNA – seem to be of utmost importance. The aim of this study was to investigate all risk factors that may potentially be increasing SDF. This study is a systematic review and meta-analysis of one hundred and ninety articles. The earliest studies were published in 2003, and the latest in 2021. Results show that several modifiable risk factors negatively affect SDF, namely; a. health conditions: varicocele [when veins become enlarged inside the pouch of skin that holds the testicles] and impaired glucose tolerance, b. infections: Chlamydia, c. malignancies: testicular tumours, and d. lifestyle factors: smoking, alcohol consumption and body mass index. Authors conclude that several lifestyle-, environmental-, and additional health factors are associated with increased SDF.
Abstract
INTRODUCTION Infertility affects one in every six couples in developed countries, and approximately 50% is of male origin. In 2021, sperm DNA fragmentation (SDF) testing became an evidence-based test for fertility evaluations depicting fertility more clearly than standard semen parameters. Therefore, we aimed to summarize the potential prognostic factors of a higher SDF. METHODS We conducted a systematic search in three medical databases and included studies investigating any risk factors for SDF values. We calculated mean differences (MD) in SDF with 95% confidence interval (CI) for exposed and non-exposed individuals. RESULTS We included 190 studies in our analysis. In the group of associated health conditions, varicocele (MD = 13.62%, CI: 9.39-17.84) and impaired glucose tolerance (MD = 13.75%, CI: 6.99-20.51) had the most significant increase in SDF. Among malignancies, testicular tumors had the highest impact, with a maximum of MD = 11.3% (CI: 7.84-14.76). Among infections, the overall effects of both Chlamydia and HPV were negligible. Of lifestyle factors, smoking had the most disruptive effect on SDF - an increase of 9.19% (CI: 4.33-14.06). Different periods of sexual abstinence did not show significant variations in SDF values. Age seemed to have a more drastic effect on SDF from age 50 onwards, with a mean difference of 12.58% (CI: 7.31-17.86). Pollution also had a detrimental effect - 9.68% (CI: 6.85-12.52). CONCLUSION Of the above risk factors, varicocele, impaired glucose tolerance, testicular tumors, smoking, pollution, and paternal age of over 50 were associated with the highest SDF. TRIAL REGISTRATION CRD42021282533.
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Effects of mild/asymptomatic COVID-19 on semen parameters and sex-related hormone levels in men: a systematic review and meta-analysis.
Che, BW, Chen, P, Yu, Y, Li, W, Huang, T, Zhang, WJ, Xu, SH, He, J, Liu, M, Tang, KF
Asian journal of andrology. 2023;25(3):382-388
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Various studies have shown that coronavirus disease 2019 (COVID-19) can cause more harm and a higher mortality rate to men. However, the literature does not clearly show that severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can cause serious and lasting damage to male reproductive function. The aims of this study were to explore the effects of mild/asymptomatic COVID-19 on semen parameters and sex-related hormone levels and to analyse the relationship between semen parameter values and semen collection time after infection, fever, and severity of COVID-19. This study is a systematic review and meta-analysis of thirteen studies of which only five were included in the meta-analysis. Results show that COVID-19 has a certain effect on male reproductive function in the short term especially within about 70 days after infection. Additionally, fever after infection only had a significant effect on sperm concentration. Authors conclude by recommending the avoidance of pregnancy for a short period of time when the male partner has been infected with COVID-19.
Abstract
Coronavirus disease 2019 (COVID-19) has yet to be proven to alter male reproductive function, particularly in the majority of mild/asymptomatic patients. The purpose of this study was to explore whether mild/asymptomatic COVID-19 affects semen quality and sex-related hormone levels. To find suitable comparative studies, a systematic review and meta-analysis was done up to January 22, 2022, by using multiple databases (Web of Science, PubMed, and Embase). Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were used to identify and choose the studies. Meta-analysis was used to examine the semen parameters and sex-related hormones of mild/asymptomatic COVID-19 patients before and after infection. The effects of semen collection time, fever, and intensity of verification on semen following infection were also investigated. A total of 13 studies (n = 770) were included in the analysis, including three case-control studies, six pre-post studies, and four single-arm studies. A meta-analysis of five pre-post studies showed that after infection with COVID-19, sperm concentration (I2 = 0; P = 0.003), total sperm count (I2 = 46.3%; P = 0.043), progressive motility (I2 = 50.0%; P < 0.001), total sperm motility (I2 = 76.1%; P = 0.047), and normal sperm morphology (I2 = 0; P = 0.001) decreased. Simultaneously, a systematic review of 13 studies found a significant relationship between semen collection time after infection, inflammation severity, and semen parameter values, with fever having only bearing on semen concentration. Furthermore, there was no significant difference in sex-related hormone levels before and after infection in mild/asymptomatic patients. Mild/asymptomatic COVID-19 infection had a significant effect on semen quality in the short term. It is recommended to avoid initiating a pregnancy during this period of time.
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Mycotoxin-Linked Mutations and Cancer Risk: A Global Health Issue.
Ekwomadu, T, Mwanza, M, Musekiwa, A
International journal of environmental research and public health. 2022;19(13)
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Mycotoxins are toxic substances produced by fungi, which can be found in common foods like maize, wheat, nuts, and foods containing them. Mycotoxins such as aflatoxins, ochratoxin, fumonisins, zearalenone, and some Penicillium toxins can alter genetic material. According to previous studies, they can damage genetic material and affect cell growth. Usage of chemicals such as fertilizers and fungicides is a common practice in the agricultural industry to protect plants from fungus and to feed them. However, fungicides can accelerate mycotoxin production. 16 studies were included in this Systematic Review and 11 in Meta-Analysis. This research looked at the harmful effects of mycotoxins such as aflatoxins, fumonisins, ochratoxin, T2, zearalenone, and some Penicillium toxins in causing cancers. The researchers evaluated the link between aflatoxin exposure and liver cancer, fumonisin B1 exposure and liver cancer, zearalenone exposure and breast cancer, zearalenone exposure and cervical cancer, citrinine and patulin exposure and colorectal cancer, and NEO, HT-2, and T-2 exposure and Oesophageal cancer. This research did not show significant associations between various mycotoxins and cancer risk. As currently, most studies are primarily focused on aflatoxin; more robust studies are needed to assess the cancer risk associated with different mycotoxin exposure. Using the results of this study, healthcare professionals can gain a better understanding of how mycotoxins affect our bodies.
Abstract
Humans continue to be constantly exposed to mycotoxins, mainly through oral exposure (dietary), inhalation, or dermal contact. Recently, it has been of increasing interest to investigate mycotoxin-linked carcinogenicity. This systematic review was conducted to synthesize evidence of the association between mycotoxin-linked mutations and the risk of cancer, to provide an overview of the data linking exposure to different mycotoxins with human cancer risk, and to provide an update on current research on the risk of cancer associated with human exposure to mycotoxins. PRISMA guidelines were used when conducting the systematic review. PubMed, MEDLINE, and CINAHL electronic databases were comprehensively searched to extract the relevant studies published from inception to May 2022. A total of sixteen relevant studies (4907 participants) were identified and included in this review. Of these, twelve studies were from Asia, while four of the studies were conducted in Africa. The overall meta-analysis result found no significant association, although some of the studies confirmed an association between mycotoxin-linked mutations and primary liver cancer risk. Mainly, the experimental studies have shown associations between mycotoxin-linked mutations and cancer risk, and there is a need for researchers to confirm these links in epidemiological studies in order to guide public health policies and interventions.
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The impact of diabetes mellitus type 1 on male fertility: Systematic review and meta-analysis.
Facondo, P, Di Lodovico, E, Delbarba, A, Anelli, V, Pezzaioli, LC, Filippini, E, Cappelli, C, Corona, G, Ferlin, A
Andrology. 2022;10(3):426-440
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The relationship between type 2 diabetes mellitus and male hypogonadism is well known, whereas the impact of type 1 diabetes mellitus (DM1) on male fertility and testis functions has been less studied. The aim of this study was to systematically review and discuss the available evidence evaluating paternity rate, male gonadal axis, and sperm parameters in men with DM1. This study is a systematic review and meta-analysis of fourteen studies. Results show: - reduced fertility potential in patients with DM1, as they have a lower number of children compared with unaffected population. In fact, the rate of children is statistically significantly lower among men who had been diagnosed with DM1 at an earlier age, according to a longer duration of the disease. - that men with DM1, compared with controls, have significantly lower normal sperm morphology, progressive motility and a trend toward a reduced semen volume, without difference in total sperm count and concentration. Authors conclude that DM1 might impair reproductive health at different levels, including functional sperm alterations definitively leading to reduced fertility rate in these patients.
Abstract
BACKGROUND Some evidence suggests that diabetes mellitus type 1 (DM1) could affect male fertility, gonadal axis, semen parameters, and spermatogenesis because of effects of hyperglycemia and insulin deficiency. Anyhow, the exact impact of DM1 on male fertility is unclear. OBJECTIVES To review the studies evaluating paternity rate, male gonadal axis, and semen parameters in men with DM1. MATERIALS AND METHODS A review of relevant literature from January 1980 to December 2020 was performed. Only studies published in English reporting data on fatherhood (rate of children by natural fertility), hormonal and seminal parameters were included. Out of 14 retrieved articles, the eight studies evaluating semen parameters were meta-analyzed. RESULTS The rate of children (four studies) was lower than controls among men affected by DM1, especially in men with a longer duration of disease. The data of gonadal hormonal profile in DM1 men (six studies) are very heterogeneous and a neutral effect of DM1 or a condition of subclinical hypogonadism could not be concluded. Meta-analysis showed that men with DM1 (n = 380), compared with controls (n = 434), have significantly lower normal sperm morphology [-0.36% (-0.66; -0.06), p < 0.05, six studies] and sperm progressive motility [33.62% (-39.13; -28.11), p < 0.001, two studies] and a trend toward a lower seminal volume [-0.51 (-1.03; 0.02), p = 0.06, eight studies], without difference in total sperm count and concentration. Data on scrotal ultrasound and sperm DNA fragmentation are too few. No study evaluated other factors of male infertility, such as transrectal ultrasound, semen infections, sperm auto-antibodies, and retrograde ejaculation. DISCUSSION DM1 might impair male fertility and testis functions (endocrine, spermatogenesis), but definition of its actual impact needs further studies. CONCLUSION Men with DM1 should be evaluated with a complete hormonal, seminal, and ultrasound workup to better define their fertility potential and need for follow up of testis functions.
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The effect of healthy dietary patterns on male semen quality: a systematic review and meta-analysis.
Cao, LL, Chang, JJ, Wang, SJ, Li, YH, Yuan, MY, Wang, GF, Su, PY
Asian journal of andrology. 2022;24(5):549-557
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Infertility has been identified by the World Health Organization as a worldwide problem. The analysis of semen quality is key in assessing male fertility. The aim of this study was to explore the effect of healthy dietary patterns on male semen quality. This study is a systematic review and meta-analysis of six articles. The six articles were cross-sectional studies involving 1244 subjects, however, 708 subjects with the lowest and highest adherence to a healthy dietary pattern were included in the meta-analysis. Results show that the sperm concentration, progressive sperm motility, and total sperm count were significantly higher in the group with high consumption of a healthy dietary pattern than those in the group with low consumption; however, there wasn’t a clear relationship between normal sperm morphology, total sperm motility, and semen volume. Authors conclude that dietary interventions should be considered in clinical work as part of the therapies improving male semen quality.
Expert Review
Conflicts of interest:
None
Take Home Message:
- This Systematic Review and Meta Analysis showed that healthy dietary patterns had beneficial effects on sperm concentration, total sperm count, and progressive sperm motility in males, which affect male fertility.
- Authors concluded that healthy dietary patterns may promote male reproductive health and thus improve semen quality in the population.
- Healthy dietary patterns meant the Mediterranean diet for 4 out of 6 studies. All healthy diet patterns were determined by the authors to be rich in plant-based foods, where saturated fats provide only a small percentage of the total energy intake.
Evidence Category:
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X
A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
- This study aimed to determine the effects of healthy dietary patterns on semen quality.
Methodology
- This meta-analysis was performed following PRISMA guidelines and included 6 cross-sectional studies with 1244 participants
- The included cross-sectional studies examined the influence of the Mediterranean, Dietary Approaches to Stop Hypertension (DASH), and prudent diet patterns on semen quality parameters.
- In 4 of the studies participants were divided into groups based on their scores for the Mediterranean diet from low to high adherence.
- 2 studies examined the DASH diet and the prudent diet and used food frequency questionnaires to compare high consumption with low consumption of healthy dietary patterns.
- The PICOS (Participants, Intervention, Comparison, Outcomes, and Study design) criteria that were used to structure the research question.
- 11 Checklists were used to assess the quality of included studies.
Results:
By comparing high consumption with low consumption of healthy dietary patterns, the results of the meta-analysis showed:
- significantly higher sperm concentrations (mean difference [MD] = 6.88 × 106 ml−1, 95% confidence interval [CI]: 1.26 × 106 ml−1–12.49 × 106 ml−1; P < 0.05)
- significant increase in total sperm count (MD = 16.70 × 106, 95% CI: 2.37 × 106–31.03 × 106; P < 0.05)
- significant increase in progressive sperm motility (MD = 5.85%, 95% CI: 2.59%–9.12%; P < 0.01) but there was no significant correlation between healthy dietary patterns and total sperm motility (MD: 6.86%, 95% CI: −0.25%–13.96%; P > 0.05).
- there was no significant association between a healthy dietary pattern and normal sperm morphology (MD: 0.28%, 95% CI: −0.33%–0.90%; P > 0.05)
- there was no significant association between a healthy dietary pattern and semen volume (MD: 0.04 ml, 95% CI: −0.20 ml–0.28 ml; P > 0.05).
Limitations:
- Included studies were all cross-sectional studies, and it is impossible to determine the causal relationship between the high intake of healthy dietary patterns and semen quality.
- The number of studies included was small, and there was not enough literature to support authors in drawing reliable conclusions.
- No comparison was made between specific diets such as dash vs Mediterranean.
Clinical practice applications:
- The authors concluded that dietary interventions should be considered in clinical work as part of the therapies improving male semen quality.
- Dietary interventions for men should be included as part of preconceptional clinical management,
- Dietary interventions for men should also be considered in infertility clinical management.
Considerations for future research:
- Randomised Clinical Trials should be conducted to build on these findings.
Abstract
The incidence of infertility has recently risen. Semen quality is an important male fertility indicator, and dietary factors can affect semen quality. We conducted this systematic review and meta-analysis to determine the effects of healthy dietary patterns on semen quality. A literature search was conducted in 3 databases (Embase, Web of Science and PubMed) on August 21, 2021. The included cross-sectional studies examined the influence of the Mediterranean, Dietary Approaches to Stop Hypertension (DASH), and prudent diet patterns on semen quality parameters; six studies (1244 subjects) were included. By comparing high consumption with low consumption of healthy dietary patterns, the results of the meta-analysis showed significantly higher sperm concentrations (mean difference [MD] = 6.88 × 106 ml-1, 95% confidence interval [CI]: 1.26 × 106 ml-1-12.49 × 106 ml-1; P < 0.05), a significant increase in total sperm count (MD = 16.70 × 106, 95% CI: 2.37 × 106-31.03 × 106; P < 0.05), and a significant increase in progressive sperm motility (MD = 5.85%, 95% CI: 2.59%-9.12%; P < 0.01). The sperm concentration, progressive sperm motility, and total sperm count were significantly higher in men with higher versus lower consumption of healthy dietary patterns. However, the results must be interpreted with caution.
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Contribution of Lactobacillus iners to Vaginal Health and Diseases: A Systematic Review.
Zheng, N, Guo, R, Wang, J, Zhou, W, Ling, Z
Frontiers in cellular and infection microbiology. 2021;11:792787
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The vaginal microbiome is an important contributor to vaginal health. Here the dominance of Lactobacilli species, alongside their antimicrobial compounds play a critical role in contributing and protecting the vaginal milieu. Conversely the disruption or absence of Lactobacilli dominance is frequently associated with vaginal disease and infections. One of the Lactobacilli species prevalent in the vaginal microbiome is Lactobacillus iners. It was long overlooked in research due to it being so difficult to culture, and it was first identified in 1999 thanks to DNA sequencing. Researchers since discovered that the relationship between L. iners and vaginal health is far more complicated and ambiguous compared to the other Lactobacilli species. This systematic review explores the current knowledge of the characteristics of L. iners and its role in vaginal health and disease. The article discusses L. iners identification, genetic make up and differences to other Lactobacilli species and how they relate to vaginal health. The article also summarizes L. iners nutrient requirements and its role in diseases like dysbiosis, bacterial vaginosis, sexually transmitted infections and biofilm formation. Furthermore the authors look at the relation between L. iners and premature birthing, fertility and menstrual cycles. A final section in discusses the antimicrobial and immune sytem activating qualities of L. iners. In light of all these findings the authors describe L . iners as a very unique Lactobacilli due to its unusual characteristics. Whether L. iners is beneficial or pathogenic for the host remains controversial, as it can adapt to high and low pH environment and is seen in health and equally dysbiotic states of infection. Hence some describe it as a transitional species that colonizes the vagina after disturbances. It may be a risk factor for infections by contributing to the onset and maintenance of dysbiotic disturbances. Further studies are needed to clarify the role of L. iners and its role on vaginal health and whether it could serve as a biomarker for vaginal inflammation. This article is a useful summary about the characteristics and role of L. iners in vaginal health in disease.
Abstract
Lactobacillus iners, first described in 1999, is a prevalent bacterial species of the vaginal microbiome. As L. iners does not easily grow on de Man-Rogosa-Sharpe agar, but can grow anaerobically on blood agar, it has been initially overlooked by traditional culture methods. It was not until the wide application of molecular biology techniques that the function of L. iners in the vaginal microbiome was carefully explored. L. iners has the smallest genome among known Lactobacilli and it has many probiotic characteristics, but is partly different from other major vaginal Lactobacillus species, such as L. crispatus, in contributing to the maintenance of a healthy vaginal microbiome. It is not only commonly present in the healthy vagina but quite often recovered in high numbers in bacterial vaginosis (BV). Increasing evidence suggests that L. iners is a transitional species that colonizes after the vaginal environment is disturbed and offers overall less protection against vaginal dysbiosis and, subsequently, leads to BV, sexually transmitted infections, and adverse pregnancy outcomes. Accordingly, under certain conditions, L. iners is a genuine vaginal symbiont, but it also seems to be an opportunistic pathogen. Further studies are necessary to identify the exact role of this intriguing species in vaginal health and diseases.
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A Systematic Review of Organic Versus Conventional Food Consumption: Is There a Measurable Benefit on Human Health?
Vigar, V, Myers, S, Oliver, C, Arellano, J, Robinson, S, Leifert, C
Nutrients. 2019;12(1)
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The demand for organic products has risen rapidly over the last decades. The reasons why consumers may favour organic over conventional products are varied. They may be for personal health and wellbeing, environmental considerations, animal welfare or perceived higher nutritional profile - which is true for some, but not all components. While the long-term safety of pesticide consumption through conventional food production has been questioned, organic foods clearly show lower levels of toxic metabolites, like heavy metals and synthetic fertilizer and pesticide residues. This systematic review aimed to assess the current evidence of organic diet consumption and human health compared to conventionally produced foods. Included were 35 papers on clinical trials and observational studies. The clinical trials studied pesticide and phytochemical excretion, antioxidant capacity, body composition, lipids and inflammatory markers. The observational studies were focused on fertility, foetal and childhood development, pregnancy, lactation and levels of pesticides in children and adults, as well as nutritional biomarkers and cancer risk in adults. An increased intake of organic produce in long-term studies appeared to reduce the incidence of infertility, birth defects, allergies, middle ear infection, pre-eclampsia, metabolic syndrome, high BMI, and non-Hodgkin lymphoma. Organic intake was also linked to reduced urinary levels of organophosphorus pesticides and herbicides. Yet, the author highlighted that organic consumers are more likely to be health conscious, physically active, eat a more plant-based diet, have higher education levels and income, and therefore are not representative of the general population. They also argue that the possible benefits from an organic diet may be partially due to the quality and composition of the diet rather than a direct effect of organic food consumption. Whereby a growing number of findings demonstrate the health benefits of organic food consumption, according to the authors, the current evidence does not yield a solid and definitive answer.
Abstract
The current review aims to systematically assess the evidence related to human health outcomes when an organic diet is consumed in comparison to its conventional counterpart. Relevant databases were searched for articles published to January 2019. Clinical trials and observational research studies were included where they provided comparative results on direct or indirect health outcomes. Thirty-five papers met the criteria for inclusion in the review. Few clinical trials assessed direct improvements in health outcomes associated with organic food consumption; most assessed either differences in pesticide exposure or other indirect measures. Significant positive outcomes were seen in longitudinal studies where increased organic intake was associated with reduced incidence of infertility, birth defects, allergic sensitisation, otitis media, pre-eclampsia, metabolic syndrome, high BMI, and non-Hodgkin lymphoma. The current evidence base does not allow a definitive statement on the health benefits of organic dietary intake. However, a growing number of important findings are being reported from observational research linking demonstrable health benefits with organic food consumption. Future clinical research should focus on using long-term whole-diet substitution with certified organic interventions as this approach is more likely to determine whether or not true measurable health benefits exist.