-
The Cochrane Database of Systematic... Aug 2016Constipation within childhood is an extremely common problem. Despite the widespread use of osmotic and stimulant laxatives by health professionals to manage... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Constipation within childhood is an extremely common problem. Despite the widespread use of osmotic and stimulant laxatives by health professionals to manage constipation in children, there has been a long standing paucity of high quality evidence to support this practice.
OBJECTIVES
We set out to evaluate the efficacy and safety of osmotic and stimulant laxatives used to treat functional childhood constipation.
SEARCH METHODS
We searched MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials, and the Cochrane IBD Group Specialized Trials Register from inception to 10 March 2016. There were no language restrictions. We also searched the references of all included studies, personal contacts and drug companies to identify studies.
SELECTION CRITERIA
Randomised controlled trials (RCTs) which compared osmotic or stimulant laxatives to placebo or another intervention, with participants aged 0 to 18 years old were considered for inclusion. The primary outcome was frequency of defecation. Secondary endpoints included faecal incontinence, disimpaction, need for additional therapies and adverse events.
DATA COLLECTION AND ANALYSIS
Relevant papers were identified and two authors independently assessed the eligibility of trials, extracted data and assessed methodological quality using the Cochrane risk of bias tool. The primary outcome was frequency of defecation. Secondary endpoints included faecal incontinence, disimpaction, need for additional therapies and adverse events. For continuous outcomes we calculated the mean difference (MD) and 95% confidence interval (CI) using a fixed-effect model. For dichotomous outcomes we calculated the risk ratio (RR) and 95% CI using a fixed-effect model. The Chi(2) and I(2) statistics were used to assess statistical heterogeneity. A random-effects model was used in situations of unexplained heterogeneity. We assessed the overall quality of the evidence supporting the primary and secondary outcomes using the GRADE criteria.
MAIN RESULTS
Twenty-five RCTs (2310 participants) were included in the review. Fourteen studies were judged to be at high risk of bias due to lack of blinding, incomplete outcome data and selective reporting. Meta-analysis of two studies (101 patients) comparing polyethylene glycol (PEG) with placebo showed a significantly increased number of stools per week with PEG (MD 2.61 stools per week, 95% CI 1.15 to 4.08). Common adverse events in the placebo-controlled studies included flatulence, abdominal pain, nausea, diarrhoea and headache. Participants receiving high dose PEG (0.7 g/kg) had significantly more stools per week than low dose PEG (0.3 g/kg) participants (1 study, 90 participants, MD 1.30, 95% 0.76 to 1.84). Meta-analysis of 6 studies with 465 participants comparing PEG with lactulose showed a significantly greater number of stools per week with PEG (MD 0.70 , 95% CI 0.10 to 1.31), although follow-up was short. Patients who received PEG were significantly less likely to require additional laxative therapies. Eighteen per cent (27/154) of PEG patients required additional therapies compared to 31% (47/150) of lactulose patients (RR 0.55, 95% CI 0.36 to 0.83). No serious adverse events were reported with either agent. Common adverse events in these studies included diarrhoea, abdominal pain, nausea, vomiting and pruritis ani. Meta-analysis of 3 studies with 211 participants comparing PEG with milk of magnesia showed that the stools per week were significantly greater with PEG (MD 0.69, 95% CI 0.48 to 0.89). However, the magnitude of this difference was quite small and may not be clinically significant. One child was noted to be allergic to PEG, but there were no other serious adverse events reported. One study found a significant difference in stools per week favouring milk of magnesia over lactulose (MD -1.51, 95% CI -2.63 to -0.39, 50 patients), Meta-analysis of 2 studies with 287 patients comparing liquid paraffin (mineral oil) with lactulose revealed a relatively large statistically significant difference in the number of stools per week favouring liquid paraffin (MD 4.94 , 95% CI 4.28 to 5.61). No serious adverse events were reported. Adverse events included abdominal pain, distention and watery stools. No statistically significant differences in the number of stools per week were found between PEG and enemas (1 study, 90 patients, MD 1.00, 95% CI -1.58 to 3.58), dietary fibre mix and lactulose (1 study, 125 patients, P = 0.481), senna and lactulose (1 study, 21 patients, P > 0.05), lactitol and lactulose (1 study, 51 patients, MD -0.80, 95% CI -2.63 to 1.03), hydrolyzed guar gum and lactulose (1 study, 61 patients, MD 1.00, 95% CI -1.80 to 3.80), PEG and flixweed (1 study, 109 patients, MD 0.00, 95% CI -0.33 to 0.33), PEG and dietary fibre (1 study, 83 patients, MD 0.20, 95% CI -0.64 to 1.04), and PEG and liquid paraffin (2 studies, 261 patients, MD 0.35, 95% CI -0.24 to 0.95).
AUTHORS' CONCLUSIONS
The pooled analyses suggest that PEG preparations may be superior to placebo, lactulose and milk of magnesia for childhood constipation. GRADE analyses indicated that the overall quality of the evidence for the primary outcome (number of stools per week) was low or very low due to sparse data, inconsistency (heterogeneity), and high risk of bias in the studies in the pooled analyses. Thus, the results of the pooled analyses should be interpreted with caution because of quality and methodological concerns, as well as clinical heterogeneity, and short follow-up. There is also evidence suggesting the efficacy of liquid paraffin (mineral oil). There is no evidence to demonstrate the superiority of lactulose when compared to the other agents studied, although there is a lack of placebo controlled studies. Further research is needed to investigate the long term use of PEG for childhood constipation, as well as the role of liquid paraffin. The optimal dose of PEG also warrants further investigation.
Topics: Adolescent; Child; Child, Preschool; Constipation; Defecation; Dietary Fiber; Enema; Female; Humans; Infant; Infant, Newborn; Lactulose; Laxatives; Magnesium Hydroxide; Male; Mineral Oil; Osmosis; Polyethylene Glycols; Randomized Controlled Trials as Topic; Senna Extract; Sennosides; Treatment Outcome
PubMed: 27531591
DOI: 10.1002/14651858.CD009118.pub3 -
Archives of Razi Institute Aug 2022Mineral oil as a barrier can minimize temperature, osmolality, and pH fluctuation of the media in the embryo production system (IVP). Regardless of these advantages,... (Review)
Review
Mineral oil as a barrier can minimize temperature, osmolality, and pH fluctuation of the media in the embryo production system (IVP). Regardless of these advantages, mineral oil quality is varied and may deteriorate during storage or transport conditions. So, it can affect the IVP outcome by absorbing the essentials factors or realizing the toxic components into the media. Although, some methods have already been developed to reduce these side effects, still there is a big concern about the safety and use of mineral oil in the IVP system. In this review, we provided an overview of the advantages and disadvantages of using mineral oil in the IVP system. We also reviewed available methods for its quality control and finally, we introduced some methods for reducing the side effects of mineral oil.
Topics: Animals; Mineral Oil; Temperature
PubMed: 36883153
DOI: 10.22092/ARI.2022.358955.2343 -
Food Additives & Contaminants. Part A,... Sep 2018Work on mineral oil hydrocarbons (MOH) contaminating food is reviewed up to about 2010, when the subject received broad publicity. It covers the period of the main... (Review)
Review
Work on mineral oil hydrocarbons (MOH) contaminating food is reviewed up to about 2010, when the subject received broad publicity. It covers the period of the main discoveries and elimination or reduction of the dominant sources: release agents used in industrial bakeries, spraying of rice, additions to animal feed, contamination of edible oils from various sources and migration from paperboard packaging. In most cases, highly refined ('white') oils were involved, but also technical oils, e.g. from the environment, and more or less crude oil fractions from jute and sisal bags. There were numerous unexpected sources, and there might still be more of those. The exposure of the consumers to MOH must have been markedly reduced in the meantime. Environmental influx may have become dominant, particularly when taking into account that these MOH go through several degradation processes which might enrich the species resisting metabolic elimination. Major gaps are in the systematic investigation of sources and the largely unavoidable levels from environmental contamination, but also in the toxicological evaluation of the various types of hydrocarbons. A regulation is overdue that avoids the present discrepancy between the low tolerance to MOH perceived as contaminants and the very high legal limits for some applications - the MOH are largely the same.
Topics: Animals; Food Contamination; Humans; Hydrocarbons; Mineral Oil
PubMed: 29894283
DOI: 10.1080/19440049.2018.1488185 -
Critical Reviews in Toxicology Oct 2019For a few years, mineral oils and their potential adverse health effects have been a constant issue of concern in many regulatory areas such as food, cosmetics, other... (Review)
Review
For a few years, mineral oils and their potential adverse health effects have been a constant issue of concern in many regulatory areas such as food, cosmetics, other consumer products, and industrial chemicals. Analytically, two fractions can be distinguished: mineral oil saturated hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons (MOAH). This paper aims at assessing the bioaccumulative potential and associated histopathological effects of MOSH as well as the carcinogenic potential of MOAH for consumer-relevant mineral oils. It also covers the absorption, distribution, metabolism, and excretion of MOSH and MOAH upon oral and dermal exposures. The use and occurrence of consumer-relevant, highly refined mineral oils in food, cosmetics and medicinal products are summarized, and estimates for the exposure of consumers are provided. Also addressed are the challenges in characterizing the substance identity of mineral oil products under REACH. Evidence from more recent autopsy and biopsy studies, along with information on decreasing food contamination levels, indicates a low risk for adverse hepatic lesions that may arise from the retention of MOSH in the liver. With respect to MOAH, at present there is no indication of any carcinogenic effects in animals dermally or orally exposed to highly refined mineral oils and waxes. Such products are used not only in cosmetics but also in medicinal products and as additives in food contact materials. The safety of these mineral oil-containing products is thus indirectly documented by their prevalent and long-term use, with a simultaneous lack of clinical and epidemiological evidence for adverse health effects.
Topics: Animals; Cosmetics; Environmental Exposure; Food Contamination; Humans; Hydrocarbons; Hydrocarbons, Aromatic; Mineral Oil
PubMed: 31939687
DOI: 10.1080/10408444.2019.1694862 -
Environmental Science. Processes &... Dec 2023The formation and sedimentation of oil-mineral aggregates (OMAs) is the major method to transport spilled oil to the seafloor. In this study, the formation and...
The formation and sedimentation of oil-mineral aggregates (OMAs) is the major method to transport spilled oil to the seafloor. In this study, the formation and sedimentation experiments of OMA using montmorillonite and four crude oils were performed in a wave tank in the presence of chemical dispersant. Most of the formed OMAs were droplet OMAs, and single droplet OMA would aggregate into multiple ones under the action of the dispersant. The size of the oil droplets trapped in the OMA increased with time and was larger for the oil with higher viscosity. The sinking velocities of OMAs formed in this study were between 100-1200 μm s and they were positively correlated with their diameter. The density of OMA was of the same order as that of the crude oil that formed them. An increase in the dispersant dosage could promote the formation of OMAs. The oil content in OMAs was higher for the denser oil in the presence of a dispersant. The maximum oil trapping efficiency of OMAs was 48.05%. This study provides fundamental data on the formation kinetics of OMAs.
Topics: Water Pollutants, Chemical; Petroleum; Mineral Oil; Geologic Sediments; Petroleum Pollution; Bentonite
PubMed: 37786335
DOI: 10.1039/d3em00327b -
Journal of Assisted Reproduction and... Apr 2022The study aims to summarize current knowledge on the use of oil in embryo culture systems, with a focus on proper management of different types of oil and possible... (Review)
Review
PURPOSE
The study aims to summarize current knowledge on the use of oil in embryo culture systems, with a focus on proper management of different types of oil and possible impact on culture systems.
METHODS
PubMed was used to search the MEDLINE database for peer-reviewed English-language original articles and reviews concerning the use of oil in embryo culture systems. Searches were performed by adopting "embryo," "culture media," "oil," and "contaminants" as main terms. The most relevant publications were assessed and discussed critically.
RESULTS
Oils used in IVF are complex mixtures of straight-chain hydrocarbons, cyclic and aromatic hydrocarbons, and unsaturated hydrocarbons, whose precise composition influences their chemical and physical properties. Possible presence of contaminants suggests their storage at 4 °C in the dark to prevent peroxidation. Washing, generally performed by manufacturers prior to commercialization, may remove trace chemical contaminants. Oils reduce evaporation from culture media at rates depending on their chemical physical properties, culture system parameters, and incubator atmosphere. Contaminants - mainly metal ion and plastic components derived from refinement processes and storage - can pass to the aqueous phase of culture systems and affect embryo development.
CONCLUSIONS
Oils are essential components of culture systems. Their original quality and composition, storage, handling, and use can affect embryo development with significant efficiency and safety implications.
Topics: Culture Media; Embryo Culture Techniques; Fertilization in Vitro; Humans; Mineral Oil; Oils
PubMed: 35445905
DOI: 10.1007/s10815-022-02479-z -
Chemical Senses Jan 2024Although studies have shown that olfaction may contribute to the perception of tastant, literature is scarce or circumstantial, especially in humans. This study aims to...
Although studies have shown that olfaction may contribute to the perception of tastant, literature is scarce or circumstantial, especially in humans. This study aims to (i) explore whether humans can perceive solutions of basic prototypical tastants through orthonasal and retronasal olfaction and (ii) to examine what volatile odor compounds (VOCs) underlie this ability. Solutions of 5 basic tastants (sucrose, sodium chloride, citric acid, monosodium glutamate [MSG], quinine) dissolved in water, and 2 fatty acids (oleic and linoleic acid) dissolved in mineral oil were prepared. Triangle discrimination tests were performed (n = 41 in duplicate) to assess whether the tastant solutions can be distinguished from blanks (solvents) through ortho- and retronasal olfaction. Participants were able to distinguish all tastant solutions from blank through orthonasal olfaction. Only sucrose, sodium chloride, oleic acid, and linoleic acid were distinguished from blank by retronasal olfaction. Ethyl dichloroacetate, methylene chloride, and/or acetone were identified in the headspace of sucrose, MSG, and quinine solutions but not in the headspace of water, sodium chloride, and citric acid solutions. Fat oxidation compounds such as alcohols and aldehydes were detected in the headspace of the oleic and linoleic acid solutions but not the mineral oil. We conclude that prototypical tastant solutions can be discriminated from water and fatty acid solutions from mineral oil through orthonasal olfaction. Differences in the volatile headspace composition between blanks and tastant solutions may have facilitated the olfactory discrimination. These findings can have methodological implications for future studies assessing gustatory perception using these prototypical taste compounds.
Topics: Humans; Smell; Sodium Chloride; Sodium Glutamate; Quinine; Mineral Oil; Taste; Water; Sucrose; Citric Acid; Linoleic Acids
PubMed: 38175732
DOI: 10.1093/chemse/bjad054 -
Current Opinion in Cardiology Jul 2022Use of omega-3 fatty acid (OM3FA) supplements to reduce risk of cardiovascular events has been investigated, largely without evidence of meaningful benefit, over the... (Review)
Review
PURPOSE OF REVIEW
Use of omega-3 fatty acid (OM3FA) supplements to reduce risk of cardiovascular events has been investigated, largely without evidence of meaningful benefit, over the last 4 decades.
RECENT FINDINGS
The first contemporary clinical trial to show benefit of OM3FA use was the REDUCE-IT trial (2018), showing a remarkable 25% relative risk reduction in the intervention group that received icosapent ethyl 4 g daily compared to a mineral oil placebo group. The STRENGTH trial (2020), which was similar in design to the REDUCE-IT trial but compared 4 g daily dose of combined OM3FA with a corn oil placebo, was terminated early due to futility.
SUMMARY
This article provides a review of the data surrounding these trials and discusses the differing results of the two trials. There are key differences in the design of the two trials, the most notable is the use of mineral oil in the REDUCE-IT trial, which was potentially a nonneutral comparator. Additionally, both trials showed an increase in the incidence of atrial fibrillation. With the unclear benefit of OM3FA supplementation and possibility of harm, the current data suggest that the risk of routine use of OM3FA outweighs the possibility of reduction in risk of cardiovascular events.
Topics: Cardiovascular Diseases; Dietary Supplements; Fatty Acids, Omega-3; Heart Disease Risk Factors; Humans; Mineral Oil; Risk Factors
PubMed: 35275889
DOI: 10.1097/HCO.0000000000000962 -
Circulation Aug 2022REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial) reported a 25% relative risk reduction in major adverse cardiovascular events with... (Randomized Controlled Trial)
Randomized Controlled Trial
Effects of Randomized Treatment With Icosapent Ethyl and a Mineral Oil Comparator on Interleukin-1β, Interleukin-6, C-Reactive Protein, Oxidized Low-Density Lipoprotein Cholesterol, Homocysteine, Lipoprotein(a), and Lipoprotein-Associated Phospholipase A2: A REDUCE-IT Biomarker Substudy.
BACKGROUND
REDUCE-IT (Reduction of Cardiovascular Events With Icosapent Ethyl-Intervention Trial) reported a 25% relative risk reduction in major adverse cardiovascular events with use of icosapent ethyl compared with pharmaceutical grade mineral oil. The mechanisms underlying this benefit remain uncertain. We explored whether treatment allocation in REDUCE-IT might affect a series of biomarkers in pathways known to associate with atherosclerosis risk.
METHODS
Serum levels of interleukin-1β, interleukin-6, high-sensitivity C-reactive protein, oxidized low-density lipoprotein cholesterol, homocysteine, lipoprotein(a), and lipoprotein-associated phospholipase A2 (Lp-PLA2) were measured at baseline, at 12 months, at 24 months, and at the end-of-study visit among REDUCE-IT participants with triglyceride levels 135 mg/dL and <500 mg/dL who were randomly allocated to treatment with either 4 grams daily of icosapent ethyl or mineral oil used as a comparator.
RESULTS
At baseline, median levels of each biomarker were similar in the 2 treatment groups. The levels of biomarkers associated with atherosclerosis increased over time among those allocated to mineral oil treatment; in this group at 12 months, the median percent increases from baseline were 1.5% for homocysteine, 2.2% for lipoprotein(a), 10.9% for oxidized low-density lipoprotein cholesterol, 16.2% for interleukin-6, 18.5% for lipoprotein-associated phospholipase A2, 21.9% for high-sensitivity C-reactive protein, and 28.9% for interleukin-1β (all values <0.001), with similar changes at 24 months. In the icosapent ethyl group, there were minimal changes in these biomarkers at 12 and 24 months. As such, at study conclusion, between-group treatment differences largely reflected increases in the mineral oil group with median percent differences of 2.4% for lipoprotein(a), 3.0% for homocysteine, 4.2% for oxidized low-density lipoprotein cholesterol, 19.8% for interleukin-6, 26.2% for Lp-PLA2, 38.5% for high-sensitivity C-reactive protein, and 48.7% for interleukin-1β (all values ≤0.007). These data are consistent with previous REDUCE-IT results in which the median percent change for low-density lipoprotein cholesterol at 12 months was -1.2% among those allocated to icosapent ethyl and 10.9% among those allocated to the mineral oil comparator.
CONCLUSIONS
Among participants in REDUCE-IT, allocation to icosapent ethyl had minimal effects on a series of biomarkers associated with atherosclerotic disease, whereas levels increased among those allocated to mineral oil. The effect of these findings on interpretation of the overall risk reductions in clinical events observed within REDUCE-IT is uncertain.
REGISTRATION
URL: https://www.
CLINICALTRIALS
gov; Unique identifier: NCT01492361.
Topics: 1-Alkyl-2-acetylglycerophosphocholine Esterase; Atherosclerosis; Biomarkers; C-Reactive Protein; Cholesterol; Cholesterol, LDL; Double-Blind Method; Eicosapentaenoic Acid; Homocysteine; Humans; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Hypertriglyceridemia; Interleukin-1beta; Interleukin-6; Lipoprotein(a); Mineral Oil
PubMed: 35762321
DOI: 10.1161/CIRCULATIONAHA.122.059410