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Nevin Manimala Statistics

Comparative effect of triamcinolone/lidocaine ultrasonophoresis and injection on pain, disability, quality of life in patients with acute rotator cuff related shoulder pain: a double blinded randomized controlled trial

Physiother Theory Pract. 2024 Feb 18:1-9. doi: 10.1080/09593985.2024.2316307. Online ahead of print.

ABSTRACT

BACKGROUND: Alleviating inflammation should be considered as one of the first steps of the treatment plan in patients with acute rotator cuff related shoulder pain (RCRSP).

OBJECTIVE: To compare the effects of triamcinolone/lidocaine ultrasonophoresis, injection on pain, disability, and quality of life in patients with acute RCRSP.

METHODS: A total of 28 acute RCRSP patients were randomly allocated into two groups of ultrasonophoresis and injection. Both groups received vitamin C and shoulder care education for 10 days and then were subjected to therapeutic interventions. Ultrasonophoresis group received triamcinolone (16 mg) and lidocaine (2mg) using ultrasonophoresis (frequency: 3 MHz, intensity: 1.50 W/Cm2), while the injection group received a single subacromial injection of triamcinolone (80 mg) and lidocaine (10 mg). The main outcomes measures were pain assessed by two scales (visual analog scale), and shoulder pain and disability index (SPADI), disability (SPADI), and quality of life (Western Ontario rotator cuff questionnaire).

RESULTS: Although the main effect of time was statistically significant for all dependent variables (P< 0.01), no significant interaction was found between group and time (P-value (0.12-0.55)). The ultrasonophoresis effect, size for pain, disability, and quality of life were 2.58, 1.43, 1.78, and 1.35, respectively. The injection effect, size for pain, disability, and quality of life were 1.98, 2.02, 1.40, and 1.60, respectively.

CONCLUSIONS: Triamcinolone/lidocaine ultrasonophoresis demonstrated similar outcomes to injection in reducing pain, improving disability, and enhancing quality of life in patients with acute RCRSP in short time. According to our findings, ultrasonophoresis with triamcinolone/lidocaine cream is as effective as triamcinolone/lidocaine injection and can be proposed as a potential adjunctive treatment for patients with acute RCRSP.

PMID:38368597 | DOI:10.1080/09593985.2024.2316307

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Inhaled endotoxin induces a systemic neutrophil response without affecting cardiovascular measures in a randomized cross-over exposure study

Inhal Toxicol. 2024 Feb 18:1-6. doi: 10.1080/08958378.2024.2316241. Online ahead of print.

ABSTRACT

OBJECTIVE: The gram-negative bacterial cell wall component endotoxin (lipopolysaccharide, LPS) is a key component of particulate matter (PM). PM exposure is associated with cardiovascular morbidity and mortality. However, the contribution of individual components of PM to acute and chronic cardiovascular measures is not clear. This study examines whether systemic inflammation induced by LPS inhalation causes acute changes in cardiovascular physiology measures.

MATERIALS AND METHODS: In this double blinded, placebo-controlled crossover study, fifteen adult volunteers underwent inhalation exposure to 20,000 EU Clinical Center Reference Endotoxin (CCRE). Peripheral blood and induced sputum neutrophils were obtained at baseline and six hours post-exposure. Blood pressure, measures of left ventricular function (ejection fraction (LVEF) and global longitudinal strain (LVGLS)), and indices of endothelial function (flow mediated dilation (FMD) and velocity time integral during hyperemia (VTIhyp)) were measured before and after treatment. Wilcoxon sign-rank tests and linear mixed models were used for statistical analysis.

RESULTS: In comparison with normal saline, LPS inhalation resulted in significant increases in peripheral blood and sputum neutrophils but was not associated with significant alterations in blood pressure, LVGLS, LVEF, FMD, or VTIhyp.

DISCUSSION AND CONCLUSIONS: In healthy adults, systemic inflammation after LPS inhalation was not associated with acute changes in cardiovascular physiology. Larger studies are needed to investigate the effects of other PM components on inflammation induced cardiovascular dysfunction.

PMID:38368594 | DOI:10.1080/08958378.2024.2316241

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Prolonged versus intermittent β-lactam infusion in sepsis: a systematic review and meta-analysis of randomized controlled trials

Ann Intensive Care. 2024 Feb 18;14(1):30. doi: 10.1186/s13613-024-01263-9.

ABSTRACT

BACKGROUND: The two latest studies on prolonged versus intermittent use of β-lactam antibiotics in patients with sepsis did not reach consistent conclusions, further contributing to the controversy surrounding the effectiveness of the prolonged β-lactam antibiotics infusion strategy. We conducted a systemic review and meta-analysis to evaluate the efficacy and safety of prolonged and intermittent β-lactam infusion in adult patients with sepsis.

METHODS: We systematically searched PubMed, EMBASE, and Cochrane Library databases for original randomized controlled trials comparing prolonged and intermittent β-lactam infusion in sepsis patients. A random-effects model was used to evaluate mortality, clinical success, microbiological success, and adverse events. We also conducted subgroup analyses to explore the impact of various factors on the mortality rates. Relative risk (RR) and corresponding 95% confidence intervals (CIs) were used to calculate the overall effect sizes for dichotomous outcomes. This meta-analysis was registered in PROSPERO (CRD42023463905).

RESULTS: We assessed 15 studies involving 2130 patients. In our comprehensive assessment, we found a significant reduction in all-cause mortality (RR, 0.83; 95% CI 0.72-0.97; P = 0.02) and a notable improvement in clinical success (RR, 1.16; 95% CI 1.03-1.31; P = 0.02) in the prolonged infusion group compared to the intermittent infusion group, whereas microbiological success did not yield statistically significant results (RR, 1.10; 95% CI 0.98-1.23; P = 0.11). No significant differences in adverse events were observed between the two groups (RR, 0.91; 95% CI 0.64-1.29; P = 0.60). Additionally, remarkable conclusions were drawn from subgroup analyses including studies with sample sizes exceeding 20 individuals per group (RR, 0.84; 95%CI 0.72-0.98; P = 0.03), research conducted post-2010 (RR, 0.84; 95%CI 0.72-0.98; P = 0.03), cases involving infections predominantly caused by Gram-negative bacteria (RR, 0.81; 95%CI 0.68-0.96; P = 0.02), as well as the administration of a loading dose (RR, 0.84; 95% CI 0.72-0.97; P = 0.02) and the use of penicillin (RR, 0.61; 95% CI 0.38-0.98; P = 0.04).

CONCLUSIONS: Compared to intermittent infusion, prolonged infusion of β-lactam antibiotics significantly decreases all-cause mortality among patients with sepsis and enhances clinical success without increasing adverse events.

PMID:38368588 | DOI:10.1186/s13613-024-01263-9

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Demonstrating the reliability of in vivo metabolomics based chemical grouping: towards best practice

Arch Toxicol. 2024 Feb 18. doi: 10.1007/s00204-024-03680-y. Online ahead of print.

ABSTRACT

While grouping/read-across is widely used to fill data gaps, chemical registration dossiers are often rejected due to weak category justifications based on structural similarity only. Metabolomics provides a route to robust chemical categories via evidence of shared molecular effects across source and target substances. To gain international acceptance, this approach must demonstrate high reliability, and best-practice guidance is required. The MetAbolomics ring Trial for CHemical groupING (MATCHING), comprising six industrial, government and academic ring-trial partners, evaluated inter-laboratory reproducibility and worked towards best-practice. An independent team selected eight substances (WY-14643, 4-chloro-3-nitroaniline, 17α-methyl-testosterone, trenbolone, aniline, dichlorprop-p, 2-chloroaniline, fenofibrate); ring-trial partners were blinded to their identities and modes-of-action. Plasma samples were derived from 28-day rat tests (two doses per substance), aliquoted, and distributed to partners. Each partner applied their preferred liquid chromatography-mass spectrometry (LC-MS) metabolomics workflows to acquire, process, quality assess, statistically analyze and report their grouping results to the European Chemicals Agency, to ensure the blinding conditions of the ring trial. Five of six partners, whose metabolomics datasets passed quality control, correctly identified the grouping of eight test substances into three categories, for both male and female rats. Strikingly, this was achieved even though a range of metabolomics approaches were used. Through assessing intrastudy quality-control samples, the sixth partner observed high technical variation and was unable to group the substances. By comparing workflows, we conclude that some heterogeneity in metabolomics methods is not detrimental to consistent grouping, and that assessing data quality prior to grouping is essential. We recommend development of international guidance for quality-control acceptance criteria. This study demonstrates the reliability of metabolomics for chemical grouping and works towards best-practice.

PMID:38368582 | DOI:10.1007/s00204-024-03680-y

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Who smokes in Australia? Cross-sectional analysis of Australian Bureau of Statistics survey data, 2017-19

Med J Aust. 2024 Feb 19;220(3):154-163. doi: 10.5694/mja2.52216.

ABSTRACT

OBJECTIVES: To assess the socio-demographic and health-related characteristics of people who smoke daily, people who formerly smoked, and people who have never smoked in Australia.

STUDY DESIGN: Cross-sectional analysis of Australian Bureau of Statistics (ABS) survey data.

SETTING, PARTICIPANTS: Adult participants (16 370 people aged 18 years or older) in the ABS 2017-18 National Health Survey (NHS); adult participants in the ABS 2018-19 National Aboriginal and Torres Strait Islander Health Survey (NATSIHS) (6423 people aged 18 years or older).

MAIN OUTCOME MEASURES: Socio-demographic and health-related characteristics of people who smoke daily, people who formerly smoked, and people who have never smoked, expressed as population-weighted proportions, overall and by Indigeneity.

RESULTS: Among adult NHS respondents, an estimated 58.8% of people who smoked daily (95% confidence interval [CI], 56.2-61.4%) were men, 61.3% (95% CI, 58.7-63.9%) were 25-54 years old, 72.5% (95% CI, 70.0-74.8%) were born in Australia, and 65.4% (95% CI, 62.8-67.8%) lived in major cities and 54.3% (95% CI, 51.6-57.0%) in areas in the two socio-economically most disadvantaged quintiles; 75.9% (95% CI, 73.5-78.1%) reported good to excellent health, 73.0% (95% CI, 70.5-75.4%) reported low to moderate psychological distress, 69.0% of those aged 25-64 years (ie, of working age) had completed year 12 (high school), and 68.5% were currently employed. An estimated 2.57 million people smoke daily in Australia: 2.37 million non-Indigenous people (92%) and 195 700 Aboriginal or Torres Strait Islander people (8%).

CONCLUSIONS: While smoking is more frequent among people living in socio-economically disadvantaged areas and in certain population sub-groups, this first quantitative national profile indicates that most people who smoke daily are in paid employment, are non-Indigenous, are in good physical and mental health, and have completed year 12. Improved comprehensive structural supply- and demand-based tobacco control, informed by the needs of priority groups and the overall profile of people who smoke, is needed to reduce daily smoking prevalence among adults to the 2030 targets of 5% or less for all Australians and 27% or less for Aboriginal and Torres Strait Islander people.

PMID:38368552 | DOI:10.5694/mja2.52216

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Cryopreservation of Limited Sperm Using A Combination of Sucrose and Taurine, Loaded on Two Different Devices, and Thawed at Two Different Temperatures

Int J Fertil Steril. 2024 Feb 2;18(2):173-179. doi: 10.22074/ijfs.2023.561957.1369.

ABSTRACT

BACKGROUND: Cryopreservation of sperm is essential for patients with low sperm counts and couples undergoing infertility treatment. The aim of this study was to compare the effects of Taurine (T) and Sucrose (S) in individual sperm cryopreservation utilizing cryotop and petri dish and thawing at 37 and 42°C.

MATERIALS AND METHODS: In this experimental study, 17 normospermic semen samples were processed using the “Swim-up” procedure and progressively motile sperm were then isolated from these samples using an inverted microscope. Sperm were added to droplets of “sucrose medium” with 25 mM Taurine antioxidant (S+T) and the commercial cryoprotectant “Sperm Freeze” (CPA), loaded on a petri dish and cryotop. After rapid freezing of the samples, they were thawed at two different temperatures (37°C and 42°C), and the sperm classical parameters, viability, and DNA fragmentation were assessed.

RESULTS: Statistical analysis displayed a significant increase in total and progressive motility in individual sperm freezing on cryotop with CPA and thawing at 42°C (P<0.05). Other parameters did not show any differences between the CPA and S+T groups and two thawing temperatures in either of the cryopreservation methods.

CONCLUSION: Although, both cryoprotectants (CPA and S+T) may preserve individual sperm effectively using cryotop, the CPA and thawing at 42°C showed a better effect on the motility percentage of the small number of sperm.

PMID:38368522 | DOI:10.22074/ijfs.2023.561957.1369

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Effectiveness of Autologous Platelet-Rich Plasma Therapy in Women with Repeated Implantation Failure: A Randomized Clinical Trial

Int J Fertil Steril. 2024 Feb 2;18(2):162-166. doi: 10.22074/ijfs.2023.553636.1305.

ABSTRACT

BACKGROUND: Platelet-rich plasma (PRP) therapy has been shown to enhance tissue regeneration by expressing several cytokines and growth factors (GFs). This study investigated the effect of intrauterine infusion of PRP as a noninvasive autologous GF on pregnancy outcomes in women with repeated implantation failure.

MATERIALS AND METHODS: This randomized clinical trial was conducted to compare the pregnancy rates between two groups of women who were candidates for the frozen-thawed embryo transfer with a history of two or more implantation failures. The PRP group (n=33) was treated with hormone replacement therapy+0.5 cc to 1 cc PRP infused into the uterine cavity two days before the embryo transfer. The control group (n=33) was only treated with hormone replacement therapy. The endometrial preparation process was done similarly in both groups. The chemical, clinical, and ongoing pregnancy, and implantation rates were compared between the two groups.

RESULTS: Our results showed that the chemical pregnancy rate was not statistically higher in the PRP group in comparison with the control group (36.4 vs. 24.2%). In addition, the clinical pregnancy, ongoing pregnancy, and implantation rates were higher in the PRP group than the control group; however, the difference between the two groups was not statistically significant.

CONCLUSION: Administration of intrauterine PRP before embryo transfer in women with repeated implantation failure (RIF) does not affect assisted reproductive technology (ART) outcomes (registration number: IRCT2016090728950N3).

PMID:38368520 | DOI:10.22074/ijfs.2023.553636.1305

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Does The Culture of Post-Thawed Cleavage-Stage Embryos to Blastocysts Improve Infertility Treatment Outcomes of Frozen-Thawed Embryo Transfer Cycles? A Randomised Clinical Trial

Int J Fertil Steril. 2024 Feb 2;18(2):146-152. doi: 10.22074/ijfs.2023.560780.1357.

ABSTRACT

BACKGROUND: There is a definite shift in assisted reproductive centres from cleavage-stage embryo transfer (ET) to blastocyst transfer that is attributed to improvements in laboratory environments and advances in the development of embryo culture media. The aim of the study was to investigate the reproductive outcomes of thawed cleavage-stage ET versus blastocysts derived from an extended culture of these embryos.

MATERIALS AND METHODS: This open-label, randomised, parallel group clinical trial study enrolled 182 women aged ≤37 years who underwent frozen-thawed ET from November 2015 to June 2020 at Royan Institute Research Centre, Tehran, Iran. The women were randomly assigned to either the thawed cleavage ET group (n=110) or the post-thaw extended culture blastocysts group (n=72). The primary outcome measure was the clinical pregnancy rate. Secondary outcome measures were implantation rate, live birth rate (LBR), and miscarriage rate. A P<0.05 indicated statistical significance.

RESULTS: There were no significant differences between the two groups in terms of demographic characteristics. Both the mean numbers of embryos transferred and good quality embryos transferred were significantly lower in the postthaw extended culture blastocysts group compared to thawed cleavage-stage ET cycles. However, the post-thaw extended culture blastocysts group had higher clinical pregnancy (56.94 vs. 40.91%, P=0.034), implantation (34.43 vs. 19.84%, P=0.001) and live birth (49.3 vs. 33.63%, P=0.036) rates compared to the thawed cleavage-stage ET group. Miscarriage and multiple gestations rates were comparable between the groups.

CONCLUSION: These results allow us to take a position in favour of post-thaw extended culture blastocysts; thus, it is important to improve the post-thawing extended culture technique (registration number: NCT02681029).

PMID:38368518 | DOI:10.22074/ijfs.2023.560780.1357

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The Effects of Thiamine Supplementation on General Health and Infertility Treatment Outcomes in Women with Polycystic Ovary Syndrome: A Triple-Blinded Randomized Placebo-Controlled Clinical Trial

Int J Fertil Steril. 2024 Feb 2;18(2):128-134. doi: 10.22074/ijfs.2023.1972708.1398.

ABSTRACT

BACKGROUND: The aim of this study was to evaluate the effects of thiamine (vitamin B1) on general health and infertility treatment outcomes in women with polycystic ovary syndrome (PCOS).

MATERIALS AND METHODS: The study is a triple-blinded, randomized, placebo-controlled clinical trial performed on 64 infertile women with PCOS referred to Sarem Hospital in Tehran, Iran. The primary outcomes of the study were general health and infertility treatment outcomes. Eligible women were randomly assigned to the vitamin B1 group (n=32, vitamin B1 tablet at a dose of 300 mg/day for 4 weeks) or the placebo group (n=32, placebo tablet daily for 4 weeks). A general health questionnaire was completed before and after the intervention by both groups, and treatment success was evaluated at the end of the study. Data were analyzed using SPSS software ver.16 P<0.05 was considered statistically significant.

RESULTS: The mean age of participants in the vitamin B1 (VB1) group was 30.4 ± 3.27 years and in the placebo (Pl) group was 29.1 ± 2.66 years with the mean duration of marriage 12.7 ± 3.01 and 13.2 ± 2.97 years respectively. Our results showed that there were significant differences between the two groups in overall score (P<0.001) and scores for all domains of the general health questionnaire including somatic symptoms (P<0.001), anxiety and insomnia (P<0.001), social dysfunction (P=0.028), and severe depression (P<0.001) after the intervention. Four weeks consumption of vitamin B1 also resulted in higher numbers of positive pregnancy tests (P=0.006), although the number of fetuses was not significantly different between the two groups after the intervention.

CONCLUSION: The results of the current study support a possible favourable effect of vitamin B1 on improving general health, infertility treatment outcome, and retrieved follicle count without changing the number of fetuses in women with polycystic ovary syndrome (registration number: IRCT201510266917N3).

PMID:38368515 | DOI:10.22074/ijfs.2023.1972708.1398

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Association between Myometrial Thickness and Assisted Reproductive Technologies Outcomes: A Prospective Cohort Study

Int J Fertil Steril. 2024 Feb 2;18(2):123-127. doi: 10.22074/ijfs.2023.555447.1314.

ABSTRACT

BACKGROUND: Myometrial thickness has been expected to be a prognosticator for lower uterine segment function. An abnormal function of the uterine muscle layer can cause common and important reproductive problems. This study aimed to evaluate the relationship between baseline myometrial thickness and assisted reproductive technologies (ART) outcomes.

MATERIALS AND METHODS: In this prospective cohort study, 453 infertile women undergoing ART cycles without any obvious uterine pathology, participated in this prospective cohort study from February 2013 to May 2015. In order to measure the myometrial thickness in the anterior and posterior of the uterine, trans-vaginal ultrasounds were conducted on days 2-4 of the cycle (menstrual phase) preceding ovarian stimulation and the day of human chorionic gonadotropin (hCG) injection. We defined three groups based on the baseline myometrial thickness in the anterior and posterior, including (A) <25 mm, (B) 25-29.9 mm and (C) ≥30 mm. Ovarian stimulation, oocyte retrieval and luteal phase support were performed in accordance with the standard long protocol. Two weeks after embryo transfer, the patients underwent a pregnancy test by checking their serum β-hCG levels. The primary outcome measure was clinical pregnancy rate. Secondary outcome measures were, implantation rate, abortion rate and live birth rate.

RESULTS: The clinical pregnancy (P=0.013) and implantation (P=0.003) rates were significantly lower in group A than in two other groups. Although the live birth rate was lower in group A than two other groups, this decrease was not statistically significant (P=0.058).

CONCLUSION: The findings may be a way for clinicians to draw focus on providing therapeutic strategies and a specific supportive care for women with a baseline myometrial thickness <25 mm in order to improve the reproductive outcome of in vitro fertilization/intracytoplasmic sperm injection (IVF-ICSI).

PMID:38368514 | DOI:10.22074/ijfs.2023.555447.1314