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Optimal Target Low-density Lipoprotein Level for Reducing the Risk of Atherosclerotic Cardiovascular Diseases: A Systematic Review and Meta-analysis

  • Min-Gyo Jang;Yeung-Eun Son;Hye Duck Choi;Junwoo Kim;Tae-Eun Kim;Kwang-Hee Shin
    • Korean Journal of Clinical Pharmacy
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    • v.33 no.4
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    • pp.270-277
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    • 2023
  • Background: As per guidelines for treating dyslipidemia, the recommended low-density lipoprotein cholesterol (LDL-C) level in extremely high-risk patients, including those with coronary artery diseases is <55 mg/dL. Although this recommendation has been adopted in the guidelines for dyslipidemia in various countries, there is limited evidence of its efficacy in reducing cardiovascular diseases (CVDs), especially among East Asian patients. This study aimed to investigate whether an LDL-C value below 55 mg/dL is associated with decreased risk of CVDs. Methods: Seven clinical trials including 50,970 patients that compared intensive lipid-lowering therapy with less therapy or placebo in patients who had >6 months of follow-up, those with a sample size of ≥150 were selected as the final literature for analysis. Risk ratios (RR) using random effects were represented with 95% confidence intervals (CI) for the reliability of the results. Results: An LDL-C level of <55 mg/dL was related to significantly reduced events of major CVDs (RR: 0.88; 95% CI: 0.80-0.98) and myocardial infarction (RR: 0.81; 95% CI: 0.73-0.90) and a reduced risk of ischemic stroke (RR 0.79; 95% CI 0.69-0.89, mean follow-up=2 years). However, an LDL-C level below 55 mg/dL did not reduce the incidence of CVD in intensive therapy in East Asian patients. Conclusions: A goal LDL-C value below 55 mg/dL was identified to be related to a decreased risk of developing CVD. However, the relation to LDL-C below 55 mg/dL with a decreased risk of CVD was not observed in East Asian patients.

The Analysis of Registration Status of Herbal Medicine and Medication Interventional Clinical Trials for Simple Obesity in Children and Adolescents -Focused on WHO ICTRP- (소아청소년 단순 비만에 대한 한약 및 약물 중재 임상시험 등록 현황 분석 - WHO ICTRP를 중심으로 -)

  • Jeong Yoon Kyoung;Choi Seo Yeon;Bang Miran;Lee Boram;Chang Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.38 no.1
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    • pp.55-77
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    • 2024
  • Objectives This study aimed to analyze the registration status and characteristics of clinical trials on herbal medicine (HM) and medication interventions for simple obesity in children and adolescents. Methods All interventional clinical trials registered in the International Clinical Trials Registry Platform of the World Health Organization until December 12, 2024, were collected. The study design, interventions, inclusion and exclusion criteria, and outcome measures were extracted. Results A total of 24 clinical trials (23 medications and 1 HM) were analyzed. The most common study designs were single-center, randomized controlled, parallel, and phase 2. Placebo controls were used in 87.5% of the studies, blinding was used in 79.1%, and quadruple blinding was the most common. Informed consent was obtained from 70.8% of the participants. Among the oral medications (66.6%), metformin was the most common (25%). Among the non-oral medications (29.1%), exenatide (Bydureon) was the most common intervention (42.8%). Body mass index was the most commonly reported primary outcome measure (79.1%), with most assessments performed at 6 months. Conclusions Based on the characteristics of the medication interventional clinical trial design analyzed in this study, additional high-quality multicenter traditional Korean medicine trials need to be designed in the future.

Efficacy of Needling at Sympathetic Point (an Auricular Acupuncture Point) in Migraine Patients: A Randomized Controlled Study

  • O. Deepika;A. Mooventhan;N. Mangaiarkarasi;N. Manavalan
    • Journal of Acupuncture Research
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    • v.41 no.2
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    • pp.115-120
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    • 2024
  • Background: Migraine is a common disabling headache that affects every aspect of a person's life. Auricular acupuncture is a cost-effective treatment modality for the management of painful neurological conditions. Previous studies have shown the beneficial effects of a combination of ear points in the management of migraines. However, no studies have evaluated the efficacy of a single auricular point (i.e., sympathetic point) in migraine. Thus, this study evaluated the efficacy of sympathetic points on pain intensity and depression levels in patients with migraine. Methods: In this randomized controlled study, 100 patients with migraine aged 18-45 years were randomly divided into either an auricular acupuncture group (AAG) (n = 50) or a placebo control group (PCG) (n = 50). The AAG underwent needling at the sympathetic point (an auricular acupuncture point), whereas the PCG underwent needling at a non-acupuncture point for 20 minutes daily for 7 days. Assessments were performed before and after the intervention using a 6-item headache impact test (HIT-6) and Beck depression inventory (BDI) scale. Statistical analyses were performed using SPSS version 16. Results: In within-group analysis, the AAG showed a significant reduction in HIT-6 and BDI, whereas the PCG showed a significant increase in HIT-6 and a significant reduction in BDI. In between-groups analyses, HIT-6 reduced significantly in the AAG compared with that in the PCG, whereas BDI reduced significantly in the PCG compared with that in the AAG. Conclusion: In patients with migraine, needling at the sympathetic point produces a greater reduction in the pain intensity level and lesser reduction in the depression level compared to needling at a non-acupuncture point.

Soluble Fiber Effect on Human Serum Leptin and Adiponectin: A Systematic Review and Dose-Response Meta-Analysis

  • Ali Zeinabi;Hadi Ghaedi;Seyed Ali Hosseini
    • Clinical Nutrition Research
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    • v.12 no.4
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    • pp.320-335
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    • 2023
  • Literature showed that soluble fiber has beneficial effects on cardiometabolic risk factors and leptin and adiponectin serum levels. Our aim in this meta-analysis was to determine the effect of soluble fiber supplementation on leptin and adiponectin serum levels. A systematic search was conducted using PubMed, Scopus, and ISI Web of Science for eligible trials up to December 2021. A random-effects model was used to pool calculated effect sizes. Our analysis showed that soluble fiber supplementation did not significantly affect adiponectin (standardized mean difference [SMD], -0.49 Hedges's, 95% confidence interval [CI], -1.20, 0.21, p value = 0.167; I2 = 95.4, p value < 0.001) and leptin (SMD, -0.8 Hedges's, 95% CI, -1.70, 0.08, p value = 0.076; I2 = 94.6, p value < 0.001) concentrations in comparison with placebo. However, in the subgroup, soluble fiber supplementation had a significant improvement in leptin concentration in overweight and obese patients (SMD, -0.22 Hedges's, 95% CI, -0.43, -0.01, p value = 0.048) and a non-significant beneficial effect in adiponectin level in female (SMD, 0.29 Hedges's, 95% CI, -0.13, 0.71, p value = 0.183) and diabetic patients (SMD, 0.32 Hedges's, 95% CI, -0.67, 1.32, p value = 0.526). A non-linear association between soluble fiber dosage and adiponectin (pnon-linearity < 0.001) was observed. Soluble fiber supplementation could not change the circulatory leptin and adiponectin levels. However, beneficial effects were seen in overweight and obese leptin, and increases in adiponectin may also be observed in female and diabetic patients. Further studies are needed to confirm this results.

Screening of nanoemulgels for physicochemical stability and antifungal efficacy

  • Andleeb Fatima;Muhammad Naeem Aamir;Shahiq-Uz-Zaman;Masood-Ur-Rehman;Zeeshan Javaid;Keng Wooi Ng;Hina Hussain;Muhammad Asif
    • Advances in nano research
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    • v.16 no.6
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    • pp.593-600
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    • 2024
  • The nanoemulgel was prepared to induce a synergistic effect along with higher efficacy. Nine sets of macroemulsion were made in which liquid paraffin was stabilized by the two non-ionic surfactants, Tween® 80 and Span® 80. Comparative stability analysis of the macroemulsions was used to determine the effective surfactant concentrations that gave the most stable systems (NE 2, NE3, NE4, NE5). High-speed homogenization was then applied. The final formulation was evaluated for globule size and polydispersablity index, physical properties (color, homogeneity, consistency, syneresis), pH, viscosity, spreadability with 200 g and 500 g weight, conductivity, drug content, stability, skin irritation, antifungal efficacy. Zeta size analysis confirmed the nanosize of the droplets in NE2 (284.8 nm), NE3 (79.89 nm), NE4 (194 nm) but not NE5 (632.8 nm), which was outside the nanoemulsion range. The antifungal assay exhibited zone of inhibition for NE3 (43±1.0 mm) and NE4 (42±1.7 mm), a marketed cream (33±1 mm), fluconazole alone (35±1 mm) and terbinafine alone (35.0±1.7 mm). The zone of inhibition of nanoemulgels increased compared with the drugs when used individually and when compared a placebo.

The Effects of Blackcurrant and Raspberry Consumption on Blood Pressure: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

  • Ali Nikparast;Fatemeh Sheikhhossein;Mohammad Reza Amini;Sogand Tavakoli;Azita Hekmatdoost
    • Clinical Nutrition Research
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    • v.12 no.1
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    • pp.54-64
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    • 2023
  • A systematic review and meta-analysis were designed to summarize studies conducted on the effects of raspberry and blackcurrant consumption on blood pressure (BP). Eligible studies were detected by searching numerous five online databases including PubMed, Scopus, Web of Science, Cochrane Library, and Google Scholar, until December 17, 2022. We pooled the mean difference and its 95% confidence interval (CI) by applying a random-effects model. Overall, the impact of raspberry and blackcurrant on BP was reported in ten randomized controlled trials (RCTs) (420 subjects). Pooled analysis of six clinical trials revealed that raspberry consumption has no significant reduction in systolic blood pressure (SBP) (weighted mean differences [WMDs], -1.42; 95% CI, -3.27 to 0.87; p = 0.224) and diastolic blood pressure (DBP) (WMD, -0.53; 95% CI, -1.77 to 0.71; p = 0.401), in comparison with placebo. Moreover, pooled analysis of four clinical trials indicated that blackcurrant consumption did not reduce SBP (WMD, -1.46; 95% CI, -6.62 to 3.7; p = 0.579), and DBP (WMD, -2.09; 95% CI, -4.38 to 0.20; p = 0.07). Raspberry and blackcurrant consumption elicited no significant reductions in BP. More accurate RCTs are required to clarify the impact of raspberry and blackcurrant intake on BP.

The Effect of Vit-D Supplementation on the Side Effect of BioNTech, Pfizer Vaccination and Immunoglobulin G Response Against SARS-CoV-2 in the Individuals Tested Positive for COVID-19: A Randomized Control Trial

  • Hawal Lateef Fateh;Goran Kareem;Shahab Rezaeian;Jalal Moludi;Negin Kamari
    • Clinical Nutrition Research
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    • v.12 no.4
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    • pp.269-282
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    • 2023
  • Vitamin D participates in the biological function of the innate and adaptive immune system and inflammation. We aim to specify the effectiveness of the vitamin D supplementation on the side effects BioNTech, Pfizer vaccination, and immunoglobulin G response against severe acute respiratory syndrome coronavirus 2 in subjects tested positive for coronavirus disease 2019 (COVID-19). In this multi-center randomized clinical trial, 498 people tested positive for COVID-19 were divided into 2 groups, receiving vitamin D capsules or a placebo (1 capsule daily, each containing 600 IU of vitamin D) over 14-16 weeks. Anthropometric indices and biochemical parameters were measured before and after the second dose of vaccination. Fourteen to 16 weeks after supplementation, the intervention group had an immunoglobulin G (IgG) increase of 10.89 ± 1.2 g/L, while the control group had 8.89 ± 1.3 g/L, and the difference was significant between both groups (p = 0.001). After the second dose of vaccination, the supplement group significantly increased their 25-hydroxy vitamin D from initially 28.73 ± 15.6 ng/mL and increased to 46.48 ± 27.2 ng/mL, and the difference between them was significant. Those with a higher body mass index (BMI) had the most of symptoms, and the difference of side effects according to BMI level was significantly different. In 8 weeks after supplementation obese participants had the lowest IgG levels than overweight or normal subjects. The proportion of all types of side effects on the second dose was significantly diminished compared with the first dose in the intervention group. Supplementation of 600 IU of vitamin D3 can reduce post-vaccination side effects and increase IgG levels in participants who received BioNTech, Pfizer vaccine.

A Concentrated Onion Extract Lowers Serum Lipid Levels in Rats Fed a High-Fat Diet (흰쥐에서 양파 농축액의 고지혈 개선 작용)

  • Kim, Ju-Youn;Seo, Yun-Jung;Noh, Sang-K.;Cha, Yong-Jun
    • Food Science and Preservation
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    • v.17 no.3
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    • pp.398-404
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    • 2010
  • It is known that onions, or bioactive compounds therein, providehealth benefits. The present study was designed to investigate whether a concentrated onion extract lowered blood lipid levels in rats fed a high-fat diet. Initially, male Sprague-Dawley rats were housed singly in an environment in which temperature and light duration were controlled, and had free access to a nutritionally adequate AIN-93G diet and deionized water. After an acclimatization period, rats were weight-matched and assigned to one of the following five groups: 1) a control group, fed the AIN-93G diet mixed with 10% (w/v) lard and 0.7% (w/v) cholesterol to induce hyperlipidemia (control); 2) three experimental groups, fed the AIN-93G diet mixed with a high-fat source plus concentrated onion extract at three different levels (termed the low-dose, medium-dose, and high-dose groups); and, 3) a placebo group, fed the AIN-93G diet with fats plus the same concentrated extract but devoid of onion-derived material. All five groups freely ingested their respective diets over 6 weeks. At 0, 3, and 6 weeks, blood samples were collected from the orbital sinus following overnight food deprivation. At 6 weeks, livers were collected. Both control and experimental groups continually gained body weight throughout the study. No significant differencein body weight gain was observed among groups. However, the serum concentrations of triglycerides, total cholesterol, and non HDL-cholesterol were significantly reduced by ingestion of concentrated onion extract. Also, the hepatic levels of total lipids and total fatty acids, especially C18:1 (oleic acid), were significantly decreased in rats fed a high level of concentrated onion extract, compared with the control and placebo groups. These results provide clear evidence that ingestion of a concentrated onion extract has a profound inhibitory effect on serum lipid levels in rats fed a high-fat diet. Our findings indicate that a concentrated onion extract may be used to alleviate hyperlipidemia by lowering serum cholesterol and triglyceride levels.

Long-Term Effects of the DHA Supplementation on Physical and Brain Development in Full-Term Infants (장기간에 걸친 DHA 보충이 영아의 신체발육 및 두뇌발달에 미치는 영향)

  • 정현주
    • Journal of Nutrition and Health
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    • v.31 no.8
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    • pp.1295-1306
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    • 1998
  • Recent research indicates that the n-3 fatty acid , docosahexaenoic acid(22 : 6n 3, DHA) plays an essential role in infant brain development . DHA is highly concentrated in brain and retinal tissues and accumulates during late fetal and early neonatal life. Diets deficient in DHA are associated with reduced levels of DHA in brain and retinal tissues. The purpose of this study is to investigate the long term effects of DHA supplementation on the growth and mental development of full-term infants. THirty four healty infants were recruited from those who were delivered at Kyung Hee Medical Center. The experimental groups were the breast milk+DHA(-) group who were fed human milk for 20 weeks after birth and thereafter were fed placebo formula for 28 weeks, the breast milk+DHA(+) group who were fed human milk for 20 weeks after birth and thereafter were fed DHA supplemented formula for 28 weeks, DHA(-) group who were fed placebo formula for 48 weeks, and DHA(+) group who were fed DHA supplemented formula for 48 weeks. The daily average intake of DHA for the breast milk+DHA(-) , breast milk+DHA(+), DHA(-) and DHA(+) groups were 39.1mg, 89.9mg, 17.7mg, and 160.224mg, respectively. The results showed that measurements of infant weight, length, head, and chest circumferncewere all in normal range and they were not influenced by the DHA supplements in their diets. There was a significant correlation between dietary DHA intake and erythrocyte DHA level. The results of flash visual evoke potential (VEP) test were not correlated with eerythrocyte DHA and dietary DHA levels at 48 weeks of age. No differences were found in Bayley mental and Psychomotor Development lndex scores among the four experimental groups at 48 weeks of age. Unlike the short-term effects there was no long-term effect of relatively small amounts of dietary DHA supplements on the scores for flash VEP and Bayley test, even thour호 there was an elevated DHA supplements on the scores for flash VEP and Bayley test, even through there was an elevated DHA content in the infants erythrocytes.

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Effects of Alcohol on Psychomotor Performance and Subjective Assessments In Normal Adults with Variation of Acetaldehyde Dehydrogenase I (정상성인에서 ALDH-I의 변이가 알콜의 정신운동성 수행과 주관적 평가에 미치는 영향)

  • Yoon, Bo Hyun;Yoon, Jin Sang
    • Korean Journal of Biological Psychiatry
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    • v.3 no.2
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    • pp.222-239
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    • 1996
  • The purpose of this study was to evaluate the effects of alcohol on the psychomotor performance and subjective assessment in healthy Korean adults with acetaldehyde dehydrogenase I(ALDH-I) isozyme variance. A total of 20 male subjects, half with active ALDH-I and the other half with inactive ALDH-I, were selected through both a self-reporting questionnaire examining alcohol sensitivity and the Higuchi's ethanol patch test detecting ALDH-I deficiency. In a doule-blind, placebo-controlled cross-over design, each subject consumed four doses of alcohol(0.25, 0.5, 0.75, 1.0g/kg) and placebo on five separate occasions at weekly intervals, Treatment order was fully balanced using a $5{\times}5$ Latin square, Psychomotor performance tests[coritical flicker fusion threshold(CFF) and choice reaction time(CRT)] and self-estimate questionnaires were conducted at baseline and at time points of 20, 40, 60, 90, 120, 150, 180 minutes after consuming the test drug for 20 minutes, Blood alcohol concentrations(BACs) using breath analyzer were measured at baseline and at time points of 10, 20, 30, 40, 50, 60, 75, 90, 105, 120, 150, 180 minutes after drinking, The BACs and the mean changes in the psychomotor performances and subjective assessments from pre-alcohol baseline, were compared between the two groups. The findings were summarized as follows : 1) BACs were tended to be higher in the inactive group than the active in all of the four alcohol doses. However significant group differences were only after the 0.5g/kg dose of alcohol. 2) The inactive group showed significant impairment in CFFT at most time points alter 0.75 and 1.0g/kg doses of alcohol. 3) In CRT, total reaction time(TRT) significantly prolonged in the inactive group than the active group at 20 minutes after 0.25 and 1.0g/kg doses of alcohol and at 40, 60, 90 minutes alter 0.75g/kg dose of alcohol. In the inactive group, recognition time component significantly increased at 20, 60, 90 minutes after 1.0g/kg dose of alcohol, while movement time component significantly increased at 40, 60 minutes after 0.75g/kg dose of alcohol. 4) Subjective evaluation of the effect of alcohol revealed that physical and mental conditions as well as a self-estimate of the effects of alcohol on performance were significantly worse in the inactive group than the active at some time points alter all of the lour alcohol doses, wihch were more pronounced after 0.75 and 1.0g/kg doses of alcohol. 5) Most of the group differences mentioned above, still remained statistically significant after BAC was entered as a covariate, These findings demonstrated that the alcohol sensitivity is higher in individuals with inactive ALDH-I than those with active ALDH-I both on the subjective assessments and the objective psychomotor performances. Furthermore, these results suggest thai the alcohol sensitivity may be determined by acetaldehyde concentration rather than BAC per se. In future studies, after more accurate genotyping for ALDH-I, the relationships between BAC, acetaldehyde concentration and alcohol sensitivities should be clearly defined.

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