Summary Isoflavones have a structure similar to 17β-estradiol, so they may be useful to postmenopausal women in preventing bone loss related to estrogen deficiency. The present study integrated the findings from 63 randomized controlled... more
Summary Isoflavones have a structure similar to 17β-estradiol, so they may be useful to postmenopausal women in preventing bone loss related to estrogen deficiency. The present study integrated the findings from 63 randomized controlled trials and found that isoflavone interventions may have benefits in the prevention and treatment of menopause-related osteoporosis. Purpose This study aimed to determine the efficacy of isoflavone interventions on bone density outcomes and the safety of isoflavone interventions in postmenopausal women by means of systematic review and meta-analysis. Methods A systematic search was performed on three databases (PubMed, Scopus, and Cochrane Library). Included studies were limited to randomized controlled trials (RCTs) assessing the effects of isoflavone intervention on bone mineral density (BMD) in postmenopausal women. Mean difference (MD) in BMD or relative risk for adverse outcomes was used as a summary effect measure; pooled-effect estimates were calculated using a random-effects model. Results A total of 63 RCTs, involving 6427 postmenopausal women, were included in the meta-analysis. Statistically significant differences in BMD at the last follow-up visit between the two groups (isoflavones vs. control) were found at the lumbar spine (MD = 21.34 mg/cm 2 , 95% CI = 8.21 to 34.47 mg/cm 2 , p = 0.001), the femoral neck (MD = 28.88 mg/cm 2 , 95% CI = 15.05 to 42.71 mg/cm 2 , p < 0.0001), and the distal radius (MD = 19.27 mg/cm 2 , 95% CI = 5.65 to 32.89 mg/cm 2 , p = 0.006). The positive effects in improved BMD were primarily associated with two formulations, i.e., genistein 54 mg/day and ipriflavone 600 mg/day. Isoflavone interventions were generally safe and well tolerated. Conclusion Isoflavone interventions, genistein (54 mg/day) and ipriflavone (600 mg/day) in particular, have beneficial effects on BMD outcomes and are safe in postmenopausal women. They may be considered as a complementary or alternative option in the prevention and treatment of menopause-related osteoporosis.
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Background Since the COVID-19 pandemic began, there have been concerns related to the preparedness of healthcare workers (HCWs). This study aimed to describe the level of awareness and preparedness of hospital HCWs at the time of the... more
Background Since the COVID-19 pandemic began, there have been concerns related to the preparedness of healthcare workers (HCWs). This study aimed to describe the level of awareness and preparedness of hospital HCWs at the time of the first wave. Methods This multinational, multicenter, cross-sectional survey was conducted among hospital HCWs from February to May 2020. We used a hierarchical logistic regression multivariate analysis to adjust the influence of variables based on awareness and preparedness. We then used association rule mining to identify relationships between HCW confidence in handling suspected COVID-19 patients and prior COVID-19 case-management training. Results We surveyed 24,653 HCWs from 371 hospitals across 57 countries and received 17,302 responses from 70.2% HCWs overall. The median COVID-19 preparedness score was 11.0 (interquartile range [IQR] = 6.0–14.0) and the median awareness score was 29.6 (IQR = 26.6–32.6). HCWs at COVID-19 designated facilities with ...
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Human subject research is a necessary step in the advancement of treatment and prevention of diseases. According to ethical principles and international human research standards, there must be regulations governing human subject research... more
Human subject research is a necessary step in the advancement of treatment and prevention of diseases. According to ethical principles and international human research standards, there must be regulations governing human subject research to protect human rights and integrity, as well as the safety and well-being of the subjects. Thailand currently does not have specific laws pertaining to human subject research, resulting in the need to improvise from various laws as well as rules and regulations by health related councils. To date, there has not been any review or analysis of pertinent laws, rules, and regulations to ascertain whether they provide the same protections for human subjects in research as those required by ethical and international standards. This article reviews, analyzes and discusses relevant Thai laws and regulations concerning human subject research focusing on the two mechanisms for human research subject protection i.e. the review of research by ethic committee ...
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Background Osteoarthritis of the knee is the most common form of arthritis. Identifying effective and safe herbal formulations that are locally available is viewed as a priority for sustainable development in a region. This study aimed to... more
Background Osteoarthritis of the knee is the most common form of arthritis. Identifying effective and safe herbal formulations that are locally available is viewed as a priority for sustainable development in a region. This study aimed to evaluate the efficacy and safety of Thai herbal formulation-6 (THF-6) in comparison with oral diclofenac in patients with moderate-to-severe osteoarthritis of the knee. Methods This randomized, double-blind, active-controlled, noninferiority trial randomly assigned patients with osteoarthritis of the knee to receive either THF-6 or diclofenac for four weeks. The primary outcome measure was the change from baseline in knee pain as measured by a 100 mm visual analog scale (VAS). Secondary outcome measures included knee stiffness, a stair climb test, the Knee Injury and Osteoarthritis Outcome Score, and safety parameters. Outcomes were assessed on a biweekly basis. Modified intention-to-treat (MITT) and perprotocol (PP) analyses were applied. Results ...
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In the present age, there is intense pressure on researchers to publish their research in ‘high-impact factor’ journals. It would be interesting to understand the trend of research publications in the field of pharmacology by exploring... more
In the present age, there is intense pressure on researchers to publish their research in ‘high-impact factor’ journals. It would be interesting to understand the trend of research publications in the field of pharmacology by exploring the characteristics of research articles, including research techniques, in relation to the journal’s key bibliometrics, particularly journal impact factor (JIF), the seemingly most mentioned metric. This study aimed to determine the characteristics and research techniques in relation to research articles in pharmacology journals with higher or lower JIF values. A cross-sectional study was conducted on primary research journals under the ‘Pharmacology and Pharmacy’ category. Analysis of 768 original research articles across 32 journals (with an average JIF of 2.565 ± 0.887) demonstrated that research studies involving molecular techniques, in vivo experiments on animals, and bioinformatics and computational modeling were significantly associated with ...
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AIM Mycophenolic acid (MPA) is an immunosuppressive drug commonly used for prophylaxis of graft rejection in solid organ transplant recipients. The main concern with the prolonged use of immunosuppressive drugs is the risk of developing... more
AIM Mycophenolic acid (MPA) is an immunosuppressive drug commonly used for prophylaxis of graft rejection in solid organ transplant recipients. The main concern with the prolonged use of immunosuppressive drugs is the risk of developing cancer. However, it remains unclear whether the immunosuppressive regimens containing MPA confer an increased degree of cancer risk. The present study aimed to determine the association between MPA exposure and the incidence of cancer in solid organ transplant recipients. METHODS A systematic search was performed on PubMed, EMBASE, and Cochrane Library. Relevant articles that have the findings on the incidence (or event) of cancer in cohorts with and without MPA exposure were retrieved for data extraction. A meta-analysis was conducted by means of the random-effects model, and the relative risk (RR) and its 95% confidence interval (95%CI) was used as a summary effect measure. RESULTS A total of 39 studies were eligible for inclusion, with 32 studies that enabled meta-analysis. MPA exposure was significantly associated with a lower risk of cancer when compared to azathioprine exposure (RR = 0.66, 95%CI = 0.53-0.81, p <0.001) or no exposure to any additional treatments (RR = 0.85, 95%CI = 0.73-0.99, p = 0.04). No significant difference in cancer risk for the comparison between MPA exposure and mTOR inhibitor exposure (RR = 1.54, 95%CI = 0.96-2.46, p = 0.07). CONCLUSIONS MPA exposure was not associated with an increased risk of cancer and may even be associated with a lower risk of cancer when compared to azathioprine or no treatment.
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Background. Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are widely prescribed for the treatment of symptomatic osteoarthritis (OA) of the knee. However, searching for alternatives such as locally available medicinal herbs to... more
Background. Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are widely prescribed for the treatment of symptomatic osteoarthritis (OA) of the knee. However, searching for alternatives such as locally available medicinal herbs to manage OA knee pain remains of clinical value. The objective of the present study was to evaluate the efficacy and safety of two yellow oil formulations in patients with OA of the knee. Methods. This prospective, randomized, single-blind, active-controlled, noninferiority study enrolled 102 patients with OA of the knee. Eligible patients were randomly assigned to apply either yellow oil formulation 3 (YOF3), yellow oil formulation 4 (YOF4), or indomethacin solution (INDO) topically four times daily for four weeks. Outcomes were assessed on a biweekly basis. The primary efficacy outcome measure was a 100 mm visual analog scale (VAS) of pain, while secondary endpoints included knee function, physical performance assessments, and safety parameters. Modifi...
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Background. Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are widely prescribed for the treatment of symptomatic osteoarthritis (OA) of the knee. However, searching for alternatives such as locally available medicinal herbs to... more
Background. Topical nonsteroidal anti-inflammatory drugs (NSAIDs) are widely prescribed for the treatment of symptomatic osteoarthritis (OA) of the knee. However, searching for alternatives such as locally available medicinal herbs to manage OA knee pain remains of clinical value. The objective of the present study was to evaluate the efficacy and safety of two yellow oil formulations in patients with OA of the knee. Methods. This prospective, randomized, single-blind, active-controlled, noninferiority study enrolled 102 patients with OA of the knee. Eligible patients were randomly assigned to apply either yellow oil formulation 3 (YOF3), yellow oil formulation 4 (YOF4), or indomethacin solution (INDO) topically four times daily for four weeks. Outcomes were assessed on a biweekly basis. The primary efficacy outcome measure was a 100 mm visual analog scale (VAS) of pain, while secondary endpoints included knee function, physical performance assessments, and safety parameters. Modifi...
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Soy isoflavones have several potential benefits related to postmenopausal health. Isoflavone glycosides, found predominantly in nonfermented soy products, e.g., soy milk, require conversion by gut microbiota to their respective... more
Soy isoflavones have several potential benefits related to postmenopausal health. Isoflavone glycosides, found predominantly in nonfermented soy products, e.g., soy milk, require conversion by gut microbiota to their respective bioavailable aglycones prior to absorption into portal circulation. Use of short-course oral ciprofloxacin for the treatment of acute uncomplicated cystitis, the incidence of which is increasing among postmenopausal women, might adversely affect gut microbiota. The objective of this one-group pre-post treatment study was to determine the effect of short-course oral ciprofloxacin on isoflavone pharmacokinetics in healthy postmenopausal women. Eleven postmenopausal subjects were assigned to consume a single oral dose of 375 mL UHT soy milk (SOY phase). Blood samples were collected immediately before soy milk ingestion and at specific times for 32 hours after soy milk ingestion. Following a washout period of at least seven days, subjects were assigned to take 25...
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Objective: To determine the isoflavone content in soy milk products commercially available in Thailand.Material and Methods: Two flavors of each of 4 brands of soy milk were obtained from retail outlets in Chiang Mai, Thailand. The... more
Objective: To determine the isoflavone content in soy milk products commercially available in Thailand.Material and Methods: Two flavors of each of 4 brands of soy milk were obtained from retail outlets in Chiang Mai, Thailand. The isoflavone content in soy milk was determined using high-performance liquid chromatography.Results: Genistin and daidzin, both β-glycoside conjugates, were found to be the main isoflavone components in soy milk. The total amount of isoflavones varied considerably among different products, ranging from 25.5 to 63.5 mg per serving (250 mL) of soy milk. Marked variation in total isoflavones was also found even among different lots of the same product.Conclusion: The isoflavone content in soy milk products available in Thailand varies substantially among different products as well as among different lots of the same product. This suggests that standardizing or, at least, declaring the isoflavone content in soy milk products is needed to facilitate the optimal...
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The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has... more
The use of lengthy, detailed, and complex informed consent forms (ICFs) is of paramount concern in biomedical research as it may not truly promote the rights and interests of research participants. The extent of information in ICFs has been the subject of debates for decades; however, no clear guidance is given. Thus, the objective of this study was to determine the perspectives of research participants about the type and extent of information they need when they are invited to participate in biomedical research. This multi-center, cross-sectional, descriptive survey was conducted at 54 study sites in seven Asia-Pacific countries. A modified Likert-scale questionnaire was used to determine the importance of each element in the ICF among research participants of a biomedical study, with an anchored rating scale from 1 (not important) to 5 (very important). Of the 2484 questionnaires distributed, 2113 (85.1%) were returned. The majority of respondents considered most elements required...
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ObjectiveThis study aimed to test the applicability and effectiveness of the enhanced informed consent form (ICF) methodology, proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), in neonatal research... more
ObjectiveThis study aimed to test the applicability and effectiveness of the enhanced informed consent form (ICF) methodology, proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), in neonatal research requiring maternal consent.DesignA single-centre open-label randomised controlled study.SettingAntenatal care clinics at Phramongkutklao Hospital, Thailand.Patients234 pregnant women who were at risk of preterm labour were enrolled; 232 individuals completed the study.InterventionsThe participants were randomly assigned to read either the SIDCER ICF or the conventional ICF.Main outcome measuresThe participants’ understanding of essential trial-related information was assessed using 25 closed-ended questions. The primary endpoint was the proportion of the participants who obtained the satisfactory level of understanding at 80% (score of ≥20/25).Results72.5% (87/120) of the participants in the SIDCER ICF group and 59.8% (67/112) of the conventional ICF...
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The most recent epidemic of Ebola virus disease (EVD) has resulted in more than 11,000 deaths in West Africa. It has threatened child health in the affected countries, including Guinea. This nationwide retrospective cohort study included... more
The most recent epidemic of Ebola virus disease (EVD) has resulted in more than 11,000 deaths in West Africa. It has threatened child health in the affected countries, including Guinea. This nationwide retrospective cohort study included all children under 20 years of age with laboratory-confirmed EVD in Guinea during the 2014-2015 Ebola outbreak for analysis. Of 8,448 children with probable or suspected EVD, 695 cases were laboratory-confirmed EVD. The overall case fatality rate (CFR) was 62.9%. Pediatric patients with younger age had a significantly higher rate of death (adjusted OR = 0.995; 95%CI = 0.990-1.000; p = 0.046), with the highest CFR of 82.9% in children aged less than 5 years. Fever (91%), fatigue (87%), and gastrointestinal signs and symptoms (70%) were common clinical features on admission of the pediatric patients, while bleeding signs were not occurring often (24%). None of clinical features and epidemiologic risk factors for Ebola were associated with mortality outcome in our cohort study. EVD is a major threat to child health, especially among children under 5 years of age. To date, none of demographic and clinical features, except younger age, have been consistently shown to affect mortality outcome in children infected with Ebola virus. What is Known: • The 2014-2015 West Africa Ebola epidemic is the largest and most widespread outbreak of Ebola virus disease (EVD) in history, with more than 11,000 deaths in Guinea, Liberia, and Sierra Leone. • During ongoing outbreak investigations, it is suggested that young children aged less than 5 years are particularly vulnerable and highly susceptible to death. What is New: • Demographic and clinical characteristics of the nationwide cohort of pediatric patients with laboratory-confirmed EVD in Guinea are reported. • The results confirm the high rate of death among EVD children under 5 years of age, while none of demographic and clinical features, except younger age, could serve as a predictor of mortality outcome in pediatric patients with EVD.
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The quality of informed consent forms (ICFs) remains an issue in clinical research. The lengthy and complicated ICFs currently being used lower research participants' ability to read and understand the information provided therein. In... more
The quality of informed consent forms (ICFs) remains an issue in clinical research. The lengthy and complicated ICFs currently being used lower research participants' ability to read and understand the information provided therein. In collaboration with the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER), we have developed the SIDCER ICF, which could be of value in improving the quality of the ICFs. The three principles underlying the SIDCER ICF were: (i) an ICF contains all the required regulatory elements; (ii) an ICF provides only such information as is relevant for the subject's decision-making; and (iii) an ICF presents information in a simple format that conveys relevant information to the target population. The SIDCER ICF template, with its instructions, was then structured to assist an investigator in developing an enhanced ICF according to the three principles. The applicability of the SIDCER ICF was tested using a phase I study protocol, and...
Cardiovascular disease (CVD) in the ageing is a major public health problem worldwide. The nature of most CVD is subclinical with pathological processes that can span over years. Use of preventive measures could be an appropriate approach... more
Cardiovascular disease (CVD) in the ageing is a major public health problem worldwide. The nature of most CVD is subclinical with pathological processes that can span over years. Use of preventive measures could be an appropriate approach to prevailing over CVD in the ageing, and herbal medicine is one of the promising preventive approaches and is currently of interest among medical societies. In the evidence-based era, herbal medicine is, however, often underestimated and approached with skepticism, mainly due to the paucity of scientific evidence. Properly designed clinical trials on herbal medicine for prevention of CVD in a geriatric population are thus of importance and of clinical value. To review ethical issues and discuss considerations when such research is proposed. Four ethical issues, including the scientific validity of research, risk-benefit assessments, subject selection and vulnerability, and informed consent, are structured and extensively discussed in this article. Ethical core considerations of prevention research of CVD on herbal medicine involve particular attention on the scientific validity of research, risk-benefit assessments, subject selection and vulnerability, and informed consent. These issues and considerations are keys, although they must be adapted to an individual research setting in which a clinical study is proposed.
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This study aimed to evaluate the applicability of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) in a clinical pharmacokinetic study by... more
This study aimed to evaluate the applicability of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) in a clinical pharmacokinetic study by comparing the volunteers' understanding of the enhanced ICF (developed based on the SIDCER methodology) and the conventional ICF (which was previously approved by local Ethics Committee and used in the clinical study). A total of 550 volunteers were randomly assigned to read either the enhanced ICF or the conventional ICF (1:1) in a mock informed consent approach and subsequently performed the post-test questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80 %; the secondary endpoints were the total score of the post-test, the score of the categorized ICF elements, and time spent for participation. The proportion of the participants in the enhanced ICF group who achieved the primary endpoint was s...
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Molecular mechanisms and pathogenesis of schistosomal-associated bladder cancer (SABC), one of the most common malignancies in Africa and parts of the Middle East, is still unclear. Identification of host molecular markers involved in... more
Molecular mechanisms and pathogenesis of schistosomal-associated bladder cancer (SABC), one of the most common malignancies in Africa and parts of the Middle East, is still unclear. Identification of host molecular markers involved in schistosomal related bladder carcinogenesis is of value in prediction of high-risk group, early detection and timely intervention. PubMed, Scopus, Google Scholar, Cochrane Library and African Journals Online databases were systematically searched and reviewed. A total of 63 articles reporting 41 host molecular factors were included in the meta-analysis. Pooled odds ratio demonstrated associations of p53 expression, telomerase activity and sFas with SABC as compared to other schistosomal patients (p53 expression: OR=9.46, 95%CI=1.14-78.55, p=0.04; telomerase by TERT: OR=37.38, 95%CI=4.17-334.85, p=0.001; telomerase by TRAP: OR=10.36, 95%CI=6.08-17.64, p&amp;amp;amp;amp;lt;0.00001; sFas: OR=34.37, 95%CI=3.32-355.51, p=0.003). In comparison to bladder cancers of other etiology, positive associations were found between SABC and p15 deletion, p16 deletion, telomerase activity and sFas (p15 deletion: OR=4.20, 95%CI=2.58-6.82, p&amp;amp;amp;amp;lt;0.00001; p16 deletion: OR=4.93, 95%CI=2.52-9.65, p&amp;amp;amp;amp;lt;0.00001; telomerase by TERT: OR=3.01, 95%CI=1.51-5.97, p=0.002; telomerase by TRAP: OR=2.66, 95%CI=1.18-6.01, p=0.02; sFas: OR=4.50, 95%CI=1.78-11.40, p=0.001). Other identified associations were reported by few numbers of studies to enable reliable interpretation. Variations in gene expression or genomic alterations of some molecular markers in SABC as compared to non-SABC or other schistosomal patients were identified. These suggest minute differences in the pathogenesis and physiological profile of SABC, in relation to non-SABC.
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Iron overload cardiomyopathy remains the major cause of death in β-thalassemia (β-thal). Conventional routine screening parameters such as serum ferritin and echocardiogram (ECG) do not permit early detection of this condition. Although... more
Iron overload cardiomyopathy remains the major cause of death in β-thalassemia (β-thal). Conventional routine screening parameters such as serum ferritin and echocardiogram (ECG) do not permit early detection of this condition. Although non-transferrin-bound iron (NTBI) is a reliable indicator for iron overload, it is still not universally available. Recently, heart rate variability (HRV), representing cardiac autonomic function, was found to be depressed in thalassemia patients. We hypothesized that HRV can be used for early detection of iron overload cardiomyopathy. Fifty patients (aged 29 ± 11 years; 31 females and 19 males) with β-thal were enrolled. The 24-hour Holter monitoring for HRV, serum ferritin, NTBI, hematological values and ECG were performed for each patient. Of the 50 patients, 29 carried β-thal major (β-TM). Non-transferrin-bound iron was weakly correlated to all time-domain HRV parameters. Low- and high-frequency domain HRV parameters were also inversely weakly correlated with NTBI. Neither HRV nor NTBI was correlated with serum ferritin. With its weak but significant correlation with NTBI, HRV may be considered to be used as a potential indicator of an iron overload condition and an early marker of cardiac involvement in patients with β-thal.
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Myocardial siderosis is known as the major cause of death in thalassemia major (TM) patients since it can lead to iron overload cardiomyopathy. Although this condition can be prevented if timely effective intensive chelation is given to... more
Myocardial siderosis is known as the major cause of death in thalassemia major (TM) patients since it can lead to iron overload cardiomyopathy. Although this condition can be prevented if timely effective intensive chelation is given to patients, the mortality rate of iron overload cardiomyopathy still remains high due to late detection of this condition. Various direct and indirect methods of iron assessment, including serum ferritin level, echocardiogram, non-transferrin-bound iron, cardiac magnetic resonance T2*, heart rate variability, and liver biopsy and myocardial biopsy, have been proposed for early detection of cardiac iron overload in TM patients. However, controversial evidence and limitations of their use in clinical practice exist. In this review article, all of these iron assessment methods that have been proposed or used to directly or indirectly determine the cardiac iron status in TM reported from both basic and clinical studies are comprehensively summarized and pr...