OBJECTIVES

The prevalence of metabolic syndrome among Filipino adults was found to be 12-19%. Diet has been one risk factor targeted to prevent complications. The association of each macronutrient component with metabolic syndrome remains unclear. There is no Philippine data on macronutrient intake and metabolic syndrome, thus, the primary objective of this study is to determine the association of food intake with metabolic syndrome among Filipino adults.

METHODS

This study utilized a cross-sectional design. Data were taken from the results of the 8th National Nutrition and Health Survey (NNHeS). Filipino adults from different regions who consented to participate and with complete anthropometric, biochemical and food recall data were included in this study.

RESULTS

There were 8,056 adults included in the study. The prevalence of metabolic syndrome was 32%. Multivariate analysis showed that increased total protein intake (OR 1.391) and increased daily consumption of meat and poultry (OR 1.397) were associated with increased risk for metabolic syndrome. On the other hand, decreased vegetable intake was associated with increased risk for metabolic syndrome, as well as higher socioeconomic status, female sex, and old age.

CONCLUSION

ncreased total protein intake and daily consumptions of meat, poultry, and decreased vegetable intake are associated with an increased risk for metabolic syndrome.

Human ; Male ; Female ; World Health Organization ; Metabolic Syndrome ; Health Surveys ; Economics ; Multivariate Analysis ; Female

BACKGROUND AND OBJECTIVE

Diabetes, a prevalent metabolic disorder characterized by hyperglycemia primarily due to insulin action and secretion, poses significant health challenges, particularly in low to medium-income countries such as the Philippines. Quassia amara, a shrub indigenous to South America and present in the Philippines, holds a rich history of utilization in alternative and complementary therapies. While previous studies have demonstrated the hypoglycemic effects of Quassia amara stem wood, investigations into the potential impact of its leaves on blood glucose levels remain scarce. Thus, this study aimed to assess the blood glucose-lowering effects of the aqueous leaf extract of Quassia amara (ALQa) on ICR strain mice.

METHODS

Diabetes was induced in thirty male ICR mice via intraperitoneal administration of alloxan monohydrate (200 mg/kg) dissolved in 0.9% Normal Saline. The mice were divided into five groups (n=6), Group I: negative control (distilled water), Group II: reference standard glibenclamide (4 mg/kg): Groups III-V: three doses of ALQa (125, 250, and 500 mg/kg) via oral gavage. A glucometer was used to monitor the fasting blood glucose levels at 0, 1-, 2-, 6-, and 24-hour postadministration.

RESULTS

Administration of alloxan monohydrate increased the FBS in the treated group to diabetic levels of >200 mg/dL. The treatment of diabetic mice with ALQa extract significantly reduced fasting blood sugar (FBS) levels in a dose-dependent manner with the highest dose of ALQa (500 mg/kg) having glucoselowering effects comparable to glibenclamide beginning with the 2-hour mark until 24-hour post-intervention. The mean FBS at 0-hour (baseline) and 1-hour postintervention were similar for all the groups. However, there was an increase in the mean FBS of the negative control group treated with distilled water in the first hour while there was already a decrease in the FBS of those allocated to glibenclamide and the three doses of ALQa. At both the second and 6-hour mark post-intervention, the mean FBS of the mice treated with ALQa 250 mg/ kg and 500 mg/kg was comparable to glibenclamide. Finally, at the 24th hour post-intervention, only the mice allocated to 500 mg/kg of ALQa had comparable FBS to glibenclamide. The degree of reduction [mean percent reduction] of the FBS from baseline to the 24th hour was 78% for glibenclamide and 69% for ALQa 500 mg/kg (p =0.816).

CONCLUSION

The aqueous extract of Quassia amara leaf at 250 and 500 mg/kg produced a dose-dependent significant blood glucose-lowering effect in the alloxan-induced diabetic mice model. The 500 mg dose demonstrated a statistically comparable reduction in FBS to glibenclamide from the 2-hour time point. These f indings suggest the potential of ALQa as an antidiabetic agent. Thus, warranting further investigation into its therapeutic mechanisms and clinical applications.

Quassia Amara ; Quassia

OBJECTIVES

In response to the need for a simple and fast way of ensuring that generic drugs especially those that contain rifampicin are bioequivalent with reference drugs, this study validated an ultra-high-performance liquid chromatography (UHPLC) method of quantifying rifampicin in human plasma. The study also validated the method's selectivity, linearity, sensitivity, accuracy, precision, and the absence of a carry-over effect adhering to the Philippine Food and Drug Administration guidelines.

METHODS

Plasma samples were prepared via protein precipitation using methanol containing ascorbic acid. Three microliters (3 uL) of the prepared samples were then analyzed in a Waters Acquity H-Class UPLC® system coupled to a tunable ultraviolet (TUV) detector with an attached UPLC® BEH C-18 column using a developed and optimized method. Briefly, the column temperature was set to 40°C and the sample temperature was set to 10°C. Elution was done using a linear gradient flow of a water-acetonitrile mixture that started with 45% acetonitrile increasing to 60% acetonitrile at 0.5 minutes and back to 45% acetonitrile at 3 minutes and having a constant flow rate of 0.5 mL/min. Detection was done at 340 nm. Method validation was performed following the ICH guidelines for Bioanalytical Method Validation, the same guidelines referenced by the ASEAN Guideline for Harmonisation of Standards and the Philippine Food and Drug Administration (FDA).

RESULTS

The method had an analysis time of 3 minutes wherein rifampicin eluted at 1.4 minutes while the internal standard, rifapentine (IS) eluted at 1.7 minutes. Since no co-eluting endogenous materials were observed for the rifampicin and the internal standard, the method was confirmed to be selective. Its linearity over the range of 2 ug/mL to 25 ug/mL has been validated where it has a limit of detection (LOD) and limit of quantification (LOQ) values of 0.64 ug/mL and 1.94 ug/mL, respectively. The interday and intraday precision, reported as % coefficient of variance (%CV), and interday and intraday accuracy, reported as %error all within the limits of ±20% for the LLOQ and ±15% for the rest indicating its reliability and reproducibility. Lastly, due to the nature of the injection of the sample into the system, wherein a blank immediately follows the highest concentration standard, the method has been cleared of a carry-over effect.

CONCLUSION

The study successfully validated a UHPLC method of quantifying rifampicin in human plasma. Due to the sample processing method used and the chromatographic conditions set, the method can prepare and analyze samples in a simple yet fast, sensitive, reliable, and reproducible manner. The method can be applied in bioavailability and bioequivalence studies of rifampicin.

Human ; Rifampin ; Rifampicin ; Bioequivalence ; Therapeutic Equivalency

Human ; Endocrinology

RATIONALE AND OBJECTIVES

The COVID- 19 pandemic and the subsequent designation of the Philippine General Hospital lead to necessary adjustments in internal medicine residency training. This study investigated the impact of the COVID-19 pandemic on internal medicine (IM) residents in the Philippine General Hospital.

METHODOLOGY

A questionnaire was developed and distributed among internal medicine residents employed in the years 2020 and 2021. Qualitative data was then gathered through on line and face-to-face interviews.

RESULTS

A total of 43 Internal Medicine residents responded. This study found that the pandemic significantly affected internal medicine residents and their overall training. The participants reported changes in the number and profile of patients seen, the limited outpatient clinical exposure, the difficulties of telemedicine, and the reduced interactions with consultants and subspecialty fellows. Infection control protocols and workforce limitations also affected the number of procedures done by the residents. Resident participants reported that they were able to allot more time to studying from the textbook because of the skeletal schedules and decreased number of patients. Other learning avenues were shifted to online conferences and lectures.

The COVID-19 pandemic a lso brought about changes in residents' day-to-day routines, schedules, and rotations. Communicating with patients and relatives was also reported to be more difficult. Lifestyle changes varied among resident s. Socialization also shifted to online avenues and social messaging platforms. Having colleagues who test positive tor COVID and subsequently requiring quarantine lead to constant changes in workforce dynamics. This lead to feelings of anxiety and isolation among its trainees.

However, a number of participants still believed that the pandemic allowed them to become better physicians. This was brought about by a sense of service and pride, camaraderie among colleagues, commitment to finishing the program, financial stability, and administrative support. Still, the participants stated areas for improvement, including more consistent protocol measures, additional financial compensation, added workforce, and more transparent administrative support. All in all, participants felt that they were still able to meet the learning outcomes and minimum competencies. Majority of the participants believed the experiences brought about by the pandemic helped them become a better internist.

CONCLUSION

Ultimately, the new challenges from the pandemic strengthened the sense of service, resilience and clinical acumen of the residents.

Human ; Covid-19 ; Education ; Training

BACKGROUND AND OBJECTIVE

Prolactinoma is the most common functioning tumor of the pituitary gland. While its clinical course and outcomes among different populations have been vastly described in the past, data of prolactinoma among Filipinos has not been explored. This paper aims to describe the clinical profile and outcome of prolactinoma among adult Filipino patients.

METHODS

We conducted a retrospective cohort study including 41 patients with prolactinoma seen at the Philippine General Hospital. The clinical profile, cranial imaging features, treatment modalities given, and their outcomes over a mean follow up of 16 months were evaluated.

RESULTS

The mean age at diagnosis was 36.76 ± 13.99 years. Majority of our cohort were females. Macroprolactinoma were found in 75.61% and giant prolactinoma in 9.76%. The remaining 12.2% were mixed GH and PRL secreting tumors. Most common symptoms at presentation were blurring of vision, headache, and amenorrhea. Median PRL levels was 353 (200-470) ng/ml. Medical therapy with Bromocriptine was the primary treatment modality used in 78% of patients. We found no significant difference between patients who underwent surgical and medical primary treatment modalities in terms of outcomes. At the end of follow up, 82.6% of patients achieved at least more than 50% reduction in their prolactin levels.

CONCLUSION

Overall, our study showed that adult Filipino patients with prolactinoma have a larger tumor size at diagnosis and a lower rate of improvement of gonadal function after treatment. There were no statistically significant differences in clinical and biochemical outcomes between the treatment modalities used.

Human ; Prolactinoma ; Pituitary Neoplasms ; Prolactin

OBJECTIVES

In response to the need for a simple and fast way of ensuring that generic drugs especially those that contain rifampicin are bioequivalent with reference drugs, this study validated an ultra-high-performance liquid chromatography (UHPLC) method of quantifying rifampicin in human plasma. The study also validated the method's selectivity, linearity, sensitivity, accuracy, precision, and the absence of a carry-over effect adhering to the Philippine Food and Drug Administration guidelines.

METHODS

Plasma samples were prepared via protein precipitation using methanol containing ascorbic acid. Three microliters (3 uL) of the prepared samples were then analyzed in a Waters Acquity H-Class UPLC® system coupled to a tunable ultraviolet (TUV) detector with an attached UPLC® BEH C-18 column using a developed and optimized method. Briefly, the column temperature was set to 40°C and the sample temperature was set to 10°C. Elution was done using a linear gradient flow of a water-acetonitrile mixture that started with 45% acetonitrile increasing to 60% acetonitrile at 0.5 minutes and back to 45% acetonitrile at 3 minutes and having a constant flow rate of 0.5 mL/min. Detection was done at 340 nm. Method validation was performed following the ICH guidelines for Bioanalytical Method Validation, the same guidelines referenced by the ASEAN Guideline for Harmonisation of Standards and the Philippine Food and Drug Administration (FDA).

RESULTS

The method had an analysis time of 3 minutes wherein rifampicin eluted at 1.4 minutes while the internal standard, rifapentine (IS) eluted at 1.7 minutes. Since no co-eluting endogenous materials were observed for the rifampicin and the internal standard, the method was confirmed to be selective. Its linearity over the range of 2 ug/mL to 25 ug/mL has been validated where it has a limit of detection (LOD) and limit of quantification (LOQ) values of 0.64 ug/mL and 1.94 ug/mL, respectively. The interday and intraday precision, reported as % coefficient of variance (%CV), and interday and intraday accuracy, reported as %error all within the limits of ±20% for the LLOQ and ±15% for the rest indicating its reliability and reproducibility. Lastly, due to the nature of the injection of the sample into the system, wherein a blank immediately follows the highest concentration standard, the method has been cleared of a carry-over effect.

CONCLUSION

The study successfully validated a UHPLC method of quantifying rifampicin in human plasma. Due to the sample processing method used and the chromatographic conditions set, the method can prepare and analyze samples in a simple yet fast, sensitive, reliable, and reproducible manner. The method can be applied in bioavailability and bioequivalence studies of rifampicin.

Human ; Rifampin ; Rifampicin ; Bioequivalence ; Therapeutic Equivalency

OBJECTIVES

In Asia, younger individuals (below age 45) are diagnosed to have type 2 diabetes with increased rates of obesity defined by lower BMI yet with greater visceral adiposity (waist circumference and waisthip ratios). The prevalence data on type 1 diabetes is not well established, considered to be low, but is seen to be increasing as well. This changing phenotype therefore, presents a clinical dilemma in terms of correctly classifying diabetes and deciding on the consequent appropriate treatment. Distinguishing type 1 from type 2 diabetes has become more difficult with type 2 diabetes dramatically increasing in young adults and children. This study aims to define the characteristics of diabetes among young adults in the Philippines to provide a basis for appropriate management amidst changes in diabetes phenotypes seen globally.

METHODS

In this cross-sectional analytic study, we characterized the demographic, metabolic, and autoimmune features of diabetes among young adult Filipinos aged 18 to 45 years old consulting at a tertiary referral center in Manila, Philippines. Baseline serum A1c, FBS, 75-g oral glucose tolerance test, insulin, serum C-peptide, insulin autoantibodies, leptin, adiponectin, lipid profile, and thyroid function tests were obtained from the participants and analyzed. The homeostasis model assessment (HOMA) was used to estimate the insulin sensitivity.

RESULTS

A total of 348 patients with diabetes were included, with females comprising two-thirds of the participants. The mean age at diagnosis of diabetes was 35.9±7.22 years. The mean BMI was 28.12 kg/m2, with median waist to hip ratio (WHR) of 0·93. Metabolic syndrome was found in 60% of participants and 67.82% were obese by body mass index. The mean A1c was 9.07±2.52%. Good glucose control (A1c less than 7.0%) was seen in 23% of participants  while nearly half (48%) had HbA1c which was >9.0%. The median levels of fasting insulin and C-peptide were 12.62 (range 1.33–90.42) mIU/L and 0.78 ng/mL (range 0–16.2), respectively. 

Included participants were diagnosed with diabetes within a year and as such, majority did not have any micro- or macrovascular complications. The most common diabetes complication was sensory neuropathy detected by monofilament testing, which was found in 28% of participants, followed by non-proliferative diabetic retinopathy in 13%. A history of previous diabetic ketoacidosis was found in 10 patients (2.87%). Glutamic acid decarboxylase (GAD) and insulin auto-antibodies were found in 3.2% and 19.3% of participants, respectively. Approximately half (51.73%) of the participants were insulin resistant by HOMA-IR.

CONCLUSION

In contrast with Caucasians and other Asians, diabetes among young Filipino adults is associated with lower BMI but with a similarly high visceral adiposity as shown by an elevated WHR. Metabolic syndrome with insulin resistance as defined by a variety of indices is predominant. Type 1 diabetes with autoantibodies occur in only a small fraction of this population. Data derived from this work can provide a framework for cluster analysis towards personalized management specific to this population.

Human ; Acids ; Adiponectin ; Adiposity ; Adult ; Aged ; Antibodies ; Asia ; Asian ; Asian Continental Ancestry Group ; Autoantibodies ; Body Mass Index ; C-peptide ; Carboxy-lyases ; Child ; Cluster Analysis ; Demography ; Diabetes Complications ; Diabetes Mellitus ; Diabetes Mellitus, Type 1 ; Diabetes Mellitus, Type 2 ; Diabetic Ketoacidosis ; Diabetic Retinopathy ; Diagnosis ; Fasting ; Female ; Glucose ; Glucose Tolerance Test ; Glutamate Decarboxylase ; Glutamic Acid ; Insulin ; Insulin Resistance ; Ketosis ; Leptin ; Lipids ; Metabolic Syndrome ; Obesity ; Patients ; Peptides ; Phenotype ; Philippines ; Population ; Prevalence ; Serum ; Therapeutics ; Thyroid Gland ; Thyroid Function Tests ; Young Adult

Objectives: The Bioavailability/Bioequivalence Unit (BA/BE Unit) of the Department of Pharmacology and Toxicology, College of Medicine, University of the Philippines Manila which has not been operational since 2012, is due for renewal of its accreditation. To date, there are only three Philippine Food and Drug Administration-accredited laboratories that perform bioequivalence studies in the Philippines. One of the prerequisites of registering specific generic medicines is the conduct of Bioequivalence (BE) studies which are performed to ensure that the generic drug is at par with the innovator drug. Thus, this study aimed to determine the feasibility of re-establishing the BA/BE Unit as a bioequivalence testing center. Methods: The feasibility study done is a qualitative descriptive analysis based on expansive literature review and performance of SWOT analysis within the BA/BE unit. Literatures were selected based on its assessed relevance to the study. The databases checked were PubMed and Google Scholar. The terms used were from the Medical Subject Heading (MeSH) including feasibility studies, therapeutic equivalency, and generic drugs. Literature review was performed on the factors affecting the four types of feasibility studies (market, technical, financial, and organizational). A SWOT analysis of the BA/BE Unit was done through the review of records and documents of previous BE studies and focus group discussion among the BA/BE Unit team members. Results: The BA/BE Unit conducted 24 bioequivalence studies from 2006-2009 and still receives inquiries from drug companies. It implements its QMS throughout the pre-analytical, analytical, and post-analytical stages of the workflow. Its organizational structure consists of qualified professionals with updated GCP and GLP certificates. Because of the adequately equipped facility, lower honoraria for government-employed personnel, and lower expenses for laboratories and in-patient admissions, the cost of conducting a bioequivalence study in the BA/BE Unit will be lower than in other BE centers. Conclusion Based on the SWOT analysis and market, technical, financial, and organizational considerations, reestablishing the BA/BE Unit as a bioequivalence testing center is feasible.
Feasibility Studies ; Therapeutic Equivalency ; Drugs, Generic

Background and Objective: Prolactinoma is the most common functioning tumor of the pituitary gland. While its clinical course and outcomes among different populations have been vastly described in the past, data of prolactinoma among Filipinos has not been explored. This paper aims to describe the clinical profile and outcome of prolactinoma among adult Filipino patients. Methods: We conducted a retrospective cohort study including 41 patients with prolactinoma seen at the Philippine General Hospital. The clinical profile, cranial imaging features, treatment modalities given, and their outcomes over a mean follow up of 16 months were evaluated. Results: The mean age at diagnosis was 36.76 ±13.99 years. Majority of our cohort were females. Macroprolactinoma were found in 75.61% and giant prolactinoma in 9.76%. The remaining 12.2% were mixed GH and PRL secreting tumors. Most common symptoms at presentation were blurring of vision, headache, and amenorrhea. Median PRL levels was 353 (200-470) ng/ml. Medical therapy with Bromocriptine was the primary treatment modality used in 78% of patients. We found no significant difference between patients who underwent surgical and medical primary treatment modalities in terms of outcomes. At the end of follow up, 82.6 % of patients achieved at least more than 50% reduction in their prolactin levels. Conclusion Overall, our study showed that adult Filipino patients with prolactinoma have a larger tumor size at diagnosis and a lower rate of improvement of gonadal function after treatment. There were no statistically significant differences in clinical and biochemical outcomes between the treatment modalities used.
Prolactinoma ; Pituitary Neoplasms ; Prolactin