A Feasibility Study on Re-establishing the Bioavailability/Bioequivalence Unit of the Department of Pharmacology and Toxicology, College of Medicine-University of the Philippines Manila.

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, re-establishing the BA/BE Unit as a bioequivalence testing center is feasible.

A systematic review and meta-analysis on the efficacy and safety of metformin as adjunctive therapy among women with metastatic breast cancer.

BACKGROUND: Breast cancer is the most common cancer among women worldwide and is one of the leading causes of cancer-related mortalities. Metformin has been found to have direct and indirect antitumor mechanisms, and because of its availability and good safety profile, it has been investigated to be useful in various malignancies including breast cancer. OBJECTIVE: This study aims to determine the efficacy and safety of metformin administration as adjunctive therapy on mortality among females with breast cancer. METHODS: This is a systematic review and meta-analysis of randomized clinical trials (RCTs) on the use of metformin as adjunctive therapy when combined with standard chemotherapy on the outcomes of progression-free survival (PFS), overall survival (OS), overall response rate (ORR), and clinical benefit rate (CBR). RESULTS: After a comprehensive literature search, only three phase 2 RCTs on the use of metformin as adjunctive therapy for locally advanced and metastatic breast cancer were included. Clinical trials on early breast cancer are still ongoing and none were included in the present review. This study, based on the systematic review, revealed that metformin added to standard chemotherapy does not improve the PFS and OS among women with metastatic breast cancer, and likewise, has no impact on the ORR with a relative risk of 1.42 95% CI 0.45-4.55 and CBR with an RR of 0.87, 95% CI 0.55-1.37. It appears to be safe and may even be protective for the development of neutropenia based on at least one study. CONCLUSION: This study clarifies that there is insufficient evidence on the benefits of metformin on survival among women with metastatic breast cancer.

Executive summary of the 2020 clinical practice guidelines for the management of hypertension in the Philippines.

Hypertension is the most common cause of death and disability worldwide with its prevalence rising in low to middle income countries. It remains to be an important cause of morbidity and mortality in the Philippines with poor BP control as one of the main causes. Different societies and groups worked and collaborated together to develop the 2020 Philippine Clinical Practice Guidelines of hypertension arising for the need to come up with a comprehensive local practice guideline for the diagnosis, treatment, and follow up of persons with hypertension. A technical working group was organized into six clusters that analyzed the 30 clinical questions commonly asked in practice, looking into the definition of hypertension, treatment thresholds, blood pressure targets, and appropriate medications to reach targets. This guideline also includes recommendations for the specific management of hypertension among individuals with uncomplicated hypertension, hypertension among those with diabetes, stroke, chronic kidney disease, as well as hypertension among pregnant women and pediatric populations. It also looked into the appropriate screening and monitoring of patients when managing hypertension, and identification of groups who are at high risk for cardiovascular (CV) events. The ADAPTE process was used in developing the statements and recommendations which were then presented to a panel of experts for discussion and approval to come up with the final statements. This guideline aims to aid Filipino healthcare professionals to provide evidence-based care for persons with hypertension and help those with hypertension adequately control their blood pressure and reduce their CV risk.

Metformin extended-release versus metformin immediate-release for adults with type 2 diabetes mellitus: A systematic review and meta-analysis of randomized controlled trials.

AIM: To compare the efficacy and tolerability of metformin extended-release (MXR) and the conventional metformin immediate-release (MIR) formulations in adults with type 2 diabetes mellitus (T2DM) METHODS: PubMed, the Cochrane Library, ClinicalTrials.gov and other sources were searched until 19 March 2021 for randomized controlled trials (RCTs) that compared equal daily doses of MXR and MIR in adults with T2DM. Random-effects model meta-analysis was performed to obtain pooled mean difference (MD) of change from baseline for continuous outcomes and risk ratio (RR) for dichotomous outcomes. Primary outcomes considered were HbA1c and key gastrointestinal (GI) symptoms (abdominal discomfort or pain, diarrhea, dyspepsia, and nausea & vomiting). RESULTS: Nine RCTs that randomized a total of 2609 adults revealed that MIR was statistically associated with better HbA1c lowering (MD 0.09% [95% confidence interval or CI, 0.01%, 0.17%]), MXR only reduced dyspepsia (RR 0.58 [95% CI, 0.34, 0.98]), and both formulations were associated with similar cumulative incidence of other key GI symptoms. CONCLUSIONS: MXR was associated with statistically worse but likely clinically similar HbA1c lowering and minimal improvement of GI intolerance compared to MIR. Protocol Registration: PROSPERO (CRD42019148008).

Association of sunlight exposure with 25-hydroxyvitamin D levels among working urban adult Filipinos.

OBJECTIVES: To determine the association of different levels of sunlight exposure, measured using the Filipino sunlight exposure questionnaire (SEQ) with 25-hydroxyvitamin D (25-OHD) levels among working urban adult Filipinos. METHODS: Seventy-five adult participants, living and working in Metro Manila, for at least 1 year, were grouped according to their perceived sunlight exposure pattern: low sunlight exposure (mostly indoor work); moderate sunlight exposure (both indoor and outdoor work); and high sunlight exposure (mostly outdoor work). After completion of the self-administered Filipino SEQ, they underwent serum 25-OHD level determination. Strength of correlation between the SEQ scores and 25-OHD levels was computed. RESULTS: Serum 25-OHD levels generally increased with increasing sunlight exposure levels. The overall Pearson's correlation between the SEQ scores and 25-OHD levels of the participants was 0.396 (P = 0.001). The correlation for the individual domains was 0.342 for intensity of sunlight exposure (P = 0.003), 0.321 for factors affecting sunlight exposure (P = 0.005), and 0.256 for sun protection practices (P = 0.027). CONCLUSIONS: The sunlight exposure of working urban adult Filipinos, as measured by the Filipino SEQ, has an overall significant, direct and moderate association with serum 25-OHD levels. This Filipino SEQ can serve as a valuable clinical tool for sunlight exposure assessment to identify individuals at risk for vitamin D deficiency.

Factors Associated with Postoperative Diabetes Insipidus after Pituitary Surgery.

BACKGROUND: Determining risk factors for diabetes insipidus (DI) after pituitary surgery is important in improving patient care. Our objective is to determine the factors associated with DI after pituitary surgery. METHODS: We reviewed records of patients who underwent pituitary surgery from 2011 to 2015 at Philippine General Hospital. Patients with preoperative DI were excluded. Multiple logistic regression analysis was performed and a predictive model was generated. The discrimination abilities of the predictive model and individual variables were assessed using the receiving operator characteristic curve. RESULTS: A total of 230 patients were included. The rate of postoperative DI was 27.8%. Percent change in serum Na (odds ratio [OR], 1.39; 95% confidence interval [CI], 1.15 to 1.69); preoperative serum Na (OR, 1.19; 95% CI, 1.02 to 1.40); and performance of craniotomy (OR, 5.48; 95% CI, 1.60 to 18.80) remained significantly associated with an increased incidence of postoperative DI, while percent change in urine specific gravity (USG) (OR, 0.53; 95% CI, 0.33 to 0.87) and meningioma on histopathology (OR, 0.05; 95% CI, 0.04 to 0.70) were significantly associated with a decreased incidence. The predictive model generated has good diagnostic accuracy in predicting postoperative DI with an area under curve of 0.83. CONCLUSION: Greater percent change in serum Na, preoperative serum Na, and performance of craniotomy significantly increased the likelihood of postoperative DI while percent change in USG and meningioma on histopathology were significantly associated with a decreased incidence. The predictive model can be used to generate a scoring system in estimating the risk of postoperative DI.

Targeted next generation sequencing of the entire vitamin D receptor gene reveals polymorphisms correlated with vitamin D deficiency among older Filipino women with and without fragility fracture.

This study aimed to discover genetic variants in the entire 101 kB vitamin D receptor (VDR) gene for vitamin D deficiency in a group of postmenopausal Filipino women using targeted next generation sequencing (TNGS) approach in a case-control study design. A total of 50 women with and without osteoporotic fracture seen at the Philippine Orthopedic Center were included. Blood samples were collected for determination of serum vitamin D, calcium, phosphorus, glucose, blood urea nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase and as primary source for targeted VDR gene sequencing using the Ion Torrent Personal Genome Machine. The variant calling was based on the GATK best practice workflow and annotated using Annovar tool. A total of 1496 unique variants in the whole 101-kb VDR gene were identified. Novel sequence variations not registered in the dbSNP database were found among cases and controls at a rate of 23.1% and 16.6% of total discovered variants, respectively. One disease-associated enhancer showed statistically significant association to low serum 25-hydroxy vitamin D levels (Pearson chi-square P-value=0.009). The transcription factor binding site prediction program PROMO predicted the disruption of three transcription factor binding sites in this enhancer region. These findings show the power of TNGS in identifying sequence variations in a very large gene and the surprising results obtained in this study greatly expand the catalog of known VDR sequence variants that may represent an important clue in the emergence of vitamin D deficiency. Such information will also provide the additional guidance necessary toward a personalized nutritional advice to reach sufficient vitamin D status.

Comparison of Fixed versus Calculated Activity of Radioiodine for the Treatment of Graves Disease in Adults.

BACKGROUND: Radioactive iodine as a treatment modality has been shown in several studies to be a safe and effective therapy for Graves disease. However, there is still no uniformity regarding optimal dosing method. The aim of this study is to compare the efficacy of calculated and fixed dosing of radioiodine for the treatment of Graves disease. METHODS: A hundred twenty-two patients diagnosed with Graves disease were randomized to receive either fixed or calculated dose of radioiodine. Those randomized to fixed activity received either low fixed activity at 9.9 mCi for thyroid gland size <40 g or high fixed activity at 14.9 mCi for thyroid gland size 40 to 80 g, and those grouped to calculated activity received 160 µCi/g of thyroid tissue adjusted for 24 hours radioiodine uptake. Thyroid function tests (free thyroxine [T4] and thyroid stimulating hormone [TSH]) were monitored at 10, 16, and 24 weeks after radioactive iodine therapy. The primary outcome, treatment failure was defined as persistently elevated free T4 and low TSH. RESULTS: Of the 122 patients randomized, 56 in the fixed dose group and 56 in the calculated dose group completed the follow-up. At the end of 6 months, the percentage of treatment failure was 37.50% in the calculated dose group versus 19.64% in the fixed dose group with a relative risk of 0.53 (95% confidence interval, 0.28 to 0.98) favoring the fixed dose group. CONCLUSION: Fixed dose radioiodine has a significantly lower incidence of persistent hyperthyroidism at 6 months post-radioactive therapy.

Prevalence of diabetes mellitus and pre-diabetes in the Philippines: A sub-study of the 7th National Nutrition and Health Survey (2008)

INTRODUCTION: Diabetes mellitus is rapidly increasing worldwide but the greatest increase is expected in developing countries including the Philippines. It is of public health concern to monitor countrywide prevalence of diabetes as it leads to significant cardiovascular-related mortality as well as significant complications such end stage renal disease, blindness, lower leg amputations and blindness.METHODOLOGY: This is a national survey to estimate the prevalence of diabetes and pre-diabetes using the criteria of the World Health Organization through a stratified multi-stage sampling design representing each of the 17 regions in the country.RESULTS AND DISCUSSION: The national prevalence of diabetes in the year 2008 was 7.2% (6.5-7.9); impaired glucose tolerance 7.0% (6.1-7.8) and impaired fasting glucose was 2.2% (2.2-3.1). There was a greater prevalence of individuals with diabetes in the urban areas at 8.5% (7.5-9.5) compared to the rural areas at 5.7% (4.6-6.8). Diabetes is slightly more preponderant among females at 7.4% (6.4-8.3) compared to males at 7.0% (6.1-8.0).CONCLUSION: The prevalence of diabetes mellitus in the Philippines is rising with the prevalence in 2008 at 7.2%. The prevalence of pre-diabetes exceeds that of diabetes mellitus at approximately 10.2%.

Primary hyperparathyroidism from a probable ectopic parathyroid adenoma with severe skeletal disease and vitamin D deficiency.

Primary hyperparathyroidism (PHPT) may lead to skeletal deformities, fractures and renal failure in symptomatic patients if untreated. We present a case of a 30-year-old woman presented with muscle weakness, weight loss, hypercalcaemia and a pathological fracture, eventually with rapidly progressive musculoskeletal disease. Subsequent biochemical, radiographic and scintigraphy findings were consistent with PHPT from an ectopic mediastinal adenoma, and concomitant vitamin D deficiency. The severe hypercalcaemia was adequately temporised with hydration, forced diuresis and intravenous bisphosphonates. Removal of the adenoma by video-assisted thoracoscopic surgery was contemplated; however, consent was withdrawn precluding histological confirmation. A review of literature shows the changing profiles of patients with PHPT, the uncommon occurrence of parathyroid adenomas in ectopic locations and possible association between severity of PHPT and vitamin D status.

Effect of malunggay (Moringa oleifera) capsules on lipid and glucose levels

OBJECTIVES: To determine the effect of malunggay leaf capsules on LDL (primary efficacy outcome measure); weight, BMI, FBS, serum glucose 2 hours after a 75 g oral glucose load, cholesterol, HDL and triglycerides (secondary efficacy outcome measures); creatinine, ALT and CBC (secondary safety outcome measures); and to determine if these are associated with adverse events. STUDY DESIGN: randomized controlled trial PARTICIPANTS: Seventy nine Filipinos, 18-55 years old with LDL>2.6 mmol/L (100 mg/dL) but of low cardiovascular risk were randomized into malunggay and placebo groups. INTERVENTION: Malunggay capsules for 30 days versus placebo RESULTS: 33 and 35 participants in the malunggay and placebo groups, respectively, completed the treatment. There was a reduction of 13.76 mg/dL in the LDL of the malunggay group, compared to a 19.28 mg/dL reduction in the placebo group (p=0.564). CONCLUSION: Malunggay leaf capsules given for 30 days among adults with serum LDL >2.6 mmol/L (100 mg/dL) but with low cardiovascular risk decreased LDL levels to the same degree as placebo. There were no significant differences in the change in the secondary efficacy and safety outcome measures, and in the occurence of adverse events.

Prevalence of thyroid dysfunction among asymptomatic elderly Filipinos at the Philippine General Hospital / Journal of the ASEAN Federation of Endocrine Societies

The elderly are a peculiar group in terms of health management, as they often present with non-specific complaints which are challenging to interpret and may not present with the usual clinical picture of a disease. Objective. The study aims to determine the prevalence of thyroid dysfunction among asymptomatic, elderly Filipinos seen at the Philippine General Hospital (PGH). Methodology. Subjects aged 60 years and older seeking out-patient medical consult for non-thyroidal illness at the PGH were recruited. Patients with known thyroid or pituitary disease, previous thyroid or pituitary surgery, intake of medications known to affect thyroid hormone levels and critical illness were excluded. Fasting blood sugar (FBS), lipid profile, free thyroxine (FT4), thyroid-stimulating hormone (TSH), and anti-thyroperoxidase (anti-TPO) levels were taken. Based on FT4 and TSH levels, subjects were classified as overt hypothyroid, subclinical hypothyroid, euthyroid, subclinical hyperthyroid, or overt hyperthyroid. Results. One hundred eighty subjects were recruited, of whom 152 (84%) were female. Hypertension was the most common comorbidity (58.33%), followed by diabetes (36.67%). One hundred sixty-two (90%) were euthyroid, 12 (6.7%) subclinical hypothyroid, 4 (2.22%) subclinical hyperthyroid, and two (1.11%) overtly hyperthyroid. No one was overtly hypothyroid. There was a trend toward increasing prevalence of diabetes, hypertension, low HDL, obesity and overall cardiovascular risk among those with subclinical hypothyroidism. Conclusion. Subclinical hypothyroidism was the most prevalent thyroid dysfunction among asymptomatic elderly included in the study.

Prevalence of undiagnosed autoimmune thyroid disease and thyroid dysfunction in Filipino patients with autoimmune rheumatic disorders / Journal of the ASEAN Federation of Endocrine Societies

OBJECTIVES:(1) To determine the prevalence of autoimmune thyroid disease among patients with autoimmune rheumatic disorders seen at the Philippine General Hospital. (2) To determine clinical features that are associated with the occurrence of autoimmune thyroid disease in these patient.METHODOLOGY:This is a cross sectional analytical study that included 155 adult Filipinos diagnosed with an autoimmune rheumatic disorder. Clinical characteristics were recorded. Serum thyrotropin, thyroxine, triiodothyronine, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody and urinary iodide excretion were determined. The prevalence of autoimmune thyroid disease was computed. Associations between clinical factors and autoimmune thyroid disease were determined.RESULTS:Overall 21.94% of the population had autoimmune thyroid disease. There was significant association between duration of the autoimmune rheumatic disorder and autoimmune thyroid disease (p-= 0.018). No significant association was noted with the other clinical factors although there was an almost significant association observed for the presence of goiter (p=0.054).CONCLUSION:Autoimmune thyroid disease commonly occurs in patients with autoimmune rheumatic disorders. As such, it is important to consider screening these patients for the coexistence of thyroid disease to help prevent the complications associated with thyroid dysfunction and avoid adding up to the morbidity of the existing autoimmune rheumatic disorder.

The Philippine thyroid diseases study (PhilTiDeS): Prevalence of thyroid disorders among adults in the Philippines / Journal of the ASEAN Federation of Endocrine Societies

BACKGROUND:The national prevalence of goiters in the Philippines was 3.7% in 1987 and 6.7% in 1993. Since then, there has been no follow-up survey on goiter prevalence, nor has there been any national survey on the prevalence of abnormal thyroid dysfunction. The PhilTiDeS is a survey on the prevalence of both goiters and thyroid disorders in the Philippines.OBJECTIVES:To determine the prevalence of various categories of abnormal thyroid dysfunction among the Filipino non-pregnant adult population and to describe the prevalence of thyroid enlargement in the Philippines in relation to thyroid dysfunction status.MATERIALS AND METHODS:The PhilTiDes was a substudy of the 2008 National Nutrition and Health Survey (NNHeS), which covered all 17 regions and 80 provinces of the Philippines. It included all Filipino adults 20 years and older, who are non-pregnant and non-lactating. A standard questionnaire was used to collect data on previous diagnosis and current treatment for thyroid disorders, and neck examination by trained field personnel was done to assess the presence of goiter. Blood was extracted, processed and sent to an accredited laboratory for free T4 and TSH testing using micro-particle enzyme immunoassay.RESULTS: A total of 4897 persons had thyroid function tests. Of these, 417 (8.53%) had thyroid function abnormalities with the most common abnormality being subclinical hyperthyroidism occurring in 5.33%. The other categories had the following prevalence: true hyperthyroidism 0.61% ; true hypothyroidism 0.41%; and subclinical hypothyroidism 2.18%. Majority of the population 4480 (91.47%) had normal thyroid function tests. Of those with subclinical hyperthyroidism, 55% are females with mean age of 48 years (95% CI 45.9-50.1 years) compared with the volunteers with normal thyroid function who were younger (mean age of 43.1, 95% CI 42.5-43.6 years). Out of the 7,227 volunteers who responded to the survey and clinical examination, a total of 674 (8.9%) had goiters. Out of the 674 subjects with goiters, 379 had diffuse enlargement (56%) while the rest had nodular goiter (44%). Among the sub-population (n= 4897) who underwent thyroid function testing, 9% of those with normal thyroid function tests have goiters.CONCLUSION: The prevalence of thyroid function abnormalities in the Philippines is 8.53% with the greatest proportion of volunteers having subclinical thyroid disease. There is a low prevalence of both true or overt hyperthyroidism and hypothyroidism. In the larger survey, it was found that 8.9% of volunteers who were examined had goiters. The etiology of these goiters will need to be ascertained in future studies.

Knowledge, attitudes and practices of persons with type 2 diabetes in a rural community: phase I of the community-based Diabetes Self-Management Education (DSME) Program in San Juan, Batangas, Philippines.

AIMS: 1. To determine the knowledge, attitudes, and practices of persons with type 2 diabetes in the rural community of San Juan, Batangas, Philippines. 2. To determine the association between patient factors such as age, sex, duration of diabetes, and type of diabetes on knowledge, attitudes, and practices regarding diabetes. METHODS: Cross-sectional analytic study done among persons with type 2 diabetes in the rural community. Participants were selected using stratified cluster sampling. Data were collected using two main methods: use of investigator-administered questionnaires and focus group discussions (FGDs). RESULTS: 156 diabetic residents were included. The overall mean percentage score on knowledge was 43%. Less than half of the respondents strongly believed in the need for patient autonomy (38%). 35 respondents were included in the FGDs. Only 4 out of 35 diabetic respondents owned a glucose meter while only 16 out of the 35 consult their doctors on a regular basis. CONCLUSIONS: The study comprises Phase I of the proposed 5-year community-based DSME Program in the Philippines. It highlights the importance of evaluating knowledge, attitudes and practices as crucial means to understand observed behaviors and guide behavioral change.

A meta-analysis on the effect of chromium picolinate on glucose and lipid profiles among patients with type 2 diabetes mellitus

BACKGROUND: The role of chromium in human nutrition was first reported in 1977 on a patient on total parenteral nutrition manifesting with neuropathy and impaired glucose tolerance attributed to chromium deficiency. After correction, nerve conduction and glucose tolerance tests normalized. Chromium is postulated to act as a cofactor for insulin action by enhancing insulin receptor phosphorylation and stimulating insulin receptor tyrosine kinase.OBJECTIVE: To compare the effect of chromium picolinate versus placebo on glycated hemoglobin (HbA1C), fasting blood sugar (FBS), 2-hours postprandial blood sugar (2HPPBS), fasting insulin (FI) and lipid profile among T2DM patients.METHODS: Literature search in Medicine, Cochrane and Herdin was made using terms such as chromium, chromium picolinate intake of >= 3 months among T2DM patients. Two reviewers independently screened abstracts and full articles. Results were plotted using Revman 4.2.RESULTS: Thirty four trials were found and six trials were included in the meta-analysis. The pooled data for 467 patients with T2DM reported lowering of HbA1c -0.34% (CI -0.45, 0.24 p0.06); FBS -16.6 mg/dl (CI -18.9, -14.41 p 0.30); 2HPPBS -17.33 mg/dL (CI -20.21, -18..81 p CONCLUSION: Chromium picolinate lowers HbA1c, FBS, 2HPPBS and FI moderately but it has no effect on lipids, However, the short duration of studies, variable quality and large heterogeneity across these data limits the strength of our conclusion, hence further studies are recommended.

The effect of Momordica charantia capsule preparation on glycemic control in type 2 diabetes mellitus needs further studies.

BACKGROUND AND OBJECTIVES: Momordica charantia, locally known as Ampalaya, is being widely used and advertised for its hypoglycemic effects. However, to date, no large clinical trial has been published on the efficacy of any type of preparation. The main objective of this study is to determine if addition of M. charantia capsules to standard therapy can decrease glycosylated hemoglobin (hemoglobin A1c or HbA1c) levels in diabetic patients with poor sugar control. STUDY DESIGN AND SETTING: A randomized, double-blind, placebo-controlled trial was conducted between April and September 2004 at the outpatient clinics of the Philippine General Hospital. The trial included 40 patients, 18 years old and above, who were either newly diagnosed or poorly controlled type 2 diabetics with A1c levels between 7% and 9%. On top of the standard therapy, the patients were randomized to either M. charantia capsules or placebo. The treatment group received two capsules of M. charantia three times a day after meals, for 3 months. The control group received placebo at the same dose. The primary efficacy endpoint was change in the A1c level in the two groups. The secondary efficacy endpoints included its effect on fasting blood sugar, serum cholesterol, and weight. Safety endpoints included effects on serum creatinine, hepatic transaminases (Alanine aminotransferase/ALT and Aspartate aminotransferase/AST), sodium, potassium, and adverse events. RESULTS: Baseline characteristics between the treatment and control groups were similar. The difference in mean change in A1c between the two groups was 0.22% in favor of M. charantia (95% CI: -0.40 to 0.84) with P=0.4825. There was no significant effect on mean fasting blood sugar, total cholesterol, and weight or on serum creatinine, ALT, AST, sodium, and potassium. There were few adverse events and these were generally mild. CONCLUSION: This is the first randomized controlled trial to shed light on the issue concerning the hypoglycemic effects of M. charantia. The investigators targeted a 1% decline in A1c at the outset with an estimated power of 88%. With the observed decline of 0.24%, the achieved power was only 11%. For this reason, we are unable to make a definite conclusion about the effectiveness of M. charantia. However, the results of this study can be used estimate the sample size for bigger studies.

Pituitary abscess manifesting with amenorrhea: A case report and review of literature

OBJECTIVE: To discuss a case of pituitary abscess presenting with amenorrhea and diabetes insipidus, and to enumerate the differential diagnosis for this conditionSIGNIFICANCE: By presenting this case, the author aims to increase awareness regarding the possibility of infectious causes of pituitary masses, thereby prompting early recognition and treatment of similar casesCASE REPORT: This is the case of a 42-year old woman admitted due to severe generalized headache, amenorrhea and polyuria of three months duration, preceded by a one-month history of remittent fever. Physical examination was normal except for bitemporal hemianopsiaLABORATORY TEST RESULTS: On admission, she had mild anemia, hypernatremia with elevated serum osmolality, and failure to concentrate urine. Hormonal examinations showed normal thyroxine and growth hormone levels, low basal serum cortisol, and elevated prolactin levels. Cranial CT scan showed widening of the sella turcica with a homogenous, isodense, slightly enhancing focus in the sellar and suprasellar area.COURSE: Initial considerations were chiasmatic glioma versus a pituitary adenoma. Transphenoidal surgery was done and intraoperatively, purulent fluid was noted. Aspirate gram stain showed 1-2 white blood cells per high power field but with no growth on culture. Subsequently, vision was fully restored but prolactin levels continued to be slightly elevated. Basal cortisol and urine specific gravity were persistently low. Repeat CT scan showed disappearance of the pituitary mass. Six months after the operation, the patient was able to go back to work but continues to take steroids and carbamazepine for the diabetes insipidus.REVIEW OF LITERATURE: There are about 100 cases of pituitary abscess in literature mimicking pituitary adenoma and presenting with headaches, amenorrhea, visual field cuts, hypopituitarism, fever and meningitis. As in this case, the abscess is frequently sterile. Pituitary abscess should be considered in patients with a primary diagnosis of pituitary adenoma with accompanying signs and symptoms suggestive of an infection. (Author)