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Biomedical subjects

C Allen

Publications and source records attributed to C Allen.

At least 19 recordsLinked to original sources

Does laparoscopic Nissen fundoplication lead to chronic gastrointestinal dysfunction?

BACKGROUND: Laparoscopic Nissen fundoplication (LNF) efficiently controls the symptoms of gastroesophageal reflux disease (GERD); however, other nonspecific gastrointestinal (GI) symptoms have been reported following LNF. The aim of this study was to evaluate the long-term effects of LNF on nonspecific GI complaints. METHODS: The basis for this study is the prospective follow-up of 515 patients (mean age 46 +/- 13 years) who underwent a LNF between 1992 and 1998. A questionnaire was designed to evaluate GERD symptoms (i.e., heartburn, epigastric pain, regurgitation, dysphagia, and fullness, score 0-60) and nonspecific GI symptoms (i.e., vomiting, diarrhea, constipation, and lack of appetite, score 0-48). Patients were assessed before surgery, at 6 months, 2 years, and 5 years after surgery. RESULTS: Laparoscopic Nissen fundoplication was associated with a significant decrease in both GERD and nonspecific GI symptoms score at 6 months and up to 5 years, in the whole group (p < 0.001). 360 patients (69.7%) had preoperative nonspecific GI symptoms and experienced a significant reduction in these symptoms following the surgery and lasting up to 5 years. The other 155 patients (30.3%) had no preoperative GI symptoms (GI symptoms score of 0). In this group, there was a small but statistically significant increase in GI symptoms score (p < 0.001). It was, however, clinically significant (defined as a score >12) in only 9.9% of the patients. CONCLUSIONS: Laparoscopic Nissen fundoplication provides an efficient treatment of GERD up to 5 years, and in a majority of patients, it is not associated with any significant increase in nonspecific GI complaints. New nonspecific bowel symptoms can develop after LNF in some patients but are unlikely to be clinically significant.

Adult↗

Self-assembly and physicochemical and rheological properties of a polysaccharide-surfactant system formed from the cationic biopolymer chitosan and nonionic sorbitan esters.

The natural cationic polysaccharide chitosan was mixed with the nonionic surfactants sorbitan monolaurate, sorbitan monooleate, or sorbitan triooleate to produce a biopolymer-surfactant system with unique properties. The mixtures of chitosan and surfactant formed emulsion-like solutions and/or creams. The known properties of the components were considered (i.e., hydrophile-lipophile balance, molecular weight, structure, and density), and various physicochemical and rheological properties of the mixtures were measured. Specifically, the critical micelle concentration of the sorbitan esters in a chitosan solution was measured using both surface tension and fluorescence-based methods. The concentration-dependent morphologies of the aggregates within the chitosan-surfactant solutions were evaluated by optical microscopy and dynamic light scattering. A schematic depicting the possible molecular arrangement of chitosan and surfactant within the various formulations was produced from consideration of the experimental findings. The degree of interaction between chitosan and the individual surfactants was assessed by FTIR analysis. The rheological properties of the chitosan-surfactant emulsions were also investigated and found to be related to the observed morphologies. Overall, clear composition-property relationships were established for these chitosan-surfactant systems which have potential applications in the food and pharmaceutical industries.

Biopolymers↗

Acupuncture-point stimulation for chemotherapy-induced nausea or vomiting.

BACKGROUND: There have been recent advances in chemotherapy-induced nausea and vomiting using 5-HT(3) inhibitors and dexamethasone. However, many still experience these symptoms, and expert panels encourage additional methods to reduce these symptoms. OBJECTIVES: The objective was to assess the effectiveness of acupuncture-point stimulation on acute and delayed chemotherapy-induced nausea and vomiting in cancer patients. SEARCH STRATEGY: We searched MEDLINE, EMBASE, PsycLIT, MANTIS, Science Citation Index, CCTR (Cochrane Controlled Trials Registry), Cochrane Complementary Medicine Field Trials Register, Cochrane Pain, Palliative Care and Supportive Care Specialized Register, Cochrane Cancer Specialized Register, and conference abstracts. SELECTION CRITERIA: Randomized trials of acupuncture-point stimulation by any method (needles, electrical stimulation, magnets, or acupressure) and assessing chemotherapy-induced nausea or vomiting, or both. DATA COLLECTION AND ANALYSIS: Data were provided by investigators of the original trials and pooled using a fixed effect model. Relative risks were calculated on dichotomous data. Standardized mean differences were calculated for nausea severity. Weighted mean differences were calculated for number of emetic episodes. MAIN RESULTS: Eleven trials (N = 1247) were pooled. Overall, acupuncture-point stimulation of all methods combined reduced the incidence of acute vomiting (RR = 0.82; 95% confidence interval 0.69 to 0.99; P = 0.04), but not acute or delayed nausea severity compared to control. By modality, stimulation with needles reduced proportion of acute vomiting (RR = 0.74; 95% confidence interval 0.58 to 0.94; P = 0.01), but not acute nausea severity. Electroacupuncture reduced the proportion of acute vomiting (RR = 0.76; 95% confidence interval 0.60 to 0.97; P = 0.02), but manual acupuncture did not; delayed symptoms for acupuncture were not reported. Acupressure reduced mean acute nausea severity (SMD = -0.19; 95% confidence interval -0.37 to -0.01; P = 0.04) but not acute vomiting or delayed symptoms. Noninvasive electrostimulation showed no benefit for any outcome. All trials used concomitant pharmacologic antiemetics, and all, except electroacupuncture trials, used state-of-the-art antiemetics. AUTHORS' CONCLUSIONS: This review complements data on post-operative nausea and vomiting suggesting a biologic effect of acupuncture-point stimulation. Electroacupuncture has demonstrated benefit for chemotherapy-induced acute vomiting, but studies combining electroacupuncture with state-of-the-art antiemetics and in patients with refractory symptoms are needed to determine clinical relevance. Self-administered acupressure appears to have a protective effect for acute nausea and can readily be taught to patients though studies did not involve placebo control. Noninvasive electrostimulation appears unlikely to have a clinically relevant impact when patients are given state-of-the-art pharmacologic antiemetic therapy.

Acupuncture Points↗

Effect of pregnancy on effectiveness of laparoscopic Nissen fundoplication.

BACKGROUND: Symptoms of gastroesophageal reflux disease (GERD) are experienced by up to 85% of pregnant women. Some young women on maintenance proton pump inhibitor (PPI) treatment are choosing surgery to stop their medical treatment and avoid severe symptoms during pregnancy. There are no reports describing the effect of pregnancy on the long-term efficacy of laparoscopic Nissen fundoplication. The aim of this study was to evaluate the effect of pregnancy on the efficacy of laparoscopic Nissen fundoplication. METHODS: This study surveyed 146 women of childbearing age with proven GERD who had undergone laparoscopic Nissen fundoplication from 1992 through 2002. The patients who became pregnant (group 1) were compared with those who did not (group 2). RESULTS: The study focused on 25 patients who became pregnant after surgery. Of these patients, 40% (n = 10) had chosen surgery as a way to discontinue PPI treatment before pregnancy. The mean time from laparoscopic Nissen fundoplication to pregnancy was 25.9 +/- 4.6 months. A total of 19 patients (76%) had no reflux symptoms, whereas 5 (20%) required antacids during pregnancy. One patient (4%) experienced an acute intrathoracic stomach migration during her pregnancy and required emergency open surgery, which resulted in the loss of her fetus. After pregnancy, six patients (24%) had recurrence of GERD symptoms, and three (12%) required a redo fundoplication. The higher rate of GERD recurrence (24% vs 16.7%) and redo surgery (12% vs 4%) in group 1 did not reach statistical significance, but showed a definite trend. CONCLUSION: For most patients, laparoscopic Nissen fundoplication is effective in controlling GERD symptoms during and after pregnancy.

Adult↗

Rapid and efficient nonviral gene delivery of CD154 to primary chronic lymphocytic leukemia cells.

Interactions between CD40 and CD40 ligand (CD154) are essential in the regulation of both humoral and cellular immune responses. Forced expression of human CD154 in B chronic lymphocytic leukemia (B-CLL) cells can upregulate costimulatory and adhesion molecules and restore antigen-presenting capacity. Unfortunately, B-CLL cells are resistant to direct gene manipulation with most currently available gene transfer systems. In this report, we describe the use of a nonviral, clinical-grade, electroporation-based gene delivery system and a standard plasmid carrying CD154 cDNA, which achieved efficient (64+/-15%) and rapid (within 3 h) transfection of primary B-CLL cells. Consistent results were obtained from multiple human donors. Transfection of CD154 was functional in that it led to upregulated expression of CD80, CD86, ICAM-I and MHC class II (HLA-DR) on the B-CLL cells and induction of allogeneic immune responses in MLR assays. Furthermore, sustained transgene expression was demonstrated in long-term cryopreserved transfected cells. This simple and rapid gene delivery technology has been validated under the current Good Manufacturing Practice conditions, and multiple doses of CD154-expressing cells were prepared for CLL patients from one DNA transfection. Vaccination strategies using autologous tumor cells manipulated ex vivo for patients with B-CLL and perhaps with other hematopoietic malignancies could be practically implemented using this rapid and efficient nonviral gene delivery system.

CD40 Ligand↗

Preference for rizatriptan 10-mg wafer vs. eletriptan 40-mg tablet for acute treatment of migraine.

Preference is a composite, patient-oriented endpoint incorporating efficacy, tolerability, formulation, and convenience of medications. The objective of this study was to compare patient preference for rizatriptan 10-mg wafer vs. eletriptan 40-mg tablet for acute treatment of migraine. In this multicentre, open-label, two-period, crossover study, out-patients were randomly assigned to treat the first of two moderate to severe migraines with rizatriptan or eletriptan and the second with the alternate therapy. Patients completed diary assessments at baseline and up to 24 h after taking study medication. At the last visit, patients completed a psychometrically validated preference questionnaire. A total of 372 patients (mean age 38 years, 85% female) treated two migraine attacks, and 342 patients (92%) expressed a preference for treatment. Significantly more (P < or = 0.001) patients preferred rizatriptan 10-mg wafer [61.1%; 95% confidence interval (CI) 55.7, 66.3] to eletriptan 40-mg tablet (38.9%; 95% CI 33.7, 44.3). The most common reason given for preference of either treatment was speed of headache relief. At 2 h, 80% and 69% of patients reported that rizatriptan and eletriptan, respectively, was convenient or very convenient to take (mean convenience score 1.99 vs. 2.31, respectively; P < or = 0.001). Both triptans were well tolerated. In this head-to-head study designed to evaluate global patient preference, significantly more patients preferred the rizatriptan 10-mg wafer to the eletriptan 40-mg tablet for acute treatment of migraine. The single most important reason for preference was speed of relief, consistent with results from previous preference studies.

Administration, Oral↗

Formulation of drugs in block copolymer micelles: drug loading and release.

Block copolymer micelles have become accepted as a viable strategy for drug formulation and delivery. Block copolymer micelles may serve as solubilizers and/or true drug carriers depending on their drug retention properties in vivo. Indeed the formulation of hydrophobic drugs in these micelle systems has been shown to provide up to a 30,000 fold increase in the water solubility of some compounds. In addition, the administration of drugs in copolymer micelles has been shown to reduce their toxicity and improve their therapeutic efficacy. The present review is focused on the drug loading and release properties of block copolymer micelles. Specifically, the properties of the drug, properties of the micelle core and the presence of interactions between the drug and the core-forming block are discussed in terms of their influence on the drug loading and release properties of the micelles. The various methods employed to prepare drug-loaded micelles are reviewed and the in vitro release assays used to predict the in vivo release characteristics of the formulations are discussed. The balance between drug loading and micelle stability is highlighted as a critical factor in the optimization of micelle-based formulations. The in vivo performance of micelles as delivery systems is evaluated by comparing the pharmacokinetics of free drug and drug administered in micelle-based formulations. Overall, the composition-property and property-performance relationships outlined in this review may aid in guiding the rational design of block copolymer micelles for drug delivery. In addition, suggestions for future research in this area are provided as a means to assist in furthering block copolymer micelles as one of the leading advanced drug delivery technologies for the systemic administration of drugs.

Animals↗

Non-steroidal anti-inflammatory drugs for pain in women with endometriosis.

BACKGROUND: Endometriosis is a common gynaecological condition that affects women and can lead to painful symptoms and infertility. It affects women's quality of life greatly, impacting on their careers, everyday activities, sexual and non-sexual relationships, and fertility. Non-steroidal anti-inflammatory drugs (NSAIDs) are the most commonly used first-line treatment for endometriosis. OBJECTIVES: To assess the effects of NSAIDs for the management of pain in women with endometriosis compared to placebo, other NSAIDs, other pain management drugs, or no treatment. SEARCH STRATEGY: We searched the Cochrane Menstrual Disorders and Subfertility Group Specialised Trials Register (May 2005) published in the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1966 to May 2005), EMBASE (1980 to May 2005) and the reference lists from relevant publications. Experts in the field were also contacted for information about possible studies. SELECTION CRITERIA: We included all randomized controlled trials (RCTs) describing the use of NSAIDs in the treatment of endometriosis in women of all ages. DATA COLLECTION AND ANALYSIS: Two review authors (CA and SH) independently read and extracted data from each of the included studies. Crossover trials were analysed using the inverse variance method in RevMan to calculate the odds ratio for binary outcomes. MAIN RESULTS: Two trials were identified but only one trial, with 24 women, was included in the analysis. Comparing NSAIDs (naproxen) to placebo, there was no evidence of a positive effect on pain relief (odds ratio (OR) 3.27, 95% CI 0.61 to 17.69) in women with endometriosis. There was also inconclusive evidence to indicate whether women taking NSAIDs (naproxen) were less likely to require additional analgesia (OR 0.12, 95% CI 0.01 to 1.29) or experience side effects (OR 0.46, 95% CI 0.09 to 2.47) when compared to placebo. AUTHORS' CONCLUSIONS: There is inconclusive evidence to show whether NSAIDs (naproxen) are effective in managing pain caused by endometriosis. There is no evidence to show whether any individual NSAID is more effective than another. As shown in other Cochrane reviews, women using NSAIDs need to be aware of the possibility that these drugs may cause unintended effects.

Anti-Inflammatory Agents, Non-Steroidal↗

Hybrid films from blends of chitosan and egg phosphatidylcholine for localized delivery of paclitaxel.

Chitosan and egg phosphatidylcholine (ePC) were used as a unique combination to prepare composite films for localized drug delivery. In comparison to other phospholipids analyzed, ePC was found to produce chitosan-based films with minimal swelling and a high degree of stability. The properties of the chitosan-ePC films were characterized and found to be dependent on the ratio of chitosan:ePC present. FTIR analysis of chitosan-ePC films revealed that their high stability may be attributed to interactions present between these two biomaterials. In vitro evaluation of the cytotoxicity and protein adsorption properties of the films were used to provide a preliminary indication of their biocompatibility. The chitosan-ePC film was also evaluated as a matrix for the localized delivery of the anti-cancer agent, paclitaxel. Nanoparticles containing paclitaxel were dispersed throughout the chitosan-ePC film to result in a drug:material ratio of 1:8 (wt/wt). The film was found to provide a sustained release of paclitaxel over a 4-month period in biologically relevant media. The biological activity of paclitaxel loaded in the chitosan-ePC film was confirmed in SKOV-3 human ovarian cancer cells.

Adsorption↗

Efficacy and safety of ezetimibe co-administered with ongoing atorvastatin therapy in achieving low-density lipoprotein goal in patients with hypercholesterolemia and coronary heart disease.

This randomised, double-blind, placebo (PBO)-controlled study evaluated the efficacy and safety of ezetimibe (EZE) co-administered with ongoing atorvastatin (ATV) therapy in 450 hypercholesterolemic patients with coronary heart disease (CHD) who had not achieved their low-density lipoprotein cholesterol (LDL-C) goal < or =2.60 mmol/l while on a stable dose of ATV 10 or 20 mg/day for > or =6 weeks. After a 4-week diet/baseline active run-in period, patients with LDL-C >2.60 mmol/l and < or =4.20 mmol/l were stratified by ATV dose and randomised (1 : 1) to EZE 10 mg or PBO for 6 weeks while continuing open-label ATV. Significantly more patients achieved an LDL-C goal < or =2.6 mmol/l with EZE than PBO (81.3 vs. 21.8%; p < or = 0.001). Compared to PBO, co-administration of EZE with ongoing ATV led to significantly (p < or = 0.001) greater reductions in LDL-C, total cholesterol, triglycerides, non-high-density lipoprotein cholesterol (non-HDL-C), and apolipoprotein B; HDL-C was significantly (p < or = 0.05) increased. Co-administration of EZE and ATV was well tolerated, with an overall safety profile similar to ATV alone.

Adult↗

Lipid-altering efficacy of switching from atorvastatin 10 mg/day to ezetimibe/simvastatin 10/20 mg/day compared to doubling the dose of atorvastatin in hypercholesterolaemic patients with atherosclerosis or coronary heart disease.

This randomised, double-blind study evaluated the efficacy and safety of ezetimibe/simvastatin (EZE/SIMVA) 10/20 mg tablet compared to doubling the atorvastatin (ATV) dose in hypercholesterolaemic patients with atherosclerotic or coronary heart disease (CHD). The study group included 435 male and female CHD patients (aged >or=18 years) who had not achieved their low-density lipoprotein cholesterol (LDL-C) goal of <2.50 mmol/l while on a stable dose of ATV 10 mg for >or=6 weeks. After a 1-week diet/stabilisation period, patients with LDL-C >or=2.50 mmol/l and <or=4.20 mmol/l were randomised (1:1) to EZE/SIMVA 10/20 mg/day (n = 221) or ATV 20 mg/day (n = 214) for 6 weeks. The primary efficacy objective was to determine the per cent reduction from baseline in LDL-C at week 6. EZE/SIMVA 10/20 mg produced significantly greater mean per cent changes from baseline in LDL-C compared with ATV 20 mg (-32.8 vs. -20.3%; p </= 0.001). A significantly greater proportion of patients achieved an LDL-C goal <2.50 mmol/l with EZE/SIMVA than ATV (77.9 vs. 51.9%; p <or= 0.001). Significant improvements in total cholesterol (-20.3 vs. -13.0%), non-high-density lipoprotein cholesterol (non-HDL-C) (-27.9 vs. -17.0%), apolipoprotein B (-23.4 vs. -14.7%) and HDL-C (1.8 vs. -0.4%) were observed after switching to EZE/SIMVA 10/20 mg for 6 weeks (p < 0.05 for all parameters). EZE/SIMVA 10/20 mg was generally well tolerated, with an overall safety profile similar to that of ATV 20 mg. EZE/SIMVA 10/20 mg produced superior lipid-altering efficacy by dual inhibition of cholesterol synthesis and intestinal absorption compared with doubling the dose of ATV from 10 to 20 mg.

Adult↗

LDL-C goal attainment with the addition of ezetimibe to ongoing simvastatin treatment in coronary heart disease patients with hypercholesterolemia.

OBJECTIVE: To evaluate the addition of ezetimibe or placebo to on-going simvastatin treatment on attaining the LDL-C treatment target of </= 2.60 mmol/L (100 mg/dL) in coronary heart disease (CHD) patients with hypercholesterolemia. METHODS: Patients with documented CHD were recruited if they were on a stable dose of simvastatin 10 mg or 20 mg for at least 6 weeks, had LDL-C > 2.60 mmol/L and </= 4.20 mmol/L (> 100 mg/dL and </= 160 mg/dL), triglycerides </= 4.00 mmol/L (355 mg/dL) and hepatic transaminases and creatine kinase </= 50% above the upper limit of normal. After a 4-week placebo and diet run-in period, eligible patients were randomized to a double-blind, placebo-controlled comparative study with ezetimibe 10mg co-administered with on-going simvastatin 10mg or 20 mg (n = 208) versus placebo to match ezetimibe co-administered with simvastatin 10mg or 20mg for 6 weeks (n = 210). RESULTS: When ezetimibe was added to on-going simvastatin therapy, a significantly greater percentage of patients attained the LDL-C target of </= 2.60 mmol/L after 6 weeks of treatment compared to placebo added to on-going simvastatin (80.4% vs. 17.4%, respectively;p </= 0.001). When co-administered with on-going simvastatin therapy, mean percentage reduction in LDL-C from baseline was significantly larger in the ezetimibe group compared to placebo (27.1% vs. 4.1%, respectively; p </= 0.001). The co-administration of ezetimibe or placebo to on-going simvastatin treatment was generally well tolerated. CONCLUSIONS: Ezetimibe co-administered with on-going simvastatin 10 mg or 20 mg treatment enabled more CHD patients with hypercholesterolemia to attain the LDL-C treatment target of </= 2.60 mmol/L.

Administration, Oral↗

Effect of oestrogen plus progestin on the incidence of diabetes in postmenopausal women: results from the Women's Health Initiative Hormone Trial.

AIMS/HYPOTHESIS: Studies examining the effect of postmenopausal hormone therapy on concentrations of glucose, insulin and diabetes incidence have been inconclusive, in part because many of the studies were too small. We examined the effect of oestrogen plus progestin on diabetes incidence and insulin resistance. METHODS: The study was a randomised, double-blind trial comparing the effect of daily 0.625 mg conjugated equine oestrogens plus 2.5 mg medroxyprogesterone acetate with that of placebo during 5.6 years of follow-up. The participants were 15,641 postmenopausal women enrolled in the Women's Health Initiative Hormone Trial. These women were aged 50 to 79 and all had an intact uterus. Diabetes incidence was ascertained by self-report of treatment with insulin or oral hypoglycaemic medication. Fasting glucose, insulin, and lipoproteins were measured in a random sample at baseline and at 1 and 3 years. RESULTS: The cumulative incidence of treated diabetes was 3.5% in the hormone therapy group and 4.2% in the placebo group (hazard ratio 0.79, 95% CI 0.67-0.93, p=0.004). There was little change in the hazard ratio after adjustment for changes in BMI and waist circumference. During the first year of follow-up, changes in fasting glucose and insulin indicated a significant fall in insulin resistance in actively treated women compared to the control subjects (Year 1 to baseline between-group difference -0.22+/-0.10, p=0.03). INTERPRETATIONS/CONCLUSION: These data suggest that combined therapy with oestrogen and progestin reduces the incidence of diabetes, possibly mediated by a decrease in insulin resistance unrelated to body size. Future studies of alternative postmenopausal hormone therapy regimens and selective oestrogen agonists and/or antagonists should consider the effects of these regimens on insulin resistance and diabetes.

Aged↗

Dystrophic ureteral calcification associated with Churg-Strauss vasculitis.

Churg-Strauss syndrome is an uncommon systemic vasculitis affecting small blood vessels. Renal involvement is typical; however, calcinosis of the urinary tract has not previously been described. Dystrophic calcification in the urinary tract is rare, although it is occasionally associated with schistosomiasis, tuberculosis, and polyarteritis nodosa. We report the case of a 19-year-old man with newly diagnosed Churg-Strauss syndrome who presented to us with dystrophic calcification in both ureters causing bilateral obstruction.

Adult↗

Insulin resistance and weight gain in postmenopausal women of diverse ethnic groups.

OBJECTIVE: This study was conducted to examine the influence of insulin resistance on weight change in postmenopausal women of various ethnic groups. SUBJECTS: Data were obtained from 3389 women (60% White, 20% Black, 12% Hispanic, and 8% Asian/Pacific Islander), ages 50-79, enrolled in either the Women's Health Initiative Clinical trial or Observational Study, whose blood samples were selected randomly from the full cohort of 161 809 women for analyses. MEASUREMENTS: Glucose, insulin, and lipids were measured on fasting serum samples drawn at baseline and after 3 y of follow-up. Weight, height, waist circumference, and blood pressure were measured. Physical activity and energy intake were assessed via questionnaire. Insulin resistance was estimated using the HOMA (homeostasis model) calculation. RESULTS: Average age was 62 y, average BMI (body mass index) was 27.4 kg/m2, and average weight change was a gain of 0.4 kg in 3 y. In a multivariate analysis, insulin resistance and insulin concentrations were independent predictors of increases in weight in White women (P=0.002 and 0.004, respectively) and in the combined group (P=0.027 and 0.039). For the whole group, after adjustment for other covariates, those in the highest quartile of insulin resistance gained 0.4 kg in 3 y, whereas those in the lowest quartile lost 0.06 kg. Similar trends were found for insulin resistance and weight gain in Hispanic and Asian/Pacific Islander women, but they did not reach statistical significance. In Black women, no relation was seen between either insulin or insulin resistance and weight change. A significant interaction between obesity and insulin resistance was observed (P=0.002 for White women and 0.032 for the whole group), so that there is weight gain with increasing insulin resistance in the leaner women, but weight loss with increasing insulin resistance in the most obese. CONCLUSION: Insulin resistance appears to be a predictor of weight gain in postmenopausal women, except for the most obese women. The effect is more pronounced in women who have a lower BMI, and the effect was not seen in the Black women who as a group had a higher BMI.

Blood Glucose↗

Surgical outcome in gastro-esophageal reflux disease patients with inadequate response to proton pump inhibitors.

Laparoscopic fundoplication (LF) has been shown to be effective in treatment of patients with gastro-esophageal reflux disease (GERD) requiring long-term medical therapy. Its effectiveness in patients with poor response to proton pump inhibitors (PPIs) has been questioned. We prospectively followed 445 patients with proven GERD inadequately controlled on PPI (up to 120 mg/day) and 274 GERD patients with good response to PPIs (20-120 mg/day) after LF. Patients in both groups underwent 24 h pH testing, esophageal manometry, symptom score evaluation, and quality-of-life (QOL) assessment (SF-36) before and at 6 months, 2 years, and 5 years after surgery. LF was associated with a marked improvement in percentage acid reflux, lower esophageal sphincter pressure, and symptom control in both groups of patients; however, the poor responders to PPIs also had a significant improvement in both physical and mental health component of the QOL assessment. Laparoscopic fundoplication provides an excellent symptom control for GERD patients, even those who have responded inadequately to large doses of PPIs. GERD patients who respond poorly to PPI therapy have significantly lowered physical and mental health QOL scores. Laparoscopic fundoplication in this group of patients leads to marked improvement of both components of QOL by 2 years after surgery.

Female↗