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2METHODS

Patients received 17beta-estradiol 2mg in combination with norethisterone acetate 1mg ( Cliane ) daily for 6 months or one placebo tablet daily for 6 months .

2METHODS

The tablets were identical in appearance .

2METHODS

After 6 months , the groups were crossed over and the patients were followed up for another 6 months .

2METHODS

The groups were homogenous with respect to age , height , bodyweight , body mass index and race .

2METHODS

For the statistical analysis , the group receiving hormone therapy was referred to as group A and the placebo group was designated group B , irrespective of the placebo/hormone therapy sequence .

4RESULTS

In group A there were fewer hot flashes ( F = 22.85 , p < 0.01 ) and an improvement in sexual interest ( F = 5.55 , p < 0.05 ) .

4RESULTS

The sequence in which the medication was received resulted in a statistically significant difference with respect to dyspareunia ( F = 9.65 , p < 0.01 ) and satisfaction with the duration of penetration ( F = 6.58 , p < 0.05 ) .

4RESULTS

In the intrapatient analysis of variation with respect to orgasmic capability and the presence of dialogue with partner regarding the couple 's sexual life , whether the placebo was taken prior to or following hormone therapy was significant ( F = 17.12 , p < 0.001 and F = 7.10 , p < 0.05 , respectively ) .

1CONCLUSIONS

Monophasic estrogen-progestogen therapy has a beneficial effect on sexuality and on hot flashes in postmenopausal women .

3OBJECTIVE

To investigate the clinical effect of the Chinese medicinal preparation Shengling Capsule on patients with oligoasthenospermia .

2METHODS

A total of 270 male patients with infertility induced by oligoasthenospermia were equally divided into a treatment and a control group , the former medicated with Shengling Capsule at the dose of 1.6 g tid , and the latter given Vit E at 50 mg tid , both for a course of 12 weeks .

2METHODS

Then we analyzed the changes in the patients ` seminal parameters and the pregnancy of their wives .

4RESULTS

After 12 weeks of medication , both the seminal parameters of the patients and pregnancy of their wives were remarkably improved , with extremely significant differences from pre-treatment and the control ( P < 0.01 ) .

1CONCLUSIONS

Shengjing Capsule can improve sperm motility and vitality as well as sperm count .

1CONCLUSIONS

With few adverse effects , it can be used as a safe and effective therapeutic for male infertility induced by oligoasthenospermia .

3OBJECTIVE

To assess the usefulness of HELISAL in the diagnosis of Helicobacter pylori infection by comparing it with ELISA , JATROX and histopathologic findings .

2METHODS

Randomized prospective study .

2METHODS

Sixty-one patients , thirty-three males and twenty-eight females , 18-73 years old , submitted to esophagogastroduodenoscopy .

4RESULTS

The sensitivity of HELISAL when compared to ELISA test was 60.8 % , the specificity 73.3 % , the positive predictive value 87.5 % , the negative predictive value 37.9 % , and the kappa index 0.26 .

4RESULTS

When compared to histopathologic test : sensitivity 60.9 % , specificity 65 % , positive predictive value 78.1 % , negative predictive value 44.7 % , kappa 0.28 .

4RESULTS

When compared to JATROX , sensitivity 57.7 % , specificity 62.5 % , positive predictive value 81.2 % , negative predictive value 34.4 % , kappa 0.21 .

1CONCLUSIONS

The sensitivity of HELISAL test is lower than that of other compared tests , and the negative predictive value is very low .

1CONCLUSIONS

The specificity and the positive predictive value are higher than the sensitivity .

1CONCLUSIONS

The kappa index shows a very low concordance .

3OBJECTIVE

To evaluate the effects of simvastatin on serum lipids and insulin sensitivity in Type 2 diabetic patients with hypercholesterolaemia .

2METHODS

A double-blind , randomized , placebo-controlled and two-period crossover study .

2METHODS

After a 2-month run-in , 19 eligible Type 2 diabetic patients with hypercholesterolaemia were randomized to receive either simvastatin or placebo for 3 months , exchanging their treatment thereafter for another 3 months .

2METHODS

Blood samples were taken in month 0 and at monthly intervals to measure serum lipids and indices of glycaemic control .

2METHODS

An euglycaemic insulin clamp was performed in months 0 , 3 and 6 to assess change of insulin sensitivity .

2METHODS

The amount of glucose infused during 90-120 min of the clamp ( M ) , and the mean values of serum insulin during 90-120 min ( I ) were measured .

2METHODS

The M and M/I ratio were used to represent the in vivo insulin sensitivity of the subject .

4RESULTS

Simvastatin significantly reduced serum total cholesterol ( TC ) by 23 + / -18 % and low density lipoprotein-cholesterol ( LDL-C ) by 30 + / -26 % .

4RESULTS

It did not alter glycaemic control .

4RESULTS

The M-values and M/I ratios were similar in both groups in each period and no drug effect on insulin sensitivity could be identified .

1CONCLUSIONS

Simvastatin significantly reduced the serum TC and LDL-C levels without alteration of insulin sensitivity in Type 2 diabetic patients with hypercholesterolaemia .

0BACKGROUND

Premenopausal African American women have a 2-3 times greater incidence of coronary heart disease ( CHD ) than do white women .

0BACKGROUND

The plasma lipid responsiveness to dietary fat , which may be associated with CHD , has not been adequately studied in premenopausal African American or white women .

3OBJECTIVE

The objective of our study was to compare the effect of diet on fasting plasma lipids and lipoproteins and postprandial lipemia in premenopausal African American and white women .

2METHODS

Thirteen African American and 9 white healthy premenopausal women were fed a low-fat , high-fiber diet and a high-fat , low-fiber diet for 4 wk each in a randomized crossover design .

2METHODS

Fasting plasma lipid and lipoprotein concentrations and the 24-h plasma triacylglycerol response to a standard fatty test meal were measured at the end of each dietary period .

4RESULTS

Plasma total and LDL-cholesterol concentrations were higher after the high-fat , low-fiber diet in both white and African American women ( P < 0.0001 ) .

4RESULTS

The 24-h area under the plasma triacylglycerol curve after the test meal was lower after the low-fat diet than after the high-fat diet ( P < 0.04 ) .

1CONCLUSIONS

African American and white women had lower fasting plasma total and LDL-cholesterol concentrations and less postprandial lipemia after the low-fat than the high-fat diet .

1CONCLUSIONS

Diets low in total and saturated fat and cholesterol and high in fiber may reduce the risk of CHD by lowering fasting plasma total and LDL-cholesterol concentrations and by reducing the lipemic response to fatty meals .

0BACKGROUND

Mirabegron is a 3-adrenoceptor agonist used for the treatment of overactive bladder .

0BACKGROUND

Mirabegron is formulated as an extended-release tablet using oral controlled-absorption system ( OCAS ) technology .

3OBJECTIVE

This study was designed to assess the effects of food on the pharmacokinetic properties of mirabegron OCAS in accordance with regulatory requirements to support dosing recommendations .

2METHODS

In this single-dose , randomized , open-label , 3-period , parallel-dose-group , crossover study , mirabegron OCAS 50 or 100 mg was administered orally to healthy adult subjects in the fasted state or after a high - or low-fat breakfast .

2METHODS

Dose administrations were separated by a washout period of at least 10 days .

2METHODS

Blood samples were drawn up to 96 hours after dosing , and plasma concentrations of mirabegron were analyzed by LC/MS-MS .

2METHODS

PK properties were determined using noncompartmental methods .

2METHODS

Primary end points for the assessment of food effects were Cmax and AUC0 - .

2METHODS

For tolerability assessment , adverse events ( AEs ) were monitored using investigators ' questionnaires and subjects ' spontaneous reports , vital sign measurements , hematology , clinical chemistry , and ECG .

4RESULTS

Thirty-eight subjects ( male , 50 % ; mean age , 32.1 years ; mean weight , 77.3 kg ; race , 76.3 % white ) were enrolled in the 50-mg dose group and 38 subjects ( male , 52.6 % ; mean age , 30.9 years ; mean weight , 74.5 kg ; race , 63.2 % white ) in the 100-mg dose group .

4RESULTS

With either fed condition or dose , the 90 % CIs for the fed/fasted ratios of both Cmax and AUC0 - of mirabegron fell below the predetermined range for bioequivalence ( 80.0 % -125.0 % ) , suggesting that food had no effect on exposure to mirabegron OCAS .

4RESULTS

With the 50-mg dose , mirabegron Cmax was reduced by 45 % with a high-fat breakfast compared with fasted conditions ( geometric mean ratio [ GMR ] , 54.8 % [ 90 % CI , 43.7 % -68.6 % ] ) and AUC0 - , by 17 % ( GMR , 83.2 % [ 90 % CI , 74.2 % -93.4 % ] ) .

4RESULTS

With the 100-mg dose , mirabegron Cmax and AUC0 - were reduced by 39 % ( GMR , 61.3 % [ 90 % CI , 47.8 % -78.7 % ] ) and 18 % ( 82.4 % [ 72.6 % -93.5 % ] ) , respectively , after a high-fat breakfast .

4RESULTS

With the 50-mg dose , mirabegron Cmax was decreased by 75 % ( GMR , 25.0 % [ 90 % CI , 19.9 % -31.3 % ] ) and AUC0 - by 51 % ( 48.7 % [ 43.3 % -54.7 % ] ) after a low-fat breakfast .

4RESULTS

Corresponding reductions with the 100-mg dose were 64 % ( GMR , 36.3 % [ 90 % CI , 28.2 % -46.8 % ] ) for Cmax and 47 % ( GMR , 53.2 % [ 90 % CI , 46.8 % -60.5 % ] ) for AUC0 - .

4RESULTS

The fed/fasted ratios for mirabegron Cmax and AUC0 - were in general independent of dose or sex .

4RESULTS

Food delayed Tmax compared with the fasted state , with similar increases with the high - and low-fat meals ( 0.9 hours with 50 mg and 1.5-2 .0 hours with 100 mg ) .

4RESULTS

Mirabegron was generally well tolerated , with no apparent difference in AE frequency between the fasted and fed states .

1CONCLUSIONS

Mirabegron OCAS tablets exhibited a decrease in mirabegron plasma exposure with food that was independent of dose ( 50 or 100 mg ) or gender but dependent on meal composition .

1CONCLUSIONS

A greater reduction in mirabegron exposure was observed after a low-fat breakfast compared with after a high-fat breakfast .

1CONCLUSIONS

Based on findings from previous studies , the effects of food observed in this study do not warrant dose adjustment in clinical practice .

1CONCLUSIONS

ClinicalTrials.gov identifier : NCT00939757 .

3OBJECTIVE

The purpose of this study was to determine predictors of worsening insulin sensitivity in postmenopausal women .

2METHODS

Seventy-one nonobese postmenopausal women were assigned randomly to receive hormone replacement therapy ( conjugated estrogens , 0.625 mg , plus medroxyprogesterone acetate , 2.5 mg ) or placebo daily for 1 year ( 34 women received hormone replacement therapy , and 37 women received placebo ) .

2METHODS

At baseline and 12 months , the women received a computed tomography scan at the L4-L5 vertebral disk space , a dual x-ray absorptiometry scan , a euglycemic hyperinsulinemic clamp to measure insulin sensitivity , and a lipid profile .

2METHODS

Declining insulin sensitivity was defined as the largest quartile change in insulin sensitivity in the women who received the placebo ( -1.42 mg/min/kg lean body mass ) .

4RESULTS

By univariate analysis , we found that significant predictors of worsening insulin sensitivity were the use of hormone replacement therapy , baseline insulin sensitivity , a younger age , and < 10 years since menopause .

4RESULTS

By logistic regression , we determined that hormone replacement therapy use and higher baseline insulin sensitivity were independent predictors of worsening insulin sensitivity .

1CONCLUSIONS

The use of hormone replacement therapy and baseline insulin sensitivity are significant independent predictors of the development of worsening insulin sensitivity in postmenopausal women .

0BACKGROUND

Ablative surgery of oropharyngeal tumors frequently leads to defects in the speech organs , resulting in impairment of speech up to the point of unintelligibility .

0BACKGROUND

The aim of the present study was the assessment of selected parameters of speech with and without resection prostheses .

2METHODS

The speech sounds of 22 patients suffering from maxillary and mandibular defects were recorded using a digital audio tape ( DAT ) recorder with and without resection prostheses .

2METHODS

Evaluation of the resonance and the production of the sounds / s / , / sch / , and / ch / was performed by 2 experienced speech therapists .

2METHODS

Additionally , the patients completed a non-standardized questionnaire containing a linguistic self-assessment .

4RESULTS

After prosthesis supply , the number of patients with rhinophonia aperta decreased from 7 to 2 while the number of patients with intelligible speech increased from 2 to 20 .

4RESULTS

Correct production of the sounds / s / , / sch / , and / ch / increased from 2 to 13 patients .

4RESULTS

A significant improvement of the evaluated parameters could be observed only in patients with maxillary defects .

4RESULTS

The linguistic self-assessment showed a higher satisfaction in patients with maxillary defects .

1CONCLUSIONS

In patients with maxillary defects due to ablative tumor surgery , an increase in speech performance and intelligibility is possible by supplying resection prostheses .

0BACKGROUND

Misoprostol is the drug of choice for medical abortion worldwide but consensus is yet to be reached regarding its preferred route of administration .

3OBJECTIVE

To compare the outcome of sublingual with vaginal administrations of misoprostol for induction of second trimester abortion .

2METHODS

A randomised comparative trial where 300 women at 13-20 weeks gestation , requiring medical abortion , were randomly assigned to sublingual or vaginal route for misoprostol administration with a dose schedule of 400 microg three-hourly , up to a maximum five doses over 24 h.

2METHODS

The same doses were repeated for another 24 h in non-responders .

2METHODS

Primary outcome measure was complete abortion rate at 24 and 48 h , and the secondary outcome measures were induction-abortion interval , failure rate , side-effects and patients ' preference to the route .

4RESULTS

No statistically significant differences in the complete abortion rates were observed at 24 h ( 64.03 % vs 61.59 % , P = 0.767 ) and at 48 h ( 79.14 % vs 82.01 % , P = 0.651 ) when sublingual and vaginal groups were compared .

4RESULTS

Mean induction-abortion intervals in sublingual and vaginal groups were 14.1 and 14.5 h , respectively ( P = 0.066 ) .

4RESULTS

Other outcome measures were also more or less similar in both groups .

4RESULTS

Differences in the incidence of side-effects were also statistically insignificant when both groups were compared .

4RESULTS

Sublingual administration of the drug was preferred by most of the women as compared to vaginal administration ( P < 0.0001 ) .

1CONCLUSIONS

Both sublingual and vaginal administrations of misoprostol are equally effective in inducing medical abortion during second trimester but sublingual route was preferred by the patients .

3OBJECTIVE

To test the hypothesis that a garlic supplement alters plasma lipoproteins , postprandial lipemia , low-density lipoprotein ( LDL ) size and high-density lipoprotein ( HDL ) subclass distribution differently in 50 moderately hypercholesterolemic subjects classified as LDL subclass pattern A or B.

0BACKGROUND

Garlic has been variably reported to reduce or not affect plasma cholesterol values .

0BACKGROUND

Low-density lipoprotein pattern B is a common inherited disorder of lipoprotein metabolism that has been shown to have a significantly greater response to several lipid lowering treatments including low fat diet when compared with LDL pattern A individuals .

2METHODS

A double blind , randomized , placebo controlled trial in an outpatient lipid research clinic was performed and included fifty moderately hypercholesterolemic subjects ( mean LDL cholesterol = 166 + / - 22 mg/dl ) classified as LDL subclass pattern A ( predominantly large LDL , n = 22 ) or B ( predominantly small LDL , n = 28 ) .

2METHODS

Following a two-month stabilization period , subjects were randomly assigned to a placebo or 300 mg three times a day of a standardized garlic tablet for three months .

4RESULTS

For all subjects , LDL pattern A and B subjects combined , garlic treatment for three months resulted in no significant change in total cholesterol , LDL cholesterol , HDL cholesterol , HDL subclass distribution , postprandial triglycerides , apolipoprotein B , lipoprotein ( a ) ( Lp [ a ] ) , LDL peak particle diameter or LDL subclass distribution .