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METHODS | Patients received 17beta-estradiol 2mg in combination with norethisterone acetate 1mg ( Cliane ) daily for 6 months or one placebo tablet daily for 6 months . | Patients received 17beta-estradiol 2mg in combination with norethisterone acetate 1mg (Cliane) daily for 6 months or one placebo tablet daily for 6 months. |
METHODS | The tablets were identical in appearance . | The tablets were identical in appearance. |
METHODS | After 6 months , the groups were crossed over and the patients were followed up for another 6 months . | After 6 months, the groups were crossed over and the patients were followed up for another 6 months. |
METHODS | The groups were homogenous with respect to age , height , bodyweight , body mass index and race . | The groups were homogenous with respect to age, height, bodyweight, body mass index and race. |
METHODS | 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 . | 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. |
RESULTS | 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 ) . | 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). |
RESULTS | 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 ) . | 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). |
RESULTS | 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 ) . | 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). |
CONCLUSIONS | Monophasic estrogen-progestogen therapy has a beneficial effect on sexuality and on hot flashes in postmenopausal women . | Monophasic estrogen-progestogen therapy has a beneficial effect on sexuality and on hot flashes in postmenopausal women. |
OBJECTIVE | To investigate the clinical effect of the Chinese medicinal preparation Shengling Capsule on patients with oligoasthenospermia . | To investigate the clinical effect of the Chinese medicinal preparation Shengling Capsule on patients with oligoasthenospermia. |
METHODS | 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 . | 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. |
METHODS | Then we analyzed the changes in the patients ` seminal parameters and the pregnancy of their wives . | Then we analyzed the changes in the patients'seminal parameters and the pregnancy of their wives. |
RESULTS | 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 ) . | 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). |
CONCLUSIONS | Shengjing Capsule can improve sperm motility and vitality as well as sperm count . | Shengjing Capsule can improve sperm motility and vitality as well as sperm count. |
CONCLUSIONS | With few adverse effects , it can be used as a safe and effective therapeutic for male infertility induced by oligoasthenospermia . | With few adverse effects, it can be used as a safe and effective therapeutic for male infertility induced by oligoasthenospermia. |
OBJECTIVE | To assess the usefulness of HELISAL in the diagnosis of Helicobacter pylori infection by comparing it with ELISA , JATROX and histopathologic findings . | To assess the usefulness of HELISAL in the diagnosis of Helicobacter pylori infection by comparing it with ELISA, JATROX and histopathologic findings. |
METHODS | Randomized prospective study . | Randomized prospective study. |
METHODS | Sixty-one patients , thirty-three males and twenty-eight females , 18-73 years old , submitted to esophagogastroduodenoscopy . | Sixty-one patients, thirty-three males and twenty-eight females, 18-73 years old, submitted to esophagogastroduodenoscopy. |
RESULTS | 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 . | 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. |
RESULTS | When compared to histopathologic test : sensitivity 60.9 % , specificity 65 % , positive predictive value 78.1 % , negative predictive value 44.7 % , kappa 0.28 . | When compared to histopathologic test : sensitivity 60. 9 %, specificity 65 %, positive predictive value 78. 1 %, negative predictive value 44. 7 %, kappa 0. 28. |
RESULTS | When compared to JATROX , sensitivity 57.7 % , specificity 62.5 % , positive predictive value 81.2 % , negative predictive value 34.4 % , kappa 0.21 . | When compared to JATROX, sensitivity 57. 7 %, specificity 62. 5 %, positive predictive value 81. 2 %, negative predictive value 34. 4 %, kappa 0. 21. |
CONCLUSIONS | The sensitivity of HELISAL test is lower than that of other compared tests , and the negative predictive value is very low . | The sensitivity of HELISAL test is lower than that of other compared tests, and the negative predictive value is very low. |
CONCLUSIONS | The specificity and the positive predictive value are higher than the sensitivity . | The specificity and the positive predictive value are higher than the sensitivity. |
CONCLUSIONS | The kappa index shows a very low concordance . | The kappa index shows a very low concordance. |
OBJECTIVE | To evaluate the effects of simvastatin on serum lipids and insulin sensitivity in Type 2 diabetic patients with hypercholesterolaemia . | To evaluate the effects of simvastatin on serum lipids and insulin sensitivity in Type 2 diabetic patients with hypercholesterolaemia. |
METHODS | A double-blind , randomized , placebo-controlled and two-period crossover study . | A double-blind, randomized, placebo-controlled and two-period crossover study. |
METHODS | 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 . | 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. |
METHODS | Blood samples were taken in month 0 and at monthly intervals to measure serum lipids and indices of glycaemic control . | Blood samples were taken in month 0 and at monthly intervals to measure serum lipids and indices of glycaemic control. |
METHODS | An euglycaemic insulin clamp was performed in months 0 , 3 and 6 to assess change of insulin sensitivity . | An euglycaemic insulin clamp was performed in months 0, 3 and 6 to assess change of insulin sensitivity. |
METHODS | 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 . | 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. |
METHODS | The M and M/I ratio were used to represent the in vivo insulin sensitivity of the subject . | The M and M/I ratio were used to represent the in vivo insulin sensitivity of the subject. |
RESULTS | Simvastatin significantly reduced serum total cholesterol ( TC ) by 23 + / -18 % and low density lipoprotein-cholesterol ( LDL-C ) by 30 + / -26 % . | Simvastatin significantly reduced serum total cholesterol (TC) by 23 + / -18 % and low density lipoprotein-cholesterol (LDL-C) by 30 + / -26 %. |
RESULTS | It did not alter glycaemic control . | It did not alter glycaemic control. |
RESULTS | 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 . | 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. |
CONCLUSIONS | Simvastatin significantly reduced the serum TC and LDL-C levels without alteration of insulin sensitivity in Type 2 diabetic patients with hypercholesterolaemia . | Simvastatin significantly reduced the serum TC and LDL-C levels without alteration of insulin sensitivity in Type 2 diabetic patients with hypercholesterolaemia. |
BACKGROUND | Premenopausal African American women have a 2-3 times greater incidence of coronary heart disease ( CHD ) than do white women . | Premenopausal African American women have a 2-3 times greater incidence of coronary heart disease (CHD) than do white women. |
BACKGROUND | 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 . | 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. |
OBJECTIVE | 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 . | 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. |
METHODS | 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 . | 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. |
METHODS | 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 . | 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. |
RESULTS | 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 ) . | 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). |
RESULTS | 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 ) . | 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). |
CONCLUSIONS | 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 . | 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. |
CONCLUSIONS | 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 . | 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. |
BACKGROUND | Mirabegron is a 3-adrenoceptor agonist used for the treatment of overactive bladder . | Mirabegron is a 3-adrenoceptor agonist used for the treatment of overactive bladder. |
BACKGROUND | Mirabegron is formulated as an extended-release tablet using oral controlled-absorption system ( OCAS ) technology . | Mirabegron is formulated as an extended-release tablet using oral controlled-absorption system (OCAS) technology. |
OBJECTIVE | 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 . | 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. |
METHODS | 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 . | 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. |
METHODS | Dose administrations were separated by a washout period of at least 10 days . | Dose administrations were separated by a washout period of at least 10 days. |
METHODS | Blood samples were drawn up to 96 hours after dosing , and plasma concentrations of mirabegron were analyzed by LC/MS-MS . | Blood samples were drawn up to 96 hours after dosing, and plasma concentrations of mirabegron were analyzed by LC/MS-MS. |
METHODS | PK properties were determined using noncompartmental methods . | PK properties were determined using noncompartmental methods. |
METHODS | Primary end points for the assessment of food effects were Cmax and AUC0 - . | Primary end points for the assessment of food effects were Cmax and AUC0 -. |
METHODS | For tolerability assessment , adverse events ( AEs ) were monitored using investigators ' questionnaires and subjects ' spontaneous reports , vital sign measurements , hematology , clinical chemistry , and ECG . | For tolerability assessment, adverse events (AEs) were monitored using investigators'questionnaires and subjects'spontaneous reports, vital sign measurements, hematology, clinical chemistry, and ECG. |
RESULTS | 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 . | 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. |
RESULTS | 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 . | 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. |
RESULTS | 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 % ] ) . | 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 %]). |
RESULTS | 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 . | 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. |
RESULTS | 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 . | 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. |
RESULTS | 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 - . | 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 -. |
RESULTS | The fed/fasted ratios for mirabegron Cmax and AUC0 - were in general independent of dose or sex . | The fed/fasted ratios for mirabegron Cmax and AUC0 - were in general independent of dose or sex. |
RESULTS | 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 ) . | 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). |
RESULTS | Mirabegron was generally well tolerated , with no apparent difference in AE frequency between the fasted and fed states . | Mirabegron was generally well tolerated, with no apparent difference in AE frequency between the fasted and fed states. |
CONCLUSIONS | 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 . | 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. |
CONCLUSIONS | A greater reduction in mirabegron exposure was observed after a low-fat breakfast compared with after a high-fat breakfast . | A greater reduction in mirabegron exposure was observed after a low-fat breakfast compared with after a high-fat breakfast. |
CONCLUSIONS | Based on findings from previous studies , the effects of food observed in this study do not warrant dose adjustment in clinical practice . | Based on findings from previous studies, the effects of food observed in this study do not warrant dose adjustment in clinical practice. |
CONCLUSIONS | ClinicalTrials.gov identifier : NCT00939757 . | ClinicalTrials. gov identifier : NCT00939757. |
OBJECTIVE | The purpose of this study was to determine predictors of worsening insulin sensitivity in postmenopausal women . | The purpose of this study was to determine predictors of worsening insulin sensitivity in postmenopausal women. |
METHODS | 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 ) . | 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). |
METHODS | 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 . | 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. |
METHODS | 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 ) . | 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). |
RESULTS | 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 . | 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. |
RESULTS | By logistic regression , we determined that hormone replacement therapy use and higher baseline insulin sensitivity were independent predictors of worsening insulin sensitivity . | By logistic regression, we determined that hormone replacement therapy use and higher baseline insulin sensitivity were independent predictors of worsening insulin sensitivity. |
CONCLUSIONS | The use of hormone replacement therapy and baseline insulin sensitivity are significant independent predictors of the development of worsening insulin sensitivity in postmenopausal women . | The use of hormone replacement therapy and baseline insulin sensitivity are significant independent predictors of the development of worsening insulin sensitivity in postmenopausal women. |
BACKGROUND | Ablative surgery of oropharyngeal tumors frequently leads to defects in the speech organs , resulting in impairment of speech up to the point of unintelligibility . | Ablative surgery of oropharyngeal tumors frequently leads to defects in the speech organs, resulting in impairment of speech up to the point of unintelligibility. |
BACKGROUND | The aim of the present study was the assessment of selected parameters of speech with and without resection prostheses . | The aim of the present study was the assessment of selected parameters of speech with and without resection prostheses. |
METHODS | 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 . | 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. |
METHODS | Evaluation of the resonance and the production of the sounds / s / , / sch / , and / ch / was performed by 2 experienced speech therapists . | Evaluation of the resonance and the production of the sounds / s /, / sch /, and / ch / was performed by 2 experienced speech therapists. |
METHODS | Additionally , the patients completed a non-standardized questionnaire containing a linguistic self-assessment . | Additionally, the patients completed a non-standardized questionnaire containing a linguistic self-assessment. |
RESULTS | 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 . | 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. |
RESULTS | Correct production of the sounds / s / , / sch / , and / ch / increased from 2 to 13 patients . | Correct production of the sounds / s /, / sch /, and / ch / increased from 2 to 13 patients. |
RESULTS | A significant improvement of the evaluated parameters could be observed only in patients with maxillary defects . | A significant improvement of the evaluated parameters could be observed only in patients with maxillary defects. |
RESULTS | The linguistic self-assessment showed a higher satisfaction in patients with maxillary defects . | The linguistic self-assessment showed a higher satisfaction in patients with maxillary defects. |
CONCLUSIONS | In patients with maxillary defects due to ablative tumor surgery , an increase in speech performance and intelligibility is possible by supplying resection prostheses . | In patients with maxillary defects due to ablative tumor surgery, an increase in speech performance and intelligibility is possible by supplying resection prostheses. |
BACKGROUND | Misoprostol is the drug of choice for medical abortion worldwide but consensus is yet to be reached regarding its preferred route of administration . | Misoprostol is the drug of choice for medical abortion worldwide but consensus is yet to be reached regarding its preferred route of administration. |
OBJECTIVE | To compare the outcome of sublingual with vaginal administrations of misoprostol for induction of second trimester abortion . | To compare the outcome of sublingual with vaginal administrations of misoprostol for induction of second trimester abortion. |
METHODS | 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. | 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. |
METHODS | The same doses were repeated for another 24 h in non-responders . | The same doses were repeated for another 24 h in non-responders. |
METHODS | 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 . | 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. |
RESULTS | 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 . | 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. |
RESULTS | Mean induction-abortion intervals in sublingual and vaginal groups were 14.1 and 14.5 h , respectively ( P = 0.066 ) . | Mean induction-abortion intervals in sublingual and vaginal groups were 14. 1 and 14. 5 h, respectively (P = 0. 066). |
RESULTS | Other outcome measures were also more or less similar in both groups . | Other outcome measures were also more or less similar in both groups. |
RESULTS | Differences in the incidence of side-effects were also statistically insignificant when both groups were compared . | Differences in the incidence of side-effects were also statistically insignificant when both groups were compared. |
RESULTS | Sublingual administration of the drug was preferred by most of the women as compared to vaginal administration ( P < 0.0001 ) . | Sublingual administration of the drug was preferred by most of the women as compared to vaginal administration (P < 0. 0001). |
CONCLUSIONS | 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 . | 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. |
OBJECTIVE | 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. | 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. |
BACKGROUND | Garlic has been variably reported to reduce or not affect plasma cholesterol values . | Garlic has been variably reported to reduce or not affect plasma cholesterol values. |
BACKGROUND | 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 . | 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. |
METHODS | 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 ) . | 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). |
METHODS | 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 . | 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. |
RESULTS | 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 . | 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. |