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BACKGROUND | The emergence of HIV as a chronic condition means that people living with HIV are required to take more responsibility for the self-management of their condition , including making physical , emotional and social adjustments . | The emergence of HIV as a chronic condition means that people living with HIV are required to take more responsibility for the self-management of their condition, including making physical, emotional and social adjustments. |
BACKGROUND | This paper describes the design and evaluation of Positive Outlook , an online program aiming to enhance the self-management skills of gay men living with HIV . | This paper describes the design and evaluation of Positive Outlook, an online program aiming to enhance the self-management skills of gay men living with HIV. |
METHODS | This study is designed as a randomised controlled trial in which men living with HIV in Australia will be assigned to either an intervention group or usual care control group . | This study is designed as a randomised controlled trial in which men living with HIV in Australia will be assigned to either an intervention group or usual care control group. |
METHODS | The intervention group will participate in the online group program ` Positive Outlook ' . | The intervention group will participate in the online group program'Positive Outlook '. |
METHODS | The program is based on self-efficacy theory and uses a self-management approach to enhance skills , confidence and abilities to manage the psychosocial issues associated with HIV in daily life . | The program is based on self-efficacy theory and uses a self-management approach to enhance skills, confidence and abilities to manage the psychosocial issues associated with HIV in daily life. |
METHODS | Participants will access the program for a minimum of 90 minutes per week over seven weeks . | Participants will access the program for a minimum of 90 minutes per week over seven weeks. |
METHODS | Primary outcomes are domain specific self-efficacy , HIV related quality of life , and outcomes of health education . | Primary outcomes are domain specific self-efficacy, HIV related quality of life, and outcomes of health education. |
METHODS | Secondary outcomes include : depression , anxiety and stress ; general health and quality of life ; adjustment to HIV ; and social support . | Secondary outcomes include : depression, anxiety and stress ; general health and quality of life ; adjustment to HIV ; and social support. |
METHODS | Data collection will take place at baseline , completion of the intervention ( or eight weeks post randomisation ) and at 12 week follow-up . | Data collection will take place at baseline, completion of the intervention (or eight weeks post randomisation) and at 12 week follow-up. |
CONCLUSIONS | Results of the Positive Outlook study will provide information regarding the effectiveness of online group programs improving health related outcomes for men living with HIV . | Results of the Positive Outlook study will provide information regarding the effectiveness of online group programs improving health related outcomes for men living with HIV. |
BACKGROUND | ACTRN12612000642886 . | ACTRN12612000642886. |
BACKGROUND | The aim of this study was to evaluate the efficacy , safety and complications of orbital steroid injection versus oral steroid therapy in the management of thyroid-related ophthalmopathy . | The aim of this study was to evaluate the efficacy, safety and complications of orbital steroid injection versus oral steroid therapy in the management of thyroid-related ophthalmopathy. |
METHODS | A total of 29 patients suffering from thyroid ophthalmopathy were included in this study . | A total of 29 patients suffering from thyroid ophthalmopathy were included in this study. |
METHODS | Patients were randomized into two groups : group I included 15 patients treated with oral prednisolone and group II included 14 patients treated with peribulbar triamcinolone orbital injection . | Patients were randomized into two groups : group I included 15 patients treated with oral prednisolone and group II included 14 patients treated with peribulbar triamcinolone orbital injection. |
METHODS | Only 12 patients in both groups ( 16 female and 8 male ) completed the study . | Only 12 patients in both groups (16 female and 8 male) completed the study. |
RESULTS | Both groups showed improvement in symptoms and in clinical evidence of inflammation with improvement of eye movement and proptosis in most cases . | Both groups showed improvement in symptoms and in clinical evidence of inflammation with improvement of eye movement and proptosis in most cases. |
RESULTS | Mean exophthalmometry value before treatment was 22.6 1.98 mm that decreased to 18.6 0.996 mm in group I , compared with 23 1.86 mm that decreased to 19.08 1.16 mm in group II . | Mean exophthalmometry value before treatment was 22. 6 1. 98 mm that decreased to 18. 6 0. 996 mm in group I, compared with 23 1. 86 mm that decreased to 19. 08 1. 16 mm in group II. |
RESULTS | Mean initial clinical activity score was 4.75 1.2 and 5 1.3 for group I and group II before treatment , respectively , which dropped to 0.83 1.2 and 0.83 1.02 , 6 months after treatment , respectively . | Mean initial clinical activity score was 4. 75 1. 2 and 5 1. 3 for group I and group II before treatment, respectively, which dropped to 0. 83 1. 2 and 0. 83 1. 02, 6 months after treatment, respectively. |
RESULTS | There was no change in the best-corrected visual acuity in both groups . | There was no change in the best-corrected visual acuity in both groups. |
RESULTS | There was an increase in body weight , blood sugar , blood pressure and gastritis in group I in 66.7 % , 33.3 % , 50 % and 75 % , respectively , compared with 0 % , 0 % , 8.3 % and 8.3 % in group II . | There was an increase in body weight, blood sugar, blood pressure and gastritis in group I in 66. 7 %, 33. 3 %, 50 % and 75 %, respectively, compared with 0 %, 0 %, 8. 3 % and 8. 3 % in group II. |
RESULTS | No adverse local side effects were observed in group II . | No adverse local side effects were observed in group II. |
CONCLUSIONS | Orbital steroid injection for thyroid-related ophthalmopathy is effective and safe . | Orbital steroid injection for thyroid-related ophthalmopathy is effective and safe. |
CONCLUSIONS | It eliminates the adverse reactions associated with oral corticosteroid use . | It eliminates the adverse reactions associated with oral corticosteroid use. |
OBJECTIVE | The aim of this prospective randomized study was to examine whether active counseling and more liberal oral fluid intake decrease postoperative pain , nausea and vomiting in pediatric ambulatory tonsillectomy . | The aim of this prospective randomized study was to examine whether active counseling and more liberal oral fluid intake decrease postoperative pain, nausea and vomiting in pediatric ambulatory tonsillectomy. |
METHODS | Families , whose child was admitted for ambulatory tonsillectomy or adenotonsillectomy , were randomly assigned to the study groups ( n = 116 ; 58 families in each group ) . | Families, whose child was admitted for ambulatory tonsillectomy or adenotonsillectomy, were randomly assigned to the study groups (n = 116 ; 58 families in each group). |
METHODS | The intervention group received the fasting instructions with face-to-face counseling for the child 's active preoperative nutrition , and the control group the fasting instructions according to the hospital 's standard procedure . | The intervention group received the fasting instructions with face-to-face counseling for the child 's active preoperative nutrition, and the control group the fasting instructions according to the hospital 's standard procedure. |
METHODS | The level of postoperative pain and nausea was scored in the postanesthesia care unit ( PACU ) during the first postoperative hour , as well as at 2 , 4 , 8 and 24h postoperatively . | The level of postoperative pain and nausea was scored in the postanesthesia care unit (PACU) during the first postoperative hour, as well as at 2, 4, 8 and 24h postoperatively. |
METHODS | The first scoring in PACU was performed by the attending nurse with a 0-10 scale . | The first scoring in PACU was performed by the attending nurse with a 0-10 scale. |
METHODS | The rest of the estimations were made independently and simultaneously by the children using a VAS scale , and by the parents using a 0-10 scale . | The rest of the estimations were made independently and simultaneously by the children using a VAS scale, and by the parents using a 0-10 scale. |
RESULTS | The children in the control group were in more pain in the PACU than the children in the intervention group , and the difference between the groups was statistically significant ( p = 0.0002 ) . | The children in the control group were in more pain in the PACU than the children in the intervention group, and the difference between the groups was statistically significant (p = 0. 0002). |
RESULTS | All pain scores , according to the children and the parents , increased after the surgery . | All pain scores, according to the children and the parents, increased after the surgery. |
RESULTS | In both groups the highest score values were found at home 8h after surgery , and no significant difference was found between the study groups . | In both groups the highest score values were found at home 8h after surgery, and no significant difference was found between the study groups. |
RESULTS | On the first postoperative morning , the children in the control group were in pain ( p = 0.047 ) . | On the first postoperative morning, the children in the control group were in pain (p = 0. 047). |
RESULTS | The children did not have significant nausea in the PACU , but the nausea increased postoperatively . | The children did not have significant nausea in the PACU, but the nausea increased postoperatively. |
RESULTS | Four hours after surgery the children were most nauseous according to all estimations ( 60 % , n = 116 ) . | Four hours after surgery the children were most nauseous according to all estimations (60 %, n = 116). |
RESULTS | More than half of the children vomited and most vomited clotted blood . | More than half of the children vomited and most vomited clotted blood. |
RESULTS | Nausea and vomiting decreased during the evening of the surgery , but six children vomited the next morning , four of them vomited blood . | Nausea and vomiting decreased during the evening of the surgery, but six children vomited the next morning, four of them vomited blood. |
RESULTS | The incidence and intensity of postoperative nausea and vomiting between the intervention and control groups were not statistically significant . | The incidence and intensity of postoperative nausea and vomiting between the intervention and control groups were not statistically significant. |
RESULTS | However , preoperative nutritional counseling and more liberal per oral fluid intake appeared to have a positive effect on the children 's well-being and helped them to better tolerate postoperative nausea and vomiting . | However, preoperative nutritional counseling and more liberal per oral fluid intake appeared to have a positive effect on the children 's well-being and helped them to better tolerate postoperative nausea and vomiting. |
CONCLUSIONS | The preoperative counseling about active preoperative nutrition significantly reduces the child 's pain during the first posttonsillectomy hours and might prepare the child to better tolerate the stress of potential postoperative nausea and vomiting . | The preoperative counseling about active preoperative nutrition significantly reduces the child 's pain during the first posttonsillectomy hours and might prepare the child to better tolerate the stress of potential postoperative nausea and vomiting. |
OBJECTIVE | To explore the effects of GengNianLe ( GNL , also called perimenopausal depression relieving formula ) , a defined formula of Chinese medicinal herbs in relieving perimenopausal depression in Chinese women . | To explore the effects of GengNianLe (GNL, also called perimenopausal depression relieving formula), a defined formula of Chinese medicinal herbs in relieving perimenopausal depression in Chinese women. |
METHODS | Between September 2004 and April 2008 , 47 Chinese women were randomized into a GNL group ( n = 21 ) and a control group which received tibolone ( n = 26 ) using a randomization chart . | Between September 2004 and April 2008, 47 Chinese women were randomized into a GNL group (n = 21) and a control group which received tibolone (n = 26) using a randomization chart. |
METHODS | Depression was rated with the 24-item Hamilton Depression Scale ( HAMD ) . | Depression was rated with the 24-item Hamilton Depression Scale (HAMD). |
METHODS | The serum levels of follicle stimulating hormone ( FSH ) , luteinizing hormone ( LH ) , and estradiol ( E ( 2 ) ) were detected before and after the treatment . | The serum levels of follicle stimulating hormone (FSH), luteinizing hormone (LH), and estradiol (E (2)) were detected before and after the treatment. |
RESULTS | After 12 weeks of treatment , HAMD scores in both groups decreased significantly ( p < 0.05 ) with no significant difference between the groups ( p > 0.05 ) . | After 12 weeks of treatment, HAMD scores in both groups decreased significantly (p < 0. 05) with no significant difference between the groups (p > 0. 05). |
RESULTS | The levels of FSH decreased significantly and the level of E ( 2 ) increased significantly in both groups , and they changed more in the control group . | The levels of FSH decreased significantly and the level of E (2) increased significantly in both groups, and they changed more in the control group. |
RESULTS | No side-effect of treatment was reported in either group during treatment . | No side-effect of treatment was reported in either group during treatment. |
CONCLUSIONS | The Chinese medicinal formula GNL showed promise in relieving perimenopausal depression and merits further study . | The Chinese medicinal formula GNL showed promise in relieving perimenopausal depression and merits further study. |
BACKGROUND | Topical formulations of nonsteroidal anti-inflammatory drugs ( NSAIDs ) are generally considered to be safer alternatives to oral NSAIDs due to lower systemic absorption . | Topical formulations of nonsteroidal anti-inflammatory drugs (NSAIDs) are generally considered to be safer alternatives to oral NSAIDs due to lower systemic absorption. |
BACKGROUND | We conducted randomized , crossover studies that compared the pharmacokinetics ( PK ) , bioequivalence and safety of topical diclofenac sodium 2 % twice daily ( BID ) , diclofenac sodium 1.5 % four times daily ( QID ) and oral diclofenac sodium in healthy subjects . | We conducted randomized, crossover studies that compared the pharmacokinetics (PK), bioequivalence and safety of topical diclofenac sodium 2 % twice daily (BID), diclofenac sodium 1. 5 % four times daily (QID) and oral diclofenac sodium in healthy subjects. |
METHODS | The results of three bioequivalence studies are reviewed . | The results of three bioequivalence studies are reviewed. |
METHODS | Healthy adult subjects ( n = 76 ) applied topical diclofenac sodium 2 % solution ( 40.4 mg/2 mL ) BID ; or 1.5 % solution ( 19.3 mg/40 drops ) QID to each knee for 7.5 consecutive days separated by a washout period . | Healthy adult subjects (n = 76) applied topical diclofenac sodium 2 % solution (40. 4 mg/2 mL) BID ; or 1. 5 % solution (19. 3 mg/40 drops) QID to each knee for 7. 5 consecutive days separated by a washout period. |
METHODS | Subjects ( n = 22 ) in one study also received oral diclofenac sodium 75 mg BID for 7.5 days . | Subjects (n = 22) in one study also received oral diclofenac sodium 75 mg BID for 7. 5 days. |
METHODS | Plasma diclofenac concentrations were determined from serial blood samples collected on Days 1 and 8 ( steady state ) , and diclofenac PK parameters were estimated by noncompartmental methods . | Plasma diclofenac concentrations were determined from serial blood samples collected on Days 1 and 8 (steady state), and diclofenac PK parameters were estimated by noncompartmental methods. |
RESULTS | The studies demonstrated comparable bioequivalence between the 2 % and 1.5 % topical solutions as well as lower systemic exposure compared to oral dosing ( approximately 93 % less ) . | The studies demonstrated comparable bioequivalence between the 2 % and 1. 5 % topical solutions as well as lower systemic exposure compared to oral dosing (approximately 93 % less). |
RESULTS | Daily systemic exposure was comparable between the two formulations with only a 12 % difference in the AUCss ( 0-24 ) ( p = 0.140 ) . | Daily systemic exposure was comparable between the two formulations with only a 12 % difference in the AUCss (0-24) (p = 0. 140). |
RESULTS | Furthermore , both topical solutions demonstrated delayed elimination with a t ( 1/2 ) of 4 - to 6-fold longer , as compared to oral diclofenac . | Furthermore, both topical solutions demonstrated delayed elimination with a t (1/2) of 4 - to 6-fold longer, as compared to oral diclofenac. |
RESULTS | The 2 % solution provided more consistent dosing relative to the 1.5 % solution when comparing AUCss ( 0-24 ) and Cmaxss across studies . | The 2 % solution provided more consistent dosing relative to the 1. 5 % solution when comparing AUCss (0-24) and Cmaxss across studies. |
RESULTS | Mild application site reactions were the most common treatment-emergent adverse event reported with topical diclofenac . | Mild application site reactions were the most common treatment-emergent adverse event reported with topical diclofenac. |
CONCLUSIONS | The steady-state PK profile of topical diclofenac 2 % solution administered BID is similar to that of the 1.5 % solution administered QID . | The steady-state PK profile of topical diclofenac 2 % solution administered BID is similar to that of the 1. 5 % solution administered QID. |
CONCLUSIONS | Systemic exposure to diclofenac is substantially lower after topical application as compared to oral administration . | Systemic exposure to diclofenac is substantially lower after topical application as compared to oral administration. |
CONCLUSIONS | ( Study 2 was registered with ClinicalTrials.gov ; NCT01202799 ; https://clinicaltrials.gov/ct2/results?term=01202799&Search=Search ) . | (Study 2 was registered with ClinicalTrials. gov ; NCT01202799 ; https://clinicaltrials. gov/ct2/results? term=01202799&Search=Search). |
BACKGROUND | No long-term studies have been reported on the effect of training programs on driving after stroke . | No long-term studies have been reported on the effect of training programs on driving after stroke. |
OBJECTIVE | The authors ' primary aim was to determine the effect of simulator versus cognitive rehabilitation therapy on fitness-to-drive at 5 years poststroke . | The authors'primary aim was to determine the effect of simulator versus cognitive rehabilitation therapy on fitness-to-drive at 5 years poststroke. |
OBJECTIVE | A second aim was to investigate differences in clinical characteristics between stroke survivors who resumed and stopped driving . | A second aim was to investigate differences in clinical characteristics between stroke survivors who resumed and stopped driving. |
METHODS | In a previously reported randomized controlled trial , 83 stroke survivors received 15 hours of simulator training ( n = 42 ) or cognitive therapy ( n = 41 ) . | In a previously reported randomized controlled trial, 83 stroke survivors received 15 hours of simulator training (n = 42) or cognitive therapy (n = 41). |
METHODS | In this 5-year follow-up study , 61 participants were reassessed . | In this 5-year follow-up study, 61 participants were reassessed. |
METHODS | Fitness-to-drive decisions were obtained from medical , visual , neuropsychological , and on-road tests ; 44 participants ( simulator group , n = 21 ; cognitive group , n = 23 ) completed all assessments . | Fitness-to-drive decisions were obtained from medical, visual, neuropsychological, and on-road tests ; 44 participants (simulator group, n = 21 ; cognitive group, n = 23) completed all assessments. |
METHODS | The primary outcome measures were fitness-to-drive decision and current driving status . | The primary outcome measures were fitness-to-drive decision and current driving status. |
RESULTS | The authors found that 5 years after stroke , 18 of 30 participants ( 60 % ) in the simulator group were considered fit to drive , compared with 15 of 31 ( 48 % ) in the cognitive group ( P = .36 ) ; 34 of 61 ( 56 % ) participants were driving . | The authors found that 5 years after stroke, 18 of 30 participants (60 %) in the simulator group were considered fit to drive, compared with 15 of 31 (48 %) in the cognitive group (P =. 36) ; 34 of 61 (56 %) participants were driving. |
RESULTS | Current drivers were younger ( P = .04 ) , had higher Barthel scores ( P = .008 ) , had less comorbidity ( P = .01 ) , and were less severely depressed ( P = .02 ) than those who gave up driving . | Current drivers were younger (P =. 04), had higher Barthel scores (P =. 008), had less comorbidity (P =. 01), and were less severely depressed (P =. 02) than those who gave up driving. |
CONCLUSIONS | The advantage of simulator-based driving training over cognitive rehabilitation therapy , evident at 6 months poststroke , had faded 5 years later . | The advantage of simulator-based driving training over cognitive rehabilitation therapy, evident at 6 months poststroke, had faded 5 years later. |
CONCLUSIONS | Poststroke drivers were younger and less severely affected and depressed than nondrivers . | Poststroke drivers were younger and less severely affected and depressed than nondrivers. |
BACKGROUND | The potential of insecticide-treated bednets ( ITNs ) to contribute to child survival has been well documented in randomised controlled trials . | The potential of insecticide-treated bednets (ITNs) to contribute to child survival has been well documented in randomised controlled trials. |
BACKGROUND | ITN coverage has increased rapidly in Kenya from 7 % in 2004 to 67 % in 2006 . | ITN coverage has increased rapidly in Kenya from 7 % in 2004 to 67 % in 2006. |
BACKGROUND | We aimed to assess the extent to which this investment has led to improvements in child survival . | We aimed to assess the extent to which this investment has led to improvements in child survival. |
METHODS | A dynamic cohort of about 3500 children aged 1-59 months were enumerated three times at yearly intervals in 72 rural clusters located in four districts of Kenya . | A dynamic cohort of about 3500 children aged 1-59 months were enumerated three times at yearly intervals in 72 rural clusters located in four districts of Kenya. |
METHODS | The effect of ITN use on mortality was assessed with Poisson regression to take account of potential effect-modifying and confounding covariates . | The effect of ITN use on mortality was assessed with Poisson regression to take account of potential effect-modifying and confounding covariates. |
RESULTS | 100 children died over 2 years . | 100 children died over 2 years. |
RESULTS | Overall mortality rates were much the same in the first and second years of the study ( 14.5 per 1000 person-years in the first year and 15.4 per 1000 person-years in the second ) . | Overall mortality rates were much the same in the first and second years of the study (14. 5 per 1000 person-years in the first year and 15. 4 per 1000 person-years in the second). |
RESULTS | After adjustment for age , time period , and a number of other possible confounding variables , ITN use was associated with a 44 % reduction in mortality ( mortality rate ratio 0.56 , 95 % CI 0.33-0 .96 ; p = 0.04 ) . | After adjustment for age, time period, and a number of other possible confounding variables, ITN use was associated with a 44 % reduction in mortality (mortality rate ratio 0. 56, 95 % CI 0. 33-0. 96 ; p = 0. 04). |
RESULTS | This level of protection corresponds to about seven deaths averted for every 1000 ITNs distributed . | This level of protection corresponds to about seven deaths averted for every 1000 ITNs distributed. |
CONCLUSIONS | A combined approach of social marketing followed by mass free distribution of ITNs translated into child survival effects that are comparable with those seen in previous randomised controlled trials . | A combined approach of social marketing followed by mass free distribution of ITNs translated into child survival effects that are comparable with those seen in previous randomised controlled trials. |
BACKGROUND | Cortical stimulation mapping ( CSM ) commonly uses visual naming to determine resection margins in the dominant hemisphere of patients with epilepsy . | Cortical stimulation mapping (CSM) commonly uses visual naming to determine resection margins in the dominant hemisphere of patients with epilepsy. |
BACKGROUND | Visual naming alone may not identify all language sites in resection-prone areas , prompting additional tasks for comprehensive language mapping . | Visual naming alone may not identify all language sites in resection-prone areas, prompting additional tasks for comprehensive language mapping. |
OBJECTIVE | To demonstrate word-finding distinctions between visual , auditory , and reading modalities during CSM and the percentage of modality-specific language sites within dominant hemisphere subregions . | To demonstrate word-finding distinctions between visual, auditory, and reading modalities during CSM and the percentage of modality-specific language sites within dominant hemisphere subregions. |
METHODS | Twenty-eight patients with epilepsy underwent CSM by the use of visual , auditory , and sentence-completion tasks . | Twenty-eight patients with epilepsy underwent CSM by the use of visual, auditory, and sentence-completion tasks. |
METHODS | Hierarchical logistic regression analyzed errors to identify language sites and provide modality-specific percentages within subregions . | Hierarchical logistic regression analyzed errors to identify language sites and provide modality-specific percentages within subregions. |
RESULTS | The percentage of sites classified as language sites based on auditory naming was twice as high in anterior temporal regions compared with visual naming , marginally higher in posterior temporal areas , and comparable in parietal regions . | The percentage of sites classified as language sites based on auditory naming was twice as high in anterior temporal regions compared with visual naming, marginally higher in posterior temporal areas, and comparable in parietal regions. |
RESULTS | Sentence completion was comparable to visual and auditory naming in parietal regions and lower in most temporal areas . | Sentence completion was comparable to visual and auditory naming in parietal regions and lower in most temporal areas. |
RESULTS | Of 470 sites tested with both visual and auditory naming , 95 sites were distinctly auditory , whereas 48 sites were distinctly visual . | Of 470 sites tested with both visual and auditory naming, 95 sites were distinctly auditory, whereas 48 sites were distinctly visual. |
RESULTS | The remaining sites overlapped . | The remaining sites overlapped. |
CONCLUSIONS | Distinct cortical areas were found for distinct input modalities , with language sites in anterior tip regions found most often by using auditory naming . | Distinct cortical areas were found for distinct input modalities, with language sites in anterior tip regions found most often by using auditory naming. |
CONCLUSIONS | The vulnerability of anterior temporal tip regions to resection in this population and distinct sites for each modality suggest that a multimodality approach may be needed to spare crucial language sites , if sparing those sites can be shown to significantly reduce the rate of postoperative language deficits without sacrificing seizure control . | The vulnerability of anterior temporal tip regions to resection in this population and distinct sites for each modality suggest that a multimodality approach may be needed to spare crucial language sites, if sparing those sites can be shown to significantly reduce the rate of postoperative language deficits without sacrificing seizure control. |
OBJECTIVE | To determine if suppressive acyclovir therapy given to term gravidas experiencing a first episode of genital herpes simplex virus ( HSV ) - infection during pregnancy decreases the need for cesarean delivery for that indication . | To determine if suppressive acyclovir therapy given to term gravidas experiencing a first episode of genital herpes simplex virus (HSV) - infection during pregnancy decreases the need for cesarean delivery for that indication. |
METHODS | Forty-six pregnant women with first episodes of genital herpes during pregnancy were randomly assigned to receive oral acyclovir 400 mg or placebo , three times per day , from 36 weeks ' gestation until delivery as part of a prospective , double-blind trial . | Forty-six pregnant women with first episodes of genital herpes during pregnancy were randomly assigned to receive oral acyclovir 400 mg or placebo, three times per day, from 36 weeks'gestation until delivery as part of a prospective, double-blind trial. |
METHODS | Herpes simplex virus cultures were obtained when patients presented for delivery . | Herpes simplex virus cultures were obtained when patients presented for delivery. |
METHODS | Vaginal delivery was permitted if no clinical recurrence was present ; otherwise , a cesarean was performed . | Vaginal delivery was permitted if no clinical recurrence was present ; otherwise, a cesarean was performed. |
METHODS | Neonatal HSV cultures were obtained and infants were followed-up clinically . | Neonatal HSV cultures were obtained and infants were followed-up clinically. |
RESULTS | None of the 21 patients treated with acyclovir and nine of 25 ( 36 % ) treated with placebo had clinical evidence of recurrent genital herpes at delivery ( odds ratio [ OR ] 0.04 , 95 % confidence interval [ CI ] 0.002-0 .745 ; P = .002 ) . | None of the 21 patients treated with acyclovir and nine of 25 (36 %) treated with placebo had clinical evidence of recurrent genital herpes at delivery (odds ratio [OR] 0. 04, 95 % confidence interval [CI] 0. 002-0. 745 ; P =. 002). |
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