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Comparisons of oral propafenone and sotalol as an initial treatment in patients with symptomatic paroxysmal atrial fibrillation.

The main goal of this study is to evaluate the safety and efficacy of propafenone versus sotalol as an initial choice of treatment in patients with symptomatic paroxysmal atrial fibrillation (AF), according to a double-blind randomized system. In the oral propafenone group (n = 41), 2 patients (5%) discontinued therapy because of gastrointestinal discomfort in 1 and dizziness in the other. Thirty-one (79%) of the 39 patients who continued the treatment had effective response to oral propafenone (>75% reduction of symptomatic arrhythmic attacks) on a mean dose of 663 +/- 99 mg/day with a decrease in attack frequency from 10 +/- 3 to 2 +/- 1 times per week. In the oral sotalol group (n = 38), 4 patients (11%) discontinued treatment because of dizziness in 2 and symptomatic bradycardia in 2. Twenty-six of the 34 patients (76%) who continued the treatment had effective response to oral sotalol on a mean dose of 200 +/- 57 mg/day with a decrease in attack frequency from 11 +/- 3 to 2 +/- 1 times per week. Comparisons of the results between propafenone and sotalol groups showed a similar incidence of intolerable (2 of 41 vs 4 of 38, p = 0.42) and tolerable side effects (10 of 39 vs 8 of 34, p = 1.0). The attack frequency at baseline (11 +/- 3 vs 10 +/- 4 times per week, p = 0.23) and after treatment (3 +/- 1 vs 3 +/- 2 times per week, p = 0.85) did not differ significantly between the 2 groups. The incidence of effective response to drugs was also similar (31 of 39 vs 26 of 34, p = 0.78). Furthermore, the decrease of symptom scores (-32 +/- 8% vs -29 +/- 7%, p = 0.18) and percentage decrease of ventricular rate (-15 +/- 4% vs -18 +/- 4%, p = 0.10) during AF were also similar between the 2 groups. In conclusion, oral propafenone and sotalol are equally effective and safe in preventing attacks and alleviating symptoms of paroxysmal AF.

Administration, Oral↗

Epidemiology and pathophysiology of symptomatic gastroesophageal reflux disease.

Symptomatic, or nonerosive, gastroesophageal reflux disease (GERD) is the most common presentation of GERD. Patients with symptomatic GERD more frequently are younger, female, weigh less, and are less likely to have a hiatal hernia compared with patients who have erosive GERD. Physiologically, these patients demonstrate minimal esophageal motor abnormalities. However, despite a common clinical presentation and similar endoscopic findings, symptomatic GERD is comprised of a heterogeneous group of patients. There are several identifiable subgroups differentiated by the underlying mechanisms causing their heartburn symptoms, distinctions that may explain the relatively low symptom response rate to potent antireflux treatment observed among these patients as compared with those with erosive esophagitis.

Clinical Trials as Topic↗

The economic and quality-of-life impact of symptomatic gastroesophageal reflux disease.

Gastroesophageal reflux disease (GERD) is one of the most common complaints in general medical practice. Symptoms of GERD have a high prevalence, which greatly affects health economics and patient health-related quality of life (HRQOL). The majority of patients who present with reflux symptoms lack esophageal mucosal injury and thus have symptomatic GERD. There appear to be no differences in either symptoms or HRQOL measures between patients with or without positive endoscopy. Although most pharmacoeconomic and HRQOL assessments have focused on erosive GERD patients, available data suggest that the impact of symptomatic GERD on HRQOL is significant and equivalent to that associated with erosive disease. Proton pump inhibitors (PPIs) improve HRQOL to a greater extent than either histamine(2)-receptor antagonists or prokinetics in patients with GERD, with PPI-based step-down or "on-demand" strategies yielding the most cost-effective benefit to health. Additional HRQOL and outcomes research focused on patients with symptomatic GERD, ideally using disease-specific assessment tools, is needed. Furthermore, these management strategies must be implemented in real world settings to validate their effectiveness and firmly establish claims of reduced need for diagnostic testing and decreased direct medical costs.

Clinical Trials as Topic↗

Factors that influence therapeutic outcomes in symptomatic gastroesophageal reflux disease.

The term "symptomatic gastroesophageal reflux disease" (GERD) refers to those patients who present with the typical GERD symptoms of heartburn and regurgitation, yet do not have endoscopic evidence of esophagitis. The primary goals of managing symptomatic GERD are to control symptoms and improve quality of life. A clinical assessment of the GERD patient can identify important clinical features, such as atypical and extraesophageal symptoms for which acid-suppressive agents tend to be less effective. Performing an endoscopy can further identify the patient as having nonerosive reflux disease, erosive esophagitis, or Barrett's esophagus-diagnoses which can help determine treatment but may not prove predictive of therapeutic response. Determining acid exposure through pH testing can predict therapeutic response, with those revealing an abnormal acid exposure time being more responsive to acid-suppressive therapy. However, the performance of an endoscopy and pH testing on each patient is clearly not practical. Whereas the natural history of symptomatic GERD is still largely undefined, acid-suppressive therapy appears to be the best approach available for both the short-term and long-term management of this disease.

Clinical Trials as Topic↗

Intermittent and on-demand use of proton pump inhibitors in the management of symptomatic gastroesophageal reflux disease.

The epidemic of gastroesophageal reflux disease (GERD) in industrialized nations is currently spreading to less-developed ones, with more than half of the patients having symptomatic or mild erosive GERD. The long-term management of GERD has been dominated by daily maintenance treatment with proton pump inhibitors (PPI) to prevent relapse. It is common, however, for many patients with mild disease and infrequent symptom relapses to use a PPI only when symptoms demand. Patients with symptomatic or mild erosive GERD are therefore ideal for on-demand or intermittent treatment. The efficacy of such a strategy of intermittent treatment, or treatment of symptoms on demand, has recently been evaluated in four randomized controlled studies. These trials demonstrate that such therapeutic strategies reduce symptoms, improve quality of life, and are cost effective. In clinical practice, the author has found these treatment strategies suitable for approximately 60% of newly diagnosed patients with GERD for the long-term management of symptomatic GERD of mild or moderate severity.

Anti-Ulcer Agents↗

Reproducibility of orthostatic hypotension in symptomatic elderly.

PURPOSE: Variations in the reported prevalence of orthostatic hypotension (4% to 33%) are attributed to population selection and varied criteria used to define orthostatic hypotension. Variation in the reproducibility of hemodynamic responses to orthostasis could be a further confounding variable. The purpose of this study was to evaluate reproducibility of orthostatic blood pressure changes in patients with documented symptomatic orthostatic hypotension. PATIENTS AND METHODS: Forty outpatients (mean age 77+/- 8 years; 24 women) were recruited after initial presentation to a morning outpatient clinic with postural symptoms of dizziness (92%), falls (67.5%), or syncope (30%). Patients had a symptomatic drop in orthostatic systolic blood pressure of >20 mm Hg documented in clinic. Subsequent cardiovascular assessment included autonomic function tests, carotid sinus massage (supine and erect), and prolonged head-up tilt tests. Blood pressure and heart rate measurements were repeated during standing and head-up tilt on two further attendances in the morning. RESULTS: A total of 67.5% patients had a drop in systolic blood pressure of >20 mm Hg on both visits during orthostatic stimuli; in the remainder, the response was not reproducible, and 5% had no significant orthostatic drop at either attendance. In 19 patients autonomic function tests were abnormal; orthostatic hypotension was reproducible in 79% of this group. In patients with normal autonomic function tests, 57% had reproducible orthostatic hypotension, of which only 60% were reproducible in those patients when further assessed in the afternoon. CONCLUSIONS: Orthostatic blood pressure responses may not be reproducible in patients with documented symptomatic orthostatic hypotension, particularly if autonomic function is normal and measurements are taken in the afternoon. Repeated systolic blood pressure measurements in the morning may be necessary to make a diagnosis in older patients with suspected orthostatic hypotension.

Accidental Falls↗

Management of the symptomatic placenta previa: a randomized, controlled trial of inpatient versus outpatient expectant management.

OBJECTIVE: Our purpose was to determine the safety, efficacy, and costs of inpatient and outpatient management of symptomatic placenta previa. STUDY DESIGN: Fifty-three women with the initial diagnosis of placenta previa at 24 to 36 weeks' gestation who required hospitalization for vaginal bleeding were stabilized and then randomized to receive either inpatient or outpatient expectant management. Twenty-seven inpatients were placed at bed rest with minimal ambulation, received weekly corticosteroids until 32 weeks of gestation, and underwent ultrasonographic examination at 2-week intervals to assess fetal growth and placental location. Twenty-six outpatients were discharged home after > or = 72 hours of hospitalization. Each week they also received corticosteroids, until 32 weeks' gestation, and ultrasonographic evaluations. Outpatients with recurrent bleeding were readmitted for evaluation. All subjects who reached 36 weeks' gestation with persistent placenta previa underwent amniocentesis. When fetal lung maturity was present, cesarean delivery was electively performed. RESULTS: There were insignificant differences between inpatients and outpatients for mean age, parity, race, type of previa (complete or partial), number of prior vaginal bleeding episodes, and initial hemoglobin value. The mean estimated gestational age at enrollment was 29.1 +/- 3.1 (SD) weeks for inpatients and 29.9 +/- 3.1 weeks for outpatients. In eight patients the placenta was found to no longer cover the internal os by 36 weeks' gestation. There were seven patients in each group who did not complete the protocol for initial treatment assignment. The average estimated gestational age at delivery for the inpatients was 34.5 +/- 2.4 weeks and 34.6 +/- 2.3 weeks for the outpatients (p = 0.90), whereas the mean birth weights were 2413.7 +/- 642.7 gm and 2607.8 +/- 587.1 gm, respectively (p = 0.28). Thirty-three patients (62.3%) had recurrent episodes of bleeding, with 26 requiring expeditious cesarean delivery. Four (14.8%) inpatients and one (3.7%) outpatient required blood transfusion (p = 0.67). There was no difference in neonatal morbidity (defined as the presence of respiratory distress syndrome, intracranial hemorrhage, or culture-proved sepsis) between the two groups (relative risk 1.16, 95% confidence interval 0.66 to 2.02). There were no neonatal deaths. The mean number of maternal hospital days differed significantly between the two groups: inpatients required an average of 28.6 +/- 20.3 days and outpatients remained hospitalized for an average of 10.1 +/- 8.5 days (p < 0.0001). Cost analysis based on maternal hospital days reveals a net savings of +15,080 per patient if women with symptomatic placenta previa initially diagnosed before 37 weeks' gestation are treated as outpatients. CONCLUSIONS: For selected patients, outpatient management of symptomatic placenta previa appears to be an acceptable alternative to traditional conservative expectant inpatient management.

Adult↗

Effect of antibiotic use on the prevalence of symptomatic vulvovaginal candidiasis.

OBJECTIVE: The purpose of the study was to evaluate the influence of antibiotic use on the prevalence of symptomatic vulvovaginal candidiasis. STUDY DESIGN: This is a case-control study of 684 women with symptomatic vulvovaginal candidiasis who were enrolled at a vaginitis clinic and 901 control subjects who attended a cytologic screening service. RESULTS: The prevalence of antibiotic use in the month preceding the visit was 19.3% (132/684) among patients with Candida infection compared with 11.9% (107/901) among control subjects (P <.001). After adjustment by logistic regression for potential confounders (age, marital status, and contraceptive method used), the odds ratio for vulvovaginal candidiasis among patients who reported antibiotic use in the month preceding the visit was 1. 75 (95% confidence interval 1.33 to 2.32). No differences in risk were found by type of antibiotic used. The likelihood of vulvovaginal candidiasis was directly related to the duration of antibiotic use and was higher in patients who had a history of repeated episodes of Candida vaginal infection. CONCLUSIONS: Antibiotic use is a short-term risk factor for symptomatic vulvovaginal candidiasis, either as a first episode or in the form of recurrence. Increasing duration of antibiotic use is directly related with an increased prevalence of Candida vaginal infection.

Adult↗

Mammographic assessment of the symptomatic nonsuspicious breast.

BACKGROUND: Evidence from breast screening programs demonstrates the value of mammography in the detection of asymptomatic breast cancer. METHODS: This study prospectively assessed the role of mammography in the management of 585 patients presenting to a breast clinic, over a 1-year period, with symptomatic breast disease and without clinical or cytological evidence of malignancy. RESULTS: Eighteen (3%) of these patients had breast cancer. Eight patients presenting with nonspecific nodularity had carcinoma. All patients had relatively early disease. CONCLUSIONS: This study suggests that patients with symptomatic disease presenting to a breast clinic represent a group at higher risk of malignancy than screened asymptomatic patients, and that symptomatic women over 40 years of age should have bilateral mammography before being discharged from the breast clinic.

Adult↗

Symptomatic mediastinal thymic cysts.

The case of a symptomatic, hemorrhagic mediastinal thymic cyst associated with idiopathic thrombocytopenic purpura is reported and the literature reviewed. Contrary to previous reports, mediastinal thymic cysts are frequently symptomatic (39%), presenting with complaints of tracheal and esophageal compression. The age distribution is the same in symptomatic and asymptomatic patients. Complete excision remains the treatment of choice.

Adolescent↗

GABA(A) and mu-opioid receptor binding in the globus pallidus and endopeduncular nucleus of animals symptomatic for and recovered from experimental Parkinsonism.

The expression of parkinsonian motor symptoms may be partly attributed to an increase in GABAergic neurotransmission from hyperactive GABA/enkephalinergic striatopallidal efferents. The present study measured pallidal GABA(A) and mu-opioid receptor binding in normal cats and cats symptomatic for and recovered from MPTP-induced parkinsonism. GABA(A) receptor binding was significantly decreased in the globus pallidus (GP) in symptomatic cats and returned to normal levels in spontaneously recovered cats. Mu-opioid receptor binding in the GP was significantly decreased in symptomatic cats and remained significantly decreased in recovered cats. These results suggest that GABA(A) but not mu-opioid receptor binding may correlate with the expression of parkinsonian motor deficits and may reflect increased pallidal GABA and ENK release in parkinsonian animals. Upon recovery from experimental parkinsonism, however, pallidal GABA(A) receptor binding returns to normal levels while mu-opioid receptor binding reflecting enkephalin release remains elevated.

1-Methyl-4-phenyl-1,2,3,6-tetrahydropyridine↗

Clinical audit and standard setting for symptomatic breast imaging in South Thames region.

Audit is recognized as an important part of the UK National Health Service Breast Screening programme. This paper describes a simple method of auditing breast imaging in symptomatic women which was applied in the South Thames (East) Region of England. No appropriate standards were available before this audit started. Standards were set at the end of the first cycle by the Regional Radiology Audit Committee and these were used in the second cycle of this audit. A comparison between hospitals which organize both breast screening and symptomatic imaging and those with units providing symptomatic breast imaging only shows no significant difference in the accuracy diagnosis and the false negative and false positive rates between the two. However non-screening units, are significantly more likely to issue an equivocal radiology report (P = 0.000001). Measures to reduce the incidence of equivocal reporting, by prospectively issuing an audit grade with the report and double reporting of equivocal images are recommended.

Breast Neoplasms↗

Clonidine raises the sweating threshold in symptomatic but not in asymptomatic postmenopausal women.

OBJECTIVE: To determine the effects of clonidine, which reduces central sympathetic activation, on the sweating threshold in postmenopausal women with and without hot flashes. DESIGN: Laboratory physiologic study. SETTING: University medical center. PATIENT(S): 12 healthy postmenopausal women reporting frequent hot flashes and 7 reporting none. INTERVENTION(S): In two separate sessions, participants received a blind intravenous injection of clonidine HCl (2 microg/kg of body weight) or placebo, followed by body heating. MAIN OUTCOME MEASURE(S): Core body temperature, mean skin temperature, sweat rate, sternal skin conductance level, and blood pressure. RESULT(S): Symptomatic women had significantly lower core body temperature sweating thresholds than asymptomatic women after receiving placebo. Clonidine significantly increased this threshold in symptomatic women but lowered it in asymptomatic women. CONCLUSION(S): These results support the hypothesis that elevated brain norepinephrine levels reduce the sweating threshold in symptomatic women, thereby contributing to the initiation of menopausal hot flashes.

Adrenergic alpha-Agonists↗

Laparoscopic bipolar coagulation of uterine vessels: a new method for treating symptomatic fibroids.

OBJECTIVE: To evaluate the effects of laparoscopic bipolar coagulation of uterine vessels in treating symptomatic fibroids. DESIGN: Prospective clinical study. SETTING: University-affiliated tertiary referral center. PATIENT(S): Eighty-seven women with symptomatic fibroids warranting surgical treatment and wanting to retain their uteri. INTERVENTION(S): Laparoscopic bipolar coagulation of uterine arteries and anastomotic sites of uterine arteries with ovarian arteries. MAIN OUTCOME MEASURE(S): Percentage reduction in the dominant fibroid size and clinical response evaluation. RESULT(S): Eighty-five (97.7%) of 87 patients underwent technically successful laparoscopic coagulation of uterine vessels without intraoperative complications. The mean follow-up time was 10.2 months. Symptomatic improvement was reported in 76 (89.4%) of 85 patients, including 18 (21.2%) with complete resolution of symptoms. Significant reductions in the dominant fibroid size (average, 76%) and the uterine volume (average, 46%) were sonographically demonstrated. Two patients conceived 4 and 9 months, respectively, after treatment. Three (3.5%) premenopausal women became postmenopausal postoperatively. CONCLUSION(S): Laparoscopic bipolar coagulation of uterine vessels appears to be a promising new method for treating fibroid-related menorrhagia and pelvic pain.

Adult↗

Successful treatment of symptomatic arteriovenous malformation of the uterus using laparoscopic bipolar coagulation of uterine vessels.

OBJECTIVE: To report a case of symptomatic arteriovenous malformation (AVM) of the uterus that was successfully treated with laparoscopic bipolar coagulation of uterine vessels. DESIGN: Case report. SETTING: University-affiliated tertiary referral center. PATIENT(S): A 66-year-old woman with symptomatic AVM of the uterus. INTERVENTION(S): Laparoscopic bipolar coagulation of uterine vessels. MAIN OUTCOME MEASURE(S): Clinical symptoms, color Doppler sonographic examination, and pelvic magnetic resonance imaging. RESULT(S): Remarkable shrinkage of the lesion size, obvious decrease in all of the impedance measurements (pulsatility, resistance, velocity indexes [systolic/diastolic]), and freedom from symptoms. CONCLUSION(S): This modality is a new alternative method for the management of patients with symptomatic AVM of the uterus who do not respond to conservative treatment.

Aged↗

Comparison of a levonorgestrel-releasing intrauterine device versus expectant management after conservative surgery for symptomatic endometriosis: a pilot study.

OBJECTIVE: To determine whether the frequency and severity of dysmenorrhea are reduced in women with symptomatic endometriosis in whom a levonorgestrel-releasing intrauterine device (Lng-IUD) is inserted after operative laparoscopy compared with those treated with surgery only. DESIGN: Open-label, parallel-group, randomized, controlled trial. SETTING: A tertiary care and referral center for patients with endometriosis. PATIENTS(S): Parous women with moderate or severe dysmenorrhea undergoing first-line operative laparoscopy for symptomatic endometriosis. INTERVENTION(S): Randomization to immediate Lng-IUD insertion or expectant management after laparoscopic treatment of endometriotic lesions. Proportions of women with recurrence of moderate or severe dysmenorrhea in the two study groups 1 year after surgery and overall degree of satisfaction with treatment. Moderate or severe dysmenorrhea recurred in 2 of 20 (10%) subjects in the postoperative Lng-IUD group and 9/20 (45%) in the surgery-only group. Thus, a medicated device inserted postoperatively will prevent the recurrence of moderate or severe dysmenorrhea in one out of three patients 1 year after surgery. A total of 15/20 (75%) women in the Lng-IUD group and 10/20 (50%) in the expectant management group were satisfied or very satisfied with the treatment received. CONCLUSION(S): Insertion of an Lng-IUD after laparoscopic surgery for symptomatic endometriosis significantly reduced the medium-term risk of recurrence of moderate or severe dysmenorrhea.

Adult↗

A prospective crossover trial of direct current electrotherapy in symptomatic hemorrhoidal disease.

Many new modalities have been developed to treat symptomatic hemorrhoidal disease. In order to determine whether direct current electrotherapy therapy is effective, a prospective, crossover study was done. Sixteen patients referred for treatment of symptomatic hemorrhoids underwent a 16-week treatment protocol. Patients were randomized to receive either medical therapy with a sham therapy, or medical therapy with active direct current electrotherapy at 4-week intervals. All patients were instructed in medical therapy including sitz baths, hydrocortisone suppositories, topical preparations, and a high fiber diet with an educational booklet. Patients who did not respond to initial therapy were crossed over at 8 weeks, receiving alternate therapy twice. Improvement in symptoms, or lack thereof, was not statistically different between the two treatment groups. Comparisons of the internal sphincter pressure, external sphincter pressure, maximum squeeze pressure, and rectal sensitivity to balloon insufflation (volume) were not statistically different before, during, or after any treatment modality (p = 0.46, 0.60, 0.33). The size and grade of hemorrhoids on entry into the study had no bearing on the outcome. In a prospective crossover trial, no difference could be found between standard medical therapy and direct current electrotherapy in the treatment of symptomatic-hemorrhoidal disease.

Administration, Topical↗

Tocolytic therapy in conservative management of symptomatic placenta previa.

OBJECTIVES: To study the effect of ritodrine therapy on maternal and perinatal outcome in cases of symptomatic placenta previa being managed conservatively. METHODS: A prospective, randomized controlled clinical trial was made of a total of 60 women whose pregnancies ranged from 28 through 34 menstrual weeks who were randomly allocated to the two study groups using Tippet's random number table. Of these women, 30 were included in the study group where tocolysis with ritodrine was given whereas the other 30 in the control group did not receive tocolysis. Prolongation of pregnancy and birth weight of the newborn were evaluated. The unpaired t-test and chi-square test were used for statistical analysis. RESULTS: Use of tocolysis in symptomatic placenta previa was associated with significant prolongation of pregnancy (25.33 vs. 14.47 days, P<0.05) and difference in birth weight (2270 g vs. 1950 g, P<0.05). There was no observed statistical difference between the two groups with regard to number of episodes of hemorrhage after admission, total amount of blood loss during stay in hospital, number of blood transfusions and maternal complications due to tocolysis in the study group. CONCLUSIONS: The present prospective study suggests that ritodrine hydrochloride in patients with symptomatic placenta previa tends to prolong the pregnancy and result in an increase in birth weight of the babies without causing any adverse effect on the mother and fetus.

Adult↗