Gabapentin, estrogen, and placebo for treating hot flushes: a randomized controlled trial.

OBJECTIVE: To compare the efficacy of gabapentin, estrogen, and placebo in the treatment of hot flushes. METHODS: We performed a randomized, double-blind, placebo-controlled trial of 60 postmenopausal women to assess the efficacy of estrogen and gabapentin in the treatment of moderate-to-severe hot flushes. Participants were randomly assigned to receive either 0.625 mg/d of conjugated estrogens (n = 20), placebo (n = 20), or gabapentin titrated to 2,400 mg/d (n = 20) for 12 weeks. Participants recorded frequency and severity of baseline hot flushes on a hot flush diary for 2 weeks before randomization and for 12 weeks after randomization. The primary outcome measure was the weekly hot flush composite score, which takes into account both severity and frequency of hot flushes. Secondary outcome measures were differences in pre- and posttreatment scores pertaining to depression (Zung Depression Scale) and other climacteric symptoms (Greene Climacteric Scale). RESULTS: Intention-to-treat analysis showed that the reduction in the hot flush composite score for both estrogen (72%, P = .016) and gabapentin (71%, P = .004) was greater than the reduction associated with placebo (54%) at the conclusion of the 12th week. The extent of reduction in hot flush composite score, however, was not significantly different between estrogen and gabapentin (P = .63). No differences were seen between groups in the Zung Depression Scale, or in any of the Greene Climacteric subscales except for the Somatic Symptom cluster, which was significantly greater in the gabapentin arm than in the placebo arm. Despite a lack of group differences in adverse events, the Headache, Dizziness, and Disorientation cluster appeared with greater frequency in the gabapentin group. Estimation of the number needed to harm in this cluster suggests that these symptoms may occur with every fourth patient treated with gabapentin. CONCLUSION: Despite the small scale of this study, gabapentin appears to be as effective as estrogen in the treatment of postmenopausal hot flushes. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, NCT 00276081. LEVEL OF EVIDENCE: I.

A randomized trial comparing long-term and short-term use of umbilical venous catheters in premature infants with birth weights of less than 1251 grams.

BACKGROUND: Umbilical vein and percutaneous central venous catheters are often used in preterm infants, but they can lead to complications, including infection. OBJECTIVE: We hypothesized that long-term umbilical vein catheter use would result in fewer infections than short-term umbilical vein catheter use followed by percutaneous central venous catheter placement. DESIGN/METHODS: Infants < or = 1250 g with umbilical vein catheters placed at admission were randomly assigned to a long-term (umbilical vein catheter up to 28 days) or short-term (umbilical vein catheter for 7-10 days followed by percutaneous central venous catheter) group. Catheter infection was defined as symptoms and > or = 1 positive blood culture for definite pathogens or >1 positive culture for other organisms, with a catheter in place. Clinically significant echocardiogram findings were defined as thrombi threatening vascular occlusion, crossing/blocking heart valves, or otherwise felt to be significant by the cardiologist. The primary outcome was time from birth to catheter infection, analyzed by the log-rank test. RESULTS: There were 106 subjects in the short-term group and 104 in the long-term group with birth weights of 915 +/- 198 and 931 +/- 193 g and gestational ages of 27.8 +/- 2.0 and 27.7 +/- 2.2 weeks, respectively. The distribution of time to catheter infection did not differ between the groups. The overall incidence of catheter infection was 13% in the short-term group and 20% in the long-term group. Median age at catheter infection was 11.5 days in the short-term group and 14 days in the long-term group. There were 7.4 infections per 1000 catheter-days in the short-term group and 11.5 per 1000 in the long-term group. Seven infections in the short-term group were in umbilical vein catheters, and 18 infections in the long-term group were in umbilical vein catheter. Echocardiograms detected 4 infants in the short-term group and 7 infants in the long-term group with significant thrombosis. All significant thrombi were at the site of the umbilical vein catheter tip. No thrombus caused hemodynamic compromise, no child had clinical symptoms of thrombosis, and none required therapy. Of the 45 small-for-gestational-age infants in the study, 9 developed thrombi (short-term group, 4; long-term group, 5). The incidence of thrombi was higher in the small-for-gestational-age group (20%) versus other study subjects (9%). There were no differences in time to full feedings or to regain birth weight or in the incidence of necrotizing enterocolitis or death. CONCLUSIONS: Infection and complication rates were similar between infants managed with an umbilical vein catheter in place for up to 28 days compared with infants managed with an umbilical vein catheter replaced by a percutaneous central venous catheter after 7 to 10 days. Umbilical vein catheter durations beyond the current Centers for Disease Control and Prevention-recommended limit of 14 days may be reasonable.

Randomized prospective study comparing routine versus selective use of sonography of the complete calf in patients with suspected deep venous thrombosis.

OBJECTIVE: We compared patient outcomes using two protocols: one routinely and the other selectively evaluating the calves completely during sonographic assessment of the lower extremities in patients with suspected deep venous thrombosis. SUBJECTS AND METHODS: In this randomized prospective study, patients were assigned to two groups. In one group, the deep calf veins were routinely evaluated in their entirety, and in the other group the calf was not evaluated unless the patient had symptoms or physical signs in the calf, in which case only the areas of symptoms or physical signs were evaluated. Patients were followed up for 3 months by medical record review, physician surveys, and telephone calls. An adverse outcome was a propagated deep venous thrombosis into the thigh or a pulmonary embolus. Examination times were recorded when possible. RESULTS: Of the 235 patients in the group in which the deep calf veins were routinely evaluated, we saw no adverse outcomes (0.0%; 97.5% one-sided confidence interval [CI], 0.6-1.6%). Of the 261 patients in the group in which the calf was only evaluated if there were signs or symptoms, we saw two adverse outcomes (0.8%; 95% CI, 0.1-2.7%). CONCLUSION: We found no significant difference in adverse outcomes in patients undergoing a protocol in which the deep calf veins were routinely evaluated or a protocol in which the calf was evaluated only if physical signs or symptoms were present.

CT in detecting urinary tract calculi: influence on patient imaging and clinical outcomes.

PURPOSE: To determine changes in examination patterns and effectiveness of care since the introduction of unenhanced helical computed tomography (CT) for examination of patients presenting to the emergency department (ED) with symptoms of urinary tract calculi (UTC). MATERIALS AND METHODS: Hospital clinical and radiology information systems were used to retrospectively identify patients presenting with UTC symptoms from January to December 1997 (before introduction of unenhanced CT) and from January to December 1999 (after introduction of unenhanced CT). Chart abstraction was used to confirm the identification of patients with presenting symptoms suggestive of UTC and assess patient outcomes. Two hundred sixty-five patients presented before (1997) and 602 after (1999) unenhanced CT was introduced. Distributions of dichotomous variables were compared between the 1997 and 1999 groups by using logistic regression. Means were compared between the groups by using analysis of variance and mean total numbers of imaging studies by using Poisson regression. RESULTS: Total number of imaging studies increased by 26.7% per patient visit (P <.001). Rates of admission following the initial ED visit (13.7% in 1997 vs 13.4% in 1999), as well as percentage of patients who subsequently returned to the ED (12.0% in 1997 vs 13.7% in 1999) or subsequently were admitted to the hospital (4.5% in 1997 vs 5.3% in 1999) in the month following the initial ED visit, were similar between the two groups. Unsuspected unenhanced CT findings that could affect acute patient care were observed at 5.9% of examinations. CONCLUSION: Use of imaging for suspected UTC has increased markedly since the introduction of unenhanced CT, with little effect on acute care of patients in the ED.