Significant Difference In Treatment Effect Research Articles

Immediate angioplasty after thrombolysis: a systematic review

The role of immediate transfer for percutaneous coronary intervention (PCI) after thrombolysis for ST-segment elevation myocardial infarction remains controversial. We performed a systematic review of the related literature to determine whether thrombolysis followed by transfer for immediate or early PCI is safe, feasible and superior to conservative management. A systematic literature search of MEDLINE, EMBASE, the Cochrane Database for Systematic Reviews and Cochrane Central Register of Controlled Trials, and the American Heart Association EndNote 7 Master Library databases, was performed to 2004 for relevant published studies. The level of evidence and the quality of the study design and methods were rated by 2 reviewers according to a standardized classification. A quantitative meta-analysis was performed to assess the effect at 6-12 months on mortality of immediate or early PCI after thrombolysis. We found 13 articles that were supportive of immediate or early PCI after thrombolysis and 16 that were neutral or provided evidence opposing it. The largest randomized trials and meta-analyses showed no benefit of routine PCI immediately or shortly after thrombolysis. The studies that were supportive were generally more recent and more frequently involved coronary stents. One large trial supported early PCI after thrombolysis for patients with myocardial infarction complicated by cardiogenic shock. Overall, the difference in mortality rates between the invasive strategy and conservative care was nonsignificant. The 3 stent-era trials showed a significantly lower mortality among patients randomly assigned to the invasive strategy (5.8% v. 10.0%, odds ratio 0.55, 95% confidence interval 0.32-0.92). Analysis of variance found a significant difference in treatment effect between stent-era and pre-stent-era trials. At present, there is inadequate evidence to recommend routine transfer of patients for immediate or early PCI after successful thrombolysis. Results of recent trials using contemporary PCI techniques, including coronary stents, appear more favourable but need to be confirmed in large randomized trials, which are currently in progress. Transfer for immediate PCI is recommended for patients with cardiogenic shock, hemodynamic instability or persistent ischemic symptoms after thrombolysis.

The Effects of CAD-Like Software on the Spatial Ability of Middle School Students

This study investigated whether the software Virtus WalkThrough Pro could be used to enhance middle school children's spatial ability as measured by the Paper Folding, Mental Rotations, and Eliot-Price Tests. The study also investigated whether the use of this software impacted males differently than females, or users with high spatial ability differently than those with low. A pretest-posttest control group quasi-experimental design was utilized. The sample group consisted of 116 students, 55 in the experimental group and 61 in the control group. Both groups were given the three measures as pretests and posttests. The investigator worked with the experimental group for 50 minutes a week for 11 weeks. Analysis of covariance determined that there were no significant gains on any measures. No significant differential treatment effects were found with respect to gender or spatial ability levels. However, males significantly outperformed females on the Eliot-Price Test.

Assessing the Effectiveness of Community-Based Substance Abuse Treatment for Adolescents

The Adolescent Treatment Models initiative, a 10-site, multimodality, prospective study, was designed to evaluate adolescent substance abuse treatment outcomes and to assess the relative efficacy of different treatment models. Based upon longitudinal data gathered at multiple assessment points using a standardized instrument, treatment outcome trajectories were determined for a cohort of 1,057 adolescents from entry into substance abuse treatment until 12 months post-intake. Client outcomes on substance use and program effectiveness were explored across individual treatment programs and levels of care. Strong treatment effects, defined as a significant reduction in alcohol and other drug use at three months post-intake, were found. The reductions of greatest magnitude in relation to pretreatment use occurred among adolescents in residential treatment. Within level of care, few significant differences in treatment effects were found between programs. Relapse effects, defined as an increase in substance use at 12 months relative to three months, were observed across nearly all programs, but varied in relation to treatment modality. This is most evident among those entering residential treatment, with the highest rate of relapse occurring among adolescents in longterm residential treatment care. Despite strong evidence of treatment effectiveness, continuing care is vital to maintenance of treatment benefit.

Interleukin 2 receptor antagonists for kidney transplant recipients.

Interleukin 2 receptor antagonists (IL2Ra) are used as induction therapy for prophylaxis against acute rejection in kidney transplant recipients. Use of IL2Ra has increased steadily, with 38% of new kidney transplant recipients in the United States, and 23% in Australasia receiving IL2Ra in 2002. This study aims to systematically identify and summarise the effects of using an IL2Ra, as an addition to standard therapy, or as an alternative to other antibody therapy. The Cochrane Renal Group's specialised register (June 2003), the Cochrane Controlled Trials Register (in The Cochrane Library issue 3, 2002), MEDLINE (1966-November 2002) and EMBASE (1980-November 2002). Reference lists and abstracts of conference proceedings and scientific meetings were hand-searched from 1998-2003. Trial groups, authors of included reports and drug manufacturers were contacted. Randomised controlled trials (RCTs) in all languages comparing IL2Ra to placebo, no treatment, other IL2Ra or other antibody therapy. Data was extracted and quality assessed independently by two reviewers, with differences resolved by discussion. Dichotomous outcomes are reported as relative risk (RR) with 95% confidence intervals (CI). One hundred and seventeen reports from 38 trials involving 4893 participants were included. Where IL2Ra were compared with placebo (17 trials; 2786 patients), graft loss was not significantly different at one (RR 0.83, 95% CI 0.66 to 1.04) or three years (RR 0.88, 95% CI 0.64 to 1.22). Acute rejection (AR) was significantly reduced at six months (RR 0.66, 95% CI 0.59 to 0.74) and at one year (RR 0.67, 95% CI 0.60 to 0.75). At one year, cytomegalovirus (CMV) infection (RR 0.82, 95% CI 0.65 to 1.03) and malignancy (RR 0.67, 95% CI 0.33 to 1.36) were not significantly different. Where IL2Ra were compared with other antibody therapy no significant differences in treatment effects were demonstrated, but adverse effects strongly favoured IL2Ra. Given a 40% risk of rejection, seven patients would need treatment with IL2Ra to prevent one patient having rejection, with no definite improvement in graft or patient survival. There is no apparent difference between basiliximab and daclizumab. IL2Ra are as effective as other antibody therapies and with significantly fewer side effects

Kava extract for treating anxiety.

Constraints on resources and time often render treatments for anxiety such as psychological interventions impracticable, while synthetic anxiolytic drugs are effective, but are often burdened with adverse events. Options which are effective and safe would be of considerable interest and a welcome addition to the therapeutic repertoire. To assess the effectiveness and safety as reported in rigorous clinical trials of kava extract compared with placebo for treating anxiety. All publications describing (or which might describe) randomised, double-blind, placebo-controlled trials of kava extract for anxiety were sought through electronic searches on EMBASE, MEDLINE, AMED (British Library), CISCOM (Research Council for Complementary Medicine, London), Central/CCTR and CCDANCTR. The search terms that were used were kava, kawa, kavain, Piper methysticum and Rauschpfeffer (German common name for Piper methysticum). Additionally, manufacturers of kava preparations and experts on the subject were contacted and asked to contribute published and unpublished material. Hand-searches of relevant medical journals (Erfahrungsheilkunde 1996 - 2002, Forsch Komplementärmed Klass Naturheilkd 1994 - 2002, Phytomed 1994 - 2002, Alt Comp Ther 1995 - 2002), conference proceedings (e.g. FACT - Focus on Alternative and Complementary Therapies 1996 - 2002) and our own files were conducted. The searches were updated to August 2002. No restrictions regarding the language of publication were imposed. To be included studies were required to be randomised, controlled trials (RCTs), i.e. trials with a randomised generation of allocation sequences, and conducted placebo-controlled and double-blind, i.e. trials with blinding of patients and care providers. Trials using oral preparations containing kava extract as the only component (mono-preparation) were considered. Trials using single constituents of kava extract alone, assessing kava extract as one of several active components in a combination preparation or as a part of a combination therapy were excluded. Data were extracted systematically according to patient characteristics, interventions and results. Methodological quality of all trials was evaluated using the standard scoring system developed by Jadad and colleagues. The screening of studies, selection, data extraction, validation and the assessment of methodological quality were performed independently by the two reviewers. Disagreements in the evaluation of individual trials were resolved through discussion. Eleven trials with a total of 645 participants met the inclusion criteria. The meta-analysis of six studies using the total score on the Hamilton Anxiety scale as a common outcome measure suggests a significant reduction in patients receiving kava extract compared with patients receiving placebo (weighted mean difference: 5.0, 95% confidence interval: 1.1 to 8.8; p = 0.01; n = 345). Adverse events as reported in the reviewed trials were mild, transient and infrequent. Compared with placebo, kava extract appears to be an effective symptomatic treatment option for anxiety. The data available from the reviewed studies suggest that kava is relatively safe for short-term treatment (1 to 24 weeks), although more information is required. Further rigorous investigations, particularly into the long-term safety profile of kava are warranted.

Effect of tenoxicam on fracture healing in rat tibiae

Background: Nonsteroidal anti-inflammatory drugs have been implicated in the development of delayed unions and nonunion after fractures in animal models. Previous investigations have identified two important factors as determinants of delayed fracture healing: early drug administration and a dose-dependent effect. Objective: The purpose of this investigation was to study the effect of tenoxicam, a nonsteroidal anti-inflammatory drug, on the fracture healing process in rat tibiae. Methods: Fifty-eight Wistar rats were randomly divided in four groups (I, II, III, and IV). Group I (control group, n=12) was given 0.1 ml saline solution per day intramuscularly. Groups II ( n=12), III ( n=12), and IV ( n=12) were administered 10 mg per kg per day of tenoxicam intramuscularly. Administration of substances was begun on a week before to 48 h after the fracturing procedure and continued during the entire experiment. Callus formation was studied histologically and histomorphologically, using light microscopy. In addition, a histologic grading based on the morphologic stage of fracture healing was carried out at 4 weeks, according to the criteria proposed by Allen et al. Results: There was a significant difference in treatment effect between Group I (saline solution) and Groups II, III, and IV (tenoxicam) ( P=0.07). Histologically and histomorphologically, there were qualitative and quantitative delay in callus formation at all tenoxicam groups. This was more pronounced the earlier the nonsteroidal anti-inflammatory drug was started, although no significant difference could be detected between Groups II, III, and IV ( P>( α=10%)). Four weeks after fracture, Group I ( n=3) showed complete osseous union, Groups II ( n=3) and III ( n=3), complete cartilaginous union, and Group IV ( n=3), incomplete osseous union, according to Allen et al. By using this rating scale, the difference between control and drug-treated groups was statistically significant ( P<0.1). Conclusion: Under studied conditions, this investigation shows that administration of tenoxicam intramuscularly delays fracture healing process in rat tibiae. These results suggest the hypothesis that early drug administration may delay bone healing after experimental fractures in animals, although it could not be detected statistically significant.

Intravesical Bacillus Calmette-Guerin Reduces the Risk of Progression in Patients with Superficial Bladder Cancer: A Meta-analysis of the Published Results of Randomized Clinical Trials

We determine if intravesical bacillus Calmette-Guerin (BCG) reduces the risk of progression after transurethral resection to stage T2 disease or higher in patients with superficial (stage Ta, T1 or carcinoma in situ) bladder cancer. A meta-analysis was performed of the published results of randomized clinical trials comparing transurethral resection plus intravesical BCG to either resection alone or resection plus another treatment other than BCG. We identified 24 trials with progression information on 4,863 patients. Based on a median followup of 2.5 years and a maximum of 15 years, 260 of 2,658 patients on BCG (9.8%) had progression compared to 304 of 2,205 patients in the control groups (13.8%), a reduction of 27% in the odds of progression on BCG (OR 0.73, p = 0.001). The percent of patients with progression was low (6.4% of 2,880 patients with papillary tumors and 13.9% of 403 patients with carcinoma in situ, reflecting the short followup and relatively low risk patients entered in many of the trials. The size of the treatment effect was similar in patients with papillary tumors and in those with carcinoma in situ. However, only patients receiving maintenance BCG benefited. There was no statistically significant difference in treatment effect for either overall survival or death due to bladder cancer. Intravesical BCG significantly reduces the risk of progression after transurethral resection in patients with superficial bladder cancer who receive maintenance treatment. Thus, it is the agent of choice for patients with intermediate and high risk papillary tumors and those with carcinoma in situ.

Randomized Trial of Procarbazine, Lomustine, and Vincristine in the Adjuvant Treatment of High-Grade Astrocytoma: A Medical Research Council Trial

Meta-analyses of the published literature suggest a survival benefit to adjuvant chemotherapy for high-grade astrocytoma, which individual small trials have been unable to demonstrate reliably. The Medical Research Council Brain Tumour Working Party initiated the largest randomized trial of adjuvant chemotherapy for glioma in an attempt to provide a definitive answer. After surgery, patients aged < or = 70 years, with World Health Organization grade 3 or 4 astrocytoma, were randomized to radiotherapy alone (RT) or RT plus procarbazine, lomustine, and vincristine (PCV) chemotherapy (RT-PCV) given at 6-week intervals to a maximum of 12 courses (procarbazine 100 mg/m2 days 1 to 10, lomustine 100 mg/m2 day 1, and vincristine 1.5 mg/m2 (max 2 mg) day 1). A neuropathology panel independently reviewed all cases. To reliably detect a 10% increase in 2-year survival (from 15% to 25%), 600 patients were required. Between September 1988 and May 1997, 15 United Kingdom centers randomized 674 patients (RT = 339 patients; RT-PCV = 335 patients). With a median follow-up for survivors of 3 years, 617 patients have died, (RT = 310 patients; RT-PCV = 307 patients). Median survival was 9.5 months for RT and 10 months for RT-PCV (hazard ratio = 0.95; 95% confidence interval, 0.81 to 1.11; log-rank P = .50). Tests for interaction revealed no significant differences in treatment effect according to tumor grade, age, performance status, or extent of neurosurgery. This trial shows no benefit to PCV chemotherapy, and current data exclude an increase in median survival of more than 10 weeks and in a 1- or 2-year survival rate of more than 7% to 8%. This suggests that no-chemotherapy control arms remain ethical in randomized trials in high-grade astrocytoma.

The effect of brimonidine tartrate on retinal blood flow in patients with ocular hypertension

PURPOSE: To study the effects of topical brimonidine tartrate 0.2%, an α 2-agonist ocular hypotensive drug, on retinal capillary blood flow in patients with ocular hypertension. METHODS: The study was a double-masked, randomized, placebo-controlled trial set in a tertiary eye center. Ocular hypertensive patients with repeatable intraocular pressures greater than 21 mm Hg and normal visual fields and optic disks were consecutively recruited. After an eye examination, baseline retinal blood flow measurements were made with confocal scanning laser Doppler flowmetry in one study eye. Patients were then randomly assigned to receive either brimonidine or placebo (saline) twice daily for 8 weeks. Blood flow and intraocular pressure measurements were then repeated after 4 and 8 weeks. RESULTS: Seventeen patients were randomly assigned to receive brimonidine, and 14 received placebo. One patient in each group failed to complete the study. The mean group differences in baseline age and intraocular pressure were not statistically significant (59.23 [±10.24] and 52.23 [±16.46] years, respectively, and 24.84 [±2.08] and 24.56 [±2.85] mm Hg, respectively). Brimonidine reduced intraocular pressure by 17.90% and 16.17% at 4 and 8 weeks, respectively, with a significant difference in treatment effect compared with the placebo group ( P < .007). The group difference in treatment effect in any of the three hemodynamic parameters velocity, volume, and flow was within 8% and not significantly different at 4 or 8 weeks ( P > .360). Based on a type I error of 0.05, our study had a power greater than or equal to 75% to detect group differences in treatment effect of greater than or equal to 15% to 20%. CONCLUSIONS: Brimonidine reduces intraocular pressure without altering retinal capillary blood flow in patients with ocular hypertension.

Intracoronary-administered urapidil does not influence myocardial contractility, metabolic activity, or coronary sinus blood flow in humans

Objective: To compare the acute effect of intracoronary administration of urapidil and saline on myocardial contractility and metabolic activity. Design: Prospective, controlled, open-label study. Setting: University teaching hospital. Participants and Interventions: Eight patients with stable coronary artery disease (CAD) undergoing elective percutaneous transluminal coronary angioplasty (PTCA) received normal saline followed by urapidil, 4 mg, injected directly into the left main coronary artery. Measurements and Main Results: Because local intracoronary administration is a non-steady-state condition, an in vitro model was used before the clinical experiments to establish the kinetic effects of acute administration of urapidil. The clinical experiments were performed in eight patients with CAD after PTCA. Measurements included a complete hemodynamic profile, coronary sinus blood flow (continuous thermodilution), left ventricular (LV) peak (+) dP/dt, LV peak (−) dP/dt, LV dP/dt/P D40, and LV end-diastolic pressures. Arterial and coronary venous blood samples were also obtained for the calculation of myocardial oxygen consumption. Baseline measurements I were first obtained, followed by intracoronary injection of 2 mL of saline. Additional measurements were obtained 1, 5, and 10 minutes after administration of saline. After a resting period (15 minutes), baseline measurements II, and intracoronary injection of urapidil, 4 mg (dissolved in 2 mL saline), additional measurements were obtained 1, 5, and 10 minutes later. Heart rate decreased 2.7 ± 3.5 beats/min after injection of saline, whereas heart rate increased 2.0 ± 1.8 beats/min after intracoronary urapidil, resulting in a significant difference in treatment effect ( p = 0.003). There were no additional differences in treatment effect for any of the other measured or calculated parameters reflecting systemic hemodynamics, LV contractility, coronary dynamics, and myocardial metabolic activity. Conclusion: The results suggest that intracoronary bolus administration of preservative-free urapidil, 4 mg, is not associated with any detectable effect on myocardial contractility or coronary smooth muscle in awake nonsurgical patients with CAD, after PTCA.

Intraocular pressure and progression of glaucomatous visual field loss

PURPOSE: To study the effects of topical brimonidine tartrate 0.2%, an α 2-agonist ocular hypotensive drug, on retinal capillary blood flow in patients with ocular hypertension. METHODS: The study was a double-masked, randomized, placebo-controlled trial set in a tertiary eye center. Ocular hypertensive patients with repeatable intraocular pressures greater than 21 mm Hg and normal visual fields and optic disks were consecutively recruited. After an eye examination, baseline retinal blood flow measurements were made with confocal scanning laser Doppler flowmetry in one study eye. Patients were then randomly assigned to receive either brimonidine or placebo (saline) twice daily for 8 weeks. Blood flow and intraocular pressure measurements were then repeated after 4 and 8 weeks. RESULTS: Seventeen patients were randomly assigned to receive brimonidine, and 14 received placebo. One patient in each group failed to complete the study. The mean group differences in baseline age and intraocular pressure were not statistically significant (59.23 [±10.24] and 52.23 [±16.46] years, respectively, and 24.84 [±2.08] and 24.56 [±2.85] mm Hg, respectively). Brimonidine reduced intraocular pressure by 17.90% and 16.17% at 4 and 8 weeks, respectively, with a significant difference in treatment effect compared with the placebo group ( P < .007). The group difference in treatment effect in any of the three hemodynamic parameters velocity, volume, and flow was within 8% and not significantly different at 4 or 8 weeks ( P > .360). Based on a type I error of 0.05, our study had a power greater than or equal to 75% to detect group differences in treatment effect of greater than or equal to 15% to 20%. CONCLUSIONS: Brimonidine reduces intraocular pressure without altering retinal capillary blood flow in patients with ocular hypertension.

Treatment of menstruation-associated migraine with the nonprescription combination of acetaminophen, aspirin, and caffeine: Results from three randomized, placebo-controlled studies

This retrospective study sought to examine the benefits of the nonprescription combination of acetaminophen, aspirin, and caffeine (AAC; Excedrin® Migraine, Bristol-Myers Squibb Company, New York, New York) for the treatment of menstruation-associated migraine compared with migraine not associated with menses. Data were derived from 3 double-masked, randomized, placebo-controlled, singledose trials enrolling subjects who met the International Headache Society's diagnostic criteria for migraine with or without aura. Subjects with incapacitating disability (attacks requiring bed rest >50% of the time) and those who usually experienced vomiting >20% of the time were excluded. Retrospective analysis of the 1220 subjects included in the efficacyevaluable data set indicated that 185 women treated menstruation-associated migraine, 781 women treated migraine not associated with menses, and 1 woman provided no information regarding menstrual status. At baseline and at 0.5, 1, 2, 3, 4, and 6 hours postdose, subjects assessed the intensity of headache pain, functional disability, nausea, photophobia, and phonophobia. Pain intensity, nausea, photophobia, and phonophobia were rated on a 4-point scale ranging from 0 = none to 3 = severe; functional disability was rated on a 5-point scale ranging from 0 = none to 4 = incapacitating. For both menstruation-associated migraine and migraine not associated with menses, the proportion of subjects with pain intensity reduced to mild or none (responders) was significantly greater with AAC than with placebo at all postdose time points from 0.5 through 6 hours ( P ≤ 0.05), with no statistically significant difference in treatment effect between menstruation-associated migraine and migraine not associated with menses at any postdose time point. Migraine characteristics such as photophobia, phonophobia, and functional disability were significantly improved in AACtreated subjects at all time points from 1 through 6 hours ( P ≤ 0.01) in both the menstruating and nonmenstruating groups. Significant relief from nausea was experienced in both menstruation-associated migraine and migraine not associated with menses, but relief appeared earlier in the AAC nonmenstruating subjects (2 hours postdose, P ≤ 0.01) than in the menstruating subjects (6 hours postdose, P ≤ 0.05). Beginning at 3 hours postdose, significantly fewer subjects treated with AAC required rescue medication ( P ≤ 0.05) for menstruationassociated migraine (AAC 6%, placebo 15%) and migraine not associated with menses (AAC 7%, placebo 14%). The most commonly used rescue medications in both the menstruating and nonmenstruating groups were nonsteroidal anti-inflammatory drugs, prescription combination analgesics/narcotics, and prescription migraine preparations. AAC was well tolerated in both menstruation-associated migraine and migraine not associated with menses; in general, adverse experiences were similar in both groups. The proportion of subjects who had 1 or more adverse experiences was significantly higher among those receiving AAC than among those receiving placebo (menstruation-associated migraine: AAC 26.4%, placebo 12.6%, P = 0.025; nonmenstruation-associated migraine: AAC 18.6%, placebo 11.4%, P = 0.005). Adverse experiences were similar in type and severity to those previously associated with single doses of acetaminophen, aspirin, or caffeine. Thus the nonprescription combination of AAC was highly effective in treating the pain, disability, and associated symptoms of both menstruation-associated migraine and migraine not associated with menses.

Effectiveness of antibiotic prophylaxis in critically ill adult patients: systematic review of randomised controlled trials

Objective: To determine whether antibiotic prophylaxis reduces respiratory tract infections and overall mortality in unselected critically ill adult patients.Design: Meta-analysis of randomised controlled trials from 1984 and 1996 that compared...

Effect of antihypertensive drug treatment on cardiovascular outcomes in women and men. A meta-analysis of individual patient data from randomized, controlled trials. The INDANA Investigators.

Trials of drug therapy for hypertension have shown that such therapy has a clear overall benefit in preventing cardiovascular disease. Although these trials have included slightly more women than men, it is still not clear whether treatment benefit is similar for both sexes. To quantify the average treatment effect in both sexes and to determine whether available data show significant differences in treatment effect between women and men. Subgroup meta-analysis of individual patient data according to sex. Analysis was based on seven trials from the INDANA (INdividual Data ANalysis of Antihypertensive intervention trials) database and was adjusted for possible confounders. 20,802 women and 19,975 men recruited between 1972 and 1990. Primarily beta-blockers and thiazide diuretics. In women, treatment effect was statistically significant for stroke (fatal strokes and all strokes) and for major cardiovascular events. In men, it was statistically significant for all categories of events (total and specific mortality, all coronary events, all strokes, and major cardiovascular events). The odds ratios for any category of event did not differ significantly between men and women. In absolute terms, the benefit in women was seen primarily for strokes; in men, treatment prevented as many coronary events as strokes. Graphical analyses suggest that these results could be completely explained by the difference in untreated risk. In terms of relative risk, treatment benefit did not differ between women and men. The absolute risk reduction attributable to treatment seemed to depend on untreated risk. These findings underline the need to predict accurately the untreated cardiovascular risk of an individual person in order to rationalize and individualize antihypertensive treatment.

The efficacy of tolrestat in the treatment of diabetic peripheral neuropathy. A meta-analysis of individual patient data.

The aim of this meta-analysis was to review the existent evidence on the effectiveness of tolrestat in the treatment of diabetic peripheral neuropathy. Individual patient data on 738 subjects from the three randomized clinical trials published on this topic were analyzed using changes in motor nerve conduction velocities (NCVs) as endpoints. Nerves investigated included median, ulnar, tibial, and peroneal. The pooled analysis of NCV taken as a continuous measurement showed a significant treatment effect, the magnitude of this benefit being approximately equal to 1 m/s for all the nerves investigated. When looking at the proportion of patients experiencing a loss of NCV of at least 1 or 2 m/s in at least two out of the four nerves investigated, it emerged that treatment reduced by > 40% the risk of such outcomes after adjusting for patients' characteristics. The odds ratios relative to the placebo group were 1.82 (1.30-2.52) and 1.70 (1.15-2.48) for a decrease of 1 and 2 m/s, that is, placebo-treated patients have an 82 and 70% increased risk for a loss of nerve function of 1 and 2 m/s, respectively. No statistically significant difference in treatment effect emerged after stratification according to baseline motor NCV and glycated hemoglobin levels. After a treatment duration ranging between 24-52 weeks, patients treated with tolrestat had a reduced risk for developing nerve function loss compared with placebo-treated patients. Future long-term trials are needed to evaluate the impact of the treatment on more clinically meaningful endpoints such as the development of foot complications.

Single-dose Azithromycin in the Treatment of Trachoma: A Randomized, Controlled Study

Purpose: To compare the safety and efficacy of single oral-dose azithromycin with a 7-week topical tetracycline ointment course in the treatment of active trachoma.Methods: A total of 64 patients with active trachoma were selected randomly to receive azithromycin (20 mg/kg) in a single dose or topical tetracycline eye ointment for 6 weeks. Clinical assessments were made before and at 4, 8, 12, and 24 weeks after treatment. Conjunctival scrapings were obtained before and after 24 weeks after treatment and fixed for Giemsa and direct immunofluorescence staining.Results: Trachoma resolved in 17 (63.3%) patients who received azithromycin compared with 19 (65.4%) who were treated with tetracycline ointment. There were no significant differences in treatment effect or baseline characteristics between the treatment groups. Both treatments were well tolerated, and no adverse events were noted.Conclusion: Single-dose azithromycin is as effective as a 6-week course of topical tetracycline ointment in the treatment of active trachoma. The findings may help establish high compliance in treating trachoma and could contribute to the control of trachoma worldwide.

The Comparative Efficacy of Christian and Secular Rational-Emotive Therapy with Christian Clients

The present study utilized a comparative psychotherapy outcome design to evaluate the relative therapeutic efficacy of Christian and secular RET with depressed Christian clients. Results showed both treatments significantly reduced depression, automatic negative thinking, irrational thinking, and general pathology. These gains were maintained after three months. There were no significant differential treatment effects. Results are discussed in terms of the implications for accommodation theory.

Dihydroergotamine nasal spray for the acute treatment of migraine

We conducted a multicenter, double-blind, parallel-group study to compare the efficacy and safety of dihydroergotamine (DHE) nasal spray and placebo over 4 hours in the treatment of migraine. Of the 112 patients enrolled, 100 were included in the "intent-to-treat" efficacy analysis. The patients self-administered either 2.0 mg DHE (0.5 mg per nostril, repeated after 15 minutes) or placebo at the onset of two separate headaches and rated hourly the drugs' effects on pain severity, pain relief, nausea, and vomiting. The physicians assessed the overall effectiveness of the drugs in relieving headache pain, nausea, and vomiting. Both the patients' and physicians' ratings indicated that DHE was significantly superior to placebo in improving headache and nausea; according to the patients' ratings, these between-group differences were already significant at the first (hour 1) evaluation. There were no significant differential treatment effects with respect to relief of vomiting. Most adverse events were mild or moderate, confined to the nasopharyngeal area, and probably related to the route of administration. We conclude that DHE nasal spray is a safe and effective treatment for the pain and nausea of migraine attacks.

Randomised controlled trial of single-dose azithromycin in treatment of trachoma

Blindness due to trachoma is a serious public health issue world wide. The currently recommended treatment of active trachoma with repeated doses of tetracycline eye ointment has many disadvantages. The new azalide antibiotic azithromycin is effective as a single oral dose in the chemotherapy of genital Chlamydia trachomatis infections, and we have assessed its efficacy for trachoma treatment. We carried out a randomised single-blind comparison of azithromycin (a single oral dose of 20 mg/kg) with conventional treatment (6 weeks of topical tetracycline plus erythromycin for severe cases) in two villages with endemic trachoma in The Gambia. The patients were followed up for 26 weeks from the start of treatment by an observer unaware of treatment allocation. By 6 months' follow-up, trachoma had resolved in 76 (78%) of 97 subjects who received azithromycin compared with 70 (72%) of 97 who were treated conventionally (95% Cl for difference - 6% to 18%). Compliance with both treatments was good, but that for conventional treatment could probably not be achieved outside the research setting. There were no significant differences in treatment effect, baseline characteristics, or re-emergent disease between the treatment groups. Azithromycin was well tolerated. As a systemic treatment effective in a single dose it has important potential for trachoma control.

Ice and High Voltage Pulsed Stimulation in Treatment of Acute Lateral Ankle Sprains

* The views expressed in this article are those of the authors and do not reflect the official policy or position of the U.S. Public Health Service. The purpose of this investigation was to compare ice versus ice and high voltage pulsed stimulation (HVPS) for the treatment of ankle sprains. Thirty young adult subjects with grade I or II lateral ankle sprains were included in this study. Subjects received treatment within 30 hours following injury and were treated once daily for three days. Group I (N = 10) received ice for 30 minutes; group II (N = 10) received combination ice and HVPS (28 pps, negative polarity, current to comfort without contraction) for 30 minutes, and group III (N = 10) received ice and HVPS (80 pps, negative polarity, 30 minutes). All groups showed a tendency toward a decrease in pain, decrease in edema, and increase in ankle dorsiflexion following treatment. ANOVA for edema and dorsiflexion changes revealed that there were no significant differences in treatment effects among groups. HVPS, as utilized, did not further affect pain, edema, or range of dorsiflexion in the treatment of acute lateral ankle sprains.J Orthop Sports Phys Ther 1988;9(9):301-304.