Bioequivalence of a combination of levothyroxine and iodine in comparison with levothyroxine only. A controlled double-blind study of bioavailability]

RATIONALE AND OBJECTIVES: The authors assessed the ability of a low-field-strength extremity-only magnet to provide visualization of the triangular fibrocartilage and the scapholunate and lunotriquetral ligaments. METHODS: Twelve human wrists were examined with a 0.2 T extremity-only magnet. T1-weighted spin echo, proton density-weighted, and T2-weighted turbo spin echo, short-tau inversion recovery, and three-dimensional gradient recalled echo images were acquired, and sections of the specimens were then made that corresponded to the magnetic resonance images. Masked imaging analyses were correlated with macroscopic and limited histopathologic findings. RESULTS: Low-field-strength extremity-only magnet allowed consistent visualization of the triangular fibrocartilage and accurate assessment of a small number of complete tears of the triangular fibrocartilage. The scapholunate ligaments in all cases were identified using a combination of imaging sequences. Consistent visualization of the lunotriquetral ligament with a low-field-strength extremity magnet was difficult. CONCLUSIONS: Magnetic resonance imaging with a low-field-strength extremity-only magnet can be used to visualize the triangular fibrocartilage and the scapholunate ligament, but not the lunotriquetral ligament.     

Megestrol acetate for anorexia in patients with far-advanced cancer: a double-blind controlled clinical trial

The aim of this study was to evaluate a low-dose regimen of megestrol acetate (MA; 320 mg/day) on appetite in advanced cancer patients. Out-patients with far-advanced non-hormone responsive tumours and loss of appetite were randomised in a phase III trial, with two consecutive phases: a 14-day double-blind placebo controlled phase (phase A) and a 76-day open phase (phase B). During phase A, patients were treated with MA, two 160 mg tablets/day, or placebo. In phase B, the MA dose was titrated to clinical response in both groups. Appetite, food intake, body weight, performance status, mood and quality of life were evaluated with standardised measures; patients' global judgement about treatment efficacy was also requested. Of 42 patients entering the study, 33 (17 MA and 16 placebo) were evaluable for efficacy. The appetite score improved significantly with MA after 7 days (P = 0.0023), and this effect was still significant at 14 days (P = 0.0064). Patients judged the treatment with MA effective in 88.2% of cases (14th day), whilst placebo was considered effective by 25% (P = 0.0003). None of the other measures showed significant changes during treatment. The remarkable effect on appetite evident after 7 days, without serious side-effects, shows that MA can produce significant subjective effects at a low-dose even in patients with far-advanced disease.     

Effect of percutaneous ethanol injection therapy versus suppressive doses of L-thyroxine on benign solitary solid cold thyroid nodules: a randomized trial

The results of studies using suppressive doses of L-T4 on benign solitary solid cold thyroid nodules have been conflicting. Recently, intranodular injection of absolute ethanol has been proposed as an effective treatment, but has been evaluated only in uncontrolled studies. Our objective was to evaluate the effect of two alternative medical treatment modalities, percutaneous ethanol injection therapy and L-T4, on the benign solitary solid cold thyroid nodule. In a prospective randomized clinical trial, 50 euthyroid patients with a single solid colloid thyroid nodule causing local discomfort were assigned to a single intranodular injection of sterile 98% ethanol (n = 25) or suppressive doses of L-T4 (n = 25). We aimed at an ethanol dose of 20-50% of the pretreatment nodular volume. The initial daily dose of L-T4 was 1.5 microg/kg BW and was adjusted monthly during the first 6 months to reduce serum TSH to subnormal levels (<0.40 mU/L). Thyroid nodule volume and total thyroid volume were assessed by ultrasound, and thyroid function was determined by routine assays before and during follow-up. Symptom scores before and at 12 months were evaluated by a questionnaire rating pressure symptoms and cosmetic symptoms. The median ethanol dose given was 21% [95% confidence interval (CI), 18;25] of the pretreatment nodule volume. In this group, the median reduction in nodule volume was 47% (CI, 33;57; P < 0.0001) compared to 9% (CI, -7;22; P = 0.09) in the L-T4 group. The difference between the two treatment regimens was statistically significant (P < 0.0001). The median reduction in perinodular thyroid volume was 20% (CI, 11;31; P = 0.03) in the L-T4 group, whereas no change was seen in the ethanol group (-2.5%; CI, -18;11; P = 0.9). Fourteen of 25 (56%) patients treated with ethanol injection and 8 of 25 (32%) treated with L-T4 had complete relief of symptoms at 12 months of follow-up (P = 0.09). No major side-effects were seen in either group. Percutaneous ethanol injection therapy administered as a single small dose results in a satisfactory clinical response in approximately 50% of patients by halving the nodule volume. The thyroid nodule-reducing effect of L-T4 suppressive therapy is insignificant, but a subjective satisfactory clinical response is seen in a subgroup of patients, probably explained by the concomitant reduction of perinodular thyroid volume.     

Prednisolone therapy of idiopathic feline lower urinary tract disease: a double-blind clinical study

A double-blind clinical study was performed to evaluate prednisolone as treatment for idiopathic feline lower urinary tract disease. No differences in response were observed in prednisolone- and placebo-treated cats.     

Substance abuse education for clinical nurses: a controlled study

BACKGROUND: A study was conducted to evaluate a substance abuse component of a workshop for nurses being promoted to the position of Advanced Clinical Nurse. METHODS: We compared whether the 88 nurses who received the educational intervention increased their knowledge and enhanced their feelings of competence regarding the care of chemically dependent patients more than a control group of nurses who received the promotion workshop without the substance abuse component. RESULTS: The nurses in the intervention group had greater increases in knowledge and competence. CONCLUSIONS: This study points out the importance of providing hospital nurses with continuing education on substance abuse to compensate for their educational deficiencies, to provide the information they need and desire, and to help them meet the ANA's practice standards.     

Low-dose antihypertensive therapy with 1.5 mg sustained-release indapamide: results of randomised double-blind controlled studies. European study group

OBJECTIVE: In accordance with international recommendations on the need to decrease doses of antihypertensive drugs, a low-dose (1.5 mg) sustained-release (SR) formulation of indapamide was developed to optimize the drug's efficacy : safety ratio. The aim of this work was to evaluate the benefit of a low-dose diuretic by consolidating the efficacy and safety results of two clinical trials with a similar design. PATIENTS AND METHODS: Clinical data were obtained in two European randomized double-blind studies with 690 mild to moderate hypertensive patients (95 mmHg < or = supine diastolic blood pressure < or = 114 mmHg using a mercury sphygmomanometer) treated respectively for 2 and 3 months, with a mean age of 53 and 57 years, 44 and 57% males, mean supine diastolic blood pressure of 100.6 and 102.5 mmHg and mean supine systolic blood pressure of 161.0 and 164.5 mmHg. RESULTS: The first study, a dose-finding study with indapamide SR at 1.5, 2 and 2.5 mg versus placebo and the immediate-release (IR) formulation of indapamide, showed that the 1.5 mg dosage of the new indapamide formulation had an improved antihypertensive efficacy : safety ratio. The second study confirmed the equivalence of blood pressure reductions with 1.5 mg indapamide SR and 2.5 mg indapamide IR, and better acceptability with 1.5 mg indapamide SR, particularly in the number of patients with serum potassium levels < 3.4 mmol/l, which was reduced by more than 50%. The long-term efficacy of 1.5 mg indapamide SR was observed through a 9-month open-treatment follow-up to the second study. CONCLUSION: The 1.5 mg SR formulation of indapamide has an improved antihypertensive efficacy : safety ratio, which is in accordance with international recommendations for the use of low-dose antihypertensive drugs and diuretics in first-line therapy of hypertension.     

Personality disorder in patients infected with HIV: a controlled study with implications for clinical care

A reversed-phase isocratic high-performance liquid chromatographic method is described for the simultaneous determination of EO9, 3-hydroxymethyl-5-aziridinyl-1-methyl-2-(1H-indole-4,7-dione)prop-beta- en-alpha-ol (I), and its ring-opened aziridine analogue EO5A (II), employing ultraviolet detection. Solid-phase sample extraction was used without addition of an internal standard. Plots of peak heights and areas of I and II were linear in the range 5-10,000 ng/ml. The lower limit of detection of both I and II in plasma was 2 ng/ml. The between-day variation of I was 13.9% at 5 ng/ml and lower than 6.2% for concentrations > or = 10 ng/ml. The between-day variation of II at 5 ng/ml was 13.8% and lower than 4.5% for concentrations > or = 10 ng/ml. The assay was developed to enable pharmacological guiding of a phase I study of I in solid tumour cancer patients.     

Sertraline in the treatment of premature ejaculation: a double-blind placebo controlled study

Twelve children with obstetric paralysis were diagnosed as having a posterior dislocation of the humeral head. The diagnosis was suspected on clinical grounds and confirmed by computed tomography (CT) scans in all cases. All 12 patients were treated with open reduction via an anterior approach. The age range at the time of surgery was from 7 months to 7 years (average, 2 years and 3 months). All patients were immobilized in a shoulder spica for 6 weeks and a further 6 weeks in an orthosis. All patients were examined by CT scans in the postoperative period, which confirmed a satisfactory reduction in all cases. With a minimal follow-up of 12 months, there have been no redislocations. This article demonstrates that dislocation of the shoulder in association with obstetric paralysis is not rare, as previously described, and shows that once diagnosed, the dislocation can be satisfactorily treated by a single anterior open reduction of the shoulder.     

Clonidine for major vascular surgery in hypertensive patients: a double-blind, controlled, randomized study

The utility of clonidine for hypertensive patients presenting for major vascular procedures remains debatable. Twenty-one hypertensive patients presenting for aortic surgery were given clonidine (n = 11) or placebo (n = 10) in a double-blind, randomized manner. Clonidine was administered 6 micrograms/kg per os 120 min before induction of anesthesia and 3 micrograms/kg intravenously (i.v.) over 60 min from aortic declamping to skin closure. Anesthesia was induced with alfentanil 20 micrograms/kg, midazolam, and atracurium and maintained with nitrous oxide 70%, an alfentanil infusion (0.25 microgram.kg-1. min-1), and isoflurane. Anesthetic requirements, circulatory variables, interventions, and isoproterenol dose-response curves (pre- and postoperatively) were determined. Plasma concentrations of clonidine, alfentanil, and vasoactive hormones were measured. When the clonidine group was compared with the placebo group, (a) isoflurane, alfentanil, and midazolam requirements were reduced by 38%, 42%, and 41%, respectively (P = 0.04, 0.03, 0.0002, respectively); (b) supplemental circulatory and anesthetic adjustments were reduced by 51% (P = 0.0006); (c) interventions with vasopressors were not significantly increased (placebo: two; clonidine: five); (d) systolic and mean arterial pressures and heart rate were reduced; (e) increases in norepinephrine, epinephrine, and plasma renin activity were suppressed, whereas vasopressin surge was attenuated; and (f) chronotropic response to isoproterenol was unaffected. Clonidine was effective in reducing anesthetic requirements and in improving circulatory stability in hypertensive patients presenting for major vascular procedures.     

Management of severe childhood hypertension with minoxidil: a controlled clinical study

The therapeutic efficacy of four antihypertensive regimens (minoxidil, propranolol, and hydrochlorothiazide; propranolol and hydrochlorothiazide; methyldopa and hydroch-orothiazide; and hydrochlorothiazide alone) was evaluated in one child with systolic hypertension and in eight children with systolic and diastolic hypertension. The mean blood pressure of 148/98+/-8/4 mm Hg observed during the hydrochlorothiazide control period fell to 142/88+/-8/4 mm Hg following methyldopa and hydrochlorothiazide, 141/85+/-6/2 mm Hg following propranolol and hydrochlorothiazide, and 128/74+/-4/2 mm Hg following minoxidil, propranolol, and hydrochlorothiazide. The only side effect directly associated with administration of minoxidil was hypertrichosis. The effectiveness of minoxidil in the present study suggests that this drug offers an important adjunct to current antihypertensive therapy in children.     

Pressure pain thresholds in patients with craniomandibular disorders before and after treatment with acupuncture and occlusal splint therapy: a controlled clinical study

Fifty-five patients (46 women and 9 men) with craniomandibular disorders and a history of pain of at least 6 months' duration participated in this trial. The patients were randomly assigned to three groups: one group to receive acupuncture; one group to receive occlusal splint therapy; and one group to act as controls. Pressure pain threshold, clinical dysfunction score, and visual analog scale measures were used to evaluate patients before, immediately after, and 6 months after treatment. A moderate, but statistically significant, correlation was found between pressure pain threshold and the number of tender spots in the masticatory muscles (tau = -.43; P < .001), degree of tenderness in the masticatory muscles (tau = -.43; P < .001), clinical dysfunction score (tau = .32; P < .001), and the visual analog scale (tau = -.25; P < .01). The short-term results showed a statistically significant improvement in all evaluations for both treatment groups. No significant differences were found in the control group. The improvements resulted in significant differences between the control and each treatment group immediately after treatment. At the 6-month follow-up, no significant differences in pressure pain threshold or clinical dysfunction score were found in the two treatment groups compared with the short-term results.     

Short-term filial therapy with German mothers: Findings from a controlled study.

Filial therapy has been shown to be an effective tool in improving parent-child relationships. This study represents a starting point for investigating the effectiveness of filial therapy with German mothers and their children. A brief form of the VanFleet filial training approach was used with a group of 15 mothers attending a health retreat for 2 weeks. Dependent variables included a measure of parenting styles, behavior ratings of children, and child-mother play interaction measures. Results showed an increase in acceptance, empathy, positive attention, and educational competence for mothers who received filial therapy and a decrease in ratings of their children's behavior difficulties. Control group members did not show similar gains. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Combined therapy with 5-aminosalicylic acid tablets and enemas for maintaining remission in ulcerative colitis: a randomized double-blind study

OBJECTIVES: To assess the efficacy of a combination of oral and topical 5-aminosalicylic acid (5-ASA) for the maintenance treatment of ulcerative colitis, we undertook a double-blind randomized clinical trial. METHODS: Patients aged 18 to 65 yr (with disease extent greater than proctitis only) were eligible for inclusion in the study if they met the following criteria: (a) history of two or more relapses in the last year; (b) achievement of remission in the last 3 months (with maintenance of remission for at least 1 month). Patients enrolled in the study were randomly assigned to one of the two following 1-yr treatments: (1) combined therapy with 5-ASA tablets 1.6 g/day and 5-ASA enemas 4 g/100 ml twice weekly; (2) oral therapy with 5-ASA tablets 1.6 g/day and placebo enemas/twice weekly. The main end point of the study was the maintenance of remission at 12 months. RESULTS: Upon completion of the study, relapse occurred in 13 of 33 patients in the combined treatment group versus 23 of 36 patients in the oral treatment group (39 vs 69%; p = 0.036). No significant side effects related to treatment were observed in either group. A simplified pharmacoeconomic analysis shows that this form of combined treatment can have a favorable cost-effectiveness ratio. CONCLUSIONS: Our results indicate that 5-ASA given daily by oral route and intermittently by topical route can be more effective than oral therapy alone. This form of combination treatment can be appropriate for patients at high risk of relapse.     

Effects of lisinopril on stress-induced peak blood pressure and sodium excretion: a double-blind controlled study

Hirudin is an anticoagulant originally extracted from the leech Hirudo medicinalis. Using recombinant DNA technology a new compound, recombinant desulphato hirudin CGP 39393 has now been produced. The aim of this study was to determine the maximum tolerated dose in patients undergoing elective hip replacement. This open safety trial represents, to our knowledge, the first experience of recombinant hirudin in orthopedic patients. In this study 48 patients undergoing primary total hip replacement were included and the safety of subcutaneous injections of 10, 15, 20 and 40 mg CGP 39393 twice daily, was evaluated. Prophylaxis was started immediately pre-operatively and continued for 8-10 days. A mandatory bilateral phlebography was performed at the end of the prophylactic treatment period and a clinical follow-up was done 6 weeks after surgery. A major bleeding event occurred in the first 3 patients receiving 40 mg CGP 39393 b.i.d. and the prophylaxis regimen at this dosage level was therefore discontinued. Median values of total blood loss and requirements of blood transfusion in the patients receiving 10-20 mg CGP 39393 were similar to those reported in previous studies on total hip replacement performed at the same centre, using other prophylactic drugs. Deep vein thrombosis (DVT) was confirmed by phlebography in 5 out of 12 patients in the 10 mg group (41.7%, 95% confidence limits [CL]: 15.2-72.3%), 1 out of 11 patients in the 15 mg group (9.1%, CL: 0.23-41.3%) and 2 out of 20 patients in the 20 mg group (10.0%, CL: 1.2-31.7%) during the prophylaxis period. CGP 39393 was safe and well tolerated, when administered as subcutaneous injections of 10-20 mg twice daily. The dose level of 40 mg CGP 39393 twice daily resulted in serious disturbance of the hemostasis in patients after hip prosthesis surgery.     

Long-term clinical effect of nilvadipine in patients with chronic heart failure: a double-blind placebo-controlled study

The long-term effect of calcium channel blockers on chronic heart failure is disappointing, probably because of reflex sympathetic activation through arterial vasodilation. However, nilvadipine may be beneficial for treatment of chronic heart failure since this drug has minimal effects on sympathetic activation. In this study, the effects of 12-week administration of nilvadipine or placebo on symptoms of heart failure and cardiac function were investigated in 23 patients with mild-to-moderate chronic heart failure in a double-blind trial. The patients were randomly assigned to either a nilvadipine group (16 mg daily) or a placebo group. Intergroup comparisons did not show significant differences in any parameters. Serious adverse effects were not observed during the study. Thus, this study failed to show any beneficial effect of nilvadipine in the long-term treatment of patients with chronic heart failure. We conclude that the long-term administration of nilvadipine (16 mg daily) is neither effective nor harmful in the treatment of patients with chronic heart failure.     

Risperidone compared with both lithium and haloperidol in mania: a double-blind randomized controlled trial

OBJECTIVE: There are many reports about the effects of prostatic intraepithelial neoplasia (PIN) on serum prostate-specific antigen (PSA) level. The aim of this study was to determine the relationship between PIN and serum free PSA/total PSA (fPSA/tPSA) ratios. METHODS: We evaluated 46 patients with PIN, 15 patients with benign prostatic hyperplasia (BPH), and 16 patients with localized prostatic carcinoma (CaP) for the amount of fPSA and tPSA with the chemiluminescent enzyme assay. RESULTS: fPSA values from BPH to high-grade PIN (PIN2 and PIN3) was increased, and then a decrease was observed from high-grade PIN to CaP. fPSA was significantly different between BPH and low-grade PIN and high-grade PIN. There was no significant difference observed between BPH and CaP. tPSA values increased from BPH to CaP. tPSA was significantly different between BPH and high-grade PIN and CaP. fPSA/tPSA ratios decreased from BPH to CaP. This ratio was significantly different between CaP and BPH and low-grade PIN. There was no significant difference between CaP and high-grade PIN. CONCLUSIONS: Our results confirm that fPSA/tPSA ratio is better at discriminating between patients with CaP and those with BPH, but not between patients with CaP and those with high-grade PIN. Due to similarities between CaP and high-grade PIN, we think that decreased fPSA/tPSA ratio obtained at the time of intial diagnosis of PIN without concurrent carcinoma could be used as predictive factors to distinguish patients in whom carcinoma will be found on subsequent biopsies from those with PIN not associated with cancer on repeat biopsy.