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Biomedical subjects

W R Thoden

Publications and source records attributed to W R Thoden.

At least 19 recordsLinked to original sources
PubMed1998

Brompheniramine, loratadine, and placebo in allergic rhinitis: a placebo-controlled comparative clinical trial.

A double-blind, randomized, placebo-controlled, parallel-group, multicenter study was conducted to compare the effectiveness of an extended-release formulation of a classical antihistamine, brompheniramine, and a second-generation compound, loratadine, in the treatment of allergic rhinitis. Subjects with symptoms of allergic rhinitis received brompheniramine 12 mg twice daily (n = 112), loratadine 10 mg once daily (n = 112), or placebo twice daily (n = 114) for 7 days. Study medications were blinded using a double-dummy technique. Subjects completed an overall evaluation of symptom relief on a daily basis and returned on treatment days 3 and 7, at which times the investigator assessed symptom severity. The investigator and subject each completed a global efficacy evaluation, and subjects were interviewed regarding adverse experiences. The primary efficacy variable was the physicians' global efficacy evaluation on day 3. Symptoms also were analyzed as summed severity scores for all symptoms and for the nasal symptom cluster of rhinorrhea, sneezing, and nasal blockage. At all post-baseline evaluations (days 3, 7, and averaged over the two days), brompheniramine was significantly better than loratadine and placebo for both sets of summed symptom scores and all three global assessments. Loratadine was significantly better than placebo for physician ratings of total symptom severity averaged over the two days and for the physician and subject ratings of the nasal cluster on day 3. Central nervous system-related symptoms were the most frequently reported adverse experiences; somnolence was reported most frequently by patients taking brompheniramine, and its occurrence was less frequent as treatment continued. A nonprescription, extended-release formulation of brompheniramine 12 mg twice daily provided significantly better relief of symptomatic allergic rhinitis than loratadine 10 mg once daily.

Adolescent↗
PubMed1997

A double-blind, placebo-controlled study of the effectiveness and safety of nizatidine in the prevention of postprandial heartburn.

BACKGROUND: Heartburn is frequently associated with overindulgence in food and drink, meal-stimulated gastric acid secretion, and a gastroesophageal reflux with a pH of 4 or lower. Nizatidine is a selective histamine2 receptor antagonist that effectively suppresses gastric acid secretion at lower than prescription doses and has been approved for nonprescription use in the prevention of postprandial heartburn. OBJECTIVE: To examine the relative effectiveness of 3 dose levels of nizatidine (225 mg, 75 mg, and 25 mg) in preventing postprandial heartburn. METHODS: Four hundred thirteen subjects with documented moderate to severe heartburn following a standard meal that provoked heartburn were randomized to receive a single dose of nizatidine at 225 mg (n = 104), 75 mg (n = 101), or 25 mg (n = 105), or placebo (n = 103) 30 minutes before the meal, at 30 minutes (immediately after completing the meal), and at 60, 90, 120, 150, 180, and 210 minutes (from beginning the meal), subjects assessed the presence or absence of heartburn (yes or no) and the severity of heartburn (100-mm visual analog scale). RESULTS: The use of both 225 mg and 75 mg of nizatidine were significantly better than placebo in preventing heartburn in the proportion of subjects with complete prevention of heartburn (15 [14.4%] and 15 [14.9%], respectively, vs 3 [2.9%]; P < .001); the effects of nizatidine, 25 mg, in 7 subjects (7%) were not distinguishable from placebo. Similar results for nizatidine, 225 mg and 75 mg, were seen for longest duration of no heartburn, total duration of no heartburn, the average severity of heartburn, and the peak heartburn severity. All 3 doses of nizatidine were superior to placebo (P < .001) in reducing average and peak heartburn severity and were well tolerated. CONCLUSIONS: Single doses of 225 mg and 75 mg of nizatidine administered 30 minutes before a standard meal intended to provoke heartburn are significantly more effective than placebo for the prevention and/or reduction of postprandial heartburn.

Adult↗
PubMed1996

Nonprescription ibuprofen and acetaminophen in the treatment of tension-type headache.

A single-dose, double-blind, randomized clinical trial was conducted to examine the relative analgesic effectiveness of 400 mg of ibuprofen (n = 153), 1,000 mg of acetaminophen (n = 151), and placebo (n = 151) in volunteers with muscle contraction headache. At regular intervals during a 4-hour period, participants evaluated headache pain intensity on a 100-mm visual analog scale and headache pain relief on a six-category scale. Both active agents were significantly different from placebo at all time points and in reducing pain intensity and providing relief of headache overall. Similarly, ibuprofen at 400 mg differed significantly from acetaminophen at 1,000 mg on both rating scales. Participants receiving ibuprofen at 400 mg achieved complete relief of headache faster than those receiving acetaminophen at 1,000 mg or placebo, and more participants taking ibuprofen experienced complete relief of headache than those taking placebo or acetaminophen. Both ibuprofen at 400 mg and acetaminophen at 1,000 mg are efficacious analgesic agents for muscle contraction headache, and ibuprofen at 400 mg is significantly more effective than acetaminophen at 1,000 mg for treating this condition.

Acetaminophen↗
PubMed1993

A placebo-controlled model for assaying systemic analgesics in children.

To assess the sore throat pain model in children as an assay for systemic analgesic agents in children under double-blind, placebo-controlled conditions, we conducted a single-dose parallel study that compared 10 mg/kg ibuprofen (n = 39), a new analgesic agent for children, and 15 mg/kg acetaminophen (n = 38), an approved analgesic for children, to placebo (n = 39) in children from 2 to 12 years of age with acute sore throat. At 1/2, 1, 2, 3, 4, 5, and 6 hours (2 hours in the pediatrician's office followed by 4 hours at home), children assessed pain intensity with a pain thermometer and pain relief with a smiley-face scale. The parent and pediatrician assessed pain intensity and change in pain; the parent also provided an overall evaluation at 6 hours. The children rated ibuprofen and acetaminophen as significantly effective compared with placebo (p < 0.05) on both scales at most posttreatment time points and overall. The parent and pediatrician also rated both active medications as significantly different from placebo on both of their scales (p < 0.05) at several time points and overall. On the parent's overall evaluation, ibuprofen was rated as effective compared with placebo (p < 0.05). Both active agents significantly (p < 0.05) reduced oral temperature in children with baseline temperatures > 99 degrees F. No treatment-related adverse effects were observed. We conclude that the sore throat pain model is a sensitive assay for identification of the activity of oral analgesic drugs in children and that ibuprofen is an effective analgesic in children.

Acetaminophen↗
PubMed1991

Caffeine as an analgesic adjuvant. A double-blind study comparing aspirin with caffeine to aspirin and placebo in patients with sore throat.

Despite its frequent clinical use in analgesic agents, caffeine has not been accepted unequivocally as an analgesic adjuvant. To evaluate this activity of caffeine, we used new study methods in a randomized controlled trial on patients with acute sore throat due to tonsillopharyngitis. Patients were randomly assigned to receive a single dose of one of three treatments: 800 mg of aspirin with 64 mg of caffeine (n = 70), 800 mg of aspirin (n = 68), or placebo (n = 69). Under double-blind conditions, during a 2-hour evaluation period, patients used different rating scales to assess pain intensity, change in pain, relief, and two qualities of throat pain, how swollen the throat felt, and difficulty swallowing. Aspirin with caffeine and aspirin alone were significantly more effective than placebo for all efficacy measurements from 30 minutes through 2 hours and overall. The aspirin-caffeine combination also showed evidence of activity at 15 minutes on the relief scale. Aspirin with caffeine was more effective than aspirin alone after 30 minutes and over the entire study period. For patients with fever, both active treatments were equally effective antipyretic agents. We conclude, therefore, that 800 mg of aspirin, given alone or with 64 mg of caffeine, is an effective analgesic and antipyretic agent. Because the aspirin-caffeine combination is significantly more effective than aspirin alone as an analgesic, we also conclude that 64 mg of caffeine is an analgesic adjuvant.

Adult↗
PubMed1991

Inhaled epinephrine and oral theophylline-ephedrine in the treatment of asthma.

Inhaled and oral over-the-counter bronchodilators are used for self-therapy by asthmatic patients. To evaluate their safety and efficacy, we compared epinephrine and theophylline combined with ephedrine with inhaled metaproterenol and the placebo. Twelve asthmatic patients were studied in a randomized, double-blind, placebo-controlled, crossover trial comparing forced expiratory volume in 1 second (FEV1) after two inhalations of epinephrine (0.2 mg/inh), 1 minute apart, followed in 15 minutes by theophylline (130 mg) with ephedrine (24 mg) versus two inhalations of metaproterenol (0.65 mg/inh), 1 minute apart, versus placebo inhaler and tablets. Onset of FEV1 greater than 15% above baseline values occurred within 15 seconds after inhalations for 100% of epinephrine-treated patients, 92% of metaproterenol-treated patients, and 33% of placebo-treated patients. FEV1 responses were significantly greater (P less than .05) for epinephrine at 0.66 to 1.66 minutes compared with the responses of metaproterenol, and epinephrine and theophylline that was combined with ephedrine compared with metaproterenol beginning at 2 hours. Mean duration of activity was 5.7 hours for the epinephrine- and theophylline with ephedrine-treated patients, 4.9 hours for metaproterenol-treated patients, and 2 hours for the placebo group. There were statistically significant differences for patients receiving epinephrine and theophylline with ephedrine versus the placebo group (P less than .001), metaproterenol patients versus the placebo group (P = .02), and patients receiving epinephrine and theophylline with ephedrine versus metaproterenol-treated patients (P less than .05). Compared with inhaled metaproterenol, inhaled epinephrine followed in 15 minutes by a theophylline-ephedrine tablet had a significantly earlier onset, longer duration of action, numerically greater peak effect, and patient preference.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Inhalation↗
PubMed1991

Headache pain model for assessing and comparing the efficacy of over-the-counter analgesic agents.

To refine the assessment of over-the-counter analgesic agents in the treatment of muscle-contraction headache, we designed a single-dose model with attention to specific methodologic features and two relevant assessments--the percentage of subjects who achieve complete relief and the time until pain is no longer experienced. Subjects were randomly assigned to receive a single dose of 1000 mg acetaminophen, 1000 mg aspirin with 64 mg caffeine, or placebo. Under double-blind conditions, subjects rated headache pain intensity and relief over 4 hours and provided a Comparative Evaluation at the end of the trial. Both active agents were significantly distinguished from placebo on the time-point analyses (p less than 0.05) and summary end point measurements (sum of pain intensity difference [SPID], total of pain relief, percentage of patients with complete relief, percentage of treatment failures, and the Comparative Evaluation), as well as causing a faster elimination of headache (p less than 0.05). The aspirin-caffeine combination was rated higher than acetaminophen on all summary measurements, particularly SPID (p less than 0.05), with significantly more patients obtaining complete relief with aspirin-caffeine (p less than 0.01) than with acetaminophen. We conclude that this headache pain model can be used to demonstrate the efficacy of over-the-counter analgesic agents and to assess their relative efficacy.

Acetaminophen↗
PubMed1989

Ibuprofen and acetaminophen in the relief of postpartum episiotomy pain.

A single-dose, double-blind, randomized clinical trial was conducted to examine the relative analgesic efficacy of ibuprofen 400 mg (n = 36), acetaminophen 1000 mg (n = 37), and placebo (n = 38) in postpartum patients who had moderate to severe pain after episiotomy. At regular intervals over 4 hours, patients evaluated pain severity and relief on categorical scales and completed a categorical overall evaluation at the end of the trial. Both active agents were effective compared with placebo (P less than .05). Ibuprofen 400 mg was more effective than acetaminophen 1000 mg for the sum of pain intensity difference, total pain relief, and reduction of pain by more than 50% (P less than .05), suggesting a more rapid onset of action and a more prolonged effect by ibuprofen 400 mg. No adverse effects were reported. Based on the results of this conventional postpartum episiotomy pain model, both agents are considered efficacious and ibuprofen 400 mg is a more effective analgesic for the relief of acute pain than acetaminophen 1000 mg.

Acetaminophen↗
PubMed1988

Sore throat pain in the evaluation of mild analgesics.

A double-blind, single-dose parallel study was conducted to assess refinements of a previously tested model for evaluating treatment of sore throat pain. Patients with tonsillopharyngitis randomly received either 400 mg ibuprofen (n = 39), 1000 mg acetaminophen (n = 40), or placebo (n = 41). At hourly intervals for 6 hours the patients reported pain intensity and pain relief on conventional scales and two sensory qualities of throat pain ("swollen throat" and "difficulty swallowing") on two new visual analog scales. Both active agents were significantly more effective than placebo for all efficacy measurements (p less than 0.01). Ibuprofen, 400 mg, was more effective than acetaminophen, 1000 mg, on all rating scales, conventional and new, at all time points after 2 hours and overall (p less than 0.01). There were no side effects. We conclude that sore throat is a pain model that can be used to discriminate between active medication and placebo, as well as between two effective over-the-counter analgesics.

Acetaminophen↗
PubMed1987

Effect of lumbar sympathectomy on muscle blood flow: distribution of perfusion measured by hydrogen clearance in skeletal muscle.

Measurements of local tissue blood flow using a technique of hydrogen clearance were used to examine the effect of lumbar sympathectomy on skeletal muscle blood flow. Polarographic recordings on 25 hydrogen desaturations were obtained with platinized platinum electrodes. Lumbar sympathectomies were done on five canines leaving the contralateral limb as a control. The hydrogen clearance data were modeled with biexponential curves: the initial rapid component and the second slow component yielded a weighted average perfusion through tissue. Average volumetric blood flow in the control limb was 6.08 +/- 0.45 ml/min/100 g tissue while the sympathectomized limb averaged 9.54 +/- 0.61 ml/min/100 g tissue (p less than 0.005). Average blood flow increases ranged from 33 to 83 percent in the sympathectomized limb over the control limb. This significant increase in muscle blood flow following lumbar sympathectomy, if of prolonged duration, may be cause for re-evaluation of the role of sympathectomy in the management of arteriosclerotic occlusive disease.

Animals↗
PubMed1986

Comparative hypotensive effects of acebutolol and hydrochlorothiazide in patients with mild to moderate essential hypertension: a double-blind multicenter evaluation.

A double-blind multicenter study compared oral acebutolol (n = 182) with hydrochlorothiazide (n = 178) in the treatment of mild to moderate essential hypertension (diastolic blood pressure 95 to 114 mm Hg). Both agents produced significant and comparable reductions in systolic, diastolic, and mean arterial blood pressures of 15.9, 14.9, and 15.3 mm Hg on acebutolol, and 15.2, 13.3, and 11.8 mm Hg on hydrochlorothiazide (p = 0.001). Acebutolol induced a significant reduction in resting heart rate of 9.3 bpm (p = 0.001) from baseline. The mean effective doses of acebutolol and hydrochlorothiazide were 757 and 68 mg, respectively. Significantly fewer patients on acebutolol experienced arrhythmia, anorexia, and flatulence, although an equal number of patients (14) in each group discontinued therapy prematurely due to side effects. More hydrochlorothiazide-treated patients developed abnormalities in the levels of serum glucose, uric acid, blood urea nitrogen (BUN), serum potassium, and chloride. No clinically significant trends in laboratory parameters were seen on acebutolol, although a small number of patients (11 on acebutolol and 3 on hydrochlorothiazide) developed asymptomatic positive antinuclear antibody (ANA) tests of low titer. The data show that acebutolol is as effective as hydrochlorothiazide in the treatment of hypertension, is as well tolerated, and produces fewer biochemical abnormalities.

Acebutolol↗
PubMed1985

Ancillary pharmacologic properties of acebutolol: cardioselectivity, partial agonist activity, and membrane-stabilizing activity.

Acebutolol, a new beta-blocking agent, possesses the ancillary pharmacologic properties of cardioselectivity and partial agonist and membrane-stabilizing activities. Compared to propranolol at equipotent doses, acebutolol produces less bronchoconstriction and preserves the bronchodilator response to isoprenaline. Similarly, acebutolol has less of an effect on peripheral vascular hemodynamics than does propranolol. Because of partial agonist activity, acebutolol produces a lesser reduction in heart rate and cardiac output than do propranolol and atenolol and has been found to have minimal effects on lipoprotein metabolism. Acebutolol may be the only beta-blocking agent that demonstrates some membrane-stabilizing activity at clinically achievable plasma concentrations. The ancillary pharmacologic properties of cardioselectivity and partial agonist activity are distinct and offer definite advantages to selected patients, particularly patients with respiratory disease, in whom cardioselective acebutolol, particularly at low doses, can minimize patient risk. The ancillary property of membrane-stabilizing activity may also guide therapy in selected patients.

Acebutolol↗
PubMed1985

Assessment of nutritional and metabolic status of paraplegics.

Nutritional and metabolic assessment using anthropometric, biochemical, immunological, and indirect calorimetric techniques was performed on 17 healthy paraplegic males with a mean age of 44.2 +/- 14.6 years and mean duration of injury of 17.8 +/- 12.3 years. Significant differences in energy expenditure were observed; only 29.4 percent were normometabolic [measured resting energy expenditure: (MREE) 90-110 percent of predicted resting energy expenditure (PREE)], 35.3 percent were hypermetabolic (MREE greater than 110 percent of PREE) and 35.3 percent were hypometabolic (MREE less than 90 percent of PREE). Obesity (weight greater than 110 percent ideal body weight) was maximum in hypometabolic patients (83.3 percent) due to the imbalance between caloric intake and energy expenditure (p less than 0.05). None of the patients had normal values for all four objective measurements of nutritional assessment (albumin, transferrin, total lymphocyte count, and cutaneous hypersensitivity). Mild malnutrition was evidenced in 47 percent of patients; 53 percent of patients demonstrated some index of moderate malnutrition. We conclude that nutritional therapy based on measurements of energy expenditure instead of predictive equations will benefit these patients. A larger long-term study is needed to determine the ideal predictive measurements of nutritional assessment with their optimal cutoff values applicable to the spinal cord-injured patient.

Adult↗
PubMed1985

Acebutolol. A review of its pharmacological properties and therapeutic efficacy in hypertension, angina pectoris and arrhythmia.

Acebutolol is a cardioselective beta-adrenoceptor blocking drug possessing both partial agonist (intrinsic sympathomimetic) and membrane stabilising activity. In hypertension, it can be administered once or twice daily with equal effectiveness, and has been as effective at lowering blood pressure as propranolol, diuretics, and other beta-blocking drugs (metoprolol, labetalol and atenolol) and more effective than methyldopa. Acebutolol has a significantly smaller effect on resting heart rate than propranolol, metoprolol and atenolol, although direct comparisons with drugs with intrinsic sympathomimetic activity have yet to be undertaken. In both angina and arrhythmia, when administered twice daily it has been as effective as standard therapeutic agents. The side effect profile of acebutolol appears to be comparable to that of other cardioselective beta-blockers. Its relative cardio-selectivity, partial agonist and membrane stabilising activity, hydrophilicity, and considerable extrarenal excretion may offer advantages over some beta-blocking drugs in specific patients. Choosing a beta-blocking agent, however, should be made with a knowledge of pharmacodynamic and pharmacokinetic properties of the various agents and careful consideration of how such properties may be of benefit to an individual patient.

Acebutolol↗
PubMed1984

Blue digit syndrome: urgent indication for digital salvage.

The sudden onset of digital ischemia due to microembolization from a proximal source (the blue digit syndrome) requires immediate attention because not only the digit, but also the entire extremity, may be at risk. In our experience, 11 patients with the blue digit syndrome were encountered. Treatment consisted of eradication of the proximal embolic source followed by lumbar sympathectomy in four patients, direct arterial surgery alone in five patients, and lumbar sympathectomy alone in two patients. The addition of lumbar sympathectomy was beneficial as it provides an additional increase in blood flow and tissue perfusion over and above that due to direct arterial surgery alone. Our experience indicates that the benefits of lumbar sympathectomy leads to enhancement of healing of pregangrenous lesions and digital salvage.

Aged↗
PubMed1983

Effect of suture technique on blood velocity waveforms in the microvascular anastomosis of autogenous vein graft.

In using autogenous vein grafts in microvascular surgery, maintenance of compliance at the site of anastomosis is of importance in achieving patency. Using high-frequency, 20 MHz, pulsed Doppler ultrasonography to monitor blood flow velocity through the vein graft, we have evaluated the effects of continuous and interrupted suture technique on anastomotic compliance in vessels less than 1.5 mm in diameter. In 15 dogs, 15 procedures of each technique, using the continuous technique in one limb and the interrupted technique on the contralateral limb, patency rates for both techniques, documented by arteriography, are 100% at a mean follow-up of 11 weeks. There were no significant differences in the blood velocity profile and pulsatility proximally, distally, and at the graft site between continuous and interrupted technique. This study confirms the suggestion that autogenous vein graft has sufficient elasticity to maintain normal arterial blood velocity waveforms.

Animals↗
PubMed1983

Lumbar sympathectomy for toe gangrene. Long-term follow-up.

We carried out a retrospective review of 45 patients (50 limbs) with toe gangrene not amenable to direct arterial surgery, and thus managed by lumbar sympathectomy alone. Follow-up data regarding toe salvage, limb salvage, and limb loss were compiled. At 5 and 8 year follow-up cumulative limb salvage was 71 percent and cumulative toe salvage was 51 percent. The presence of diabetes did not significantly influence limb or toe salvage. Mortality during the immediate postoperative period was 2 percent. In the majority of patients with digital gangrene who are not amenable to arterial surgery, lumbar sympathectomy is of benefit for salvaging the limb and the toes.

Aged↗