A randomized, controlled trial to assess a novel colorectal cancer screening strategy: the conversion strategy--a comparison of sequential sigmoidoscopy and colonoscopy with immediate conversion from sigmoidoscopy to colonoscopy in patients with an abnormal screening sigmoidoscopy.

OBJECTIVE: Our study was a randomized, controlled trial to assess a novel strategy that provides comprehensive colorectal cancer screening in a single visit versus traditional sigmoidoscopy and, where appropriate, colonoscopy on a subsequent day. METHODS: Consecutive patients referred for screening were randomized to control or so-called "conversion" groups. Patients in the control group were prepared for sigmoidoscopy with oral phospho-soda. Those with an abnormal sigmoidoscopy were scheduled for colonoscopy on a future day after oral polyethylene glycol preparation. In the conversion group, patients were prepared with oral phosphosoda. Patients with a polyp >5 mm or multiple diminutive polyps were converted from sigmoidoscopy to colonoscopy, allowing comprehensive screening in a single visit. Clinical outcomes were assessed by postprocedure physician and patient questionnaires. RESULTS: Two hundred thirty-five patients were randomized (control = 121, conversion = 114). In the control group, 28% had an indication for colonoscopy. Three of 33 (9%) with an abnormal sigmoidoscopy did not return for colonoscopy. At colonoscopy, 27% had a proximal adenoma. In the conversion group, 28% had an abnormal sigmoidoscopy and underwent conversion to colonoscopy. Forty-one percent undergoing colonoscopy in the conversion group had a proximal adenoma. Physicians reported no differences in preparation or procedure difficulty, whereas patients reported no differences in the level of comfort or overall satisfaction between groups. When queried regarding preferences for future screening, 96% chose the conversion strategy. CONCLUSIONS: The conversion strategy led to similar outcomes compared to traditional screening while improving compliance with colonoscopy in patients with an abnormal sigmoidoscopy.

Double-blind, placebo-controlled study comparing the efficacy and safety of fexofenadine hydrochloride (120 and 180 mg once daily) and cetirizine in seasonal allergic rhinitis.

BACKGROUND: Fexofenadine hydrochloride (HCl) is a new H(1) antihistamine used twice daily in some countries. OBJECTIVE: A multicenter, double-blind, parallel-group, placebo-controlled trial compared the efficacy and safety of fexofenadine HCl (120 and 180 mg administered once daily) and cetirizine (10 mg once daily) in the treatment of seasonal allergic rhinitis. METHODS: After a 3- to 5-day run-in period, patients meeting entrance criteria were randomized to receive placebo, fexofenadine HCl 120 mg once daily, fexofenadine HCl 180 mg once daily, or cetirizine 10 mg once daily (active control) for 2 weeks. Eight hundred twenty-one patients comprised the intention-to-treat population and 722 patients completed the study. Symptom assessments were conducted 12 hours after the dose for the previous 12 hours and again at 24 hours after the dose for the previous 12 hours. In addition, assessment was made immediately before dosing in the morning for the previous 30 minutes. Total symptom score was calculated as the sum of scores for the 4 individual symptoms: (1) sneezing, (2) rhinorrhea, (3) itchy nose, palate, or throat, and (4) itchy, watery, or red eyes; the nasal congestion score was also recorded. RESULTS: Both doses of fexofenadine HCl were superior to placebo in reducing the total symptom score. Efficacy was maintained for the entire dosing interval (ie, for 24 hours). There were no differences in efficacy between the 2 doses of fexofenadine HCl or between either dose of fexofenadine HCl and cetirizine. There was no major side effect, but the combined incidence of drowsiness or fatigue was greater with ce-tirizine (9%) than with placebo (4%) (P =.07) or fexofenadine (4%) (P =.02). CONCLUSIONS: Once-daily fexofenadine is thus a valuable addition to the nonsedating group of H(1) receptor antagonists currently available for the treatment of seasonal allergic rhinitis.

Unsuspected infection is infrequent in asymptomatic outpatients with refractory ascites undergoing therapeutic paracentesis.

OBJECTIVE: Large-volume paracentesis is a safe and effective means of treating patients with refractory ascites. However, there is limited information regarding the need for ascitic fluid studies in asymptomatic outpatients presenting for therapeutic paracentesis. The aim of this prospective study was to define the incidence and natural history of peritoneal fluid infection in asymptomatic outpatients undergoing therapeutic paracentesis. METHODS: Over a 13-month period, 118 therapeutic paracenteses were performed in 29 outpatients with decompensated cirrhosis (Child-Pugh class B = 38%, C = 62%). After a brief medical history and physical examination, ascitic fluid cell count with differential and culture were obtained from all participating subjects. Seven (24%) of the subjects were receiving norfloxacin prophylaxis, accounting for antibiotic coverage during 40% of the procedures performed. The clinical course and outcome of study subjects during a mean follow-up of 137 days was reviewed. RESULTS: All 118 (100%) of the ascitic fluid samples demonstrated absolute neutrophil counts of <250/mm3 (mean = 6.5 +/- 22.5 pmn/mm3). Asymptomatic bacterascites was identified from three of the 118 (2.5%) fluid samples, but all of these subjects spontaneously recovered without treatment or sequelae. During follow-up, six episodes of symptomatic or hospital-associated peritoneal fluid infection were identified in study participants, emphasizing the importance of fluid studies in other clinical settings. CONCLUSIONS: Although further studies are needed, the routine culture of ascitic fluid in asymptomatic outpatients with refractory ascites requiring therapeutic paracentesis may not be necessary when there is a low index of suspicion for occult infection. In circumstances of clinical uncertainty, however, obtaining ascitic fluid cell counts with differential is recommended to insure patient safety.

Nasal budesonide offers superior symptom relief in perennial allergic rhinitis in comparison to nasal azelastine.

BACKGROUND: Allergic rhinitis is usually treated with oral antihistamines or nasal steroids. Topically active nasal antihistamine is a new treatment modality for allergic rhinitis. The efficacy in comparison to well established topical treatment alternatives is not fully known. OBJECTIVE: To compare the efficacy of intranasally administered azelastine to budesonide, at their respectively recommended dosage, on the symptoms of perennial rhinitis patients. METHODS: A placebo-controlled, randomized, parallel group study was conducted to compare the efficacy and tolerability of intranasal budesonide aqueous suspension (256 microg once daily) with azelastine hydrochloride nasal spray (280 microg twice daily (560 microg/day)) and with placebo in the treatment of perennial allergic rhinitis. The 195 patients (with at least a 2-year history of perennial allergic rhinitis) recorded individual nasal symptom scores, the degree of symptom control achieved and any adverse events experienced over a 2-week baseline period and a 6-week treatment period. RESULTS: Following treatment, the reductions in mean combined and individual nasal symptom scores from baseline values were significantly greater in the budesonide group compared with the placebo group (P < .0001 for all variables except runny nose P = .01). In patients treated with budesonide, there were also significantly larger reductions from baseline values in combined nasal symptom scores (P < .01) and in scores for all individual nasal symptoms (P < or = .05) compared with those treated with azelastine. The reductions from baseline in both combined and individual nasal symptom scores did not differ between azelastine and placebo. The study medications were well tolerated, producing no unexpected or serious treatment-related adverse events. CONCLUSION: A once-daily dose of 256 microg of intranasal budesonide aqueous suspension is significantly more effective at relieving the symptoms of perennial allergic rhinitis compared with a twice daily dose of 280 microg of azelastine nasal spray.

A comparison of aqueous suspensions of budesonide nasal spray (128 micrograms and 256 micrograms once daily) and fluticasone propionate nasal spray (200 micrograms once daily) in the treatment of adult patients with seasonal allergic rhinitis.

The efficacy of aqueous suspensions of budesonide nasal spray and fluticasone propionate nasal spray, in the treatment of seasonal allergic rhinitis, was compared in a large, placebo-controlled, two-center study. A 1-week baseline period was followed by a 4- to 6-week treatment period during which 635 adult patients, aged 18-72 years, were randomized to receive either placebo, budesonide 128 micrograms, or 256 micrograms once daily, or fluticasone propionate, 200 micrograms once daily. Nasal and eye symptoms, overall treatment efficacy and safety assessments were made during the study period. Combined, as well as individual, nasal symptoms were significantly improved in all three active treatment groups compared with placebo therapy. Treatment with 256 micrograms/day of budesonide was found to be significantly more effective in reducing the sneezing score compared with 200 micrograms/day of fluticasone propionate. Analysis of symptom scores on days when the pollen count was greater than 10 grains/m3 revealed 256 micrograms/day of budesonide therapy to be significantly more effective in reducing combined symptom scores as well as the individual scores for sneezing and runny nose, compared with 200 micrograms/day fluticasone propionate. The higher dose of budesonide (256 micrograms/day) was also more effective than the lower dose (128 micrograms/day) in reducing sneezing scores and statistical significance was almost reached for the reduction in combined symptom and runny nose scores. Substantial or total control of symptoms was achieved by 31.4%, 85.3%, 88.4%, and 81.9% of patients receiving placebo, 128 micrograms/day of budesonide, 256 micrograms/day of budesonide, and 200 micrograms/day of fluticasone propionate, respectively. The incidence of adverse events was low in all treatment groups. In conclusion, both budesonide and fluticasone propionate treatments were effective and well-tolerated in the treatment of seasonal allergic rhinitis. However, 256 micrograms/day of budesonide tended to be more effective than 200 micrograms/day of fluticasone propionate and 128 micrograms/day of budesonide, especially when patients were exposed to a higher pollen load.

Can an antihistamine delay appearance of hay fever symptoms when given prior to pollen season?

Mizolastine is a new, nonsedating antihistamine providing satisfactory symptom relief in allergic conditions. The purpose of this study was to determine whether the onset of hay fever symptoms could be delayed in patients known to suffer seasonal allergic rhinoconjunctivitis symptoms if mizolastine was given before the pollen season. This double-blind study involved 342 patients, randomly allocated to once-daily 10 mg mizolastine (n = 115), once-daily 120 mg terfenadine (n = 116), or placebo (n = 111) groups. All patients started treatment on 1 May, before the onset of the grass pollen season. The prophylactic effect of test drugs was assessed on their ability to delay the time to the first hay fever crisis of the season, which was defined by the occurrence of one of the following events: use of rescue medication, study withdrawal because of treatment failure, or total diary symptom score over 18. Active treatments prolonged the time to the first crisis by approximately 1 week (mizolastine 55 days, terfenadine 57 days) in comparison with placebo (50 days) (survival curve analysis: Logrank test, P = 0.01; Wilcoxon test, P = 0.03). Tolerability was satisfactory and comparable between groups. Thus, mizolastine can be safely used to delay and to treat symptoms of seasonal allergic rhinitis.

Case report: arthropathy as the presenting symptom in hereditary hemochromatosis.

Hemochromatosis is characterized by excessive absorption and subsequent deposition of iron in various organs and is prevalent in 1 out of 20,000 hospitalized patients. Most patients with hereditary hemochromatosis (HHC) become symptomatic between the ages of 50 and 60 years. Distinct forms of arthritis have been associated with HHC and may be the initial clinical manifestation in some patients. This is a case of a patient who had chronic hip and back pain and painless swelling over the knuckles. Radiographs revealed classical signs of HHC. Early recognition and prompt institution of phlebotomy can improve the outcome of patients with HHC.

Erythromycin as a prokinetic agent: a prospective, randomized, controlled study of efficacy in nasoenteric tube placement.

OBJECTIVES: Erythromycin, a macrolide antibiotic, has been shown to mimic the effects of the polypeptide motilin in the gastrointestinal tract. To determine whether erythromycin ethylsuccinate elixir would facilitate the transpyloric passage of a standard nasoenteric feeding tube once the tube was placed into the stomach, 20 patients were randomized to receive erythromycin or standard therapy. METHODS: Twenty patients (ages 45-78), mean age 63 yr, all male, had 43-inch nasoenteric tubes placed and were randomized to receive erythromycin ethylsuccinate elixir (400 mg/5 ml per os every 8 h for three doses) through the feeding tube or to receive standard therapy that involved no drug intervention. RESULTS: Three placements resulted in immediate transpyloric passage. This represented 3/21 (14%) with immediate passage. One patient dropped out after initial tube placement. The remaining 17 patients had initial tube placement in the stomach; of these, eight were randomized to receive erythromycin and nine to receive standard therapy. Six of the eight nasoenteric tubes in the erythromycin group achieved transpyloric passage in 1 day. Zero of the nine nasoenteric tubes in the standard therapy group achieved transpyloric passage in 1 day (p = 0.0023, Fisher's exact test). CONCLUSION: This study demonstrates that erythromycin ethylsuccinate elixir improves the success of transpyloric feeding tube passage in 1 day and is superior to the standard therapy, which consists of no drug intervention.

An evaluation of dental stones after repeated exposure to spray disinfectants. Part I: Abrasion and compressive strength.

This study investigated the effect of repeated applications of spray disinfectants on gypsum surfaces. Types III and IV gypsum products were evaluated in combination with iodophor, acid glutaraldehyde, phenol, and water spray. Results demonstrated greater resistance to abrasion with increasing numbers of water or disinfectant spray applications. Acid glutaraldehyde spray decreased the compressive strength of type III stone by 26%, phenol increased the compressive strength of type IV stone by 18%, and iodophor had no significant effect on either stone relative to compressive strength.

A comparative study of terfenadine at two dose levels in the management of hayfever.

One hundred and twenty patients with hayfever were enrolled in a single-centre, double-blind crossover study designed to compare the efficacy and safety of terfenadine at doses of 60 mg bd and 120 mg bd. A two-week placebo run-in period was followed by the two treatment periods, each lasting two weeks. Assessments of hayfever symptoms were made daily by patients and at each clinic visit by the investigator. Adverse events were recorded at the end of each treatment period. At the end of the study both investigator and patient rated the overall efficacy and the patient recorded treatment preference. The data were examined by analysis of variance (ANOVA) for treatment, period and crossover effects. Pollen counts were recorded for the duration of the study. Seventy-four patients completed the study, the majority of withdrawals occurring during the placebo phase. There was no significant difference in symptom relief between the two doses of terfenadine. The number of adverse events, including drowsiness, was similar for the two treatments and for placebo. Mean and peak pollen counts both correlated well with symptom severity. These data show that terfenadine 60 mg bd is an adequate dose for the treatment of hayfever symptoms.

Dose response curve of allergen and histamine in skin prick tests.

Twenty-six Dermatophagoides pteronyssinus (D.pt.) sensitive subjects were skin prick tested in duplicate with 15 concentrations of D.pt. ranging from 0.0018 to 17.8 mg/ml, 15 concentrations of the major allergen of D.pt., antigen P1, ranging from 0.0002 to 1.88 mg/ml and 15 concentrations of histamine dihydrochloride solution ranging from 0.048 to 114.0 mg/ml. Weal areas and concentrations were transformed by taking logs and linear and non-linear regression curves fitted, allowing for confounding variables, such as subject, and interactions. The weal areas over all concentrations fitted "S" shaped curves with essentially straight central portions, parallel between materials, with differences between subjects but parallel within subjects. The dose response curves of P1 and D.pt. were coincident when the concentrations were adjusted to allow for differences in potency. The concentrations of allergen and histamine commonly used for standardisation purposes will give weals that can be plotted along a straight line, but at higher and lower concentrations the response will tail off. This accounts for previously ambiguous results. Standardisation of allergens using 10 mg/ml histamine is preferable to 1 mg/mg.

Clinical evaluation of removable partial denture rest seat adaptation.

The clinical relationship between the removable partial denture cast occlusal rest and the corresponding rest seat was examined. Under the conditions of the study, it was found that rests of mandibular Class I and II removable partial dentures fit significantly better than those of mandibular Class III and IV prostheses. No significant difference was noted between similar types of maxillary removable partial dentures in this regard. In evaluating the fit of specific portions of the occlusal rest, it was found that the marginal ridge zone was more closely adapted to the rest seat than other zones for all types of removable partial dentures. However, contact, as defined in this analysis, was found to exist on a random basis in all four quadrants of the occlusal rests evaluated. In spite of this fact, one fifth of the occlusal rests did not contact the opposing rest seat at any point. Improved fit with length of service was not substantiated by a cross-sectional analysis. Suggestions were made to assist the clinician in achieving a better fit between the framework and dentition in removable partial dentures.

Comparison of kinetic interactions of nadolol and propranolol with cimetidine.

Plasma levels of nadolol and propranolol following a single 80 mg dose of each beta blocker in the presence and absence of cimetidine were determined in 12 healthy male subjects. Cimetidine increased (p less than 0.01) the area under the plasma concentration-time curve and peak plasma levels of propranolol by 46% and 35%, respectively. Nadolol kinetics were not altered significantly by cimetidine, except for a reduction in time to reach peak concentrations. The higher blood levels of propranolol during administration of cimetidine were not associated with any changes in resting blood pressure or heart rate compared with propranolol alone. Cimetidine had no effect on elimination half-lives or apparent mean residence times for either beta blocker.