Evaluating screening age for colonoscopy: a quality assurance assessment.

OBJECTIVE: To evaluate colonoscopies in patients aged 40 to 49 and 50 to 59 years from multiple endoscopy surgery centers serving a wide geographical area. METHODS: An observational prospective multicenter quality assurance review was conducted in 49 Ambulatory Surgery Centers in 17 states with 315 gastroenterologists. Care of patients and routine of gastroenterologists continued as standard practice with patients attending for purposes of screening, surveillance, and symptoms. RESULTS: There were 1688 and 5090 consecutive qualified patients aged 40 to 49 and 50 to 59 years, respectively, receiving colonoscopies in a designated 4 week period. There was no significant difference (P=0.55) in the screening category between ages 40 to 49 (n=420) and 50 to 59 years (n=2705) in incidence of colon polyps although the older age group had more than 6 times the number of patients than the younger age group. Age group of 40 to 49-year-old males (21.5%) are at similar risk to 40 to 49-year-old females (21.1%) in development of carcinoma and adenoma polyps combined. Age group of 50 to 59-year-old males (31.3%) appear at greater risk (P<0.0001) than age 50 to 59-year-old females (18.4%) in development of carcinoma and adenoma polyps combined in the screening category. For surveillance and symptom categories significant differences (P<0.05) occurred between both age groups 40 to 49 and 50 to 59 years for males but not females in development of carcinoma and adenoma polyps combined. CONCLUSIONS: The equal risk of colon polyps in screening colonoscopies for age 40 to 49 and 50 to 59 years suggest reexamination of current recommendations for 50 years as the beginning age for screening colonoscopy. Further studies are needed to examine sex differences and cost effectiveness of screening colonoscopies beginning at age 40 years and to explore these factors as well in surveillance and symptom categories.

Efficacy and safety of ursodeoxycholic acid in primary, type IIa or IIb hypercholesterolemia: a multicenter, randomized, double-blind clinical trial.

BACKGROUND: Ursodeoxycholic acid (UDCA) is a therapeutic bile acid used in dissolution of gallstones and treatment of several cholestatic liver diseases. Results obtained from primary biliary cirrhosis patients treated with UDCA suggested that this agent exerts significant cholesterol-lowering effects and justifies evaluation in primary hypercholesterolemic patients without liver disease. Purpose of this study was to determine whether UDCA had potential to be an effective, safe cholesterol-lowering agent in primary type IIa or IIb hypercholesterolemia. METHODS: This was a multicenter randomized, double blind, placebo-controlled trial. After a 6-week placebo lead-in period during which two qualifying lipid profiles were obtained, patients with a mean serum LDL-cholesterol (LDL-C) between 130 and 190mg/dL, triglycerides <400mg/dL and HDL-cholesterol >30mg/dL were randomized to UDCA or matching placebo for 24 weeks. RESULTS: Seven sites screened 200 patients with 134 patients meeting the entry criteria who were randomized to the two treatments. There were 125 patients meeting the efficacy evaluation criteria, 57 on UDCA and 68 on placebo. LDL-C change from weeks 0 to 24 showed no significant difference between groups. No significant differences in changes for total cholesterol, HDL-cholesterol and triglycerides were observed. Both groups had similar adverse event profiles. CONCLUSIONS: UDCA did not show intrinsic cholesterol-lowering properties and therefore is not a useful therapy in treating type IIa or type IIb hypercholesterolemic patients. UDCA was confirmed as a well tolerated and safe drug in this population.

Steroid injection for osteoarthritis of the hip: a randomized, double-blind, placebo-controlled trial.

OBJECTIVE: To determine the efficacy of fluoroscopically guided corticosteroid injection for hip osteoarthritis (OA) in a randomized, double-blind, placebo-controlled trial. METHODS: Fifty-two patients with symptomatic hip OA were randomly allocated to receive placebo (10 mg bipuvicaine, 2 ml saline) (n = 21) or corticosteroid treatment (10 mg bipuvicaine, 40 mg triamcinolone hexacetonide) (n = 31). Patients were followed up for 1, 2, 3, and 6 months. The primary outcome measure was the pain improvement response, defined as a 20% decrease in the Western Ontario and McMaster Universities OA Index (WOMAC) pain score (on 5 100-mm visual analog scales [VAS]) (WOMAC20) from baseline to 2 months postinjection. Secondary outcomes were a 50% decrease in the WOMAC pain score (WOMAC50), changes in other WOMAC subscale scores, patient's global assessment of health (on a 100-mm VAS), and Short Form 36 (SF-36) quality of life indices. Analyses were based on the intent-to-treat principle. RESULTS: The mean WOMAC pain score fell 49.2% (decreasing from 310.1 mm to 157.4 mm) at 2 months postinjection in patients receiving corticosteroid, compared with a decrease of 2.5% (from 314.3 mm to 306.5 mm) in the placebo group (P < 0.0001). The proportion of WOMAC20 responders at 2 months' followup was significantly higher in the corticosteroid group (67.7%) compared with the placebo group (23.8%) (P = 0.004); similar proportions of WOMAC50 responders were observed between groups (61.3% in the corticosteroid group versus 14.3% in the placebo group; P = 0.001). Response differences were maintained at 3 months' followup (58.1% responders in the corticosteroid group versus 9.5% responders in the placebo group; P = 0.004). Significant differences in the WOMAC stiffness and physical function scores (P < 0.0001), patient's global health scores (P = 0.005), and SF-36 physical component scores (P = 0.04) were observed, with patients in the corticosteroid group showing greater improvements. There were no differences in the frequency of adverse events between groups. CONCLUSION: This placebo-controlled trial confirms that corticosteroid injection can be an effective treatment of pain in hip OA, with benefits lasting up to 3 months in many cases. Future studies should address questions related to the benefits of repeated steroid injection and the effects of this treatment on disease modification.

Transverse morphology of the sacroiliac joint: effect of angulation and implications for fluoroscopically guided sacroiliac joint injection.

OBJECTIVE: Effects of angulation of computed tomography (CT) reconstruction plane on sacroiliac (SI) joint morphology were studied, and factors influencing the approach to fluoroscopically guided SI joint injection were assessed. DESIGN AND PATIENTS: CT scans of pelvises were reformatted on 41 subjects, aged 51.7 (+/-15.1) years. Transverse images were reconstructed at the caudal 3 cm of the SI joint tilting plane of reconstruction from -30 degrees to +30 degrees at 15 degrees increments. Anteroposterior diameter of joint (depth), angle from sagittal plane (orientation angle), and distance from skin were measured. Joint contour was classified, and presence of bone blocking access to the joint was recorded. Comparison between angles were analysed by t-test. Relationships between variables were assessed by a Pearson correlation test. RESULTS: Depth was shorter with angulation in the inferior direction (P<0.01). Orientation angle increased with superior angulation (P<0.01). Distance from skin increased (P<0.01) with angulation in either direction. Joint contour was significantly different from baseline at each angle (P<0.001) but highly variable. Inferior angulation resulted in interposition of ilium between skin and SI joint, and superior angulation caused bone block due to the lower sacrum. None of these features was identified without tilting of the reconstruction plane, and effects were more pronounced with steeper angulation. CONCLUSION: Angulation of the reconstruction plane considerably affects the appearance of the sacroiliac joints. By shortening joint depth, an inferiorly directed approach to SI joint injection may make fluoroscopic guidance easier, although associated bony interposition can prevent access to the synovial compartment. A superiorly directed approach is more likely to have adverse effects.

Photodynamic therapy with porfimer sodium for ablation of high-grade dysplasia in Barrett's esophagus: international, partially blinded, randomized phase III trial.

BACKGROUND: Barrett's esophagus (BE) may lead to high-grade dysplasia (HGD) and adenocarcinoma. The objective was to examine the impact of treating patients with BE and with HGD by using porfimer sodium (POR) and photodynamic therapy (PDT) for ablating HGD and reducing the incidence of esophageal adenocarcinoma. METHODS: The design was a multicenter, partially blinded (pathology), randomized clinical trial conducted in patients with BE who have HGD. There were 30 contributing centers. A total of 485 patients were screened, with 208 in the intent-to-treat population and 202 in the safety population. Patients were randomized on a 2:1 basis to compare PDT with POR plus omeprazole (PORPDT) with omeprazole only (OM). The main outcome measurement was complete HGD ablation occurring at any time during the study period. RESULTS: There was a significant difference (p < 0.0001) in favor of PORPDT (106/138 [77%]) compared with OM (27/70 [39%]) in complete ablation of HGD at any time during the study period. The occurrence of adenocarcinoma in the PORPDT group (13%) (n=18) was significantly lower (p < 0.006) compared with the OM group (28%) [corrected] (n=20). The safety profile showed 94% of patients in the PORPDT group and 13% of patients in the OM group had treatment-related adverse effects. The limitations of the study were that PDT therapy may have had to be applied more than once and that patients spent more time in treatment. The patients and the physicians were not blinded to the treatment. CONCLUSIONS: PORPDT in conjunction with omeprazole is an effective therapy for ablating HGD in patients with BE and in reducing the incidence of esophageal adenocarcinoma.

Recurrent herpes simplex labialis: selected therapeutic options.

Recurrent infection with herpes simplex virus 1 (HSV1), called herpes simplex labialis (HSL), is a global problem for patients with normal immune systems. An effective management program is needed for those with frequent HSL recurrences, particularly if associated morbidity and life-threatening factors are present and the patient's immune status is altered. Over the past 20 years, a variety of antiviral compounds (acyclovir, penciclovir, famciclovir, valacyclovir) have been introduced that may reduce healing time, lesion size and associated pain. Classical lesions are preceded by a prodrome, but others appear without warning, which makes them more difficult to treat. Various methods of application (intravenous, oral, topical) are used, depending on whether the patient is experiencing recurrent HSL infection or erythema multiforme or is scheduled to undergo a dental procedure, a surgical procedure or a dermatological face peel (the latter being known triggers for recurrence). This article outlines preferred treatment (including drugs and their modes of application) for adults and children in each situation, which should assist practitioners wishing to use antiviral therapy.