A comparative evaluation of sclerosants for esophageal varices: a prospective randomized controlled study

The aim of this prospective randomized controlled study was to find a safe and effective sclerosing solution for endoscopic injection sclerotherapy in the treatment of esophageal variceal bleeding. Ninety consecutive patients with portal hypertension and variceal bleeding were randomized to receive sclerotherapy with 5% ethanolamine oleate, 3% sodium tetradecyl sulfate, or absolute alcohol at an interval of 3 weeks. Sixty-four patients who received more than three sessions were analyzed. All three agents were found to have similar success and complication rates (p greater than 0.05). However, absolute alcohol required fewer sessions (p less than 0.01) and lesser amounts (p less than 0.01) to produce successful variceal sclerosis and had the added advantage of low cost and easy availability.     

Comparison of Pycnogenol and Daflon in treating chronic venous insufficiency: a prospective, controlled study.

The aim of this study was to investigate the clinical efficacy of oral Pycnogenol (Horphag Research Ltd., UK) in patients with severe chronic venous insufficiency (CVI) in comparison to the combination of diosmin and hesperidin (Daflon, Servier, France). A group of 86 patients with severe chronic venous insufficiency (CVI), venous hypertension, ankle swelling) and previous history of venous ulcerations received either oral Pycnogenol (capsules) 150 mg or 300 mg daily for 8 weeks or Daflon, 1,000 mg/day. All patients completed the study without dropouts. At the end of the study, microcirculatory results indicated: a progressive decrease of skin flux at rest (RF); a significant decrease in capillary filtration (RAS); an improvement in the symptomatic venous score (ASLS); a reduction in edema; a significant improvement (increase) in pO(2) and a decrease in pCO(2) in the Pycnogenol group. A significant level of improvement was reached after 4 weeks of treatment in most patients (p < .05) of the Pycnogenol group while clinical improvement was significant only in 6 subjects in the Daflon group. The positive effects of treatment with Pycnogenol after 8 weeks were significantly larger in comparison with the Daflon group. In conclusion, this study confirms the fast clinical efficacy of Pycnogenol in patients with chronic venous insufficiency and venous microangiopathy and its superiority-considering the evaluated parameters-to the combination of diosmin and hesperidin.     

Barium swallow study in routine clinical practice: a prospective study in patients with chronic cough,

OBJECTIVE:

To assess the routine use of barium swallow study in patients with chronic cough.

METHODS:

Between October of 2011 and March of 2012, 95 consecutive patients submitted to chest X-ray due to chronic cough (duration > 8 weeks) were included in the study. For study purposes, additional images were obtained immediately after the oral administration of 5 mL of a 5% barium sulfate suspension. Two radiologists systematically evaluated all of the images in order to identify any pathological changes. Fisher''s exact test and the chi-square test for categorical data were used in the comparisons.

RESULTS:

The images taken immediately after barium swallow revealed significant pathological conditions that were potentially related to chronic cough in 12 (12.6%) of the 95 patients. These conditions, which included diaphragmatic hiatal hernia, esophageal neoplasm, achalasia, esophageal diverticulum, and abnormal esophageal dilatation, were not detected on the images taken without contrast. After appropriate treatment, the symptoms disappeared in 11 (91.6%) of the patients, whereas the treatment was ineffective in 1 (8.4%). We observed no complications related to barium swallow, such as contrast aspiration.

CONCLUSIONS:

Barium swallow improved the detection of significant radiographic findings related to chronic cough in 11.5% of patients. These initial findings suggest that the routine use of barium swallow can significantly increase the sensitivity of chest X-rays in the detection of chronic cough-related etiologies.     

Rapid relief of signs/symptoms in chronic venous microangiopathy with pycnogenol: a prospective, controlled study

The aim of this study was to investigate the clinical efficacy of oral Pycnogenol (Horphag Research Ltd, UK) in patients with severe chronic venous insufficiency. Patients with severe venous hypertension (chronic venous insufficiency, ankle swelling) and history of venous ulcerations were treated with Pycnogenol. Patients received oral Pycnogenol (50 mg capsules, 3 times daily for a total of 150 mg daily) for 8 weeks. A group of 21 patients was included in the treatment group and 18 equivalent patients were observed as controls (no treatment during the observation period). All 21 patients (age 53 years; range, 42-60 years; M:F=11:10) in the treatment group completed the 8-week study. Also the 18 controls completed the follow-up period. There were no drop-outs. The average ambulatory venous pressure was 59.3 (SD 7.2; range 50-68) with a refilling time shorter than 10 seconds (average 7.6; SD 3). There were no differences in ambulatory venous pressure or refilling time between the treatment and control patients. The duration of the disease-from the first signs/symptoms-was on average 5.7 years (SD 2.1). At 4 and 8 weeks, in all Pycnogenol-treated subjects, microcirculatory and clinical evaluations indicated a progressive decrease in skin flux, indicating an improvement in the level of microangiopathy; a significant decrease in capillary filtration; a significant improvement in the symptomatic score; and a reduction in edema. There were no visible effects in controls. In conclusion, this study confirms the fast clinical efficacy of Pycnogenol in patients with chronic venous insufficiency and venous microangiopathy. The study indicates the significant clinical role of Pycnogenol in the management, treatment and control of this common clinical problem. The treatment may be also useful to prevent ulcerations by controlling the level of venous microangiopathy.     

Tailored regimen of interferon alpha for HBeAg-positive chronic hepatitis B: a prospective controlled study

Summary.  The response to interferon-alpha treatment of patients with chronic hepatitis B under the current protocol is not satisfactory. The aim of this study was to try an alternative approach to improve treatment outcome. Of 374 HBeAg-positive patients, 127 of them received 5 million units of interferon-alpha thrice weekly for 6 months and constituted the control group, while 247 in the study group received the same dosage but the duration of treatment was tailored. The study protocol provided for continuation of treatment if HBV DNA levels were continuously decreasing. The treatment ended when viral, antigenic and biochemical endpoints were reached or when HBV DNA levels were no longer decreasing. The median length of tailored treatment was 10 (range 6–24) months. The end-of-treatment response rates were 39.3% and 23.6% ( P  = 0.002), and after 12-month, follow-up, the sustained response rates were 40.5% and 28.3% ( P  = 0.013) in the study and control groups, respectively. Excluding the patients who dropped out, 228 and 115 completed a median of 40- and 44-month-long follow-up; the long-term response was thus 45.3% and 33.1% ( P  = 0.014) in the respective groups. Interferon-alpha treatment tailored in length demonstrated significantly increased efficacy in patients with chronic hepatitis B.     

Effect of cholecystectomy on bowel function: a prospective, controlled study

BACKGROUND: Published estimates of the prevalence of postcholecystectomy diarrhoea derive from retrospective or uncontrolled data. They ignore functional bowel syndromes and possible changes in diet and drug use. AIMS: To determine prospectively whether and how often cholecystectomy leads to changes in bowel function and bowel symptoms, especially to liquid stools, over and above any non-specific effect of laparoscopic surgery. SUBJECTS: Patients: 106 adults undergoing laparoscopic cholecystectomy (85 women, 21 men). Controls: 37 women undergoing laparoscopic sterilisation. METHODS: Before and 2-6 months after surgery patients were administered questionnaires about bowel frequency, bowel symptoms, diet, and drugs, and kept records of five consecutive defecations with assessment of stool form or appearance on a seven point scale. RESULTS: In cholecystectomised women, stated bowel frequency increased, on average by one movement a week, and fewer subjects felt that they became constipated. However, records showed no consistent change in bowel frequency, stool form, or defecatory symptoms. Six women reported diarrhoea after the operation but in only one was it clearly new and in her it was mild. Change in dietary fibre intake did not associate with change in bowel function but stopping constipating drugs did in a minority. In women being sterilised there was no consistent change in bowel function. In men having cholecystectomy no consistent changes were observed. CONCLUSIONS: In women, cholecystectomy leads to the perception of less constipation and slightly more frequent defecations but short term recordings show no consistent change in bowel function. Clinical diarrhoea develops rarely and is not severe.     

Sports injuries in elderly athletes: a three-year prospective, controlled study

A 3-year prospective, controlled study of sports injuries in elderly athletes (over 60 years of age) treated at an outpatient sports clinic was carried out in order to determine the number, profile, and specific features of these injuries compared with those of young athletes (between 21 and 25 years). During the study period, 57 elderly and 457 young adult athletes visited the clinic. The majority of the patients in both groups were male (83% of the veterans and 85% of the young). Forty-eight veterans (84%) were endurance sportsmen, while only 115 of the young patients (25%) went in for endurance sports. In both groups the knee joint was most frequently affected, in the young athletes (36%) more frequently than in the elderly (21%). In the elderly athletes shoulder (18%) as well as Achilles tendon and calf (20%) complaints were significantly more common than among young athletes (7% and 5%, respectively). Most (70%) of the injuries in the elderly were overuse injuries, but these comprised only 41% in the young.     

Idiopathic chronic cough and organ-specific autoimmune diseases: a case-control study

The marked female predominance in cases of idiopathic chronic cough and its association with mild chronic lymphocytic airway inflammation suggests an underlying autoimmune process. We set out to test the hypothesis that idiopathic chronic cough is associated with other organ-specific autoimmune diseases in a case control study. Twenty-two patients with idiopathic chronic cough and 65 community-matched controls for age and sex who responded to a self-administered questionnaire were asked about the presence of autoimmune disease, other medical problems and drug history. All subjects were invited to have a blood test for an autoimmune screen. Thirteen out of 22 (59%) patients with idiopathic chronic cough and eight out of 65 (12%) age- and sex-matched controls reported organ-specific autoimmune disease (odds ratio 8.8; 95% confidence interval 2.4-31.8, P<0.001). Organ-specific autoantibodies were present in a significantly higher proportion of cases than controls (40% vs. 13%; P = 0.047). These findings suggest a relationship between idiopathic chronic cough and organ-specific autoimmunity.     

A prospective evaluation of esophageal testing and a double-blind, randomized study of omeprazole in a diagnostic and therapeutic algorithm for chronic cough

OBJECTIVE: Recent studies suggest an association between chronic cough and gastroesophageal reflux. Our study aims were 1) to define the prevalence of acid reflux induced cough in the general community, 2) to examine the ability of esophageal testing to identify gastroesophageal reflux related cough, and 3) to assess the utility of omeprazole in a chronic cough algorithm. METHODS: Patients with chronic cough of unknown etiology, who were mostly from the community, were evaluated. Subjects underwent a chest x-ray, methacholine challenge test, and empiric trial of postnasal drip therapy, and completed daily cough symptom diaries subjectively evaluating cough frequency and severity on a graded scale of 0-4 (combined maximum 8). After excluding other causes of cough, the remaining patients underwent esophageal and pH testing. Those testing positive were randomized to omeprazole 40 mg b.i.d. or placebo for 12 weeks. Follow-up was 1 yr. RESULTS: A total of 71 patients were screened; 48 were excluded. Twenty-three patients were evaluated for gastroesophageal reflux disease; six (26%) were eventually determined to have an acid-related cough. Of these patients, 17 had a positive pH test, six (35%) of whom showed a striking improvement or resolution of their cough during omeprazole treatment which was sustained for up to 1 yr. Six had a negative pH test, none of whom responded to omeprazole therapy. No significant differences were seen between responders (n = 6) and nonresponders (n = 11) for demographic factors, baseline symptom frequency and duration, or physiological parameters (motility/pH). CONCLUSIONS: Acid-related chronic cough was present in 26% (six of 23) of patients evaluated for gastroesophageal reflux disease. Esophageal testing does not reliably identify patients with acid induced chronic cough responsive to proton pump inhibitor therapy. We suggest that the best diagnostic and therapeutic approach, after excluding asthma and postnasal drip syndrome, is empiric treatment for 2 wk with a high dose proton pump inhibitor.     

Etiologic diagnosis of chronic osteomyelitis: a prospective study

BACKGROUND: Although bone specimens were established 25 years ago as the gold standard for etiologic diagnosis of chronic osteomyelitis, recent studies suggest that nonbone specimens are as accurate as bone to identify the causative agent. We examined concordance rates between cultures from nonbone and bone specimens in 100 patients. METHODS: Prospective study conducted at Hospital Universitario San Vicente de Paul, a 750-bed university-based hospital located in Medellín, Colombia. We included patients with chronic osteomyelitis who had been free of antibiotic therapy for at least 48 hours, excluding those with diabetic foot and decubitus ulcers. At least 1 nonbone and 1 bone specimen were taken from each individual and subjected to complete microbiologic analysis. RESULTS: Bone cultures allowed agent identification in 94% of cases, including anaerobic bacteria in 14%. Cultures of nonbone and bone specimens gave identical results in 30% of patients, with slightly better concordance in chronic osteomyelitis caused by Staphylococcus aureus (42%) than by all other bacterial species (22%). However, statistical concordance determined by the Cohen kappa statistic was less than 0 (-0.0092+/-0.0324), indicating that the observed concordance was no better than that expected by chance alone (P>.99). CONCLUSIONS: Appropriate diagnosis and therapy of chronic osteomyelitis require microbiologic cultures of the infected bone. Nonbone specimens are not valid for this purpose.     

Bowel preparation increases the diagnostic yield of capsule endoscopy: a prospective, randomized, controlled study

BACKGROUND: The aim of this study was to determine the value of small-bowel preparation for patients undergoing capsule endoscopy. METHODS: The study design was prospective, randomized, and controlled. Eighty patients referred for capsule endoscopy were randomized into two equal groups. Patients in Group A (mean age 54.40 [15.65] years) ingested 2 L of a polyethylene glycol/electrolyte solution 16 hours before the test, whereas patients in Group B (mean age 59.85 [14.58] years) prepared for the procedure by taking only clear liquids during the prior day. The primary outcome evaluated was the effect of bowel preparation on the quality of capsule images, as assessed with an objective scoring system in which cleansing was graded as "adequate" or "inadequate" by blinded examiners. A secondary outcome was the effect of bowel preparation on diagnostic yield. For this purpose, the results of capsule endoscopy were classified as positive findings, findings of uncertain significance, and no findings. RESULTS: Cleansing of the small intestine was considered "adequate" in 36 patients in Group A (90%) vs. 24 patients of Group B (60%) (p = 0.004). A diagnosis was established in 26 patients in Group A (65%) compared with 12 patients in Group B (30%) (p = 0.003). CONCLUSIONS: Bowel preparation before capsule endoscopy improves visualization of the small intestine, which may lead to an improvement in diagnostic yield.     

Endoscopic retrograde cholangiopancreatography in the elderly: a prospective and comparative study

OBJECTIVE: In this study we aimed to compare the utility and safety of endoscopic retrograde cholangiopancreatography (ERCP) in elderly and younger groups of people. METHODS: The study involved 299 patients who underwent ERCP for the first time between March 2002 and January 2003. Group A consisted of 202 patients who were 69 years of age or younger and group B involved 97 patients who were 70 years of age or older. The patients were prospectively identified and data were gathered on them prospectively. Clinical and biochemical features, ERCP procedures, ERCP diagnosis, complications and length of hospital stay were compared between the two groups. RESULTS: Group B patients presented with more specific symptoms compared with group A. Laboratory findings were similar in both groups other than mean bilirubin levels, which were higher in the elderly group. Selective biliary cannulation was technically successful in 99% of both groups. Pre-cut papillotomy was performed in 49.5% of group A patients and 56.7% of group B patients. Choledocholithiasis was the most frequent diagnosis in both groups. Benign biliary stenosis was more frequent in group A and malignant biliary stenosis in group B. Among the malignant aetiologies, pancreatic carcinoma was the most common cancer in both groups. Post-procedural complications developed in 27 (9%) patients. There were 16 (7.9%) complications (six bleeding, five pancreatitis, three perforation and two cholangitis) in the 202 patients aged under 70 years. In comparison, 11 (11.3%) of the 97 patients aged over 70 years developed a complication (bleeding in six, pancreatitis in one, perforation in one, cholangitis in two and ileus in one). Twelve (nine group A and three group B) patients died within 5-30 days of the procedure. Length of hospital stay was comparable for both groups (15.53+/-12.43 days in group A and 14.84+/-11.56 days in group B). CONCLUSIONS: Diagnostic and therapeutic ERCP has similar outcomes in both elderly and younger patients. ERCP is effective and safe in elderly patients with naive papilla. The more invasive procedures like pre-cut papillotomy may be performed safely in the elderly.     

Retrograde ileoscopy in chronic nonbloody diarrhea: a prospective,case-control study

OBJECTIVE: Chronic nonbloody diarrhea (CND) is a frequent intestinal disorder, with a relevant economic impact. Besides colonic diseases, alterations of the terminal ileum could be involved in CND pathogenesis. The aim of this study was to assess the role of retrograde ileoscopy with biopsy in CND patients. METHODS: Patients complaining of CND and matched control subjects were enrolled in the study. Retrograde ileoscopy with biopsy was attempted in all cases. Endoscopic and histological features of Crohn's disease, nonspecific ileitis, and nodular lymphoid hyperplasia were recorded for each patient. Exclusion criteria were presence of any colonic alterations at either endoscopy or histology as well as failure of ileal intubation. RESULTS: Overall, 156 patients were recruited. Ileal intubation was successful in 149 (95.5%), but 11 (7%) patients were excluded because colonic diseases were detected at histology. At endoscopy, alterations of the terminal ileum were significantly more frequent in patients than in controls (47/138 vs 15/138; p < 0.0001). Crohn's disease (9/138 vs 0/138; p = 0.007) and nonpecific ileitis (18/138 vs 2/138; p = 0.0009) were significantly more frequent in patients than in controls as well as nodular lymphoid hyperplasia (33/138 vs 16/138; p = 0.008). A final diagnosis of Crohn's disease was achieved on the basis of both endoscopic and histological findings in eight (5.8%) patients. CONCLUSIONS: Retrograde ileoscopy is an useful procedure in CND because of its ability to detect alterations in the terminal ileum. Its inclusion in diagnostic workup should be considered.     

Chemotherapy in advanced gastric cancer: a controlled, prospective, randomised multi-centre study.

Seventy-six patients with advanced gastric adenocarcinoma were studied in a prospecitive, randmoised, controlled trial using vincristine, methotrexate, cyclophosphamide, and 5-fluorouracil in an initiation course and mitomycin-C with 5-fluorouracil as maintenance therapy. Thirty-seven patients were inoperable and 39 had the primary tumour resected with histological evidence of residual disease. Survival in the inoperable group was short and showed no significant difference between treated and control patients. The median survival times for treated and control groups were 9.5 and 9.0 weeks respectively. In the resected patients there was no difference in ultimate overall survival between the groups but up to 20 weeks there was a suggestion that the probability of survival in treated patients was higher (P = 0.06). The patients were well-matched and it is concluded that chemotherapy has had an early effect but that a further trial with more detailed stratification, particularly of staging and histological grade, is needed. No patient received treatment for longer than two years and unacceptable toxicity occurred in only two patients. Nausea occurred more frequently in the treated group but was short-lived and clinically manageable.     

Corticosteroid injections in polymyalgia rheumatica: a double-blind, prospective, randomized, placebo controlled study

OBJECTIVE: To determine the efficacy and safety of shoulder corticosteroid injections in polymyalgia rheumatica (PMR). METHODS: Twenty consecutive patients with active PMR were randomized into a 7 month, double blind, placebo controlled study. Patients received either bilateral shoulder injections of 40 mg of 6-methylprednisolone acetate or placebo (1 ml saline solution). Responders were treated weekly with the same regimen for a total of 4 bilateral injections and then followed for 6 months. Response was defined as a 70% reduction in visual analog scale (VAS) score for pain and for patient and physician global assessment, and duration of morning stiffness. Bilateral shoulder magnetic resonance imaging (MRI) was performed at different times to evaluate the response of lesions to therapy. RESULTS: All 10 corticosteroid treated patients responded to the first injection with a significant reduction in duration of morning stiffness, VAS pain scale, patient and physician global assessment, erythrocyte sedimentation rate, and C-reactive protein. Interleukin 6 serum levels were significantly reduced after the 2nd injection. In 5 patients, the response persisted throughout the followup period. The other 5 withdrew within 4 weeks after the 4th injection due to recurrence of symptoms. None of the 10 patients of the placebo group responded to the first injection. The difference between the 2 groups was significant (p = 0.03). No side effects were recorded. MRI showed marked improvement of shoulder lesions one week after first injection and an almost complete resolution one week after last injection in the responders. CONCLUSION: Shoulder corticosteroid injections seem to be an effective and safe therapy for PMR.