Clinical trial: an efficacy evaluation of reduced bisacodyl given as part of a polyethylene glycol electrolyte solution preparation prior to colonoscopy.

BACKGROUND: In an attempt to further improve patient preparation experience with reduced volume gut lavage solutions using 2-L sulphate-free electrolyte lavage solution plus 20-mg bisacodyl (HalfLytely with Bisacodyl Tablets Bowel Prep Kit, Braintree Laboratories, Inc., Braintree, MA, USA), a low bisacodyl dose preparation was developed using 10 mg bisacodyl. AIM: To compare preparation methods using the 10- or 20-mg bisacodyl with 2-L sulphate-free electrolyte lavage method. METHODS: At 10 US centres, 455 patients undergoing colonoscopy for routine clinical indications were equally randomized to receive 10- or 20-mg bisacodyl with 2-L sulphate-free electrolyte lavage method. Colonoscopists rated the efficacy of colon cleansing, blinded to the preparation assignment. RESULTS: Physician assessment of colon cleansing showed no difference between those randomized to receive the 10- or 20-mg bisacodyl preparations (P = 0.52). The 10-mg preparation had lower symptom scores for cramping (P < 0.001) and overall discomfort (P = 0.001). Other reported adverse experiences were few, mild and not different between groups. CONCLUSION: Two-litre sulphate-free electrolyte lavage method solution with 10-mg bisacodyl is as effective as the 20-mg bisacodyl preparation for cleansing the colon prior to colonoscopy. The 10-mg bisacodyl regimen has an improved safety profile, with significantly reduced cramping, nausea and overall discomfort.

Review article: colon cleansing preparation for gastrointestinal procedures.

Adequate cleansing is essential for reliable diagnostic and surgical colon procedures. Accuracy and safety depend on good preparation. Patient compliance is enhanced by simplicity and well-tolerated methods. Several methods are available. Diet and cathartic regimens utilize clear liquids or diets designed to leave a minimal colonic residue. Laxatives, cathartics and enemas are employed. Gut lavage solutions are osmotically balanced electrolyte lavage products. Oral sodium phosphate solutions and tablets are available and are attractive because of good efficacy with a small volume of administration. For colonoscopy and colon surgery preparation, these methods have been proven safe and effective. For barium enema X-ray, lavage requires an adjunctive agent such as bisacodyl to enhance barium coating. Overall, all regimens are well-tolerated. This review discusses the development and clinical experience with various colon cleansing regimens.

Management of severe gastroesophageal reflux disease.

Gastroesophageal reflux disease (GERD) affects more than one third of the population. It is generally a chronic condition and has the potential to be serious. Some patients with GERD experience persistent daytime or nighttime heartburn and some sustain severe damage, including ulceration, stricture, and Barrett's esophagus, which can predispose to development of adenocarcinoma. Extraesophageal manifestations of GERD can include otolaryngologic, respiratory, and cardiac problems. Severe GERD responds best to agents that suppress gastric acid secretion. Of these, proton pump inhibitors (PPIs) provide the most effective control of gastric acidity and are, therefore, the medical treatment of choice. In fact, nonresponse to a PPI should raise the suspicion that the diagnosis is not GERD. Proton pump inhibitors are quickly becoming the treatment of choice for GERD, especially for severe or refractory cases. For patients whose GERD is refractory even to PPIs or who are unwilling to face years of PPI therapy, antireflux surgery remains an option.

A randomized, placebo-controlled, multicenter study of the safety and efficacy of a new polyethylene glycol laxative.

OBJECTIVE: This study was designed to determine the efficacy and safety of a new laxative, Braintree polyethylene glycol (PEG) laxative (Miralax, Braintree Laboratories, Braintree, MA). METHODS: This investigation was designed as a placebo-controlled, blinded, randomized, multicenter parallel trial. Study subjects were constipated but otherwise healthy outpatients who had < or =2 stools during a 7-day qualification period. Braintree PEG laxative 17 g or dextrose placebo p.o. in 8 oz of water for a 14-day treatment period. A diary recorded each bowel movement and subjective symptoms of stool consistency, ease of passage, cramps, and flatus. CBC, blood chemistries and urinalysis were performed before and after the treatment period. RESULTS: There were 151 randomized subjects, 131 female and 20 male. An increase in bowel movement frequency was observed with the PEG laxative as compared to placebo (p<0.001), with the greatest difference in efficacy in wk 2 of treatment (p<0.001). By wk 2 of treatment, on average, placebo subjects had 2.7 bowel movements/wk and PEG-treated study subjects had 4.5 movements/wk (p<0.01), or more than one bowel movement every 2 days. Investigator (p<0.005) and patient (p<0.001) subjective assessment of perception of treatment effectiveness, and patient evaluations of stool consistency and passage showed significant improvement in the active treatment group (p<0.001). There were no significant differences in laboratory changes or adverse experiences recorded between groups. CONCLUSION: Braintree PEG laxative is safe and effective in the short term for the treatment of constipation.

Irritable bowel syndrome and lactose maldigestion in recurrent abdominal pain in childhood.

BACKGROUND: The aim of this study was to evaluate the impact of irritable bowel syndrome (IBS) and lactose maldigestion in children with recurrent abdominal pain. METHODS: Children who had abdominal pain associated with defecation or change in bowel habit, disordered defecation, and distension were diagnosed with IBS, and lactose maldigestion was defined by lactose breath hydrogen testing. Children with IBS were managed with increased fiber intake, while those with lactose maldigestion restricted dietary lactose. A telephone survey was conducted to determine the response to treatment. RESULTS: The mean age of the 59 boys and 87 girls was 9.5 +/- 3.0 years. Children with IBS and lactose maldigestion had more frequent abdominal pain than children without these conditions, but they required less medication for relief of symptoms. CONCLUSIONS. Lactose maldigestion may be a contributory factor in children with IBS, and lactose avoidance in these patients may reduce medication use to relieve symptoms.

Obscure gastrointestinal bleeding.

The process of unraveling small bowel pathology by endoscopic means may be the last frontier for gastroenterologists. When the source of blood loss remains obscure after upper and lower gastrointestinal endoscopy, small intestinal pathology becomes a considerarion. Traditionally, the 3 m of small bowel have been examined with contrast and nuclear radiology with discouraging results. Barium, smallbowel follow through x-rays have low yield. Enteroclysis is a radiographic technique using contrast and careful examination with a 10 to 25% diagnostic yield in obscure gastrointestinal bleeding. Nuclear bleeding scans and angiography have reported varying degrees of success.

Immune globulin and vaccine therapy to prevent hepatitis A infection.

The hepatitis A virus is usually transmitted person-to-person due to fecal-oral exchange of virus. Approximately 30,000 infections are reported each year in the United States, with the actual incidence being much greater. Prophylaxis with immune globulin has had a minimal impact on the overall incidence of hepatitis A. The recent availability and proven efficacy of a hepatitis A vaccine offers the hope that the incidence of infection may be substantially reduced. Pre- and postexposure prophylaxis should be targeted to individuals at increased risk of either acquiring infection, transmitting infection, or developing fulminant hepatitis, or to help control epidemics. This article reviews the current literature and discusses recommendations for pre- and postexposure prophylaxis against hepatitis A virus.

Bleeding ulcer: inject or clip?

The authors retrospectively compared endoscopic injection therapy with endoscopic hemoclipping by examining 113 patients over a 10-yr period between 1985 and 1995 who had gastrointestinal bleeding and who received one or the other procedure. Endoscopic injection using ethanol alone, epinephrine plus ethanol, or aethoxysclelol plus ethanol was performed in 87 cases. Endoscopic hemoclipping was performed in 26 cases from 1993 to 1995. The permanent hemostasis rate of endoscopic injection was 84% and that of endoscopic hemoclipping was 100%. Complications associated with endoscopic injection included enlargement of the ulcer bed, bleeding caused by exposed vessels within the expanded ulcer and one case of perforation. No complications were noted among patients treated with endoscopic hemoclipping.

Patient-controlled anesthesia for colonoscopy using propofol: results of a pilot study.

BACKGROUND: We studied the feasibility of using patient-controlled anesthesia (PCA) for conscious sedation during colonoscopy. METHODS: Patients having elective colonoscopy had medications delivered in bolus fashion by PCA pump (Abbot Lifecare Provider 5500 Infusion System). Four patients received propofol as 20 mg/dose boluses, and four patients received propofol in a 0.3 mg/kg/dose. Twelve patients received propofol at 0.2 mg/kg/dose with alfentanil at 4 microg/kg/dose. RESULTS: There were no clinically unacceptable changes in continuously monitored blood pressure, pulse rate, ECG, or respiratory rate. There were no adverse effects from the sedation and no complications due to colonoscopy. Recovery time was rapid, but recall persisted in most subjects. Pain and overall discomfort in patients given propofol only were rated as moderate by most subjects. CONCLUSION: Patient-controlled anesthesia is feasible for use in endoscopic sedation. Propofol alone did not allow adequate pain relief, but propofol and alfentanil together seemed to provide good control of pain.

Patient participation in colon cancer screening programs.

BACKGROUND: The objectives of this study were to survey compliance and identify factors that influence continued participation with periodic colon cancer screening guidelines once patients are seen for their first screening. METHODS: The study group consisted of 95 patients who had initial fecal occult blood tests (FOBT) and flexible sigmoidoscopy (FS) in 1991 as part of a gastroenterologist-directed, aggressively managed colon cancer screening registry. Regular notices are sent to patients and their primary care provider for annual FOBT and FS at 3- to 5-year intervals. RESULTS: Of 70 (74%) reviewed, 2 had died and 3 were having colonoscopic surveillance. Thirty-two of the 65 (49%) contacted eligible study subjects were no longer participating. Reasons stated were as follows: unaware that screening was due (14), too busy (6), unpleasant experience (3), and change to insurance provider that did not cover screening (9 [commercial-3, managed care-1, Medicare-5]). CONCLUSIONS: Despite aggressive program management, 44% of nonparticipators reported that they were unaware that screening was due. Sixteen percent of those who did not continue to participate had graduated to Medicare, which did not cover screening costs. Factors that influence continued participation need to be considered in the design of public education and marketing promotions.

Recurrent abdominal pain and lactose maldigestion in school-aged children.

Recurrent abdominal pain of childhood affects 10 to 15% of school-aged children and leads to disability and learning difficulties. Lactose maldigestion may be a causative or contributory factor that when identified may lead to improvement. Thus, formal diagnostic testing using breath hydrogen lactose challenge methods is encouraged. This review focuses on this important condition and management options.

Gastrointestinal lavage for colon cleansing.

Colon cleansing preparations for diagnostic and surgical procedures continue to be evaluated in an effort to improve the quality of colon exam. Modifications of older barium enema x-ray preparations have led to the development of many alternative forms of bowel cleansing. Formal study has allowed carefui comparison of gut lavage, diet and cathartic as well as oral sodium phosphate preparation. Gut lavage with electrolyte lavage solutions represents the most popular form of bowel preparation. Patient variability and special circumstances such as gastroparesis, surgically altered anatomy or patient preferences may dictate selection of colon cleansing preparations.

Does lactose maldigestion really play a role in the irritable bowel?

Patients who met International Congress of Gastroenterology criteria for irritable bowel syndrome (IBS) and had breath hydrogen lactose testing were interviewed to determine whether detection of lactose maldigestion (LM) had an impact on their symptoms. Of 199 patients initially evaluated, 161 (81%) were contacted and asked to rate their symptoms. At baseline, 47 (29%) of the IBS group had LM. Before testing, 23 (49%) were aware that ingestion of lactose-containing food was associated with their gastrointestinal symptoms. Lactose-maldigesting IBS subjects (IBSLM, n = 47) and those who had IBS and no LM (n = 114) were similar in terms of age, sex, and ethnic background. Interviews performed 41 +/- 1.1 (SEM) months after baseline evaluation revealed no significant differences in abdominal pain, altered bowel habits, bloating/distension, mucus, and relief with defecation among those with IBS or LMIBS. Overall symptoms resolved, improved, did not change, or worsened in a manner not statistically different between IBS and IBSLM groups. IBSLM subjects (a) felt that identifying LM helped them gain awareness of food-symptom relationships (78.7%), (b) experienced some improvement in symptoms (83%), (c) were avoiding lactose foods (87.2%), or (d) used lactase enzyme supplements (38.3%). Identifying LM did not significantly affect rated variables.

Biochemical effects of oral sodium phosphate.

Our objective was to monitor serum and urine biochemical changes after oral sodium phosphate cleansing in a prospectively designed study. The study subjects were seven healthy, asymptomatic adults. Sodium phosphate 45 ml diluted in 45 ml water was given orally at baseline and 12 hr later. Calcium, ionized calcium, phosphorus, sodium, potassium, creatinine, and PTH were analyzed at 2, 4, 6, 9, 12, 14, 16, 18, 21 and 24 hr after the first challenge. Urinary calcium, phosphorus, sodium, potassium, and cyclic AMP were analyzed at baseline and every 2 hr after oral sodium phosphate. Blood pressure, pulse, and respiratory rate were recorded every 2 hr and symptom questionnaires using visual analog scales were completed. A marked rise in phosphorus (peak range 3.6-12.4 mg/dl, P < 0.001) and falls in calcium (P < 0.001) and ionized calcium (P < 0.001) were seen. Rises seen in PTH and urinary cAMP confirmed the physiologic significance of the biochemical effect. There were no significant changes in other serum and urine laboratory or clinical assessments. Reported significant symptoms included bloating, cramps, abdominal pain, and nausea. Significant hypocalcemia and hyperphosphatemia after oral sodium phosphate raises concern about its use in normal individuals. Oral sodium phosphate should not be administered in patients with cardiopulmonary, renal, or hepatic disease.