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.

Fat absorption in patients with functional intestinal lymphangiectasia and lymphangiectic cysts.

Nine patients with endoscopically identified dilated lacteals of the duodenum were studied for evidence of pathologic intestinal lymphangiectasia. Three of the nine patients also had lymphangietic cysts in association with dilated lacteals. Duodenal biopsies, laboratory data, and imaging studies were performed in each patient. In addition, a 14C triolein fat absorption study was performed to assess subclinical malabsorption. Biopsies revealed dilated lymphatic channels in all patients, but laboratory studies failed to suggest intestinal losses of protein or fat, and radiographic abdominal imaging failed to define any of the causes of secondary lymphangiectasia. Eight of the nine patients had adequate fat absorption as measured by the 14C triolein breath test. Our data suggest that patients with incidentally discovered dilated lacteals and no clinical evidence of malabsorption may have a functional intestinal lymphangiectasia. Follow-up endoscopy probably is not warranted in this population.

Cholecystokinin cholescintigraphy: detection of abnormal gallbladder motor function in patients with chronic acalculous gallbladder disease.

CCK cholescintigrams were performed in 374 patients with recurrent postprandial right upper quadrant pain, biliary colic, and a normal gallbladder sonogram and/or cholecystogram. The results of these examinations were correlated with the patients' final medical/surgical diagnoses. Twenty-seven patients recruited as control volunteers without objective clinical evidence of biliary disease also underwent CCK cholescintigraphy to determine if the degree of gallbladder contraction post-CCK differs in symptomatic versus asymptomatic subjects. Decreased gallbladder motor function was identified (maximal gallbladder ejection fraction response to CCK less than 35%) in 94% of patients with histopathologically confirmed chronic acalculous cholecystitis or the cystic duct syndrome and in 88% of patients clinically believed to have chronic acalculous biliary disease. Decreased gallbladder motor function does not distinguish symptomatic from asymptomatic gallbladder disease.

Endoscopic appearance and significance of functional lymphangiectasia of the duodenal mucosa.

Intestinal lymphangiectasia is found in a wide variety of pathologic conditions. Functional lymphangiectasia has not been well characterized. We report 20 patients followed for 9 to 55 months (mean 30 months) after incidental detection at endoscopy of lymphangiectasia. Our study indicates that functional lymphangiectasia is not pathologic and does not warrant repeat endoscopy in the absence of other clinical indications.

Amebic colitis masquerading as acute inflammatory bowel disease: the role of serology in its diagnosis.

Amebic colitis needs to be considered in the differential diagnosis of infectious colitis or inflammatory bowel disease (IBD). Misdiagnosing amebic colitis as idiopathic inflammatory disease may be fatal. Although stool studies remain the initial approach to diagnosis, the incidence of false-negatives associated with this method is high. We report two cases of amebic colitis presenting as inflammatory bowel disease in which the diagnosis of amebic colitis was made by serology. Neither patient had any risk factors for acquiring amebiasis. Paired serology for amebic infections (2-4 weeks apart) should be performed in patients being evaluated for infectious colitis and inflammatory bowel disease.

Detection of heterotopic gastric mucosa in the upper esophagus with 99mTc-pertechnetate scintigraphy.

Five patients with patches of gastric fundal type columnar epithelium in the proximal esophagus at the level of the upper esophageal sphincter diagnosed by upper endoscopy underwent 99mTc-pertechnetate scintigraphy (TcO4-). In all instances, the patches contained both chief cells and mucus-secreting cells. One patient had dysphagia localized to the area of columnar epithelium. Two cases of heterotopic gastric mucosa in the upper esophagus (HGM-UE) were demonstrated by TcO4-. In both, thyroid uptake was absent due to complete suppression of thyroid function by thyroid hormone supplements. TcO4- accumulated in thyroid glands of the other three patients, causing overlapping activity between the thyroid gland and HGM-UE. TcO4- scintigraphy is suitable for the detection of HGM-UE only in those patients who have had a total thyroidectomy or are on suppressive thyroid therapy.

Angiolipoma of the stomach as a cause of chronic upper gastrointestinal bleeding.

Angiolipomas are benign vascular fatty neoplasms, usually found in the subcutis of the trunk. Gastric angiolipomas have not been described. We report a gastric angiolipoma causing chronic gastrointestinal bleeding that did not respond to electrocoagulation and required surgical resection. Its classic endoscopic appearance is described. It may be managed endoscopically, utilizing either heater probe or laser photocoagulation and, therefore, should be recognized endoscopically prior to treatment.

CT diagnosis of dorsal pancreas agenesis.

We report a case of agenesis of dorsal pancreas diagnosed by CT. This anomaly can easily be confused with pancreas divisum on endoscopic retrograde cholangiopancreatography alone.

Ectopic gastric mucosa in proximal esophagus. Its clinical significance and hormonal profile.

We have found 20 cases of ectopic gastric mucosa in the proximal esophagus. Five patients had symptoms, usually a burning sensation in the neck and/or dysphagia. We report the results of immunoperoxidase staining of this tissue for gastrin, somatostatin, vasoactive intestinal peptide, and bombesin. In 85% of biopsy specimens tested, one or more polypeptides were present. Gastrin and bombesin were found more frequently in symptomatic patients, and somatostatin in asymptomatic patients. Chronic inflammatory changes were more frequent in symptomatic patients.

Cholecystokinin cholescintigraphic findings in the cystic duct syndrome.

Fourteen patients with a cystic duct syndrome (CDS) underwent cholecystokinin (CCK) cholescintigraphy. All patients presented with persistent postprandial right upper quadrant pain and biliary colic. None of the patients had an abnormal oral cholecystography, gallbladder (GB) ultrasound exam or upper GI series. Each patient (NPO after 12 a.m.) received 5 mCi of technetium-99m disofenin. When the GB maximally filled, 0.02 microgram/kg CCK was administered (3 min) intravenously. Background corrected gallbladder ejection fractions (GBEFs) were determined every 5 min X 4 by rationing the pre-CCK GB counts minus post-CCK GB counts to pre-CCK GB counts. GBEFs were: 12% (3 patients), 17% (2), 0%, 1.3%, 3%, 4%, 6%, 11%, 14%, 18.5%, and 22% (1 each). All patients underwent a surgical exploration and all had macro- or microscopically abnormal cystic ducts (five fibrotic, seven elongated and narrow, two kinked) with (12 patients) or without (2 patients) concomitant chronic cholecystitis. No patient with a partially occluded cystic duct with or without concomitant chronic cholecystitis had an ejection fraction that exceeded 22%. In an appropriate clinical setting, a low EF response to CCK should alert the physician to the presence of either chronic acalculous cholecystitis, CDS, or the combination of both.

Crohn's disease with persistence of Clostridium difficile, surgical elimination.

Clostridium difficile has been associated with increased activity of Crohn's disease in some patients, and in them its eradication has proved beneficial. We have seen a patient unresponsive to two courses of vancomycin with persistence of C. difficile colonization and toxin production in whom surgical intervention eliminated the C. difficile cytotoxin and organism.

The dilated common duct sign. A potential indicator of a sphincter of Oddi dyskinesia.

The cholescintigraphic findings of a Sphincter of Oddi dyskinesia (SOD) in a 45-year-old woman with persistent right upper quadrant pain and biliary colic are reported. After an overnight fast, the patient was injected with 5 mCi of Tc-99 disofenin and .02 micrograms/kg of cholecystokinin (CCK) post maximal gallbladder filling. Pre and postcholescintiscans were obtained and gallbladder ejection fractions determined. The hepatobiliary scan was normal, except for a delay in biliary-bowel transit. The gallbladder responded normally to CCK, however, the Sphincter of Oddi responded abnormally, as there was a paradoxical response to CCK manifested by a marked dilatation of the common bile duct. We postulate that this dilatation (the dilated common duct sign) was due to an inappropriate response of the smooth muscle of the Sphincter of Oddi (contraction vs relaxation) to CCK and was the cause of this patient's biliary colic. The dilated common duct sign should alert the physician to the possibility of a Sphincter of Oddi dyskinesia.

Electromyelography, a useful test for evaluation of the sacral spinal cord.

Bradley was the first to describe an accurate and objective test for the evaluation of the integrity of the sacral spinal cord involved with micturition. Measurements of the latency time from an electrical stimulation of the proximal urethra and its response, the contraction of the anal sphincter, was found to be approximately 70 msec. The neural pathways involved with this reflex include the afferent pelvic nerves and the efferent pudendal nerves. Prolonged latency times signify damage to this sacral arc. This testing, which Bradley termed electromyelography, can help to diagnose, in a more definitive fashion, some abnormalities of micturition. We report on 3 patients with varied lesions of the sacral neural pathways and their urodynamic evaluation, including cystometry, sphincter electromyography and measurements of latency times of evoked responses of the anal sphincter. All 3 cases showed prolonged latency times with 1 reverting to normal after improvement of the underlying disorder. The usefulness of electromyelography and its ease of implementation are stressed. Measurements of evoked response may be an important addiction in the evaluation of complicated neurourological problems.