Chronic Diarrhea

Twenty-four patients (16 men and 8 women, ages ranging from 21 to 76 years) had relatively severe chronic diarrhea due to a variety of causes: functional enterocolonopathy (3), Crohn's disease of the ileum or colon (8) [5 had undergone moderate to extensive resections], non-specific ulcerative colitis (7) [1 with ileorec- tal anastomosis], abdominal carcinomatosis (4) [1 with irradiation proctitis and ileitis], and diver- ticulosis (2) [1 with ileosigmoid fistula].² Daily stools passed ranged from 2 to 25, with bowel movements among individual patients averaging between 6.8 to 11.1 stools per day. Patients were given polycarbophil or psyllium mucilloid in a daily dose of 5 g divided into two equal doses administered at 12-hour intervals with 8 ounces of water. Some patients were given a kaolin-pectin preparation (not specified) in 1-ounce doses 4 times daily. Medication was continued for 2 weeks; some patients participated in trials with other medications. Food and liquid intakes were recorded.

The rate of stool passage decreased to an average of 2.3 to 3.3 per day in 63% of trials with polycarbophil and 67% of trials with psyllium mucilloid; the difference was not statistically significant. Kaolin-pectin preparation failed to show any effectiveness in reducing the frequency of stools.

Improved stool consistency was reported in 73% of trials with polycarbophil and in 67% of trials with psyllium mucilloid, with the relief of tenesmus being subjectively more effective with polycarbophil.

In those cases in which both polycarbophil and psyllium mucilloid had been tried (each for 2 weeks), the subjective impression of investigators and patients were combined to arrive at an estimate of relative efficacy of the two preparations; polycarbophil was thought to be better than psyllium mucilloid by 49% of the patients, the same as psyllium mucilloid by 33%, and inferior to psyllium mucilloid by 8%.

The effect of orally administered calcium polycarbophil on gastrointestinal transit was evaluated radiographically in 14 patients (7 males, 7 females), aged 30 to 79 years.¹⁷ Twelve of the patients had chronic diarrhea of functional or organic origin poorly responsive to symptomatic treatment. Diagnoses included functional diarrhea (3), chronic ulcerative colitis (2), regional ileitis (2), diverticulosis (2), postcolectomy diarrhea (1), cholelithiasis with reflex diarrhea (1), and chronic gastrogenous diarrhea (1).Two additional subjects had gastrointestinal disorders (1 with duodenal ulcer; 1 postgastrectomy) without diarrhea or rapid transit. A standard barium meal was ingested with evaluations at 1, 3, 24 and 48 hours. A period of time after the initial study was permitted for the bowel to be cleared of barium; thereafter, oral calcium polycarbophil suspension equivalent to 1 g polycarbophil was given 4 times daily for 4 days; the barium studies were repeated on the 5th day with the subject continuing to take the medication.

Each patient served as his own control. The degree of retarded transit was appraised as none, slight, moderate, or marked. Marked retardation was defined as complete retention of the barium at 48 hours; moderate was defined as less complete retention, but with at least a fair amount of barium retained in the colon. The 2 patients without diarrhea showed no change in the rate of movement of the barium; 9 of the 12 patients showed moderate or marked slowing of gastrointestinal transit, and 2 showed slight slowing.

No information on dietary habits, degree of activity, concomitant medications, etc. was reported.

Adverse Effects

Many subjects receiving polycarbophil or its calcium analog at the recommended daily dose of 4 to 5 g do not register any complaints or describe side effects. When complaints are made, epigastric fullness or heaviness, abdominal bloating and distention, and flatulence are most common (Table 4).

Table 4. Adverse Effects Reported With the Administration of Polycarbophll

^alncreased with both polycarbophll and psyllium mucilloid.

^bGastrointestinal symptoms subsided while continuing to take medication.

^clnitial dosage of 4 g daily was reported as resulting in a "jell-like fecal mass of approximately 300 grams."

^dDaily administration of resin for periods ranging up to two years of continuous use were deemed safe, free from gastrointestinal irritation, or toxicity, or electrolyte imbalance.

^eln 2 children, whose diarrhea was associated with vomiting, regurgitation followed the administration of calcium polycarbo- phil.

^fBoth medications were well-accepted and well-tolerated.

9Two patients complained of severe abdominal cramping and subsequently vomited 2 to 3 days after initiating treatment: polycarbophll in one and psyllium mucilloid in the other; one patient had moderate tubular narrowing of the colon due to ulcerative colitis; the other patient had extensive ileitis with fixation of multiple loops of bowel. No evidence of obstruction in either case was documented, and symptoms subsided spontaneously after discontinuance of the drugs.

Precautions

As with all bulk-forming agents, calcium poly- carbophil should not be used in patients with stenotic lesions compromising the lumen of the gastrointestinal tract.

Acknowledgement

The assistance of Elmer R. Deffenbaugh, R.Ph., Manager of Product Information, Pharmaceutical Division, A. H. Robins Company, Richmond, Virginia 23220, in providing safety and efficacy information on calcium polycarbophll is acknowledged.