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PubMedDate not supplied

Loperamide-simethicone vs loperamide alone, simethicone alone, and placebo in the treatment of acute diarrhea with gas-related abdominal discomfort. A randomized controlled trial.

CONTEXT: Acute diarrhea with gas-related abdominal discomfort is a common, usually self-limited disorder with substantial social and economic impact. OBJECTIVE: To compare the efficacy and safety of a loperamide hydrochloride-simethicone combination product with those of loperamide alone, simethicone alone, and placebo in treating acute diarrhea with gas-related abdominal discomfort. DESIGN: Randomized, placebo-controlled, double-blind trial of 48 hours' duration. SETTING: A primary care, ambulatory practice in Acapulco, Mexico. PATIENTS: A total of 493 outpatient adults aged 18 to 63 years, with acute nonspecific diarrhea with at least moderately severe abdominal discomfort. INTERVENTIONS: Each patient was randomly assigned to receive 2 chewable tablets containing loperamide hydrochloride, 2 mg, and simethicone, 125 mg (n = 124); loperamide hydrochloride, 2 mg (n = 123); simethicone, 125 mg (n = 123); or placebo (n = 123). This was followed by 1 tablet after each unformed stool, up to 4 tablets in any 24-hour period. MAIN OUTCOME MEASURES: Time to last unformed stool and time to complete relief of gas-related abdominal discomfort were the protocol-specified primary outcomes. Secondary outcomes included time to complete relief of diarrhea, number of unformed stools, and patient-assessed variables at the end of the study (overall illness relief, diarrhea relief, and abdominal discomfort relief). RESULTS: Patients who received loperamide-simethicone had significantly (P < .001) shorter time to last unformed stool and faster relief of gas-related abdominal discomfort than patients who received loperamide, simethicone, or placebo alone. Loperamide-simethicone was significantly (P < or = .01) more effective than the other 3 treatments for all end-of-study patient-assessed outcomes and all clinically important secondary outcomes. No significant differences in adverse events were found among treatment groups. CONCLUSIONS: The loperamide-simethicone combination chewable product provides faster and more complete relief of acute nonspecific diarrhea and associated gas-related abdominal discomfort (gas pain, cramps, gas pressure, and bloating) than either of its components or placebo. The combination is well tolerated.

Abdominal Pain↗
PubMed1999

Studies on the antidiarrhoeal properties of pentaclethra macrophylla leaf extracts.

The aqueous (WE) and ethanol (EE) leaf extracts of Pentaclethra macrophylla were tested for antidiarrhoeal activity using experimental animal models. The i.p. LD50 values were established to be 770 mg/kg and 280 mg/kg for the aqueous (WE) and ethanol (EE) extracts, respectively. Antidiarrhoeal potential of the extracts was evidenced by a significant reduction in faecal output and protection from castor oil-induced diarrhoea in rats treated with the extracts. In addition the extracts significantly (p < 0.05) decreased propulsive movement of gastrointestinal contents in mice. On isolated tissue preparations, the extracts significantly reduced in a non-specific manner contractions evoked by acetylcholine, nicotine and histamine. The extracts inhibited the growth of common pathogenic microorganisms. The antispasmodic as well as the antimicrobial effects of the extracts may explain the rationale for the use of the plant in traditional medicine as a popular antidiarrhoeal recipe.

Animals↗
PubMed1999

Relationship between the antidiarrhoeal effects of Hange-Shashin-To and its active components.

This study was designed to examine the relationship between the antidiarrhoeal effects of Hange-Shashin-To (TJ-14) and its active components. Oral treatment with TJ-14 at 1000 mg/kg significantly inhibited castor oil-induced diarrhoea. Both the 50% methanol eluate fraction (fraction III) and the methanol eluate fraction (fraction IV) showed antidiarrhoeal effects at oral doses of 68 mg/kg and 63 mg/kg, respectively, corresponding to 1000 mg/kg of TJ-14. TJ-14 (1000 mg/kg, p.o.) showed a significant increase in blood corticosterone levels. Increased blood corticosterone was noted after the oral administration of 63 mg/kg of fraction IV. The inhibitory activity of TJ-14 on cyclooxygenase-2 (COX-2) was also observed in fractions III and IV. The main component of fraction III was Scutellariae Radix-derived baicalin. Fraction IV contained Glycyrrhizae Radix-derived glycyrrhizin and isoliquiritin, Coptidis Rhizoma-derived berberine, coptisine and palmitine. Ginseng Radix-derived saponins were also present in fraction IV. These compounds inhibited castor-oil induced diarrhoea at oral doses of 10 or 30 mg/kg. Thus, the present results indicate that Scutellariae Radix, Glycyrrhizae Radix, Ginseng radix and Coptidis Rhizoma-derived components are involved in the antidiarrhoeal action of TJ-14.

Animals↗
PubMed2000

Evaluation of antidiarrhoeal profile of Jussiaea suffruticosa linn. extract in rats.

The antidiarrhoeal potential of a methanol extract of the aerial parts of Jussiaea suffruticosa Linn. (MEJS) was studied with several experimental models of diarrhoea in rats. MEJS treated rats showed significant inhibitory activity against castor oil induced diarrhoea and PGE(2) induced enteropooling. It also showed a significant reduction in gastrointestinal motility following a charcoal meal in rats. The extract exhibited significant antidiarrhoeal potential at doses of 100,200 and 300 mg/kg in all the animal models and thus established the efficacy of MEJS as a potent antidiarrhoeal agent.

Animals↗
PubMed1995

Randomized trial of loperamide versus dose escalation of octreotide acetate for chemotherapy-induced diarrhea in bone marrow transplant and leukemia patients.

This study compares maximal daily doses of loperamide to escalating doses of continuous intravenous (CI) octreotide acetate in bone marrow transplant (BMT) and leukemia patients. Following chemotherapy, BMT and leukemia patients who developed > or = 600 ml of stool volume in a 24-hr period were randomized to receive loperamide 4 mg po q6h or octreotide 150 micrograms mixed in hyperalimentation solution or normal saline and administered CI. Patients were assessed at 48 hr intervals for decrease in stool volume from baseline. Complete response (CR) was defined as > or = 50% from baseline stool volume (BSV). Patients receiving octreotide who did not achieve a CR at 48 hr were dose escalated by doubling the dose to a maximum of 2,400 micrograms with evaluations at 48 hr intervals. Patients receiving loperamide who did not achieve a CR at 48 hr had treatment discontinued. A total of 36 patients were enrolled in the study. Of these, all were evaluable for intention to treat, and 31 were evaluable for initial response. Based on intent to treat at the initial 48 hr, patients receiving loperamide had a higher complete response rate (86% vs. 45%, P = 0.033) than did those who received octreotide. By treatment analysis (patients who actually received the drug), patients receiving loperamide had a higher complete response rate (92% vs. 56%, P = 0.0448) than did those who received octreotide at the 150 micrograms dosage level. Additional octreotide patients eventually achieved a CR at a higher dosage level (78%). Loperamide at maximal doses of 4 mg po q6h is more effective than octreotide 150 micrograms CI in treating diarrhea following chemotherapy in BMT and leukemia patients. Higher doses of octreotide may be required in a significant number of patients not responding to lower doses.

Adult↗
PubMed2005

Synthesis by microwave irradiation and antidiarrhoeal activity of benzotriazinone and saccharine derivatives.

The synthesis by microwave irradiation and the biological results of novel benzotriazinone and saccharine derivatives with potential antidiarrhoeal activity is described. Conventional and microwave heatings were compared for the reactions. Good yields and short reaction times are the main advantages of our synthetic route. Among the tested compounds, compound 12 inhibited motility both in in-vitro and in-vivo tests.

Animals↗
PubMed1978

A "carrier effect" observed in assay of antidiarrhoeal drug compounds.

A carrier effect has been shown to exist in a stable isotope dilution assay for diphenoxylate. When a tetradeuterated analogue is used as a carrier and internal standard a sevenfold increase in sensitivity is observed for the unlabelled compound. Examination of a related pharmacologically active compound (SC-27166) showed a much smaller effect.

Antidiarrheals↗
PubMedDate not supplied

Pharmacology, toxicology, clinical efficacy, and adverse effects of calcium polycarbophil, an enteral hydrosorptive agent.

Calcium polycarbophil is the calcium salt of polyacrylic acid crosslinked with divinyl glycol. It is chemically and physiologically inert. In dilute alkali it possesses marked hydrophilic capacity (60 to 100 times its weight), which is the basis for its therapeutic use. In daily dosages of 4 to 5 g in adults, it appears to be quite safe, is non-toxic, does not interfere with digestion or absorption, and does not cause gastrointestinal irritation. It appears to be effective in the treatment of both constipation and diarrhea due to functional or organic causes. Several days of continuous use are necessary before effectiveness becomes apparent. Clinical studies, of which there are relatively few, range from uncontrolled, unblinded evaluations of an almost anecdotal nature to well controlled, double-blind, crossover studies. Additional carefully controlled studies on dietary influences, exercise, and patient compliance would be helpful. Adverse effects, which are minimal, include epigastric fullness or heaviness, abdominal distention and bloating, and flatulence. As with all bulk-forming agents, calcium polycarbophil should not be used by persons who have stenotic lesions of the gastrointestinal tract.

Acrylic Resins↗
PubMedDate not supplied

Drug therapy of inflammatory bowel disease.

Although the etiology of inflammatory bowel disease is unknown and specific therapy is unavailable, enough information on existing empiric agents is available to allow rational therapy. These agents include sulfasalazine, steroids, immunosuppressive drugs, metronidazole and cholestyramine. Sulfasalazine is a two-part molecule that depends on bacterial cleavage in the colon to deliver locally acting 5-aminosalicylate, whose mechanism of action may relate to inhibition of prostaglandin synthesis. The other half of the molecule, sulfapyridine, is responsible for most of the side effects of the drug. While the efficacy of sulfasalazine in the treatment and prevention of attacks of ulcerative colitis is well established, its use in Crohn's disease appears to be limited to patients with active colitis and ileo-colitis. Sulfasalazine is of major benefit in preventing relapses in patients with ulcerative colitis in remission. New formulations of 5-aminosalicylate may allow delivery of the apparently active moiety to the small bowel and colon without concomitant sulfapyridine toxicity. Corticosteroids are highly effective in acute attacks of ulcerative colitis and Crohn's ileitis and ileo-colitis; the mechanism of antiinflammatory action remains speculative. However, maintenance therapy with steroids is ineffective in preventing relapses or recurrent attacks of either ulcerative colitis or Crohn's disease. Steroid enemas allow topical administration to patients with distal colitis and proctitis with few systemic side effects. In children with growth failure associated with active Crohn's disease, amelioration by steroid therapy may actually restore normal growth. Immunosuppressive agents such as azathioprine and 6-mercaptopurine are of little value in active Crohn's disease when administered alone; however, in combination with other agents they may help diminish steroid dose, close fistulae and prevent relapse. Their mode of action likely depends on long-term cytostatic effects on immune effector cells. Concern for leukopenia and the development of late malignancy has limited their use to patients not responding to other therapies. Metronidazole, an antimicrobial agent that is effective against anaerobes, has recently been shown useful in Crohn's disease involving the colon and perianal area. Its mechanism of action is uncertain, but may be related to its antibacterial actions on anaerobes. Cholestyramine can be successfully used to control bile salt-induced diarrhea in Crohn's patients with terminal ileal resections. Effective drug therapy of inflammatory bowel disease is only part of a total program of management including reassurance, frequent explanation, well-timed use of surgery, and an understanding physician.

Adjuvants, Immunologic↗
PubMed1993

Lack of inhibition of adhesion of an enteropathogenic Escherichia coli by polycarbophil.

Anionic polyacrylic acid polymers, such as polycarbophil, have a number of properties that would make them suitable carriers for sustained antibiotic release formulations in the intestinal tract. However, little is known with regards to possible microbial adhesion to polycarbophil. The aim of this study was to evaluate for such an interaction using the rabbit enteric pathogen Escherichia coli RDEC-1 (serotype O15:H-). RDEC-1 mediates attaching and effacing binding to intestinal epithelium in a manner morphologically identical to that observed in both human enteropathogenic E. coli and enterohemorrhagic E. coli infections. RDEC-1 bacteria were grown to promote the expression of the mannose-resistant AF/R1 adhesion pili. A nonpiliated mutant, strain M34, was used as a negative control. Using radioactive labeling of bacteria, we quantitated adhesion of piliated RDEC-1 in the presence of polycarbophil using an in vitro adhesion assay system. Binding of piliated RDEC-1 in the adhesion assay was greater than for nonpiliated M34 for all concentrations of bacteria greater than 10(9) (P < .05). Polycarbophil did not cause concentration-dependent inhibition of piliated RDEC-1 binding (P > .05). We conclude polycarbophil does not interfere with the AF/R1 adhesin ligand of RDEC-1. Use of this polymer as a mucoadhesive drug delivery vehicle for nonabsorbable antibiotics in the treatment of gastrointestinal infections would not be expected to interfere with the protective effects of intestinal mucins.

Acrylic Resins↗