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Fecal ammonia in patients with adenomatous polyps and cancer of the colon.

The correlation between high intakes of protein and high incidence of human colonic cancer is unexplained. Appreciable amounts of ammonia are generated in the large bowel through bacterial degradation of proteins and peptides, and experimental studies indicate that ammonia may select for neoplastic growth. Fecal concentrations of ammonia did not differ among 17 patients with former colonic adenomas [40.6 +/- 4.5 (SE) mM], 17 patients with former colonic cancer (51.4 +/- 3.9 mM), and 16 healthy controls (46.4 +/- 6.1 mM). By use of an in vitro fecal incubation system, possible alterations in bacterial fermentation and formation of ammonia were investigated. Fecal suspensions were incubated for 6 and 24 hours with and without addition of fermentable substrates (ispaghula husk, wheat bran, albumin, and glucose; 10 mg/ml). The in vitro production of ammonia in unsupplemented fecal homogenates from both groups of patients was comparable with the production found in homogenates from healthy controls, and the response to fermentable substrates was similar in all three groups. Addition of albumin caused a marked increase in the production of ammonia, and addition of glucose increased bacterial assimilation of ammonia considerably. These well-known characteristics of bacterial metabolism of ammonia apparently did not differ between healthy individuals and patients investigated more than three months after colonoscopic polypectomy or colonic cancer resection.

Adenoma↗

Ispaghula (Vi-Siblin) versus standard preparation for barium enema.

PURPOSE: To compare 2 methods of colonic cleansing before double-contrast barium enema. A standard preparation of bisacodyl was compared with a preparation of dietary fibre (ispaghula). MATERIAL AND METHODS: The patients referred for double-contrast barium enema were randomly allocated to one of the colonic cleansing regimens. The effectiveness and patient acceptance of the preparations were evaluated. RESULTS: There was a significantly poorer colon cleanness score in the ispaghula group (p = 0.0001). Patient tolerance of the 2 regimens was not significantly different. CONCLUSION: Ispaghula alone is not sufficient as a cleansing preparation for double-contrast barium enema.

Barium Sulfate↗

Development of modified release diltiazem HCl tablets using composite index to identify optimal formulation.

This article reports the preparation of tartaric acid treated ispaghula husk powder for the development of modified release tablets of diltiazem HCl by adopting direct compression technique and a 32 full factorial design. The modified ispaghula husk powder showed superior swelling and gelling as compared to untreated powder. Addition of compaction augmenting agent such as dicalcium phosphate was found to be essential for obtaining tablets with adequate crushing strength. In order to improve the crushing strength of diltiazem HCl tablets, to modulate drug release pattern, and to obtain similarity of dissolution profiles in distilled water and simulated gastric fluid (pH 1.2), modified guar gum was used along with modified ispaghula husk powder and tartaric acid. A novel composite index, which considers a positive or a negative deviation from an ideal value, was calculated considering percentage drug release in 60, 300, and 540 min as dependent variables for the selection of a most appropriate batch. Polynomial equation and contour plots are presented. The concept of similarity factor (f2) was used to prove similarity of dissolution in water and simulated gastric fluid (pH 1.2).

Compressive Strength↗

Modulation of drug release rate of diltiazem-HCl from hydrogel matrices of succinic acid-treated ispaghula husk.

The feasibility of using succinic acid-treated ispaghula husk in matrix-based tablets of diltiazem-HCl was investigated. The sample prepared using 4:1 weight ratio of ispaghula husk to succinic acid showed improved swelling and gelling. A 3(2) factorial design was employed to investigate the effect of amount of succinic acid-treated ispaghula husk and dicalcium phosphate (DCP) on the percentage of the drug dissolved in 60, 300, and 480 min from the compressed tablets. The results of multiple linear regression analysis revealed that the significance of the amount of succinic acid-treated ispaghula husk was greater in magnitude than that of the amount of DCP in controlling the drug release. Acceptable batches were identified from a contour plot with constraints on the percentage drug released at the three sampling times. A mathematical model was also evolved to describe the entire dissolution profile. The results of F-test revealed that the Higuchi model fits well to the in vitro dissolution data. The tablets showed considerable radial and axial swelling in distilled water. Succinic acid-treated ispaghula husk can be used as an economical hydrophilic matrixing agent.

Calcium Channel Blockers↗

Therapy-related café coronary deaths: two case reports of rare asphyxial deaths in patients under supervised care.

Café coronary deaths, as initially characterized, denote fatal occlusion of the upper airway by food substances. Such fatalities typically occur in individuals who either are clinically inebriated or have clinically significant neuromuscular dysfunction. Both conditions impair mastication and deglutition. The authors review the accidental deaths of two neurologically compromised patients under supervised care. Both subjects underwent complete medicolegal autopsy. In one case, ingestion of a prescribed emollient laxative precipitated death; in the other, death was attributable to aspiration of a contrast medium during a diagnostic radiographic procedure. These therapy-related deaths, which are regarded as a variation of the traditionally described café coronary fatalities summarized in the discussion, represent adverse events occurring during medical care. The adverse outcomes reviewed here are potentially avoidable and require special attentiveness by the clinicians directed to the particular condition of each patient. Such true aspiration-related deaths are confirmed on autopsy examination and are to be differentiated from the findings of agonal aspiration of gastric contents commonly encountered by the autopsy pathologist investigating deaths due to a great variety of natural and traumatic causes.

Aged↗

Physical exercise, use of Plantago ovata and aspirin, and reduced risk of colon cancer.

To evaluate certain risk and protective factors for colon cancer in our population, we conducted a paired case-control study where cases were all people diagnosed with colon cancer who were registered at the Cancer Data Exchange Systems of the Community of Madrid between January 1995 and December 1996, and controls were randomly taken from electoral lists. The study population consisted of 424 persons. Using SPSS for Windows, variables were adjusted by multiple logistic regression. The results indicate that lack of physical exercise is associated with an increased risk of colon cancer, with an odds ratio (OR) of 2.8 (95% confidence interval (CI) 1.28-6.21) as compared with moderate activity 1-2 days a week. The risk decreases linearly with increasing physical exercise, and this association remains after stratifying the analysis for the existence of constipation. The consumption of is associated with a reduced risk of colon cancer in constipated patients, with an OR of 0.094 (0.014-0.639), as is aspirin use, with an OR of 0.980 (0.898-0.999). These results were obtained after adjusting all the ORs for diet, smoking, alcohol consumption, family history and socio-demographic factors such as marital status and educational level.

Aged↗

Effect of administration of activated charcoal and fibre on absorption, excretion and steady state blood levels of digoxin and digitoxin. Evidence for intestinal secretion of the glycosides.

The effects of activated charcoal and fibre on absorption and stationary plasma levels of digoxin and digitoxin have been studied. The effect of fibre alone is small but an interactive effect on absorption may occur if fibre and digoxin are ingested simultaneously. Charcoal effectively decreases glycoside absorption even when administered after the glycosides. During maintenance therapy with digoxin or digitoxin, charcoal administration decreased the glycoside plasma levels by 31.2% and 18.3% respectively. It is suggested that even digoxin may have a significant biliary excretion and enterohepatic circulation or that this glycoside has a significant intestinal secretion. The therapeutic implication of this study is that charcoal may be of value, not only in the management of acute glycoside poisoning, but also in some cases of more chronic intoxication.

Adult↗

Ispaghula sensitization in workers manufacturing a bulk laxative.

Exposure to ispaghula dust in a pharmaceutical factory resulted in chest tightness/wheeze, nasal, and ocular or skin symptoms in 48 of 92 exposed workers. Whilst symptoms were not incapacitating in the majority (44) of these, one worker required antihistamines and three others experienced severe respiratory symptoms when exposed to the dust. These three were atopic, had a positive RAST and skin test to ispaghula; a combination unique to them. There was a significant relationship between work-related symptoms and atopic status, however, smoking did not influence symptoms, total serum IgE and specific anti-ispaghula IgE. We conclude that handling ispaghula produces an irritant effect in most exposed people, however, sensitization to the dust can occur with severe respiratory symptoms.

Adult↗

A randomized cross-over study of the efficacy of codeine phosphate versus Ispaghulahusk in patients with gynaecological cancer experiencing diarrhoea during pelvic radiotherapy.

Diarrhoea is the commonest acute complication during radiotherapy treatment to the pelvis. Codeine phosphate and a low residue diet is the standard therapy for radiation-induced diarrhoea at The Royal Marsden NHS Trust. The hypothesis put forward was that Ispaghulahusk and codeine phosphate were equally effective in the treatment of diarrhoea during radiotherapy. Participants in the study were female patients who had experienced change of bowel habit whilst receiving radiotherapy for their gynaecological cancer. Quantitative data was collected from patient diaries and treatment flow-sheets. Ten patients were randomized into the trial, five to codeine phosphate, and five to Ispaghulahusk. Continuing the trial was questioned after 10 patients had been treated. All five patients in the codeine phosphate arm received adequate control, while the five patients allocated to the Ispaghulahusk arm were all crossed-over to codeine phosphate with resolution of their diarrhoea. The results show that Ispaghulahusk, whilst not totally ineffective at controlling diarrhoea, was significantly less effective than codeine phosphate. Our conclusion is that there is insufficient reason to change to a less effective and less palatable preparation for the control of radiation-induced diarrhoea.

Codeine↗

Dust exposure challenge test as a measure of potential allergenicity and occupational disease risk in handling of Ispaghula products.

It is known that workers in the pharmaceutical industry, and nurses, can become sensitized and develop allergic respiratory symptoms by handling bulk laxatives containing Ispaghula powder. Fifteen individuals allergic to Ispaghula were challenged with a commercially available Ispaghula product and three other products manufactured in a way to make them less dusty. The results show that the use of products with smaller amounts of airborne particles results in a lower incidence of symptoms and thus probably reduces the potential occupational risk of sensitization to the Ispaghula allergen.

Allergens↗

Ispaghula therapy in irritable bowel syndrome: improvement in overall well-being is related to reduction in bowel dissatisfaction.

This placebo controlled, double-blind, cross-over trial involving 20 patients was conducted to assess the effect of ispaghula husk on the major bowel symptoms and the whole gut transit time in irritable bowel syndrome (IBS) and to determine if changes in these parameters were related to global improvement. All 20 patients were interviewed at the end of the treatment periods and 14 patients kept concurrent daily records. Ispaghula therapy resulted in improvement in global symptoms and satisfying bowel movements (P less than 0.001) but produced no change in abdominal pain or flatulence. There was a correlation between the improvement of well-being and the number of days of satisfying bowel movements (P less than 0.001) but not with the indexes of pain, stool frequency or changes in the transit time. The easing of bowel dissatisfaction appears to be a major reason for the therapeutic success of ispaghula in IBS.

Adult↗

Bulk laxative ileus.

In an elderly nursing home resident who had taken excessive dosages of bulk laxative for many years, small-bowel obstruction developed, requiring surgical intervention. A carcinoma of the ascending colon probably was the immediate cause of the obstruction, which resulted in the accumulation and inspissation of the bulk laxative throughout the small bowel. Great care should be exercised in the long-term use of these laxatives.

Adenocarcinoma↗

Randomized clinical trial of Plantago ovata seeds (dietary fiber) as compared with mesalamine in maintaining remission in ulcerative colitis. Spanish Group for the Study of Crohn's Disease and Ulcerative Colitis (GETECCU).

OBJECTIVE: Butyrate enemas may be effective in the treatment of active distal ulcerative colitis. Because colonic fermentation of Plantago ovata seeds (dietary fiber) yields butyrate, the aim of this study was to assess the efficacy and safety of Plantago ovata seeds as compared with mesalamine in maintaining remission in ulcerative colitis. METHODS: An open label, parallel-group, multicenter, randomized clinical trial was conducted. A total of 105 patients with ulcerative colitis who were in remission were randomized into groups to receive oral treatment with Plantago ovata seeds (10 g b.i.d.), mesalamine (500 mg t.i.d.), and Plantago ovata seeds plus mesalamine at the same doses. The primary efficacy outcome was maintenance of remission for 12 months. RESULTS: Of the 105 patients, 102 were included in the final analysis. After 12 months, treatment failure rate was 40% (14 of 35 patients) in the Plantago ovata seed group, 35% (13 of 37) in the mesalamine group, and 30% (nine of 30) in the Plantago ovata plus mesalamine group. Probability of continued remission was similar (Mantel-Cox test, p = 0.67; intent-to-treat analysis). Therapy effects remained unchanged after adjusting for potential confounding variables with a Cox's proportional hazards survival analysis. Three patients were withdrawn because of the development of adverse events consisting of constipation and/or flatulence (Plantago ovata seed group = 1 and Plantago ovata seed plus mesalamine group = 2). A significant increase in fecal butyrate levels (p = 0.018) was observed after Plantago ovata seed administration. CONCLUSIONS: Plantago ovata seeds (dietary fiber) might be as effective as mesalamine to maintain remission in ulcerative colitis.

Adult↗

Effect of codeine phosphate, Lomotil, and Isogel on iileostomy function.

The effect on ileostomy function of codeine phosphate, Lomotil, or Isogel was tested in 20 subjects at home living a normal life, studied over two three-day periods on and off treatment. Codeine phosphate 60 mg three times daily was associated with a reduction in the mean total weight of ileostomy output and the ileostomy outputs of water, sodium, and potassium (p < 0.05). The proportion of faecal solids increased on codeine and the effluent appeared thicker but the output of faecal solids remained unchanged. Mean faecal fat increased on codeine. The transit rate from mouth to stoma was slower in four of the five subjects on codeine and a further two subjects withdrew from the trial with temporary intestinal obstruction while on the drug. Lomotil two tablets three times daily was associated with a small and statistically not quite significant fall in the mean total weight of ileostomy output and the ileostomy output of water. Sodium and potassium outputs in the effluent fell on Lomotil (p < 0.05) but the other parameters remained unchanged. Isogel 15 ml three times daily was associated with an increase in the mean total weight of ileostomy output and the ileostomy outputs of water, sodium, potassium, and faecal solids (p < 0.01). Although the effluent looked more viscid on Isogel, the proportion of faecal solids was unchanged. These results suggest that codeine phosphate has a beneficial effect on ileostomy function, reducing the loss of water and electrolytes, while Lomotil has a similar but less effective action in the dosage tested. By contrast, Isogel increases the ileostomy loss of water and electrolytes and will aggravate their depletion in patients with excessive fluid effluents. The increase in faecal fat associated with taking codeine phosphate suggests that it should be stopped before collecting specimens for faecal fat estimations.

Adolescent↗