Agave tequilana Fructans Versus Psyllium plantago for Functional Constipation : Randomized Double-blind Clinical Trial.

GOAL: The aim of this study was to evaluate the efficacy of supplementation with Agave tequilana Weber blue variety fructans (Predilife) in the improvement of symptoms in functional constipation. BACKGROUND: Fiber supplementation is the first-line treatment for constipation. Fibers-like fructans have a known prebiotic effect. MATERIALS AND METHODS: A randomized, double-blind, study comparing agave fructans (AF) against psyllium plantago (PP). Four groups were randomized. Group 1: AF 5 g (Predilife), group 2: AF 10 g (Predilife), group 3: AF 5 g (Predilife)+10 g maltodextrin (MTDx), and group 4: PP 5 g+10 g MTDx. The fiber was administered once daily for 8 weeks. All fibers were similarly flavored and packaged. Patients kept their usual diet and fiber sources were quantified. Responders were defined as ≥1 complete spontaneous bowel movement from baseline to 8 weeks. Adverse events were reported. The study was registered in Clinicaltrials.gov with registration number NCT04716868. RESULTS: Seventy-nine patients were included (group 1: 21, group 2: 18, group 3: 20, and group 4: 20), of which 62 (78.4%) were women. The responders were similar across groups (73.3%, 71.4%, 70.6%, and 69%, P >0.050). After 8 weeks, all groups significantly increased complete spontaneous bowel movements, showing the greatest increase in spontaneous bowel movements in group 3 ( P =0.008). All groups improved in symptoms, stool consistency, and quality of life. Diet and fiber intake were similar between groups. Adverse events were mild and similar between groups. CONCLUSIONS: AF (Predilife) are as effective at different doses and combined with MTDx as PP and are a feasible option for the treatment of functional constipation.

Catastrophic gastric rupture in a horse secondary to psyllium pharmacobezoars.

A mare was euthanized because of gastric rupture secondary to complete duodenal obstruction by 2 bezoars located in the pylorus and proximal duodenum. Infrared spectroscopy showed that the bezoars were composed of psyllium. The mare had been receiving treatment with a pelleted psyllium product at 4 times the recommended dosage. Veterinarians should be aware that treatment of colic in horses with pelleted psyllium products could be associated with gastric impaction.

Rupture gastrique catastrophique secondaire à des pharmacobézoards de psyllium en boulettes chez un cheval. Une jument a été euthanasiée en raison d'une rupture gastrique secondaire à une obstruction duodénale complète par deux bézoards situés dans le pylore et le duodénum proximal. La spectroscopie infrarouge a montré que les bézoards se composaient de psyllium. La jument avait reçu un traitement composé d'un produit de psyllium en boulettes à quatre fois la dose recommandée. Les vétérinaires devraient être au courant que le traitement des coliques chez les chevaux avec des produits de psyllium en boulettes pourrait être associé à une impaction gastrique.(Traduit par Isabelle Vallières).

Satiety effects of psyllium in healthy volunteers.

Controlling hunger between meals is a challenge for many individuals. This manuscript comprises 2 sequential clinical trials investigating the effects of psyllium (Metamucil) on satiety, both using a randomized, double-blind, placebo-controlled cross-over design. The first study determined the effects of 3.4 g, 6.8 g, and 10.2 g of psyllium taken before breakfast and lunch for 3 days. The second study determined the effects of 6.8 g (taken before breakfast and lunch on Days 1 and 2 and before breakfast on Day 3) on the satiety of participants receiving an energy restricted meal in the morning (breakfast) for 3 days. Efficacy endpoints were mean inter-meal hunger, desire to eat, and Satiety Labeled Intensity Magnitude Visual Analog Scale scores. In Study 1, all 3 psyllium doses resulted in directional or statistically significant mean reductions in hunger and desire to eat, and increased fullness between meals compared to placebo, with both higher doses better than placebo or 3.4 g. The 6.8 g dose provided more consistent (p ≤ 0.013) satiety benefits versus placebo. In Study 2, satiety was assessed similarly to Study 1. A significant (p ≤ 0.004) decrease in the 3-day mean hunger and desire to eat, as well as an increase in fullness for psyllium relative to placebo was observed. Most adverse events were mild gastrointestinal symptoms and were similar for psyllium compared to placebo. These results indicate that psyllium supplementation contributes to greater fullness and less hunger between meals.

Loperamide Versus Psyllium Fiber for Treatment of Fecal Incontinence: The Fecal Incontinence Prescription (Rx) Management (FIRM) Randomized Clinical Trial.

BACKGROUND: Fecal incontinence is a devastating condition with few US Food and Drug Administration-approved pharmacologic treatment options. Loperamide and psyllium, both first-line treatments, have different mechanisms of action without any comparative data. OBJECTIVE: The purpose of this study was to examine the effectiveness and tolerability of loperamide compared with psyllium for reducing fecal incontinence. We hypothesized that psyllium fiber supplementation would be more effective than loperamide for reducing fecal incontinence episodes and have fewer adverse effects. DESIGN: We conducted a randomized, double-blind, placebo-controlled crossover trial comparing loperamide (followed by psyllium) with psyllium (followed by loperamide). SETTINGS: Our sites included outpatient clinics within a Veterans Affairs medical center and university affiliate. PATIENTS: Participants included community-dwelling adults (n = 80) with at least 1 fecal incontinent episode on a 7-day bowel diary. INTERVENTION: Participants received either daily loperamide (plus placebo psyllium powder) or psyllium powder (plus loperamide placebo) for 4 weeks. After a 2-week washout, participants crossed over to 4 weeks of alternate treatment. MAIN OUTCOME MEASURES: The primary outcome was the number of fecal incontinence episodes from 7-day bowel diaries. Secondary outcomes included symptom severity, quality of life, and tolerability. RESULTS: Mean age was 60.7 ± 10.1 years; 68% were men. After determining nonsignificant carryover effects, combined analyses showed no differences between the loperamide and psyllium groups for reducing fecal incontinent episodes, symptom severity, or quality of life. Within each group, both loperamide and psyllium reduced fecal incontinent episodes and improved symptom severity and quality of life. Constipation occurred in 29% of participants for loperamide vs 10% for psyllium. LIMITATIONS: Limitations include the washout period length and dropout rate after crossing over to the second intervention. CONCLUSIONS: Both loperamide and psyllium improve fecal incontinence. Loperamide was associated with more adverse effects, especially constipation.

Individualized microbiotas dictate the impact of dietary fiber on colitis sensitivity.

BACKGROUND: The observation that the intestinal microbiota is  central in the development of IBD suggests that dietary fiber, the microbiota's primary source of nourishment, could play a central role in these diseases. Accordingly, enriching diets with specific soluble fibers remodels microbiota and modulates colitis sensitivity. In humans, a recent study suggests that the microbiota of select IBD patients might influence the impacts they would experience upon fiber exposure. We sought here to define the extent to which individual microbiotas varied in their responsiveness to purified soluble fiber inulin and psyllium. Moreover, the extent to which such variance might impact proneness to colitis. RESULTS: We observed a high level of inter-individual variation in microbiota responsiveness to fiber inulin and psyllium: while microbiotas from select donors exhibited stark fiber-induced modulation in composition, pro-inflammatory potential, and metabolomic profile, others were only minimally impacted. Mice transplanted with fiber-sensitive microbiomes exhibited colitis highly modulated by soluble fiber consumption, while mice receiving fiber-resistant microbiotas displayed colitis severity irrespective of fiber exposure. CONCLUSION: The extent to which select soluble fibers alter proneness to colitis is highly influenced by an individual's microbiota composition and further investigation of individual microbiota responsiveness toward specific dietary fiber could pave the way to personalized fiber-based intervention, both in IBD patients and healthy individuals. Video Abstract.

Psyllium Fiber Protects Against Colitis Via Activation of Bile Acid Sensor Farnesoid X Receptor.

BACKGROUND & AIMS: Fiber-rich foods promote health, but mechanisms by which they do so remain poorly defined. Screening fiber types, in mice, revealed psyllium had unique ability to ameliorate 2 chronic inflammatory states, namely, metabolic syndrome and colitis. We sought to determine the mechanism of action of the latter. METHODS: Mice were fed grain-based chow, which is naturally rich in fiber or compositionally defined diets enriched with semi-purified fibers. Mice were studied basally and in models of chemical-induced and T-cell transfer colitis. RESULTS: Relative to all diets tested, mice consuming psyllium-enriched compositionally defined diets were markedly protected against both dextran sulfate sodium- and T-cell transfer-induced colitis, as revealed by clinical-type, histopathologic, morphologic, and immunologic parameters. Such protection associated with stark basal changes in the gut microbiome but was independent of fermentation and, moreover, maintained in mice harboring a minimal microbiota (ie, Altered Schaedler Flora). Transcriptomic analysis revealed psyllium induced expression of genes mediating bile acids (BA) secretion, suggesting that psyllium's known ability to bind BA might contribute to its ability to prevent colitis. As expected, psyllium resulted in elevated level of fecal BA, reflecting their removal from enterohepatic circulation but, in stark contrast to the BA sequestrant cholestyramine, increased serum BA levels. Moreover, the use of BA mimetics that activate the farnesoid X receptor (FXR), as well as the use of FXR-knockout mice, suggested that activation of FXR plays a central role in psyllium's protection against colitis. CONCLUSIONS: Psyllium protects against colitis via altering BA metabolism resulting in activation of FXR, which suppresses pro-inflammatory signaling.

The effect of psyllium supplementation on blood pressure: a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND/AIMS: Global incidence of hypertension is estimated to be, in excess of, one billion people, and given the efficacy of soluble dietary fibers, in particular, Psyllium, to positively impact blood pressure in patients with hypertension, it is of clinical importance that consensus on its supplementation be established. Therefore, the aim of the study was systematically review and meta-analyze the effect of psyllium supplementation on blood pressure of hypertensive patients in randomized controlled trials. METHODS: We searched six universal databases including; Pubmed/Medline, Ovid, Cochrane Library, Google Scholar, Embase, and Scopus until November 2018. Both combined and stratified analyzes were conducted. A fixed-effects or random- effects model was used to assess the mean effect sizes. RESULTS: An eventual 11 trials with 592 participants were considered as eligible for inclusion in the present meta-analysis. The meta-analysis revealed a significant reduction of 2.04 mmHg in systolic blood pressure (weighted mean difference, -2.04; 95% confidence interval, -2.82 to -1.63; p < 0.001). Whilst meta-regression highlighted that the hypotensive effect of psyllium was stronger in subjects with higher baseline blood pressure. CONCLUSION: Given the overarching benefits and lack of reported side effects, particularly for hypertensive patients, health care providers and clinicians should consider the use of psyllium supplementation for the treatment or abatement of hypertension, or hypertensive symptoms.

[Plantago psyllium-secondary anaphylaxis. Case report]. / Anafilaxia secundaria a plantago psyllium. Reporte de caso.

BACKGROUND: Psyllium is a derivative of Plantago ovata ground seed and husk that is used as bulk-forming laxatives owing to its hydrocolloid properties. CASE REPORT: 43-year-old female nurse with previous diagnosis of drug allergy and allergic rhinitis who, after the preparation and administration of a laxative, developed rhinoconjunctivitis symptoms, urticarial syndrome, angioedema and bronchospasm, which led to conclude that she had an anaphylactic reaction. She was treated with adrenaline, corticosteroids and antihistamines. After symptom resolution, with in vivo tests by means of the skin prick technique and by in vitro assay (specific IgE), hypersensitivity to plantago psyllium was determined. DISCUSSION: Most cases of anaphylaxis have been reported with psyllium ingestion, since, through that route, antigenic burden is higher. It should be noted that, even when exposure in the described patient was only by inhalation, manifestations were life-threatening.

Antecedentes: El psyllium es un derivado de la semilla y cáscara pulverizada de Plantago ovata, que se usa como laxante de volumen debido a sus propiedades hidrocoloides. Reporte de caso: Mujer de 43 años, de profesión enfermera, con diagnóstico de alergia a fármacos y rinitis alérgica, quien posterior a la preparación y administración de un laxante presentó síntomas rinoconjuntivales, síndrome urticariforme, angioedema y broncoespasmo, por lo que se concluyó que presentaba anafilaxia. Fue tratada con adrenalina, corticoides y antihistamínicos. Después de la resolución del cuadro, por pruebas in vivo mediante técnica de punción cutánea y por estudio in vitro (IgE específica) se determinó hipersensibilidad a plantago psyllium. Discusión: La mayoría de los casos de anafilaxia se ha reportado por ingestión de psyllium debido a que por esa vía es mayor la carga antigénica. Llama la atención la paciente descrita, en quien la exposición fue únicamente por inhalación, sin embargo, las manifestaciones que presentó fueron potencialmente letales.

Psyllium as therapeutic and drug delivery agent.

There is no doubt that fibers, in particular viscous dietary fibers, have positive effects on human health, both in the prevention and in treatment of chronic diseases. Dietary fibers from psyllium have been used extensively both as pharmacological supplements, food ingredients, in processed food to aid weight control, to regulation of glucose control for diabetic patients and reducing serum lipid levels in hyperlipidemics. Keeping in view, the pharmacological importance of psyllium polysaccharide and its gel-forming nature, this article discusses the therapeutic value of psyllium for the treatment of constipation, diarrhea, irritable bowel syndrome, inflammatory bowel disease-ulcerative colitis, colon cancer, diabetes and hypercholesterolemia and exploitation of psyllium for developing drug delivery systems.

Laxative drug products for over-the-counter human use; psyllium ingredients in granular dosage forms. Final rule.

The Food and Drug Administration (FDA) is issuing a final rule establishing that over-the-counter (OTC) laxative drug products in granular dosage form containing the bulk-forming psyllium ingredients (psyllium (hemicellulose), psyllium hydrophilic mucilloid, psyllium seed, psyllium seed (blond), psyllium seed husks, plantago ovata husks, and plantago seed) are not generally recognized as safe and effective (GRASE) and are misbranded. This final rule includes, but is not limited to, any granules that are swallowed dry prior to drinking liquid; dispersed, suspended, or partially dissolved in liquid prior to swallowing; chewed, partially chewed, or unchewed, and then washed down (or swallowed) with liquid; or sprinkled over food. FDA is issuing this final rule after considering reports of esophageal obstruction associated with the use of psyllium laxatives in granular dosage form. These cases continue to occur despite efforts to promote safe use through label warnings and directions. This final rule does not apply to psyllium laxatives in nongranular dosage forms, such as powders, tablets, or wafers. This final rule is part of FDA's ongoing review of OTC drug products.

Hypocholesterolemic effects of different bulk-forming hydrophilic fibers as adjuncts to dietary therapy in mild to moderate hypercholesterolemia.

Hypercholesterolemia is a significant risk factor for coronary heart disease, and the hypocholesterolemic effects of psyllium are well established. This placebo-controlled, parallel study compared psyllium with methylcellulose, calcium polycarbophil, and placebo as dietary adjuncts in treating mild to moderate hypercholesterolemia. Of 163 men and women recruited with serum cholesterol levels above 5.17 mmol/L (200 mg/dL), 105 completed 8 weeks of an American Heart Association step I diet and then augmented the diet with one of the fiber supplements for 8 additional weeks. Incremental differences from placebo for low-density lipoprotein cholesterol were -8.8% for psyllium, -3.2% for methylcellulose (not significant), and +8.7% for calcium polycarbophil; and for total cholesterol the differences were -4.3% for psyllium (not significant), -1.4% for methylcellulose (not significant), and +5.9% for calcium polycarbophil. Compliance was 94% to 96%, and only mild gastrointestinal side effects were observed. In managing mild to moderate hypercholesterolemia, methylcellulose and calcium polycarbophil provide little or no additional benefit, while psyllium significantly enhances the American Heart Association diet effects.

Psyllium decreased serum glucose and glycosylated hemoglobin significantly in diabetic outpatients.

Psyllium is a bulk-forming laxative and is high in both fiber and mucilage. The beneficial effect of dietary fiber in the management of type II diabetes, has not been totally demonstrated. The purpose of this study was to determine the plasma-lowering effects of 5.1g b.i.d. of psyllium husk fiber, as an adjunct to dietary and drug therapy on lipid and glucose levels, in patients with type II diabetes. Patients were randomly selected from an outpatient clinic of primary care to participate in a double-blind placebo-controlled study in which Plantago ovata Forsk., or placebo was given in combination with their anti-diabetic drugs. Forty-nine subjects were included in the study that were given diet counseling before the study and then followed for 8 weeks in the treatment period. Fasting plasma glucose (FBS) was measured every 2 weeks, and total plasma cholesterol (TC), LDL-cholesterol (LDL-C), HDL-cholesterol (HDL-C), triglyceride (TG), and insulin levels were measured every 4 weeks. Glycosylated hemoglobin (HbA1c) was also measured at the beginning and ending of the study. The test products (psyllium or placebo) were supplied to subjects in identically labeled foil packets containing a 5.1g dose of product, to consume two doses per day, half an hour before breakfast and dinner. Both products were well tolerated, with no serious adverse events related to treatment was reported in either. Better gastric tolerance to metformin was recorded in the psyllium group. FBS, and HbA1c, showed a significant reduction (p<0.05), whereas HDL-C increased significantly (p<0.05) following psyllium treatment. LDL/HDL ratio was significantly decreased (p<0.05). Our results show that 5.1g b.i.d. of psyllium for persons with type II diabetes is safe, well tolerated, and improves glycemic control.

Psyllium fiber improves glycemic control proportional to loss of glycemic control: a meta-analysis of data in euglycemic subjects, patients at risk of type 2 diabetes mellitus, and patients being treated for type 2 diabetes mellitus.

BACKGROUND: A number of health benefits are associated with intake of soluble, viscous, gel-forming fibers, including reduced serum cholesterol and the attenuation of postprandial glucose excursions. OBJECTIVE: We assess the effects of psyllium, which is a soluble, gel-forming, nonfermented fiber supplement, on glycemic control in patients who were being treated for type 2 diabetes mellitus (T2DM) and in patients who were at risk of developing T2DM. DESIGN: A comprehensive search was performed of available published literature (Scopus scientific database) and clinical records stored by Procter & Gamble with the use of key search terms to identify clinical studies that assessed the glycemic effects of psyllium in nondiabetic, pre-T2DM, and T2DM patients. RESULTS: We identified 35 randomized, controlled, clinical studies that spanned 3 decades and 3 continents. These data were assessed in 8 meta-analyses. In patients with T2DM, multiweek studies (psyllium dosed before meals) showed significant improvement in both the fasting blood glucose (FBG) concentration (-37.0 mg/dL; P < 0.001) and glycated hemoglobin (HbA1c) [-0.97% (-10.6 mmol/mol); P = 0.048]. Glycemic effects were proportional to baseline FBG; no significant glucose lowering was observed in euglycemic subjects, a modest improvement was observed in subjects with pre-T2DM, and the greatest improvement was observed in subjects who were being treated for T2DM. CONCLUSIONS: These data indicate that psyllium would be an effective addition to a lifestyle-intervention program. The degree of psyllium's glycemic benefit was commensurate with the loss of glycemic control. Because the greatest effect was seen in patients who were being treated for T2DM, additional studies are needed to determine how best to incorporate psyllium into existing prevention and treatment algorithms with concomitant hypoglycemic medications.

Long-term cholesterol-lowering effects of psyllium as an adjunct to diet therapy in the treatment of hypercholesterolemia.

BACKGROUND: Hypercholesterolemia is a major risk factor for coronary heart disease and nutrition management is the initial therapeutic approach. OBJECTIVE: This multicenter study evaluated the long-term effectiveness of psyllium husk fiber as an adjunct to diet in the treatment of persons with primary hypercholesterolemia. DESIGN: Men and women with hypercholesterolemia were recruited. After following an American Heart Association Step I diet for 8 wk (dietary adaptation phase), eligible subjects with serum LDL-cholesterol concentrations between 3.36 and 4.91 mmol/L were randomly assigned to receive either 5.1 g psyllium or a cellulose placebo twice daily for 26 wk while continuing diet therapy. RESULTS: Serum total and LDL-cholesterol concentrations were 4.7% and 6.7% lower in the psyllium group than in the placebo group after 24-26 wk (P < 0.001). Other outcome measures did not differ significantly between groups. CONCLUSIONS: Treatment with 5.1 g psyllium twice daily produces significant net reductions in serum total and LDL-cholesterol concentrations in men and women with primary hypercholesterolemia. Psyllium therapy is an effective adjunct to diet therapy and may provide an alternative to drug therapy for some patients.

Long-term effects of consuming foods containing psyllium seed husk on serum lipids in subjects with hypercholesterolemia.

The effects of consuming foods containing 0 (control), 3.4, 6.8, or 10.2 g psyllium seed husk (PSH)/d for 24 wk on the serum lipid profile were assessed in this randomized, double-blind controlled study. Men and women (n = 286) with LDL-cholesterol concentrations between 3.36 and 5.68 mmol/L (130 and 220 mg/dL) were randomly assigned to one of four treatment groups after following a low-fat diet for > or = 8 wk. At week 24, LDL cholesterol was 3% above baseline in the control group. In the group consuming 10.2 g PSH/d, LDL cholesterol remained below baseline during treatment, with a value 5.3% below that of the control group at week 24 (P < 0.05 compared with the control group). No significant differences were observed in HDL cholesterol or triacylglycerol. Although modest, the effect of 10.2 g PSH/d on LDL cholesterol (relative to the control) persisted throughout the 24-wk treatment period, indicating potential for long-term benefit.

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.

A multi-centre, general practice comparison of ispaghula husk with lactulose and other laxatives in the treatment of simple constipation.

An open, multi-centre study in general practice compared with efficacy, speed of action and acceptability of ispaghula husk (Fybogel Orange, Reckitt & Colman Products, UK), lactulose and other laxatives in the treatment of patients with simple constipation. A total of 65 GPs recruited 394 patients, of whom 224 (56.9%) were assigned to treatment with ispaghula and 170 (43.1%) to other laxatives (mainly lactulose) for up to four weeks. Thirteen patients withdrew before treatment started, so that 381 entered the study. Patients were assessed by their GP before entry and after two and four weeks of treatment. Patients also kept daily records of their bowel movements. After four weeks' treatment, ispaghula husk was assessed by the GPs to be superior to the other treatments in improving bowel function and in overall effectiveness, palatability and acceptability. Patients' reports of time to first bowel movement showed little difference between the treatments. Over 60% of patients in each treatment group passed a first motion within 24 hours, and over 80% within 36 hours. Ispaghula husk produced a higher percentage of normal, well-formed stools and fewer hard stools than other laxatives. Incidences of soiling, diarrhoea and abdominal pain were lower in the group receiving ispaghula husk. Overall, ispaghula husk was an effective treatment for simple constipation, and was associated with better stool consistency and a lower incidence of adverse events compared with lactulose or with other laxatives.

Ispagula powder: an allergen in the work environment.

Bulk laxatives based on ispagula powder have given no known allergic side effects when administered perorally. Twenty-seven out of 64 workers in a pharmaceutical factory developed rhinitis, conjunctivitis or asthma when engaged in the packing of ispagula husks, an operation which gives rise to dust. The symptoms are accounted for by a type 1 allergy acquired from ispagula husks. This allergy can be demonstrated by intracutaneous and provocation tests. Occupational health measures were taken which reduced the dust content to a minimum; thereafter only one new case of sensitization was recorded during the next 24 months of observation. Five similar cases were reported among nursing staff exposed to the dust of ispagula while administering doses of bulk laxative.

A study to assess the effect of dietary supplementation with soluble fibre (Minolest) on lipid levels in normal subjects with hypercholesterolaemia.

Hypercholesterolaemia is one of the major risk factors in the development of coronary artery disease. In recent years, many nonprescription treatments have become available for cholesterol lowering. Minolest is a product that contains guar gum and psyllium as the principal active ingredients. We conducted a randomised, placebo-controlled, double-blind, parallel-group study to assess the efficacy of Minolest as a lipid-lowering agent. Secondary aims included assessment of the effect on blood pressure and obesity. We also looked at the acceptability of the product and side effects associated with its ingestion. After a 4-week run-in period, 83 subjects were randomised to receive placebo or Minolest (16.5 g/day) for 3 months. Seven subjects defaulted follow up, 5 in the placebo group and 2 in the active treatment group. In addition, 9 subjects (5 on active treatment and 4 on placebo) had total cholesterol fall into the optimal range (< 5.2 mmol/l) during the run-in phase and were removed from the study. At baseline in the active treatment group, total cholesterol was 6.1 (5.43 to 8.06) mmol/l, triglyceride 1.54 (0.56 to 4.19) mmol/l, HDL cholesterol 1.32 +/- 0.43 mmol/l and LDL cholesterol 4.1 (3.10 to 6.27) mmol/l. In the placebo group, total cholesterol was 5.84 (5.32 to 8.38) mmol/l, triglyceride 1.47 (0.69 to 11.0) mmol/l, HDL cholesterol 1.15 +/- 0.33 mmol/l and LDL cholesterol 3.87 (2.46 to 5.14) mmol/l. The differences in the baseline characteristics were not statistically significant except the LDL-cholesterol. Minolest produced a 3.24% (SD = 7.85%, P = 0.020) decrease in total cholesterol and 5.45% decrease in LDL cholesterol (SD = 10.25%, P = 0.0034) but no significant difference in serum triglyceride, weight, body mass index or blood pressure. This was not seen in the placebo group. The percentage fall in LDL cholesterol increased to 7.16% and 7.37% in subjects who consumed at least 50% and 70% of the treatment respectively. There were few side effects. The authors conclude that this product has a small impact on the lipid profile and may be useful only in subjects with mild hypercholesterolaemia and a low risk of coronary artery disease.

The long-term safety and tolerability of ispaghula husk.

The safety and tolerability of ispaghula husk, which can now be used as an adjunct to diet for the treatment of mild-to-moderate hypercholesterolaemia, was assessed in 93 healthy subjects over a 52-week period. The study looked at the nutritional, biochemical, and haematological effects of ispaghula. Over the study period there were small but statistically significant changes in some measurements of minerals and vitamin levels, and in some haematological and biochemical parameters. However, none of these were of clinical significance, with the possible exception of changes in vitamin B12 levels. A daily dose of 10.5 g ispaghula was well tolerated and the majority of adverse events recorded were minor, of short duration and either unrelated or possibly related to the study treatment. The results suggest that ispaghula husk can be used with confidence for the long-term treatment of mild-to-moderate hypercholesterolaemia.