Evaluation of bowel preparation regimens for colonoscopy including a novel low volume regimen (Plenvu): CLEANSE study.

BACKGROUND: Poor bowel preparation is the leading cause of failed colonoscopies and increases costs significantly. Several, split preparation, 2 day regimens are available and recently, Plenvu, a low-volume preparation which can be given on 1 day has been introduced. AIMS: Assess efficacy and tolerability of commonly used purgative regimens including Plenvu. METHOD: In this service evaluation, patients undergoing screening colonoscopy at St Mark's Hospital, London (February 2020-December 2021) were provided Plenvu (1 or 2 days), Moviprep (2 days) or Senna & Citramag (2 days).Boston Bowel Preparation Scale (BBPS) score, fluid volumes and procedure times were recorded. A patient experience questionnaire evaluated taste, volume acceptability, completion and side effects. RESULTS: 563 patients were invited to participate and 553 included: 218 Moviprep 2 days, 108 Senna & Citramag 2 days, 152 Plenvu 2 days and 75 Plenvu 1 day.BBPS scores were higher with Plenvu 1 and 2 days vs Senna & Citramag (p=0.003 and 0.002, respectively) and vs Moviprep (p=0.003 and 0.001, respectively). No other significant pairwise BBPS differences and no difference in preparation adequacy was seen between the groups.Patients rated taste as most pleasant with Senna & Citramag and this achieved significance versus Plenvu 1 day and 2 days (p=0.002 and p<0.001, respectively) and versus Moviprep (p=0.04). CONCLUSION: BBPS score was higher for 1 day and 2 days Plenvu versus both Senna & Citramag and Moviprep. Taste was not highly rated for Plenvu but it appears to offer effective cleansing even when given as a same day preparation.

Randomized controlled trial of 3 days fasting and oral senna, combined with mannitol and simethicone, before capsule endoscopy.

BACKGROUND AND STUDY AIMS: The approach to small bowel preparation before capsule endoscopy (CE) is still suboptimal. PATIENTS AND METHODS: One hundred eighty patients were randomly allocated to 3 groups. Patients in Group A took 250 mL 20% mannitol and 1 L 0.9% saline orally at 05:00 hours on the day of the procedure. In Group B the same preparation was taken at 20:00 on the day before, and at 05:00 on the day of CE; in addition, 20 mL oral simethicone was taken 30 minutes before CE. Group C was treated identically to Group B, except that the patients fasted for 3 days and took 3 g senna orally 3 times daily before CE. The length of bowel containing green luminal contents was assessed by ImageJ software and bowel cleanliness was evaluated by computed assessment of the cleansing score. RESULTS: Cleansing of the whole small bowel and the distal small bowel were significantly different between the 3 groups (χ = 22.470, P = .000; χ = 17.029, P = .000, respectively). There were also significant differences between the 3 groups in the length of small bowel and specifically the length of the distal small bowel containing green luminal contents (χ = 12.390, P = .000, χ = 15.141, P = .000, respectively), but not with regard to the proximal small bowel (χ = 0.678, P = .509). CONCLUSIONS: Three days fasting and oral senna, combined with 20% mannitol and simethicone, before CE, can reduce the effects of bile on the small bowel and improve small bowel cleansing, especially in the distal small intestine.

Management of chronic constipation in patients with diabetes mellitus.

AIM: The aim of this review is to provide an overview of the clinical assessment and evidence-based treatment options for managing diabetes-associated chronic constipation. METHODS: A literature search of published medical reports in English language was performed using the OVID Portal, from PUBMED and the Cochrane Database of Systematic Reviews, from inception to October 2015. A total of 145 abstracts were identified; duplicate publications were removed and 95 relevant full-text articles were retrieved for potential inclusion. RESULTS: Chronic constipation is one of the most common gastrointestinal symptoms in patients with diabetes, and occurs more frequently than in healthy individuals. Treatment goals include improving symptoms and restoring bowel function by accelerating colonic transit and facilitating defecation. Based on guidelines and data from published literature, food and dietary change with exercise and lifestyle change should be the first step in management. For patients recalcitrant to these changes, laxatives should be the next step of treatment. Treatment should begin with bulking agents such as psyllium, bran or methylcellulose followed by osmotic laxatives if response is poor. Lactulose, polyethylene glycol and lactitol are the most frequently prescribed osmotic agents. Lactulose has a prebiotic effect and a carry-over effect (continued laxative effect for at least 6 to 7 days, post cessation of treatment). Stimulants such as bisacodyl, sodium picosulphate and senna are indicated if osmotic laxatives are not effective. Newer agents such as chloride-channel activators and 5-HT4 agonist can be considered for severe or resistant cases. CONCLUSION: The primary aim of intervention in diabetic patients with chronic constipation is to better manage the diabetes along with management of constipation. The physician should explain the rationale for prescribing laxatives and educate patients about the potential drawbacks of long-term use of laxatives. They should contact their physician if short-term use of prescribed laxative fails to provide relief.

Comparative Study of Three Regimens of Bowel Preparation Before Transabdominal Ultrasonography of the Colon.

The objective of the study was to compare the efficacy of three bowel preparation regimens for transabdominal colon ultrasonography. A total of 192 consecutive patients were given one of three regimens (senna, magnesium sulfate or polyethylene glycol electrolyte powder) before ultrasonographic examinations. The cleaning grade (I = emptying; II = filled or filled + empty; III = I or II with some retention; and IV = retention [grades I and II were termed "qualified"]) and cleaning range (A = all seven colon sections were qualified; B = four to six sections were qualified; C = three or less sections were qualified) were evaluated retrospectively. Senna was found more effective than polyethylene glycol in terms of cleaning grade (p < 0.001), qualified rate (p < 0.001) and cleaning range (p = 0.003). Senna was better than magnesium sulfate in cleaning grade (p < 0.001). Our results suggest that senna seems to be the preferred regimen for bowel preparation before transabdominal colonic ultrasonography.

Changing clinical guidelines from delayed to early aperient administration for enterally fed intensive care patients was associated with increased diarrhoea: a before-and-after, intention-to-treat evaluation.

BACKGROUND: The 14-bed intensive care unit of a tertiary referral hospital adopted a guideline to start docusate sodium with sennosides when enteral nutrition was started. This replaced a guideline to start aperients after 24h of enteral nutrition if no bowel action had occurred. We sought to determine the effect of this change on the incidence of diarrhoea and constipation in intensive care. METHODS: Retrospective audit of the medical records of consecutive adult patients admitted to intensive care and given enteral nutrition, excluding those with a primary gastrointestinal system diagnosis, between Jan-Aug 2011 (the delayed group, n=175) and Jan-Aug 2012 (the early group, n=175). The early aperient guideline was implemented during Sep-Dec 2011. RESULTS: The early and delayed groups were similar in age (median 62 years vs. 64 years; P=0.17), sex (males 65% vs. 63%; P=0.91), and postoperative cases (31% vs. 33%; P=0.82) and had similar proportions who received mechanical ventilation (95% vs. 95%; P=1.00), an inotrope or vasopressor (63% vs. 70%; P=0.17), renal replacement therapy (8% vs. 10%; P=0.71), opiates (77% vs. 80%; P=0.60), antibiotics (89% vs. 91%; P=0.72) and metoclopramide (46% vs. 55%; P=0.11). A significantly larger proportion of the early group received an aperient (54% vs. 29%, P<0.001) and experienced diarrhoea (38% vs. 27%, P=0.04), but the groups had similar proportions affected by constipation (42% vs. 43%, P=0.91). CONCLUSIONS: Changing guidelines from delayed to early aperient administration was associated with an increase in the incidence of diarrhoea but was not associated with the incidence of constipation. These findings do not support changing guidelines from delayed to early aperient administration.

[Bowel preparation for colonoscopy. Any significant progress on the horizon?]. / Preparación para colonoscopia. ¿Algún avance significativo en el horizonte?

Colonoscopy is the method of choice for colorectal cancer screening. To be effective, screening colonoscopy must have high quality standards. The key element is the quality of the preparation. However, up to 20% of patients are inadequately prepared and, at present, anterograde washing is the least tolerated part of the procedure. In the choice of preparation, safety is a prerequisite and efficacy is a priority. Tolerance is a secondary but nevertheless influential factor in the quality of preparation and has consequently been the primary focus of many recent studies. In the last few years, a rapidly increasing number of studies have evaluated new drugs, dosages and adjuvant therapies to improve efficacy and tolerability. These studies have collaterally shown that inadequate preparation and lack of adherence to the prescribed regimen can be partially predicted, making it essential to identify this patient subgroup and invest the necessary effort in their instruction. New individualized and flexible approaches are expected for the different clinical scenarios. The search for the ideal colonoscopy preparation, which would be tolerable, safe and above all effective, remains open.

Experimental evaluation of radioiodinated sennoside B as a necrosis-avid tracer agent.

Necrosis-avid agents are a class of compounds that selectively accumulate in the necrotic tissues after systemic administration, which can be used for in vivo necrosis imaging and targeted therapies. In order to search for a necrosis-avid tracer agent with improved drugability, we labelled iodine-131 on sennoside B (SB) as a naturally occurring median dianthrone compound. The necrosis targetability and clearance properties of (131)I-SB were evaluated in model rats with liver and muscle necrosis. On SPECT/CT images, a "hot spot" in the infarcted liver lobe and necrotic muscle was persistently observed at 24 h and 72 h post-injection (p.i.). Gamma counting of the tissues of interest revealed a radioactivity ratio of necrotic to viable liver at 4.6 and 3.4 and of necrotic to viable muscle at 7.0 and 8.8 at 24 h and 72 h p.i., respectively. The good match of autoradiographs and fluoromicroscopic images with corresponding histochemical staining suggested preferential uptake of (131)I-SB in necrotic tissue. Pharmacokinetic study revealed that (131)I-SB has an elimination half-life of 8.6 h. This study indicates that (131)I-SB shows not only prominent necrosis avidity but also favourable pharmacokinetics, which may serve as a potential necrosis-avid diagnostic agent for assessment of tissue viability.

Same-day colonoscopy preparation with Senna alkaloids and bisacodyl tablets: a pilot study.

AIM: To evaluate the efficacy of same-day bowel preparation with Senna alkaloids combined with bisacodyl tablets in routine colonoscopy procedures. METHODS: Between March and June 2013, a same-day bowel preparation was implemented in our endoscopy unit. The preparation consisted of a semi-liquid, fiber-free diet one day prior to the procedure, with two bisacodyl tablets after lunch and dinner, and 250 mL of Senna alkaloid with 1.5 L of drinking water at 6 am the day of the procedure. The quality control parameters of colonoscopy were evaluated and implemented according to the guidelines of the American Society for Gastrointestinal Endoscopy. The pre-procedure, during-procedure and post-procedure patient data were collected and analyzed: (1) pre-procedure (age, gender, comorbid diseases, colonoscopy indications, complete lack of compliance with the bowel preparation protocol); (2) during-procedure (sedation dose, duration of colonoscopy, withdrawal time, cecal intubation rate, polyp detection rate, Boston Bowel Preparation Scores and presence of foam and clear liquid); and (3) post-procedure (visual analogue scale score, pain during the procedure, patient satisfaction and premature withdrawal due to the insufficient bowel preparation). RESULTS: A total of 75 patients were included in this study with a mean age of 54.64 ± 13.29 years; 53.3% (40/75) were female and 46.7% (35/75) were male. A complete lack of compliance with the bowel preparation protocol was seen in 6.7% of patients (5/75). The mean total duration of colonoscopy was 16.12 ± 6.51 min, and the mean withdrawal time was 8.89 ± 4.07 min. The cecal intubation rate was 93.8% (61/64) and the polyp detection rate was 40% (30/75). The mean Boston Bowel Preparation Score was 7.38 ± 1.81, with the following distribution: right colon, 2.34 ± 0.89; transverse colon, 2.52 ± 0.67; left colon, 2.52 ± 0.63. The mean visual analogue scale score was 4.59 ± 1.57. Due to insufficient bowel preparation, seven patients (7/75; 9.3%) were asked to repeat the procedure. Of these, five patients had poor or modest compliance with the protocol, and two patients reported constipation. Premature withdrawal due to insufficient bowel preparation was 2.7% (2/75). The overall satisfaction with the protocol was 86.7% (65/75), with patients reporting they would prefer the same protocol in a repeat procedure. CONCLUSION: The same-day administration of Senna alkaloids appears to be a safe and effective bowel cleansing protocol for colonoscopy procedures.

Randomized, double-blind, placebo-controlled trial of oral docusate in the management of constipation in hospice patients.

CONTEXT: The stool softener docusate is widely used in the management of constipation in hospice patients. There is little experimental evidence to support this practice, and no randomized trials have been conducted in the hospice setting. OBJECTIVES: To assess the efficacy of docusate in hospice patients. METHODS: This was a 10-day, prospective, randomized, double-blind, placebo-controlled trial of docusate and sennosides vs. placebo and sennosides in hospice patients in Edmonton, Alberta. Patients were included if they were age 18 years or older, able to take oral medications, did not have a gastrointestinal stoma, and had a Palliative Performance Scale score of 20% or more. The primary outcome measures were stool frequency, volume, and consistency. Secondary outcomes were patient perceptions of bowel movements (difficulty and completeness of evacuation) and bowel-related interventions. RESULTS: A total of 74 patients were randomized into the study (35 to the docusate group and 39 to the placebo group). There were neither significant differences between the groups in stool frequency, volume, or consistency, nor in difficulty or completeness of evacuation. On the Bristol Stool Form Scale, more patients in the placebo group had Type 4 (smooth and soft) and Type 5 (soft blobs) stool, whereas in the docusate group, more had Type 3 (sausage like) and Type 6 (mushy) stool (P=0.01). CONCLUSION: There was no significant benefit of docusate plus sennosides compared with placebo plus sennosides in managing constipation in hospice patients. Docusate use should be considered on an individual basis.

A prospective audit of the efficacy, safety, and acceptability of low-volume polyethylene glycol (2 L) versus standard volume polyethylene glycol (4 L) versus magnesium citrate plus stimulant laxative as bowel preparation for colonoscopy.

BACKGROUND: High-quality video colonoscopy requires adequate preparation of the bowel to ensure both adequate procedure completion rates and polyp detection rates. We sought to examine our practice to determine which bowel preparation cleansed most effectively in our patients. AIM: A prospective audit of the efficacy, safety, and acceptability of low-volume polyethylene glycol (2-L Moviprep; Norgine Pharmaceuticals) versus standard volume polyethylene glycol (4-L KleanPrep; Norgine Pharmaceuticals) versus magnesium citrate (Citramag; Sanochemia UK Ltd.) plus stimulant laxative as bowel preparation for colonoscopy. SETTING: District General Hospital. PATIENTS: Patients attending for day case colonoscopy. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Overall cleansing grades of preparations used: patient compliance, taste, and acceptability. METHODS: A prospective audit of patient experience of taking bowel preparation and blinded colonic scoring assessment of bowel cleansing of each of the tested regimes. RESULTS: A total of 258 (female,138; 53.5%) patients were recruited, 91 in the KleanPrep group (F:45, 49.5%), 86 patients in the Moviprep group (female, 45; 52.3%), and 81 in the Senna/Citramag group (female, 44; 54.3%). Significantly more patients were unable to take the prescribed dose of KleanPrep when compared with the other 2 regimes (19.6%; P<0.0001 vs. Moviprep; P<0.0001 vs. Senna/Citramag). A total of 45.65% of patients reported KleanPrep as tasting unpleasant. This was significantly more than both Moviprep (10.47%; P=0.008) and Senna/Citramag (9.88%; P<0.0001). The overall cleansing efficacy across the 3 groups (those with grades A or B) was 73.9%, 74.5%, and 86.5% for KleanPrep, Moviprep, and Senna/Citramag, respectively. In this series Senna/Citramag proved significantly better at bowel cleansing than KleanPrep (P<0.05) and it showed a trend toward better cleansing when compared with Moviprep (P=0.08). LIMITATIONS: Nonrandomized trial. Split-dosing regime for morning and afternoon lists may have confounded results. CONCLUSIONS: In summary, low-volume PEG (Moviprep) and Senna/Citramag combination were better tolerated than large volume PEG with Senna/Citramag providing superior mucosal cleansing.

Strategic pain management: the identification and development of the IAHPC opioid essential prescription package.

The aim of this study was to determine by consensus the components of an opioid essential prescription package (OEPP) to be used when initiating a prescription for the control of moderate to severe chronic pain. Palliative care physicians (n=60) were sampled from the International Association for Hospice and Palliative Care (IAHPC) membership list to represent a range of countries of varying economic levels and diverse geographical regions. Using a Delphi study method, physicians were asked to rank preferences of drug and dosing schedule for first-line opioid, antiemetic, and laxative for the treatment of adults with chronic pain due to cancer and other life-threatening conditions. Overall response rates after two Delphi survey rounds were 95% (n=57) and 82% (n=49), respectively. A consensus (set at ≥75% agreement) was reached to include morphine as first-line opioid at a dose of 5 mg orally every 4 hours. Consensus was reached to include metoclopramide as a first-line antiemetic, but there was no consensus on "regular" or "as needed" administration. No consensus was reached regarding a first-line laxative, but a combination of senna and docusate secured 59% agreement. There was consensus (93% agreement) that laxatives should always be given regularly when opioid treatment is started. Further work is needed to establish a recommended dose of metoclopramide and a type and dose of laxative. The resulting OEPP is international in scope and is designed to ensure that opioids are better tolerated by reducing adverse effects of opioids, which could lead to more sustained improvements in pain management.

Low-volume bowel preparation is inferior to standard 4 1 polyethylene glycol.

BACKGROUND: Four liters or more of orally taken polyethylene glycol solution (PEG) has proved to be an effective large-bowel cleansing method prior to colonoscopy. The problem has been the large volume of fluid and its taste, which is unacceptable to some examinees. We aimed to investigate the effectiveness of 2 l PEG combined with senna compared with 4 l PEG for bowel preparation. METHODS: The design was a single-center, prospective, randomized, investigator-blinded study with parallel assignment, in the setting of the Endoscopy Unit of Umeå University Hospital. Outpatients (n = 490) scheduled for colonoscopy were enrolled. The standard-volume arm received 4 l PEG, and the low-volume arm received 36 mg senna glycosides in tablets and 2 l PEG. The cleansing result (primary endpoint) was assessed by the endoscopist using the Ottawa score. The patients rated the subjective grade of ease of taking the bowel preparation. Analysis was on an intention-to-treat basis. RESULTS: There were significantly more cases with poor or inadequate bowel cleansing after the low-volume alternative with senna and 2 l PEG (22/203) compared with after 4 l PEG (8/196, p = 0.027). The low-volume alternative was better tolerated by the examinees: 119/231 rated the treatment as easy to take compared with 88/238 in the 4 l PEG arm (p = 0.001). CONCLUSIONS: 4 l PEG treatment is better than 36 mg senna and 2 l PEG as routine colonic cleansing before colonoscopy because of fewer failures.

A new regimen of bowel preparation for PillCam colon capsule endoscopy: a pilot study.

BACKGROUND: Colon capsule endoscopy (CCE) represents a new diagnostic, endoscopic technology for colonic exploration. Current protocols of preparation led to discordant rates of adequate cleansing level or CCE excretion. AIM: To evaluate the effect of a new regimen of bowel preparation for CCE on colon cleansing levels and on rate of capsule excretion. STUDY: 60 patients were prospectively enrolled. The new regimen of preparation consisted of a split regimen of PEG administration and of a 45 mL dose of sodium phosphate (NaP). Four senna tablets and a low-residue diet were also included. CCE excretion rate, colon cleansing, and accuracy were assessed. RESULTS: Forty-six patients were included in the final analysis, 13 patients (22%) being excluded because of preparation protocol deviations and one due to CCE technical failure (2%). At CCE, bowel preparation was rated as good in 78% of patients, fair in 20% and poor in 2%. CCE excretion rate occurred in 83% of patients. CCE sensitivity and specificity for significant findings was 100% and 95%, respectively. CONCLUSIONS: The combination of a split-dose of PEG solution with a low dose of NaP boosters resulted in high rates of adequate cleansing level and CCE excretion.

Half doses of PEG-ES and senna vs. high-dose senna for bowel cleansing before colonoscopy: a randomized, investigator-blinded trial.

OBJECTIVES: Patients' compliance with and tolerance of large-volume polyethylene glycol electrolyte solution (PEG-ES) have prompted continuous investigation with alternative forms of cleansing. High-dose senna is superior to PEG-ES for the quality of bowel cleansing, patient compliance, and tolerance, but its acceptance may be influenced by the incidence of abdominal pain. We hypothesized that a combination of half doses of PEG-ES and senna could minimize the incidence of abdominal pain without affecting the quality of bowel preparation. METHODS: This randomized, investigator-blinded trial has been conducted on consecutive outpatients scheduled for elective colonoscopy at a single community-based hospital. Patients were randomly assigned to receive either 12 tablets of 12 mg senna and 2 l of PEG-ES (half-dose group, HDG) or 24 tablets of senna divided in two doses (senna group, SG) the day before colonoscopy. The main outcome measures were the quality of colon cleansing (Aronchick scoring scale) and the incidence of preparation-related abdominal pain. Secondary outcome measures were patients' compliance with the cleansing regimen, overall tolerability, prevalence of predefined side effects, and quality of right colon cleansing. RESULTS: A total of 296 patients were enrolled (HDG=151 and SG=145). Overall cleansing was excellent to good in 90.1 and 88.3% patients in HDG and SG, respectively (P=0.62). Preparation-related moderate-to-severe abdominal pain was reported by 6% patients in HDG and 15.2% in SG (P=0.009). No significant differences were observed for secondary outcomes. CONCLUSIONS: The regimen combining half doses of PEG-ES and senna provides high-quality bowel preparation and acceptable patient tolerance, with less abdominal pain compared with high-dose senna.

Senna treatment in pregnant women and congenital abnormalities in their offspring--a population-based case-control study.

Previously, the possible teratogenic effect of frequently used laxative drug, senna has not been checked in case-control epidemiological study. Objective of the study was the comparison of cases with congenital abnormalities (CAs) and their matched controls without CAs in the population-based large data set of the Hungarian Case-Control Surveillance System of Congenital Abnormalities. Of 22,843 cases with CA, 506 (2.2%) had mothers with senna treatment, while of 38,151 control newborn infants without CA, 937 (2.5%) were born to mothers with senna treatment (adjusted OR with 95% CI: 1.0, 0.9-1.1), and of 834 malformed controls with Down syndrome, 26 (3.1%) had mothers with the use of senna (OR with 95% CI: 0.7, 0.5-1.1). The range of senna doses was between 10mg and 30 mg, but most pregnant women used 20mg daily. The mothers with senna treatment showed the characteristics of pregnant women with constipation (elder with larger proportion of primiparae). There was no higher risk for 23 different CA groups after the senna treatment during the second and/or third gestational month of 260 mothers, i.e. in the critical period of most major CAs, compared with their 500 matched controls. Gestational age at delivery was somewhat longer (0.2 week) and the rate of preterm birth was lower (6.6% vs. 9.2%) in newborn infants without CA born to mothers with senna treatment compared with babies born to mothers without senna treatment. In conclusion, senna treatment did not associate with a higher risk of CAs in the offspring of pregnant women with constipation.

Addition of senna improves quality of colonoscopy preparation with magnesium citrate.

AIM: To prospectively investigate the effectiveness and patient's tolerance of two low-cost bowel cleansing preparation protocols based on magnesium citrate only or the combination of magnesium citrate and senna. METHODS: A total of 342 patients who were referred for colonoscopy underwent a colon cleansing protocol with magnesium citrate alone (n = 160) or magnesium citrate and senna granules (n = 182). The colonoscopist rated the overall efficacy of colon cleansing using an established score on a 4-point scale. Patients were questioned before undergoing colonoscopy for side effects and symptoms during bowel preparation. RESULTS: The percentage of procedures rescheduled because of insufficient colon cleansing was 7% in the magnesium citrate group and 4% in the magnesium citrate/senna group (P = 0.44). Adequate visualization of the colonic mucosa was rated superior under the citramag/senna regimen (P = 0.004). Both regimens were well tolerated, and did not significantly differ in the occurrence of nausea, bloating or headache. However, abdominal cramps were observed more often under the senna protocol (29.2%) compared to the magnesium citrate only protocol (9.9%, P < 0.0003). CONCLUSION: The addition of senna to the bowel preparation protocol with magnesium citrate significantly improves the cleansing outcome.

Are bowel purgatives and prokinetics useful for small-bowel capsule endoscopy? A prospective randomized controlled study.

BACKGROUND: Capsule endoscopy (CE) is limited by incomplete small-bowel transit and poor view quality in the distal bowel. Currently, there is no consensus regarding the use of bowel purgatives or prokinetics in CE. OBJECTIVE: To evaluate the usefulness of bowel purgatives and prokinetics in small-bowel CE. DESIGN: Prospective single-blind randomized controlled study. SETTING: Academic endoscopy unit. PATIENTS: A total of 150 patients prospectively recruited. INTERVENTION: Patients were randomized to 1 of 4 preparations: "standard" (fluid restriction then nothing by mouth 12 hours before the procedure, water and simethicone at capsule ingestion [S]); "standard" + 10 mg oral metoclopramide before the procedure (M); Citramag + senna bowel-purgative regimen the evening before CE (CS); Citramag + senna + 10 mg metoclopramide before the procedure (CSM). MAIN OUTCOME MEASUREMENTS: Gastric transit time (GTT) and small-bowel transit time (SBTT), completion rates (CR), view quality, and patient acceptability. SECONDARY OUTCOME MEASURES: positive findings, diagnostic yield. RESULTS: No significant difference was noted among groups for GTT (median [minutes] M, CS, and CSM vs S: 17.3, 24.7, and 15.1 minutes vs 16.8 minutes, respectively; P = .62, .18, and .30, respectively), SBTT (median [minutes] M, CS, and CSM vs S: 260, 241, and 201 vs 278, respectively; P = .91, .81, and .32, respectively), or CRs (85%, 85%, and 88% vs 89% for M, CS, and CSM vs S, respectively; P = .74, .74, and 1.00, respectively). There was no significant difference in view quality among groups (of 44: 38, 37, and 40 vs 37 for M, CS, and CSM, vs S, respectively; P = .18, .62, and .12, respectively). Diagnostic yield was similar among the groups. CS and CSM regimens were significantly less convenient (P < .001), and CS was significantly less comfortable (P = .001) than standard preparation. CONCLUSIONS: Bowel purgatives and prokinetics do not improve CRs or view quality at CE, and bowel purgatives reduce patient acceptability.

CT colonography: optimisation, diagnostic performance and patient acceptability of reduced-laxative regimens using barium-based faecal tagging.

To establish the optimum barium-based reduced-laxative tagging regimen prior to CT colonography (CTC). Ninety-five subjects underwent reduced-laxative (13 g senna/18 g magnesium citrate) CTC prior to same-day colonoscopy and were randomised to one of four tagging regimens using 20 ml 40%w/v barium sulphate: regimen A: four doses, B: three doses, C: three doses plus 220 ml 2.1% barium sulphate, or D: three doses plus 15 ml diatriazoate megluamine. Patient experience was assessed immediately after CTC and 1 week later. Two radiologists graded residual stool (1: none/scattered to 4: >50% circumference) and tagging efficacy for stool (1: untagged to 5: 100% tagged) and fluid (1: untagged, 2: layered, 3: tagged), noting the HU of tagged fluid. Preparation was good (76-94% segments graded 1), although best for regimen D (P = 0.02). Across all regimens, stool tagging quality was high (mean 3.7-4.5) and not significantly different among regimens. The HU of layered tagged fluid was higher for regimens C/D than A/B (P = 0.002). Detection of cancer (n = 2), polyps > or =6 mm (n = 21), and < or =5 mm (n = 72) was 100, 81 and 32% respectively, with only four false positives > or =6 mm. Reduced preparation was tolerated better than full endoscopic preparation by 61%. Reduced-laxative CTC with three doses of 20 ml 40% barium sulphate is as effective as more complex regimens, retaining adequate diagnostic accuracy.

The bowel cleansing for colonoscopy. A randomized trial comparing three methods.

INTRODUCTION: Colonoscopy is the procedure of choice for the detection and ablation of small lesions o the colonic mucosa. A proper bowel cleansing is mandatory. So far several regimens have been proposed but rather none has shown a clear-cut advantage over the others. Aim of this study was to compare cleansing ability and patients' compliance of three oral regimens. PATIENTS AND METHODS: Two-hundred and seventy-three patients were block randomised into three groups. Group A (92 patients) received tablets containing senna 12 mg and Magnesium Sulphate 15 mg the day before colonoscopy. Group B (98 patients) received a Polyethylene Glycol-based solution of two litres plus 4 tablets of Bisacodyl the day before the exam. Group C (83 patients) received Sodium Phosphate 40 milliliters the day before and the day of colonoscopy. Results of 265 patients were available for the analysis. Eight patients were excluded because inability to follow prescription. The lower incidence of constipation in group C was not significant. The other parameters were homogeneously distributed in the three groups. RESULTS: The 79 patients of the group C achieved a better bowel cleansing as compared with the 90 of group A (p = 0.0003) and the 96 of group B (p = 0.034). Constipated patients had a significantly better cleansing with Sodium Phosphate preparation compared with senna plus Magnesium Sulphate (p = 0.017), but not significantly better compared with Golytely solution. Compliance and rate of total colonoscopy performed were not statistically different in the three groups. CONCLUSIONS: Sodium Phosphate solution gave better bowel preparation, with the same compliance, than either senna or Polyethylene solution. In constipated patients Sodium Phosphate showed good efficacy resulting in good cleansing rates similar to that of non-constipated patients. The poor results obtained by Polyethylene were related to the little amount of solution taken even if associated to Bisacodyl.

An oral carcinogenicity and toxicity study of senna (Tinnevelly senna fruits) in the rat.

Senna (Tinnevelly senna fruits), a known laxative derived from plants, was administered by gavage to Sprague-Dawley (Crl:CD (SD) BR) rats once daily at dose levels of 0, 25, 100 and 300 mg/kg/day for up to 104 consecutive weeks. Based upon clinical signs related to the laxation effect of senna, the highest dose (300 mg/kg/day) was considered to be a maximum tolerated dose. Sixty animals per sex were assigned to the control and dose groups. Assessments included clinical chemistry, hematology, full histology (control and high-dose groups; in addition, low and mid dose: intestinal tract, adrenals, liver, kidneys, brain and gross lesions) and toxicokinetics. The primary treatment-related clinical observation was mucoid feces seen at 300 mg/kg/day. When compared to controls, animals administered 300 mg/kg/day had slightly reduced body weights, increased water consumption and notable changes in electrolytes in serum (increases in potassium and chloride) and urine (decreases in sodium, potassium and chloride). The changes in electrolytes are most likely physiologic adaptations to the laxative effect of senna. At necropsy, dark discoloration of the kidneys was observed in animals in all treated groups. Histological changes were seen in the kidneys of animals from all treated groups and included slight to moderate tubular basophilia and tubular pigment deposits. In addition, for all treated groups, minimal to slight hyperplasia was evident in the colon and cecum. These histological changes, together with the changes seen in the evaluation of clinical chemistry and urine parameters, have been shown to be reversible in a previous 13-week rat study of senna. No treatment-related neoplastic changes were observed in any of the examined organs. Based upon these data, it is concluded that senna is not carcinogenic even after daily administration for 2 years at dosages of up to 300 mg/kg/day in Sprague-Dawley rats.