Sodium picosulfate/magnesium citrate: a review of its use as a colorectal cleanser.

Oral sodium picosulfate/magnesium citrate (CitraFleet; Picolax), consisting of sodium picosulfate (a stimulant laxative) and magnesium citrate (an osmotic laxative), is approved for use in adults (CitraFleet; Picolax) and/or adolescents and children (Picolax) as a colorectal cleansing agent prior to any diagnostic procedure (e.g. colonoscopy or x-ray examination) requiring a clean bowel and/or surgery. It is dispensed in powder form (sodium picosulfate 0.01 g, magnesium oxide 3.5 g, citric acid 12.0 g per sachet), with the magnesium oxide and citric acid components forming magnesium citrate when the powder is dissolved in water. In adult patients, two sachets of sodium picosulfate/magnesium citrate was at least as effective and well tolerated as oral magnesium citrate 17.7 or 35.4 g, or oral polyethylene glycol 236 g in adult patients undergoing a double-contrast barium enema procedure in three large, randomized, comparative clinical studies. In contrast, sodium picosulfate/magnesium citrate was less effective than a sodium phosphate enema preparation in two studies in patients undergoing flexible sigmoidoscopy. A similar number of patients receiving two sachets of sodium picosulfate/magnesium citrate or two 45 mL doses of oral sodium phosphate the day before a double-contrast barium enema procedure achieved satisfactory barium coating and none/minimal faecal residue in one study. However, the data from three of these studies should be interpreted with caution because the administrative regimens used differed from that recommended. Sodium picosulfate/magnesium citrate is also an effective and generally well tolerated colorectal cleansing agent in children and adolescents; the preparation was more effective than oral bisacodyl 0.01 or 0.02 g plus a sodium phosphate enema preparation in this population. Further research is thus required to accurately position sodium picosulfate/magnesium citrate and fully establish its efficacy and tolerability prior to various exploratory or surgical procedures. Nevertheless, oral sodium picosulfate/magnesium citrate provides a useful option in the preparation of the colon and rectum in adults, adolescents and children undergoing any diagnostic procedure (e.g. colonoscopy or x-ray examination) requiring a clean bowel and/or surgery. Oral sodium picosulfate/magnesium citrate acts locally in the colon as both a stimulant laxative, by increasing the frequency and the force of peristalsis (sodium picosulfate component), and an osmotic laxative, by retaining fluids in the colon (magnesium citrate component), to clear the colon and rectum of faecal contents. It is not absorbed in any detectable quantities. Sodium picosulfate is a prodrug: it is hydrolyzed by bacteria in the colon to the active metabolite 4,4'-dihydroxydiphenyl-(2-pyridyl)methane. Sodium picosulfate/magnesium citrate may be associated with a dehydrating effect, as evidenced by a reduction in bodyweight and increased haemoglobin levels; some at-risk patients may experience postural hypotension and older patients may require additional electrolytes. In three large (n >100), randomized, single-blind clinical studies, two sachets of oral sodium picosulfate/magnesium citrate was at least as effective as oral magnesium citrate 17.7 or 35.4 g, or oral polyethylene glycol 236 g as a colorectal cleansing agent in adult patients undergoing a double-contrast barium enema procedure. In contrast, sodium picosulfate/magnesium citrate was less effective than a sodium phosphate enema preparation in two studies in patients undergoing flexible sigmoidoscopy. A similar number of patients receiving two sachets of sodium picosulfate/magnesium citrate or two 45 mL doses of oral sodium phosphate the day before a double-contrast barium enema procedure achieved satisfactory barium coating and none/minimal faecal residue in one study. However, the data from three of these studies should be interpreted with caution because the administrative regimens used differed from that recommended. In children and adolescents, sodium picosulfate/magnesium citrate was significantly more effective as a colorectal cleansing agent than oral bisacodyl 0.01 or 0.02 g plus a sodium phosphate enema preparation in a randomized, single-blind study; dosages were adjusted for age in this study. Oral sodium picosulfate/magnesium citrate is generally well tolerated in adult patients undergoing various investigational colorectal procedures. Adverse events were generally mild to moderate in intensity and mainly gastrointestinal in nature (e.g. abdominal cramps/pain, nausea); other common treatment-emergent adverse events included disturbance of daily activity, headache and sleep disturbance. This combination is at least as well tolerated as oral sodium phosphate or oral polyethylene glycol, with moderate/severe nausea and vomiting occurring less frequently in sodium picosulfate/magnesium citrate recipients than in those receiving oral sodium phosphate, and abdominal bloating/pain and nausea developing less often with sodium picosulfate/magnesium citrate than polyethylene glycol therapy. The incidence of abdominal pain and sleep disturbance in sodium picosulfate/magnesium citrate versus oral magnesium citrate recipients was similar in one study, but significantly lower with sodium picosulfate/magnesium citrate in another. While the incidence of most adverse events was similar in recipients of sodium picosulfate/magnesium citrate and a sodium phosphate enema preparation, more patients receiving sodium picosulfate/magnesium citrate reported moderate/severe flatulence, incontinence and sleep disturbance, and more patients receiving the enema preparation reported rectal soreness. The tolerability profile of sodium picosulfate/magnesium citrate in patients aged >70 years is reportedly similar to that in patients aged <70 years. Abdominal pain also occurred less frequently with sodium picosulfate/magnesium citrate than with oral bisacodyl plus a sodium phosphate enema preparation in children and adolescents.

Factors affecting outcomes in colonoscopy.

There are many factors that influence successful outcomes in colonoscopy. The aims of this study were to evaluate these factors and determine ways to improve outcomes. All participants (N=229) who underwent planned colonoscopy between July and September 2004 were retrospectively included. Participants included 118 men and 111 women with a mean age of 59 years. Completion rate was 92%. Reasons of failure included poor bowel preparation (2.2%, p< .025), bowel looping (2.2%, p< .025), participant discomfort (1.3%), and obstructing lesion (1.3%). Mean midazolam dose was 3.8 mg. Three participants (1.3%) had midazolam alone, and all had complete colonoscopy. One hundred thirty-three participants (60.7%) had additional meperidine, with a completion rate of 94%. Eighty three participants (37.9%) had additional meperidine and Buscopan, with a completion rate reduced to 89.2%. There was no correlation between sedatives used and completion rate. Completion rate of colonoscopy in our unit was acceptable at 92%. A combination of midazolam and meperidine gave the best completion rates (94%). The two main reasons for incompletion were poor bowel preparation and excessive bowel looping.

Randomized clinical trial comparing sodium picosulfate with mannitol on the preparation FOR colonoscopy in hospitalized patients.

BACKGROUND: The cleansing of the colon for a colonoscopy exam must be complete so as to allow the visualization and inspection of the intestinal lumen. The ideal cleansing agent should be easily administered, have a low cost, and minimum collateral effects. Sodium picosulfate together with the magnesium citrate is a cathartic stimulant and mannitol is an osmotic laxative, both usually used for this purpose. AIMS: Assess the colon cleanliness comparing the use of mannitol and sodium picosulfate as well as evaluate the level of patient satisfaction, the presence of foam, pain, and abdominal distension in hospitalized patients undergoing colonoscopy. METHODS: A prospective, randomized, single-blind study with 80 patients that compared two groups: mannitol (40) and sodium picosulfate (40). Both groups received the same dietary orientation. The study was approved by the hospital's Ethics and Research Committee. The endoscopist was blind to the type of preparation. Outcomes evaluated: level of the colons cleanliness, patients satisfaction, the presence of foam, abdominal pain and distension, and the duration of the exam. The data was analyzed by means of the chi-squared test for proportions and Mann-Whitney for independent samples. RESULTS: There were no statistically significant differences between the groups in relation to the level of the colon's cleanliness, patients satisfaction, the presence of foam, abdominal pain, and the duration of the exam. Fifteen percent of the exams of the mannitol group were interrupted while from the sodium picosulfate group it was 5%. The presence of foam was similar for both groups. The average duration for carrying out the exam was 28.44 minutes for the mannitol group and 35.59 minutes for the sodium picosulfate group. Abdominal distension was more frequent in the mannitol group. If they would have to do the same exam, the answer was that 80% said yes from the mannitol group and 92.5% from the sodium picosulfate group. CONCLUSION: The quality of the colon preparation, foam formation, exam duration, and the collateral effects (nauseas, vomiting, and abdominal pain) were similar in both kinds of preparations. Abdominal distension was greater in the mannitol group. Both methods of preparation were well accepted by the hospitalized patients.

Randomized clinical trial comparing sodium picosulfate with mannitol on the preparation FOR colonoscopy in hospitalized patients

BACKGROUND: The cleansing of the colon for a colonoscopy exam must be complete so as to allow the visualization and inspection of the intestinal lumen. The ideal cleansing agent should be easily administered, have a low cost, and minimum collateral effects. Sodium picosulfate together with the magnesium citrate is a cathartic stimulant and mannitol is an osmotic laxative, both usually used for this purpose. AIMS: Assess the colon cleanliness comparing the use of mannitol and sodium picosulfate as well as evaluate the level of patient satisfaction, the presence of foam, pain, and abdominal distension in hospitalized patients undergoing colonoscopy. METHODS: A prospective, randomized, single-blind study with 80 patients that compared two groups: mannitol (40) and sodium picosulfate (40). Both groups received the same dietary orientation. The study was approved by the hospital’s Ethics and Research Committee. The endoscopist was blind to the type of preparation. Outcomes evaluated: level of the colon’s cleanliness, patient’s satisfaction, the presence of foam, abdominal pain and distension, and the duration of the exam. The data was analyzed by means of the chi-squared test for proportions and Mann-Whitney for independent samples. RESULTS: There were no statistically significant differences between the groups in relation to the level of the colon’s cleanliness, patient’s satisfaction, the presence of foam, abdominal pain, and the duration of the exam. Fifteen percent of the exams of the mannitol group were interrupted while from the sodium picosulfate group it was 5 percent. The presence of foam was similar for both groups. The average duration for carrying out the exam was 28.44 minutes for the mannitol group and 35.59 minutes for the sodium picosulfate group. Abdominal distension was more frequent in the mannitol group. If they would have to do the same exam, the answer was that 80 percent said yes from the mannitol group and 92.5 percent...

RACIONAL: A limpeza do cólon para o exame de colonoscopia deve ser completa de modo a permitir a visualização e inspeção do lúmen intestinal. O agente de limpeza ideal deveria ser de fácil administração, com baixo custo e com o mínimo de efeitos colaterais. O picosulfato de sódio juntamente com o citrato de magnésio é um estimulante catártico e o manitol é um laxativo osmótico, ambos geralmente utilizados para este propósito. OBJETIVOS: Verificar a limpeza do cólon comparando o uso de manitol e picosulfato de sódio assim como avaliar o nível de satisfação do paciente, presença de espuma, dor e distensão abdominal em pacientes hospitalizados submetidos a colonoscopia. MÉTODOS: Estudo prospectivo, randomizado, simples-cego com 80 pacientes que comparou dois grupos: manitol (40) e picosulfato de sódio (40). Ambos os grupos receberam a mesma orientação dietética. O estudo foi aprovado pelo Comitê de Ética do hospital e pelo Comitê de Pesquisa. O endoscopista foi cego para o tipo de preparo. Desfechos avaliados: nível de limpeza do cólon, satisfação do paciente, presença de espuma, dor e distensão abdominal e tempo de duração do exame. Os dados foram analisados pelas médias de testes qui-quadrado para proporções e Mann-Whitney para amostras independentes. RESULTADOS: Não houve diferença significativa entre os grupos em relação ao nível de limpeza do cólon, satisfação do paciente, presença de espuma, dor abdominal e tempo de exame. Quinze porcento dos exames do grupo manitol foram interrompidos enquanto que grupo picosulfato de sódio foi de 5 por cento. A presença de espuma foi similar em ambos os grupos. A média de duração do exame foi de 28h 44min para o grupo manitol e 35h 59min para o grupo picosulfato de sódio. A distensão abdominal foi mais freqüente no grupo manitol. Se eles tivessem que repetir o exame, a resposta foi de 80 por cento disse sim do grupo manitol e 92,5 por cento do grupo picosulfato de sódio. CONCLUSÕES: A qualidade do...

Oral sodium phosphate (Fleet) is a superior colonoscopy preparation to Picopre (sodium picosulfate-based preparation).

PURPOSE: Small-volume bowel preparation is better tolerated than 4-liter polyethylene glycol lavage. However, the efficacy of various small-volume bowel preparation agents for colonoscopy has not been clearly defined. This randomized, controlled trial was designed to compare oral sodium phosphate (Fleet) with Picoprep (sodium picosulfate-based preparation). METHODS: Two hundred twenty-five outpatients, aged 65 years or younger, who would undergo colonoscopy by two endoscopists were randomized to receive two bottles of oral sodium phosphate or three sachets of Picoprep. A standardized questionnaire was completed by all patients and the endoscopists. The endoscopists were blinded to the preparation used. RESULTS: One hundred three patients were randomized to oral sodium phosphate (Fleet) (Group 1) and 122 patients to Picoprep (Group 2). Three patients were excluded because of colonic strictures. The groups were similar in age and gender, indications for colonoscopy, and previous colonic surgery. The quality of bowel cleansing in patients taking oral sodium phosphate (Fleet) was significantly better than Picoprep as assessed by the endoscopists (P = 0.0014). Both types of bowel preparation were associated with similar incidence of nausea (P = 0.4927), dizziness (P= 0.9663), abdominal cramps (P = 0.7157), and patient acceptability (P = 0.0767). Equal majority from either group would use the same bowel preparation again (91 percent of oral sodium phosphate (Fleet) and 93 percent of Picoprep group; P = 0.6172). Although Picoprep was better tasting (P = 0.0273), oral sodium phosphate (Fleet)was perceived to be a good preparation agent by a greater (although not significant) proportion of patients (P = 0.0853). CONCLUSIONS: Oral sodium phosphate (Fleet) is more effective in bowel cleansing than Picoprep as a bowel preparation agent. Both agents have similar side effects and patient acceptance.

[Comparison of the effectiveness and tolerability of the saccharosum-sennosid-B solution and sodium-picosulfate in preparation for colonoscopy. Prospective, multicenter, randomized study]. / A saccharosum + sennosid-B oldat és a Na-pikoszulfát effektivitásának és tolerálhatóságának összehasonlítása kolonoszkópos elókészítés során. Multicentrikus, prospektív, randomizált vizsgálat.

INTRODUCTION: The effectivity, evaluability of the colonoscopic procedure depends greatly on the preparation and the cleanliness of the colon. A large scale of laxatives used for colon preparation are also available in our country (phenolphtalein, Karlsbad-salt, saccharosum + sennosid-B solution, bisacodyl, powder mixtures). AIMS: The authors examined in 5 gastroenterology centres the tolerability and effectivity of two frequently used laxatives--saccharosum + sennosid-B solution and Na-picosulphate--during colonoscopic preparation in 157 patients. METHODS: Exclusion criteria were: severe anemia, renal insufficiency, cardiac failure, active ulcerative colitis and Crohn's disease, possible stenotising colonic process and hypersensibility to one of the compounds. The patients were randomised prospectively. In the case of the saccharosum + sennosid-B solution the colon preparation was performed according to the manufacturers prescriptions, in the case of the Na-pikosulfate the investigator's own procedure was used based on literature data. The tolerability of the preparation was assessed using a questionnaire. The investigators made their statements concerning the cleanliness of the different colon sections based on uniform criteria. RESULTS: Both methods showed good efficacy concerning the cleanliness of the colon. The patients considered the Na-picosulphate better tolerable--based on the questionnaire data. The authors consider the analysis of further laxatives to help improve the work of their fellow endoscopists.

A blinded, randomized comparison of a novel, low-dose, triple regimen with fleet phospho-soda: a study of colon cleanliness, speed and success of colonoscopy.

BACKGROUND AND STUDY AIMS: A clean colon is essential for an efficient examination. The aim of this study was to compare a novel low-dose, low volume triple regimen with Fleet Phospho-soda. METHODS: A blinded, experienced colonoscopist examined 132 consecutive patients randomly allocated to receive either a triple regimen consisting of senna syrup (sennoside B), Picolax (sodium picosulphate), and Klean Prep (polyethylene glycol 3350), or Fleet Phospho-soda (sodium dihydrogen phosphate and disodium phosphate dodecahydrate). The colonoscopist recorded cleanliness according to a scoring system (1-very clean to 4-solid stools), and time taken to reach the caecum. RESULTS: In the triple regimen group (n = 81), 73% scored 1 or 2 compared with 57% in the Fleet Phospho-soda group (n = 51, p = 0.037 Mann-Whitney U-test). Examination to caecum was achieved in 95% of the triple regimen group and 89% of the Fleet Phospho-soda group. Among those examined as far as the caecum, the time to reach the caecum was 11 minutes (range 5-50) in the triple regimen group compared with 16 minutes (range 5-65) in the Fleet Phospho-soda group (p = 0.08, Mann-Whitney U-test). Patient tolerability was not assessed in this study. CONCLUSIONS: This novel triple regimen produces a cleaner colon than Fleet Phospho-soda, is associated with a trend towards a quicker and more efficient colonic examination, and is also 30% cheaper per patient.

A comparison of Fleet Phospho-soda with Picolax in the preparation of the colon for double contrast barium enema.

This study was performed to compare the patient acceptability and the efficacy of two different agents for bowel preparation prior to double contrast barium enema. One-hundred and ninety-four outpatients were randomized to have either two sachets of Picolax or two bottles of Fleet Phospho-soda and restricted to clear fluids on the day prior to their examination. Patients answered a short questionnaire before their enema. The decubitus films were assessed for faecal residue and bowel coating by three observers blinded to the type of preparation used. There was no significant difference in faecal residue nor in the bowel coating between the preparations. However patients found Picolax significantly easier to take, being better tasting and provoking less nausea and vomiting than Fleet Phospho-soda.

The optimum bowel preparation for flexible sigmoidoscopy.

With the proposed introduction of a flexible sigmoidoscopic screening programme for colorectal cancer, patient compliance is of paramount importance. Therefore, the bowel preparation providing optimum cleansing of the bowel with the least associated discomfort and inconvenience for the patient must be found. Patients were randomized to receive either Picolax the evening before the examination or self-administered Fleet enemas prior to the investigation. The endoscopist and nurse practitioner who collected data on a standard questionnaire were blinded to the preparation used. Bowel preparation was graded by the endoscopist as: excellent, good, adequate or poor. One hundred and two consecutive patients were randomized: 56 to the Fleet enema group and 46 to the Picolax group. Self-administered Fleet enemas provided a significantly superior bowel preparation with 52 (93%) being judged adequate or better, as opposed to 34 (74%) in the Picolax group. In addition, Fleet enemas were associated with significantly fewer adverse associated symptoms: 11 (20%) vs 24 (52%). Patients reported to be willing to receive Fleet enemas again in 53 (95%) vs 37 (80%) for the Picolax group. The self-administered Fleet enema is superior to Picolax in terms of bowel preparation for flexible sigmoidoscopy and the incidence of associated adverse symptoms.

A blinded clinical trial comparing conventional cleansing enema, Pico-salax and Golytely for barium enema bowel preparation.

UNLABELLED: An evaluator-blinded randomized clinical trial was undertaken to assess the effectiveness and patient acceptance of three bowel cleansing regimens: conventional cleansing enema, Pico-salax and Golytely. PATIENTS AND METHODS: One hundred and fifty patients, referred for barium enema examination, were allocated to one of the three regimens. Both the radiographers and the radiologists did not know the method of preparation. Radiographers were requested to enter the patients' data, the number of bowel openings, the patients' comments of the preparation and side effects. Films were reviewed independently by two experienced radiologists for the degree of bowel cleanliness and quality of barium coating. RESULTS: The mean (standard deviation) of bowel opening frequency for the cleansing enema, Pico-Salax and Golytely were 3.6(4.4), 8.3(4.8) and 7.1(4.2), respectively, with less bowel opening in the cleansing enema. There was less nausea associated with the cleansing enema (P = 0.006), more vomiting with Golytely (P = 0.008), less abdominal fullness with Pico-salax (P = 0.0006), less anorectal irritation with Golytely (P = 0.025), and no difference in the abdominal pain amongst three groups. There was no statistically significant difference in the number of bowel openings between the groups. Patients found that Pico-salax tasted better than Golytely (P = 0.0094) and Golytely was less accepted in the amount of fluid intake (P = 0.0018 and P < 0.0002 comparing Golytely with the cleansing enema and Pico-salax). Chi-squared testing showed no statistically significant difference in bowel cleanliness and quality of barium coating among the three preparations. CONCLUSIONS: There was no difference in the effectiveness of the three regimens. Pico-salax seems the most acceptable because it has the fewest side effects.

Barium enema preparation: a study of low-residue diet, "Picolax' and 'Kleen-Prep'.

A prospective, randomized three-arm trial is presented of 150 consecutive patients attending for double-contrast barium enema (BE). This compares 'Picolax' (a combined stimulant and osmotic agent), 'Picolax' following a 3 day low-residue diet and 'Kleen-Prep' (a polyethylene-glycol osmotic agent). Faecal clearance, mucosal coating and colon fluid were scored in four colonic segments by two radiologists working independently and blinded to the preparation used. Analyses of an elderly subgroup and of side effects was performed. Low-residue diet conferred no benefit to Picolax preparation, which was satisfactory (ability to exclude 5 mm polyps) in 80% of patients. Kleen-Prep failed to achieve adequate preparation in 46%, due to excess fluid and poor mucosal coating. Kleen-Prep caused more patient nausea, abdominal bloating and pain than Picolax. Patients 70 years and older had similar results. Low-residue diet need not be used in addition to Picolax. Kleen-Prep as a single agent is not recommended for BE preparation.

Colonic preparation with Picolax: patient tolerance and approaches to fluid replacement.

Sodium picosulphate (Picolax) is widely used for bowel preparation prior to colonic investigation or surgery. The most troublesome side effect reported is headache, which has been thought to be due to dehydration. In a prospective randomized study we investigated the incidence of adverse effects in patients given Picolax prior to barium enema examination, and assessed the incidence of adverse effects with different oral fluid regimens. A total of 197 outpatients were allocated to one of five fluid regimens on the day prior to the enema: (a) 4 pints of Dioralyte (glucose and electrolyte solution); (b) 4 pints of half-strength Dioralyte; (c) 4 pints of water; (d) 6 pints of water; and (e) free fluids. In a questionnaire, 36% of patients had no headache (graded 0/5), while 38% had a significant headache (graded 3/5 or greater). Sixteen per cent had significant abdominal pain, 42% had dry mouths, 43% thirst and 34% tiredness or irritability. There was no correlation between headache and fluid regimen. Furthermore, we have found no evidence of dehydration. None of the five fluid regimens was shown to offer any advantage, and we therefore recommend that patients be allowed to drink according to thirst when taking Picolax.

A trial to assess the effectiveness of bowel preparation prior to intravenous urography.

A randomized prospective trial was undertaken to compare the relative effectiveness of two commonly used bowel preparations (senna tablets and sodium picosulphate powder) administered to patients before they underwent out-patient intravenous urography. Their 'control' films were compared with plain 'kidneys, ureters, and bladder' (KUB) radiographs of patients who had had no bowel preparation. The results show no significant difference in the degree of faecal shadowing between those receiving a bowel preparation and the unprepared patients. Nor is there any difference between the two laxatives. We conclude that the routine administration of a bowel preparation is unlikely to improve the diagnostic quality of out-patient intravenous urograms. In addition, 40% of the urogram patients found the effects of the laxatives to be unpleasant or very unpleasant.

[Simple and efficient cleansing of the large intestine for colonic radiography]. / Enkel og effektiv tømming av tykktarmen før røntgen colon.

A clinical trial documented the excellent cleansing effect of a single low dose of the oral laxative sodium picosulphate. To achieve good preparation of the colon it is essential to ensure a combined regimen including simple diatary restrictions and liberal fluid intake during the two days preceding the radiological examination. An additional mechanical washout lavage is time-consuming and uncomfortable, and usually unnecessary for outpatients.

Barium enemas are a headache.

The frequency of headache after Picolax (sodium picosulphate, Nordic Ltd) preparation for barium enema was investigated and its association with dehydration, as assessed by haemoconcentration, was determined. Eleven out of 41 patients (26.8%) complained specifically of headaches. Although patients with and without headaches developed significant increases in haemoglobin concentration after Picolax preparation, the rise in haemoglobin in those with headaches was significantly greater than in those without (P less than 0.05). In both groups the haemoglobin concentration returned to normal after a bowel washout. These results suggest an association between dehydration and headache developing after a Picolax regimen. It may be possible to prevent this symptom by advising on the intake of specific volumes of fluid during preparation for barium enema.