Increased Tone of the Human Colon Muscle by Bisacodyl In Vitro

BACKGROUND/AIMS: Although bisacodyl is a widely administered laxative, its underlying mechanism of action remains generally unknown. This study focuses on investigating the effects of bisacodyl on the human colon muscle contraction, and elucidating its mechanism of action. METHODS: Sigmoid colon muscle strips (20 longitudinal and 18 circular muscles) were obtained from 20 subjects who underwent colectomy for colon cancer. Isometric force measurements were calculated in response to electrical field stimulation (EFS, 0.3 milliseconds in trains of 10 Hz for 20 seconds, 150 V). Peak and nadir (tone) during and after EFS, were measured in a controlled state, and after sequential addition of bisacodyl (1 μM), atropine (1 μM), N-nitro-L-arginine (L-NNA, 100 μM), MRS2500 (1 μM), and tetrodotoxin (TTX, 1 μM) to the organ bath. RESULTS: Transient phasic contractions were observed during EFS, and after cessation of EFS. In the longitudinal muscles, nadir during EFS, and tone after EFS, significantly increased after addition of bisacodyl, and persisted after sequential addition of atropine, L-NNA, MRS2500, and TTX, indicating a direct action of bisacodyl on the smooth muscle. In the second experiment, pretreatment of TTX abolished EFS-induced phasic contractions. Although no phasic contraction was produced after perfusion of bisacodyl, tone was increased, thereby supporting evidence of a direct mechanism of action of bisacodyl on the colon smooth muscle. CONCLUSIONS: Bisacodyl increases the tone of longitudinal muscle in the human sigmoid colon through a direct action on the smooth muscle. Further study is warranted to investigate the neural mechanism of action of bisacodyl.

Effect of bisacodyl on rats with slow transit constipation

The effect of bisacodyl on the treatment of rats with slow transit constipation (STC) was studied. Forty-five female Wister rats were divided into control group, STC group, and STC bisacodyl group. The immunohistochemical method was used to determine interstitial cells of Cajal (ICC) and the expression of c-Kit protein. Body mass and the number of defecations were significantly decreased in the STC group compared with the control group on the 100th day after diphenoxylate administration, while dry weight of feces was significantly increased and the intestinal transit time was prolonged. There were significant differences in the number of defecations, dry weight of feces, and intestinal transit time among the three groups. The number of defecations was higher, dry weight of feces was lower, and intestinal transit time was shorter in the STC bisacodyl group compared to the STC group. In addition, ICC basement membrane dissolution occurred in the colon wall of the STC group. The connection between ICC and surrounding cells was destroyed, and the nucleus shrunken to different degrees. Moreover, c-Kit expression in the STC group was significantly lower than the control group. The connection between ICC and surrounding cells in the STC bisacodyl group was significantly stronger than the STC group, and the number of ICC and the expression of c-Kit were increased. Bisacodyl could reduce the severity of STC in rats by increasing the number of ICC and the expression of c-Kit.

Tolerancia, seguridad y eficacia de la preparación intestinal con un día de PEG3350 + bisacodilo en comparación con 2 días de PEG3350 + bisacodilo en pacientes pediátricos / Tolerance, safety and efficacy of the one-day preparation of PEG3350 + bisacodyl compared to 2 days of PEG3350 + bisacodyl in pediatric patients

Resumen: Introducción: Múltiples preparaciones intestinales se han utilizado en niños sometidos a una colonoscopia, con limitación variable debido a la aceptación, tolerancia y la limpieza adecuada. El objetivo del estudio fue comparar la tolerancia seguridad y eficacia de la preparación intestinal para colonoscopia de 1 día con PEG 3350 (polietilenglicol) (4 g/kg/día) + bisacodilo y el tratamiento con 2 días de preparación con PEG 3350 (2 g/kg/día) + bisacodilo en pacientes pediátricos. Métodos: Se realizó un ensayo clínico, aleatorizado y ciego. Se incluyeron pacientes de 2 a 18 años, que ameritaron colonoscopia en forma programada. Los pacientes se asignaron de manera aleatoria en dos grupos: 1 día de preparación con PEG 3350 4 g/kg/día + bisacodilo y 2 días de preparación con PEG 3350 2 g/kg/día + bisacodilo. Por medio de un cuestionario, exploración física y valoración endoscópica (escala de Boston), se determinó la tolerancia, seguridad y eficacia de las 2 preparaciones a evaluar. Se realizó una prueba t de Student para variables cuantitativas y χ2 para variables cualitativas. Resultados: No hubo diferencias significativas en las tasas de cumplimiento, los efectos adversos y la extensión de la evaluación colonoscópica. Conclusiones: La tolerancia y seguridad entre la preparación intestinal para colonoscopia de 1 día con PEG 3350 (polietilenglicol) (4 g/kg/día) + bisacodilo y la preparación de 2 días con PEG 3350 (2 g/kg/día) + bisacodilo fue semejante. La calidad de la limpieza fue buena en ambos grupos, siendo parcialmente más eficaz en el grupo de 1 día con PEG 3350 (polietilenglicol) (4 g/kg/día).

Abstract: Background: Multiple intestinal preparations have been used in children undergoing colonoscopy, with variable limitation due to acceptance, tolerance, and proper cleaning. The objective of this study was to compare the tolerability, safety and efficacy of the colonoscopy preparation with 1 day with PEG 3350 (poliethylenglycol) (4 g/kg/day) + bisacodyl compared to 2 days of preparation with PEG 3350 (2 g/kg/day) + bisacodyl in pediatric patients. Methods: A clinical, randomized, and blind trial was performed. Patients aged 2 to 18 years scheduled for colonoscopy were included. Patients were randomized into two groups: 1 day of preparation with PEG 3350 4 g/kg/day + bisacodyl and 2 days of preparation with PEG 3350 2 g/kg/day + bisacodyl. Through a questionnaire, physical examination and endoscopic evaluation (Boston scale), the tolerance, safety and efficacy of the 2 preparations to be evaluated were determined. Student's t test was performed for quantitative variables and χ2 for qualitative variables. Results: There were no significant differences in compliance rates, adverse effects, and extent of colonoscopic evaluation. Conclusions: Tolerance and safety between the intestinal preparation for 1-day colonoscopy with PEG 3350 (4 g/kg/day) + bisacodyl and the 2-day preparation with PEG 3350 (2 g/kg/day) + bisacodyl were similar. The quality of cleanliness was good in both groups, being partially more effective in the 1-day group with PEG 3350 (4 g/kg/day).

Clinical Efficacy of Abdominal Acupoint Massage for Treatment of Functional Constipation in Elderly Patients / 胃肠病学

The prevalence of functional constipation (FC) is increased in elderly population, and seeking for a simple, safe and effective treatment modality is of great importance.Aims: To assess the clinical efficacy and safety of abdominal acupoint massage in elderly FC patients.Methods: A total of 151 elderly patients with FC were enrolled and randomly assigned into three groups: group A was treated with bisacodyl 5 mg once a day orally, group B with massage on Guanyuan, Zhongwan and Tianshu acupoints three times a day and group C with their combination.The treatment course was 4 weeks.The stool frequency per week was recorded, and the Patient Assessment of Constipation Symptoms scale (PAC-SYM) was scored.Results: The baseline data were comparable among the three groups (P>0.05).When compared with those before treatment, there was an increase in stool frequency per week and decrease in overall and dimensional scores of PAC-SYM at 1, 2, and 4 weeks after the beginning of treatment in all the three groups (P<0.05).Bisacodyl was superior to acupoint massage for improving stool frequency, consistency and rectal symptoms (P<0.05), while acupoint massage was superior to bisacodyl for alleviating abdominal symptoms (P<0.05).Mild adverse effects were recorded in patients receiving oral bisacodyl, and no adverse effects were observed in patients receiving acupoint massage.Conclusions: Abdominal acupoint massage is safe and effective for improving stool frequency and constipation-associated symptoms especially abdominal symptoms such as abdominal pain and distention in elderly FC patients.

Similarity Evaluation of Dissolution Curves for Generic Preparation and Reference Preparation of Bisaco-dyl Enteric-coated Tablets / 中国药房

OBJECTIVE:To investigate the similarity of dissolution curves between generic preparations and reference prepara-tions of Bisacodyl enteric-coated tablets in various dissolution mediums,and to provide reference for improving production technolo-gy and internal quality of generic preparations. METHODS:Paddle method was adopted with rotation speed of 75 r/min. The disso-lution test was performed using 1000 mL pH 6.0 phosphate buffer solution,pH 6.8 phosphate buffer solution,water containing 2% sodium lauryl sulfate. HPLC method was used to determine average accumulative dissolution of main components from 3 kinds of generic preparations and reference preparations at different time points to draw out dissolution curves. Similarity factor(f2)meth-od was used to the similarity of dissolution curves. RESULTS:Dissolution curves of reference preparations were basically the same in 3 kinds of dissolution mediums. But the dissolution curve f2 of one generic preparation among 3 manufactures to dissolution curve of reference preparation were ≥50,namely the similarity. CONCLUSIONS:The quality of generic Bisacodyl enteric-coat-ed tablets produced by different manufacturers is obviously different;the generic preparations needs to be further improved in the production technology and internal quality. For domestic generic preparation,it is necessary to strengthen the real-time monitoring of its dissolution curve,to ensure the drug quality.

Bisacodyl Induced Severe Rectal Ulcer with Proctitis / 이화의대지

Constipation is a prevalent, often chronic, gastrointestinal motility disorder. Bisacodyl, a stimulant laxative, is widely used to treat constipation in adults and children. This drug is usually safe, but it has some side effects including diarrhea, abdominal pain, colitis, and proctitis. There have been reports that rectal administration of bisacodyl could cause injury to the rectal mucosa by mechanical and chemical mechanisms. However, there has been no report of severe proctitis with rectal ulcers in patients taking oral bisacodyl. In this report, we describe the case of an 80-year-old woman with severe rectal ulcers and proctitis after taking oral bisacodyl for several days, and review the literature.

Determination of Content and Content Uniformity of Bisacodyl Enteric-coated Tablet by HPLC / 中国药房

OBJECTIVE:To establish a method for the determination of content and content uniformity in Bisacodyl enter-ic-coated tablet. METHODS:HPLC method was performed on the column of Agilent ZORBAX C18 with mobile phase of acetoni-trile-20 mmol/L ammonium acetate(adjusted pH to 5.0 with acetic acid)(55∶45,V/V),the detection wavelength was 265 nm,col-umn temperature was 30℃,flow rate was 1.0 ml/min,and the volume injection was 20 μl. RESULTS:The linear range of bisaco-dyl was 50-1 000 μg/ml(r=0.999 9);RSDs of precision,stability and reproducibility tests were lower than 1%;recovery was 99.50%-101.17%(RSD=0.5%,n=9). CONCLUSIONS:The method is reproducible with high accuracy,and suitable for the quali-ty control of Bisacodyl enteric-coated tablet.

Simultaneous Residual Determination of Two Organic Solvents in Bisacodyl Raw Material by Head-space GC / 中国药房

OBJECTIVE:To establish a method for simultaneous residual determination of dichloromethane and ethyl acetate in bisacodyl raw material. METHODS:Head-space GC was performed on the capillary column of 6% cyanopropyl phenyl-94% di-methyl polysiloxane(DB-624)by temperature programming,the temperature of injector was 220 ℃,detector was flame ionization detector with temperature of 250 ℃,carrier gas was high purity nitrogen with the flow rate of 3.0 ml/min,split ration was 1∶10, headspace heating temperature was 70 ℃,equilibration time was 30 min,volume of headspace vial was 5 ml,and the injection volume was 1 ml. RESULTS:The linear range was 6-120μg/ml for dichloromethane(r=0.999 9)and 50-1 000μg/ml for ethyl ac-etate(r=0.999 9);the limit of quantitation was 0.2,1.7 μg,limit of detection was 0.06,0.5 μg;RSDs of precision,stability and reproducibility tests were no higher than 3%;recoveries were 100.30%-102.00%(RSD=0.63%,n=9) and 100.10 %-101.30%(RSD=0.44%,n=9). CONCLUSIONS:The method is simple and accurate,and can be used for the simultaneous residual deter-mination of dichloromethane and ethyl acetate in bisacodyl raw material.

Effect on colorectal cleansing of CT colonography with gulping down bisacodyl before or after oral taking polyethylene glycol / 重庆医学

Objective To comparative study the effect on colorectal cleansing of CT colonography with gulping down 10 mg bisacodyl before or 1 h after oral taking 2 liter polyethylene glycol .Methods Forty participants with informed consent were appor‐tioned to group A ,group B randomly ,20 cases in each group .On the day before CT colonography ,participants in group A oral took 20 mL of 40% W/V barium sulfate prior to 3 mealtime ,and 20 mL of 60% diatrizoate meglumine diluted in 250 mL of water after supper ,then gulped down 10 mg bisacodyl enteric‐coated tablets 1 hour before oral taking 2 liter polyethylene glycol electrolyte so‐lution .Participants in group B were the same as that in group A ,with the exception of gulping down 10 mg bisacodyl enteric‐coated tablets 1 hour after oral taking 2 liter polyethylene glycol electrolyte solution .Cleansing efficacy of stool and fluid ,and attenuation value of remainder fluid between the two groups were analyzed statistically .Results In group A ,score of cleansing efficacy of stool (1 .96 ± 0 .11) was lower than that in group B (2 .01 ± 0 .12) ,segments with good cleansing efficacy of stool (87/120 segments , 72 .50% ) was higher than that in group B (83/120 segments ,69 .17% ) ,the difference was not statistically significant (P>0 .05) .In group A ,score of cleansing efficacy of fluid (1 .50 ± 0 .06) was lower than that in group B (1 .53 ± 0 .06) ,segments with good cleansing efficacy of fluid(113/120 segments ,94 .17% ) was higher than that in group B (111/120 segments ,92 .50% ) ,the differ‐ence was not statistically significant (P>0 .05) .Attenuation value of remainder fluid [(729 ± 29)HU ] in group A was higher than that in group B[(653 ± 25)HU] ,the difference was statistically significant(P<0 .05) .Conclusion Gulping down 10 mg Bisacodyl before or after oral taking 2 liter polyethylene glycol has no effect on cleansing of stool and fluid ,with good cleansing efficacy .The former has better cleansing efficacy of fluid ,is beneficial to detecting polyps for CT colonography .

Evaluation of Measurement Uncertainty for the Content of Bisacodyl Enteric-coated Tablet by HPLC / 中国药房

OBJECTIVE:To a evaluation method for the measurement uncertainty for the content of Bisacodyl enteric-coated tablet. METHODS:HPLC external standard method was conducted for content determination of Bisacodyl enteric-coated tablet, and mathematical model for uncertainty evaluation was established to systematically analyze and evaluate the influential factors in processes of solution preparation and instrument measurement. RESULTS:HPLC external standard method showed the content was 97.8%,confidence probability was 95%,expanded uncertainty was 2.8%,and determination result was (97.8 ± 2.8)%,k=2. CONCLUSIONS:The established method is suitable for the evaluation of measurement uncertainty for the content of Bisacodyl en-teric-coated tablet. Regularly calibrated verification for HPLC equipment and strict control of the weighing process will help to im-prove the accuracy measured by HPLC.

Study on the Determination Method for Related Substances in Bisacodyl Raw Material and Enteric-coated Tablet / 中国药房

OBJECTIVE:To establish a method for the determination of related substances in bisacodyl raw material and enteric-coated tablet. METHODS:HPLC was performed on the column of Hibar C18 with mobile phase of acetonitrile-20 mmol/L ammonium acetate (acetic acid adjust pH to 5.0)(55∶45,V/V),detection wavelength was 265 nm,flow rate was 1.0 ml/min, column temperature was 30℃,and the injection volume was 20 μl. RESULTS:The linear range of bisacodyl was 0.25-5.0 mg/ml (r=0.999 9);the limits of detection and quantification were 19-25 ng and 61-68 ng for bisacodyl and impurity A,B,C,D and E;RSDs of precision,stability and reproducibility tests were lower than 2%;recovery was 99.50%-101.00%(RSD=0.5%,n=9). CONCLUSIONS:The method is specific, sensitive and reproducible, and can be used for the determination of related substance in bisacodyl raw material and enteric-coated tablet.

BOWEL PREPARATION BEFORE COLONOSCOPY FOR CHILDREN: comparison of efficacy of three different methods

Background - Colonoscopy is an important diagnostic and therapeutic procedure. Adequate bowel preparation is mandatory. Several regimens were discussed in the literature. Among the drugs which has recently used, polyethylene glycol is one of the most popular agents. Objectives - The aim of this study was to compare efficacy of three different methods for 1 day preparation before colonoscopy. Methods - This study included children with the range of ages (2-21) who had an indication of colonoscopy. Exclusion criteria were based on the history of previous surgery, parental disagreement, and patients who did not use preparation protocol. Three methods for bowel preparation were studied: 1- Polyethylene glycol only; 2- Polyethylene glycol and bisacodyl suppositories; 3- Polyethylene glycol plus normal saline enema. Boston Bowel Preparation Score was used for evaluation of preparation. SPSS version 16.0 (Chicago, IL, USA) were used for data analysis. Results - In this study 83 cases completed the bowel preparation completely. Acceptable bowel preparation was seen in 24 (85.71%), 36 (94.73%), and 14 (82.35%) of cases in PEG, PEG + bisacodyl, and PEG + normal saline enema groups respectively. PEG + bisacodyl suppositories was more effective than PEG + normal saline for the preparation of the first segment ( P=0.05). For second and third segment of colon, BPPS score was higher in PEG + bisacodyl suppositories compared to other regimens, but this difference was not statistically significant. Conclusion - There was no significant difference between 1 day colonoscopy regimens in terms of bowel preparation score. Lowest score was seen in PEG + enema group compared to other group.

Contexto - A colonoscopia é um procedimento diagnóstico e terapêutico importante. A preparação intestinal adequada é obrigatória. Vários esquemas são discutidos na literatura. Dentre as drogas que se têm usado recentemente, o polietilenoglicol é um dos agentes mais utilizados. Objetivo - O objetivo deste estudo foi comparar a eficácia de três métodos diferentes para a preparação feita 1 dia antes de colonoscopia. Métodos - Este estudo incluiu crianças com a gama de idades entre 2 e 21 anos, que tinham indicação de colonoscopia. Os critérios de exclusão foram baseados em história da cirurgia anterior, não aprovação dos pais e pacientes que não utilizaram o protocolo de preparação. Três métodos para a preparação do intestino foram estudados: 1-polietilenoglicol; 2 - polietilenoglicol e bisacodil supositórios; 3 - polietilenoglicol e enema de solução salina. O escore de Boston para preparação intestinal foi usado para a avaliação e os dados foram analisados pelo SPSS versão 16.0 (Chicago, Il, USA). Resultados - Um total de 83 pacientes concluiu completamente o preparo intestinal. Houve preparo aceitável em 24 (85,71%), 36 (94,73%) e 14 (82,35%) dos casos, nos grupos PEG, PEG + bisacodil e PEG + enema salino, respectivamente. PEG + bisacodil supositórios foi mais eficaz do que a PEG + solução salina para a preparação do primeiro segmento ( P=0,05). Para segundo e terceiro segmento do cólon, a pontuação de BPPS foi maior no grupo PEG + bisacodil supositórios em comparação com outros regimes, mas essa diferença não foi estatisticamente significativa. Conclusão - Não houve nenhuma diferença significativa entre os regimes de preparo para colonoscopia de um dia em termos de pontuação de preparação do intestino. A nota mais baixa foi vista no grupo PEG + enema em comparação com outros grupos.

Determination of Purity and Uncertainty Evaluation of Bisacodyl by Differential Scanning Calorimetry / 中国药房

OBJECTIVE:To establish the purity determination of bisacodyl by differential scanning calorimetry(DSC)and the valuation of uncertainty. METHODS:DSC was conducted to detect the purity of bisacodyl and determine the optimal testing condi-tions. According to related standards,indium enthalpy change values,measurement repeatability,weighing process,instrument tem-perature deviation and system software deviation were systematically analyzed. The results were verified by HPLC. RESULTS:When the fiducial probability P was 0.95,the standard value and uncertainty of content of bisacodyl was (99.88 ± 0.06)% mea-sured by DSC. Weighing process,instrument temperature deviation and system software deviation had great effects on the total un-certainty. The result of HPLC and DSC were the same. CONCLUSIONS:The established DSC can quickly and accurately determine the chemical purity of bisacodyl. The uncertainty evaluation is reliable. Regularly calibrated and verificated equipment and strict con-trol of the weighing process will help to improve the accuracy measured by DSC;and it provides a new analysis method for the de-termination of purity of bisacodyl.

Efficacy of Bisacodyl Given as Part of a Polyethylene Glycol-based Bowel Preparation Prior to Colonoscopy in Hospitalized Patients: A Prospective Ramdomized Trial / 대한소화기학회지

BACKGROUND/AIMS: Inpatient status can cause inadequate bowel preparation. The majority of previous studies regarding bowel preparation have focused on comparing the effects of different purgative regimens in outpatients. However, data on bowel preparation for inpatients are lacking. The aim of this study was to investigate whether bisacodyl plus polyethylene glycol (PEG) can improve bowel preparation in hospitalized patients. METHODS: A prospective, randomized and observer-blind study was performed. A total of 196 hospitalized patients undergoing colonoscopy were randomized to receive 4 L PEG (PEG only group) or 4 L PEG+bisacodyl 10 mg (bisacodyl added group). The adequacy of bowel preparation was scored using the Ottawa bowel preparation scale. RESULTS: One hundred and eighty-three subjects completed the study; 96 in the bisacodyl added group and 87 in the PEG only group. There were no significant differences between the bisacodyl added group and the PEG only group with respect to the score of bowel cleansing (3.59+/-2.81 vs. 3.82+/-3.03, p=0.607), quality of bowel cleansing (adequate preparation 89.6% vs. 85.1%, p=0.380), and overall adverse events (66.7% vs. 52.9%, p=0.057). However, a larger proportion of patients in the PEG only group were able to ingest the entire solution as prescribed than in the bisacodyl added group (98.9% vs. 75.0%, p<0.001). CONCLUSIONS: In hospitalized patients, the quality of bowel preparation did not differ depending on whether bisacodyl is added or not. In addition, patient compliance based on consumption of cleansing agent was better in the PEG only group.

Bowel preparation for performing a colonoscopy: prospective randomized comparison study between a low-volume solution of polyethylene glycol and bisacodyl versus bisacodyl and a mannitol solution / Preparo de cólon para realização de colonoscopia: estudo prospectivo randomizado comparativo entre solução de polietilenoglicol baixo volume mais bisacodil versus solução de manitol mais bisacodil

CONTEXT: Colonoscopy is currently the gold standard method to examine the colon, the rectum and the terminal ileum. In order to perform the colonoscopy, it is necessary to clean the bowel and use medications that are generally poorly tolerated by the patients. OBJECTIVE: Compare the tolerability, acceptability, safety and efficacy of two solutions used for intestinal preparation for a colonoscopy. METHODS: One hundred patients matched for sex and age were prospective randomized into two groups. Polyethylene glycol group received bisacodyl 10 mg plus 1 L of polyethylene glycol the night before and 1 L on the day of the exam. Mannitol group received bisacodyl 20 mg the day before and 1 L of a 10% mannitol solution on the day of the exam. The diet was the same for both groups. Tolerability and acceptability were measured using previously validated questionnaires. In terms of safety, variations in vital signs before and after the preparation were recorded, in addition to any complications. The quality of the preparation was graded based on the Boston and Ottawa scales. RESULTS: Ninety-six percent (96%) completed the study. As for tolerability, the mannitol preparation group exhibited a significantly higher frequency of nausea, vomiting, abdominal pain, and abdominal distension than polyethylene glycol group (P < 0.05). Acceptability was significantly better in polyethylene glycol group. The polyethylene glycol solution has also previously been shown to be safer than mannitol. No difference was observed in the quality of the preparation between the two preparation methods. CONCLUSIONS: The following conclusions can be made: polyethylene glycol solution had higher tolerability, acceptability, and safety than the mannitol and should be used instead of mannitol. Both preparation solutions have similar efficacy.

CONTEXTO: O exame de colonoscopia é atualmente o padrão-ouro para investigação do cólon e íleo terminal. Para sua realização há necessidade de limpeza do cólon com soluções que, em geral, são mal toleradas pelos pacientes. OBJETIVO: Comparar duas soluções de preparo intestinal para colonoscopia quanto à tolerabilidade, aceitabilidade, segurança e efetividade. MÉTODOS: Cem pacientes pareados por sexo e idade foram randomizados prospectivamente em dois grupos. O grupo polietilenoglicol recebeu bisacodil 10 mg + 1 litro de polietilenoglicol na véspera e 1 litro no dia do exame. O grupo manitol recebeu bisacodil 20 mg na véspera e 1 litro de manitol 10% no dia do exame. A dieta foi a mesma nos dois grupos. A tolerabilidade e aceitabilidade foram aferidas por questionários previamente validados. Quanto à segurança foram avaliados: variação de sinais vitais antes e após o preparo e complicações, além de quaisquer sinais de complicação. A qualidade do preparo foi graduada através das escalas de Boston e Ottawa. RESULTADOS: Noventa e seis pacientes (96%) completaram o estudo. Quanto à tolerabilidade o grupo manitol apresentou manifestação significativamente maior de náusea, vômito, dor abdominal e distensão abdominal do que o grupo polietilenoglicol (P<0,05). Aceitabilidade foi significativamente melhor com o grupo polietilenoglicol. O grupo polietilenoglicol também se mostrou mais seguro. Não se observou diferença na qualidade do preparo entre os métodos. CONCLUSÕES: A solução de polietilenoglicol apresentou melhor tolerabilidade, aceitabilidade e segurança e deve ser usada ao invés da solução de manitol. Ambas as soluções são semelhantes em eficácia.

A Prospective Trial Comparing 4 L-Polyethylene Glycol with 2 L-Polyethylene Glycol Plus Bisacodyl Tablets for Colon Preparation / 대한소화기내시경학회지

BACKGROUND/AIMS: The aim of the study was to prospectively compare low-volume PEG plus 20 mg bisacodyl with the standard 4 L PEG with regards to the adequacy of bowel preparation, patient compliance and the side effects. METHODS: From September 2007 to January 2008, 59 patients who had previously undergone screening colonoscopy with 4 L PEG and had been diagnosed with colonic polyps were admitted for polypectomy. The colonoscopists, who were unaware of the preparation that was administered, evaluated the adequacy of the bowel cleansing. Detailed questionnaires were also used to assess patient compliance, the difficulty of bowel preparation, side effects and patient preference. RESULTS: The physician's evaluation of the colon cleansing showed better adequacy with 4 L PEG than with 2 L PEG plus bisacodyl (p<0.05). There was no difference in patient compliance between the 2 bowel preps. The patients in the 2 L PEG plus bisacodyl group tolerated the bowel preparation more easily than the patients in the 4 L PEG (81.4% vs. 15.3%, respectively). Moreover, the scores of the visual analog scale for the difficulty of bowel preparation were 5.8+/-2.3 in the 4 L PEG group and 3.2+/-1.9 in the 2 L PEG plus bisacodyl (p<0.01). The majority (89.8%) of the patients preferred 2 L PEG plus bisacodyl (p<0.001). The 2 L PEG plus bisacodyl group revealed less nausea, vomiting and sleep discomfort (p<0.05), but they had more abdominal pain (p<0.01). CONCLUSIONS: 2 L PEG plus bisacodyl is not as effective as the standard 4 L PEG for colon cleansing. However, 2 L PEG plus bisacodyl can be used for patients who have difficulty drinking a large amount of PEG.

A Prospective Randomized Trial Comparing Divided Dose of Polyethylene Glycol Solution with Stimulant Laxative Plus Low Dose Polyethylene Glycol Solution for Colon Cleansing / 대한소화기내시경학회지

BACKGROUND/AIMS: This study compared the efficacy and patient's tolerance between those given a divided dose of a polyethylene glycol solution (PEG) and those given a stimulant laxative plus a reduced dose of PEG. METHODS: 190 consecutive patients for colon cleasing were randomized into 3 groups. In group A, 2 L of PEG was administered on the evening prior to the colonoscopy followed by 2 L of the same solution on the morning of colonoscopy. In group B, 2 L of PEG was administered in the morning only. In group C, 2 bisacodyl tablets (10 mg) were administered on the evening prior to colonoscopy and 2 L of PEG was administered in the morning. The patients completed a questionnaire to assess their tolerance to the bowel preparation before the colonoscopy. The endoscopists scored the adequacy of the bowel preparation using the Ottawa scale along with their satisfaction with the quality of the procedure. RESULTS: While 4 patients (6.7%) could not completely take the recommended dose in group A, all patients in groups B and C could take the recommended dose (p=0.012). The patients in Group B had a better tolerance and fewer side effects than those in Group A (p=0.01). A higher adequacy of bowel preparation was observed in group A than in group B (p=0.000) and there appeared to be a higher adequacy of bowel preparation in Group C than in Group B (p=0.06). CONCLUSIONS: The 2 L PEG solution only does not appear to be as effective as a bowel cleansing agent for colonoscopy compared with the divided 4 L PEG solution. No statistical difference in the side effects and efficacy was observed between the divided 4 L PEG solution and the combination of bisacodyl 10 mg with 2 L of a PEG solution.