Comparative efficacy of polyethylene glycol 3350 monotherapy against polyethylene glycol 3350 plus sodium picosulfate combined therapy in treating fecal impaction in pediatric functional constipation patients

Background: Functional constipation (FC) is a common pediatric problem worldwide. The management of FC comprises of a short initial disimpaction phase followed by long-term maintenance phase. Currently, polyethylene glycol (PEG) is considered as standard disimpaction therapy in pediatric FC patients. The aim of our study was to compare the efficacy of polyethylene glycol 3350 monotherapy with polyethylene glycol 3350 and sodium picosulfate combined therapy in treating fecal impaction in pediatric FC patients. Methods: All children (aged >1 year) diagnosed with FC as per ROME IV criteria and presenting to the out-patient department of pediatric gastroenterology, hepatology and nutrition unit of a tertiary health centre in north Indian Himalayan state were randomized into two open label, prospective, parallel groups, namely group A (receiving PEG 3350 monotherapy) and group B (receiving combined PEG 3350 plus sodium picosulfate therapy), over a period of 13 months. The outcome was evaluated as successful disimpaction with onset of loose/watery stools (Type-7 of Bristol stool chart scale). The success rates and mean time to disimpaction for two groups were computed and compared. Results: Eighty-one patients were randomized into two groups. The mean time to disimpaction was found to be significantly lower (p<0.001) for group B (2.37±1.16 days) when compared to group A (4.00±1.43 days). There was successful resolution of impaction in both groups. No adverse events were reported in either group. Conclusions: Combined PEG 3350 and sodium picosulfate therapy significantly reduces the disimpaction time when compared with PEG 3350 monotherapy in pediatric population, however both the therapies appear similar in achieving successful disimpaction.

Picossulfato de sódio comparado ao Manitol no preparo intestinal para colonoscopia: uma revisão sistemática / Sodium picosulfate compared to mannitol for bowel preparation before colonoscopy: a systematic review

Introdução: A colonoscopia é considerada o exame padrão ouro para diagnóstico do câncer de intestino. Porém o sucesso do exame depende do preparo colônico eficaz. Objetivo: Avaliar a eficácia do picossulfato de sódio (PS) comparativamente ao manitol (MN) no preparo intestinal precedente ao exame de colonoscopia. Material e Métodos: Revisão sistemática de ensaios clínicos randomizados controlados (ECRs). A busca por evidências na literatura científica foi conduzida nas bases de dados PubMed, Embase, Cochrane Library e Biblioteca Virtual da Saúde por meio da combinação dos seguintes indexadores e operadores booleanos: "colonoscopy" AND "picosulfate sodium" AND "mannitol". O risco de viés foi avaliado pela ferramenta RoB 2.0. Resultados: O efeito do PS sobre a limpeza colônica foi similar ou até mesmo inferior àquele demonstrado pelo MN. Entretanto, observou-se maior tolerabilidade e palatabilidade e menor frequência de efeitos colaterais associados ao PS em comparação ao MN. Ressalta-se a carência de rigor metodológico dos estudos incluídos, visto que 33% destes foram classificados com "alto risco" de viés, enquanto 66,7% apresentaram "alguma preocupação". Conclusão: Em comparação ao MN, o uso de PS não promove uma maior qualidade de limpeza colônica, embora esteja relacionado à menor ocorrência de efeitos colaterais, maior tolerabilidade e palatabilidade. Assim, sugere-se que a inclusão do PS seja considerada apenas em pacientes com intolerância importante ou surgimento de efeitos adversos que inviabilizem o preparo com MN.

Introduction: Colonoscopy is considered the gold standard test for diagnosing bowel cancer. The success of the exam, however, depends on effective colonic preparation. Objective: To evaluate the effectiveness of Sodium Picosulfate (PS) compared to Mannitol (MN) in intestinal preparation before colonoscopy examination. Material and Methods: Systematic review of randomized controlled clinical trials (RCTs). The search for evidence in the scientific literature was conducted in the PubMed, Embase, Cochrane Library and Virtual Health Library databases by combining the following indexers and Boolean operators: "colonoscopy" AND "picosulfate sodium" AND "Mannitol". The risk of bias was assessed using the RoB 2.0 tool. Results: The effect of PS on colonic cleansing was similar or even lower than that demonstrated by MN. However, greater tolerability and palatability and a lower frequency of side effects associated with PS were observed compared to MN. The lack of methodological rigor of the included studies is highlighted, as 33% of these were classified as "high risk" of bias, while 66.7% presented "some concern". Conclusion: Compared to MN, the use of PS does not promote a higher quality of colon cleansing, although it is related to the lower occurrence of side effects, greater tolerability and palatability. Therefore, it is suggested that the inclusion of PS must be considered only in patients with significant intolerance or the emergence of adverse effects that make preparation with MN unfeasible.

No inferioridad entre dos agentes de bajo volumen (picosulfato de sodio/citrato de magnesio frente al sulfato de sodio/potasio/magnesio) en la preparación del colon para procedimientos diagnósticos: estudio observacional / Non-inferiority between two low-volume agents (sodium picosulfate/magnesium citrate vs. sodium sulfate/potassium/magnesium) to prepare the bowel for diagnostic procedures: an observational study

Resumen Introducción: el cáncer colorrectal es un problema de salud pública; sin embargo, la detección temprana reduce su morbimortalidad. La colonoscopia es el procedimiento de elección para detectar lesiones premalignas y el éxito depende de una limpieza adecuada. El objetivo es evaluar el desempeño de dos preparaciones de bajo volumen empleados en un hospital de alto nivel. Materiales y métodos: estudio prospectivo en adultos que asistieran a colonoscopia en la Fundación Santa Fe de Bogotá, Colombia. Las preparaciones se evaluaron con la escala de Boston, con puntaje ≥ 6 puntos para una limpieza adecuada. Se realizó un análisis de regresión logística para establecer la efectividad de los medicamentos con un cálculo de no inferioridad del 3 %-5 %. Resultados: 598 pacientes fueron evaluados. El 49 % (293) fue expuesto al picosulfato de sodio/citrato de magnesio y el 51 % (305) fue expuesto al sulfato de sodio/potasio/magnesio. Con un promedio de Boston de 6,98 ± 1,86 (78 % con puntaje de Boston ≥ 6) y 7,39 ± 1,83 (83 %), respectivamente (p = 0,649). Según el análisis de la presencia y frecuencia de síntomas no deseados, el picosulfato fue mejor tolerado (p < 0,001). Conclusiones: los estudios de preparación intestinal en pacientes de un escenario real son muy escasos. Los medicamentos de bajo volumen obtuvieron una efectividad global y por segmento de colon similar, confirmando la no-inferioridad; el picosulfato de sodio/citrato de magnesio fue mejor tolerado. Un estudio de costo-efectividad podría definir esto según las necesidades de la población de estudio.

Abstract Introduction: Colorectal cancer is a public health problem; however, early detection reduces morbidity and mortality. Colonoscopy is the procedure of choice for detecting precancerous lesions, and success depends on proper bowel cleansing. Objective: To evaluate the performance of two low-volume agents used in a high-level hospital. Materials and methods: Prospective study in adults who underwent colonoscopy at the Fundación Santa Fe in Bogotá, Colombia. Preparations were evaluated using the Boston Bowel Preparation Scale. A score ≥6 points indicated adequate preparation. A logistic regression analysis was carried out to establish the effectiveness of the medicines with a non-inferiority ratio of 3-5%. Results: 598 patients were evaluated. 49% (293) received sodium picosulfate/magnesium citrate and 51% (305) received sodium sulfate/potassium/magnesium, with an average Boston score of 6.98±1.86 (78% Boston ≥6) and 7.39±1.83 (83%), respectively (p=0.649). According to the analysis of the presence and frequency of unwanted symptoms, picosulfate was better tolerated (p < 0.001). Conclusions: Bowel preparation studies in patients from a real-life scenario are scarce. Low-volume agents had similar overall and segmental effectiveness in the colon, confirming non-inferiority; sodium picosulfate/magnesium citrate was better tolerated. A cost-effectiveness study could establish the best option according to the needs of the study population.

Clinical comparison of low-volume agents (oral sulfate solution and sodium picosulfate with magnesium citrate) for bowel preparation: the EASE study

BACKGROUND/AIMS: This study compared the efficacy, compliance, and safety of bowel preparation between sodium picosulfate with magnesium citrate (SPMC) and oral sulfate solution (OSS). METHODS: A prospective randomized multicenter study was performed. Split preparation methods were performed in both groups; the SPMC group, 2 sachets on the day before, and 1 sachet on the day of the procedure, the OSS group, half of the OSS with 1 L of water on both the day before and the day of the procedure. The adenoma detection rate (ADR), adequacy of bowel preparation using the Boston Bowel Preparation Scale (BBPS) score, patient satisfaction on a visual analog scale (VAS), and safety were compared between the 2 groups. RESULTS: This study analyzed 229 patients (121 in the SPMC group and 108 in the OSS group). ADR showed no differences between 2 groups (51.7% vs. 41.7%, P>0.05). The mean total BBPS score (7.95 vs. 8.11, P>0.05) and adequate bowel preparation rate (94.9% vs. 96.3%, P>0.05) were similar between the 2 groups. The mean VAS score for taste (7.62 vs. 6.87, P=0.006) was significantly higher in the SPMC group than in the OSS group. There were no significant differences in any other safety variables between the 2 groups except nausea symptom (36.1% vs. 20.3%, P=0.008). CONCLUSIONS: Bowel preparation for colonoscopy using low volume OSS and SPMC yielded similar ADRs and levels of efficacy. SPMC had higher levels of satisfaction for taste and feeling than did OSS.

Double blinded randomized clinical trial to assess the effectiveness of several preparations for colonoscopy / Ensaio clínico randomizado duplo cego para avaliar a eficácia de várias preparações para colonoscopia

ABSTRACT Introduction: Colonoscopy is the screening gold standard to investigate several conditions in the colon. The excellence of preparation is a determining factor for a quality colonoscopy. Objective: Compare the quality of colon preparations for colonoscopy with different kinds of laxative medications in a public hospital of Belo Horizonte, Brazil. Method: A prospective double blind randomized clinical trial was conducted from June 2016 to March 2017. A total of 117 Patients were randomised in four groups to receive a type of preparation (Sodium picosulfate, Mannitol, Lactitol, Lactulose). The patients answered a questionnaire and peripheral blood samples were collected before and after the preparation.The quality of the cleansing was accessed according to the Boston Bowel Preparation Scale. Results: 99.1% of patients have taken the recommended dose and 79.5% reported a good tolerability. Endoscopists performed complete colonoscopy in 89.7%, with an polipectomy rate of 47%. The total effectiveness rate of the solutions were 88%. There were no statistically significant differences between groups (p = 0.271). Regarding the laboratory parameters, differences were seen in the pre- and post-test values of sodium, chlorine and creatinine but without exceeding reference values. Conclusion: The four preparations were effective for colon cleansing, with good acceptance, differing only as for costs.

RESUMO Introdução: a colonoscopia é o padrão ouro de triagem para pesquisa de várias doenças colônicas. A excelência de preparação é um fator determinante para uma colonoscopia de qualidade. Objetivo: Comparar a qualidade das preparações do cólon para colonoscopia com diferentes tipos de medicamentos laxantes em um hospital público de Belo Horizonte, Brasil. Método: Foi realizado um ensaio clínico randomizado duplo cego prospectivo de junho de 2016 a março de 2017. Um total de 117 pacientes foi randomizado em quatro grupos para receber um tipo de preparação (picossulfato sódico, manitol, lacticol, lactulose). Os pacientes responderam a um questionário e amostras de sangue periférico foram coletadas antes e depois da preparação. A qualidade da limpeza foi acessada de acordo com a Boston Bowel Preparation Scale. Resultados: 99,1% dos pacientes tomaram a dose recomendada e 79,5% relataram boa tolerabilidade. Os endoscopistas realizaram colonoscopia completa em 89,7%, com taxa de polipectomia de 47%. A taxa de eficácia total das soluções foi de 88%. Não houve diferenças estatisticamente significantes entre os grupos (p = 0,271). Em relação aos parâmetros laboratoriais, foram observadas diferenças nos valores pré e pós-teste de sódio, cloro e creatinina, mas sem exceder os valores de referência. Conclusão: As quatro preparações foram eficazes para limpeza do cólon, com boa aceitação, diferindo apenas quanto aos custos.

Intestinal preparations for colonoscopy. Comparative study: mannitol, picosulphate and macrogol / Preparos intestinais para colonoscopia. Estudo comparativo: manitol, picossulfato e macrogol

ABSTRACT Bowel preparation is mandatory prior to elective colonoscopy and their effectiveness is closely related to the quality of the examination. There are many preparations on the market and there is no consensus on which is best. This study aimed to compare three solutions for colon preparation in patients undergoing colonoscopy. We conducted a prospective study with 61 patients divided randomly into three groups: one that received a standard dose of macrogol, another received a standard dose of 10% mannitol and another received a standard dose of sodium picosulphate. Patients and examining endoscopists responded to questionnaires for compiling data. In the results we noticed that 10% mannitol, despite being less tolerated by the patient when compared to sodium picosulphate, presents better results in colonic cleaning, being therefore superior in this regard. Macrogol was considered as an intermediate in relation to the other two preparations. As for tolerability, preference is given to sodium picosulphate as best tolerated, followed by mannitol and by macrogol, which is poorly tolerated by the patient. We conclude that as the main objective of bowel preparation in colonoscopy is the quality of colonic cleaning, 10% mannitol was superior to the other preparations studied.

RESUMO O preparo intestinal é mandatório antes da realização das colonoscopias eletivas e sua eficácia está intrinsecamente relacionada à qualidade do exame. Existem diversos preparos no mercado e não há consenso sobre qual é melhor. Este estudo teve como objetivo comparar três soluções para preparo de cólon em pacientes submetidos à colonoscopia. Foi realizado um estudo prospectivo com 61 pacientes distribuídos de forma randomizada em três grupos: um recebeu macrogol, outro manitol a 10% e outro picossulfato de sódio em doses padrão. Os pacientes e os endoscopistas examinadores responderam a questionários para compilação de dados. Nos resultados notamos que o manitol a 10%, apesar de ser menos tolerado pelo paciente quando comparado ao picossulfato de sódio, apresenta melhores resultados na limpeza colônica, sendo, portanto, superior neste quesito. O macrogol foi considerado como intermediário em relação aos outros dois preparos. Quanto à tolerabilidade, a preferência recai sobre o picosulfato de sódio como o mais bem tolerado, seguido pelo Manitol; macrogol foi o menos tolerado pelo paciente. Concluímos que, como o principal objetivo do preparo intestinal na colonoscopia é a qualidade da limpeza colônica, o manitol a 10% mostrou-se superior aos demais preparos estudados.

Evaluación comparativa de efectividad y tolerabilidad con polietilenglicol y picosulfato de sodio-citrato de magnesio como agentes de preparación intestinal para colonoscopia / Comparative evaluation of effectiveness and tolerability with polyethylene glycol and sodium picosulfate-magnesium citrate as intestinal preparation agents for colonoscopy

Resumen Introducción La efectividad de la colonoscopia depende de múltiples factores, destacando la calidad de preparación intestinal y la tolerabilidad que tenga el paciente a la preparación administrada. Objetivo Comparar dos agentes de preparación intestinal, el polietilenglicol (PEG) y el picosulfato de sodiocitrato de magnesio (PSCM) en términos de efectividad y tolerabilidad de la preparación. Pacientes y Método Ensayo clínico aleatorizado en pacientes ambulatorios sometidos a colonoscopia en Clínica INDISA. Evaluando efectividad y tolerabilidad con el Boston Bowel Preparation Score (BBPS) y cuestionario de Lawrence [compuesto por escala Likert, dos preguntas cualitativas y escala visual análoga (EVA)], respectivamente. Resultados 189 pacientes, de los cuales 123 se aleatorizaron a PEG y 66 a PSCM. El BBPS en los pacientes que utilizaron PEG, la media fue 7,51 (DS 1,66) y con PSCM fue 7,12 (DS 1,71) (p = 0,111). Al analizar la tolerabilidad con escala Likert, la media con PEG fue 0,94 (DS 0,68) y con PSCM fue 0,63 (DS 0,61) (p = 0,0004). La EVA con PEG tuvo una media de 7,68 (DS 2,4) y con PSCM de 9,04 (DS 1,59) (p < 0,0001). Al preguntar ausentismo laboral, no hubo diferencias significativas en ambos grupos y al preguntar si ocuparía la misma preparación en una futura colonoscopia, hubo significancia estadística a favor del PSCM (p = 0,026). Conclusión No encontramos diferencias en la efectividad de preparación intestinal al comparar PEG y PSCM, sin embargo, el PSCM es mejor tolerado.

Introduction The effectiveness of colonoscopy depends on multiple factors, being two of the most important ones an adequate bowel preparation and the patient's tolerability to the preparation. Objectives Compare effectiveness and tolerability of two bowel preparation agents, polyethylene glycol (PEG) and sodium picosulfate/magnesium citrate (SPMC). Patients and Methods Randomized clinical trial on outpatients that went into colonoscopy in INDISA Clinic. We evaluated effectiveness and tolerability with Boston Bowel Preparation Score (BBPS) and Lawrence questionnaire [composed by Likert scale, two qualitative questions and Visual Analogue Scale (VAS) for pain], respectively. Results 189 patients, 123 were randomized to PEG and 66 to SPMC. BBPS average in patients in the PEG branch was 7.51 (SD 1.66) and for SPMC 7.12 (SD 1.71) (p = 0.111). Likert scale for evaluating tolerability average for PEG was 0.94 (SD 0.68) and for SPMC 0.63 (SD 0.61) (p = 0.0004). VAS scale for PEG had an average of 7.68 (SD 2.4) and for PSCM 9.04 (SD 1.59) (p < 0.0001). When we asked for workplace absenteeism, there were no significant differences between both groups and when we asked about using the same intestinal preparation in a future colonoscopy there was statistical significance in favor to SPMC (p = 0.026). Conclusions No differences were noted on effectiveness between the PEG and SPMC bowel preparations. Nevertheless, SPMC appeared to be better tolerated by patients.

Improvement of Synthesis Technology for Sodium Picosulfate / 中国药房

OBJECTIVE:To improve the synthesis technology of sodium picosulfate. METHODS:The synthesis technology of sodium picosulfate was improved by changing reaction solvent,charging sequence,refined method and formation of crystal water. Using phenol as raw material,it was condensed with 2-pyridinecarboxaldehyde to achieve 4,4′-(pyridin-2-ylmethylene)diphenol, and its yield rate was investigated. Sodium picosulfate was obtained after esterification,salification,formation of crystal water, and then its purity was determined. RESULTS:The yield rate of key intermediate 4,4′-(pyridin-2-ylmethylene) diphenol reached above 88%,and the purity of refined products reached over 99.5%. Sodium picosulfate monohydrate was stable,and the content of single impurity was less than 0.1%. CONCLUSIONS:The improved technology is simple with mild conditions,and suitable for large-scale production.

Sodium Picosulfate with Magnesium Citrate (SPMC) Plus Laxative Is a Good Alternative to Conventional Large Volume Polyethylene Glycol in Bowel Preparation: A Multicenter Randomized Single-Blinded Trial

BACKGROUND/AIMS: We investigated whether sodium picosulfate with magnesium citrate (SPMC) plus bisacodyl compares favorably with conventional polyethylene glycol (PEG) with respect to bowel cleansing adequacy, compliance, and safety. METHODS: We performed a multicenter, prospective, single-blinded study in outpatients undergoing daytime colonoscopies. Patients were randomized into a split preparation SPMC/bisacodyl group and a conventional split PEG group. We compared preparation adequacy using the Boston bowel preparation scale (BBPS), ease of use using a modified Likert scale (LS), compliance/satisfaction level using a visual analogue scale (VAS), and safety by monitoring adverse events during the colonoscopy between the two groups. RESULTS: A total of 365 patients were evaluated by intention to treat (ITT) analysis, and 319 were evaluated by per protocol (PP) population analysis (153 for SPMC/bisacodyl, 166 for PEG). The mean total BBPS score was not different between the two groups in both the ITT and PP analyses (p>0.05). The mean VAS score for satisfaction and LS score for the ease of use were higher in the SPMC/bisacodyl group (p<0.001). The adverse event rate was lower in the SPMC/bisacodyl group than in the PEG group (p<0.05). CONCLUSIONS: The SPMC/bisacodyl treatment was comparable to conventional PEG with respect to bowel preparation adequacy and superior with respect to compliance, satisfaction, and safety.

Effectiveness of Sodium Picosulfate/Magnesium Citrate (PICO) for Colonoscopy Preparation

PURPOSE: Bowel preparation with sodium phosphate was recently prohibited by the U.S. Food and Drug Administration. Polyethylene glycol (PEG) is safe and effective; however, it is difficult to drink. To identify an easy bowel preparation method for colonoscopy, we evaluated three different bowel preparation regimens regarding their efficacy and patient satisfaction. METHODS: In this randomized, comparative study, 892 patients who visited a secondary referral hospital for a colonoscopy between November 2012 and February 2013 were enrolled. Three regimens were evaluated: three packets of sodium picosulfate/magnesium citrate (PICO, group A), two packets of PICO with 1 L of PEG (PICO + PEG 1 L, group B), and two packets of PICO with 2 L of PEG (PICO + PEG 2 L, group C). A questionnaire survey regarding the patients' preference for the bowel preparation regimen and satisfaction was conducted before the colonoscopies. The quality of bowel cleansing was scored by the colonoscopists who used the Aronchick scoring scale and the Ottawa scale. RESULTS: The patients' satisfaction rate regarding the regimens were 72% in group A, 64% in group B, and 45.9% in group C. Nausea and abdominal bloating caused by the regimens were more frequent in group C than in group A or group B (P < 0.01). Group C showed the lowest preference rate compared to the other groups (P < 0.01). Group C showed better right colon cleansing efficacy than group A or group B. CONCLUSION: Group A exhibited a better result than group B or group C in patient satisfaction and preference. In the cleansing quality, no difference was noted between groups A and C.

Comparison of the Efficacy and Tolerability between Same-day Picosulfate and Split-dose Polyethylene Glycol Bowel Preparation for Afternoon Colonoscopy: A Prospective, Randomized, Investigator-blinded Trial

BACKGROUND/AIMS: In the present study, we evaluated the efficacy and tolerability between same-day bowel preparation protocols using 2 sachets of Picosulfate and a 4 L split-dose polyethylene glycol (PEG) bowel preparation for afternoon colonoscopy. METHODS: The study had a single-center, prospective, randomized, and investigator-blinded, non-inferiority design. We evaluated bowel preparation quality according to the Ottawa scale, patient tolerability, compliance, incidence of adverse events, sleep quality, and polyp/adenoma detection rate. RESULTS: Among the 196 patients analyzed (mean age, 55.3 years; 50.3% men), 97 received the same-day regimen of 2 sachets of picosulfate (group A) and 99 received the 4 L split-dose PEG regimen (group B). The Ottawa score of the total colon was 4.05+/-1.56 in group A and 3.80+/-1.55 in group B (P=0.255). The proportion of patients having adequate bowel preparation in the same-day picosulfate group (61.5%) was slightly less than the 4 L PEG group (71.3%); however, the difference was not statistically significant (P=0.133). Tolerability of the group A regimen was superior to that of the group B regimen (P<0.000). The same-day picosulfate regimen was associated with fewer adverse events, such as abdominal bloating (P=0.037) and better sleep quality (P<0.000). CONCLUSIONS: The same-day picosulfate regimen and the 4 L split-dose PEG regimen had similar efficacy in bowel preparation for afternoon colonoscopy. However, the same-day picosulfate regimen was easier to administer, produced fewer adverse events, and enabled better sleep quality.