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.

Acute Gastric Injury Caused by Undissolved Sodium Picosulfate/Magnesium Citrate Powder

Sodium picosulfate/magnesium citrate (SPMC) is a widely used oral bowel cleansing agent considered to be relatively safe. However, partially dissolved or undissolved SPMC powder may cause severe injuries of the esophagus and stomach. We report a very rare case of acute gastric injury without esophageal damage caused by the ingestion of undissolved SPMC powder. A 69-year-old man experienced epigastric pain after swallowing SPMC powder without dissolving it in water in preparation for a screening colonoscopy. He realized his mistake immediately and subsequently drank 2 L of water. The esophagogastroduodenoscopy conducted after 12 hours indicated an acute gastric ulceration without injury of the esophagus or duodenum. The endoscopy conducted after 6 weeks of oral proton pump inhibitor treatment showed healing of the gastric injury. This suggested that drinking large amounts of water after ingesting partially dissolved or undissolved SPMC powder can prevent serious esophageal injury, but offers no preventive benefit for acute gastric injury.

Severe Hyponatremia with Mental Change after Ingestion of Picosulfate Sodium/Magnesium Citrate for Bowel Preparation / 대한내과학회지

Picosulfate sodium/Magnesium citrate (PS/MC) is a common bowel cleansing agent for colonoscopy. It is equally effective and better tolerated by patients with regard to taste and volume than polyethylene glycol. However, because of its osmotically active characteristics, PS/MC can cause plasma volume depletion and electrolyte disturbances, such as hyponatremia. Here, we report a case of severe hyponatremia combined with loss of consciousness in a 59-year-old woman following ingestion of PS/MC as bowel preparation for a screening colonoscopy. Upon arrival, serum sodium level was 109 mEq/L and urine osmolality and sodium levels were 393 mOms/Kg and 99 mmol/L, respectively. She was euvolemic and showed normal kidney, thyroid, and adrenal function. Based on these findings, inappropriate anti-diuretic hormone syndrome (SIADH) was diagnosed. She was treated with 3% hypertonic saline and completely recovered without any neurologic sequelae. This case shows that SIADH can be caused by PS/MC (not accompanied by dehydration), even in patients without any underlying renal, heart, or liver diseases.

Secado por aspersión de citrato de calcio y magnesio a partir de dolomita / Spray drying of calcium and magnesium citrate from dolomite

Introduction: calcium is an essential nutrient required in substantial amounts, but many diets are deficient in calcium making supplementation necessary or desirable. On the other hand, spray drying is an important technology used in the pharmaceutical industry. In this process the end-product must comply with precise quality standards. Objective: To evaluate the spray drying of calcium and magnesium citrate and to make comparison with the traditional method of drying. Methods: calcium and magnesium citrate salt was obtained at bench scale from dolomite and suspended in water in a proportion 1:10 (w/v) and spray-dried. The final batches were evaluated by chemical and technological analysis methods Results: the results showed that calcium, magnesium, citric acid and total ash content have similar concentrations regardless of the used drying method. Residual moisture content of the dried product by spray drying method was higher than that of the dried sample by traditional method. Nevertheless, all the results were below the maximum allowable limit. The physical properties of the samples for each drying method were similar except for density because the spray-dried samples showed values lower than those of traditionally dried samples(AU)

Introducción: el calcio es un nutriente esencial que se requiere en cantidades sustanciales, pero muchas dietas son deficientes de calcio, lo que hace necesario suplementar el mismo. Por otro lado, el secado por aspersión es una tecnología importante usada en la industria farmacéutica. Con este proceso de secado se obtiene un producto final que obedece a los estándares de calidad necesarios. Objetivo: este estudio se realizó para evaluar el secado por aspersión del citrato de calcio y magnesio y su comparación con el método tradicional de secado. Métodos: se obtuvieron lotes de citrato de calcio y magnesio a escala de banco a partir de dolomita y se suspendieron en agua en una proporción 1:10 (masa/volumen). Posteriormente fueron secados mediante secado por aspersión. Se evaluaron los lotes obtenidos mediante métodos de análisis químicos y tecnológicos. Resultados: los resultados mostraron que el contenido de calcio, magnesio, ácido cítrico y cenizas totales eran similares independiente del método de secado empleado. El contenido de humedad residual en las muestras secadas por aspersión fue superior al de las muestras secadas por el método tradicional. No obstante, los resultados obtenidos en ambos casos estaban por debajo del límite máximo permisible. Las propiedades físicas de las muestras para cada método de secado estudiado fueron similares, excepto para la densidad, dónde se observó que las muestras secadas por aspersión tienen valores de densidad menores que las muestras secadas por el método tradicional. Conclusiones: los resultados demuestran que las condiciones de secado por aspersión estudiadas son adecuadas para el secado del citrato de calcio y magnesio obtenido a partir de dolomita(AU)

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.

Evaluación de citrato de calcio y magnesio obtenido de dolomitas cubanas / Evaluation of calcium and magnesium citrate from Cuban dolomite

INTRODUCTION: calcium and magnesium salts are used as nutritional supplements obtained from natural sources such as dolomite, which is a double complex of calcium and magnesium carbonate. In search of a calcium raw material with greater bioavailability, a process of obtaining calcium and magnesium citrate salt from dolomite deposits was developed. OBJECTIVE: to evaluate calcium and magnesium citrate from dolomite. METHODS: chemical and technological analysis, Powder X-ray Diffractometry attenuated total reflection-Fourier transform infrared spectrometry (ATR-FTIR), differential scanning calorimetry and thermogravimetric analysis were all used. RESULTS: the chemical analysis confirmed the existence of calcium (over 10 percent), and of magnesium (4.5 and 5 percent) whereas citric acid content was under 3 percent, The levels of toxic metals were below the maximum allowable limits for pharmaceutical products. The density values were below those of the dolomite, with high porosity and flow deficit. The X-ray diffractomery indicated that dolomite was transformed into calcium and magnesium citrate salts whereas, the infrared spectra showed the presence of characteristic COO¯, -OH and -CH2 groups of citrates. The differential scanning calorimetry showed that salt had three endothermic peaks at 101.7 ºC, 167.1 ºC y 194.6 ºC and on the other hand, termogravimetry analysis confirmed that 30.9 percent of the total mass is lost at temperatures lower than 295 ºC..CONCLUSIONS: the presence of calcium and magnesium citrate salt is corroborated(AU)

INTRODUCCIÓN: las sales de calcio y magnesio son utilizadas como suplementos nutricionales y se obtienen a partir de fuentes naturales, dentro de las cuales se encuentra la dolomita, que es un complejo doble de carbonato de calcio y magnesio. En la búsqueda de una materia prima de calcio con mayor biodisponibilidad, ha sido desarrollado un proceso de obtención de sales de citrato de calcio y magnesio a partir de dolomitas. OBJETIVO: evaluar el citrato de calcio y magnesio obtenido a partir de dolomita. MÉTODOS: se emplearon métodos de análisis químicos y tecnológicos, difracción de rayos X, reflexión total atenuada en el infrarrojo medio con transformada de Fourier, calorimetría diferencial de barrido y análisis termogravimétrico. RESULTADOS: los resultados del análisis químico demostraron la presencia de calcio (superior al 10 por ciento) y magnesio (entre 4,5 y 5 por ciento), mientras que el contenido de ácido cítrico fue menor al 3 por ciento. Los niveles de metales tóxicos estaban por debajo de los límites máximos permisibles para productos farmacéuticos. Los valores de densidades fueron inferiores a las densidades de la dolomita, con la presencia de un elevado porcentaje de porosidad y deficiente flujo. El análisis por difracción de rayos X demostró que la dolomita fue transformada en sales de citrato de calcio y magnesio, mientras que los espectros infrarrojos mostraron que las principales absorciones se corresponden con las de los grupos COO¯, -OH y -CH2, características todas de citratos. Los estudios por calorimetría diferencial de barrido indicaron que la sal presentaba tres transiciones endotérmicas a 101,7 ºC, 167,1 ºC y 194,6 ºC, y el análisis termogravimétrico corroboró que a temperaturas menores de 295 ºC ocurre una pérdida de masa que representa el 30,9 por ciento de la masa total. CONCLUSIONES: se corrobora la presencia de sal de citrato de calcio y magnesio(AU)

Hiperhidrosis focal primaria asociada a eritromelalgia primaria / Primary focal hyperhidrosis associated to primary erythromelalgia

Paciente femenina de 30 años de edad que consulta por un cuadro de hiperhidrosis, asociado a sensación de calor desde su niñez. Sufre crisis de calor en cara, cuello, parte superior del tronco y los cuatro miembros, que la inducen a transpirar. Durante estos episodios nota sensación de calor, dolor y con aparición de rubor en manos y pies. Los síntomas ceden con aplicación de frío. Estos síntomas que presenta desde su adolescencia, dificultan el sueño, sus tareas habituales y el trato social. Sus antecedentes familiares respecto del mismo cuadro son floridos. Los estudios hematológicos, inmunológicos, la electromiografía y el ecodoppler de miembros superiores, resultaron dentro de límites normales. En el video sobre capilaroscopía periungueal de manos, se constata cambios micro vasculares inespecíficos. En la prueba de provocación mediante aumento de la temperatura, se obtiene resultado positivo a 39°C para miembros superiores. La paciente presenta signo-sintomatología compatible con hiperhidrosis focal primaria. Los episodios de calor, rubor y dolor de los cuatro miembros, que ceden a la exposición al frío fueron interpretados como eritromelalgia, en base a la clínica y los antecedentes familiares. Para la hiperhidrosis se indica solución de cloruro de aluminio hexa-hidratado al 20%, de aplicación tópica y para la eritromelalgia citrato de magnesio en grageas 528 mg, de dos a cuatro por día. Según la bibliografía por nosotros revisada, la asociación de hiperhidrosis focal primaria y eritromelalgia primaria familiar, no se ha registrado en la literatura.

Female patient, aged 30 years-old, attending a medical consultation with hyperhidrosis associated with episodes of warmth and sweating since childhood, located in face, neck, upper thorax and extremities. These episodes are accompanied by heat, pain and reddening in hands and feet. The symptoms disappear to cold exposure. These symptoms altered sleep, daily activities and social life. A positive family history with similar clinical characteristics was obtained. Hematological and immunological studies, as well as upper limbs electromyography and ecodoppler are within normal parameters. Unspecific microvascular alterations were observed with finger-periungueal video capillaroscopy. A provoking test yielded positive results when rising temperature to 39°C in upper limbs. The patient symptoms are compatible with focal primary hyperhidrosis. Heat, reddening and pain in the upper and low extremities responding to cold exposure and the positive family history led us to diagnose erythromelalgia. The hyperhidrosis treatment consisted of a topical application of 20% hexhydrate aluminum chloride. For erythromelalgia treatment 528 mg magnesium citrate pills, 2-4 daily were administered. Literature review to find out association of primary focal hyperhidrosis with primary familiar erythromelalgia was negative.

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.

Effect of Potassium Magnesium Citrate and Vitamin B-6 Prophylaxis for Recurrent and Multiple Calcium Oxalate and Phosphate Urolithiasis

PURPOSE: To study the effects of long-term treatment with potassium magnesium citrate and vitamin B-6 prophylaxis (Urikind-KM6; 1,100-mg potassium citrate, 375-mg magnesium citrate, and 20-mg pyridoxine hydrochloride/5 mL) every 8 hours over 3 years. MATERIALS AND METHODS: A total of 247 patients with recurrent idiopathic hypocitraturia with or without hyperuricosuria and randomized controls were studied prospectively for 3 years. The total patients were divided into three groups. Control group 1 consisted of 61 patients (24.7%) who had moderate to severe hypocitraturia with or without hyperuricosuria and were recurrent stone formers but discontinued prophylaxis because of drug intolerance within 1 month of therapy. Control group 2 constituted 53 patients (21.5%) who were first-time stone formers and who had mild hypocitraturia with or without hyperuricosuria and were not put on prophylactic therapy and were followed for 3.16+/-0.08 years. Control group 3 constituted 133 patients (54.8%) who were recurrent stone formers who had moderate to severe hypocitraturia with or without hyperuricosuria and were put on prophylaxis therapy and were followed for 3.16+/-0.08 years. All patients were followed up at 6-month intervals. RESULTS: Potassium magnesium citrate prophylaxis produced a sustained increase in 24-hour urinary citrate excretion from initially low values (221.79+/-13.39 mg/dL) to within normal to high limits (604.04+/-5.00 mg/dL) at the 6-month follow-up. Urinary pH rose significantly from 5.62+/-0.2 to 6.87+/-0.01 and was maintained at 6.87+/-0.01. The stone recurrence rate declined from 3.23+/-1.04 per patient per year to 0.35+/-0.47 per patient per year. CONCLUSIONS: Potassium magnesium citrate prophylaxis was effective in reducing the recurrence of calcium oxalate and phosphate urolithiasis.

Effect observation on magnesium citrate combined with compound polyethylene glycol electrolyte powder in bowel preparation before colonoscopy / 中国医师进修杂志

Objective To study the effect of magnesium citrate combined with compound polyethylene glycol electrolyte powder in bowel preparation before colonoscopy.Methods One hundred and six colonoscopy patients with lower digestive tract symptom were divided into study group (54 cases) and control group (52 cases) by random digits table method,the bowel preparation in study group was magnesium citrate combined with compound polyethylene glycol electrolyte powder,in control group was compound polyethylene glycol electrolyte powder.The lesions detection rate,bowel preparation quality,time of first defecation,number of defecation,time of colonoscopy,results of the electrolyte level and liver and kidney function after medication and adverse reaction were compared between two groups.Results There were no statistical differences in lesions detection rate,time of colonoscopy,results of the electrolyte level and liver and kidney function after medication between two groups (P ＞ 0.05).The total effective rate of bowel preparation quality in study group was significantly higher than that in control group [96.3％(52/54) vs.82.7％ (43/52)],the time of first defecation was significantly shorter than that in control group [(32.5 ± 26.1) rmin vs.(47.2 ± 22.4) min],the number of defecation was significantly much than that in control group [(8.2 ± 2.9) times vs.(6.2 ± 2.6) times],there were statistical differences (P ＜ 0.05).The incidence of nausea in study group was significantly lower than that in control group [22.2％ (12/54) vs.48.1％ (25/52)],there was statistical difference (P ＜ 0.05).There were no statistical differences in the incidences of vomiting,abdominal distention and abdominal pain between two groups (P ＞ 0.05).Conclusion Magnesium citrate combined with compound polyethylene glycol electrolyte powder used in preoperative bowel preparation for colonoscopy has better clinical application value.

Tiempo de filtración del citrato de calcio y magnesio obtenido a partir de dolomita cubana / Filtration time for calcium cytrate and magnesium from the Cuban dolomite

El citrato de calcio y magnesio es una materia prima de calidad farmacéutica obtenida a partir de dolomitas cubanas, con la finalidad de ser empleada en la producción de formas terminadas para suplir calcio y magnesio en personas con deficiencias de estos minerales. Como parte de la optimización del proceso tecnológico de obtención, se estudió el tiempo de filtración con el objetivo de evaluar el comportamiento a escalas superiores. Para ello se realizó un estudio de desescalado para determinar las condiciones en la escala de banco, empleando como criterio de escalado mantener igual consumo de potencia por unidad de volumen. A través de la ecuación fundamental de la filtración, se determinó el tiempo de esta operación. El estudio de filtración dio como resultados que el valor de la resistencia del medio filtrante era Rm= 6,08 × 1010 m-1 y la resistencia de la torta a= 1,239 × 1010 m/kg-1 a una diferencia de presión constante (Dp= 9,99 × 104 kg/m·s2). Mientras que el tiempo medio de filtración fue de 494,6 s (8,24 ± 3,0 min). En conclusión, los resultados mostraron que el tiempo de filtración es adecuado para el proceso tecnológico estudiado, y el estudio de escalado demostró la viabilidad del proceso de filtración

Calcium and magnesium citrate is a raw material of pharmaceutical quality obtained from Cuban dolomites to be used in those people with deficiency in these two minerals. As part of the technological process optimization, the filtering time was studied to evaluate the possible behaviour at higher scales. To this end, one scale-down study was made to determine the conditions at bench scale by keeping the same power consumption per volume unit. The fundamental filtering equation allowed determining the time for this operation. The results of this study showed that the resistance value of the filtering material was Rm= 6.08 · 1010 m-1 and the resistance of the mass was a= 1,239 , 1010 m·kg-1 at constant pressure (Dp= 9,99 × 104 kg/m·s2). The filtration time was 494,6 s (8,24 ± 3,0 min). The results showed that the filtration time was correct for the studied technological process and the scale up study demonstrated the feasibility of the filtration process