[Results of a cohort single-center randomized study of the modulating effect of the drug Mexidol in the rehabilitation of patients who suffered acute cerebral insufficiency]. / Rezul'taty kogortnogo odnotsentrovogo randomizirovannogo issledovaniya moduliruyushchego effekta preparata Meksidol v reabilitatsii patsientov, perenesshikh ostruyu tserebral'nuyu nedostatochnost'.

OBJECTIVE: Evaluation of the effect of pharmacological modulation of the rehabilitation process with the drug mexidol as an adjuvant component of the rehabilitation treatment of cognitive-emotional disorders in patients who have suffered acute cerebral insufficiency (ACI) due to acute cerebrovascular accident or traumatic brain injury. MATERIAL AND METHODS: The study was conducted as a randomized interventional prospective study and consisted of 5 visits. Patients were divided into 2 groups: main (n=30, standard therapy + Mexidol IV 500 mg per day for 10 days, followed by Mexidol FORTE 250 orally, 1 tablet 3 times a day for 8 weeks) and control (n=30, standard therapy for 66 days). RESULTS: The study randomized 60 patients who underwent ACN and received rehabilitation treatment in accordance with regional routing. In the main group, there was an improvement in cognitive functions comparable to the control group (p<0.001, in both groups there was an improvement in the Schulte test «work efficiency¼ and «total execution time¼, according to the MoCA scale (visit 5 - 23.8±2.6 vs 22.9±31, p=0.227). A significant superiority of the main group over the control group was shown in such indicators as a decrease in anxiety (according to the HADS scale) (visit 4 - 2.6±2.4 vs 4.4±2.4, p=0.004), a decrease in the severity of depression (according to the Beck scale) (visit 3 - 7.5±4.5 vs 11.4±5.6, p=0.005). There was a tendency for the main group to be superior in terms of muscle strength (according to the MRC scale (visit 4 - 3.3±5.1 vs 2.1±2.2, p=0.051), level of vital activity (according to the ShRM - visit 5 - 2.9±0.7 vs 3.3±0.6, p=0.053). A statistically significant increase in the level of mobility of patients in the group using the drug Mexidol was proven compared to the control group (the difference in the Rivermead index at the 5th visit was 10.3±2.8 and 8.0±2.8, respectively, p=0.006), the average increase in the Rivermead index by visit 5 (5.4±2.1 vs 3.4±1.6, p<0.001). A decrease in intensive care aftereffects syndrome (ITS) scores was detected in both groups; a statistically significant decrease in the severity of ITS in relation to the previous visit was detected only in the group using the drug Mexidol (p<0.001). In the main group, the best indicators of the dynamics of systolic cerebral blood flow velocity and overshoot coefficient were also determined, compared to the control group. There were no adverse events recorded in the study. CONCLUSION: A positive modulating effect of Mexidol has been demonstrated in terms of accelerating the restoration of tolerance to cognitive loads, improving the psycho-emotional background by reducing symptoms of anxiety and depression, and secondary improving the results of motor rehabilitation in the early recovery period in patients who have undergone ACI, including those with manifestations of PIT syndrome. During the study, no adverse events were recorded, as well as significant differences in vital functions in the study groups, which indicates comparable safety of therapy in the control and main groups.

Sodium picosulfate/magnesium citrate versus 4L split-dose polyethylene glycol for bowel cleansing prior to colonoscopy in high fibre diet African patients.

INTRODUCTION: an adequate bowel preparation is essential for good mucosal inspection during colonoscopy. This study aims to compare the efficacy of two validated oral lavage solutions for colonoscopy preparation in African patients. METHODS: a prospective observational study of patients undergoing colonoscopy in a referral endoscopy facility in Port Harcourt, Nigeria, using sodium picosulfate magnesium citrate (SPMC) and 4L split-dose polyethylene glycol (PEG). Variables collated were sociodemographic, primary indication, comorbidities, Aronchick bowel preparation scale, polyp/adenoma detection, caecal intubation and outcome. Statistical analysis was performed using IBM SPSS version 20. RESULTS: one hundred and twenty-four patients received PEG prior to colonoscopy and SPMC in 175 patients. The age range was from 22 to 92 years; mean age of 53.8 ± 14.2 years for PEG group and 55.3 ± 13.2 years for SPMC group (p=0.361). There were 215 males and 84 females. An excellent/good bowel preparation scale was recorded in 77 (62%) PEG group and 130 (74.3%) for SPMC group (p=0.592). PEG was predominantly used in the early years of endoscopists practice with the odds ratio (OR) of no polyp detection in the PEG vs SPMC groups as 1.64 (confidence interval CI 1.06-2.55) versus 0.76 (CI 0.62-0.92), respectively (p=0.016). For no adenoma detection, OR was 4.18 (CI 1.12-15.60) versus OR 0.63 (CI 0.52-0.75), respectively (p=0.012). CONCLUSION: there is similar efficacy profile using either split volume PEG or SPMC prior to colonoscopy in these African patients. Polyp and adenoma detection rates are highly dependent on the expertise of the endoscopist.

Effect of Xymedon and Mexidol in Combination with Antineoplastic Drugs on Spermatogenesis Indicators and Functional State of Spermatozoa in Rats with Walker-256 Carcinoma.

We compared the effect of Xymedon (100 mg/kg), Mexidol (50 mg/kg), and their combination on spermatogenesis indicators and functional state of spermatozoa in rats with Walker-256 carcinoma treated with doxorubicin (4 mg/kg) and cyclophosphamide (45 mg/kg) (once intraperitoneally on day 11 after tumor cells transplantation). Xymedon and Mexidol were injected intramuscularly for 10 days starting from day 11 of the experiment. The studied parameters were evaluated on experimental days 14 and 21. We have established that gonadoprotective effect of Xymedon developed gradually and persisted longer than that of Mexidol. It manifested in an increase in the number of epithelial spermatogenesis cells (spermatogonia by 3.2 times, early spermatids by 2.2 times, late spermatids by 2.9 times, and Leydig cells by 4 times) in the testes and also the proportion of viable progressively and non-progressively motile epididymal spermatozoa (by 2 times). The combination of Xymedon and Mexidol stimulated spermatogenesis (with restoration of the initial level of spermatocytes, an increase in the number of early spermatids by 65.5 and 99% in comparison with Xymedon alone and Mexidol alone, respectively) and increased the number of viable epididymal spermatozoa more effectively than Xymedon and Mexidol alone by 54 and 60%, respectively.

[The efficacy and safety of Mexidol Forte 250 as part of long-term sequential therapy in patients with carotid stroke]. / Éffektivnost' i bezopasnost' preparata Meksidol Forte 250 v ramkakh dlitel'noi posledovatel'noi terapii u bol'nykh s ishemicheskim insul'tom v karotidnoi sisteme.

AIM: To evaluate an effect of long-term sequential therapy with mexidol and mexidol forte on the functional outcome of patients with carotid ischemic stroke. MATERIAL AND METHODS: The study included 50 patients with newly developed carotid stroke, hospitalized in the stroke unit on the first day from the onset of the disease. Patients of the main group (n=25) received mexidol in a dose of 500 mg intravenously once a day for 14 days, then mexidol forte 250 in tabs 250 mg 3 times a day for 60 days. Patients of the comparison group (n=25) received standard basic therapy. The significance of intergroup differences was assessed using the Mann-Whitney test, Fisher's exact test, and relative risk (OR) calculation. Differences were considered significant at a level of p<0,05. RESULTS: After 14 days of therapy, both groups of patients showed a positive trend compared to baseline. At the same time, patients of the mexidol group had a higher MoCA score (U=173,5, p=0,006), a lower score when performing tasks on dynamic praxis (U=214,0, p=0,028) and optical spatial disturbances (U=170,5, p=0,003), better memorization strength (181,5, p = 0,006) and better performance on abstraction MOCA subtest (U=200,5, p=0,014). By the 74th day, the absence of moderate cognitive impairment (MoCA> 26 points) was diagnosed in 17 patients (68%) of the main group and 14 patients (56%) of the comparison group. No significant differences were found. Moreover, patients of the main group had a significantly lower NIHSS score (U=124,0, p<0,001) and a lower degree of disability: a total mRS score 0-2 was achieved in 19 (76%) patients of the main group and only in 12 (48%) patients of the comparison group (OR=3,34, F=0,07, p<0,05). Also, patients receiving long-term sequential therapy with mexidol and mexidol forte 250 had milder spatial disorders than patients of the comparison group. CONCLUSION: Consecutive treatment with mexidol and mexidol forte 250 in the acute and early recovery periods of ischemic stroke positively affects the regression of local neurological symptoms, increases the likelihood of achieving independence in everyday life by 3,34 times, and reduces the severity of optical-spatial, neurodynamic and memory impairments.

[Results of the sequential use of Mexidol and Mexidol Forte 250 in patients with chronic cerebral ischemia]. / Rezul'taty posledovatel'nogo primeneniia preparatov Meksidol i Meksidol Forte 250 u bol'nykh s khronicheskoi ishemiei golovnogo mozga.

AIM: To study the efficacy and safety of mexidol's intravenous injections (500 mg once a day) for 14 days, followed by oral administration of mexidol FORTE 250 at a dose of 250 mg (1 tablet) 3 times a day for 60 days, in treatment of chronic cerebral ischemia (CCI) in patients with hypertension and atherosclerosis of the brachiocephalic arteries. MATERIAL AND METHODS: The observation program included 60 patients with an established diagnosis of CCI confirmed by neuroimaging methods. Patients of the main group (n=26) received mexidol along with basic therapy, patients of the comparison group (n=26) received only basic therapy. RESULTS AND CONCLUSION: The results of the experience show the high efficacy and safety of sequential therapy (parenteral therapy followed by tablets of mexidol FORTE 250). The treatment improves emotional and cognitive status, decreases static-motor disorders and severity of subjective neurological symptoms. High adherence of patients to the therapy is shown.

A Randomized Trial Comparing the Bowel Cleansing Efficacy of Sodium Picosulfate/Magnesium Citrate and Polyethylene Glycol/Bisacodyl (The Bowklean Study).

Bowel cleansing is essential for a successful colonoscopy, but the ideal clearing agent and the volume have yet to be determined. A small-volume cleanser is important for patient compliance. This study aimed to compare the bowel cleansing efficacy, safety, tolerability, and acceptability of a 300-mL small-volume sodium picosulfate/magnesium citrate (PSMC) preparation-Bowklean with one 2-L polyethylene glycol (PEG)/bisacodyl-Klean-Prep/Dulcolax preparation under identical dietary recommendations. This multicenter, randomized, parallel-group, pre-specified noninferiority study enrolled 631 outpatients scheduled to undergo colonoscopy (Bowklean = 316 and Klean-Prep/Dulcolax = 315). After bowel preparation, an independent evaluator blinded to the subject's treatment allocation rated the quality of the colon cleansing. Efficacy was evaluated using the Aronchick Scale and Ottawa Bowel Preparation Scale (OPBS). Safety was assessed by monitoring adverse events. Tolerability and acceptability were measured via a patient questionnaire. Bowklean was non-interior to Klean-Prep/Dulcolax in overall colon cleansing but was associated with significantly better preparation quality. Notably, Bowklean was associated with significantly greater tolerability and acceptability of bowel preparations than Klean-Prep/Dulcolax. Safety profiles did not differ significantly between the groups. Our data indicate that Bowklean is a more effective and better-tolerated bowel cleansing preparation before colonoscopy than Klean-Prep/Dulcolax. Bowklean may therefore increase positive attitudes toward colonoscopies and participation rates.

[The effect of Mexidol on cerebral mitochondriogenesis at a young age and during aging]. / Vliianie Meksidola na tserebral'nyi mitokhondriogenez v molodom vozraste i pri starenii.

AIM: To study the ability of mexidol to induce cerebral mitochondriogenesis in the brain of young and aging rats. MATERIAL AND METHODS: Expression level of marker proteins of cerebral mitochondriogenesis was evaluated during treatment with mexidol (20, 40, 100 mg/kg; 20 days; intraperitoneally) in the cerebral cortex of young (3 month) and aging (6, 9, 12, and 15 month) outbred male rats, using the Western blot analysis. RESULTS: It has been shown for the first time that the course injections of mexidol in doses of 40 and 100 mg/kg is accompanied by dose-dependent induction of the succinate receptor SUCNR1 and protein markers of mitochondrial biogenesis: transcription coactivator PGC-1α, transcription factors (NRF1, TFAM), catalytic subunits of respiratory enzymes (NDUV2, NDUV2,cytb, COX2) and ATP synthase (ATP5A) in the cerebral cortex of young and aging outbred male rats. Mexidol-dependent overexpression of subunits of mitochondrial enzymes and PGC-1α is observed only with the course of the drug. CONCLUSION: The results indicate the ability of mexidol to induce cerebral mitochondriogenesis and eliminate mitochondrial dysfunction in young and aging animals and, thus, exert an effect on one of the key pathogenetic links of the development of disorders in aging and neurodegenerative diseases.

[Optimal Laxatives for Oral Colonoscopy Bowel Preparation: from High-volume to Novel Low-volume Solutions].

Optimal bowel preparation is essential for a more accurate, comfortable, and safe colonoscopy. The majority of postcolonoscopy colorectal cancers can be explained by procedural factors, mainly missed polyps or inadequate examination. Therefore the most important goal of optimal bowel preparation is to reduce the incidence of colorectal cancer. Although adequate preparation should be achieved in 85-90% or more of all colonoscopy as a quality indicator, unfortunately 20-30% shows inadequate preparation. Laxatives for oral colonoscopy bowel preparation can be classified into polyethylene glycol (PEG)-electrolyte lavage solution, osmotic laxatives, stimulant laxatives, and divided into high-volume solution (≥3 L) and low-volume solution (<3 L). The updated 2019 European Society of Gastrointestinal Endoscopy (ESGE) guideline is broadly similar to the 2014 American Society for Gastrointestinal Endoscopy (ASGE) recommendations and reaffirms the importance of split-dosing. However, new ESGE guideline, unlike the 2014 ASGE recommendation, suggests the use of high volume or low volume PEG-based regimens as well as that of non-PEG based agents that have been clinically validated for most outpatient scenarios. For effective, safe, and highly adherent bowel preparation, physicians who prescribe and implement colonoscopy should properly know the advantages and limitations, the dosing, and the timing of regimens. Recently many studies have attempted to find the most ideal regimens, and more convenient, effective, and safe regimens have been developed by reducing the dosing volume and improving the taste. The high tolerability and acceptability of the new low-volume regimens suggest us how we should use it to increase the participation of the national colorectal cancer screening program.

The quality of colonoscopy preparation in a private clinical practice setting.

No data are available on the quality of the preparation for colonoscopy in private medicine in Spain. We report a retrospective study of the efficacy and tolerability of bowel preparation in the standard clinical practice in a private center.

Efficacy, Tolerability, and Safety of Low-Volume Bowel Preparations for Patients with Inflammatory Bowel Diseases: The French Multicentre CLEAN Study.

BACKGROUND: Standard high-volume polyethylene glycol [PEG] bowel preparations [PEG-4L] are recommended for patients with inflammatory bowel disease [IBD] undergoing colonoscopy. However, low-volume preparations [≤2 L of active volume] are often used in clinical practice. The aim of this study was to evaluate the efficacy, tolerability, and safety of the various bowel preparations for patients with IBD, including low-volume preparations. METHODS: We conducted a French prospective multicentre observational study over a period of 1 month. Patients aged 18-75 years with IBD with an indication of colonoscopy independent of the study were enrolled. The choice of the preparation was left to the investigators, as per their usual protocol. The patients' characteristics, disease, and colonoscopy characteristics were recorded, and they were given self-reported questionnaires. RESULTS: Twenty-five public and private hospitals enrolled 278 patients. Among them, 46 had a disease flare and 41 had bowel stenoses. Bowel preparations for colonoscopy were as follows: 42% received PEG-2L, 29% received sodium picosulfate [Pico], 15% received PEG-4L, and 14% had other preparations. The preparation did not reach the Boston's score efficacy outcome in the PEG-4L group in 51.2% of the patients [p = 0.0011]. The preparation intake was complete for 59.5% in the PEG-4L group, compared with 82.9% in the PEG-2L group and 93.8% in the Pico group [p < 0.0001]. Tolerability, as assessed by the patients' VAS, was significantly better for both Pico and PEG-2L compared with PEG-4L, and better for Pico compared with PEG-2L [p = 0.008; p = 0.0003]. In multivariate analyses, low-volume preparations were independent factors of efficacy and tolerability. Adverse events occurred in 4.3% of the patients. CONCLUSIONS: Preparations with PEG-2L and Pico were equally safe, with better efficacy and tolerability outcomes compared with PEG-4L preparations. The best efficacy/tolerance/safety profile was achieved with the Pico preparation.

The impact of low- versus standard-volume bowel preparation on participation in primary screening colonoscopy: a randomized health services study.

BACKGROUND: The aim of this study was to evaluate the impact of low-volume vs. standard-volume bowel preparation on participation in screening colonoscopy, bowel preparation quality, and lesion detection rates. METHODS: This was a multicenter, randomized, health services study within the population-based primary colonoscopy screening program in Poland. Individuals aged 55 - 62 years were randomized in a 1:1 ratio to bowel preparation with a low-volume (0.3 L sodium picosulfate with magnesium citrate) or standard-volume (4 L polyethylene glycol) regimen and then invited to participate in screening colonoscopy. The primary outcome measure was the rate of participation in screening colonoscopy. Compliance with the assigned bowel preparation, bowel preparation quality, and lesion detection rates were also evaluated. RESULTS: A total of 13 621 individuals were randomized and 13 497 were analyzed (6752 in the low-volume group and 6745 in the standard-volume group). The participation rate (16.6 % vs. 15.5 %; P = 0.08) and compliance rate (93.3 % vs. 94.1 %; P = 0.39) did not differ significantly between the groups. In the low-volume group, fewer participants had adequate bowel preparation compared with the standard-volume group (whole colon 79.0 % vs. 86.4 %, P < 0.001; proximal colon 80.1 % vs. 87.3 %, P < 0.001). Detection rates of advanced adenoma (AADR) and advanced serrated polyps (ASPDR) were lower in the low-volume group than in the standard-volume group (AADR in the proximal colon 2.6 % vs. 4.3 %, P = 0.02; ASPDR in the whole colon 2.0 % vs. 3.3 %, P = 0.04; ASPDR in the proximal colon 1.0 % vs. 1.9 %, P = 0.048). CONCLUSION: When compared with a standard-volume bowel preparation with polyethylene glycol, low-volume bowel preparation with sodium picosulfate/magnesium citrate did not improve participation rate or lesion detection rates, and negatively affected bowel preparation quality.

[The study of the efficacy and safety of Mexidol and Mexidol Forte 250 in patients with chronic cerebral ischemia]. / Issledovanie éffektivnosti i bezopasnosti primeneniia Meksidola i Meksidola Forte 250 u bol'nykh s khronicheskoi ishemiei mozga.

AIM: To study the efficacy and safety of Mexidol used intravenously (500 mg 1 time per day) for 14 days, followed by the oral administration of Mexidol Forte 250 in a dose of 250 mg 3 times a day for 60 days, in patients with chronic cerebral ischemia (CCI). MATERIAL AND METHODS: The study included 56 patients with CCI due to a combination of hypertension and atherosclerosis. The results of physical examinations (control of blood pressure, heart rate etc.), dynamics of complaints, scores on CGI, MoCa, MFI-20, HRSD, HARS and the Tinetti test were evaluated. RESULTS AND CONCLUSION: The high level of efficacy and safety of intravenous injections of Mexidol followed by the oral administration of Mexidol Forte 250 are demonstrated. This scheme of therapy contributes to a significant decrease in the objective and subjective symptoms of CCI, leads to improvements in the emotional, cognitive and motor spheres.

Comparative safety of bowel cleansers: protocol for a systematic review and network meta-analysis.

INTRODUCTION: The US Food and Drug Administration has withdrawn the bowel cleansing kit HalfLytely (PEG 3500) with 10 mg bisacodyl tablets due to an increased risk of ischaemic colitis compared with the same kit with only 5 mg bisacodyl. This is of interest in Canada given that the bowel cleansing kit Bi-Peglyte (PEG 3500) with 15 mg bisacodyl is currently approved for use. The objective is to assess the comparative safety of various bowel cleansers with or without bisacodyl, with a primary interest inpolyethylene glycol (PEG)-based and sodium-picosulfate-based products. METHODS AND ANALYSIS: Given the existing volume of the literature, the review will be conducted in two stages. Stage 1 will consist of a scoping exercise by searching MEDLINE, Embase and the Cochrane Library (up to 21 November 2017) to identify randomised controlled trials, quasirandomised studies and non-randomised studies in which any bowel cleanser regimens were compared among persons undergoing colonoscopy. The outcomes will be mapped to establish a listing of the studies and their comparisons and outcomes currently available in the literature. From this, a data synthesis plan will be determined. In stage 2, a systematic review with meta-analyses will be pursued, focused on the bowel cleanser comparisons and outcomes of interest identified in stage 1. Two reviewers will screen, extract and quality assess the articles. Outcomes of interest include ischaemic colitis, electrolyte imbalances and their consequences, seizures, bowel perforation and patient tolerability. If sufficient data exist and studies are of sufficient homogeneity, network meta-analyses (NMAs) will be performed. ETHICS AND DISSEMINATION: Ethics approval was not necessary due to study design. Updating the safety profile of bowel cleansers among the generally healthy population undergoing colonoscopy is pertinent given recent approval changes. This will be the first NMA within this population. Policy considerations may be reconsidered to minimise risk during bowel cleanser use. PROSPERO REGISTRATION NUMBER: CRD42018084720.

Split-dose bowel cleansing with picosulphate is safe and better tolerated than 2-l polyethylene glycol solution.

BACKGROUND: In physically less fit patients and patients requiring repeated exams, adequate bowel preparation for colonoscopy remains problematic, particularly because patients need to drink large volumes of unpleasant-tasting fluids. A further concern is potential unwarranted fluid shifts. AIMS: This study aimed to compare the safety and burden of a small-volume sodium picosulphate/magnesium citrate preparation (SPS-MC) with a 2-l ascorbic-acid-enriched polyethylene glycol solution plus bisacodyl pretreatment (PEG-Asc+B). PATIENTS AND METHODS: Patients referred for colonoscopy were randomized to SPS-MC or PEG-Asc+B administered as a split-dose regimen. Patients received advice on the recommended 4-l SPS-MC and 2-l PEG-Asc+B fluid intake. Safety was assessed by blood sampling before and after the preparation and during a 30-day follow-up period. A questionnaire assessed tolerability and perceived burden of the preparation. RESULTS: A total of 341 patients underwent colonoscopy. Blood sampling showed a slight but significant decrease in sodium, chloride and osmolality and increase in magnesium in the SPS-MC group and a decrease in bicarbonate in the PEG-Asc+B group. Hyponatraemia and hypermagnesaemia without clinical signs were observed in 16 (14 SPS-MC) and 13 SPS-MC patients, respectively. Patients reported significantly fewer physical complaints and a significantly higher completion rate with SPS-MC. Patients receiving SPS-MC rated the intake as being easier and better tasting. In the event of a repeat colonoscopy, 59.7% of patients in the PEG-Asc+B and 93.6% of patients in the SPS-MC group would opt for the same preparation again. CONCLUSION: Despite electrolyte shifts, both SPS-MC and PEG-Asc+B appeared clinically safe. From a patient's perspective, a small-volume preparation formula such as SPS-MC is preferred, resulting in fewer physical complaints and greater ease of intake.

[Preventive therapy with mexidol in toxic damage to the heart]. / Preventivnaia terapiia meksidolom toksicheskogo povrezhdeniia serdtsa.

The purpose of this study was to efficacy of mexidol in the prevention of toxic damage to the heart in acute pancreatitis. MATERIAL AND METHODS: The paper presents the results of experimental studies conducted on 30 adult mongrel adult dogs, which simulated acute focal pancreatic necrosis. We studied the influence of mexidol in the complex therapy for changes in the qualitative and quantitative composition of the lipid tissue structures of the heart, the intensity of processes of lipid peroxidation, antioxidant capacity, phospholipase A2 activity and morphofunctional state of the heart muscle in experimental acute focal pancreatic necrosis. Th. RESULTS AND DISCUSSION: The preventive use of antioxidant drug mexidol in complex treatment of acute focal pancreatic necrosis, which limits the development of endogenous intoxication, increased intensity of lipid peroxidation and restores antioxidant capacity, reduces leading to phospholipase activity in tissue structures of the heart, corrigiruet lipid metabolism and morphofunctional state of the heart, and, consequently, toxic damage to the heart during endotoxic.

Efficacy and Safety of Sodium Picosulfate/Magnesium Citrate for Bowel Preparation in a Physically Disabled Outpatient Population: A Randomized, Endoscopist-Blinded Comparison With Ascorbic Acid-Enriched Polyethylene Glycol Solution Plus Bisacodyl (The PICO-MOVI Study).

BACKGROUND: Because of its volume, adequate bowel preparation remains problematic in physically unfit patients. OBJECTIVE: This study aimed to compare a small-volume sodium picosulfate/magnesium citrate preparation with a 2-L ascorbic acid-enriched polyethylene glycol solution plus bisacodyl. DESIGN: This study has a noninferiority design, assuming that ascorbic acid-enriched polyethylene glycol solution plus bisacodyl is 70% efficacious in achieving an Ottawa score ≤7 and accepting a difference in success rate of <15% with a target enrollment of 146 patients per group. SETTING: This study was conducted in an outpatient department. PATIENTS: Patients referred for diagnostic colonoscopy were randomly assigned. Key exclusion criteria were severe kidney disease, ASA class ≥III, and hospital admission. INTERVENTION: Patients were randomly assigned to receive sodium picosulfate/magnesium citrate or ascorbic acid-enriched polyethylene glycol solution plus bisacodyl according to a split-dose regimen. Patients in the sodium picosulfate/magnesium citrate group received advice on the recommended 4-L fluid intake. Patients in the ascorbic acid-enriched polyethylene glycol solution plus bisacodyl group received 2 bisacodyl tablets 2 days before and advice on the additionally recommended 2-L fluid intake. MAIN OUTCOME MEASURES: To assess bowel-cleansing adequacy, the Ottawa, Aronchick, and Boston scores were used. Colonoscopy quality measures were obtained. Safety was assessed for a 30-day follow-up period. RESULTS: Overall, 341 patients (169 men, mean age 57.0 years; BMI 26.2 kg/m) were included. Comorbidities were present in 76.2% of patients, and 75.4% of patients used medication. An adequate Ottawa score was obtained in 81.4% and 75.8% of patients receiving ascorbic acid-enriched polyethylene glycol solution plus bisacodyl and sodium picosulfate/magnesium citrate (difference of 5.6% (95% CI, -3.5 to -14.6; p = 0.023)), showing noninferiority of the sodium picosulfate/magnesium citrate therapy. Ottawa segmental scores were lower for sodium picosulfate/magnesium citrate in the right and transverse colon. In both groups, successful ileocecal intubation was achieved in 95%. No medication-related adverse events were reported. LIMITATIONS: These results in a physically disabled ambulant population cannot be extrapolated to immobile, hospitalized patients. CONCLUSIONS: Sodium picosulfate/magnesium citrate proved to be noninferior to ascorbic acid-enriched polyethylene glycol solution plus bisacodyl in efficacy and safety. Timing of the colonoscopy and addition of bisacodyl to sodium picosulfate/magnesium citrate warrants further consideration. See Video Abstract at http://links.lww.com/DCR/A461.

The optimal bowel preparation intervals before colonoscopy: A randomized study comparing polyethylene glycol and low-volume solutions.

BACKGROUND & AIMS: The optimal duration of bowel preparation has only been assessed for polyethylene glycol (PEG). The aim of the study was to determine the intervals for achieving a satisfactory quality/tolerability of the preparation using PEG/ascorbic acid (PEGA) and sodium picosulphate/magnesium citrate (SPMC), and to compare them with 4L of PEG. METHODS: A randomized, endoscopist-blinded, multicentre study. The 612 outpatients referred to a colonoscopy, were prepared using PEG, SPMC, PEGA. The quality, tolerability, duration of the preparation, and the interval from the end of the preparation to the colonoscopy was assessed. RESULTS: Optimum duration of the preparation was similar for both PEG and SPMC (≥7.3 vs. ≥8.8 h, overall ≥8.4 h). Optimum interval to the colonoscopy was ≤11.8 h and did not differ between preparations (PEG, PEGA ≤ 11.8, SPMC ≤ 13.3 h). These times were the only predictors for a satisfactory preparation. The tolerability depends on the product type (SPMC) only. Timing of the preparation or the other factors had no impact on tolerability. CONCLUSION: The optimum intervals for bowel preparation are identical for all preparations. Satisfactory preparation is achived at the preparation length ≥8.4 h and the time to colonoscopy ≤11.8 h.

Impact of patient audiovisual re-education via a smartphone on the quality of bowel preparation before colonoscopy: a single-blinded randomized study.

BACKGROUND AND AIMS: Education on preparation is essential for successful colonoscopy. This study aimed to evaluate the impact of audiovisual (AV) re-education via a smartphone on bowel preparation quality before colonoscopy. METHODS: A prospective, endoscopist-blinded, randomized, controlled study was performed. Patients who underwent colonoscopy with 3 purgatives, including 4 L of polyethylene glycol (4-L PEG), 2 L of PEG with ascorbic acid (2-L PEG/Asc), and sodium picosulfate with magnesium citrate (SPMC), were enrolled and randomized into the AV re-education via smartphone group (AV group, n = 160) and a control group (n = 160). The primary outcome was the quality of the bowel preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes included instruction adherence using adherence score (AS) and patient satisfaction with education using a visual analog scale (VAS). RESULTS: A total of 283 patients (AV group, n = 139; control group, n = 144) were analyzed per protocol. The mean BBPS (7.53 vs 6.29, P < .001) and the proportion with adequate preparation were higher in the AV group. The mean BBPS of the AV group was significantly higher than that of the control group for the 2-L PEG/Asc and SPMC preparations, but not for the 4-L PEG preparation. The mean AS and the mean VAS score were all significantly higher in the AV group. Among the 3 purgatives, the mean AS was lowest in the 4-L PEG group (P = .041). CONCLUSIONS: AV re-education via smartphone was easy and convenient, and enhanced preparation quality, patient adherence to instructions, and patient satisfaction.

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.