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Randomised clinical trial: Polyethylene glycol 3350 with sports drink vs. polyethylene glycol with electrolyte solution as purgatives for colonoscopy - The incidence of hyponatraemia
Abstract
Background
Polyethylene glycol 3350 plus sports drink (PEG-SD) is a hypo-osmotic purgative commonly used for colonoscopy, though little safety data are available.AimTo evaluate the effect of PEG-SD on serum sodium (Na) and other electrolytes compared with PEG-electrolyte solution (PEG-ELS).Methods
We performed a single center, prospective, randomised, investigator-blind comparison of PEG-ELS to PEG-SD in out-patients undergoing colonoscopy. Laboratories were obtained at baseline and immediately before and after colonoscopy. The primary endpoint was development of hyponatraemia (Na <135 mmol/L) the day of colonoscopy. Changes in electrolyte levels were computed as the difference between the lowest value on the day of colonoscopy and baseline. Purgative tolerance and efficacy were assessed.ResultsA total of 389 patients were randomised; 364 took purgative and had baseline and day of colonoscopy labs (180 PEG-SD, 184 PEG-ELS). The groups were well matched except for a higher fraction of women and Blacks in PEG-ELS. Seven patients (3.9%) in PEG-SD and four patients (2.2%) in PEG-ELS developed hyponatraemia (OR = 1.82, 95% CI: 0.45–8.62, P = 0.376). Changes in electrolytes from baseline were small but significantly worse with PEG-SD for sodium, potassium and chloride (P = 0.001, 0.012, 0.001, respectively). Preparation completion, adverse events, and overall colon cleansing were similar between the groups, but PEG-ELS had more excellent preparations (52% vs. 30%; P = 0.001).Conclusions
Greater, but very modest, electrolyte changes occur with PEG-SD. Hyponatraemia is infrequent with both purgatives. A significant increase in hyponatraemia was not identified for PEG-SD vs. PEG-ELS, but the sample size may have been inadequate to identify a small, but clinically important difference. ClinicalTrials.gov identifier NCT01299779.
... This is likely because bowel preparation is repeatedly cited as the worst part of the colonoscopy experience and an impediment to recommended surveillance [2]. To combat prep hesitancy on the part of patients, many physicians have adopted an unapproved bowel preparation for colonoscopy that consists of an over-the-counter polyethylene glycol (PEG-3350) laxative combined with a "sports drink" (PEG-SD) such as Gatorade® [3]. A stimulant laxative (e.g., bisacodyl) is frequently included in this regimen. ...
... Studies of its effects on fluid and electrolyte balance have shown that in normal volunteers PEG-SD results in body absorption of large volumes of water and substantial losses of sodium. In a study by Matro et al. [3], patients were randomized to receive PEG-SD (n = 180) or polyethylene glycol with electrolytes and ascorbic acid (PEG-EA), an FDA approved bowel preparation (MOVIPREP ®, Salix Pharmaceuticals, Bridgewater, NJ) (n = 184) and collected clinical chemistry data at baseline and on the day of colonoscopy. The incidence of hyponatremia (serum sodium < 136 mmol/L) was higher in the PEG-SD group (3.9%) versus the PEG-EA treated group (2.2%). ...
... Studies by Walker et al. [4] have demonstrated that PEG-SD produces less cleansing diarrhea (2.0 L) than other FDA approved bowel preparations (e.g., oral sulfate solution = 3.3 L, PEG-EA = 3.0 L) which helps to explain reports by Matro et al. [3], that PEG-SD bowel preparation produces inferior cleansing compared to other FDA approved preparations. Nevertheless, physicians continue to recommend PEG-SD because patient perception and completion rates are better relative to high-volume 4-liter options [1,3,5,6]. ...
Background
Acceptability and tolerance of bowel preparation is critical to overcome patient hesitancy in undergoing colon cancer screening and surveillance colonoscopy. To improve patient experience, a new sports drink-flavored bowel preparation containing polyethylene glycol (PEG) and sulfate salts (FPSS) was developed to provide a similar experience to a commonly used but not United States Food and Drug Administration (FDA) approved PEG and sports drink bowel preparation (PEG-SD), while also achieving improved cleansing efficacy.
Methods
This FPSS preparation, approved by the FDA in June 2023, was evaluated in a non-randomized Phase 2 study in which 40 patients requiring colonoscopy were prepared with FPSS and 20 with PEG-SD.
Results
Overall cleansing success was high with FPSS based on unblinded local endoscopist assessment (93%) and blinded central reading (97%), exceeding PEG-SD which achieved success rates of 84% (local read), 74% and 68% (blinded central reads). Similar differences favoring FPSS were seen for excellent preparations and cleansing success by colon segment as rated by local endoscopists. Both preparations were well-tolerated, with 93% of FPSS patients rating their preparation as Tolerable to Very Easy to consume, compared to 100% of PEG-SD. Patients who had previously taken a preparation for colonoscopy found FPSS and PEG-SD better than their prior preparation (73% and 70%, respectively) and nearly all would request their assigned study preparation again in the future. About two thirds of FPSS patients agreed that the preparation tasted similar to a sports drink.
Conclusion
The new sports drink-like flavored preparation compares favorably to PEG-SD for bowel cleansing efficacy while achieving similar patient satisfaction. The study was registered at www.clinicaltrials.gov (NCT03328507) on 01/11/2017.
... This is likely because bowel preparation is repeatedly cited as the worst part of the colonoscopy experience and an impediment to recommended surveillance [2]. To combat prep hesitancy on the part of patients, many physicians have adopted an unapproved bowel preparation for colonoscopy that consists of an over-the-counter polyethylene glycol (PEG-3350) laxative combined with a "sports drink" (PEG-SD) such as Gatorade® [3]. A stimulant laxative (e.g., bisacodyl) is frequently included in this regimen. ...
... Studies of its effects on uid and electrolyte balance have shown that in normal volunteers PEG-SD results in body absorption of large volumes of water and substantial losses of sodium. In a study by Matro et al [3], patients were randomized to receive PEG-SD (n = 180) or polyethylene glycol with electrolytes and ascorbic acid (PEG-EA), an FDA approved bowel preparation (MOVIPREP ®, Salix Pharmaceuticals, Bridgewater, NJ) (n = 184) and collected clinical chemistry data at baseline and on the day of colonoscopy. The incidence of hyponatremia (serum sodium < 136 mmol/L) was higher in the PEG-SD group (3.9%) versus the PEG-EA treated group (2.2%). ...
... Studies by Walker et al [4] have demonstrated that PEG-SD produces less cleansing diarrhea (2.0 L) than other FDA approved bowel preparations (e.g., oral sulfate solution = 3.3 L, PEG-EA = 3.0 L) which helps to explain reports by Matro et al. [3], that PEG-SD bowel preparation produces inferior cleansing compared to other FDA approved preparations. Nevertheless, physicians continue to recommend PEG-SD because patient perception and completion rates are better relative to high-volume 4-liter options [1,3,5,6]. ...
Background:
Acceptability and tolerance of bowel preparation is critical to overcome patient hesitancy in undergoing colon cancer screening and surveillance colonoscopy. To improve patient experience, a new sports drink-flavored bowel preparation containing polyethylene glycol (PEG) and sulfate salts (FPSS) was developed to provide a similar experience to a commonly used but not unapproved PEG and sports drink bowel preparation (PEG-SD), while also achieving improved cleansing efficacy.
Methods:
This FPSS preparation, approved by the United States Food and Drug Administration in June 2023, was evaluated in a non-randomized Phase 2 study in which 40 patients requiring colonoscopy were prepared with FPSS and 20 with PEG-SD.
Results:
Overall cleansing success was high with FPSS based on unblinded local endoscopist assessment (93%) and blinded central reading (97%), exceeding PEG-SD which achieved success rates of 84% (local read), 74% and 68% (blinded central reads). Similar differences favoring FPSS were seen for excellent preparations and cleansing success by colon segment as rated by local endoscopists. Both preparations were well-tolerated, with 93% of FPSS patients rating their preparation as Tolerable to Very Easy to consume, compared to 100% of PEG-SD. Patients who had previously taken a preparation for colonoscopy found FPSS and PEG-SD better than their prior preparation (73% and 70%, respectively) and nearly all would request their assigned study preparation again in the future. About two thirds of FPSS patients agreed that the preparation tasted similar to a sports drink.
Conclusion:
The new sports drink-like flavored preparation compares favorably to PEG-SD for bowel cleansing efficacy while achieving similar patient satisfaction. The study was registered at www.clinicaltrials.gov (NCT03328507).
... 1 While adequate colonic cleansing is a prerequisite for an optimal visualisation of colonic mucosa, safety of the formulation is a 'must', particularly when endoscopy is performed in healthy subjects for colorectal cancer screening. A systematic review of safety issues associated with bowel cleansing concluded that, with formulations containing polyethylene glycol and electrolytes (PEG-ELS), adverse events are uncommon, but potentially serious. 1 In a recent issue of Alimentary Pharmacology & Therapeutics, Matro et al. 2 added another piece to puzzle. They performed a RCT, comparing PEG 3350 plus sport drink (PEG-SD) with PEG-ELS, specifically designed to evaluate safety measures, with the incidence of hyponatremia as primary end-point. ...
... In addition, significantly more patients with low serum sodium had diabetes and a greater proportion had hypertension, cardiovascular disease or liver disease. 2 While this study adds to the current literature the identification of risk factors for development of asymptomatic hyponatremia, it was not powered to detect the incidence of severe symptomatic hyponatremia, which can occur after different PEG formulations. Indeed, over the past years, nine cases of severe, symptomatic, hypotonic hyponatremia have been reported (Table 1), 3-8 one of which had a fatal outcome. ...
... We read with interest the editorial prepared by Professors Scarpignato and Blandizzi. 1 The authors summarise nine case reports of severe symptomatic hyponatraemia, published over 9 years and from five countries, in patients using polyethylene glycol 3350 (PEG)-based purgatives. [2][3][4][5][6][7] Three occurred with PEG-electrolyte solution (PEG-ELS), three with PEG-sports drink (PEG-SD) and three with an unclassified PEG purgative. Even assuming marked under-reporting of this serious event, one must consider the denominator to put this in perspective. ...
... In our anecdotal experience to date, it is better tolerated by patients and is a similar cost relative to MgC. It carries a small theoretical risk of electrolyte disturbance as a hypo-osmotic agent [18,25,30]. Similar low volume PEG preparations combined with sports drinks have been associated with small laboratory-based, clinically insignificant drops in electrolytes, though have not been shown to have increased adverse events relative to the iso-osmolar Golytely preparation [25,30]. ...
... It carries a small theoretical risk of electrolyte disturbance as a hypo-osmotic agent [18,25,30]. Similar low volume PEG preparations combined with sports drinks have been associated with small laboratory-based, clinically insignificant drops in electrolytes, though have not been shown to have increased adverse events relative to the iso-osmolar Golytely preparation [25,30]. ...
Purpose
To compare MiraLAX, a hypo-osmotic lavage, and magnesium citrate (MgC), a hyper-osmotic agent for bowel preparation at CTC.
Methods
398 total screening CTC studies were included in this retrospective, single institution study. 297 underwent preparation with a double-dose MgC regimen (mean age, 61 ± 5.5 years; 142 male/155 female) and 101 with 8.3 oz (equivalent to 238 g PEG) of MiraLAX (mean age, 60 ± 9.6 years; 45 male/56 female). Oral contrast for tagging purposes was utilized in both regimens. Studies were retrospectively analyzed for residual fluid volume and attenuation by automated analysis, as well for subjective oral contrast coating of the normal colonic wall and polyps. 50 patients underwent successive CTC studies utilizing each agent (mean, 6.1 ± 1.7 years apart), allowing for intra-patient comparison. Chi-squared, Fisher’s exact, McNemar, and t-tests were used for data comparison.
Results
Residual fluid volume (as percentage of total colonic volume) and fluid density was 7.2 ± 4.2% and 713 ± 183 HU for the MgC cohort and 8.7 ± 3.8% and 1044 HU ± 274 for the MiraLAX cohort, respectively (p = 0.001 and p < 0.001, respectively). Similar results were observed for the intra-patient cohort. Colonic wall coating negatively influencing interpretation was noted in 1.7% of MgC vs. 6.9% of MiraLAX examinations (p = 0.008). Polyps were detected in 12% of all MgC vs. 16% of all MiraLAX CTCs (p = 0.29).
Conclusion
CTC bowel preparation with the hypo-osmotic MiraLAX agent appears to provide acceptable diagnostic quality that is comparable to the hyper-osmotic MgC agent, especially when factoring in patient safety and tolerance.
... High-quality bowel cleansing is a prerequisite for colonoscopy. Polyethylene glycol (PEG)-based solution is the most widely used intestinal cleansing agent, although several cases have been reported to cause hyponatremia [2][3][4], it is a relatively safe option for patients at risk of electrolyte imbalance and dehydration [5]. As the most common electrolyte abnormality, hyponatremia is closely related to the brain. ...
... The main symptoms of hyponatremia are nausea, vomiting, headache, seizures, and coma. However, cerebral edema is rare [3,15]. We demonstrate again that bowel preparation with PEG for colonoscopy with PEG may lead to brain cerebral edema associated with hyponatremia. ...
Background:
Adequate bowel preparation is critical for colonoscopy screening. At present, the most widely used intestinal cleaner recommended at home and abroad is Polyethylene glycol (PEG). Intestinal cleansers can cause electrolyte disturbances and hyponatremia. However, hyponatremic encephalopathy due to hyponatremia induced by PEG solution, although rare, can lead to serious irreversible sequelae and even death.
Case summary:
In this report, we discuss a case of neurological dysfunction due to hyponatremia, also known as hyponatremic encephalopathy, observed in a 63-year-old woman who underwent PEG-based bowel preparation for colonoscopy. She was eventually transferred to our intensive care unit for treatment due to her Glasgow Coma Scale score of 9/15 (Eye opening 2; Verbal response 1; Motor response 6) and abnormal laboratory tests.
Conclusion:
Physicians should be thoroughly familiarized with the patient's history before prescribing PEG for bowel preparation, and timely identification of patients with hyponatremic encephalopathy is essential as delayed treatment is associated with poor neurological outcomes. An intravenous infusion of 3% sodium chloride is recommended at the onset of early symptoms. The goal of treatment is to adequately treat cerebral edema while avoiding serum sodium correction beyond 15 to 20 mEq/L within 48 h of treatment to prevent osmotic demyelination syndrome.
... Notably, 5.0% of patients in the 1 L-PEG group (6/120) vs 2.5% in the 2 L-PEG group (3/120) experienced hyponatremia after bowel cleansing in this study. Hyponatremia has previously been described in one study on 2 L-PEG/ELS (2%) (26) and another study on 2 L and 4 L-PEG/ELS (5% and 6%, respectively) (9). These values correspond to the percentage of hyponatremia in the 1 L-PEG/Asc group in our study. ...
BACKGROUND
Polyethylene glycol with ascorbic acid (PEG/Asc) is a well-established bowel preparation solution with guaranteed effectiveness and safety. A new low-volume agent, 1 L-PEG/Asc, has recently been released. This study aimed to compare the bowel cleansing efficacy and safety of 1 L-PEG/Asc and 2 L-PEG/Asc administered to adult outpatients in a split-dose manner.METHODS
Outpatients undergoing colonoscopy enrolled in a single-blind, single-center, non-inferiority study conducted between July and October 2021 were randomized in a 1:1 manner to 1 L-PEG/Asc or 2 L-PEG/Asc groups. Bowel cleansing was assessed using the Boston Bowel Preparation Scale (BBPS) and the Harefield Cleansing Scale (HCS) in intention-to-treat (ITT) and per-protocol populations.RESULTSTwo hundred and forty subjects were randomized and allocated, with 120 patients in the 1 L and 2 L-PEG/Asc groups, respectively. Non-inferiority was demonstrated for overall successful bowel cleansing (BBPS: 92.5% vs. 90.8%; 95% confidence interval [CI], -0.054-0.087) and the high-quality cleansing rate of the right-sided colon (BBPS=3, 40.0% vs. 35.8%; 95% CI, -0.082-0.165; HCS ≥3, 50.0% vs. 43.3%; 95% CI, -0.060-0.194) in the ITT population. The overall incidence of adverse events was similar in both groups ([82/120] 68.3% vs. [72/120] 60.0%; p=0.178). The tolerability, acceptability, and compliance rates of both regimens were similar, with no significant differences.CONCLUSIONS
Compared to 2 L-PEG/Asc, 1 L-PEG/Asc achieved successful overall bowel cleansing efficacy with high-quality cleansing in the proximal colon and proved its non-inferiority. Therefore, 1 L-PEG/Asc is an acceptable alternative bowel-cleansing solution.
... P=0.04) [27]. In addition, isolated cases of hyponatremia have been reported, likely due to electrolyte shifts with the hypoosmotic solution [28][29][30][31][32]. Given these electrolyte shifts, the Miralax-Gatorade preparation is not recommended for patients with congestive heart failure or advanced liver disease with ascites [33]. ...
Colonoscopy is an important screening and therapeutic modality for colorectal cancer. Unlike other screening tests, colonoscopy is dependent on pre-procedure bowel preparation. If the bowel preparation is poor, significant pathology may be missed. Many factors are known to improve bowel preparation. This review will highlight those factors that may optimize the bowel preparation, including choice of bowel preparation, grading or scoring of the bowel preparation, special factors that influence preparation, and diet prior to colonoscopy that affects bowel preparation. The aim of the review is to offer suggestions and guide endoscopists on how to optimize the bowel preparation for the patients undergoing colonoscopy.
... Only Abbas et al (10), Sorser et al (11), and Walia et al (12) have evaluated serum electrolyte changes prospectively, in 37, 18, and 44 children, respectively, ingesting a 1-day prep regimen, with some finding minor individual chemistry changes but no clinically significant differences in electrolyte levels after prep ingestion. Use of PEG 3350 þ sport drink (PEG-SD) for bowel prep has been reported to cause hyponatremia and seizure in adults (13,14). Furthermore, limited data exist on risk of hypo-or hyperkalemia with high volume of PEG-SD ingestion. ...
Objectives:
Electrolyte-free polyethylene glycol powder (PEG-3350) has been widely used for colonoscopy preparation (prep), however limited safety data on electrolyte changes exists with 1-day prep regimens. The primary aim of this study was to determine the proportion of patients with significant serum chemistry abnormalities pre- and at the time of colonoscopy. Secondary aims included evaluation of prep tolerance and bowel cleansing efficacy.
Methods:
We performed a prospective descriptive observational study of pediatric patients scheduled for outpatient colonoscopy who received our standard 1-day, weight-based 4 g/kg PEG-3350 prep with a single stimulant laxative dose and had serum chemistry testing within 60 days prior to and at the time of colonoscopy. A standardized bowel cleanliness tool (Aronchick scale) was completed by the endoscopist.
Results:
155 patients had serum electrolytes data pre- and post-prep. Comparison of each patient's chemistries demonstrated statistical equivalence with the 1 exception of blood urea nitrogen levels (p = 0.56). Hypokalemia was detected post-prep in 37 subjects (24%), but none had a serum level below 3.3 mmol/L, which was deemed to be of no clinical significance. Five patients were hypoglycemic post-prep; 3 were ≤ 7 years old (p = 0.02). The colon cleanliness rating was excellent or good in 77% and suboptimal in 23% of patients.
Conclusion:
A 1-day, weight based PEG-3350 bowel prep in children appears safe. Changes in electrolyte levels and renal function were not clinically significant. However, children ≤7 years old seem to be at a higher risk of hypoglycemia compared to older children.
Colorectal cancer (CRC) is the third most common cancer in the United States. Early detection through colonoscopy significantly improves survival rates. Detecting colon polyps depends on the quality of bowel preparation. However, inadequate bowel preparation remains a significant issue in clinical practice. Efforts to address this challenge have led to the development of bowel preparation regimens emphasizing efficacy, tolerability, and safety. Bowel preparation options can be categorized by their osmotic and volume properties. Isosmotic solutions based on polyethylene glycol-electrolyte lavage solutions (PEG-ELS) are available in both low-volume PEG-ELS with ascorbic acid (PEG-Asc) (e.g., MoviPrep, PLENVU) and high-volume formulations (e.g., GoLYTELY, CoLyte), as well as sulfate-free high-volume PEG-ELS formulations (SF-PEG-ELS). Hyperosmotic solutions include oral sulfate solution (OSS) (e.g., SUPREP), sodium phosphate tablets (NaP) (e.g., OsmoPrep), oral sulfate tablets (OST) (e.g., SUTAB), flavored PEG with sulfate salts (FPSS) (e.g., SUFLAVE), and magnesium citrate. Hypoosmotic solutions consist of PEG-sports drink (PEG-SD). In addition, combination solutions are available, such as sodium picosulfate with magnesium citrate (SPMC) with laxatives (e.g., CLENPIQ), and OSS with SF-PEG-ELS (Suclear). Each regimen differs in terms of cost, volume, taste, contraindications, and potential adverse effects. Therefore, clinicians must carefully evaluate each patient to determine the most suitable regimen for their patients.
Introduction:
A new bowel preparation for colonoscopy has been developed containing poorly absorbed sulfate salts and polyethylene glycol 3350, which retain water within the intestinal lumen resulting in copious diarrhea, thereby cleansing the bowel. The product was formulated to be safe and effective with a sports drink-like flavor. This study evaluated the new flavored polyethylene glycol and sulfate solution (FPSS) compared with a Food and Drug Administration-approved bowel preparation containing sulfate salts only [oral sulfate solution (OSS)].
Methods:
Five hundred adults were enrolled in this multicenter, noninferiority study. Subjects were assigned FPSS or OSS administered in split-dose regimens (PM/AM). FPSS subjects took 2 L of the flavored osmotic solution (1 L at night and 1 L in the morning). OSS was taken according to its approved labeling. Colonoscopies were graded globally and segmentally by blinded local investigators using a 4-point scale (excellent, good, fair, and poor), with "good" and "excellent" considered successful. Safety was assessed by adverse events (AEs) and laboratory testing.
Results:
A high rate of cleansing success was seen with FPSS (94%), which was noninferior to OSS (94%). This conclusion was confirmed by blinded central readers. Segmental success rates were >90% for both preparations, including the right colon. Questionnaire ratings indicated the FPSS experience was preferred over OSS with 87% of FPSS subjects noting their preparation was "tolerable" to "very easy" to consume versus 74% for OSS. The majority of FPSS subjects agreed their preparation tasted like a sports drink. Gastrointestinal symptoms were the most common AEs. There was no difference between preparations for any AE and no clinically significant differences in laboratory parameters.
Conclusions:
The new sports drink-like flavored preparation achieved a high level of cleansing in the study, demonstrating noninferiority to OSS. FPSS was well-tolerated with low rates of expected gastrointestinal symptoms. The optimized flavor of FPSS resulted in significantly better acceptance ratings.
Introduction:
Split-dose bowel preparation leads to superior colon cleansing for colonoscopy. However, the magnitude of benefit in detecting colonic polyps is uncertain. We performed a systematic review to synthesize the data on whether using a split-dose bowel preparation regimen improves the detection of polyps when compared with other dosing methods or regimen products.
Methods:
We searched MEDLINE, EMBASE, and CENTRAL databases (from the inception to June 2017) for randomized controlled trials that assessed the following: split-dose vs day-before, split-dose vs same-day (as colonoscopy), or different types of split-dose regimens for patients undergoing colonoscopy. We excluded studies limited to inpatients, children, or individuals with inflammatory bowel disease. We compared the number of patients undergoing colonoscopy with recorded detection of polyps, adenomas, advanced adenomas, sessile serrated polyps (SSPs), right colonic adenomas, right colonic polyps, or right colonic SSPs.
Results:
Twenty-eight trials fulfilled the inclusion criteria (8,842 participants). Of the seven trials comparing split-dose vs day-before bowel preparation regimens, there was an increased detection rate of adenomas (risk ratio (RR) 1.26, 95% confidence intervals (CIs): 1.10-1.44; 4 trials; 1,258 participants), advanced adenomas (RR 1.53, 95% CI: 1.22-1.92; 3 trials; 1,155 participants), and SSPs (RR 2.48, 95% CI: 1.21-5.09; 2 trials; 1,045 participants). Pooled estimates from 8 trials (1,587 participants) evaluating split-dose vs same-day bowel preparations yielded no evidence of statistical difference. For various split-dose vs split-dose trials, 14 fulfilled the criteria (5,496 participants) and no superior split-regimen was identified.
Conclusions:
Compared with day-before bowel preparation regimens, split-dose bowel preparations regimens increase the detection of adenomas, advanced adenomas, and have the greatest benefit in SSP detection.
Objectives:
National societies provide little guidance regarding which colonoscopy bowel preps are best tolerated and most effective; this reflects a lack of comparative effectiveness studies that directly evaluate the available preps in a "real-world" setting. To address this gap, we conducted a prospective, commercially unfunded comparative effectiveness study of currently available bowel preps and measured their impact on bowel cleansing.
Methods:
We included patients aged ≥18 years, who presented for an outpatient colonoscopy at a large medical center serving more than 70 academic and community-based endoscopists who are free to prescribe the bowel prep of their choice. The primary outcome was bowel cleansing quality as measured by the Boston Bowel Preparation Scale. We performed regression models with random effects on the outcomes to adjust for confounding.
Results:
Approximately 4,339 colonoscopies were performed by 75 endoscopists. Magnesium citrate, MiraLAX with Gatorade, MoviPrep, OsmoPrep, Prepopik/Clenpiq, and Suprep all had significantly higher prep tolerability compared with GoLYTELY (all P < 0.05). For bowel cleansing, Suprep (7.28 ± 1.66; P < 0.001), MoviPrep (7.11 ± 1.62; P = 0.004), and MiraLAX with Gatorade (7.09 ± 1.64; P < 0.001) had higher total Boston Bowel Preparation Scale scores compared with GoLYTELY (6.67 ± 1.87); there were no significant differences among the remaining preps. Split-prep dosing was associated with better cleansing; however, men, opioid and tricyclic antidepressent users, and patients with diabetes and cirrhosis had worse cleansing (all P < 0.05).
Conclusions:
In this prospective, real-world comparative effectiveness study of available bowel preps, we found that MiraLAX with Gatorade, MoviPrep, and Suprep were prospectively associated with superior tolerability and bowel cleansing.
Background & aims:
Some features of patients are associated with inadequate bowel preparation, which reduces the effectiveness of colonoscopy examination. We performed a systematic review and meta-analysis of the association between patients' sociodemographic characteristics, health conditions, and medications with inadequate bowel preparation.
Methods:
We searched the PubMed, Scopus, and Cochrane Review databases for randomized controlled trials and cohort (prospective and retrospective), case-control, and cross-sectional studies published through March 2016. We collected information on study design, study population, and bowel preparation. For each factor, we obtained the odds ratio (OR) for inadequate bowel preparation. We conducted the meta-analyses using the random effects approach and investigated any identified heterogeneity and publication bias via graphical methods, stratification, and meta-regression.
Results:
We performed a meta-analysis of 67 studies, comprising 75,818 patients. The estimated pooled OR for inadequate bowel preparation was small for sociodemographic characteristics: 1.14 for age, 1.23 for male sex (excluding studies in Asia, which had substantial heterogeneity and publication bias), and 1.49 for low education. The effect of high body mass index differed significantly in studies with mostly female patients (OR, 1.05) vs those with mostly male patients (OR, 1.30) (P=.013 for the difference). ORs for constipation and cirrhosis were heterogeneous; adjusted ORs were larger than unadjusted ORs (1.97 vs 1.29 for constipation and 3.41 vs 1.36 for cirrhosis). Diabetes (OR, 1.79), hypertension (OR, 1.25), stroke or dementia (OR, 2.09), and opioid use (OR, 1.70) were associated with inadequate bowel preparation. History of abdominal surgery (OR, 0.99) did not associate with inadequate bowel preparation. Use of tricyclic antidepressants had a larger effect on risk of inadequate bowel preparation in studies of mostly female patients (OR, 2.62) than studies of mostly male patients (OR, 1.42) (P=.085 for the difference).
Conclusion:
In a systematic review and meta-analysis, we found no single patient-related factor to be solely associated with inadequate bowel preparation. Health conditions and use of some medications appear to be stronger predictors than sociodemographic characteristics.
Background:
We assessed the efficacy and tolerability of 5 low-volume bowel preparations for colonoscopy.
Study:
We performed an investigator-blinded, randomized trial of 5 bowel preparations: 64 ounces of Gatorade and 306 or 357 g of PEG, both given the day prior; Gatorade and 306 g PEG, 2 L PEG-electrolyte solution with ascorbic acid, and sulfate solution, all 3 given as a split dose. One thousand outpatients consumed their preparation before a morning colonoscopy. The primary endpoint was colon cleanliness assessed by the Chicago Bowel Preparation Scale (BPS). Tolerability was assessed using a subject questionnaire. Another primary endpoint was patient acceptance of a split-dose bowel preparation assessed using a subject questionnaire.
Results:
No statistically significant differences in the modified Chicago BPS were found among Gatorade and 357 g of PEG given as a day-prior dose and the 3 split-dose arms with 98.5% of colons cleansed adequately. The Gatorade and 357 g of PEG had significantly lower Chicago BPS fluid scores and Chicago BPS total scores (indicating dryer colons that required more irrigation) than the 3 split-dose arms. The Gatorade and PEG preparations were better tolerated. Many subjects are unwilling to consume a split-dose preparation and the majority of subjects would prefer a day-prior preparation with this preference highly dependent on the type of preparation they just consumed.
Conclusions:
The cleanliness of the colons was not significantly different among the 3 split-dose preparations. Day-prior dosing of Gatorade and 357 g of PEG allowed the mucosa to be visualized as well as did the split-dose preparations.
Hyponatraemia is the most common electrolyte disturbance in hospitalized patients. There is an increasing awareness of the impact of hyponatraemia on the perioperative management of surgical patients.
We performed a literature review. We have included relevant data from different surgical disciplines for analysis. In this review we discuss the differential diagnosis of hyponatraemia, and explain the specific relevance of hyponatraemia to pre-, peri- and post-operative care.
Hyponatraemia is common during the preoperative period and is associated with an increase in subsequent peri-operative complications, such as wound infection, pneumonia, higher mortality rate and higher direct and indirect costs. Furthermore, data shows poorer surgical outcomes when plasma sodium concentration drops. Careful preoperative evaluation of the hyponatraemic patient enables assessment of surgical risk and individualization of the management of hyponatraemia.
We outline a practical guide to the assessment of the cause of hyponatraemia, which dictates the correct management of hyponatraemia and the correct selection of perioperative fluids. Finally, for the therapeutic role of the new vasopressin antagonist drugs in the treatment of surgical hyponatraemia is discussed in two illustrative surgical clinical cases.
Copyright © 2014 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.
MiraLAX with Gatorade is a low-volume bowel preparation regimen that has been used widely in community practice and is anecdotally better tolerated than Golytely. Despite its widespread use, there are little data on the efficacy and tolerability of this solution and no safety data in the literature. The primary aim of this study was to compare the efficacy, safety, and tolerability of single-dosed and split-dosed regimens of MiraLAX/Gatorade with Golytely for bowel preparation before colonoscopy.
Adults presenting for outpatient colonoscopy were screened for enrollment into this single-blinded randomized controlled trial. Patients with severe cardiac or renal disease and patients with electrolyte abnormalities were excluded. Subjects were randomized into four groups: 4 l Golytely single-dosed (Go-Si), 4 l Golytely split-dosed (Go-Sp), 238 g MiraLAX in 64 oz of Gatorade single-dosed (Mlax-Si), and MiraLAX/Gatorade split-dosed (Mlax-Sp) groups. Laboratory data including complete blood count, comprehensive metabolic panel, and osmolality were collected before the day of bowel preparation and just before the start of colonoscopy. Subjects completed a survey assessing taste and tolerability of the solution. Colonoscopies were recorded using video recording software and de-identified. Colonoscopy videos were evaluated for efficacy of cleansing by two blinded endoscopists. Two validated bowel preparation scales were used to assess bowel cleansing: the Boston Bowel Preparation Scale (BBPS; 0-9 best) and Ottawa Scale (0-14 worst).
A total of 222 patients were evaluated in this study (86.2% male, mean age 59.4). Of these, 57 subjects were randomized to the Go-Si group, 51 to Go-Sp group, 60 to Mlax-Si group, and 54 to Mlax-Sp group. There was no significant difference in age, gender, or timing of colonoscopy between the groups (P>0.05). Mean BBPS scores were: Go-Si=6.07, Go-Sp=8.33, Mlax-Si=6.62, and Mlax-Sp=8.01. Mean Ottawa score for the groups were: Go-Si group=6.77, Go-Sp=4.12, Mlax-Si=6.25, and Mlax-Sp=4.8. Go-Sp resulted in significantly better cleansing than Go-Si (P<0.01). Mlax-Sp resulted in significantly better cleansing than Mlax-Si (P<0.01). There was no significant difference in BBPS between Go-Sp and Mlax-Sp. There were no clinically significant electrolyte changes from baseline in any subject in any group after bowel prep (P>0.05). Subjects rated the taste and overall experience of Mlax/Gatorade preparation better than Golytely (P<0.01). In all, 96.8% of Mlax/Gatorade subjects were willing to repeat the same preparation vs. 75% for Golytely subjects (P<0.01).
Split-dosed MiraLAX/Gatorade was an effective, safe, and tolerable option for bowel preparation before colonoscopy in the low-risk patients in this study. MiraLAX/Gatorade appears to be more tolerable than Golytely as a bowel cleansing regimen and was the preferred agent by the patients in this study.
The development of a 21-item self-report inventory for measuring the severity of anxiety in psychiatric populations is described. The initial item pool of 86 items was drawn from three preexisting scales: the Anxiety Checklist, the Physician’s Desk Reference Checklist, and the Situational Anxiety Checklist. A series of analyses was used to reduce the item pool. The resulting Beck Anxiety Inventory (BAI) is a 21-item scale that showed high internal consistency (α = .92) and test—retest reliability over 1 week, r (81) = .75. The BAI discriminated anxious diagnostic groups (panic disorder, generalized anxiety disorder, etc.) from nonanxious diagnostic groups (major depression, dysthymic disorder, etc). In addition, the BAI was moderately correlated with the revised Hamilton Anxiety Rating Scale, r (150) = .51, and was only mildly correlated with the revised Hamilton Depression Rating Scale, r (153) = .25.
The effect of commercial oral rehydration solutions ("sports drinks") relative to water on risk of nephrolithiasis has not been studied previously. We studied the effect of two sports drinks, Performance (Shaklee Corp., Pleasanton, CA, USA) and Gatorade (Gatorade, Chicago, IL, USA) on urinary chemistry and measures of lithogenicity in non-stone formers. Performance has a pH of 4.3, and contains 21 mmol/L of sodium, 5.3 mmol/L of potassium, 0.8 mmol/L of calcium, and 19.5 mmol/L of citrate. Gatorade pH ranges from 2.9 to 3.2, and contains 20 mmol/L of sodium, 3.2 mmol/L of potassium, negligible calcium, and 13.9 mmol/L of citrate. Subjects drank 946 ml (32 oz) of tap water daily for 3 days, and recorded diet history. This was followed by a second 3-day experimental period during which subjects drank 946 ml (32 oz) of sports drink daily, duplicating diets from part 1. In each 3-day period, urine was collected for 24 h during days 2 and 3. Urine chemical analysis was performed, and supersaturations of calcium oxalate, calcium phosphate and uric acid were calculated. Nine subjects completed the study using Performance, ten used Gatorade. Urine volumes and creatinine excretions were not different during the control and experimental periods. Performance increased mean citrate excretion by 170 mg/day (95% CI 57-284 mg/day; P = 0.01) and increased urine pH by 0.31 (95% CI 0.03-0.59; P = 0.03). Gatorade did not significantly change urinary citrate excretion or pH. Neither drink caused significant differences in the excretion of sodium and calcium or any supersaturation value. Ingestion of Performance, but not Gatorade, led to an increase in mean urinary citrate excretion and pH as compared to water. The increase in citrate is likely to be a clinically significant effect. pH is an important determinant of alkali load in beverages containing organic anions. Performance, with more citrate and a higher pH than Gatorade, could represent a superior alternative to water for reducing urinary lithogenicity. Most sports drinks with significant carbohydrate content however may contain too many calories, and fructose, to be preferred beverages for stone prevention.
Low-volume bowel preparation regimens for colonoscopy are reported to improve patient acceptance and compliance. We sought to compare the bowel cleansing efficacy, tolerability, and acceptability of three low-volume regimens: an oral sodium phosphates solution 45/45 ml (NaP-45/45), a reduced-dose oral sodium phosphates solution 45/30 ml (NaP-45/30), and polyethylene glycol plus bisacodyl (PEG-2L).
A total of 121 patients were evaluated (mean age 55.2 +/- 8.9 years). Bowel cleansings rated as excellent and good were significantly different among the groups: NaP-45/45 = 98%, NaP-45/30 = 88%, and PEG-2L = 76% (P < 0.04). Side effects were not significantly different except for greater thirst in the NaP-45/45 group (P = 0.001) and increased vomiting in females using PEG-2L (two-tailed interaction, P < 0.10). Willingness to retake the preparation was higher among the sodium phosphates regimens (88, 95, and 73%, respectively; P = 0.019).
Better cleansing and willingness to retake the regimen was achieved with the oral sodium phosphates solutions than with polyethylene glycol plus bisacodyl.
Problem-based learning has been used in medical school in a number of different countries around the world for over 50 years, with both undergraduate and graduate students. Instead of the traditional lectures, laboratory practical classes and tutorial system of education, students in small groups are presented with a problem that they must try to solve. They are assisted by a 'facilitator' who helps them formulate the problem and generally advises them but does not supply information. The students have to decide what information they need to solve the problem, find it and communicate it to the others in the group. At this stage a solution may be apparent, but several more group discussions to reformulate the problem followed by re-iterations of the information seeking process may be needed before a solution can be found. The theory is that because information is sought and presented in a relevant context, it is valued and is more likely to be remembered. At the end of the session student reflect on how they performed. Problem-based learning has been criticised from a number of points of view, especially that it does not present a coherent curriculum, the curriculum is not necessarily 'covered', and that in many medical schools the implementation has been less than optimal.
Recent data suggest that colonoscopy is superior to other screening procedures for the detection of colorectal cancer in people aged over 50.1 The American College of Gastroenterology has recently recommended that individuals over 50 at average risk of colon cancer should have elective colonoscopy every 10 years, and those at higher risk more frequently.2 In the United States, 239 000 inpatient colonoscopies were performed in 1995,3 and this figure rose by 20% to 286 000 by 1999.4 Yet complications of elective colonoscopy are reported to be infrequent: colon perforation or bleeding occurs in fewer than 1% of cases, and electrolyte disorders are not even mentioned.1,5–8
Preparation of the colon for colonoscopy involves a thorough cleansing of the large bowel by one of several different methods, in some of which large volumes of a liquid cleansing agent may be given: one method involves drinking 4 l polyethylene glycol solution; another involves taking 90 ml sodium phosphate solution.5,9 Both methods can lead to diarrhoea with nausea, vomiting, and potential dehydration,9 often resulting in raised plasma concentrations of antidiuretic hormone.10 Thus electrolyte imbalance may occur, either from increased oral water intake with abnormal fluid retention or from increased fluid losses into the gastrointestinal tract.
Furthermore, preparation for colonoscopy causes substantial release of antidiuretic hormone,10 and gastrointestinal fluid losses may cause excessive thirst, so increasing fluid intake. In patients with impaired ability to excrete water, the raised plasma antidiuretic hormone concentrations can lead to hyponatraemia; if thirst is impaired, excessive fluid losses can lead to hypernatraemia. In elderly patients in hospital, acute hypernatraemia and hyponatraemia may be fatal,11,12 yet there are no reports of fatal electrolyte complications associated with elective colonoscopy. We recently saw three patients who developed symptoms of hypernatraemia or hyponatraemia (dysnatraemia) as a complication of elective colonoscopy.
Background:
New bowel cleansers for colonoscopy that lead to improved efficacy, safety, and tolerability are needed.
Objective:
This study evaluated a nonphosphate, dual-action, low-volume, orange-flavored preparation containing sodium picosulfate and magnesium citrate (P/MC).
Design:
Multicenter, assessor-blinded, randomized, noninferiority study.
Setting:
University hospitals, academic medical centers, and private clinics across the United States.
Patients:
Adults preparing for colonoscopy.
Interventions:
P/MC versus 2 L of polyethylene glycol solution (2L PEG-3350) and two 5-mg bisacodyl tablets.
Main outcome measurements:
This phase 3 study investigated the efficacy, safety, and tolerability of split-dose administration of P/MC versus day-before dosing of 2L PEG-3350 and two 5-mg bisacodyl tablets (SEE CLEAR I study). Efficacy was evaluated by using the Aronchick and Ottawa scales; noninferiority and superiority analyses were performed. Safety was assessed by monitoring adverse events (AEs). Tolerability was measured via a patient questionnaire.
Results:
The intent-to-treat population consisted of 601 patients who self-administered P/MC (n = 304) or 2L PEG-3350 and bisacodyl tablets (n = 297). P/MC was superior to 2L PEG-3350 and bisacodyl tablets in overall colon cleansing (84.2% vs 74.4%; 1-sided 97.5% confidence interval [CI], 3.4) (Aronchick scores of excellent or good) and in cleansing of the ascending (89.5% vs 78.8%; 1-sided 97.5% CI, 4.9), mid (transverse and descending) (92.4% vs 85.9%; 1-sided 97.5% CI, 1.6), and rectosigmoid (92.4% vs 87.2%; 1-sided 97.5% CI, 0.4) segments of the colon (Ottawa scores of excellent, good, or fair). Commonly reported AEs related to the bowel preparations were nausea, vomiting, headache, and chills. Patient-reported tolerability, including ease of consumption and taste, was significantly higher for P/MC than 2L PEG-3350 and bisacodyl tablets (P < .0001).
Limitations:
Because of differences in administration and volume of the bowel preparations, the study was designed to be a single-assessor, blinded study.
Conclusions:
The bowel-cleansing effects and patient acceptability of split-dose P/MC were superior to day-before dosing with 2L PEG-3350 and bisacodyl tablets.
Objectives:
Optimal bowel preparation is vital for the efficacy and safety of colonoscopy. The inconvenience, discomfort, required consumption of large volumes of product, and potential adverse effects associated with some bowel preparations deter patients from colonoscopy and may provide inadequate cleansing. A dual-action, non-phosphate, natural orange-flavored, low-volume preparation containing sodium picosulfate and magnesium citrate (P/MC) is currently being reviewed for bowel cleansing.
Methods:
This was a phase 3, randomized, multicenter, assessor-blinded, prespecified non-inferiority, head-to-head study to investigate the efficacy, safety, and tolerability of day-before administration of P/MC vs. 2L polyethylene glycol solution and two 5-mg bisacodyl tablets (2L PEG-3350 and bisacodyl tablets (HalfLytely and Bisacodyl Tablets Bowel Prep Kit)) in adult patients preparing for colonoscopy (SEE CLEAR II Study). The primary objective of the study was to demonstrate the non-inferiority of P/MC to 2L PEG-3350 and bisacodyl tablets in overall colon cleansing using a modified Aronchick scale. In addition, efficacy in the ascending, mid (transverse and descending), and recto-sigmoid segments of colon was evaluated using a modified Ottawa scale. Patient acceptability and tolerability of the bowel preparations were assessed via a standard questionnaire. Safety was assessed based on the monitoring of adverse events (AEs) and meaningful findings on clinical evaluations including physical examinations, vital sign measurements, and electrocardiograms (ECGs).
Results:
A total of 603 patients were randomized to receive either P/MC (n = 300) or 2L PEG-3350 and bisacodyl tablets (n = 303). Based on the Aronchick scale, successful overall cleansing was similar in patients receiving P/MC (83.0%) and patients receiving 2L PEG-3350 and bisacodyl tablets (79.7%). P/MC demonstrated non-inferiority to 2L PEG-3350 and bisacodyl tablets in overall cleansing of the colon, as measured by the Aronchick scale. Similarly, the efficacy of P/MC, as measured by the Ottawa scale, was non-inferior to 2L PEG-3350 and bisacodyl tablets in cleansing the ascending, mid, and recto-sigmoid segments of the colon. Patient-reported acceptability and tolerability for each item examined on the questionnaire was significantly greater for P/MC compared with 2L PEG-3350 and bisacodyl tablets (P<0.0001).Treatment-emergent AEs related to the bowel preparation reported by 1% of patients receiving P/MC or 2L PEG-3350 and bisacodyl tablets were nausea (3.0% vs. 4.3%), vomiting (1.4% vs. 2.0%), and headache (2.7% vs. 1.7%). No clinically meaningful changes were noted in either treatment arm in data collected from physical examinations, vital sign measurements, and ECGs.
Conclusions:
When administered as a day-before dose, the bowel cleansing effects of P/MC were non-inferior compared with 2L PEG-3350 and bisacodyl tablets using the clinician-rated Aronchick and Ottawa scales. Treatment acceptability was significantly more favorable in patients receiving P/MC than in patients receiving 2L PEG-3350 and bisacodyl tablets.
This article describes a three-part laboratory project that integrates a full chemical speciation analysis for use in undergraduate analytical chemistry classes. Laboratory analyses include base standardization, potentiometric or colorimetric titration, and ion chromatography. Potentiometric or colorimetric titration is used to analyze for citric acid, potassium hydrogen phosphate, and citrate while ion chromatography is used to analyze for chloride, phosphate, and total citrate in commercially available sports drinks and powders. The examples illustrated in the article include formulation analyses of Gatorade and Powerade liquid beverages. Determining the formulation of the beverage requires integrating theory with lab data through a detailed analysis of the chemical speciation of citrate and phosphate. Keywords (Audience): Second-Year Undergraduate
Low-volume bowel preparations for colonoscopy improve tolerability.
We compared the efficacy, tolerability, and safety of a new low-volume sulfate solution with a standard 4-L polyethylene glycol electrolyte lavage solution as bowel preparation for colonoscopy.
Multicenter, single-blind, randomized, noninferiority study.
Five academic and community endoscopy centers in the United States.
One hundred thirty-six outpatients undergoing colonoscopy.
Patients were randomized to receive 4 L sulfate-free electrolyte lavage solution (SF-ELS) given the night before colonoscopy versus 12 oz oral sulfate solution (OSS) given in equally divided doses the evening before and the morning of colonoscopy.
Successful (ie, good or excellent) bowel preparation.
Successful bowel preparation was more frequent with OSS than with SF-ELS (98.4% vs 89.6%; P = .04). Excellent preparation also was achieved more frequently with OSS (71.4% vs 34.3%; P < .001). Patients receiving OSS had less residual stool in the cecum and ascending colon and less residual fluid in the cecum and ascending, transverse, and descending colon compared with SF-ELS. The percentage of patients with GI side effects and adverse events was not significantly different between the 2 groups.
The OSS was administered in split doses, whereas the SF-ELS was administered the evening before (which is its FDA-approved regimen).
Oral sulfate solution is promising as a safe low-volume preparation for colonoscopy. (Clinical trial registration number: NCT00856843.).
A case of colonoscopy-induced hyponatraemic encephalopathy led us to study the risk of hyponatraemia after gastrointestinal endoscopy. We assessed 40 patients before and after colonoscopy. 20 gastroscopy patients served as controls. Our findings show a high incidence (7.5%) of hyponatraemia after colonoscopy, in association with raised serum concentrations of arginine vasopressin. Physicians should be aware of this complication, since it may contribute to psychological and neurological symptoms after colonoscopy.
Familial risk and environmental stress promote the development of alcohol dependence. We investigated whether a positive family history of alcoholism affects the neuroendocrine response to a standardized laboratory stress test in healthy subjects without alcohol use disorders. Twenty-four high-risk subjects with a paternal history of alcoholism (PHA) and 16 family history negative (FHN) controls were evaluated. Psychosocial stress was induced by having subjects deliver a 5-min speech and mental arithmetics in front of an audience on separate days, after drinking either placebo or ethanol (0.6 g/kg) in a randomized sequence. Adrenocorticotropin (ACTH) was measured in 10 plasma samples covering up to 75 min after the stress test. Plasma arginine vasopressin (AVP) was determined before the stressor, at the time of maximum ACTH secretion, and at 75 min after stress onset. The stress test induced a phasic increase in ACTH secretion. At the time of maximum ACTH, AVP was significantly increased in relation to baseline. Compared to placebo, alcohol administration significantly attenuated maximum ACTH concentration in PHA but not FHN subjects, and decreased AVP measured in the same samples in PHA but not FHN subjects. We conclude that activation of the hypothalamic-pituitary-adrenal system by psychosocial stress is accompanied by an increase in peripheral plasma AVP levels. Secretion of both ACTH and AVP suggest that alcohol attenuates the stress response selectively in PHA but not FHN subjects. This might imply some short-term positive alcohol effect in sons of alcoholics, but also constitute a mechanism by which their risk to develop alcohol use disorders is increased.
Estimates of the current number of endoscopic colorectal cancer screening and follow-up examinations being performed are limited. A national study was therefore conducted among US physician practices.
Approximately 1800 medical practices were surveyed from a list of all practices known to have purchased or leased lower endoscopic equipment between 1996 and 2000. Questions were asked regarding the current number of lower endoscopic procedures performed and the potential maximum number that could be performed.
In 2002, a total of 8207 practices reported performing flexible sigmoidoscopy or colonoscopy in the United States. Gastroenterologists performed 43.7% (95% confidence interval [CI], 37.2-50.2) of all sigmoidoscopies and 82.5% (95% CI, 80.3-84.7) of all colonoscopies. Primary care physicians performed 24.9% (95% CI, 20.3-29.5) of all sigmoidoscopies and 2.0% (95% CI, 1.4-2.6) of all colonoscopies. All physicians combined performed approximately 2.8 million (95% CI, 2.4-3.1) flexible sigmoidoscopies and 14.2 million (95% CI, 12.1-16.4) colonoscopies but reported that they could increase to approximately 9.5 million flexible sigmoidoscopies (95% CI, 8.4-10.5) and 22.4 million colonoscopies (95% CI, 20.1-24.8) in 1 year.
Approximately 2.8 million flexible sigmoidoscopies and 14.2 million colonoscopies were estimated to have been performed in 2002. Physicians reported that they could perform an additional 6.7 million flexible sigmoidoscopies and 8.2 million colonoscopies in 1 year. These additional procedures could be used for the unscreened population and should be considered in the estimate of the national capacity to provide colorectal cancer screening to all eligible persons in the United States.
Pedialyte and Gatorade are advocated for the treatment of dehydration in viral gastroenteritis, but there is limited evidence to support their use. We examine the efficacy, safety, and palatability of Pedialyte, Gatorade, and a New Oral Rehydration Solution (N-ORS). This was a randomized double-blind trial conducted in an inpatient, community hospital. Seventy-five consecutive adult patients (male, 42; female, 33) admitted with viral gastroenteritis were randomized to receive Gatorade, Pedialyte, or N-ORS for 48 hours. A yogurt/rice diet was allowed ad libitum. Stool and urine output, electrolytes, fluid intake, body weight, hematocrit, and palatability of solutions were measured.
Sixty completed the study. Stool frequency, consistency, and body weight improved (p < .001) in all 3 groups, but there was no difference between groups. Likewise, urine output, hematocrit, and correlations between fluid ingested, stool weight, or urine output were similar. At admission and 24 and 48 hours later, hypokalemia was observed in 7, 10, and 8 patients with Gatorade; 3, 2, and 1 with N-ORS; and 2, 2, and 1 with Pedialyte, respectively. Similarly, hyponatremia was observed in 6, 9, and 3 patients with Gatorade; 5, 3, and 4 with N-ORS; and 4, 5, and 4 with Pedialyte. Tastewise, Gatorade and N-ORS were rated higher (p < .05) than Pedialyte. Limitations were a smaller sample size and higher dropout (20%).
Gatorade and N-ORS seem to be as effective as Pedialyte in correcting dehydration and in improving bowel symptoms. All 3 solutions were safe. Unlike other groups, hypokalemia persisted in the Gatorade group. Gatorade and N-ORS may be effective in the treatment of dehydration associated with mild viral gastroenteritis.
A 62-year-old woman noted an unpleasant, sweet taste in her mouth. She otherwise felt well and was taking no medications. Because dysgeusia is a rare manifestation of hyponatremia, her serum sodium level was tested and was 122 mmol per liter. The serum osmolality was 250 mOsm per kilogram of water, the urinary osmolality 635 mOsm per kilogram of water, the urinary sodium 85 mmol per liter, and the urinary potassium 40 mmol per liter. Her thyroid function and adrenal function were normal. A computed tomographic (CT) scan of the thorax showed a mass in the lower lobe of the left lung, which proved to be a small-cell carcinoma. How should her hyponatremia be treated?
Polyethylene glycol (PEG)-based gut lavage solutions are safe and effective, but require consumption of large volumes of fluid. We compared a new 2 L solution of PEG plus ascorbic acid (PEG + Asc) with standard 4 L PEG with electrolytes (PEG + E) for bowel cleansing before colonoscopy to determine efficacy, safety, and patient acceptability.
Consenting adult inpatients scheduled to undergo colonoscopy were randomized to receive either 2 L PEG + Asc or 4 L PEG + E. Preparations were taken as split doses the evening before colonoscopy and the following morning. The PEG + Asc group took 1 L at each administration (i.e., total dose of 2 L). The PEG + E group took 2 L at each administration (i.e., total dose of 4 L). Bowel cleansing success was assessed via videotapes by independent, blinded raters. Statistical noninferiority was predefined as a difference of <15% in the lower limit of the 97.5% confidence interval for treatment difference. Patient views on the preparations were elicited. Adverse events were noted.
Successful gut cleansing was achieved in 136 of 153 (88.9%) cases of the PEG + Asc group and 147 of 155 (94.8%) cases of the 4 L PEG + E group (mean difference -5.9 [-12.0-infinity]). The difference fell within the predefined limit for noninferiority. Clinical and laboratory parameters showed no difference in safety profile. Patient ratings of acceptability and taste were better for the PEG + Asc group than for the PEG + E group (P < 0.025).
The combination of ascorbic acid and PEG-based bowel preparation reduces the volume patients have to drink without compromising efficacy or safety. The low-volume PEG + Asc preparation was more acceptable to patients, and should, therefore, improve effectiveness in routine practice.
Affective disorders comprise mood disorders such as unipolar depression and anxiety disorders, including generalized anxiety, post-traumatic stress disorder, panic, phobia and obsessive-compulsive disorder. The etiology of these disorders is related to stress. Further, they are characterized by alterations of the hypothalamus-pituitary-adrenal (HPA) axis function, controlling the endocrine response to stress. Vasopressin is a nonapeptide that is mainly expressed and/or released in the hypothalamus and the pituitary, but also in other brain areas particularly in limbic regions. It strongly contributes to the endocrine and neural response to stress. Therefore, it has been suggested that vasopressin may be involved in affective disorders. Here, we review both clinical and preclinical data that investigated this hypothesis. Several studies show an increased plasmatic level of vasopressin in anxiety disorders as well as in unipolar depression. Further, a single nucleotide polymorphism (SNP) of the vasopressin V(1b) receptor has been found to protect against depression. Preclinical data are convergent with the clinical findings. For example, Brattleboro rats, that display decreased vasopressin function, show reduced anxiety, reduced depressive-like behavior and decreased HPA function. Rats selected for high anxiety behavior exhibit increased HPA function related to a SNP in the vasopressin locus resulting in an overexpression of vasopressin. Antagonism of the V(1b) receptor decreases anxiety and depressive-like behaviors in rodents, as well as HPA responsivity to stress. Taken together, these data indicate that affective disorders may be related to excessive vasopressin function and consequently that a treatment with vasopressin receptor antagonists may be an effective treatment.