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1.
Dig Dis Sci ; 58(8): 2156-66, 2013 Aug.
Article in English | MEDLINE | ID: mdl-23456498

ABSTRACT

OBJECTIVE: In this randomized clinical trial, we have compared the Shudh™ colon cleanse (SCC) with HalfLytely(®) colon prep (HCP) to evaluate the efficacy, bowel preparation time (BPT), adverse events, electrolyte abnormalities and patient acceptability. METHODS: Patients were randomized to receive either SCC (n = 65) or HCP (n = 68). All colonoscopies were performed by a single, blinded endoscopist. Colon prep was evaluated on a 5 point grading scale. Statistical non-inferiority was pre-defined as a difference of <15 % in the lower limit of the 95.5 % confidence interval for the treatment difference. Data that were collected include bowel prep score, BPT, adverse events, electrolyte abnormalities and patient acceptability. RESULTS: Bowel preparation efficacy was rated as "successful" for 59/65 (90.7 %) in SCC versus 66/68 (97.1 %) in HCP. This gave a success difference of -6.4 % with a 1-sided 95 % lower confidence limit (LCI) for the difference = -13.3 % (non-inferiority p = 0.25). This difference fell within the predefined limit for non-inferiority. The average BPT for SCC was 1.9 h versus 10.9 in HCP (p < 0.001). No serious adverse events were reported in either group. None of the patients in either group had any clinically significant electrolyte imbalance. Patient ratings for palatability and willingness to repeat were significantly better for SCC (p < 0.05). CONCLUSION: SCC was found to not be inferior to PEG with regards to the quality of bowel preparation. It is worth highlighting that a major advantage of SCC is shorter BPT.


Subject(s)
Colonoscopy/methods , Mind-Body Therapies , Sodium Chloride/pharmacology , Adult , Aged , Female , Humans , Male , Middle Aged , Pilot Projects , Sodium Chloride/administration & dosage , Sodium Chloride/adverse effects , Time Factors , Young Adult
2.
J Altern Complement Med ; 16(12): 1269-77, 2010 Dec.
Article in English | MEDLINE | ID: mdl-21114406

ABSTRACT

BACKGROUND: Colonoscopy is now the gold standard for colon cancer screening and a vital diagnostic and therapeutic tool in 21st century medical practice. Although advances have been swift since colonoscopy came into wide use a generation ago, its effectiveness can be compromised by patients' ability to adequately prepare for the procedure. Many patients dread this task more than the procedure itself. While no prep regimen can be ideal for all patients, the authors present a novel approach that represents a potential time-saving improvement for younger, healthier patients. It is a modern version of an Indian practice called shankh prakshalana, in which lukewarm saline is used in combination with five yoga postures to cleanse the bowel. OBJECTIVE: The objective of this study was to examine the safety, efficacy, and tolerability of lukewarm saline and yoga (LWS/yoga) as a colonoscopy preparation in comparison with NuLytely(®) (PEG-3350, sodium chloride, sodium bicarbonate, and potassium chloride solution) used according to the manufacturer's instructions. RESEARCH DESIGN: This was a pilot study comprising 54 healthy adults, ages 18-65, equally divided into two groups: Group A preparing with lukewarm saline and yoga postures (LWS/yoga); and Group B preparing with NuLytely(®) as directed on the label. MEASUREMENTS: Data were collected on the quality of bowel preparation, patient safety, patient tolerability, and side-effects. The setting was a Joint Commission accredited outpatient endoscopy clinic. INTERVENTIONS: Patients performed the series of five yoga postures known as shankh prakshalana, interrupting the exercises at regular intervals to consume 480 mL of lukewarm saline. The solution was prepared by adding 9 g of sodium chloride per liter of lukewarm water (99°F-102°F/37.2°C-38.9°C). RESULTS: The mean total score was significantly better in Group A versus Group B (20.63 ± 5.09 versus 16.48 ± 5.18, p < 0.0007). In Group A, 24/27 (88.9%) of patients had excellent or optimum total scores, compared with 21/27 (77.8%) in Group B (not significant). In our pilot study, LWS/yoga, used under supervision, produced better colon preparation than Nulytely, used as directed. LIMITATIONS: A randomized, endoscopist-blinded study is needed to confirm these results. CONCLUSIONS: Shankh prakshalana is effective as a colonoscopy preparation.


Subject(s)
Cathartics , Colonoscopy/methods , Electrolytes , Polyethylene Glycols , Sodium Chloride , Yoga , Adolescent , Adult , Aged , Humans , Middle Aged , Pilot Projects , Treatment Outcome , Young Adult
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