scholarly journals Assessment of Bowel Preparation Using Low-Volume Sulphate-Based Preparations in Comparison with Macrogols: A Multicenter, Randomized, Comparative Clinical Study of the 3rd Phase

2019 ◽  
Vol 29 (2) ◽  
pp. 60-75
Author(s):  
E. D. Fedorov ◽  
V. V. Veselov ◽  
S. V. Kashin ◽  
E. V. Tikhomirova ◽  
A. V. Veselov ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Sodium Sulphate ◽  
Sulphate Solution ◽  
P Value ◽  
Common Symptom ◽  
Polyp Detection ◽  
Diagnostic Colonoscopy ◽  
Intention To Treat ◽  
Low Volume ◽  
Research Centres

Oral sulphate solution(OSS: sodium sulphate, potassium sulphate and magnesium sulphate) is a low-volume osmotic agent for cleansing the intestines.Aim: in a multicentre, prospective, randomized, 3rd phase study with two parallel groups, the effectiveness, safety and tolerability of OSS was evaluated in comparison with Macrogol 4000 with electrolytes (a reference preparation for bowel cleansing in Russia) in adult patients who were scheduled for routine diagnostic colonoscopy.Methods. This study was conducted in three Russian research centres during the March–December, 2015 period. Men and women over the age of 18 scheduled to undergo routine diagnostic colonoscopy were randomly assigned either to the OSS group or to the Macrogol group with a fractional use mode before the colonoscopy. The colonoscopy researchers were not aware of which preparation had been taken by the patients. Anonymized video records were centrally analysed by three experts. The primary end point was the proportion of patients with a successful bowel preparation for colonoscopy ≥ 6 points, as determined by the Boston Bowel Preparation Scale of quality assessment (BBPS scale).Results. 296 patients were randomized in the study (147 patients were treated with OSS, 149 patients received Macrogol); 294 participants were included in the Intention to Treat population (ITT-population), and 274 participants were included in the population of patients who completed the study according to the protocol (Per-Protocol; PP-population) (139 patients received OSS, 135 patients received Macrogol). The proportion of patients with a successful bowel preparation (BBPS ≥6 scores) was high in both groups (OSS [PP-population]: 97.2 % (95 % confidence interval [CI] 89.5–99.3), Macrogol [PP-population]: 97.7 % (95 % CI: 90.7–99.4)). The corrected difference between the groups was -0.5 % (95 % CI: -4.2–3.3), thereby demonstrating “no less effective” of OSS as compared to Macrogol. Compliance with the drug use regime was higher in the OSS group than in the Macrogol group (95.7 % versus 82.3 %, respectively, p-value = 0.0011, ITT-population).The most common symptom reported in patients was nausea (27.9 % in the OSS group and 12.9 % in the Macrogol group). The proportion of patients who developed nausea was significantly higher in the OSS group than in the Macrogol group (25.2 % compared with 10.2 % when taking the first dose of the preparation (p = 0.0008) and 19.7 % compared with 6.8 % when taking the second dose of the preparation (p = 0.0016)). Differences in other symptoms (bloating, abdominal pain or abdominal discomfort) between the groups were not significant, with the severity of symptoms being generally mild. The safety profile of the investigated preparations in patients withinflammatory bowel disease (IBD) in remission did not differ from that in the general patient population. The differences in terms of secondary endpoints were not identified, including BBPS assessment for different sections of the colon, the level of polyp detection, the duration and completeness of colonoscopy, and the investigator’s satisfaction with the procedure. The analysis by subgroups also did not reveal any significant differences.Conclusion. In this study, the “not less effectiveness” of the sulphate solution was demonstrated as compared to Macrogol in a fractional use mode. Both preparations were well tolerated. Despite the higher incidence of nausea in the OSS group, the patients showed significantly higher compliance with the OSS mode as compared to that of Macrogol. This study is registered with the ClinicalTrials.gov Registry of Clinical Trials, No. NCT02321462.Conflict of interest: this study was sponsored by Ipsen Pharma.Acknowledgements: the authors express their sincere gratitude to all the patients who participated in the study, as well as to specialists having provided medical care for the patients, researchers and employees of the participant research centres. The authors also express their appreciation to Olga Kapitonova, an employee of the Almedis company (Moscow, Russia) for her assistance in compiling medical texts, which activity was carried out under the financial support of the Ipsen company (Moscow, Russia) in accordance with the Good Publication Practice (GPP).

scholarly journals Assessment of Bowel Preparation Using Low-Volume Sulphate-Based Preparations in Comparison with Macrogols: A Multicenter, Randomized, Comparative Clinical Study of the 3rd Phase

2019 ◽  
Vol 29 (1) ◽  
pp. 68-83
Author(s):  
Evgeny D. Fedorov ◽  
Viktor V. Veselov ◽  
Sergey V. Kashin ◽  
Ekaterina V. Tikhomirova ◽  
Alexey V. Veselov ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Sodium Sulphate ◽  
Sulphate Solution ◽  
P Value ◽  
Common Symptom ◽  
Polyp Detection ◽  
Diagnostic Colonoscopy ◽  
Intention To Treat ◽  
Comparative Clinical Study ◽  
Low Volume

Oral sulphate solution(OSS: sodium sulphate, potassium sulphate and magnesium sulphate) is a low-volume osmotic agent for cleansing the intestines.Aim:in a multicentre, prospective, randomized, 3rd phase study with two parallel groups, the effectiveness, safety and tolerability of OSS was evaluated in comparison with Macrogol 4000 with electrolytes (a reference preparation for bowel cleansing in Russia) in adult patients who were scheduled for routine diagnostic colonoscopy.Methods.This study was conducted in three Russian research centres during the March–December, 2015 period. Men and women over the age of 18 scheduled to undergo routine diagnostic colonoscopy were randomly assigned either to the OSS group or to the Macrogol group with a fractional use mode before the colonoscopy. The colonoscopy researchers were not aware of which preparation had been taken by the patients. Anonymized video records were centrally analysed by three experts. The primary end point was the proportion of patients with a successful bowel preparation for colonoscopy ≥6 points, as determined by theBoston Bowel Preparation Scale of quality assessment(BBPS scale).Results.296 patients were randomized in the study (147 patients were treated with OSS, 149 patients received Macrogol); 294 participants were included in theIntention to Treat population(ITT-population), and 274 participants were included in thepopulation of patients who completed the study according to the protocol(Per-Protocol; PP-population) (139 patients received OSS, 135 patients received Macrogol). The proportion of patients with a successful bowel preparation (BBPS ≥6 scores) was high in both groups (OSS [PP-population]: 97.2 % (95 % confidence interval [CI] 89.5–99.3), Macrogol [PP-population]: 97.7 % (95 % CI: 90.7–99.4)). The corrected difference between the groups was -0.5 % (95 % CI: -4.2–3.3), thereby demonstrating “no less effective” of OSS as compared to Macrogol. Compliance with the drug use regime was higher in the OSS group than in the Macrogol group (95.7 % versus 82.3 %, respectively, p-value = 0.0011, ITT-population).The most common symptom reported in patients was nausea (27.9 % in the OSS group and 12.9 % in the Macrogol group). The proportion of patients who developed nausea was significantly higher in the OSS group than in the Macrogol group (25.2 % compared with 10.2 % when taking the first dose of the preparation (p = 0.0008) and 19.7 % compared with 6.8 % when taking the second dose of the preparation (p = 0.0016)). Differences in other symptoms (bloating, abdominal pain or abdominal discomfort) between the groups were not significant, with the severity of symptoms being generally mild. The safety profile of the investigated preparations in patients withinflammatory bowel disease(IBD) in remission did not differ from that in the general patient population.The differences in terms of secondary endpoints were not identified, including BBPS assessment for different sections of the colon, the level of polyp detection, the duration and completeness of colonoscopy, and the investigator’s satisfaction with the procedure. The analysis by subgroups also did not reveal any significant differences.Conclusion.In this study, the “not less effectiveness” of the sulphate solution was demonstrated as compared to Macrogol in a fractional use mode. Both preparations were well tolerated. Despite the higher incidence of nausea in the OSS group, the patients showed significantly higher compliance with the OSS mode as compared to that of Macrogol.This study is registered with the ClinicalTrials.gov Registry of Clinical Trials, No. NCT02321462.

scholarly journals An Enhanced High-Volume Preparation for Colonoscopy Is Not Better Than a Conventional Low-Volume One in Patients at Risk of Poor Bowel Cleansing: A Randomized Controlled Trial

2021 ◽  
Vol 8 ◽  
Author(s):  
Antonio Z. Gimeno-García ◽  
Goretti Hernández ◽  
José Luis Baute Dorta ◽  
Cristina Reygosa ◽  
Raquel de la Barreda ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Bowel Preparation ◽  
Controlled Trial ◽  
High Volume ◽  
Risk Difference ◽  
Predictive Score ◽  
Clinical Trial Registration ◽  
Intention To Treat ◽  
Bowel Cleansing ◽  
Low Volume

Objective: We tested the hypothesis that an enhanced bowel preparation strategy (EBS) improves colonic cleansing in patients at high risk for inadequate bowel cleansing (HRI).Methods: This prospective randomized clinical trial included consecutive HRI patients referred for outpatient colonoscopy between February and October 2019. HRI was considered if patients scored >1.225 according to a previously validated bowel-cleansing predictive score. HRI patients were randomized (1:1) to a low-volume conventional bowel cleansing strategy (CBS) (1-day low residue diet (LRD) plus 2 L of polyethylene glycol (PEG) plus ascorbic acid) or to an EBS (3-day LRD plus 10 mg oral bisacodyl plus 4 L PEG). The Boston Bowel Preparation Scale (BBPS) was used to assess the quality of cleanliness. Intention-to-treat (ITT) and per protocol (PP) analyses were performed. A sample size of 130 patients per group was estimated to reach a 15% difference in favor of EBP.Results: A total of 253 HRI patients were included (mean age 69.8 ± 9.5 years, 51.8% women). No statistically significant differences were found in the BBPS scale between the two groups in the ITT analysis (CBS 76.8% vs. EBS 79.7%, P = 0.58) or PP analysis (CBS 78% vs. EBS 84.3%, P = 0.21), risk difference 2.9% (95% CI−7.26 to 39.16) in the ITT analysis, or risk difference 6.3% (95% CI−3.48 to 16.08) in PP analysis. No differences in preparation tolerance, compliance, adverse effects, or colonoscopy findings were found.Conclusion: EBS is not superior to CBS in hard-to-prepare patients. (EUDRACT: 2017-000787-15, NCT03830489).Clinical Trial Registration:www.ClinicalTrials.gov, identifier NCT03830489.

ASSESSMENT OF CORRELATION BETWEEN LEUKODERMA AND PSYCHIATRIC ILLNESS

2019 ◽  
Vol 3 (8) ◽  
Author(s):  
Dr. Mukesh Batra
Keyword(s):  
Psychiatric Illness ◽  
Study Participant ◽  
Simple Random Sampling ◽  
Anxiety Symptoms ◽  
Control Group ◽  
P Value ◽  
Common Symptom ◽  
Cross Sectional ◽  
Duration Of Disease ◽  
Illness Anxiety

Background: Leukoderma is an acquired disease of pigmentation which is presented by depigmented areas of different shape and sizes on the skin. In various researches it was reported that these defects in melanocytes occurred due to autoimmune pathway or the complex causation of oxidative stress and genetics. Material & Methods: In the present cross‑sectional prospective study 100 patients who were diagnosed with Leukoderma and controls who were not having depigmentation of skin and without any known clinical disease were enrolled for present study by simple random sampling. Written informed consent was taken from each study participant. Clearance from institutional ethical committee was also taken prior to the study. Results: The prevalence of psychiatric illness among leukoderma group was 22% and among 78% patients we did not found any psychiatric illness. The most common symptom was depression which was present among 22% of patients with Leukoderma and 18% patients with Leukoderma had anxiety symptoms. Among the control group depression was present in 5 % subjects and anxiety symptoms were present in 7% of subjects. The mean WHO-Quality of life scores was low among Leukoderma group in relation to the control group (p value <0.05). On correlation with psychiatric illness, observations were statistically non-significant (p > 0.05) with HAMA-A and HAMA- D. The observations were statistically significant (p < 0.05) with GHQ total and BSA score. Conclusion:  Higher prevalence of psychitric morbidity among patients with leukoderma and it was found associated with duration of disease and BSA scores. The most common symptom was depression which was followed by anxiety symptoms. Key words: Leukoderma, psychiatric illness, anxiety, depression.

Patient Tolerability of Bowel Preparation is Associated with Polyp Detection Rate During Colonoscopy

2014 ◽  
Vol 23 (2) ◽  
pp. 135-140 ◽  
Author(s):  
Edward W. Holt ◽  
Kidist K. Yimam ◽  
Hanley Ma ◽  
Richard E. Shaw ◽  
Richard A. Sundberg ◽  
...  
Keyword(s):  
Bowel Preparation ◽  
Primary Outcome ◽  
Secondary Outcome ◽  
Polyp Detection ◽  
Cross Sectional ◽  
Quality Outcomes ◽  
Negative Experience ◽  
Polyp Detection Rate ◽  
Patient Reported ◽  
Bowel Prep

Background & Aims: A number of factors have been identified that influence the yield of screeningcolonoscopy. The perceived tolerability of bowel preparation has not been studied as a predictor of quality outcomes in colonoscopy. We aimed to characterize the association between patient-perceived tolerability of bowel preparation and polyp detection during colonoscopy.Methods: We performed a cross-sectional cohort study of 413 consecutive adult patients presenting foroutpatient colonoscopy at two outpatient endoscopy centers at our institution. We developed a standardized questionnaire to assess the patient's experience with bowel preparation. Bowel preparation quality was measured using the validated Ottawa scale and colonoscopic findings were recorded for each patient. The primary outcome was polyp detection and the secondary outcome was the quality of bowel preparation.Results: Patient-reported clarity of effluent during bowel preparation correlated poorly with Ottawa score during colonoscopy, k=0.15. Female gender was an independent risk factor for a poorly tolerated bowel prep (OR 3.93, 95% CI 2.30 - 6.72, p<0.001). Report of a poorly tolerated bowel prep was independently associated with the primary outcome, polyp detection (OR 0.39, 95% CI 0.18 - 0.84, p=0.02) and also with the secondary outcome, lower quality bowel preparation (OR 2.39, 95% CI 1.17 - 4.9, p=0.02).Conclusions: A patient-perceived negative experience with bowel preparation independently predicted both a lower quality bowel preparation and a lower rate of polyp of detection. Assessment of the tolerability of bowel preparation before colonoscopy may be a clinically useful predictor of quality outcomes during colonoscopy.

scholarly journals A CLINICAL STUDY TO ASSESS THE EFFICACY OF SHWASAHARA DASHEMANI GHANAVATI IN CARDIAC ASTHMA W.S.R L.V.F

2021 ◽  
Vol p6 (1) ◽  
pp. 3179-3185
Author(s):  
Roopa M.R ◽  
Vasudev A Chate ◽  
Shreevathsa Shreevathsa ◽  
Mohan Kumar G
Keyword(s):  
Standard Treatment ◽  
Intervention Group ◽  
Simple Random Sampling ◽  
Control Group ◽  
P Value ◽  
Common Symptom ◽  
Open Label ◽  
Post Test ◽  
Clinically Significant ◽  
Cardiac Asthma

Introduction: Shwasa is said as Shigrapranahara Roga. It occurs as the main disease and also a symptom in various diseases. Shwasakruchrata is a common symptom that occurs in Hrudroga. Acharya Charaka mentioned the unique classification of drugs based on their action. Shwasahara Dashemani is one among them. It is containing 10 herbal drugs which are specially indicated in Shwasa Roga. Hence to evaluate the efficacy of Shwasahara Dashemani in Lakshana Roopi Shwasa in L.V.F (Cardiac Asthma) has taken for the study. Aim and Objective: The objective is to assess the efficacy of Shwasahara Dashemani in L.V.F with dyspnea (Cardiac Asthma). Method: The present study is a controlled comparative, open-label, clinical trial with pre and post-test design. A total of 40 subjects of a diagnosed case of L.V.F with dyspnea (Cardiac Asthma) were selected by using a simple random sampling method. Control group subjects were intervened with standard treatment of L.V.F and intervention group subjects were intervened with standard treatment of L.V.F along with Shwasahara Dashemani Ghana Vati, for the duration of 30 days. Its efficacy was assessed before treatment (0th day) and after treatment (31st day) by using BDI (Baseline Dyspnea Index Scale). Results: The P-value of dyspnea of the control group is 1.000 and the P-value of dyspnea of the intervention group is 0.105. This shows that the results of both groups are statistically not significant. But as compared to the control group, the intervention group is clinically significant because after the intervention 35% of subjects had shown improvement in the intervention group. Conclusion: As compared to the control group, in the intervention group Shwasahara Dashemani Ghanavati is clinically significant in relieving cardiac asthma when used with standard treatment of L.V.F. Keyword: Shwasahara Dashemani. Cardiac Asthma, L.V.F, Dyspnea

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