An Open-labeled Clinical Study to Evaluate the Safety and Efficacy of “Anuloma DS” in Improving Constipation

Background: Constipation is a common gastrointestinal problem in the general population. Despite a plethora of well-established and safe treatment options, the improvement is not satisfactory for many patients. This has prompted interest in alternative therapeutic strategies for constipation. Methods: This open-label, non-comparative single-arm clinical study evaluated the efficacy and safety of the polyherbal formulation “Anuloma DS”, 1 tablet daily at bedtime, in improving bowel movements in 30 adult patients with functional constipation. Patients were evaluated at baseline (Visit 1, Day 0) and follow-ups during Visit 2 (Day 7 ± 2), Visit 3 (Day 14 ± 2) and Visit 4 (End of the Study) at Day 30 ± 2. Results: There was a significant increase in the mean of spontaneous bowel movement every week from day 7 to days 14 and 30. All constipation symptoms such as abdominal bloating (aadmana), abdominal pain/discomfort (aanaha), feeling of incomplete evacuation and straining during passing stool improved significantly as did the SGA and the PGA scores. Conclusion: Anuloma DS is highly effective for the treatment of chronic functional constipation. No treatment-related side effects were reported by the study participants.

Safety and efficacy of vibrating capsule in the treatment of functional constipation: a single center randomized controlled study / 中华消化杂志

Objective:Based on the previous animal experiments, to preliminarily explore the safety and efficacy of self-developed new smartphone-controlled vibrating capsule (VC) in the treatment of patients with functional constipation (FC).Methods:At the Outpatient Department of Gastroenterology, Changhai Hospital, Naval Medical University, 24 patients with FC were prospectively enrolled. The trial process included basic period for ≥two weeks, treatment period for six weeks, and follow-up visits ≥six (once every two weeks). During treatment period, the patients were assigned into sham capsule group, VC at low frequency mode group and VC at high frequency mode group and the patients swallowed 12 corresponding capsules. The safety of VC treatment was evaluated based on the observation the occurrence of adverse events (AE) in patients of three groups, which included abdominal pain, abdominal distention, capsule retention and abnormal laboratory indicators. The efficacy of VC treatment was assessed by comparison of the patients of three groups in mean complete spontaneous bowel movements (CSBM) per week, mean spontaneous bowel movements (SBM) per week, capsule discharge time, patient assessment of constipation quatity of life questionnaire (PAC-QOL), patient assessment of constipation symptom questionnaire (PAC-SYM). Chi-square test, least significant difference- t test, Kruskal-Wallis test, Wilcoxon rank sum test and Fisher exact test were used for statistical analysis. Results:Two patients were lost in follow up. In the end, seven, eight and seven patients were enrolled in sham capsule group, VC at low frequency mode group and VC at high frequency mode group. AE occurred in three patients. At the sixth week of treatment, the difference between average CSBM in one week and baseline of sham capsule group, VC at low frequency mode group and VC at high frequency mode group was 0.0 (0.0, 2.0), 2.0 (1.0, 2.8) and 1.0 (0.0, 5.0), respectively; and the difference between average SBM in one week and baseline of sham capsule group, VC at low frequency mode group and VC at high frequency mode group was -1.0 (2.0, 2.0), 1.0 (-0.8, 2.0) and 1.0 (0.0, 4.0), respectively. During the six weeks of treatment period, the difference between mean CSBM per week and baseline of three, seven and five patients of sham capsule group, VC at low frequency mode group and VC at high frequency mode group was more than one, and the difference between SBM per week and baseline of two, five and five patients was more than one. At the sixth week of treatment, capsule discharge time of VC at low frequency mode group and VC at high frequency mode group was shorter than that of sham capsule group ((65.7±9.3) and (59.1±3.4) h vs. (96.7±10.0) h), and during the whole treatment period capsule discharge time of VC at low frequency mode group and VC at high frequency mode group was shorter than that of sham capsule group ((63.6±8.6) and (59.8±6.6) h vs. (100.5±13.1) h), and the differences were statistically significant ( t=3.119, 3.584, 2.832 and 3.036, all P<0.05). The PAC-SYM score of patients of sham capsule group, VC at low frequency mode group and VC at high frequency mode group during the period of treatment was 14.3±2.0, 9.9±2.3 and 7.0±2.0, respectively, there were no statistically significant differences among the three groups ( P>0.05). The PAC-QOL score of patients of sham capsule group, VC at low frequency mode group and VC at high frequency mode group during the period of treatment was 31.3±4.4, 24.0±3.8 and 13.9±4.1, respectively, and the PAC-QOL score of VC at high frequency mode group was lower than that of sham capsule group, and the difference was statistically significant ( t=2.808, P=0.012), however, there was no statistically significant difference in the PAC-QOL score between VC at low frequency mode group and sham capsule group, and between VC at high frequency mode group and VC at low frequency mode group (both P>0.05). Conclusions:VC can be safely used in patients with FC, which can promote defecation and relieve the symptoms of constipation. However, there is no significant difference in the therapeutic effect of capsules with different vibration frequencies.

Association between the frequency of bowel movements and the risk of colorectal cancer in Chinese adults / 中华流行病学杂志

Objective@#To examine the association between the frequencies of bowel movement (BMF) and the risk of colorectal cancer (CRC).@*Methods@#In this study, 510 134 participants from the China Kadoorie Biobank (CKB) were included, after excluding those who reported as having been diagnosed with cancer at the baseline survey. The baseline survey was conducted from June 2004 to July 2008. The present study included data from baseline and follow-up until December 31, 2016. We used the Cox proportional hazards regression models to estimate the HR and the 95%CI of incident CRC with BMF.@*Results@#During an average follow-up period of 9.9 years, 3 056 participants were documented as having developed colorectal cancer. In the site-specific analysis, 1 548 colon cancer and 1 475 rectal cancer were included. Compared with participants who had bowel movements on the daily base, the multivariable-adjusted HR (95%CI) for those who had more than once of BMF were 1.24 (1.12-1.39) for CRC, 1.12 (0.95-1.31) for colon cancer, and 1.37 (1.18-1.59) for rectal cancer. We further examined the association between BMF and CRC, according to the stages of follow-up, the corresponding HR (95%CI) for CRC, colon and rectal cancer were 1.59 (1.36-1.86), 1.43 (1.14- 1.80), and 1.76 (1.41-2.19) for the first five years, while such associations became statistically insignificant in the subsequent follow-up (P for all interactions were <0.05), as time went on. As for CRC, colon or rectal cancers among participants who had lower bowel movements, the risks were not significantly different from those who had bowel movements everyday.@*Conclusions@#Participants who had BMF more than once a day, appeared an increased risk of CRC in the subsequent five years. Since abnormal increase of bowel movements is easily recognizable, programs should be set up on health self- management and early screening for CRC.

Effects of intestinal microbiota of patients with chronic constipation on the expression of serotonin transporter and the bowel movement in mice / 中华消化杂志

Objective To investigate the effects of intestinal microbiota of patients with chronic constipation on the expression of serotonin transporter (SERT) and the bowel movement in mice.Methods Fecal samples of patients with slow transit constipation met Rome Ⅲ criteria and healthy normal controls were collected and made into fecal microbiota solution.Twenty specfic pathogen free (SPF) mice were divided into experiment group and control group.The mice of two groups were both pre-treated with streptomycin to establish the germ-free mice model.The mice of control group were gavaged with mixed fecal microbiota solution of healthy normal controls and the mice of experiment group were gavaged with mixed fecal microbiota solution of patients with chronic constipation.Mice were sacrificed after fed for 15 days.Defecation parameters and ink discharge time of mice were detected.The expressions of SERT mRNA and SERT protein in mice intestinal tissues were detected with real time-polymerase chain reaction and Western blotting.The 5-hydroxytryptamine (5-HT) levels of mice intestinal tissues were evaluated by enzyme-linked immunosorbent assay (ELISA) and double immunofluorescent staining.The methods of t test and Chi-square test were performed for statistical analysis.Results On the 15th day,the total number of the feces within 2 h of the experiment group and control group was 8.55±1.83 and 12.14±2.90,respectively,and the difference was statistically significant (t=3.33,P＜0.05).The weight of feces were (151.90 ± 32.42) mg and (246.72 ± 64.01) mg,respectively,and the difference was statistically significant (t=4.18,P＜0.01).The dry weight of feces were (65.52±11.76) mg and (92.93±23.07) mg,respectively,and the difference was statistically significant (t=3.37,P＜0.05).The water content of feces were (56.63 ± 3.01) ％ and (61.95 ± 3.70) ％,respectively,and the difference was statistically significant (t=3.57,P＜0.05).The defecating time of first black feces of the experiment group and control group were (83.24±11.31) min and (69.06±2.72) min,respectively,and the difference was statistically significant (t=-2.74,P＜0.05).The expressions of SERT mRNA and SERT protein levels in mice intestine tissues of the experiment group were significantly higher than those of the control group (t =2.61,-6.89;both P＜0.05).5-HT level of mice intestinal tissues of the experimental group and control group were (151.69± 10.18) ng/mL and (198.77 ± 25.99) ng/mL,respectively,and the difference was statistically significant (t=-4.13,P＜0.01).Conclusion Intestinal microbiota of patients with chronic constipation may influence the expression of SERT in the mice intestinal tissues,and then decrease the level of 5-HT,slowing the bowel movement in mice.

Leptin and gastrointestinal motility / 国际外科学杂志

Leptin,a peptide encoded by the obese gene,is primarily secreted by adipocytes,which is a critical hormone controlling food intake, body weight, energy expenditure and neuroendocrine function. Leptin can alter the reactivity of the gastrointestinal neuromuscular, thereby to regulate the gastric emptying and bow-el movement. Leptin seems to be a new gut hormone that has a close relationship with the function and dis-ease of gastrointestinal tract. This article reviews the relationship of leptin and gastrointestinal motility.

Three Cases of Bronchial Asthma where Respiratory Symptoms were Relieved by Improving Defecation / 日本東洋医学雑誌

In Kampo, “lung medicines” are usually used to treat patients with bronchial asthma, according to the type of cough and sputum, and the degree of dyspnea which presents. However, it is also important to exclude exacerbating factors. In Kampo, the lungs and large intestine are thought to have a close relationship. We report three bronchial asthma patients whose cough and dyspnea were ameliorated by improving bowel movements. We discuss the types of bronchial asthma patients who might be effectively treated by controlling their defecation. We suggest that, when patients with mild bronchial asthma who have not previously had trouble with their bowel movements complain of respiratory distress with abnormal bowel movement, it might be effective to apply “large intestine medicines” to relieve their respiratory problems. (122 words)

The safety of bedside bowel movement during the early phase of patients with acute myocardial infarction / 中国实用护理杂志

Objective To explore the safety of bedside bowel movement during the earlY phase of patients with acute myocardial infarction(AMI).Methods 55 patients were randomly divided into the experimental group(28 cases)and the control group(27 cases).The experimental group adopted bedside bowel movement while the control group used routine in-bed bowel movement.The heart rate,blood pressure and myocardial oxygen comsumption(D-P)were observed.Results The heart rate,systolic blood pressure,and diastolic blood pressure in the control group were higher than those in steady state(P＜0.05).While in the experimental group the above factors were not statistically different from those in steady state (P＞0.05).The D-P both increased in the two groups compared with that in steady state(P＜0.05).The incidence of uncomfortable complaint and complications were not different between the two groups but the rate of constipation and mean in-hospital days were lower than those in the control group(P＜0.05).Conclusion It proved safe and applicable for patients with AMI to adopt bedside bowel movement during 24 to 72hours after infarction under the electrocardiac and blood pressure monitoring if their vital signs were steady and did not have any serious complications.

Three Cases of Acute Abdomen Treated with Daikenchuto in Emergency Room / 日本東洋医学雑誌

Daikenchuto has been attracting nationwide attention in recent years, with its therapeutic efficacy on posto-perative complaints and complications. We treated three patients with acute abdomen using daikenchuto. They suffered from severe abdominal pains and abdominal radiographs showed small intestine gases. All three recovered from their pains or nausea after taking daikenchuto, and were discharged home without hospital admission. The use of daikenchuto against acute abdomen is recommended in emergency medicine.

Effect of Anesthetic Methods on Gastrointestinal Bowel Movement after Colon Surgery / 대한마취과학회지

BACKGROUND: Gastrointestinal bowel movements are reduced by opioid-based anesthesia. Remifentanil is commonly used as total intravenous anesthesia. This study compared to the effect of various anesthetic methods on gastrointestinal bowel movement after colon surgery. METHODS: Ninety patients were allocated randomly into three groups. Thirty patients received intraoperative inhalation anesthesia (desflurane + N2O, Group I), 30 patients received intraoperative total intravenous anesthesia (propofol + remifentanil, Group II), and 30 patients received intraoperative epidural anesthesia (epidural lidocaine + propofol, Group III). All patients received postoperative epidural analgesia with a mixture of ropivacaine and morphine. The time to the first passage of flatus, hospital stay and visual analog pain scale were recorded. RESULTS: There was no significant difference in first passage of flatus among groups (Group I: 92.7 +/- 19.6, Group II: 86.9 +/- 19.4, Group III: 81.9 +/- 12.8 hours, P = 0.063). There were no significant difference in the hospital stay and visual analog scale among the three groups. CONCLUSIONS: Total intravenous anesthesia with remifentanil did not reduce the gastrointestinal bowel movements compared with those of inhalation or epidural anesthesia.

Difference in Time of Bowel Sounds and Passing of Gas in Abdominal Hysterectomy Patients having San-Yin-Jia (SP-6) Acupressure / 간호학회지

PURPOSE: The purpose of this study was to compare differences in the time when bowel sounds were heard and gas was passed in women who had an abdominal hysterectomy and were treated for 5 minutes (experimental group A) or 10 minutes (experimental group B) with San-Yin-Jiao (SP-6) acupressure. METHOD: The design of this study was a nonequivalent control group non-synchronized post test only design. The participants included 142 women, 39 in experimental group A, 30 in experimental group B, and 73 in the control group. Data was collected using a structured questionnaire which included items on general characteristics and a self report of time when gas was passed. Differences for the three groups as to time when bowel sounds were heard and gas was passed were analyzed using ANOVA. RESULT: The time when bowel sounds were heard was statistically significantly shorter in both experimental groups compared to the control group(F=10.29, p=.000). The time when gas was passed was statistically significantly shorter in experimental group B(10 min) compared to the control group(F=4.68, p=.011). CONCLUSION: It could be concluded that SP-6 acupressure of 10 minutes was effective in shortening the time until bowel sounds were heard and gas was passed for women who had had an abdominal hysterectomy. Replication of the study with a larger number of participants is necessary in order to be able to generalize the results.

Passive Bowel Movement with a New Colostomy Device: An Acute Experiment in Dog

In some clinical situations such as cerebrovascular accident, pelvic bone fracture or any bed ridden states patients do not have self control of their bowel movement. Nursing care around the perianal area is not an easy job. There is no devices which substitude the work because of the chracteristics of the anatomy of the anorectum and the fecal matter made of solid and gel state component. AIM: to evaluate the possibility of passive evacuation of the fecal matter from the rectum with a newly developed silicon device. MATERIAL AND METHODS: A New Colostomy Device (NCD; US Patent No. 5,569,216) for fixing in the stoma or rectum of human body, includes an internal balloon, a ring figured external balloon surrounding the internal balloon, a connecting tube disposed under the both internal and external balloons and supply tube containing a pair of air passages and an enema fluid passages. It is designed to be inserted into the rectum and is held in place by an inflatable external balloon and drains irrigated fecal matter through a thin collapsible connecting tube which exist in the anal canal. Six mongrel dog with 20~25 kg of body weight was used for the acute experiment. Three types (1.5, 2.0, 2.5 cm in luminal diameter of the solid portion) of NCD were applied in 3 consecutive every other days. For softening of the stool, normally harder than that of human, Psyllium dextrose 30 gm was added to the daily food. Average 750 cc of tepid water was administered through the device for bowel irrigation. Anesthesia was not used in each procedures. The amount evacuated fecal matter and remained solid stool in rectum were checked. To evaluate the rectal mucosal injury anoscopic examinations were performed. RESULTS: Stool evacuation was closely correlated with the intemal diameter of the device and stool component. The device with 2.5 cm in luminal diameter passed fecal matter well enough in 5 of 6 dogs however, smaller devices did not. Accidental prolapse of NCD were noted in 4 of 6 cases with 2.5 cm sized and all of 1.5 and 2.0 sized devices eventually until last push. CONCLUSION: The NCD with 2.5 cm of internal diameter could be used in selected clinical situations.