Effects of Automatic Abdominal Massage Device in Treatment of Chronic Constipation Patients: A Prospective Study.

BACKGROUND AND AIM: Manual abdominal massage has been shown to effectively treat slow-transit constipation, but it is labor-intensive. To offer an alternative treatment option for constipation, the Bamk-001 automatic abdominal massage device was developed. The aim of this study was to assess the effect of the Bamk-001 device on symptom profiles and colon transit time (CTT) in patients with chronic constipation. METHODS: Thirty-seven patients with chronic functional constipation diagnosed using the Rome IV criteria were enrolled prospectively from December 2018 to February 2019. All patients received device-assisted automatic abdominal massage for 15 min twice daily, once in the morning before breakfast and once at night, for 14 days. CTT was measured before and at the end of the study period. Slow-transit constipation and very-slow-transit constipation were defined as CTT ≥ 48 h and ≥ 72 h, respectively. Patients' symptom profiles regarding overall defecation satisfaction and device-related adverse events were analyzed. RESULTS: Among the 37 patients, the mean age was 40.1 ± 11.8, and 5.4% (n = 2) were men. The Bamk-001 device significantly improved CTT from 54.0 (33.6-75.6) to 28.8 (18.0-52.8) h (p = 0.001) in patients with chronic constipation. In subgroup analysis, CTT improved significantly from 54.0 (33.6-75.6) to 28.8 (18.0-52.8) h (p = 0.003) and from 88.2 (74.4-124.8) to 45.6 (27.3-74.1) h (p = 0.005) in the slow-transit and very-slow-transit constipation groups, respectively (p = 0.001). Moreover, all patient symptoms were alleviated after treatment. No serious adverse events were reported. CONCLUSION: The Bamk-001 automatic abdominal massage device showed significant care efficacy, including the improvement in CTT and symptom profiles in patients with slow-transit constipation. The use of an automatic abdominal massage device as an adjunct in the management of constipation is a potentially beneficial intervention for patients with slow-transit constipation.

Efficacy of iron supplementation in patients with inflammatory bowel disease treated with anti-tumor necrosis factor-alpha agents.

BACKGROUND: Anemia is a common extraintestinal manifestation of inflammatory bowel disease (IBD). However, data on the influence of anti-tumor necrosis factor-alpha (anti-TNF-α) agents and iron supplementation on anemia in patients with IBD are sparse. We assessed the effect of iron supplementation in patients with IBD initially treated with an anti-TNF-α agent. METHODS: Data from 79 IBD patients who started anti-TNF-α treatment at a tertiary hospital were analyzed. The patients were divided into the anti-TNF-α (n = 52) and anti-TNF-α with iron supplementation (n = 27) groups. Effects on laboratory parameters, the prevalence of anemia, and disease activity were evaluated at baseline (year 0) and 1 year later. RESULTS: The hemoglobin (Hb) level significantly increased between years 0 and 1 in both groups [12.0 ± 1.8-13.3 ± 2.0 g/dL in the anti-TNF-α group (p < 0.001) and 9.8 ± 2.4-11.7 ± 2.3 g/dL in the anti-TNF-α and iron supplementation group (p = 0.004)]. In a subgroup analysis of severely anemic patients with IBD, iron supplementation increased the magnitude of the improvement in Hb level (8.5 ± 1.5-11.4 ± 2.1 g/dL; p = 0.001) compared with the anti-TNF-α group (9.3 ± 0.8-11.4 ± 2.7 g/dL; p = 0.081). Disease activity was significantly improved in both groups at year 1 compared with year 0. Persistent anemia was significantly correlated with severe anemia at baseline (p = 0.017). CONCLUSION: In anemic patients with IBD, anti-TNF-α agents led to clinically meaningful improvements in anemia independent of iron supplementation. Also, iron supplementation could be helpful in severely anemic patients with IBD.

DA-9701 improves colonic transit time and symptoms in patients with functional constipation: A prospective study.

BACKGROUND AND AIM: DA-9701, a newly developed prokinetic agent formulated with Pharbitis Semen and Corydalis Tuber, has been shown to effectively treat functional dyspepsia. Recently, it has also been suspected to improve gastrointestinal motor function. The aims of this study were to assess the effect of DA-9701 on colonic transit time (CTT) and symptoms of functional constipation. METHODS: Thirty-three patients with functional constipation based on the Rome III criteria were prospectively enrolled. The patients received 30-mg DA-9701 three times a day for 24 days. CTT was estimated initially and at the end of treatment. Symptoms such as spontaneous bowel movements, straining, stool form, feeling of incomplete emptying and anorectal blockage, abdominal discomfort and pain, overall defecation satisfaction, and incidence of adverse events were also analyzed. RESULTS: Twenty-seven patients completed the study. DA-9701 was associated with a significantly reduced CTT from 34.9 ± 17.6 to 23.7 ± 19.1 h (P = 0.001). Segmental CTT also significantly decreased after treatment (right CTT: from 16.8 [0.0-28.8] to 6.0 [0.0-25.2] hours, P < 0.001; rectosigmoid transit time: from 13.2 [0.0-38.4] to 6.0 [0.0-33.6] hours, P = 0.021). In addition, all constipation-related subjective symptoms, including spontaneous bowel movement frequency, significantly improved compared with those before treatment. Serious adverse events did not occur. CONCLUSIONS: DA-9701 accelerates colonic transit and safely improves symptoms in patients with functional constipation. Therefore, we suggest that this novel agent could help to treat patients with this condition.

A comparative study of DA-9601 and misoprostol for prevention of NSAID-associated gastroduodenal injury in patients undergoing chronic NSAID treatment.

Misoprostol is reported to prevent non-steroidal anti-inflammatory drug (NSAID)-associated gastroduodenal complications. There is, however, limited information regarding the efficacy of DA-9601 in this context. We performed a comparative study on the relative efficacy of DA-9601 and misoprostol for prevention of NSAID-associated complications. In this multicenter, double-blinded, active-controlled, stratified randomized, parallel group, non-inferiority trial, 520 patients who were to be treated with an NSAID (aceclofenac, 100 mg, twice daily) over a 4-week period were randomly assigned to groups for coincidental treatment with DA-9601 (60 mg, thrice daily) (236 patients for full analysis) or misoprostol (200 µg, thrice daily) (242 patients for full analysis). [corrected]. The primary endpoint was the gastric protection rate, and secondary endpoints were the duodenal protection rate and ulcer incidence rate. Endpoints were assessed by endoscopy after the 4-week treatment period. Drug-related adverse effects, including gastrointestinal (GI) symptoms, were also compared. At week 4, the gastric protection rates with DA-9601 and misoprostol were 81.4 % (192/236) and 89.3 % (216/242), respectively. The difference between the groups was -14.2 %, indicating non-inferiority of DA-9601 to misoprostol. Adverse event rates were not different between the two groups; however, the total scores for GI symptoms before and after administration were significantly lower in the DA-9601 group than in the misoprostol group (-0.2 ± 2.8 vs 1.2 ± 3.2; p < 0.0001). DA-9601 is as effective as misoprostol in preventing NSAID-associated gastroduodenal complications, and has a superior adverse GI effect profile.