Comparing lansoprazole and omeprazole in onset of heartburn relief: results of a randomized, controlled trial in erosive esophagitis patients

OBJECTIVE: This randomized, double-blind, multicenter study was conducted to confirm a previous finding that lansoprazole relieves heartburn faster than omeprazole in patients with erosive esophagitis. METHODS: A total of 3510 patients with erosive esophagitis and at least one episode of moderate to very severe daytime and/or nighttime heartburn during the 3 days immediately before the screening visit were randomized to lansoprazole 30 mg once daily or omeprazole 20 mg once daily for 8 wk. Patients recorded the presence and severity of daytime and nighttime heartburn in daily diaries. On treatment days 1-4, patients were telephoned to confirm the completion of their daily diary. The primary efficacy parameters were the percentage of heartburn-free days and heartburn-free nights, as well as the average severity of daytime and nighttime heartburn. RESULTS: During treatment day I and all evaluation time points including the entire 8-wk treatment period, significantly (p < 0.05) higher percentages of patients treated with lansoprazole than those treated with omeprazole did not experience a single episode of heartburn. Onset of heartburn relief was more rapid in lansoprazole-treated versus omeprazole-treated patients: on day 1, 33% versus 25% of lansoprazole- versus omeprazole-treated patients were heartburn-free. The percentages of heartburn-free days and heartburn-free nights were also significantly (p < 0.01) greater for patients treated with lansoprazole at all evaluation time points. Heartburn severity was significantly less among those treated with lansoprazole compared with omeprazole. Both treatments were safe and well tolerated. CONCLUSIONS: Over 8 wk, lansoprazole 30 mg once daily relieved heartburn symptoms faster and more effectively than omeprazole 20 mg once daily in patients with erosive esophagitis.     

Beneficial effect of probiotics supplements in reflux esophagitis treated with esomeprazole: A randomized controlled trial

BACKGROUND Reflux esophagitis(RE) is a common digestive disorder, and its frequent recurrences cause significant physical pain and are financially burdensome to patients. However, studies on the natural history of treated RE are few. Although proton pump inhibitors(PPIs) as the first-line treatment provide notable symptomatic relief, disordered gut microbiota has been observed among PPI users. Probiotics are commonly administered to patients to regulate the disordered intestinal flora.AIM To evaluate the therapeutic effects in RE patients treated with a combination of esomeprazole and probiotics [Bacillus subtilis(B. subtilis) and Enterococcus faecium(E. faecium)].METHODS One hundred and thirty-four RE patients were randomized into two groups of 67 subjects each. The probiotics group was administered with esomeprazole 20 mg b.i.d. and live combined B. subtilis and E. faecium enteric-coated capsules 500 mg t.i.d. for eight weeks; the placebo group was administered with esomeprazole 20 mg b.i.d. and placebo for eight weeks. Subsequently, 12-wk follow-up was carried out on patients who achieved both endoscopic and clinical cure. Endoscopy,reflux diagnostic questionnaire(RDQ), gastrointestinal symptom rating scale(GSRS), and lactulose hydrogen breath test were performed to evaluate the therapeutic effects. A difference of P < 0.05 was considered statistically significant.RESULTSSixty-six patients in the probiotics group and 64 patients in the placebo group completed the 8-wk treatment. The healing rate and RDQ score had no significant difference between the two groups(P > 0.05). However, the GSRS diarrhea syndrome score was decreased significantly in the probiotics group(P = 0.002),and the small intestinal bacterial overgrowth negative rate in the probiotics group was significantly higher than that in the placebo group(P = 0.002). Of 114 endoscopically and clinically cured patients, 96 completed the follow-up. The logrank test showed that the time to relapse was shorter in the placebo group than in the probiotics group(P = 0.041). Furthermore, the therapy had a significant influence on relapse time, and the risk of relapse in the probiotics group was lower than that in the placebo group at any time point during the 12-wk followup(hazard ratio = 0.52, P = 0.033).CONCLUSION Esomeprazole combined with probiotics(B. subtilis and E. faecium) have a beneficial effect on RE treatment and patient management.     

Oral pantoprazole for erosive esophagitis: a placebo-controlled, randomized clinical trial. Pantoprazole US GERD Study Group

OBJECTIVES: The aim of this dose-response study was to compare the effectiveness of 10 mg, 20 mg, and 40 mg of pantoprazole with that of placebo tablets in the healing and symptom relief of gastroesophageal reflux disease associated with erosive esophagitis, and to determine the optimal dose. METHODS: A total of 603 patients with endoscopically confirmed (Hetzel-Dent scale) erosive esophagitis of grade 2 (64.5%) or grades 3 or 4 (35.3%) were enrolled in a double-blind, multicenter study and randomly assigned to receive pantoprazole (10 mg, 20 mg, or 40 mg) or placebo, administered once daily in the morning, for 4 or 8 wk depending on healing. RESULTS: The healing rates after 4 wk for placebo and pantoprazole 10 mg, 20 mg, and 40 mg/day were 14%, 42%, 55%, and 72%, respectively (p < 0.001 for all doses of pantoprazole vs placebo). Cumulative healing rates after 8 wk for placebo and pantoprazole 10 mg, 20 mg, and 40 mg/day were 33%, 59%, 78%, and 88%, respectively (p < 0.001 for all doses of pantoprazole vs placebo). The 40-mg pantoprazole dose produced greater rates of healing and earlier healing of esophagitis than either the 10- or 20-mg dose, regardless of severity. Pantoprazole, at any dose, was significantly more effective than placebo in relieving reflux symptoms. Patients on pantoprazole 40 mg experienced relief of symptoms on day 1 of treatment. No serious treatment-related adverse events occurred. CONCLUSIONS: Pantoprazole was safe and effective for healing erosive esophagitis and provided rapid symptomatic relief. These results indicate that pantoprazole offers a new option for treatment of erosive esophagitis. Among the three doses studied, the 40-mg dose was the most effective.     

Effect of esomeprazole on nighttime heartburn and sleep quality in patients with GERD: a randomized, placebo-controlled trial

OBJECTIVES: Sleep disturbances are common in patients with gastroesophageal reflux disease (GERD). This study examined the effects of esomeprazole on nighttime heartburn, GERD-related sleep disturbances, sleep quality, work productivity, and regular activities. METHODS: This multicenter, randomized, double-blind, placebo-controlled trial included adults with GERD-associated sleep disturbances and moderate-to-severe nighttime heartburn (recorded by patient diary during screening). Patients received oral esomeprazole 40 mg (n = 220) or 20 mg (n = 226) or placebo (n = 229) once daily for 4 wk. The primary outcome was relief of nighttime heartburn. Secondary outcomes included resolution of sleep disturbances, sleep quality measured by the Pittsburgh Sleep Quality Index (PSQI) questionnaire, and work productivity measured by the Work Productivity and Activity Impairment Questionnaire. RESULTS: Nighttime heartburn was relieved in 53.1% (111/209), 50.5% (111/220), and 12.7% (28/221) of patients who received esomeprazole 40 mg, esomeprazole 20 mg, and placebo, respectively. Differences (95% CI) versus placebo were 40.5% (32.4%, 48.5%) and 37.8% (29.9%, 45.7%) and were highly significant (p < 0.0001). GERD-related sleep disturbances resolved in significantly more (p < 0.0001) patients who received esomeprazole 40 (73.7%) or 20 mg (73.2%) than in those who received placebo (41.2%). Both esomeprazole groups had greater PSQI global score changes from baseline (p < 0.0001 vs placebo) and more (p < 0.0001 vs placebo) work hours saved per week per patient compared with baseline (esomeprazole 40 mg, 11.6 h; esomeprazole 20 mg, 12.3 h; placebo, 6.2 h). CONCLUSIONS: Esomeprazole reduced nighttime heartburn and GERD-related sleep disturbances and improved sleep quality and work productivity.     

Retraction note to: Beneficial effect of probiotics supplements in reflux esophagitis treated with esomeprazole: A randomized controlled trial

We have decided to retract the above article for further consideration due to a data labelling error.     

Maintenance of healed erosive esophagitis: a randomized six-month comparison of esomeprazole twenty milligrams with lansoprazole fifteen milligrams.

BACKGROUND AND AIMS: The aim was to compare esomeprazole with lansoprazole for the maintenance of healed erosive esophagitis and resolution of gastroesophageal reflux disease-related symptoms in a United States population. METHODS: Patients who entered this double-blind, randomized, parallel-group, multicenter, maintenance trial had been treated and healed (no endoscopic evidence of erosive esophagitis) with esomeprazole 40 mg or lansoprazole 30 mg once daily (patients with Los Angeles grades C and D erosive esophagitis at baseline) or esomeprazole 40 mg (patients with Los Angeles grades A and B erosive esophagitis at baseline) and had no heartburn or acid regurgitation symptoms during the previous week. Patients were randomized to maintenance once-daily therapy with esomeprazole 20 mg (n = 512) or lansoprazole 15 mg (n = 514) for up to 6 months. Esophago-gastroduodenoscopies were done at months 3 and 6, and investigators assessed symptom severity at months 1, 3, and 6. Endoscopic/symptomatic remission was defined as no erosive esophagitis and no study withdrawal as a result of reflux symptoms. RESULTS: The estimated endoscopic/symptomatic remission rate during a period of 6 months was significantly higher (P = .0007) for patients who received esomeprazole 20 mg once daily (84.8%) compared with those who received lansoprazole 15 mg (75.9%). Most patients had no heartburn (383/462 and 369/466) or acid regurgitation (401/462 and 400/466) symptoms at 6 months, and there were no significant differences between treatments. Both treatments were well-tolerated. CONCLUSION: Esomeprazole 20 mg is more effective than lansoprazole 15 mg in maintaining endoscopic/symptomatic remission in patients with healed erosive esophagitis.     

Efficacy and safety of entecavir in lamivudine-refractory patients with chronic hepatitis B: randomized controlled trial in Japanese patients

Background and Aim:  Entecavir is a potent inhibitor of both wild-type and lamivudine-resistant hepatitis B virus (HBV) with proven clinical efficacy. We conducted a randomized, double-blind, multicenter study in Japan (ETV-052) evaluating the efficacy and safety of two doses of entecavir in adult patients with lamivudine-refractory chronic hepatitis B infection.
Methods:  Eighty-four patients with chronic hepatitis B who were refractory to lamivudine therapy were switched from lamivudine to daily oral doses of 0.5 mg entecavir (41 patients) or 1 mg entecavir (43 patients) for 52 weeks.
Results:  The proportions of patients achieving the primary end-point (≥2 log₁₀ reduction in HBV-DNA from baseline by polymerase chain reaction assay or undetectable HBV-DNA levels [<400 copies/mL] at week 48) were 90% and 93% for entecavir 0.5 mg and 1 mg, respectively, with 33% of patients in each dosing group achieving <400 copies/mL. The mean reduction in HBV-DNA from baseline was 3.58 and 3.75 log₁₀ copies/mL for entecavir 0.5 mg and 1 mg, respectively. High proportions of patients achieved alanine aminotransferase normalization at week 48 (0.5 mg 86%, 1 mg 78%). Histological improvement was observed in most patients (0.5 mg 52%, 1 mg 60%). Virological breakthrough (increase in HBV-DNA of ≥1 log₁₀ copies/mL from nadir) was observed in one patient but was not associated with selection of entecavir-associated resistance substitutions. Entecavir was well tolerated, with no patients discontinuing study drug due to adverse events.
Conclusions:  These findings indicate that entecavir is safe and effective for the treatment of Japanese adults with lamivudine-refractory chronic hepatitis B.     

Efficacy of vonoprazan 10 mg compared with 20 mg for the initial treatment in patients with erosive esophagitis: a randomized pilot study

Background

The study aimed to investigate the efficacy of vonoprazan 10 mg compared with 20 mg in patients with erosive esophagitis.

Method

Seventy-three patients with erosive esophagitis were randomly divided into two groups either vonoprazan 20 mg (n?=?37) or 10 mg (n?=?36). They were administered each dose for 4 weeks as the initial treatment followed by maintenance treatment with 10 mg for 8 weeks. The primary endpoints were mucosal healing rate and symptom relief at 4 weeks. The secondary endpoint was symptom relief at 12 weeks after the maintenance treatment. Mucosal healing was assessed endoscopically, and symptom relief was assessed using the FSSG score.

Results

At 4 weeks, the endoscopic healing rates of the 20 mg and 10 mg groups were 94.6% and 94.4%, respectively. The FSSG scores of the 20 mg and 10 mg groups were significantly decreased in both treatment groups from 13 (4–39) to 4 (0–25) and 14 (4–40) to 3 (0–29), respectively. At 12 weeks, the scores further decreased to 2 (0–13) and 2 (0–26), respectively. The vonoprazan 10 mg group showed a similar therapeutic effect to the 20 mg group in mucosal healing at 4 weeks and in symptom relief throughout the study period. When stratified by esophagitis grading, these findings were still demonstrated in grade A/B patients but not in grade C/D patients.

Conclusion

Our findings suggest that initial treatment with vonoprazan 10 mg might be useful especially in patients with mild erosive esophagitis. Large controlled studies are warranted to confirm our investigation.

     

康复新液联合埃索美拉唑及莫沙必利治疗糜烂性食管炎的疗效观察

[目的]探讨康复新液联合埃索美拉唑、莫沙必利治疗糜烂性食管炎(EE)的疗效。[方法]72例EE患者,随机分成2组,治疗组36例,给予康复新液10 ml,3次/d,埃索美拉唑20 mg,2次/d,莫沙必利5 mg,3次/d,口服。对照组36例,给予埃索美拉唑20 mg,2次/d,莫沙必利5 mg,3次/d,口服。于治疗8周后观察症状的缓解情况,同时复查胃镜观察治疗效果。[结果]8周后治疗组症状改善总有效率为94.5%,对照组为88.8%,2组比较差异无统计学意义(P0.05);胃镜复查治疗组食管炎症总有效率为97.2%,对照组为86.1%,2组比较差异有统计学意义(P0.05)。[结论]康复新液联合埃索美拉唑、莫沙必利治疗EE临床疗效较好。     

电针治疗老年非痴呆血管性认知损害的随机对照试验

目的 探究电针治疗老年非痴呆血管性认知损害(VCI-ND)的有效性和安全性.方法 2018年1月-2019年6月,收集上海中医药大学附属市中医医院门诊就诊的老年VCI-ND患者70例,随机分为观察组和对照组.观察组取百会、印堂、四神聪、神庭、脑户、人中、风池(双侧)、神门(双侧)、内关(双侧)及三阴交(双侧),电针治疗...     

Efficacy and safety of loxoprofen hydrogel patch versus loxoprofen tablet in patients with knee osteoarthritis: a randomized controlled non-inferiority trial

This study is aimed at comparing the efficacy and safety of loxoprofen sodium hydrogel patch (LX-P) with loxoprofen sodium tablet (LX-T) in patients with knee osteoarthritis (OA). One hundred sixty-nine patients were enrolled in a randomized, controlled, double-blind, double-dummy, multicenter, non-inferiority trial of LX-P. Patients were randomly assigned to either LX-P or LX-T groups for a 4-week treatment. The primary efficacy endpoint was the proportion of patients with an overall improvement of ≥50 %, and the secondary efficacy endpoint was the proportion of patients with an improvement of ≥25 % from baseline in each of the seven main symptoms. The non-inferiority trial was based on a power of 80 % and significance level of 2.5 % with a non-inferiority margin of ?10 %. In both intention-to-treat (ITT) and per-protocol (PP) analyses, LX-P was as effective as LX-T in regard to the primary endpoint. In the ITT analysis, the difference between the two groups was 12.6 % [95 % confidence interval, ?1.7 to 26.9 %]. No significant differences were found between the two groups in any of the secondary efficacy outcomes. A lower incidence of adverse events was observed in LX-P group; however, the difference was not statistically significant. No serious adverse events were reported in the LX-P group, whereas one case was reported in LX-T group. Based on the present study, topical loxoprofen patch was non-inferior to oral loxoprofen in patients with knee osteoarthritis.     

Efficacy of adding sodium alginate to omeprazole in patients with nonerosive reflux disease: a randomized clinical trial

Nonerosive reflux disease (NERD) is the most common form of gastroesophageal reflux disease. Patients with NERD have a lower response rate to proton pump inhibitors (PPIs) than patients with erosive esophagitis when gauged from relief of heartburn. Sodium alginate decreases the acidity of refluxate and protects the esophageal mucosa. However, whether the addition of sodium alginate to PPI therapy can improve NERD symptoms remains unknown. Accordingly, the aim of this study was to evaluate the efficacy of adding sodium alginate to basal PPI therapy for NERD. Patients who had experienced heartburn on at least 2 days per week during the 1-month period before entering the study and had no endoscopic mucosal breaks (grade M or N according to Hoshihara's modification of the Los Angeles classification) were randomized to one of two treatments for 4 weeks: omeprazole (20 mg once daily) plus sodium alginate (30 mL four times a day) (group A) or omeprazole (20 mg once daily) alone (group B). Eighty-seven patients were enrolled, and 76 patients were randomly assigned to group A (n = 36) or group B (n = 40). Complete resolution of heartburn for at least 7 consecutive days by the end of treatment was significantly more common in group A (56.7%) than in group B (25.7%). One patient from group A had mild drug-related diarrhea that was not clinically serious. In conclusion, omeprazole combined with sodium alginate was better than omeprazole alone in Japanese patients with NERD.     

Efficacy and safety of oral and early-switch therapy for community-acquired pneumonia: a randomized controlled trial

PURPOSE: We sought to determine the safety, efficacy, and cost of oral therapy for patients with community-acquired pneumonia. In patients with nonsevere pneumonia, conventional (parenteral) treatment was compared with the oral route; in patients with severe pneumonia, conventional treatment was compared with early switch from parenteral to oral therapy. SUBJECTS AND METHODS: We randomly assigned 85 hospitalized patients with nonsevere pneumonia to one of two groups: 41 received oral antimicrobials from admission, and 44 received parenteral antimicrobials until they had been afebrile for 72 hours before switching to oral treatment. We randomly assigned 103 patients with severe pneumonia who had initially been treated with parenteral antimicrobials to one of two groups: 48 were switched to oral therapy after 48 hours of treatment (early switch), and 55 received a full 10-day course of parenteral antibiotics. RESULTS: Among patients with nonsevere pneumonia, there were no deaths in the oral treatment group, and one death (2%) in the parenteral treatment group (95% confidence interval [CI] for between-group [oral minus parenteral] difference: -7% to 2%, P = 0.3). The time to resolution of morbidity was < or =5 days in 34 (83%) patients in the oral treatment group and 39 (88%) patients in the parenteral treatment group (P = 0.5); there were treatment failures in 4 (10%) patients in the oral treatment group and 14 (32%) patients in the parenteral treatment group (P = 0.02). Among patients with severe pneumonia, there was one (2%) death in the early-switch group and no deaths in the full course of parenteral antibiotics groups (95% CI for between-group [early switch vs. full course] difference: -2% to 6%, P = 0.5). The time to resolution of morbidity was < or =5 days in 38 (79%) patients in the early-switch group and 41 (75%) in the full-course group (P = 0.3). There were 12 (25%) treatment failures in the early-switch group and 13 (24%) in the full-course group (P = 0.9). There were fewer adverse events in the oral and early-switch groups, primarily due to lower rates of infusion-related phlebitis. Significant cost savings, mainly due to a shorter hospitalization, occurred among patients with severe pneumonia in the early-switch group. CONCLUSION: Inpatients with nonsevere community-acquired pneumonia can be effectively and safely treated with oral antimicrobials from the time of admission, whereas those with severe pneumonia can be treated with early-switch therapy.     

Efficacy and safety of entecavir versus tenofovir treatment in chronic hepatitis B patients: A randomized controlled trial

Aim

Entecavir (ETV) and tenofovir disoproxil fumarate (TDF) are considered among the most potent antiviral agents for the treatment of chronic hepatitis B infection. We aimed to compare treatment efficacy and safety of ETV and TDF in nucleoside‐naïve chronic hepatitis B patients.

Methods

Inclusion criteria were compensated chronic hepatitis B patients who were either hepatitis B e antigen (HBeAg)‐positive or HBeAg‐negative. Exclusion criteria were co‐infection with hepatitis C virus and/or HIV, concurrent malignancy, and decompensated cirrhosis. Virological, biochemical, and serological end‐points at week 96 and 144 were compared. Of 400 patients, 200 patients received ETV and 200 received TDF.

Results

There were no significant differences between the two groups in baseline characteristics including age (41.6 ± 11.5 vs. 41.2 ± 11.6, mean baseline hepatitis B virus DNA (5.91 ± 1.79 vs. 5.94 ± 1.68 log₁₀ IU/mL), mean baseline alanine aminotransferase (68.1 ± 64.1 vs. 76.8 ± 79.8 U/L), and cirrhosis (15.5% vs. 14.5%). At week 144 of treatment, 91 and 94% of the ETV and TDF groups, respectively, achieved undetectable hepatitis B virus DNA. In HBeAg‐positive patients, HBeAg seroconversion could be achieved in 27.4% and 33.7% at week 144 for ETV and TDF groups, respectively. Quantitative hepatitis B surface antigen dropped significantly over 144 weeks of treatment period but only 1.0 to 1.5% experienced hepatitis B surface antigen loss. Safety profiles were consistent with previous reports of monotherapy.

Conclusion

Both ETV and TDF showed potent antiviral activity against hepatitis B. Either ETV or TDF can be recommended as a treatment of choice for patients with chronic hepatitis B. Both drugs were safe and well tolerated.