Double-Blind Trial Shows Comparable Efficacy in Treatment and Control Groups for Gastric Symptoms

Secondary Efficacy End Points Evaluation and Comparison

The trial utilized both Full Analysis Set (FAS) and Per Protocol Set (PPS) analyses to evaluate and compare the secondary efficacy endpoints, including scores for symptoms such as abdominal pain, loss of appetite, and nausea. The FAS analysis revealed a clinical effective rate of 91.2% in the treatment group and 84.5% in the control group, with no statistically significant difference (p = 0.1421). Similarly, the PPS analysis showed effective rates of 92.1% and 87.0% for the treatment and control groups, respectively, again with no significant difference (p = 0.2392).

Non-Inferiority Comparison of Clinical Effectiveness

The study also assessed the non-inferiority of the treatment group compared to the control group using the Visual Analog Scale (VAS) score for individual secondary symptoms. The FAS analysis indicated an 86.1% clinical effective rate in the treatment group versus 80.0% in the control group, with no significant difference (p = 0.1165). The PPS analysis supported these findings, showing an 87.0% effective rate in the treatment group compared to 80.0% in the control group (p = 0.1824).

Relief and Disappearance Rate of Stomach Pain Symptoms

Gastric pain symptoms showed a remission rate of 83.2% in the treatment group and 86.0% in the control group, with no significant difference (p = 0.5784). The disappearance rate of these symptoms was 62.4% in the treatment group and 52.0% in the control group, also with no significant difference (p = 0.1371). The remission and disappearance times for gastric pain symptoms were comparable between the two groups.

Gastric Distension Relief and Disappearance Time

The remission rate for gastric distension symptoms was 74.3% in the treatment group and 78.0% in the control group, with no significant difference (p = 0.5338). The disappearance rate was 64.4% in the treatment group and 59.0% in the control group, again with no significant difference (p = 0.4348). However, the disappearance time for gastric distension symptoms was shorter in the treatment group compared to the control group (p = 0.0116).

Helicobacter Pylori Negative Rate

After four weeks of medication, the negative rate of H. pylori was 69.3% in the treatment group and 76.0% in the control group, with no statistically significant difference (p = 0.2872). The negative conversion rate of H. pylori also showed no significant difference between the two groups.

This comprehensive analysis demonstrates that the treatment group was non-inferior to the control group across various measures of efficacy for gastric symptoms, providing valuable insights into the management of these conditions.