背景:最近的研究表明,尽管促动力剂,酸抑制剂,对于功能性消化不良(FD)患者,幽门螺杆菌感染的根治性治疗可能有效,很大比例的患者仍然对这些治疗没有反应或可能遭受严重的不良反应。许多中草药可以调节整个身体的状态,在治疗功能性疾病方面具有特殊的优势。本研究旨在验证碧灵胃痛颗粒(BLWTG)的疗效,一种传统的中草药复方配方,在缓解FD患者的上腹痛综合征(EPS)中,以期为本病的临床治疗提供有效的方剂。
目的:评价BLWTG治疗FD患者EPS的临床疗效和安全性。
方法:在这个多中心中,分层,随机化,双盲,安慰剂对照,平行组临床试验,符合条件的患者被随机分为BLWTG组和安慰剂组,治疗6周.观察并比较疗效指标,包括EPS的严重程度和频率,疼痛缓解时间和安全性指标,包括不良事件。
结果:基线人口统计学数据和临床特征,如上腹痛症状,疼痛强度,和攻击的频率,在随机化前两组之间进行匹配。治疗6周后,中心效应消除后,安慰剂组和BLWTG组的上腹痛分别为28.33%和85.59%,分别为(P<0.05)。在6周,安慰剂组和BLWTG组的上腹痛缓解率分别为15%和69.49%,分别为(P<0.05)。两组患者FD临床总评分在第2、4、6周差异均有统计学意义(P<0.05)。消除中心效应和交互效应后第6周,两组在功能性消化疾病生活质量问卷中的每个项目得分和总分均显示出显着性差异(P<0.05)。两组患者的不良事件发生率差异无统计学意义,观察期间未发现严重不良事件.
结论:与安慰剂相比,BLWTG可明显改善FD患者的EPS,无严重不良反应。
BACKGROUND: Recent research suggests that although prokinetic agents, acid suppressors, and radical treatment for Helicobacter pylori infection may be effective in patients with functional dyspepsia (FD), a large proportion of patients still fail to respond to these treatments or may suffer from severe adverse reactions. Many traditional Chinese medicinal herbs can regulate the status of the entire body and have special advantages in the treatment of functional diseases. The present study was designed to verify the efficacy of Biling Weitong Granules (BLWTG), a traditional Chinese medicinal herbal compound formula, in alleviating epigastric pain syndrome (EPS) in FD patients, in an attempt to provide an effective prescription for the clinical treatment of this disease.
OBJECTIVE: To evaluate the clinical efficacy and safety of BLWTG in treating EPS in patients with FD.
METHODS: In this multicenter, stratified, randomized, double-blind, placebo-controlled, parallel group clinical trial, eligible patients were randomized into the BLWTG and placebo groups who were treated for 6 wk. Efficacy indicators including the severity and frequency of EPS and the time to pain resolution and safety indicators including adverse events were observed and compared.
RESULTS: The baseline demographic data and clinical characteristics, such as epigastric pain symptoms, pain intensity, and frequency of attacks, were matched between the two groups before randomization. After 6 wk of treatment and after the center effect was eliminated, the epigastric pain was significantly improved in 28.33% and 85.59% of the patients in the placebo and BLWTG groups, respectively (P < 0.05). At 6 wk, the resolution rate of epigastric pain was 15% and 69.49% in the placebo and BLWTG groups, respectively (P < 0.05). The differences of total FD clinical score between these two groups were significant (P < 0.05) at 2, 4, and 6 wk (P < 0.05). The scores of each item and the total score in the Functional Digestive Disorders Quality of Life Questionnaire showed significant differences between the two groups at 6 wk after both the center and interaction effects were eliminated (P < 0.05). There was no significant difference in the incidence of adverse events between the two groups, and no serious adverse event was noted during the observation.
CONCLUSIONS: Compared with placebo, BLWTG markedly improved EPS in FD patients without causing serious adverse reactions.