背景:功能性消化不良(FD),慢性上消化道综合征,严重影响患者的生活质量,造成重大的经济负担。由于FD的病理机制尚未完全阐明,常规疗法,如动力,质子泵抑制剂,抗抑郁药有一些局限性。Siho-sogan-san(SHS)通常用作传统医学的治疗替代品;但是,支持其在FD中应用的科学和临床证据仍然不足。
目的:本综述旨在评估SHS联合西药治疗FD的安全性和有效性。
方法:11个数据库,包括EMBASE,Medline,和Cochrane图书馆,搜索2022年12月31日之前发表的关于FD的随机对照试验(RCT)。在根据纳入和排除标准进行两项独立研究和选定研究后,通过ReviewManager软件汇集和合成临床数据.结果参数包括总临床有效率(TCE),症状改善的时间,胃动素和促肾上腺皮质激素释放激素(CRH)的水平,和不良事件。使用Cochrane的偏倚风险工具进行质量评估。
结果:共确定了12项研究,其中包括867名参与者,比较了WM与SHS或联合治疗(SHS加WM)。通过对包括363名患者在内的5项研究的荟萃分析,与WM相比,SHS显示出安全增加TCE的阳性结果[风险比=1.36,95%置信区间(CI)1.22至1.51,P<0.00001]。症状改善的时间,包括腹痛,打气,恶心,呕吐,和腹胀,联合治疗比WM组明显缩短。此外,联合治疗导致胃动素的分泌高于单用WM[平均差异=67.95,95%CI39.52~96.39,P<0.00001].在联合治疗组和WM组之间没有观察到CRH水平的显著差异。对于子组分析,与不考虑PI的组相比,基于模式识别(PI)类型的SHS给药显示出更大的效应大小.
结论:这些结果表明,SHS和联合治疗可以被认为是治疗FD的有效和安全的选择。然而,由于纳入研究的质量低,需要更精心设计的研究性研究和具有更长治疗和随访期的RCT.
BACKGROUND: Functional dyspepsia (FD), a chronic upper gastrointestinal syndrome, seriously affects the quality of life of patients and poses a significant economic burden. Since the pathological mechanisms of FD have not been fully elucidated, conventional therapies such as prokinetics, proton pump inhibitors, and antidepressants have some limitations. Siho-sogan-san (SHS) is commonly used as a therapeutic alternative in traditional medicine; however, scientific and clinical evidence supporting its application in FD remains insufficient.
OBJECTIVE: This
review aimed to assess the safety and effectiveness of SHS and in combined with Western medicine (WM) for the treatment of FD.
METHODS: Eleven databases, including EMBASE, Medline, and Cochrane Library, were searched for randomized controlled trials (RCTs) on FD published before December 31, 2022. After two independent reveiwers sceened and selected studies according to the inclusion and exclusion criteria, clinical data was pooled and synthesized via
Review Manager software. The outcome parameters included total clinical effectiveness rate (TCE), time for symptom improvement, levels of
motilin and corticotropin-releasing hormone (CRH), and adverse events. Cochrane\'s risk of bias tool was used for quality assessment.
RESULTS: A total of 12 studies that included 867 participants comparing WM with SHS or combination therapy (SHS plus WM) were identified. Through a meta-analysis of five studies including 363 patients, SHS compared with WM showed a positive result in safely increasing TCE [risk ratio = 1.36, 95% confidence interval (CI) 1.22 to 1.51, P < 0.00001]. The time for symptom improvement, including abdominal pain, belching, nausea, vomiting, and abdominal distension, was significantly more shortened in the combination therapy than WM group. Furthermore, combination therapy resulted in greater secretion of
motilin than WM alone [mean difference = 67.95, 95% CI 39.52 to 96.39, P < 0.00001]. No remarkable difference was observed in CRH levels between the combination therapy and WM groups. For a subgroup analysis, the administration of SHS based on the type of pattern identification (PI) showed larger effect size than in the group that do not consider PI.
CONCLUSIONS: These results suggest that SHS and combination therapy can be considered effective and safe options for the treatment of FD. However, owing to the low quality of the included studies, more well-designed investigational studies and RCTs with longer treatment and follow-up period are needed.