Effect and Mechanism of Auricular Acupressure on Insomnia in Patients With Functional Dyspepsia：a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- the effective rate at week 2
研究概览
简要总结
Functional dyspepsia refers to a chronic digestive system disease with upper abdominal symptoms originating from the gastroduodenal region, and after clinical examination, including upper gastrointestinal endoscopy, the organic diseases causing the above symptoms are excluded. According to Rome IV standard, functional dyspepsia can be divided into two categories: postprandial discomfort syndrome and epigastric pain syndrome. FD not only seriously affects the quality of life of patients, but also causes a heavy social and economic burden. Therefore, active prevention and treatment of FD, especially PDS, has become an unavoidable problem in clinic.
Epidemiological investigation shows that about 30% FD patients have many negative emotions such as insomnia, anxiety and depression, and many anti-negative emotional drugs themselves can cause gastrointestinal side effects, which are considered to be the key reasons for the recurrence of symptoms. In recent years, people have paid more and more attention to the brain-gut axis. Microbial-intestinal-brain axis can also affect brain function by releasing neurotransmitters and inflammatory mediators. In addition, the interaction between bile acids and intestinal microflora may also affect the normal function of the intestine. However, the relationship between specific bile acids, microflora and functional dyspepsia is still uncertain.
At present, the effective and safe treatment methods for FD with insomnia are still very limited. In recent years, Auricular Acupressure has obvious advantages in treating FD with insomnia. This study plans to study the clinical efficacy and mechanism of Auricular Acupressure on functional dyspepsia with insomnia. Provide more treatment methods and ideas for clinicians, popularize and apply green diagnosis and treatment methods, bring good news to more patients, and produce remarkable economic and social benefits
详细描述
- The effective rate. The effective rate was based on the proportion of patients whose PSQI score of ≥ 50% at 2 weeks as compared with the baseline
- PSQI score. The PSQI is a widely used questionnaire to assess one's sleep quality for the past month, with 7 components for 7 specific features of sleep.
- sleep quality assessed by actigraphy: Objectively record the clinical sleep changes of the patients before and after treatment by the ActiGraph wGT3X-BT.
- modified FDSD
- SF-NDI: Evaluate the functional dyspepsia of patients with functional dyspepsia and insomnia by SF-NDI.
- SAS, SDS: SAS and SDS were used to evaluate the patients' psychological status.
- HAS, HRV: Assess the autonomic nervous function of patients before and after treatment by the excessive arousal scale and heart rate variability.
- To study the therapeutic mechanism of patients before and after treatment by detecting fecal intestinal microecological flora and Short-chain fatty acid spectrum metabonomics.
- The changes of tongue and pulse before and after treatment were detected by tongue and pulse meter
- Averse events. Any adverse events, such as unfavorable or unintended signs, symptoms, or diseases, related to the AA treatment or the administration of these comorbidity was reported by patients and professional nurses. Severe adverse events had to be reported to the principal investigator and the data and safety monitoring board within 24 hours after their occurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
During clinical trials, subjects, evaluators, data managers, and statisticians are unaware of treatment assignments. After randomization and allocation by an independent data manager, it is handed over to the nurse, who will not be involved in the results evaluation or data analysis. Neither the study participants nor the investigators had any effect on randomization and assigned hiding. The participants were told there were two treatment options. Two months after the study, patients were asked to complete a blind assessment and a perceived efficacy assessment, and were asked to guess which treatment they had received to test the success of the blind. All researchers will receive training on the methodological specifications of this study prior to the trial and strictly adhere to the principle of task separation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •It meets the diagnostic criteria of functional dyspepsia and insomnia
- •Age 18 years or older
- •The following drugs were not taken for at least 2 weeks before enrollment: antibiotics (oral, intramuscical and intravenous), microecological preparations (probiotics, prebiotics and Biostime, etc.) and other drugs affecting the gastrointestinal flora, any drugs or health products that improve sleep quality or inhibit neural activity in the brain, drugs related to the treatment of functional dyspepsia or other related treatments
- •Agree to participate in the study voluntarily and sign the informed consent
排除标准
- •Secondary insomnia caused by medication or other diseases;
- •Patients with comorbid mental disorders, as well as severe diseases of the heart, liver, kidneys and other systems;
- •Those who have previously received this treatment method or participated in other clinical trials within 6 months;
- •Presence of contraindications for auricular patches, such as skin hypersensitivity or damage to the application site;
- •Pregnant and lactating women.
结局指标
主要结局
the effective rate at week 2
时间窗: 2-week
The effective rate was based on the proportion of patients whose PSQI score of ≥ 50% at 2 weeks as compared with the baseline PSQI score
次要结局
- the effective rate at week 8(8-week after treatment)
- short form-Nepean dyspepsia Index(baseline, 2 weeks, 8 weeks after treatment)
- Pittsburgh Sleep Quality Index(baseline, 2 weeks, 8 weeks after treatment)
- Self-rated Anxiety Scale(baseline, 2 weeks, 8 weeks after treatment)
- Self-rated Depression Scale(baseline, 2 weeks, 8 weeks after treatment)
- Hyperarousal scale(baseline, 2 weeks, 8 weeks after treatment)
- Heart rate variability(baseline, 2 weeks, 8 weeks after treatment)
- Sleep efficiency(baseline, 2 weeks, 8 weeks after treatment)
- Total sleep time.(baseline, 2 weeks, 8 weeks after treatment)
- Wake After Sleep Onset(baseline, 2 weeks, 8 weeks after treatment)
- Sleep fragmentation index(baseline, 2 weeks, 8 weeks after treatment)
- OTE(baseline, 2 weeks, 8 weeks after treatment)
- modified FDSD,(baseline, 2 weeks, 8 weeks after treatment)