目的通过一项开放标签研究明确一种含有植物成分和食用油的膳食补充剂(极爱胶囊^TM)是否可以减轻胃肠道不适患者主诉的胃肠道症状,从而改善其生活质量。方法纳入50例(女性40例,男性10例)患有胃肠道疾病或存在胃肠道症状的患者作为研究对...目的通过一项开放标签研究明确一种含有植物成分和食用油的膳食补充剂(极爱胶囊^TM)是否可以减轻胃肠道不适患者主诉的胃肠道症状,从而改善其生活质量。方法纳入50例(女性40例,男性10例)患有胃肠道疾病或存在胃肠道症状的患者作为研究对象,其平均年龄为(51.1±12.7)岁(年龄范围24~77岁),于每餐餐前30 min服用5粒膳食补充剂,连续服用90 d,研究期间采用功能性消化不良生存质量量表(functional digestive disorder quality of life questionnaire,FDDQL)与患者总体印象变化量表(patient global impression of change,PGIC)评估患者临床症状与生活质量。结果服用膳食补充剂后,患者综合评分显著提高(P=0.018),不适症状、日常活动和焦虑症状均显著改善(P=0.000、0.029、0.018),且多于服用膳食补充剂20 d内改善最明显,而饮食、睡眠、健康认知、疾病应对和压力影响均无明显改善(P=0.398、0.136、0.686、0.309、0.785);服用膳食补充剂90 d后,50例患者中有28例患者完成PGIC问卷调查评估,评分为(4.800±0.169)分,整体症状与生活质量均显著改善(P=0.000);研究期间,所有患者的血液抗氧化物、维生素、矿物质、必需脂肪酸、胰腺酶及氨基酸水平均未出现显著改变,安全性较高。结论极爱胶囊^(TM)可显著缓解肠易激综合征、胃食管反流等多种消化系统疾病患者的腹胀、腹痛等不适症状,改善患者日常活动状态及焦虑情绪等,提高患者生活质量,且安全性较高。展开更多
Background: Different treatments have been developed and used to control symptoms and improve quality of life in patients with digestive diseases and disorders. Although the use of drugs or alternative approaches has ...Background: Different treatments have been developed and used to control symptoms and improve quality of life in patients with digestive diseases and disorders. Although the use of drugs or alternative approaches has improved symptom severity in some but not all patients, often these improvements were not sustainable. Objectives: An open label clinical study was initiated to determine if oral capsules containing a dietary supplement of herbs and oils (GI RegenerateTM) could reduce self-reported gastrointestinal symptoms and improve quality of life (QOL) indicators in patients with gastrointestinal conditions. Methods: Participants included 50 patients (40 females and 10 males) of mean age of 51.1 ± 12.7 years (range, 24 - 77 years) with a diagnosis of a gastrointestinal disorder or gastrointestinal symptoms. These patients consumed five soft-gels containing the test supplement 30 minutes before each meal for 90 days. Symptoms were evaluated by medical staff, and patient health status was self-reported using a validated quality of life questionnaire (Quality of Life Digestive Survey) designed for functional digestive disorders. Exit interviews (Patient Global Impression of Change, PGIC) were conducted by the medical staff. Results: Participants in the study responded with improved symptom severities and QOL scores to the test dietary supplement within the 90 day period;most improvements occurred within 20 days on the test dietary supplement. By the end of the study there were significant overall global improvements in the symptoms and QOL health surveys (p = 0.0183), with significant improvements in symptom discomfort (p = 0.0004), daily activities (p = 0.029) and anxiety (p = 0.018). In contrast, there were insignificant improvements in diet (p = 0.398), sleep (p = 0.136), health perception (p = 0.686), coping with the disease (p = 0.309) and impact of stress (p = 0.785). Using the PGIC exit interview that measured each patient’s impression of overall global change in symptoms and QOL these data also indicated overall significant improvements in symptoms and in satisfaction with the test supplement (moderately better improvements in symptoms and QOL or score of 4.8 ± 0.169, p 50 years) versus younger (Conclusions: The GI RegenerateTM natural dietary supplement safely and significantly reduced gastrointestinal symptoms and improved quality of life in subjects with a broad spectrum of gastrointestinal disorders and symptoms.展开更多
文摘目的通过一项开放标签研究明确一种含有植物成分和食用油的膳食补充剂(极爱胶囊^TM)是否可以减轻胃肠道不适患者主诉的胃肠道症状,从而改善其生活质量。方法纳入50例(女性40例,男性10例)患有胃肠道疾病或存在胃肠道症状的患者作为研究对象,其平均年龄为(51.1±12.7)岁(年龄范围24~77岁),于每餐餐前30 min服用5粒膳食补充剂,连续服用90 d,研究期间采用功能性消化不良生存质量量表(functional digestive disorder quality of life questionnaire,FDDQL)与患者总体印象变化量表(patient global impression of change,PGIC)评估患者临床症状与生活质量。结果服用膳食补充剂后,患者综合评分显著提高(P=0.018),不适症状、日常活动和焦虑症状均显著改善(P=0.000、0.029、0.018),且多于服用膳食补充剂20 d内改善最明显,而饮食、睡眠、健康认知、疾病应对和压力影响均无明显改善(P=0.398、0.136、0.686、0.309、0.785);服用膳食补充剂90 d后,50例患者中有28例患者完成PGIC问卷调查评估,评分为(4.800±0.169)分,整体症状与生活质量均显著改善(P=0.000);研究期间,所有患者的血液抗氧化物、维生素、矿物质、必需脂肪酸、胰腺酶及氨基酸水平均未出现显著改变,安全性较高。结论极爱胶囊^(TM)可显著缓解肠易激综合征、胃食管反流等多种消化系统疾病患者的腹胀、腹痛等不适症状,改善患者日常活动状态及焦虑情绪等,提高患者生活质量,且安全性较高。
文摘Background: Different treatments have been developed and used to control symptoms and improve quality of life in patients with digestive diseases and disorders. Although the use of drugs or alternative approaches has improved symptom severity in some but not all patients, often these improvements were not sustainable. Objectives: An open label clinical study was initiated to determine if oral capsules containing a dietary supplement of herbs and oils (GI RegenerateTM) could reduce self-reported gastrointestinal symptoms and improve quality of life (QOL) indicators in patients with gastrointestinal conditions. Methods: Participants included 50 patients (40 females and 10 males) of mean age of 51.1 ± 12.7 years (range, 24 - 77 years) with a diagnosis of a gastrointestinal disorder or gastrointestinal symptoms. These patients consumed five soft-gels containing the test supplement 30 minutes before each meal for 90 days. Symptoms were evaluated by medical staff, and patient health status was self-reported using a validated quality of life questionnaire (Quality of Life Digestive Survey) designed for functional digestive disorders. Exit interviews (Patient Global Impression of Change, PGIC) were conducted by the medical staff. Results: Participants in the study responded with improved symptom severities and QOL scores to the test dietary supplement within the 90 day period;most improvements occurred within 20 days on the test dietary supplement. By the end of the study there were significant overall global improvements in the symptoms and QOL health surveys (p = 0.0183), with significant improvements in symptom discomfort (p = 0.0004), daily activities (p = 0.029) and anxiety (p = 0.018). In contrast, there were insignificant improvements in diet (p = 0.398), sleep (p = 0.136), health perception (p = 0.686), coping with the disease (p = 0.309) and impact of stress (p = 0.785). Using the PGIC exit interview that measured each patient’s impression of overall global change in symptoms and QOL these data also indicated overall significant improvements in symptoms and in satisfaction with the test supplement (moderately better improvements in symptoms and QOL or score of 4.8 ± 0.169, p 50 years) versus younger (Conclusions: The GI RegenerateTM natural dietary supplement safely and significantly reduced gastrointestinal symptoms and improved quality of life in subjects with a broad spectrum of gastrointestinal disorders and symptoms.
