Gastroenterology Medicine & Research

Investigating the Influence of Early Gastric Discomfort Symptoms on Life Quality and the Interventional Effects of a Stomach-Protecting Formula

Jialun Chen, Bingqi Xie, Wanxiang Zhang, Qianying Chen and Dan Gan*

Department of Research and Development, Sirio pharma Co., LTD., China

*Corresponding author: Dan Gan, Department of Research and Development, Sirio pharma Co, LTD, NO.1133 Changning Road, Shanghai 200042, China

Submission:February 23, 2022;Published: March 04, 2022

DOI: 10.31031/GMR.2022.06.000646

ISSN 2637-7632
Volume6 Issue5

This study was a single arm trial approved by China Ethics Committee of Registering Clinical trials (Approved Number: ChiECRCT20200130). This study was registered in Chinese Clinical Trial Registry Center (Registration Number: ChiCTR2000032741).

Entry criteria

Diagnosis of GERD requires a combination of symptom judgment and endoscopy inspection. Among the symptoms of gastric discomfort (acid reflux, stomach burning, gastroesophageal reflux, bloating, nausea and vomiting, stomach pain, etc.), most patients didn’t have large areas of erosion. Endoscopy is not suitable for patients with early gastric discomfort as an initial diagnosis [1]. This study was based on the classification criteria of the self-assessment scale for gastric discomfort.

Inclusion criteria

A. Diagnosed with gastric discomfort (one or more symptoms of gastric burning, gastroesophageal reflux, bloating, nausea and vomiting, and stomach pain)

B. Lasted more than 1 month, average ≥3 times a week

C. Aged 18 years or older

Exclusion criteria:

a) Pregnant or lactating

b) Gastrointestinal bleeding, gastrointestinal tumors or surgery

c) Under medications, and others who are not suitable for testing

Study design and operations

Subjects involved took samples once or twice a day for one week (7 days) on an empty stomach (more than half an hour before or after meals) or under circumstance of stomach upset. Products for test were provided by Sirio pharma Co., LTD., (Production License Number: SC10644050700110) as foil sachets. The contents per sachet (2g) contained 500mg Gastro-AD soybean protein powder, 500mg water-soluble dietary fiber (resistant dextrin), and 10mg Hericium erinaceus powder. According to the Asia‐Pacific consensus on the management of gastroesophageal reflux disease and Consensus on the diagnosis and treatment of gastroesophageal reflux disease with integrated traditional Chinese and western medicine, questionnaire for self-rating scale of early gastric discomfort was made below [10,15]:

1. Symptoms were divided into 7 types, such as bloating, acid reflux, belching, and other types

2. In the light of severity, scores recorded from 1 to 10, and 0 represented no obvious symptoms

The questionnaire for the quality of life covered related dimensions referred to sleep quality PSQI, health survey SF-36 and anxiety self-assessment SAS. Mental state, emotional anxiety, sleep disorders and memory and thinking were included. Adverse events were monitored on the whole time with a local professional doctor standing by for emergency.

Statistical analysis

Continuous data was showed as the mean ± standard deviation, which was tested by Shapiro-Wilk firstly, t test for normal distributed data, and Mann Whitney U test for non-normal distributed data, with P<0.05 representing significant difference, and P<0.01 indicating extremely significant difference [16].

Participants

Of 99 participants involved in this study, 14 dropped out for personal reasons, 85 completed the whole test. 33 females and 52 males aged from 18 to 75 years old, accounting for 39%, 61% of the gender distribution respectively. As for age distribution, Table 1 provided more details. During the whole test, no adverse events were reported.

Table 1: Age distribution of subjects.

Improvement in quality of life

Stomach discomfort has a large negative impact on patients’ quality of life. Data from the recruited subjects indicates that early stomach discomfort had a direct impact on mental state, emotional anxiety, sleep disorders, and memory and thinking, accounting for 62%, 48%, 40% and 25% respectively. Only 9% of them had no complaint. After a week intervention, all indicators for quality of life were improved to some extent (Table 2).

Table 2: Influence of gastric disorder on quality of life.

Relief in stomach discomfort

In the pre-intervention, Bloating, acid reflux and belching, accounting for 72%, 58% and 33%, respectively. By using the stomach-protecting formula, these annoying symptoms participants complained showed a downtrend. Bloating and acid reflux were relieved significantly (P<0.01, Table 3), belching and acute stomach pain were also alleviated (P<0.05, Table 3). Other symptoms, such as vomiting, heartburn and halitosis got a relief in the post-intervention, while not statistically difference are found (Table 3).

Table 3: Scores on symptoms based on the self-rating scale.

Note: *P<0.05, **P<0.01

Effectual time

For a product solution, it is of great value if the symptoms of consumers could be addressed timely. In this study, 63% subjects claimed that the product helped them to feel better in 30 minutes, and 83% subjects responded positively in 60 minutes (Table 4). These results suggested that products were effective in relieving symptoms of stomach upset quickly

Table 4: Effectual time of intervention.

The common medical treatment for GERD patients are oral acid inhibitors, gastric motility drugs, or surgical treatment [17,18]. However, the relevant therapy is complicated, easy to relapse, with high costs and a long course of treatment [1]. Oral acid inhibitors and gastric motility drugs could neutralize or empty gastric acid instantly, but these drugs will also change the physiological environment of stomach, affecting the absorption of nutrients. In contrast, in the opinion of traditional Chinese medicine, “Nourishing the stomach” is the key point to protect stomach. Therefore in China, a compound derived from medicinal and edible materials is often used to relieve symptoms gradually. Fermented soybean protein powder neutralizes gastric acid and inactivates pepsin;[5] resistant starch can resist the digestion of amylase and glycosidase;[7] and mixing both of them can increase the viscosity of gastric juice and reduce the frequency and amount of gastric juice reflux. Hericium erinaceus has long been used in nourishing and protecting the stomach recorded by Traditional Chinese medicine. Latest studies have verified that Hericium erinaceus polysaccharide promotes the secretion of anti-inflammatory cytokines by activating dendritic cells in human peripheral blood mononuclear cells and regulating the immune response of TH1, to the purpose of protecting the gastric mucosa [9].

It was suggested that patients with GERD should control their weight. Overweight people should exercise and avoid eating at night or before going to bed [1,19]. Chocolate, caffeine, alcohol, acidic or spicy foods are not recommended [1]. In modern society, people often have a tight pattern of work and life, and irregular habits such as staying up late and overtime, irregular diets, and intemperance uptake of irritant substances (such as alcohol, spicy food and drugs), leading to the digestive system “burden” [20,21]. Nowadays, people with stomach acid reflux, heartburn, flatulence and other gastric discomforts are increasing. In this test, 48% people aged from 18 to 30 years old are in novice period or rising period. They often work overtime and have irregular diets. We demonstrated that symptoms of gastric discomfort are becoming more diverse and the patients are getting younger. It has been proved that gastric discomfort is directly relevant to the quality of life. During the intervention, with the relief of symptoms, mental state, memory and thinking can be improved, meanwhile anxiety and sleep disorders could also be alleviated significantly [13,14,22]. In this study, we confirmed it with a stomach-protecting formula. 4 of the symptoms were relieved by more than 60%, up to 72%; 83% of the people involved in the study showed positive effects within 60 minutes. This study demonstrated that formula with fermented soybean protein powder, resistant starch and Hericium erinaceus powder as the main functional materials can alleviate the symptoms of early stomach discomfort quickly and effectively and improve the quality of life.

The authors thank the participants for their contribution to this study.

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