Somatostatin plus Gastroscopic Administration of Omeprazole for the Treatment of Acute Upper Gastrointestinal Bleeding: An Exploration of a Promising Alternative.

Objective: To analyze the efficacy and safety of somatostatin combined with gastroscopic administration of omeprazole in the treatment of acute upper gastrointestinal bleeding.
Methods: Eligible 112 patients with acute upper gastrointestinal bleeding treated in our hospital from May 2019 to July 2020 were randomized at a ratio of 1 : 1 either to the control group (somatostatin) or observation group (somatostatin combined with omeprazole gastroscope administration). The treatment efficacy, the average hemostasis time, rebleeding rate, average length of hospital stay, and the incidence of adverse reactions were compared.
Results: The study group demonstrated significantly higher total effective rate than the control group (96.45% vs. 80.36%, <0.05). The study group demonstrated superior performances compared to the control group with respect to the average hemostasis time ((14.17 ± 2.53 h) vs. (28.84 ± 4.07 h)), rebleeding rate (3.57% vs. 14.28%), and average length of hospital stay ((5.86 ± 1.26 d) vs. (9.74 ± 1.07 d)) (all p < 0.05). The chi-square test revealed a remarkably lower total incidence of adverse reactions in the study group vs. control group which was (4 (7.14%) vs. 12 (21.43%)) (p < 0.05).
Conclusion: The combination of somatostatin and gastroscopic administration of omeprazole might be a promising alternative for the treatment of acute upper gastrointestinal bleeding. It improves the clinical treatment effect and controls the symptoms of patients, with a good safety profile.

1. Introduction

Acute upper gastrointestinal bleeding is a common digestive system disease and is attributable to lesions of the stomach, gallbladder, and esophagus. The main presentations include hematemesis, black stools, and bloody stools. Upper gastrointestinal bleeding is a common clinical emergency, which can be caused by inflammation, mechanical, vascular, tumor, and adjacent organ lesions and systemic diseases involving the gastrointestinal tract. It is more common in peptic ulcer, acute gastric mucosal lesions, esophageal varices, gastric cancer, etc. Due to its sudden onset and rapid progression, it may cause peripheral circulation disorders under the circumstances of blood loss, exceeding 1000 mL or 20% of the circulating blood volume in the short run, leading to high morbidity and mortality [1].

Clinically, the treatment for the disease is inconsistent owing to the various strategies targeting different sites of the upper gastrointestinal bleeding and the causes of bleeding. Hemostasis currently serves as the main goal in clinical settings, and the specific methods include but are not limited to acid suppression, protection of gastric mucosa, maintenance of high pH value in the stomach, and constriction of visceral blood vessels [2, 3]. Somatostatin and omeprazole are currently the main clinical drugs for the treatment of acute upper gastrointestinal bleeding. Although they attenuate the clinical symptoms when used alone, the overall therapeutic effect is less than ideal [4, 5]. In traditional Chinese medicine (TCM), it falls into the category of “hematemesis” and “bloody stool,” and a previous study reported a promising efficiency of TCM. Accordingly, with an aim to seek a more effective strategy for acute upper gastrointestinal bleeding, this study investigated the efficacy and safety of somatostatin combined with gastroscopic administration of omeprazole. The results are reported as follows:

2. Study Design and Participants

2.1. Study Population

Eligible 112 patients with acute upper gastrointestinal bleeding treated in our hospital from May 2019 to July 2020 were randomized at a ratio of 1 : 1 either to the control group or observation group. In the control group, there were 32 males and 24 females, aged 26–55 years, with an average age of 36.5 ± 3.8 years; in the observation group, there were 28 males and 28 females, aged 25–57 years, with an average age of 37.1 ± 4.4 years. The baseline data were well balanced in the two groups. This study has been approved by the ethics committee of the hospital.

2.2. Inclusion and Exclusion Criteria

2.2.1. Inclusion Criteria

(1) Clinical manifestations include hematemesis, melena, and bloody stool; (2) diagnosed after examination; (3) patients and their families were informed of the research content and voluntarily signed the informed consent.

2.2.2. Exclusion Criteria

(1) Patients who were in pregnancy or breastfeeding; (2) with vital tissues and organs dysfunction; (3) with allergies to the drugs used in the study.

2.3. Intervention

Upon admission, relevant examinations were performed for all patients and symptomatic treatment was carried out, such as blood transfusion, hemostasis, and nutritional support. After that, the control group was treated with somatostatin, and the dosage of the drug could be gradually reduced after the patient's bleeding decreased. The study group was additionally given omeprazole via an indwelling gastric tube under the guidance of a gastroscope. Also, if the patient presents bleeding after 48 hours, the bleeding should be stopped under a gastroscope again and medication be administered [6, 7].

Additionally, all patients were given Sanqi Baishen Decoction: 5 g of Panax notoginseng, 12 g of Bletilla pseudobulbi, 30 g of Codonopsis, 15 g of cuttlebone, 15 g of Atractylodes, 15 g of rhizoma nelumbinis, 30 g of Astragalus, 15 g of Poria, 10 g of licorice root, 10 g of dried tangerine peel, and 15 g of blast-fried ginger. Also, it can be added or subtracted according to the symptoms and decocted in water, and 200 ml of juice was extracted and administered in cold 2–5 times, 1 dose per day. After the fecal occult blood test turned negative and the symptoms of hematemesis and melena disappeared, the medication was stopped.

2.4. Outcomes

The treatment efficacy includes markedly effective, effective, or ineffective, and the effective rate of the two groups was calculated and compared. Markedly effective: the clinical symptoms were significantly improved within 72 hours of treatment, the hematemesis and melena disappeared, the blood pressure, pulse, and bowel sounds were not abnormal, the vital signs were stable, the hemoglobin level and hematocrit increased significantly, the fecal occult blood turned negative, and no bleeding was found in gastroscopy. Effective: the clinical symptoms of the patients were controlled to a certain extent within 72 hours of treatment, the degree of hematemesis and melena was greatly relieved, no abnormality was found in blood pressure, pulse, and bowel sounds detected, and the level of hemoglobin and hematocrit increased, and no bleeding or a small amount of active bleeding after gastroscopy. Ineffective: after treatment, the patient had no visible improvement in clinical symptoms, severe hematemesis, blood in the stool, active bowel sounds, unstable vital signs, and noticeable signs of gastroscopy, and the bleeding required prompt surgical intervention for hemostasis.

The average hemostasis time, rebleeding rate, and average length of hospital stay were observed and compared in the two groups.

The incidence of adverse reactions including diarrhea, dizziness, pale complexion, and nausea and vomiting were recorded and counted.

2.5. Statistical Analysis

All data analyses were performed with the SPSS 22.0 statistical software. Enumeration data (%) and measurement data () were verified via the chi-square and t-test, respectively. The statistical significance was set at a p value < 0.05.

3. Results

3.1. Effectiveness of Treatment

According to our results, in the control group, 19 cases were markedly effective, 26 cases were effective, and 11 cases were ineffective; in the observation group, 21 cases were markedly effective, 33 cases were effective, and 2 cases were ineffective. It was observed that the study group demonstrated a significantly higher total effective rate than the control group (96.45% vs. 80.36%, p < 0.05) (see Table 1).

Table 1

Comparison of effective rates (n (%)).

Groups	n	Markedly effective	Effective	Ineffective	Total
Control group	56	19	26	11	45 (80.36)
Study group	56	21	33	2	54 (96.43)
x 2	—	—	—	—	7.409
P value	—	—	—	—	0.008

3.2. Hemostasis Time, Rebleeding Rate, and Hospital Stay

The study group demonstrated superior performances compared to the control group with respect to the average hemostasis time ((14.17 ± 2.53 h) vs. (28.84 ± 4.07 h)), the rebleeding rate (3.57% vs. 14.28%), and the average length of hospital stay ((5.86 ± 1.26 d) vs. (9.74 ± 1.07 d)) (all p < 0.05, Table 2).

Table 2

Comparison of hemostasis time, rebleeding rate, and hospital stay ().

Groups	n	Hemostasis time (h)	Rebleeding rate (n (%))	Hospital stay (d)
Control group	56	28.84 ± 4.07	8 (14.28)	9.74 ± 1.07
Study group	56	14.17 ± 2.53	2 (3.57)	5.86 ± 1.26
x 2/t	—	22.908	3.953	17.565
P value	—	<0.001	0.047	<0.001

3.3. Incidence of Adverse Reactions

The chi-square test revealed a remarkably lower total incidence of adverse reactions in the study group versus the control group (4 (7.14%) vs. 12 (21.43%)) (p < 0.05) (see Table 3).

Table 3

Comparison of the incidence of adverse reactions (n (%)).

Groups	n	Diarrhea	Dizziness	Pale complexion	Nausea and vomiting	Total
Control group	56	1	3	5	3	12 (21.43)
Study group	56	0	1	2	1	4 (7.14)
x 2	—	—	—	—	—	4.507
P value	—	—	—	—	—	0.034

4. Discussion

Acute upper gastrointestinal bleeding is a common digestive system disease with high morbidity and mortality. In recent years, factors such as the fast pace of life, high living pressure, and irregular living habits, give rise to the prevalence of upper gastrointestinal bleeding [8, 9]. Nevertheless, there remains no consensus on treatment methods for upper gastrointestinal bleeding due to the inconsistent sites of bleeding and causes of bleeding.

Somatostatin [10] is a synthetic drug that enhances gastric mucus secretion and reduces gastrointestinal blood flow and has little impact on systemic hemodynamics [11, 12], which obtained ideal results in patients with gastrointestinal bleeding [13]. Omeprazole [14], a proton pump H+-K+-ATPase inhibitor, can effectively inhibit the secretion of H+ by parietal cells and the secretion of gastric acid caused by various stimuli and can maintain a high pH in the stomach, laying a favorable foundation for coagulation [15, 16]. To our knowledge, omeprazole has a potent function of inhibiting gastric acid and rapidly mitigating symptoms [17]. A prior study argued that the esophagus, stomach, duodenal bulb, and the posterior mucosa of the bulb can be visibly displayed via gastroscopic administration [18, 19]. Therefore, gastroscopic administration of somatostatin plus omeprazole can serve as a treatment strategy for acute upper gastrointestinal bleeding. Remarkably, our study showed a remarkable efficacy and safety of somatostatin combined with omeprazole gastroscopic administration in the treatment of acute upper gastrointestinal bleeding. Consistently, previous studies reported a similar conclusion to our results [15, 17].

Additionally, Sanqi Baishen Decoction can not only warm the middle and replenish Qi, stop bleeding, and eliminate blood stasis but also clarify the source and clear the source; it can also neutralize the middle and relieve pain, remove dampness, and remove turbidity. Therefore, it produces a beneficial efficacy on the upper gastrointestinal tract and the accompanying gastrointestinal symptoms, showing the characteristics of strengthening the healthy Qi without hindering the fighting against pathogens, tonifying without stagnation, and combating without hyperactivity.

Taken together, the combination of somatostatin and gastroscopic administration of omeprazole might be a promising alternative for the treatment of acute upper gastrointestinal bleeding. It improves the clinical treatment effect and controls the symptoms of patients, with a good safety profile.