Effects of Chaihu Guizhi Ganjiang Decoction Combined with Standard Triple Therapy on Reducing Serum CagA and Hp-NAP in Patients with H.pylori-Related Gastritis

Yang Weixia (杨为霞), Wang Jinhua (王金华), Chen Zhaoyang (陈兆洋), Zhang Feng (张 凤)

Department of Internal Medicine of Traditional Chinese Medicine, Dachang Hospital, Shanghai 200436, China

ABSTRACT OBJECTIVE: To explore the effects of Chaihu Guizhi Ganjiang Decoction combined with standard triple therapy on treating H.pylori-related gastritis. METHODS: Eighty-two patients with H. pylori-related gastritis treated in our hospital from January 2016 to December 2017 were selected according to the random number table method and divided into experimental group and control group, with 41 patients in each group. The control group was treated with standard triple therapy, while the experimental group was additionally treated with modified Chaihu Guizhi Ganjiang Decoction.The venous blood of one elbow was taken before and after treatment. The concentrations of serum CagA and Hp-NAP were detected by enzyme-linked immunosorbent assay (ELISA). The symptoms were evaluated according to the change of symptom scores before and after the intervention. The H.pylori eradication rate was calculated. RESULTS: There was no significant difference in CagA and Hp-NAP concentrations between the 2 groups before intervention (P ＞ 0.05).After intervention, CagA and Hp-NAP concentrations in experimental group were (19.21±6.27) ng/L and (24.37±6.10)ng/L respectively which were lower than (25.81±7.14) ng/L and (32.09±5.73) ng/L of control group. The differences were statistically significant (P ＜ 0.05). The total effective rate of major symptoms in experimental group was 39 cases(95.12%), which was significantly higher than that of the control group (31 cases, 75.61%). There was statistically significant difference between the 2 groups (P ＜ 0.05). The eradication rate of H.pylori was 38 cases (92.68%) in the experimental group, which was significantly higher than 31 cases (75.61%) of the control group. The difference between the 2 groups was statistically significant (P ＜ 0.05). CONCLUSION: Chaihu Guizhi Ganjiang Decoction combined with standard triple therapy can effectively reduce CagA, Hp-NAP of serum level in patients with H.pylori-related gastritis,improve efficacy of symptoms and eradication rate of H.pylori, and is worthy of clinical promotion.

KEYWORDS: Chaihu Guizhi Ganjiang Decoction combined with standard triple therapy; H.pylori-relatated gastritis; Symptomatic efficacy; H.pylori eradication rate

Chronic gastritis is a common disease with high incidence. Helicobacter is one of the major causes[1].The clinical symptoms of H.pylori-related gastritis are epigastric dull pain, fullness in the epigastrium, sour regurgitation, heartburn, dry mouth, bitter taste, loose stools, nausea, vomiting. It will lead to weight loss, which seriously affects patients' physical health and quality of life[2,3]. Long periods of the H.pylori infection will lead to intestinal epithelium metaplasia or gastric mucosa atrophy,which will possibly develop into carcinomatous change[4].At the present stage, H.pylori infection has become a global issue. The rate of H.pylori infection is 40%-90% in China. The key of the H.pylori related gastritis preservation and treatment is to release inflammation[5,6]reaction and to eliminate alimentary symptoms. Recently, Western Medicine has made some progress in the treatment of the H.pylori related gastritis. However, unstrict usage of the antibiotics makes H.pylori tolerance rise, which is more difficult to achieve ideal eradication rate[7,8]. This study made some achievements in treating H.pylori related gastritis by standard triple therapy combined with Chaihu Guizhi Ganjiang Decoction.

DATA AND METHODS

General data

A total of 82 cases of H.pylori related gastritis patients treated in our hospital from January 2016 to December 2017 were selected. Among those cases, there are 51 male patients and 31 female patients, whose age ranged from 16 to 67 years old. Its average age was 47.28±7.82 years old and the course of disease ranged from 1 to 13 years. Its average course was 6.72±1.32 years. According to random table method, all patients were divided into experimental group and control group,with 41 patients in each one. There were 26 male patients,15 female patients in the experimental group, and their average age was 47.31±7.64 years old. The average course of the treatment was 6.82±1.28 years. There were 25 male patients, 16 female patients in the control group.Their average age ranged was 46.97±7.92 years old. The average course was 6.62±1.30 years. The 2 groups had no statistical differences in sex, age and course (P ＞ 0.05).

Inclusion criteria: ① All patients are diagnosed as H.pylori related gastritis patients by electric gastroscope,14C breath test and gastric musoca pathologic detection.② The patients had not administrated gastric mucosa protectant, proton pump inhibitor, antibiotics, antacids and so on, which could affect prescriptions used in study in 2 weeks before study. ③ Patients and their families know and agree with this study.

Exclusion criteria: ① The patients are pregnant or in lactation period. ② The patients have serious hemorrhage of digestive tract, pyloric obstruction and serious stomach operation history. ③ The patients may have tumor of other systems. ④ The patients also have renal insufficiency, diabetes mellitus, hematopoiesis system diseases or serious cardiovascular diseases. This study was approved by the hospital ethics committee.

Methods

The observation group adopted standard triple therapy. The specific methods were as follows: ① The patients took Omeprazole twice a day and 20 mg for one dosage. ② The patients took Aspirin twice a day and 1 g for one dosage. ③ The patients took Metronidazole twice a day and 0.4 g for one dosage. If patients are allergic to Aspirin, they took Claricid twice a day and 0.5 g for one dosage. 14 days is one course.

Additionally, the experimental group was administrated with Modified Chaihu Guizhi Ganjiang Decoction. The specific methods were as follows: ① Chaihu Guizhi Ganjiang Decoction was composed of Radix Stellariae 15 g, Ramulus Cinnamomi 6 g, Rhizoma Zingiberis 6 g,Radix et Rhizoma Glycyrrhizae Praeparata cum Melle 8 g,Radix Scutellariae Hypericifoliae 15 g, Fructus Trichosanthis 20 g, Concha Ostreae 15 g. If patients had serious gastralgia,add Rhizoma Corydalis. If patients had acid regurgitation,add cuttle bone. If patients had abdominal distension,add Fructus Aurantii, Pericarpium Citri Reticulatae. If patients had constipation, add Semen Cassiae. ② The herbs mentioned above should be sank in 600 mL water for 30 minutes and decocted with strong fire, and then change to mild fire for 30 minutes. The 200 mL decoction was obtained. After that, add 300 mL water, and decocted with strong fire, then changed to mild fire. Finally 150 mL decoction was obtained. ③ Mix 150 mL decoction with 300 mL decoction and take it twice a day in the morning and evening for each. 14 days as one treatment course.

Diagnosis criteria

H.pylori infection diagnosis criteria

① H.pylori thallus was found in tissue section of gastric mucosa in patients. ②14C breath test of patients is positive. Patients accords with any one of above can be diagnosed as H.pylori infection.

Diagnosis criteria of chronic gastritis

Diagnosis criteria of chronic gastritis according to Study of clinical digestion diseases of traditional and western medicine: ① The results of fiber gastroscope show patients have gastric mucosa edema, hyperemia, gastric mucosa dot,hemorrhage or erosion. ② More than 2 symptoms of those symptoms in patients appeared, including acid regurgitation,stomach pain, gastric upset, abdominal distension, belching,sour regurgitation, heartburn and so on.

Observation index

CagA, Hp-NAP concentration of serum in patients

Venous blood of elbow was taken and enzymelinked immunosorbent assay was used to detect CagA and Hp-NAP concentration of serum in patients of the 2 groups before and after treatment

Efficacy on primary symptoms

The symptom grade was assessed based on conditions of acid regurgitation, stomach pain, gastric upset, abdominal distension, belching, and tongue and pulse manifestation before and after intervention.The grades were calculated according to symptommanifestation, and the specific methods were as follows:① Adopt classification rating scale to calculate grades and to classify 4 levels based on their conditions. ② The grade is 0, if patients have no symptoms. ③ The grade is 1, if patients have slight abnormal feelings. ④ The grade is 2, if symptoms are marked and do not affect normal life. ⑤ The grade is 3, if symptoms manifest as inflammation and seriously affect normal life of patients.

Table 1. Comparison of CagA, Hp-NAP concentration of serum in the 2 groups' patients (ng/L)

Table 2. Comparison of efficacy on primary symptoms between the 2 groups

The symptoms therapeutic effects were evaluated according to the changes of symptoms scores before and after intervention conditions: ① Basically patients whose symptoms disappear and symptoms grade has decreased up to 95% are viewed as cured cases. ② Patients whose symptoms have been improved markedly and whose symptoms grade has decreased up to 75% to 95% are viewed as markedly effective cases. ③ Patients whose symptoms have been slightly improved and whose symptoms grade has decreased up to 35% to 75% are viewed as effective cases. ④ Patients whose symptoms have not been improved and whose symptoms grade has decreased below 35% are viewed as an ineffective cases.

The total effective cases = cured cases + markedly effective cases + effective cases

The H.pylori eradicating rate of the 2 groups was calculated. The eradicating criteria of H.pylori:14C breath test was conducted after 4 weeks of drug suspension.H.pylori is eradicated if the detect result is negative.

Statistical methods

SPSS 19.0 was adopted to analyze data in this study.Measurement data was tested by t test. Enumeration data was tested by χ2test. The difference between the 2 groups'data has statistical significance when P ＜ 0.05.

RESULTS

CagA, Hp-NAP concentration of serum in the 2 groups

The CagA, Hp-NAP concentration difference between the 2 groups had no statistical significance before intervention(P ＞ 0.05). The CagA, Hp-NAP concentration in experimental group was lower than that of control group, and the difference was statistically significant (P ＜ 0.05). See Table 1.

Comparison of efficacy on primary symptoms between the 2 groups

The total effective rate of primary symptoms of experimental group was markedly higher than that of control group. The difference between the 2 groups had statistical significance (P ＜ 0.05). See Table 2.

H.pylori eradicating rate of the 2 groups

H.pylori eradicating rate of experimental group was markedly higher that that of control group. The difference between the 2 groups had statistical significance (P ＜ 0.05).See Table 3.

Table 3. Comparison of H.pylori eradicating rate between the 2 groups (cases (%))

DISCUSSION

H.pylori related gastritis is a common clinical digestive disease, which mainly manifests as epigastric distension, epigastric pain, epigastric upset and so on[9]. Doctors of Western Medicine perceive that main toxicological factor is CagA, which affects development of chronic gastritis through impairing gastric mucosa cells. Besides, Hp-NAP, one of extracts of H.pylori,exerts an active influence on inflammation cells and when combined with specificity receptor, it will activate damage, proliferation and apoptosis of DNA in cells[10-11].If Helicobacter pylori acts on gastric mucosa without immediate treatment for a long time, it will act as promotor, which will gradually make chronic gastritis develop to gland atrophy, intestine epithelial metaplasia,or even, carcinogenesis[12]. Recently western medicine conventionally adopts triple therapy to treat H.pylori related gastritis. However, drug-resistance of H.pylori has risen gradually and eradicating rate fails to achieve patients' expectation since abuse of various antibiotics[13].Chinese medicine holds that this disease derives from dampness-heat of spleen and stomach, of which deficiency of spleen and stomach is the root cause and dampnessheat blocking middle-energizer is the manifestation[14].Chaihu Guizhi Ganjiang Decoction is from Treatise on Cold Damage, of which Fructus Trichosanthis can clear heat and promote fluid production, Radix Stellariae and Radix Scutellariae Hypericifoliae can reconcile shaoyang and disperse the stagnated liver qi, Ramulus Cinnamoni and Rhizoma Zingiberis can warm yang and expell coldness. This formula can disperse the stagnated liver qi for relieving qi stagnation and warmly invigorate spleen yang.

CagA and Hp-NAP concentration in patients of the 2 groups before intervention in this study has no statistical significance (P ＞ 0.05), while after intervention CagA and Hp-NAP concentration in patients of experimental group was lower than that of observation group (P ＜ 0.05), indicating that there is statistical significance. It shows Chaihu Guizhi Ganjiang Decoction combined with triple therapy can effectively reduce CagA and Hp-NAP concentration in serum of patients. The reason is Chaihu Guizhi Ganjiang Decoction can effectively disperse the stagnated liver qi for relieving qi stagnation and warmly invigorate spleen yang. Some study shows digestive diseases caused by H.pylori mostly are dampness-heat of spleen and stomach syndrome[15]. Positive rate in patients of this pattern is markedly higher that of other patterns. H.pylori eradicating rate could rise after treating from warmly invigorating spleen yang. After that extract, Hp-NAP, and toxicological factor CagA concentration will decrease. In this study, the total effective rate of primary symptoms in patients from experimental group was higher than that of control group. Data from the 2 groups had statistical significance (P ＜ 0.05). The possible reason might be, to some extent, antibiotics abuse exerts negative influence on conventional treatment of triple therapy. In this study,although triple therapy improves H.pylori related gastritis to some extent, its therapeutic effects decrease with enhance of H.pylori resistance. Chaihu Guizhi Ganjiang Decoction combined with triply therapy can make up for bad therapeutic effects attributing to resistance increase. Thus, total effective rate of main symptoms in experimental group is clearly higher than that of control group. In this study, the eradicating rate of H.pylori in experimental group was obviously higher than that of control group. The difference between the 2 groups had statistical significance (P ＜ 0.05). The possible reason might be abuse of antibiotics leading to the increase of H.pylori resistance and triple therapy is still used to treat diseases. As a result of that, eradicating rate was low.Adopting Chaihu Guizhi Ganjinag Decoction on the basis of triple therapy can effectively remedy this problem.

All in all, Chaihu Guizhi Ganjiang Decoction combined with conventional triple therapy can effectively decrease Cag and Hp-NAP concentration of serum in patients of H.pylori related gastritis, improve therapeutic effects and eradicating rate of H.pylori, which deserves clinical promoting.