Clinical Study Report on Treatment of “Pingwei Granule Mixture”

Author: Yili Hu


Abstract:

Purpose: To observe the clinical effect of Pingwei Granule Mixture for syndrome of dampness-heat of spleen and stomach of chronic non-atrophic gastritis.


Methods: In open randomized controlled clinical trial, 180 cases of chronic non-atrophic gastritis with dampness-heat syndrome of spleen and stomach were divided into treatment group (120 cases) and control group (60 cases). The treatment group was treated with Pingwei Granule Mixture (92g) three times a day with boiling water, each time half an hour before meals; the control group was treated with omeprazole tablets 20 mg twice a day, each time half an hour after meals, potassium citrate capsules 150 mg, three times a day, each time half an hour before meals. Four weeks is a course of treatment.


Results: The total clinical effective rate of the treatment group and the control group were 93.33% and 73.33%, respectively (P<0.05). The effective rates of the five main symptoms of stomach ache, abdominal distention, loose stool, anorexia and yellow greasy coating on the tongue in the treatment group and the control group were 91.89% and 75.93%, 95.83% and 71.67%, 91.92% and 72.72%, 94.20% and 72.97%, 92.50% and 73.33% (P < 0.01).For 30 cases of each group, the total effective rate of gastroscopy was 90.00% and 66.67% in the treatment group and control group respectively (P < 0.05); the short-term clearance rate of Helicobacter pylori was 82.47% of 97 cases in the treatment group and 51.11% of 45 cases in the control group (P < 0.01), and the long-term eradication rate was 56.25% and 27.27% (P < 0.05).


Conclusion: Pingwei Granule Mixture has a good clinical effect on chronic non-atrophic gastritis with dampness-heat syndrome of spleen and stomach. It can relieve the main symptoms, improve the mucosal phase of gastroscope and resist the Helicobacter pylori. It is worth further promotion.


Keyword: #PingweiGranuleMixture #ChronicNonatrophicGastritis #stomach #ClinicalResearch


I. Research Purpose


Chronic non-atrophic gastritis is a common clinical chronic disease. More than 80% of adults have different degrees of non-atrophic gastritis[1], which seriously affects people's quality of life. The main type of syndrome of active inflammation of chronic non-atrophic gastritis is dampness-heat of spleen and stomach [2].


Therefore, it is of great significance to study the curative effect of dampness-heat syndrome of spleen and stomach in the treatment of chronic non-atrophic gastritis.


Modern medical research believes that the etiology and pathogenesis of chronic non-atrophic gastritis are mainly: the enhancement of gastric mucosal injury factor (aggression factor), such as mechanical, temperature, chemical and biological factors, which repeatedly damage gastric mucosa for a long time, resulting in persistent inflammation; or gastric mucosal congestion and hypoxia caused by some chronic diseases, resulting in decreased gastric mucosal tolerance to stimulants; Helicobacter pylori (HP) infection, HP-secreted enzymes and toxins enter epithelial cells and cause damage to the mucosal inflammation; duodenal fluid reflux, weaken the barrier function of the gastric mucosa, so that the gastric mucosa is affected by digestive juice, producing inflammation, erosion, bleeding, etc.[3] Since Warren and Marshall first isolated HP from patients with gastritis in 1983, a large number of studies have found that this bacterium is the main pathogen of chronic gastritis. Therefore, HP infection is the main cause of chronic gastritis. In the treatment, besides using gastric mucosal protective agents and eliminating aggressive factors, clearing out HP infection is the primary mean of treatment. However, clinically, we found that after HP clearance, there are still a considerable number of patients whose symptoms have not been alleviated. According to the pathogenesis, western medicine has put forward various therapeutic schemes, such as eradication of Helicobacter pylori, inhibition of gastric acid secretion and neutralization of gastric acid, treatment of bile reflux, mucosal protective agents and prokinetic drugs and other treatment options [4]. Although there are many therapeutic drugs, there is a lack of effective drugs with comprehensive treatment effect.


Chronic non-atrophic gastritis belongs to the category of "Stomachache" and "distention syndrome" in traditional Chinese medicine. Traditional Chinese medicine has accumulated rich experience in the treatment of chronic non-atrophic gastritis. In the syndrome differentiation of chronic gastritis, dampness-heat syndrome of spleen and stomach accounts for a higher proportion [4, 5,6], and mainly with acute and active inflammation. Gastric mucosal congestion, edema and erosion were obvious [4, 5]. As a kind of exogenous evil, the infection rate of HP is the highest in the dampness-heat syndrome of spleen and stomach in TCM. The relationship between HP infection and TCM syndrome type is: dampness-heat syndrome of spleen and stomach type>stomach meridian stasis type>liver-stomach disharmony type>weakness of spleen and stomach type>deficiency of stomach yin type [7, 8]. The pathogenesis of the disease is mainly the exogenous evil of dampness and heat, or the weakness of the spleen and stomach that unable to transport. Endogenous dampness or improper diet results in dampness originated from interior, and the internal and external dampness stagnate inside and generate heat to form dampness-heat syndrome. Dampness and heat obstruct in middle jiao which lead to the irregular flow of qi in spleen and stomach and protracted or recurrent qi stagnation and blood stasis after long time, and refractory gastritis. It can be seen that dampness-heat of spleen and stomach is the key to the pathogenesis of chronic non-atrophic gastritis. and clearing away dampness-heat is the principle of treating dampness-heat of spleen and stomach in chronic non-atrophic gastritis. In this study, "Pingwei Granule Mixture" with heat-clearing and dampness-dissipating was selected to carry out a systematic clinical study on the dampness-heat of spleen and stomach syndrome of chronic non-atrophic gastritis in order to confirm the obvious curative effect of this preparation in order to develop effective prescriptions for the treatment of chronic non-atrophic gastritis with dampness-heat in spleen and stomach syndrome, which has good comprehensive curative effect, obvious improvement of symptoms, low recurrence rate, less side effects and good effect on anti-Helicobacter pylori.


II. Clinical Research


We used the preparation "Pingwei Granule Mixture" to treat chronic non-atrophic gastritis with dampness-heat syndrome of spleen and stomach and observed its clinical efficacy, symptoms and changes in gastroscope and HP eradication. The details are as follows:


1.Clinical data


1.1 General data

All the observed cases were not treated with relevant drugs within 2 weeks. They were randomly divided into treatment group (120 cases) and control group (60 cases). There was no significant difference in age, gender and duration of disease between the two groups (P>0.05), so the data was comparable. See Table 1.

Table1 Comparison of general data between treatment group and control group

1.2 Diagnostic criteria

1.2.1 Diagnostic criteria of Western medicine:

According to the Chinese consensus on chronic gastritis (2017, Shanghai) [9], atrophic gastritis is not included in this study.

  • The course of the disease is prolonged, with different degrees of dyspepsia, anorexia, nausea, and upper abdominal pain associated with eating. There may be mild tenderness in the left upper abdomen.

  • It can be diagnosed according to the diagnostic criteria of fiberoptic gastroscopy and biopsy for chronic non-atrophic gastritis.

(1) Diagnostic criteria of gastroscopy

  • Increased mucus attaches to the mucous membrane and is not easy to fall off. After washing with water, the surface of the mucosa became red or erosion and peeling off, similar to the nature of the white moss on the surface of the shallow ulcer.

  • Small patches or dots of red, some places are congested and some places are not, so it is spotted. Reddish realm is not obvious, the color is bright red, linear congestion is common in the folds.

  • Red and white or patches, scattered evenly red dots, the mucosa among red dots is slightly pale.

  • Edema,mucous strong reflection of light,slightly pale, swollen feeling, obvious gastric fossa.

  • Erosion, exfoliation of fold mucosa, often with white tongue coating.

(2)Diagnostic criteria of histopathology


  • Biopsy: Five specimens were taken. Two of the sinuses ventriculi were taken from the greater curvature and lesser curvature 2-3 cm from the pylorus, two of the corpora ventriculi were taken from the greater curvature 8 cm from the cardia (about the middle of the greater curvature of the stomach) and the lesser curvature 4 cm from the proximal side of the gastric angle, and one from the gastric angle.

  • Neutrophil infiltration is active on the background of chronic inflammation, and chronic inflammatory cells in the mucosa are chronic inflammation.

  • Classification of gastric mucosal inflammation:

  1. Mild: Chronic inflammatory cells are few and limited to the superficial of mucosa, not more than 1/3 of the mucosal layer, and a few neutrophils infiltrated the lamina propria;

  2. Medium: Chronic inflammatory cells are denser, not more than 2/3 of neutrophils in mucosal layer, and there are more in the mucosal layer. Surface epithelial cells, pit epithelial cells or glandular epithelial cells can be seen.

  3. Severe: Chronic inflammatory cells are dense, occupying the whole mucosa; neutrophils are dense, or pit abscesses can be seen in addition to moderate findings.

1.2.2 Diagnostic criteria for Traditional Chinese Medicine:

The diagnostic criteria for dampness-heat of spleen and stomach according to the Guiding Principles for Clinical Research of New Drugs in Traditional Chinese Medicine


Main symptoms:

① yellow and greasy tongue coating;

② fullness or swelling or pain of stomach;

③loose stool;

④poor appetite.


Secondary symptoms:

①bitter and sticky mouth;

②chest tightness;

③thirsty but drink less;

④ heavy limbs;

⑤nausea.


Diagnosis:

(1) Has the main symptoms ① and two of other main symptoms;

(2) Has the main symptoms ① and one of other main symptom, and two of secondary symptoms;

(3) Has the main symptoms ① and three of secondary symptoms. It can be diagnosed by having any one of the above three.


1.3 Case inclusion criteria Patients who meet the criteria of diagnosis of chronic non-atrophic gastritis by western medicine and differentiation of symptoms and signs of traditional Chinese medicine can be included in the trial cases.


1.4 Case exclusion criteria

  • Under 18 or over 65 years of age, pregnant or lactating women, allergic.

  • Secondary chronic gastritis.

  • Complicated with severe primary diseases such as cardiovascular, cerebrovascular, liver and kidney and hematopoietic system and so on, psychiatric patients, etc.

  • Those who do not use drugs according to regulations cannot judge the efficacy, or the data is incomplete, which may affect the efficacy or safety judgment.


2.Treatment method


Composition of Pingwei Granule Mixture: twelve kinds of granules, including Rhizoma Atractylodis 8g, almond 8g, ageratum 8g, Acorus gramineus Soland 8g, Mangnolia officinalis 8g, Rhizoma Polygoni 8g, Radix Paeoniae Rubra 8g, red-rooted salvia 10g, Coptis chinensis 6g, Poria cocos 8g, Amomum cardamomum 6g and so on, totaled 92 grams. In the treatment group, the above granules were divided into three times, and orally administered 150 ML boiled water half an hour before meals. The control group was treated with 150mg bismuth potassium citrate capsule ( Guangzhou Baiyunshan Guanghua Pharmaceutical Co., Ltd.) three times a day for half an hour before meals; 20mg Omeprazole Tablet (Changzhou Siyao Pharmaceutical Co., Ltd.), twice a day, half an hour after meals.


The above treatment is a course of treatment. Gastroscopy, pathology and Helicobacter pylori examination were performed to evaluate the clinical efficacy after the course of treatment. From the date of observation, patients are required to avoid tobacco, alcohol, strong tea and spicy stimulation, fried greasy and other undigestible foods, and to discontinue any medicines and methods that affect the judgement of curative effect. The follow-up period was 6 months.


3. Observation indicators and methods


3.1 Observation of curative effect:

Symptoms and signs, gastroscopy, histopathological examination, Helicobacter pylori examination, etc.


3.1.1 Symptom observation:

Observe five main symptoms: epigastric pain, abdominal swelling, loose stool, poor appetite, yellow greasy tongue coating, take grading scores and compare before and after treatment.

  • Level III: Severe (3 points)

  • Level II: Moderate (2 points)

  • Level I: Mild (1 point)

  • Level 0: Asymptomatic (0 points).

3.1.2 Gastroscopy mucosal examination:

The mucosal phase (congestion, edema, erosion) of gastroscope was observed and recorded in all the observed cases 1-2 weeks before treatment. Gastroscopy was performed again of some observed cases within 1-2 weeks after treatment.


3.1.3 When the gastroscopic examination was performed within 1-2 weeks before and after treatment, the rapid urease test was performed. One month after the end of treatment, 14C urea breath test was performed.


3.2 Safety observation

Routine blood, urine, stool tests and liver and kidney function tests of observed cases were performed 1-2 weeks before and after treatment.


4. Criteria for therapeutic effects


4.1 Criteria for comprehensive clinical efficacy:

Formulated with reference to the Guiding Principles for Clinical Research of New Drugs in Traditional Chinese Medicine by the Ministry of Health:

  • Clinical cured: symptoms and signs disappear;

  • Significant effect: Symptoms and signs improved more than 2 grades.

  • Effective: Symptoms and signs improved more than 1 grade;

  • Invalid: No change or deterioration of symptoms and signs.

4.2 Criteria for efficacy of single symptom

  • Cured: Symptoms disappear and the score is 0.

  • Significant effect: Symptoms improve by more than 2 grades and scores decrease by more than 2/3.

  • Effective: Symptoms improve more than 1 grade, scores decrease by more than 1/3, but not more than 2/3.

  • Invalid: No change in symptoms, no change in scores.

4.3 Standardization of curative effect under gastroscope

  • Cured: Acute inflammation disappeared, chronic inflammation was mild and bile reflux disappeared under gastroscope and biopsy.

  • Improved: Acute inflammation disappeared, chronic inflammation improved and bile reflux decreased under gastroscopy and biopsy.

  • Effective: Under gastroscope and biopsy, the degree of acute and chronic inflammation is reduced, and bile reflux is slightly reduced.

  • Invalid: no change under gastroscope and treatment.


4.4 Criteria for the efficacy of Helicobacter pylori (HP)

  • Recent clearance: Within one month after the end of treatment, 14C urea breath test was negative.

  • Long-term eradication: One month after the end of treatment, 14C urea breath test was negative.

5. Therapeutic outcome


5.1 Comparison of clinical efficacy between the two groups: See Table 2. The results showed that the curative effect of the treatment group was better than that of the control group (P < 0.05).

Table 2 Comparison of clinical efficacy between two groups n (%)

5.2 Comparison of symptoms between the two groups before and after treatment:See Table 3.


Table 3 Comparison of curative effect of main symptoms between two groups

5.3 There were 60 cases of gastroscopy review in the two groups, 30 cases in the treatment group and 30 cases in the control group. The comparison of gastroscopy results is shown: see Table 4.


Table 4 Comparison of curative effect between two groups under gastroscopy

5.4 There were 142 cases of HP positive in the two groups, 97 cases in the treatment group and 45 cases in the control group. Comparisons of anti-HP efficacy: See Table 5.

Table 5 Comparison of anti-HP efficacy between two groups

5.5 Analysis of adverse reactions

There were no abnormalities in blood、urine、 stool routine and liver and kidney function before and after treatment. No significant adverse reactions were found in the two groups during the drug administration period and after the treatment.


III. Conclusion


Chronic non-atrophic gastritis is the most common chronic disease in the clinic. It is located in the stomach and closely related to the spleen. The characteristics of the disease is asthenia in origin and excess in superficiality. Weakness of spleen and stomach is the foundation, and dampness and heat is the sign. The clinical manifestation is excess in superficiality mainly. According to the treatment principles of "releasing the excess, cooling the heat" and "Treating the middle jiao should focus on the balance, no balance no equilibrium" ,the "Pingwei Granule Mixture" is used to clear away heat and dampness, invigorate the function of spleen and stomach, promote the circulation of qi and blood. In the prescription, Rhizoma Atractylodis enters the spleen, stomach and liver meridians which can dry dampness and invigorate the function of spleen; almond ventilates the qi of lung in upper jiao, because the lung is concerned with qi of the whole body. When the qi defuses, so does the dampness; Amomum cardamomum, Acorus gramineus Soland, Mangnolia officinalis dissipate dampness and promote the circulation of qi and relieve epigastric distention; Poria cocos clears dampness and promotes diuresi, strengthens spleen and hamonizes stomach; ageratum resolves dampness with aromatics from inside to superficiality, which is benefit for the gasification function of lung, spleen, kidney and sanjiao; Coptis chinensis clears heat in dampness;there is qi stagnation, blood stasis and dampness stagnation, so we use light and smart products such as Rhizoma Polygoni, Radix Paeoniae Rubra and red-rooted salvia to activate blood circulation to dissipate blood stasis. When the blood flows, so does the qi. When the qi defuses, so does the dampness. The whole prescription promotes an unimpeded flow in three-jiao by dispersing in the upper, unblocking in the middle and percolating in the lower to gain the effect of clearing away heat and dampness, strengthening spleen and hamonizing stomach, in order to make the blood flow smoothly and dampness defuse, the spleen is healthy and vigorous, three-jiao unblocked, then all the symptoms will be eliminated. Modern pharmacological studies have confirmed that, Rhizoma Atractylodis has the effect of anti-experimental gastritis, and can regulate gastrointestinal motility [9]; almond has anti-inflammatory analgesic and anti-mutation effects [9]; Poria cocos can prevent gastric ulcer [9]; Acorus gramineus Soland, Mangnolia officinalis can promote the secretion of digestive juice, inhibit abnormal fermentation of gastrointestinal tract and relax gastrointestinal smooth muscle spasm [9, 10]; Coptis chinensis has anti-microbial and anti-inflammatory effects [9]; Rhizoma Polygoni has the effects of cholagogue, inhibiting gastrointestinal motility, anti-inflammatory and analgesia(9); red-rooted salvia has anti-coagulation, anti-inflammatory, analgesic and anti-gastric ulcer effects [9]; Radix Paeoniae Rubra has the effects of anti-platelet aggregation and relieving intestinal spasm[9].


Clinical observation on 180 cases of chronic non-atrophic gastritis with Syndrome of dampness-heat of spleen and stomach (60 cases in control group). The results showed that the total clinical effective rate of the treatment group was 93.33%, and that of the control group was 73.33%. There was a significant difference in the total effective rate between the two groups; Compared with the control group, the treatment group had significant differences in stomach ache, abdominal distention, loose stool, anorexia and yellow greasy coating on the tongue; improvement of the mucosal phase of gastroscope, short-term clearance and long-term eradication of Hp were better than those of the control group. It has definite curative effect, high safety and no toxic side effects.


IV. Main research results and innovations


"Pingwei Granule Mixture" is a new Chinese medicine preparation for the treatment of chronic non-atrophic gastritis with syndrome of dampness-heat of spleen and stomach. Clinical studies showed that the therapeutic effect of the treatment group on chronic non-atrophic gastritis with syndrome of dampness-heat of spleen and stomach was significantly better than that of the control group; the main symptoms of stomach ache, abdominal distention, loose stool, anorexia and yellow greasy coating on the tongue and gastroscopic mucosal phase (congestion, edema, erosion) were improved significantly; the effect of short-term clearance and long-term eradication of Helicobacter pylori was better than that of the control group. It shows that "Pingwei Granule Mixture" has a good therapeutic effect on chronic non-atrophic gastritis with syndrome of dampness-heat of spleen and stomach. The main technical indicators exceed the expected target and reach the domestic leading level.


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