Clinical observation on 48 cases of mild and moderate ulcerative colitis treated with Jiawei Sanren Decoction

Fengxian Bai, Yahui Huang

1 Shaanxi University of Chinese Medicine, Xianyang, Shaanxi Province, China

2 Xi’an Traditional Chinese Medicine Hospital, Xi’an, Shaanxi Province, China

Abstract

Key words: ulcerative colitis; spleen-deficiency damp-heat type; Jiawei Sanren decoction; Mesalazine slow release tablets; Mesalazine suppository

Introduction

Subjects and Methods

Subjects

Ninety-six patients who were diagnosed with spleen deficiency and damp-heat type UC through colonoscopy and pathology at the Outpatient and Inpatient Department of Spleen and Gastroenterology in Xi’an Traditional Chinese Medicine Hospital from October 2017 to December 2018 were included in this study, they were randomly divided into treatment group and control group,each containing 48 cases.In the treatment group, there were 20 males and 28 females, who aged 16-78 years, with an average age of (42.15±12.18) years, the course of disease was 3-11 weeks and the average course was (7.23±2.48)weeks; in the control group, there were 22 males and 26 females, who aged 16-87 years, with an average age of(42.63±12.56) years, the course of disease was 3-11 weeks and the average course was (7.06±2.54) weeks; statistical analysis showed that, there was no statistical difference in the gender, age, and course of disease in the two groups before treatment (P＞0.05).

Diagnostic criteria

Western medicine diagnostic criteria

Refer to the Interpretation of the Consensus on Diagnosis and Management of Inflammatory Bowel Disease(Guangzhou, 2012) formulated by the Inflammatory Bowel Disease Group, Chinese Society of Gastroenterology[4].

TCM diagnostic criteria

Refer to the Interpretation of the Expert Consensus on TCM Diagnosis and Management of Ulcerative Colitis(2017) formulated by the Branch of Spleen and Stomach Diseases, China Association of Chinese Medicine[5].Symptoms of spleen-deficiency damp-heat type included:diarrhea, abdominal pain, bloody purulent stool, more purulent feces and less white feces, or mixed with indigested food, tenesmus, anal burning, scanty dark urine, with or without abdominal fullness and distension,limb drowsiness, low appetite, tired expression and other spleen qi deficiency, as well as dry mouth and bitter mouth.The tongue is red or dark red, with or without indentation, yellow greasy fur, slide or fine pulses.

通過對比國內(nèi)外繼續(xù)教育現(xiàn)狀和護(hù)理教育教學(xué)模式發(fā)現(xiàn)，我國和發(fā)達(dá)國家還存在較大差距[14]。要想使我國的護(hù)理水平不斷提升，就需要借鑒國外的先進(jìn)經(jīng)驗(yàn)，對我國的護(hù)理繼續(xù)教育體系進(jìn)行不斷完善。對相關(guān)法律法規(guī)進(jìn)行完善，通過法制手段來推行醫(yī)藥護(hù)理繼續(xù)教育。將管理機(jī)制理順，通過相關(guān)部門的領(lǐng)導(dǎo)形成一定規(guī)模的辦學(xué)機(jī)構(gòu)，各層次應(yīng)保證協(xié)調(diào)和統(tǒng)一，為建設(shè)護(hù)理隊(duì)伍形成良好的教學(xué)群體[15]。

Inclusion and exclusion criteria

Inclusion criteria

(1) Those who meet the western medical diagnostic criteria for mild to moderate UC; (2) Those who have TCM syndromes of spleen- deficiency damp-heat; (3)Each patient have signed the informed consent in person.Exclusion criteria

(1) Those with severe UC, or requiring urgent treatment, or accompanied by serious complications,such as intestinal perforation, rectal or colon tumors or obstruction or stenosis caused by the tumor, stenosis caused by other reason, toxic megacolon; (2) women who are breast-feeding or pregnant or preparing for pregnancy;(3) those who have a previous history of allergies to various drugs or who are allergic; (4) those who have severe primary diseases in cardiovascular, cerebrovascular,liver, lung, kidney and other systems, or have to take other drugs for oral treatment and those with mental illness; (5)in addition to Jiawei Sanren Decoction or Mesalazine slow release tablets, UC patients undergoing other treatment regiments; (6) those with poor compliance, unable to take drugs regularly and observers regularly.

Treatment

Treatment group: Jiawei Sanren Decoction was orally given, the prescription was consisted of 30 g raw coix seed,10 g cardamom, 10 g fried apricot, 10 g officinal magnolia bark, 12 g ginger processed pinellia, 12 g lophatherum gracile, 15 g plantain herb, 9 g costustoot, 10 g ash bark,15 g sargentg loryvine stem, and 6 g panax notoginseng.TCM decoction could be modified according to individual symptoms of each patient through addition or subtraction:white paeony root 20 g and radices sileris 10 g were added for those with abdominal pain before stool; lindera aggregate 15 g was added for those with abdominal pain after stool; hairyvein agrimony 15 g, carbonized sanguisorba root 15 g, and stir-baked flos sophorae 15 g were added for those with more bloody stool; gorgon fruit 30 g and fructus chebulae 20 g were added for those who have more frequent stools; donkey-hide gelatin 15 g and stir-baked rhizome dioscoreae 30 g were added for those who have consumption of yin caused by chronic diarrhea;radix bupleuri 10 g, rhizome cimicifugae 8 g and pueraria 10 g were added for those with Tenesmus.The decoction was given one dose per day, two decoctions with water, in morning and evening.

Control group: Oral Mesalazine slow release tablets(Ferring GmbH, Germany, registration certificate No.:H20160693, PENTASA 500 mg × 100 tablets/box), 2 tablets/time, 4 times/day.

Both groups were given Mesalazine suppositories (Ferring GmbH, Germany, registration certificate No.: H20160582,PENTASA 1 g × 28 pieces/box), and the course of treatment was 2 months.Patients were instructed to have less greasy food during the treatment, while raw, cold,spicy and hard food were forbidden, and avoid eating pungent-warm foods such as beef and lamb, adjust the clothes according to the climate, regulate emotions, avoid fatigue or stay-up, have good rest, and exercise properly.

Outcome measures

Comprehensive clinical efficacy, colonoscopy morphology and histology score, TCM symptom score, and incidence of adverse reactions during treatment in the two groups of patients were observed before and after treatment.And the recurrence rate was observed after 6-month follow-ups.The comprehensive clinical efficacy and TCM symptom scores refer to the Interpretation of the Expert Consensus on TCM Diagnosis and Management of Ulcerative Colitis (2017)formulated by the Branch of Spleen and Stomach Diseases,China Association of Chinese Medicine[5]; the colonoscopy morphology and histology scores refer to scoring criteria of Ekstrom GM, Dieleman GM[6-7]; at 3 months after withdrawal, the symptom scores of diarrhea and bloody purulent stool exceeding more than 50% before treatment was assessed as recurrence, otherwise non-recurrence[8]; all patients received the blood and urine routine test, liver and kidney function test, and electrocardiogram before and after treatment, so as to observe the incidence of adverse reactions in the two groups[9].

Statistical analysis

SPSS 22.0 software was used for statistical analysis of the outcome measures.The measurement data (conforming to normal distribution) were expressed as mean±standard deviation (±s) usingttest.The counting data were expressed as the number of cases and percentages usingx2test; the difference was statistically significant ifP＜0.05 was obtained from the test results.

Results

Comparison of clinical comprehensive efficacy between the two groups (Table 1)

Table 1 Comparison of comprehensive clinical efficacy between the two groups (n, %)

Comparison of colonoscopy morphology and histology scores (Tables 2 and 3)

Table 2 Comparison of morphological scores between the two groups before and after treatment ( ±s)

Table 2 Comparison of morphological scores between the two groups before and after treatment ( ±s)

Note: Compared with the control group, aP＞0.05, the difference is not statistically significant; bP＜0.05, the difference is statistically significant.

Group n Before treatment After treatment Treatment 48 1.67+0.48a 0.67+0.63b Control 48 1.60+0.49 0.92+0.85

Table 3 Comparison of histological scores between the two groups before and after treatment ( ±s)

Table 3 Comparison of histological scores between the two groups before and after treatment ( ±s)

Note: Compared with the control group, aP＞0.05, the difference is not statistically significant; bP＜0.01, the difference is statistically significant.

Group n Before treatment After treatment Treatment 48 2.54+0.62a 1.46+0.85b Control 48 2.50+0.68 1.81+0.89

Comparison of TCM symptom scores between the two groups (Table 4)

Table 4 Comparison of total scores of TCM symptoms between the two groups before and after treatment ( ±s)

Table 4 Comparison of total scores of TCM symptoms between the two groups before and after treatment ( ±s)

Note: Compared with the control group, aP＞0.05, the difference is not statistically significant; bP＜0.01, the difference is statistically significant.

Group n Before treatment After treatment Treatment 48 12.98+4.78a 5.52+4.99b Control 48 12.85+4.95 7.69+6.23

Comparison of recurrence rates between the two groups (Table 5)

Table 5 Comparison of recurrence rates between the two groups (n, %)

Comparison of adverse reactions between the two groups

During the treatment, no adverse reactions occurred in the treatment group, while in the control group two cases experienced nausea and vomiting, two cases had abdominal pain and diarrhea, and three cases had skin itching.The incidence of adverse reactions was 14.58%.The difference was statistically significant between the two groups (P＜0.05).

Discussion

UC is a chronic, recurrent, non-specific intestinal inflammatory disease.The etiology and pathogenesis of this disease remain unclear yet, and it is believed to be related to several factors such as immunity, infection,genetics, and environment[10].Western medicine treatment is currently widely represented by aminosalicylic acid preparations, glucocorticoids, immunosuppressive agents,biological agents and other drugs.Western medicine treatment mainly works by reducing the concentration of free radicals in the human body and the activity of natural killer cells.It achieves obvious clinical efficacy, but induces high incidence of adverse reactions and high recurrence rate, and the patient’s compliance is poor, while TCM treatment scheme is individualized and specific, and have advantages such as low incidence of adverse reactions and low recurrence rate[10-11].

In the TCM theory, UC corresponds to dysentery, diarrhea,bloody stool, hemorrhoidal hamorrhage, and perianal abscess.However, due to the prolonged course of the disease, UC is now regarded as chronic dysentery[12-13].In the Huangdi Neijing (Inner Canon of Yellow Emperor),it refers to intestinal dysentery and bloody urine, and the key factors leading to this disease include the invasion of external evils and inadequate diet.As mention in the Su Wen (Plain Questions), if you drink indiscriminately and live irregularly, you will suffer from it....When the disease invades the five internal organs, the congestion, dysentery with indigested food in the stool, or hematochizia will occur.When the shaoyin are excessive, the vomiting,dysphoria, abdominal pain and loose stool may occur,leading to bloody stool[14].This disease is mainly located in the intestine, and also involves other organs such as the spleen, stomach, liver and kidney.The disease onset is manifested as dampness pathogen, taking spleen deficiency as the root cause.Spleen deficiency is associated with the invasion of external evil, the generation of internal dampness, and the formulation of chronic heat-syndrome.The Yizong Bidu (Required Readings for Medical Professions) proposed that, where there is a dampness,there is a dysentery.In the Yiyuan (Source of Medicine),the dampness is the root cause of dysentery.Professor Huang also believes that both external and internal evils can lead to deficiencies of the spleen and stomach,dysfunction of the transportation, loss of water and cereal essence.Once congested, the spleen may transport the dampness and heat to the intestinal tract, which accordingly fails to exert conduction effect, and damp-heat causes injury to lipid membranes superficial and lymph vessels, the qi and blood stagnation induces corruption and blood stagnation, so clinically manifested as diarrhea and bloody stool.Therefore, UC is characterized by spleen deficiency, damp-heat, and blood stasis.The treatment should emphasize on the supplement of the spleen, the elimination of the dampness and the removal of blood stasis.

Sanren Tang was first reported in the Chapter Upper Jiao of Wenbing Tiaobian (Detailed Analysis of Epidemic Warm Diseases), the prescription was consisted of raw coxi seed, apricot, cardamom, officinal magnolia bark,pinellia ternate, lophatherum gracile, ricepaper plant pith,and talc.Among them, apricot functions in the upper jiao, cardamom regulates the middle jiao, coxi seed favors the lower jiao, thus sanjiao (triple energy) is dredged, and water dampness runs smoothly from the top to the bottom.

Officinal magnolia bark and pinellia ternate contribute to ventilate qi and dispel dampness; ricepaper plant pith and talc contribute to clear heat and eliminate dampness,it also transport the heat and dampness to the lower jiao and exert effects.All the above four drugs act to transport qi, eliminate dampness and clear heat, in addition, and bamboo leaf also clears dampness and heat.The previous prescription is effective to treat the dampness-caused qi stagnation.However, Professor Huang proposes that the talc in the formula is relatively cold in nature, and it is easy to damage the spleen and stomach, so it is suggested to be deleted, except for patients with excess-heat[15];meanwhile, plantain herb is used, instead of ricepaper plant pith, which not only strengthen the diuretic effect,discharge dampness and heat from urination, but also has the functions of dispelling wind, cooling blood, and detoxifying; on the basis of the original prescription,we added some drugs: costustoot is used to promote qi circulation qi and guide stagnation; ash park clears heat and detoxifies; pseudo-ginseng and sargentgloryvine stem should regulate viral energy, activate blood and dissolve stasis.These four drugs work together to promote blood circulation,which leads to the self-healing of bloody stool, and to regulate qi flow, which self-eliminate tenesmus.Supplemented with Jiawei Sanren Decoction, they contribute to clear the dampness and heat, harmonize qi and blood, and treat the diarrhea[16].Professor Huang emphasized three points in the treatment process: 1.Focusing on the patient’s complaint, combining with other symptoms, accurately differentiating the syndrome, which is the foremost priority; 2.Observing the patient’s tongue image, because pulse condition may be subjective and vary from different doctors, tongue reaction is more objective and can be preferred when necessary; 3.Emphasizing on protecting the stomach qi, as stated in the Huangdi Neijing (Inner Canon of Yellow Emperor), you can live with stomach qi and will die without stomach qi.Meanwhile, dietary pattern and mood should be regulated.

In summary, this study concluded that Jiawei Sanren Decoction has significant curative effect on mild to moderate ulcerative colitis, it also can significantly alleviate clinical symptoms of patients, relieve intestinal mucosal inflammation, promote intestinal mucosal histological healing, reduce its recurrence rate, and induce no obvious adverse reactions, it has potential of clinical promotion and application, and provides evidence for the integrated TCM and western medicine treatment of UC.