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. 2024 Jul 5;103(27):e38704. doi: 10.1097/MD.0000000000038704

Efficacy and safety of BaitouWeng decoction for ulcerative colitis: A meta-analysis of randomized and controlled trials

Qian Xie a,✉, Wenlong Yu a, Yuancong He a, Guocheng Deng a, Hongyan Yang a, Jiarou Chen a, Jianlong Liang a, Xuxin Zeng a,*, Jialiang Guo a, Rong Ma a,b
PMCID: PMC11224827  PMID: 38968514

Abstract

Background:

To systematically evaluate the therapeutic effect of BaitouWeng Decoction in patients with ulcerative colitis (UC), evaluate its safety and effectiveness, and provide a reference for clinical medication.

Methods:

The research literature on the treatment of UC with BaitouWeng Decoction was searched in databases such as China National Knowledge Infrastructure, Wanfang Data, VIP database for Chinese Technical Periodicals, Chinese BioMedical Literature Database, and PubMed. The literature was screened by setting inclusion and exclusion criteria, strictly following the inclusion and exclusion criteria, and following the search strategy for literature screening, data extraction, and methodological quality evaluation. According to the Cochrane System Evaluation Manual, methodological quality evaluation was conducted on the included studies using the bias risk assessment tool for randomized controlled trials. For meta-analysis, Review Manager software was used.

Results:

A total of 24 articles were included, including 2131 patients. Meta-analysis showed that compared with conventional Western medicine, BaitouWeng Decoction can significantly improve the effective rate (odds ratio = 5.10, 95% confidence interval [CI] [3.74–6.96], P < .00001), reduce the traditional Chinese medicine syndrome score (mean difference [MD] = −4.23, 95% CI [−5.17–−3.30], P < .00001), Baron endoscopic score (MD = −0.68, 95% CI [−0.78–−0.58], P < .00001), and intestinal lesion activity score (MD = −2.29, 95% CI [−1.15–−1.03], P < .00001); improve serum factors and reduce serum tumor necrosis factor α levels (MD = −16.84, 95% CI [−19.92–−13.76], P < .00001), serum interleukin-8 levels (MD = −10.41, 95% CI [−10.87–−9.95], P < .00001), and increased serum interleukin-10 levels (MD = 4.96, 95% CI [2.76–7.16], P < .00001).

Conclusion:

BaitouWeng Decoction has good efficacy and safety in treating UC. BaitouWeng Decoction improved the symptoms of colitis injury and inhibited inflammatory response. However, more rigorously designed randomized controlled trials with blinding, concealment, and placebo controls should be conducted on Baitouweng decoction to generate higher quality evidence and longer-term studies on sustained benefits are needed.

Keywords: BaitouWeng decoction, meta-analysis, randomized and controlled trials, ulcerative colitis

Highlight.

  • This systematic review evaluated BaitouWeng Decoction for ulcerative colitis (UC).

  • BaitouWeng Decoction could improved UC symptom.

  • BaitouWeng Decoction is a potential traditional Chinese patent that has good efficacy and safety in treating UC.

1. Introduction

Ulcerative colitis (UC) is a chronic, nonspecific intestinal inflammatory disease characterized by continuous and diffuse inflammation of the colorectal mucosa. The incidence is increasing, which brings great inconvenience to patients’ lives.[1] Aminosalicylic acids[2] and glucocorticoids are the first choices for the treatment of active UC.[3] Moderate-to-severe patients often choose immunosuppressants, and the use of Western medicine to treat UC can significantly reduce the symptoms of the active phase. However, due to other limitations such as a high recurrence rate and excessive adverse reactions, the use of Western medicine by digestive surgeons is more conservative.[4] Traditional Chinese medicine (TCM) possesses the distinctive characteristics of being multi-component, multi-target, multi-pathway, exhibiting integrity, exhibiting minimal side effects, and exhibiting broad application, thereby presenting distinct advantages in the treatment of UC.

The BaitouWeng Decoction is a representative of TCM, first published in the “Cold Theory,” composed of Pulsatilla chinensis (Bge.) Regel, Coptis chinensis Franch. Phellodendron chinense Schneid., and Fraxinus rhynchophylla. It has the effect of clearing heat and detoxifying, cooling blood, and stopping dysentery. It also treats heat poison dysentery, abdominal pain, tenesmus, burning anus, dysentery, and blood. It is more red than white, thirsty for water, red tongue, yellow fur, and pulse string number.[5] As per the most recent findings of TCM diagnosis and treatment experts in the common consciousness, BaitouWeng Decoction treatment for heat and toxin incandescent syndrome of UC.[6] Pharmacological studies have shown that BaitouWeng Decoction has anti-inflammatory, antibacterial, antitumor, and immune regulatory properties.[7] It is mainly used for the treatment of bacillary dysentery,[8] infectious diarrhea,[9] unformed enteritis,[10] and UC.[11] It is an important prescription for the treatment of intestinal diseases. The chemical study showed that the compound contains alkaloids, coumarins, and saponins, among which the coumarin esculentine can remove hydroxyl and peroxidation radicals. BaitouWeng Decoction contains >5 saponins, which have antioxidant, anti-inflammatory, and immune-enhancing effects. They may also be used to treat UC.[7] A growing number of studies on traditional Chinese and Western medicine have provided novel and personalized treatment schemes, among which the BaitouWeng Decoction and its addition and subtraction therapy are the most effective. There have been systematic reviews of the BaitouWeng Decoction or a combination of BaitouWeng Decoction and Western or Chinese medicine in the treatment of UC. Nonetheless, in light of the recent revisions in the literature, this study intends to incorporate additional literature to comprehensively assess the safety and effectiveness of BaitouWeng Decoction in patients with UC, thereby furnishing references for clinical practice.

2. Information and method

The system evaluation has been registered with PROSPERO under the registration number CRD42023410216.

2.1. Literature search

The main databases searched included the database of China National Knowledge Infrastructure, Wanfang Data, VIP, Chinese BioMedical, PubMed, and other databases, and we searched the relevant articles on the treatment of BaitouWeng Decoction for UC since its inception until Oct. 2023. The keywords for the literature search were (“ulcerative colitis” OR “UC”) AND (“BaitouWeng Decoction”) AND (“randomized clinical trials” OR “clinical trials”).

2.2. Inclusion criteria

The research-based clinical trial literature pertains to BaitouWeng Decoction as a treatment for UC, utilizing blinding or concealment. In Western medicine, patients diagnosed with UC are not limited by age, sex, or region. The control group was treated with traditional Western medicines (mesalazine, cefoxitin, sulfamazopyridine salicylate, prednisone, etc). The observation group utilized the BaitouWeng Decoction as the fundamental formula, incorporating Western medicine, and the dosage forms and intervention methods, including enema and oral administration, were not restricted to meeting the aforementioned requirements. The outcome indicators must include an evaluation of efficacy, not just the efficacy rate, TCM syndrome score, or endoscopic score.

2.3. Exclusion criteria

We excluded literature without a control group, literature from non-clinical studies, literature with insufficient specific indicators, literature without full-text access, and studies using BaitouWeng Decoction in both the treatment and control groups were excluded.

2.4. Data extraction

References were included and excluded independently by 3 researchers, and relevant data were extracted from the references. Data extraction included the first author’s name, publication year, number of patients, treatment effectiveness, baron endoscopy score, TCM syndrome score, serum inflammatory factor level, lesion activity score under colonoscopy, adverse reactions, and recurrence. Three people were opposed, and the instructor adjudicated.

2.5. Quality evaluation criteria

The quality of the selected studies was assessed using a bias risk assessment tool documented on the Cochrane website. The evaluation criteria included random sequence generation, assignment concealment, subject, investigator, outcome evaluator blindness, objective completeness of outcome measurement reporting, and other biases. Finally, the quality evaluation of high risk, unclear, and low risk is provided for each item in the research literature. Grades of Recommendation, Assessment, Development and Evaluation (GRADE) were executed through GRADEpro software (Cochrane).

2.6. Statistical analysis

Data were analyzed using the RevMan 5.3 software. The odds ratio (OR) was used as the effect statistic for bitaxonomic variables, and the mean difference (MD) was used for continuous variables. Heterogeneity was analyzed by the X2 test. If I2 < 50% or a small number of included papers (≤5), the fixed-effects model was used; in contrast, a random-effects model was used. Statistical significance was set at P < .05.

3. Results

3.1. Literature search results

A total of 855 papers were obtained from the preliminary search, and after inclusion and exclusion according to the screening criteria, a total of 24 randomized controlled experimental papers were finally selected for inclusion. The screening process of the literature is shown in Figure 1. The 24 randomized controlled trials (RCTs) selected[11–34] included 2131 patients with UC, 1075 in the experimental group, and 1056 in the control group. The basic characteristics of the selected literature are shown in Table 1.

Figure 1.

Figure 1.

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Flow chart of literature search.

Table 1.

Table of basic characteristics of the literature.

Study or subgroup Assignment method Course of UC Number of cases Intervention measures Dosing cycle Outcome indicators
Experimental Control Control Experimental
Gao 2019[11] Random number table 2–11 yr 43 43 Oral administration of Mesalazine enteric-coated tablets and physiological saline enema BaitouWeng Decoction(100mL) + physiological saline (100 mL)
enema		 4 wk 1. Comprehensive clinical evaluation
2. Symptom scores
3. Recurrence rate
Chen and Pu 2020[12] Random 1–9 yr 30 30 Oral Prednisone and Sulfasalazine BaitouWeng Decoction
warm-taken		 4 wk 1. Comprehensive clinical evaluation
2. Comprehensive clinical evaluation
Li and Guo 2012[13] Random 2 mo −3.8 yr 78 78 Mesalazine suppository inserted into the anus Adjusted BaitouWeng Decoction enema 16 wk 1. Traditional Chinese Medicine Syndrome Score
2. Baron Endoscopy Score
Chen et al 2014[14] Random 6 mo −8 yr 33 33 Cefoxitin + Ornidazole sodium chloride injection Adjusted BaitouWeng Decoction enema 2 wk 1. Comprehensive clinical evaluation
2. Baron Endoscopy Score
3. Traditional Chinese Medicine Syndrome Score
Li and Wan 2013[15] Random 1–1.5 yr 33 27 Oral SASP Flavored BaitouWeng Decoction retention enema 8 wk 1. Colonoscopy efficacy indicators
Liu 2012[16] Random 4 mo −10 yr 87 81 Take orally Olsalazine Sodium capsules Flavored BaitouWeng Decoction retention enema 12 wk 1. Colonoscopy efficacy indicators
Li 2015[17] Random 4 mo −4 yr 19 18 Olsalazine Sodium capsules BaitouWeng Decoction with water 4 wk 1. Comprehensive clinical evaluation
Ye and Lu 2020[18] Random 2–8 yr 32 28 Mesalazine granules BaitouWeng Decoction
warm-taken		 8 wk 1. Hemorheology index
2. Baron Endoscopy Score
Tan et al 2016[19] Random number table 4.7 ± 3.7 yr 35 31 Oral Mesalazine sustained-release granules BaitouWeng Decoction
take orally, retention enema		 4 wk 1. Baron Endoscopy Score
2. Histological score
3. IL-10 level
4. TNF-α level
Gu 2018[20] Random 1–9 yr 35 35 Oral administration of Mesalazine enteric-coated tablets + physiological saline enema Oral administration of Mesalazine enteric-coated tablets + adjusted BaitouWeng Decoction enema 4 wk 1. Comprehensive clinical evaluation
2. Recurrence rate
Wu, Zhang, and Cao 2018[21] Random 2–11 yr 30 30 Mesalazine sustained-release granules BaitouWeng Decoction
take orally and retention enema		 4 wk 1. Mayo, Baron Score
2. Comprehensive clinical evaluation
3. Adverse reactions
Kang et al 2023[22] Random 2–9 yr 55 55 Mesalazine sustained-release granules BaitouWeng Decoction
 4 wk 1. Traditional Chinese Medicine Syndrome Score
2. Comprehensive clinical evaluation
3. BBPS Score
4. IL-6, IL-8, TNF-α level
Song 2016[23] Random 1–11 yr 32 32 Take orally Prednisone and Sulfasalazine Piza BaitouWeng Decoction
retention enema		 4 wk 1. Comprehensive clinical evaluation
Shi and Wen 2017[24] Random 3–7 yr 63 63 Sulfasalazine enema Adjusted BaitouWeng Decoction enema 6 wk 1. Traditional Chinese Medicine Syndrome Score
2. Improvement of mucosal condition
3. Mucosal tissue IL-8 expression
4. Mucosal tissue NF-κB mRNA expression
Dai et al 2017[25] Random 3–8 yr 17 17 Sulfasalazine retention enema Adjusted BaitouWeng Decoction enema 6 wk 1. Traditional Chinese Medicine Syndrome Score
2. Evaluation of Traditional Chinese Medicine Efficacy
3. Observation of colonic mucosal lesions
4. Intestinal mucosa NF-κB mRNA
Tang and Yang 2017[26] Random 10 mo–5 yr 34 34 Mesalazin enteric-coated tablets Flavored BaitouWeng Decoction warm-taken 4 wk 1. Comprehensive clinical evaluation
2. Adverse reactions and mucosal changes under colonoscopy
3. TNF-α, IL-8 level
4. Traditional Chinese Medicine Syndrome Score
Zou et al 2016[27] Random 16–20 mo 34 34 Oral administration of Sulfasalazine tablets Flavored BaitouWeng Decoction 4 wk 1. Comparison of patients’ basic information
2. Main symptom disappearance rate
3. Traditional Chinese Medicine Syndrome Score
4. Activity score of lesions under colonoscopy
5. Pathological changes
Wu and Jia 2021[28] Random 1–6 yr 40 40 Oral administration of Mesalazine enteric-coated tablets Flavored BaitouWeng Decoction enema 8 wk 1. Comprehensive clinical evaluation
2. Traditional Chinese Medicine Syndrome Score
3. Serum inflammatory factor levels
Jin et al 2021[29] Random 0.5–4 yr 50 52 Mesalazine enema Flavored BaitouWeng Decoction enema 8 wk 1. Comprehensive clinical evaluation
2. Traditional Chinese Medicine Syndrome Score
3. Intestinal mucosal sign integral
4. Inflammatory factor levels
5. Comparison of gut microbiome
Liu Hongpan 2020[30] Random 5 mo–6 yr 54 54 Orally Mesalazin enteric-coated tablets + live combined Bacillus Subtilis and Enterococcus Faecium enteric-coated capsules Mesalazin enteric-coated tablets + live combined Bacillus Subtilis and Enterococcus Faecium enteric-coated capsules + flavored BaitouWeng Decoction enema 10 wk 1. IL-6, IL-8, TNF-α level
2. Colon mucosal lesion score
3. Traditional Chinese Medicine Syndrome Score
4. Comprehensive clinical evaluation
Xu and Ma 2019[31] Random 2.7–6.4 yr 62 62 Orally Mesalazin Take orally Mesalazin + BaitouWeng Decoction enema 24 wk 1. Comprehensive clinical evaluation
2. Enteroscopy score
3. Activity of ulcerative colitis
4. Changes in T cell subpopulations
5. Incidence of adverse reactions
Long Haibo 2017[32] Random 8–27 mo 30 30 Mesalazin, Prednisone Flavored BaitouWeng Decoction 4 wk 1. Comprehensive clinical evaluation
2. C-reactive protein inflammatory observables
Wang Ping 2021[33] Random ≥4 wk 100 100 Orally Sulfasalazine Take orally Sulfasalazine+
Flavored BaitouWeng Decoction		 – 1. Comprehensive clinical evaluation
2. Incidence of adverse reactions
3. Incidence of complications
Zhou Wenrui 2017[34] Random None 49 49 Orally Sulfasalazine Flavored take orally BaitouWeng Decoction and enema 12 wk Comprehensive clinical evaluation
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IL = interleukin, BBPS = boston bowel preparation scale, UC = ulcerative colitis.

3.2. Risk of bias assessment

Among the 24 selected papers, 2 studies used the random number table method[11,19] for random assignment, while the remaining papers mentioned random assignment but did not have a complete record of the method used to perform random assignment. None of the selected papers described hidden, blinded, selective reporting, and other biases of the assignment method, and the experimental results were complete (Fig. 2).

Figure 2.

Figure 2.

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Study bias risk graph.

3.3. Results of meta-analysis

3.3.1. Efficacy evaluation

  1. Efficacy rate: The results of the heterogeneity analysis indicated that P = .99 and I²=0% were deemed as no heterogeneity, hence a fixed-effects model was used. The results showed that BaitouWeng Decoction significantly enhanced the efficiency of treatment for patients with UC (OR = 5.10, 95% confidence interval [CI] [3.74–6.96], P < .00001). The forest plot is shown in Figure 3.

  2. TCM syndrome scores: The results of the heterogeneity analysis showed that P < .00001 and I²=93% considered strong heterogeneity. Therefore, a random effects model was chosen for evaluation. A meta-analysis showed that the BaitouWeng Decoction significantly decreased TCM syndrome scores in patients with UC (MD = −4.76, 95% CI [−6.16–−3.36], P < .00001). The forest plot is shown in Figure 4A. The sensitivity analysis of the literature was completed using an item-by-item deletion of individual studies for TCM syndrome scores. None of the final results produced more significant changes.

  3. Baron endoscopy score: The results of the Baron endoscopy score heterogeneity analysis showed that P = .97 and I²=0% considered it to be heterogeneous, thus a fixed-effect model was used. The results of the meta-analysis showed that the BaitouWeng Decoction significantly reduced Baron endoscopy score in patients with UC (MD = −0.68, 95% CI [−0.78–−0.58], P < .00001). The forest plot is shown in Figure 4B.

  4. Enteroscopic lesion activity score: The results of the heterogeneity analysis showed that P < .00001 and I²=97% considered it highly heterogeneous. However, due to the small number of included studies, it was chosen to be evaluated using a fixed-effects model. A meta-analysis showed that BaitouWeng Decoction significantly decreased in the colonoscopic lesion activity score in patients with UC (MD = −1.09, 95% CI [−1.15–−1.03], P < .00001). The forest plot is shown in Figure 4C. The sensitivity analysis showed that the study of Liu et al in 2020[30] had significant impact on the results. Excluding the study, there was no heterogeneity (I2 = 0%).

Figure 3.

Figure 3.

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Meta-analysis of the clinical efficacy in the experimental and control group.

Figure 4.

Figure 4.

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Meta-analysis of different scores in the experimental and control group. (A) TCM evidence scores. (B) Baron endoscopic scores. (C) Colonoscopic lesion activity scores. TCM = traditional Chinese medicine.

3.3.2. Serum factor levels

  1. Serum tumor necrosis factor α (TNF-α): The results of the heterogeneity analysis showed that P = .03 and I² = 67% considered moderate heterogeneity; therefore, a random effects model was chosen for evaluation. BaitouWeng Decoction significantly decreased TNF-α (MD = −16.84, 95% CI [−19.92–−13.76], P < .00001) in the serum of patients with UC. The forest plot is shown in Figure 5A.

  2. Serum interleukin (IL)-1β: The results of the heterogeneity analysis showed that P = .37 and I² = 0% considered no heterogeneity; therefore, a fixed-effects model was chosen for evaluation. A meta-analysis showed that BaitouWeng Decoction significantly decreased IL-1β (MD = −11.09, 95% CI [−11.85–−10.33], P < .00001) in the serum of patients with UC. The forest plot is shown in Figure 5B.

  3. Serum IL-6: The results of the heterogeneity analysis showed that P = .02 and I² = 82% considered moderate heterogeneity; therefore, a random effects model was chosen for evaluation. A meta-analysis showed that BaitouWeng Decoction significantly reduced IL-6 levels (MD = −35.76, 95% CI [−37.85–−33.66], P < .00001) in the serum of patients with UC. The forest plot is shown in Figure 5C.

  4. Serum IL-8: The heterogeneity analysis showed that P < .00001 and I² = 99% were considered strong heterogeneity, but because of the relatively small amount of literature selected (≤5), a fixed-effects model was chosen for evaluation. The dendrogram of the meta-analysis showed that BaitouWeng Decoction resulted in a significant decrease in serum IL-8 levels in patients with UC (MD = −10.41, 95% CI [−10.87–−9.95], P < .00001). The forest map is shown in Figure 5D.

  5. Serum IL-10 and IL-13: The results of the heterogeneity analysis showed that P = .01, I² = 78%, P = .02, and I² = 82% considered it to be relatively heterogeneous. Due to the relatively small amount of literature selected (≤5), it was chosen to be evaluated using a fixed-effects model. The meta-analysis showed that BaitouWeng Decoction significantly increased IL-10 (MD = 4.30, 95% CI [3.78–4.82], P < .00001) and IL-13 (MD = 10.30, 95% CI [9.5–11.10], P < .00001) in serum of UC patients. The forest plots are shown in Figure 5E and F.

  6. Colon NF-kB: In addition, 2 studies reported NF-kB expression in the colon. The results showed that BaitouWeng Decoction induced NF-kB (MD = −0.02, 95% CI [−0.05–0.01], P = .23) in the colon of patients with UC, which was not significantly different. The forest plot is shown in Figure 5G.

Figure 5.

Figure 5.

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Meta-analysis of inflammation factors in the experimental and control group. (A) Serum TNF-α. (B) Serum IL-1β. (C) Serum IL-6. (D) Serum IL-8. (E) Serum IL-10. (F) Serum IL-13. (G) Colon NF-κB. IL = interleukin, TNF-α = tumor necrosis factor α.

Due to the limited number of studies, some of the above indicators exhibit significant heterogeneity. Therefore, we did not conduct a sensitivity analysis on its item-by-item deletion.

3.3.3. Recurrence rate and adverse effects

  1. Recurrence rate: The results of the heterogeneity analysis showed that P = .92 and I² = 0% considered it to be heterogeneous; therefore, a fixed-effect model was used. The results of the meta-analysis showed that the Baituang decoction significantly reduced UC recurrence in patients with UC (OR = 0.13, 95% CI [0.04–0.46], P = .002). The forest plot is shown in Figure 6A.

  2. Gastrointestinal adverse reactions and skin rash: The adverse reactions included gastrointestinal reactions, skin rash, granulocytopenia, and liver and kidney damage. Due to the larger sample size, the gastrointestinal adverse reactions were chosen for analysis. The results of the heterogeneity analysis showed that P = .93 and I² = 0%, or P = .68 and I² = 0% considered it to be heterogeneous, so the fixed-effect model was used. The results of the meta-analysis showed that the incidence of adverse reactions was significantly lower in the experimental group than in the control group (OR = 0.31, 95% CI [0.16–0.59], P = .0005). However, the BaitouWeng Decoction exhibited a tendency for skin rash (OR = 0.38, 95% CI [0.13–1.15], P = .09). The forest plot is shown in Figure 6B and C.

Figure 6.

Figure 6.

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Meta-analysis of recurrence rate and adverse effects in the experimental group compared with the control group. (A) Recurrence rate. (B) Gastrointestinal adverse reactions. (C) Skin rash.

3.4. Publication bias analysis

A dearth of studies was incorporated for all outcome indicators,with the exception of efficiency. therefore, a single funnel plot was drawn to assess the reliability of studies regarding efficiency. The funnel plot showed a high degree of symmetry, which could potentially indicate the absence of significant publication bias (Fig. 7).

Figure 7.

Figure 7.

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Efficient funnel diagram.

3.5. GRADE evaluation

GRADEpro was used to evaluate the evidence level of outcome indicators included in the meta-analysis (Table 2). The results showed that the efficacy rate, baron endoscopy score, gastrointestinal adverse reactions, and skin rash were intermediate-quality evidence. The evidence of TCM syndrome scores, serum TNF- α, IL-1 β, IL-8, IL-10, colon NF-KB, and recurrence rate is of low quality. The enteroscopic lesion activity score, serum IL-6, and IL-13 are extremely low-quality evidence.

Table 2.

GRADE evidence quality evaluation of outcomes.

Outcomes N of studies Evidence quality evaluation N of patients Experimental Control Relative (95% CI) Absolute (95% CI) Quality (GRADE)
Risk of bias Inconsistency Indirectness Imprecision Others
Efficacy rate 22 −1* 0 0 0 0 2005 955/1010 (94.6%) 770/995 (77.4%) OR 5.10 [3.74–6.96] 172 more per 1000 (from 154 more to 186 more) ⊕⊕⊕O/B
TCM syndrome scores 7 −1* −1† 0 0 0 668 334 334 MD −4.76 [−6.16–−3.36] – ⊕⊕OO/C
Baron endoscopy score 4 −1* 0 0 0 0 342 175 167 MD −0.68 [−0.78–−0.58] – ⊕⊕⊕O/B
Enteroscopic lesion activity score 3 −1* −1† 0 0 −1‡ 200 154 154 MD −1.01 [−1.07–−0.95] – ⊕OOO/D
Serum TNF-α 4 −1* −1† 0 0 0 346 173 173 MD −16.84 [−19.92–−13.76] – ⊕⊕OO/C
Serum IL-1β 2 −1* 0 0 0 −1‡ 182 92 90 MD −11.09 [−11.85–−10.33] – ⊕⊕OO/C
Serum IL-6 2 −1* −1† 0 0 −1‡ 218 109 109 MD −35.76 [−37.85–−33.66] – ⊕OOO/D
Serum IL-8 5 −1* −1† 0 0 0 468 235 233 MD −10.41 [−10.87–−9.95] – ⊕⊕OO/C
Serum IL-10 3 −1* −1† 0 0 0 242 122 120 MD 4.30 [3.78–4.82] – ⊕⊕OO/C
Serum IL-13 2 −1* −1† 0 0 −1‡ 182 92 90 MD 10.30 [9.50–11.10] – ⊕OOO/D
Colon NF-kB 2 −1* 0 0 0 −1‡ 160 80 80 MD −0.02 [−0.05–0.01] – ⊕⊕OO/C
Recurrence rate 3 −1* 0 0 0 −1‡ 183 3/92 (3.3%) 19/91 (20.9%) OR 0.13 [0.04–0.46] 176 fewer per 1000 (from 198 fewer to 101 fewer) ⊕⊕OO/C
Gastrointestinal adverse reactions 9 −1* 0 0 0 0 847 11/429 (2.6%) 35/418 (8.4%) OR 0.31 [0.16–0.59] 56 fewer per 1000 (from 69 fewer to 33 fewer) ⊕⊕⊕O/B
Skin rash 4 −1* 0 0 0 0 514 4/257 (1.6%) 11/257 (4.3%) OR 0.38 [0.13–1.15] 26 fewer per 1000 (from 37 fewer to 6 more) ⊕⊕⊕O/B
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CI = confidence interval, GRADE = Grades of Recommendation, Assessment, Development and Evaluation, IL = interleukin, MD = mean difference, OR = odds ratio, TCM = traditional Chinese medicine, TNF-α = tumor necrosis factor α.

*Randomization methods, allocation concealment, and blinding have significant biases. †Heterogeneity test, I2 > 50%. ‡Few included studies and samples.

4. Discussion

4.1. Summary of evidence

UC is a chronic, nonspecific intestinal inflammatory disease that is characterized by continuous and diffuse inflammation of the colorectal mucosa.[1] According to TCM, UC is characterized by excessive heat and toxin, large intestinal dampness-heat, and spleen deficiency with dampness encumbrance. Chinese medicinal compound formulas are commonly used for BaitouWeng Decoction, Huanglian Detoxification decoction, and Paeoniae decoction. BaitouWeng Decoction is representative of the treatment of UC with excessive heat and toxins. Modern pharmacological studies have found that BaitouWeng Decoction has a more obvious therapeutic effect in mouse models of UC. This is due to its ability to inhibit the expression of inflammatory factors, restore the morphology of intestinal villi, and restore the quality of goblet cells.[35] Studies have shown that TNF-α has the ability to induce the release of inflammatory factors and arachidonic acid metabolites by certain cells, decrease intestinal mucosal permeability, and be closely associated with the apoptosis of intestinal epithelial cells. Furthermore, its content is correlated with the disease process of UC.[36] In patients with UC, IL-8, whose main role is chemotaxis and activation of neutrophils, also induces an inflammatory response that is positively correlated with the course of the disease.[37] IL-10 is an anti-inflammatory mediator that counteracts other inflammatory mediators, thereby reducing the inflammatory response and related effects. BaitouWeng Decoction has the ability to inhibit the expression of pro-inflammatory cytokines such as IL-1β, TNF-α, and IL-17 while promoting the expression of anti-inflammatory cytokines such as IL-10. The results in a reduction in the damage to the colonic mucosa in UC model mice, and a correction of the imbalance in the body’s immune function.[38]

In this study, we systematically evaluated the difference in efficacy between BaitouWeng Decoction and Western medicine in the treatment of UC using efficacy evaluation as the main index. The results showed that the efficacy in the experimental group was significantly better than that in the control group. The experimental group scored lower than the control group in the meta-analysis of the TCM syndrome score, Baron endoscopic score, and colonoscopic lesion activity score. This indicates that BaitouWeng Decoction exerted a better healing effect on the intestinal mucosa, which is consistent with a previous study.[39] A meta-analysis of serum levels of TNF-α and IL-8 showed that the experimental group was significantly lower than the control group. In addition, the serum IL-10 levels in the experimental group were significantly higher than those in the control group. This indicates that BaitouWeng Decoction could reduce inflammatory factors, increase anti-inflammatory factors, and effectively eliminate oxygen free radicals, thereby exerting a therapeutic or alleviating effect on UC. Moreover, the experimental group had fewer relapses and adverse reactions in the gastrointestinal tract and skin than the control group. This indicates that the BaitouWeng Decoction has better safety profiles. This study further confirms the efficacy and safety of BaitouWeng Decoction in the treatment of UC.

4.2. Research limitations

The review presents some inherent and methodological limitations in study design. We searched databases in both Chinese and English, which may have resulted in language bias. The 24 included trials were conducted in China, which may limit the generalization of the results. The included studies were RCTs without disclosing research details such as randomization methods, allocation concealment, and blinding, which also reduces the certainty of the evidence. In addition, there exist certain apprehensions regarding the potential for bias, as exemplified by the Cochrane risk of bias tool and GRADE evaluation. Due to the low methodological quality of published trials in TCM greatly hinders the systematic evaluation process. Despite these adverse factors, we aspire to summarize the issues and shortcomings through the present review to provide a basis for further research. More rigorously designed RCTs should be conducted on BaitouWeng decoction to generate higher quality evidence, including details of randomization methods, allocation concealment, blinding, and placebo controls. More attention should be paid to the choice of outcome measurement tools and statistical methods. Several studies have yet to report significant or long-term results of BaitouWeng decoction. Therefore, further studies on the sustained benefits are needed. Furthermore, future studies should evaluate efficacy against standard medical treatments head-to-head.

5. Conclusion

BaitouWeng Decoction has shown better clinical efficacy in increasing efficiency, reducing adverse reactions, and decreasing relapse rates in the prevention and treatment of UC. Its mechanism of action is believed to be related to the inhibition of inflammatory responses. However, most studies have observed only clinical efficacy and related adverse reaction indicators, without observing or reporting biochemical indicators in the serum or plasma. Subsequent research is expected to provide mechanistic insights through clinical studies that will serve as a reference for the treatment of UC. However, more prospective, high-quality, large-sample, multicenter, RCTs are needed in clinical practice to improve the quality of the literature and reduce the risk of bias in systematic reviews. And longer-term studies on sustained benefits are needed.

Author contributions

Conceptualization: Qian Xie.

Data curation: Wenlong Yu.

Formal analysis: Yuancong He, Guocheng Deng.

Funding acquisition: Jialiang Guo.

Investigation: Wenlong Yu, Yuancong He, Guocheng Deng.

Methodology: Qian Xie, Wenlong Yu.

Software: Wenlong Yu, Jianlong Liang, Rong Ma.

Supervision: Hongyan Yang, Jiarou Chen.

Validation: Jianlong Liang, Rong Ma.

Visualization: Qian Xie, Yuancong He, Guocheng Deng.

Writing – original draft: Qian Xie, Rong Ma.

Writing – review & editing: Xuxin Zeng, Jialiang Guo.

Abbreviations:

CI
confidence interval
GRADE
Grades of Recommendation, Assessment, Development and Evaluation
IL
interleukin
MD
mean difference
OR
odds ratio
RCT
randomized controlled trial
TCM
traditional Chinese medicine
TNF-α
tumor necrosis factor α
UC
ulcerative colitis

XZ, JG, and RM contributed equally to this work.This study was supported by the National Natural Science Foundation of China (Nos. 82373835, 82173781, and 81872832), Guangdong Basic and Applied Basic Research Foundation (No. 2023A1515110768 and 2019A1515010806), Key Field Projects (Intelligent Manufacturing) of General Universities in Guangdong Province (No. 2020ZDZX2057), and Scientific Research Projects (Characteristic Innovation) of General Universities in Guangdong Province (grant no. 2019KTSCX195); Guangdong Province College Student Innovation and Entrepreneurship Plan Project (No. S202311847093, 202311847019), Student Academic Fund of Foshan University (xsjj202312zrb12); Guangdong Province Climbing Plan Project (No. pdjh2024a388); Foshan Science and Technology Bureau (No. 2320001007283).

The authors approve the manuscript submitted and published.

The authors have no conflicts of interest to disclose.

All data generated or analyzed during this study are included in this published article [and its supplementary information files].

How to cite this article: Xie Q, Yu W, He Y, Deng G, Yang H, Chen J, Liang J, Zeng X, Guo J, Ma R. Efficacy and safety of BaitouWeng decoction for ulcerative colitis: A meta-analysis of randomized and controlled trials. Medicine 2024;103:27(e38704).

Contributor Information

Wenlong Yu, Email: 1677546404@qq.com.

Yuancong He, Email: 2421814197@qq.com.

Guocheng Deng, Email: 3367272489@qq.com.

Hongyan Yang, Email: 1695067778@qq.com.

Jiarou Chen, Email: 2960513024@qq.com.

Jianlong Liang, Email: 543538654@qq.com.

Xuxin Zeng, Email: adhesion2002@163.com.

Jialiang Guo, Email: janalguo@126.com.

Rong Ma, Email: 648510213@qq.com.

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