Effectiveness of traditional Chinese medicine in treating gastrointestinal dysfunction in patients with acute stroke: a systematic review and meta-analysis of 16 randomized controlled trials.

BACKGROUND: Gastrointestinal dysfunction is one of the complications after stroke. If it is not treated in time, it will affect the rehabilitation process after stroke and reduce the quality of life of patients. In this study, we conducted a systematic review and meta-analysis of the reports on the treatment of gastrointestinal dysfunction after stroke with traditional Chinese medicine (TCM) in recent years to provide evidence for clinical diagnosis and treatment. METHODS: The clinical randomized controlled trials (RCTs) published in Chinese Biomedical Literature Database (CBM), China National Knowledge Infrastructure (CNKI), Medline, and Web of Science databases from January 2010 to August 2021 were searched. After screening the qualified literatures, literature quality evaluation was performed. The software Stata 16.0 was used to analyze and compare the outcome indicators of TCM and conventional western medicine treatment, and the utility of TCM in the treatment of gastrointestinal disorders after stroke was comprehensively evaluated. RESULTS: A total of 16 studies were finally selected including a total of 1,589. Meta-analysis showed that TCM treatment of gastrointestinal disorders after stroke was more effective than conventional western medicine treatment [odds ratio (OR) =3.94; 95% confidence interval (CI): 2.63 to 5.89; P=0.000]. It was also shown that TCM can reduce the recovery time of bowel sounds and is superior to conventional western medicine [standard mean difference (SMD) =-1.92; 95% CI: -2.51 to -1.34; P=0.000]; reduce defecation and flatulence recovery time (SMD =-2.51; 95% CI: -3.41 to -1.61; P=0.000); increase gastrin level (SMD =0.80; 95% CI: 0.35 to 1.25; P=0.001); increase motilin level (SMD =2.27; 95% CI: 1.55 to 3.00; P=0.000); increase serum albumin level (SMD =0.72; 95% CI: 0.54 to 0.90; P=0.000); increase transferrin levels (SMD =1.11; 95% CI: 0.86 to 1.36; P=0.000); and it can increase serum prealbumin levels (SMD =1.50; 95% CI: 0.78 to 2.22; P=0.000). DISCUSSION: The use of TCM in the treatment of gastrointestinal dysfunction after stroke can effectively reduce symptoms, shorten the recovery time of bowel sounds, the first defecation and flatulence time, promote gastric motility and gastrointestinal hormone secretion, and improve the nutritional status of patients.

Treatment of functional constipation with the Yun-chang capsule: a double-blind, randomized, placebo-controlled, dose-escalation trial.

BACKGROUND AND AIM: Functional constipation is a common functional bowel disorder for which there is no reliable medical treatment. This study was designed to determine the therapeutic efficacy and safety of the Yun-chang capsule, a Chinese herbal formula, in the treatment of patients with functional constipation. METHODS: In our multi-center, prospective, double-blind, randomized, placebo-controlled, dose-escalation trial, patients with functional constipation received 70 mg of Yun-chang capsule plus 35 mg placebo (group A), 105 mg of Yun-chang capsule (group B), or 105 mg placebo (group C), three times daily for 2 weeks. The primary end-points were the changes in main symptom score and cumulative symptom score 2 weeks after the treatment. The secondary end-points were adverse events. RESULTS: A total of 140 patients were recruited and 132 met the inclusion criteria; 44 patients constituted each of the three treatment groups. Compared with patients in group C, patients in groups A and B had significant improvement in the main symptom score, cumulative symptom score, the change from baseline of the main symptom score, and the change from baseline of the cumulative symptom score at week 1 and week 2. The scores showed slight superiority of group B over group A at week 1 and week 2, although these differences were not statistically significant. There were no differences in adverse events. CONCLUSIONS: The Yun-chang capsule is efficacious and safe for the treatment of patients with functional constipation. Larger and longer-term trials are required to fully assess the benefits and safety of this treatment for functional constipation.

[Yunchang Capsule in treatment of functional constipation: a randomized, double-blinded controlled, multicenter trial].

BACKGROUND: Although there are some Chinese herbal medicines in treatment of constipation, but no multi-center randomized controlled trials have been carried out to prove their effectiveness. OBJECTIVE: To evaluate the safety and efficacy of Yunchang Capsule in treatment of functional constipation with deficiency of both qi and yin and internal accumulation of poisonous pathogenic factors syndrome, and to explore the clinical dosage. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: A randomized, double-blinded controlled, multicenter trial was conducted. A total of 240 patients with functional constipation from West China Hospital of Sichuan University, Affiliated Hospital of Chengdu University of Traditional Chinese Medicine, Affiliated Hospital of Jiangxi University of Traditional Chinese Medicine, the First Affiliated Hospital of Tianjing University of Traditional Chinese Medicine and Fujian Academy of Traditional Chinese Medicine were randomly divided into three groups: low dose group (80 cases), high dose group (80 cases) and control group (80 cases). Patients in the low dose group were treated with two pills (0.35 g/pill) of Yunchang Capsule and one pill of Yunchang Capsule simulant for three times daily; patients in the high dose group were treated with three pills (0.35 g/pill) of Yunchang Capsule for three times daily; and patients in the control group were treated with three pills (0.35 g/pill) of Biantong Capsule for three times daily. The therapeutic course was 14 days. MAIN OUTCOME MEASURES: Clinical symptoms, syndromes, and adverse effects were observed before and after the treatment, and blood, urine and stool tests, hepatorenal function and electrocardiogram were also examined. RESULTS: Two cases were excluded, eleven cases were lost to follow-up, and there were 234 patients entered to intention-to-treat (ITT) analysis. After the treatment, the therapeutic effects were calculated by full analysis set (FAS) and per-protocol population set (PPS) analysis respectively. The effects on functional constipation in FAS showed the response rates in the low dose, high dose and control groups were 86.25% (69/80), 82.90% (63/76), and 70.52% (55/78) respectively, and PPS analysis showed the response rates were 85.71% (66/77), 83.56% (61/73), and 70.13% (54/77) respectively. There were no significant differences among the three groups (P>0.05). The effects on traditional Chinese medicine syndrome in FAS showed the response rates in the low dose, high dose and control groups were 78.75% (63/80), 69.74% (53/76), and 67.95% (53/78) respectively, and PPS analysis showed the response rates were 77.92% (60/77), 69.87%(51/73), and 67.53% (52/77) respectively. There were also no significant differences among the three groups (P>0.05). No severe adverse events were observed. CONCLUSION: Both low dose and high dose of Yunchang Capsule are effective and safe in treatment of functional constipation with deficiency of both qi and yin and internal accumulation of poisonous pathogenic factors syndrome.

[Influence of integrated traditional Chinese and Western medicine therapy on serum resistin levels in patients with severe acute pancreatitis: a randomized controlled trial].

BACKGROUND: Resistin level is high in patients with severe acute pancreatitis (SAP), and resistin is expected to be a new marker for evaluating the severity of acute pancreatitis. OBJECTIVE: To explore the influence of integrated traditional Chinese and Western medicine therapy on serum resistin levels in SAP patients. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: Twenty-eight SAP patients meeting inclusion criteria from Department of Integrated Traditional Chinese and Western Medicine, West China Hospital, Sichuan University were included, and the patients were randomly divided into treatment group and placebo group. There were 13 patients in the treatment group and 15 patients in the placebo group. Patients in the treatment group were given traditional Chinese herbal medicine in addition to the conventional treatment. Patients in the placebo group were given placebo in addition to the conventional treatment. MAIN OUTCOME MEASURES: The serum resistin levels on admission, and days 1, 3, 5, and 7 after the admission were detected. RESULTS: The serum resistin levels on admission in all the patients were higher than normal level, and there was no significant difference between the two groups (P>0.05). On days 1, 3, 5, and 7 after admission, the resistin levels in the treatment group were (3.29 + or - 1.66) microg/L, (3.71 + or - 1.05) microg/L, (3.08 + or - 1.47) microg/L and (3.62 + or - 1.67) microg/L, and in the control group (5.16 + or - 1.93) microg/L, (5.07 + or - 1.53) microg/L, (4.88 + or - 1.47) microg/L and (5.12 + or - 1.48) microg/L, respectively. The resistin levels were lower in the treatment group than in the control group (P<0.05). CONCLUSION: Serum resistin level in SAP patients can be decreased by integrated traditional Chinese medicine and Western medicine therapy.

[Effect of an early application of chaiqin chengqi decoction in treating severe acute pancreatitis complicated with acute respiratory distress syndrome].

OBJECTIVE: To investigate the therapeutic effects of an early application of Chaiqin Chengqi Decoction (CQCQD) on severe acute pancreatitis (SAP) complicated with acute respiratory distress syndrome (ARDS). METHODS: Forty patients of SAP-ARDS were equally randomized into the early-treated group (ET) and the late-treated group (LT), CQCQD was administered to them immediately and 3 days later after hospitalization respectively. Baseline materials in the two groups at the entry were insignificantly different (P > 0.05), and the same conventional Western medical therapy were available to them all. The Acute Physiology and Chronic Heath Evaluation II (APACHE I) scores, the incidence and sustained time of complications, the occurrence of infection, requirement of operation shifting on day 7, as well as the duration resided in hospital and mortality in patients were observed and compared. RESULTS: Comparisons of the above-mentioned clinical indexes between groups showed that the APACHE II score was lower (5.1 +/- 2.0 scores vs 9.3 +/- 4.3 scores, P < 0.01); the incidence of shock was lesser (1/20 vs 7/19); the duration of ARDS, renal failure, cardiac insufficiency, hepatic dysfunction, cerebropathy and enteroplegia, as well as the duration in hospital and the requirement of operation shifting were all shorter significantly (P < 0.05) in the ET group than those in the LT group, but no statistical difference (P > 0.05) was shown in terms of the infection incidence and the mortality. CONCLUSION: An early application of CQCQD in the treatment of SAP could shorten the duration of complications and the couse of disease, lower the requirement of operation shifting. But further study with large samples for explore its impact on the infection incidence and the mortality is needed.

[Value of four scoring systems for predicting prognosis of severe acute pancreatitis].

OBJECTIVE: To evaluate the value of Ranson, acute physiology and chronic health evaluation II (APACHE II), Balthazar CT and pancreatitis outcome prediction (POP) scoring systems in predicting the prognosis of severe acute pancreatitis (SAP). METHODS: A total of 253 consecutive patients with SAP, admitted into West China Hospital of Sichuan University from January 2004 to August 2007 were studied retrospectively. Data associated to Ranson, APACHE II, Balthazar CT and POP scoring systems after admissions were recorded. Four outcome signals including death, local complications, operation transformation, and development of multiple organ dysfunction syndrome (MODS) were analyzed. The receiver operating characteristic (ROC) curves were also drawn and the areas under the ROC curve (AUC) were obtained to compare the sensitivity, specificity, Youden index, and likelihood ratio positive test (LRPT) of the clinical scoring systems in assessing the prognosis of SAP. RESULTS: Through comparison of AUC, Ranson score could be used to predict the outcomes except for local complications (P=0.00), and all its diagnosis threshold was 5. APACHE II score showed that it could assess the outcomes of SAP except for local complications (P=0.00). Its thresholds in mortality, operation transformation, and incidence of MODS were 14, 10, and 12 respectively. Balthazar CT could predict all the outcomes, and the threshold was 6. POP score could predict all the outcomes except for local complications, and its predictive value in mortality was particularly prominent. The sensitivity and specificity of POP in predicting death were 0.90 and 0.92 as the cutoff was no less than 14. The thresholds of POP in mortality, operation transformation, and incidence of MODS were 14, 8, and 10 respectively. CONCLUSION: The prognostic ability of the four scoring systems is not the same. Ranson, APACHE II and POP scoring systems can predict the severity of SAP and entire complication, but they can't predict the local complications. POP score may predict the mortality well, and Balthazar CT scanning can predict all the outcomes, but the sensitivity and specificity are low.

[Risk factor analysis of severe acute pancreatitis complicated by pancreatic encephalopathy].

OBJECTIVE: To study the risk factors for severe acute pancreatitis (SAP) complicated by pancreatic encephalopathy (PE). METHODS: Clinical data from 255 patients with SAP from January 2005 to December 2006 were reviewed. Thirty-one SAP patients had PE, and 224 SAP patients did not. Clinical characteristics of SAP patients in both PE group and non-PE group were analyzed. RESULTS: Ranson scale and the incidence rates of acute respiratory distress syndrome (ARDS), renal failure, hypoproteinemia, hypocalcemia and hyperglycosemia in PE group were higher than those in non-PE group (P<0.05). There were no significant differences in acute physiology and chronic health evaluation II and CT severity index scales, the activities of amylase and lipase, the incidence rate of liver function failure, the infection rate and the operability between the PE group and the non-PE group (P>0.05). Multivariate logistic regression analysis showed that ARDS and hyperglycosemia were high risk factors. Cure rate in PE group was higher than that in non-PE group. CONCLUSION: Nosogenesis of PE is the result of multiple factors. ARDS and hyperglycosemia may be the high risk factors for PE.

[Clinical study of Yihuo Qingxia method in treating hyperlipoidemia-related severe acute pancreatitis in early stage].

OBJECTIVE: To investigate the therapeutic effect of Yihuo Qingxia method, a traditional Chinese medicine therapeutic method for replenishing qi to activate blood, clearing away heat and dredging intestines, in treating hyperlipoidemia-related severe acute pancreatitis (SAP) in early stage. METHODS: One hundred and four patients with hyperlipoidemia-related SAP were divided into two groups: early group (admitted to hospital within 3 days after onset) and late group (admitted to hospital from 3 days to 7 days after onset). There were 52 cases in each group. All the patients were treated by Yihuo Qingxia method. RESULTS: There were no statistical differences in 48-hour Ranson scores, CT scores, 24-hour acute physiology and chronic heath evaluation II scores (APACHE II scores), and the levels of 24-hour serum triglyceride (TG) and serum glucose in the two groups (P>0.05). At the 10th day after onset, the serum TG level in early group was lower than that in late group (P<0.01). The incidences of acute respiratory distress syndrome, acute renal failure, hepatic inadequacy, congestive heart failure, shock, encephalopathy, infection and alimentary tract hemorrhage in early group were higher than those in late group (P<0.05). The mortality in early group was lower than that in the late group (P<0.05). The length of hospital stay in early group was shorter than that in late group (P<0.05). CONCLUSION: Yihuo Qingxia method has a good efficacy in treating hyperlipoidemia-related SAP in early stage.

[Effects of Chaiqin Chengqi Decoction on activation of nuclear factor-kappaB in pancreas of rats with acute necrotizing pancreatitis].

OBJECTIVE: To explore the mechanism of Chaiqin Chengqi Decoction (CQCQD) in treatment of rats with acute necrotizing pancreatitis (ANP). METHODS: Thirty SD rats were randomly divided into 3 groups: sham-operated (SO) group, ANP group and CQCQD-treated group. ANP was induced by retro-pumping 3.5% sodium cholate to common bile duct. Blood sample was collected from abdominal vein for examination and the pancreatic tissue samples were taken for making pathology section 6 hours later. The pancreatic tissue (HE staining) was observed by light microscope. The content of tumor necrosis factor-alpha (TNF-alpha) and interleukin-6 (IL-6) was detected with the method of enzyme-linked immunosorbent assay, and the activation of nuclear factor-kappaB (NF-kappaB) in pancreas was detected by immunohistochemical method. RESULTS: Compared with the SO group, there was dramatic increase in the white blood cell (WBC) counts and AMY level in the ANP group (P<0.05, P<0.01). Compared with the ANP group, the WBC counts and AMY level in CQCQD-treated group were significantly reduced (P<0.05). The edema, inflammatory infiltration, haemorrhage and necrosis scores and total pathological score in the ANP group were obviously higher than those in the SO group (P<0.01). The edema, haemorrhage and inflammatory infiltration scores and the total pathological score in CQCQD-treated group were decreased (P<0.05). The integral optical density of NF-kappaB p65 positive cells of pancreas in CQCQD-treated group was lower than that in the ANP group (P<0.05). CONCLUSION: CQCQD can reduce the content of serum TNF-alpha and IL-6, depress the activation of NF-kappaB, and lessen the pancreatic lesions.

[Impact of Chai Qin Cheng Qi Decoction on cholinergic anti-inflammatory pathway in rats with severe acute pancreatitis].

OBJECTIVE: To test the change of true choline esterase (TChE) and cholineacetyltransferase (ChAT) and their correlation with interleukin-6 (IL-6) and Tumor Necrosis Factor-alpha (TNF-alpha), and the impact of Chai Qin Cheng Qi Decoction (CQCQD) on cholinergic anti-inflammatory pathway in rats with severe acute pancreatitis (SAP). Methods Thirty SD rats were randomly divided into three groups: control group (pseudo-operated), SAP group and CQCQD-treated group, each with 10 rats. Blood samples were taken six hours after injection of testing agents for biochemical test, which included the test of amylase, TNF-alpha, IL-6, TChE, and ChAT. RESULTS: The rats in SAP group had higher levels of serum IL-6, TNF-alpha and TChE and lower levels of serum ChAT than those in control group (P < 0.05). The serum IL-6 was positively correlated with TChE (r = 0.95, P = 0.000) and negatively correlated with ChAT (r = -0.91, P = 0.000). The TNF-alpha was also positively correlated with TChE (r = 0.93, P = 0.000) and negatively correlated with ChAT (r = -0.95, P = 0.004). The rats in CQCQD-treated group had lower levels of serum IL-6, TNF-alpha and TChE and higher levels of serum ChAT than those in SAP group (P < 0.01). The increase of white blood cell, alanine aminotransferase, aspartate aminotransferase and lactate dehydrogenase was observed in the control group first and followed by the CQCQD-treated group and SAP group sequentially (P < 0.05). Conclusions Cholinergic anti-inflammatory pathway plays an important role in the pathological changes of SAP in rats. CQCQD can relieve the systemic inflammatory response syndrome and reduce the functional damage of organs through interference on the cholinergic antiinflammatory pathway. More studies are needed to reveal the mechanism of such impact.

[Clinical study on severe acute pancreatitis associated with hypoalbuminemia in early stage].

OBJECTIVE: To investigate the occurring mechanism and clinical characteristics of severe acute pancreatitis (SAP) associated with hypoalbuminemia in early stage and its influence on prognosis of SAP and the preventive and therapeutic management of this disease. METHODS: One hundred and thirty-eight cases diagnosed as SAP complicated by hypoalbuminemia in early stage were accepted in our hospital from August 1, 2003 to December 31, 2004, and they were divided into 2 groups according to the level of plasma albumin: mild hypoalbuminemia (30 to 35 g/L) group and severe hypoalbuminemia (<30 g/L) group. The complications in the early stage, related parameters, and the incidence rate of infection and mortality in the later stage were evaluated respectively. RESULTS: The incidence rates of renal dysfunction, shock, cardiovascular failure and gastrointestinal hemorrhage, the score of acute physiology and chronic health evaluation II (APACHE II ) and the frequencies of pulse and breath in the severe hypoalbuminemia group were all higher than those in the mild hypoalbuminemia group (P<0.05 or P<0.01). The differences of incidence rate of hepatic failure and the scores of Ranson and Balthazar CT between these two groups had no statistical significance (P>0.05). The incidence rate of infection and the mortality in the severe hypoalbuminemia group were higher than those in the mild hypoalbuminemia group (P<0.01) in the later stage of SAP. CONCLUSION: Hypoalbuminemia in the early stage can accelerate the deterioration in pathophysiology of SAP. The lower level of the plasma albumin is in the early stage, the more complications and the higher incidence rate of infection and mortality will be in the later stage. To relieve the extent of systemic inflammatory response syndrome (SIRS) and abundant supplement of albumin, amino acid and lipid in time may be crucial to prevent the occurrence and deterioration of hypoalbuminemia.

[Clinical study of Chaiqin Chengqi Decoction in treating severe acute biliary pancreatitis].

OBJECTIVE: To study the therapeutic effects of Chaiqin Chengqi Decoction (CQCQD) in treating severe acute biliary pancreatitis. METHODS: Ninety patients with severe acute biliary pancreatitis were treated with CQCQD, and they were divided into two groups: early-treated group (54 patients treated with CQCQD within 3 days after the onset of severe acute biliary pancreatitis) and late-treated group (36 patients treated with CQCQD between 3 and 7 days after the onset of severe acute biliary pancreatitis). The complication incidence rate, operation rate, mortality rate and hospitalization period were examined. RESULTS: The incidence rates of encephalopathy, infection and gastrointestinal hemorrhage were lower in the early-treated group than those in the late-treated group (P<0.05). The hospitalization periods of the early- and late-treated groups were (24.9+/-18.4) days and (51.6+/-45.9) days respectively (P<0.05). The general mortality rate was 14.4%. The mortality rate of the early-treated group (7.4%) was significantly lower as compared with that of the late-treated group (25.0%) (P<0.05). The operation rate of the early-treated group (11.1%) was also significantly lower as compared with that of the late-treated group (27.8%) (P<0.05). CONCLUSION: Treating severe acute biliary pancreatitis with CQCQD in early stage may reduce the complication incidence rate, shorten the hospitalization period, and decrease the operation rate and mortality rate.

[Clinical study on the treatment of severe acute pancreatitis by integrated traditional Chinese medicine and Western medicine].

OBJECTIVE: To sum up clinical experiences and formulate a new treatment program for the effective managment of severe acute pancreatitis(SAP) by integrated TCM and western medicine. METHODS: The therapeutic regimens and end results of 1376 cases of SAP in three periods were reviewed and analyzed. Period I (1980-1990) was characterized by early surgical intervention supplemented with integrated traditional Chinese and western medical therapy, period II (1991-1993) by integrated traditional Chinese and western medical therapy supplemented with surgery for early complications, and period III (1994-2003) by integrated traditional Chinese and western medical therapy supplemented with surgery for local infectious complications at a late stage in the course of disease. RESULTS: With use of integrated traditional Chinese and western medical therapy in the treatment of SAP, the proportion of surgical operation and the case-fatality rate kept declining in the three consecutive periods, the proportions of operation being 77.59%, 54.54% and 19.38%, and the case-fatality rates being 40.52%, 17.17% and 10.77%, respectively. CONCLUSION: Integrated TCM and western medicine is effective for most SAP cases, and surgery is indicated mainly for late complications such as necrotizing infection. Early surgery should be handled with more circumspection and strictness in most of the patients with SAP.