Post-marketing Re-evaluation of Tongxiening Granules () in Treatment of Diarrhea-Predominant Irritable Bowel Syndrome: A Multi-center, Randomized, Double-Blind, Double-Dummy and Positive Control Trial / 中国结合医学杂志

OBJECTIVE@#To evaluate the efficacy and safety of Tongxiening Granules (, TXNG) in the treatment of irritable bowel syndrome with predominant diarrhea (IBS-D).@*METHODS@#A randomized, double-blind, double-dummy, and positive parallel controlled clinical trial was conducted from October 2014 to March 2016. Totally 342 patients from 13 clinical centers were enrolled and randomly assigned (at the ratio of 1:1) to a treatment group (171 cases) and a control group (171 cases) by a random coding table. The patients in the treatment group were administered orally with TXNG (5 g per time) combined with pinaverium bromide Tablet simulator (50 mg per time), 3 times per day. The patients in the control group were given TXNG simulator (5 g per time) combined with pinaverium bromide Tablets (50 mg per time), 3 times per day. The treatment course lasted for 6 weeks. The improvement of Irritable Bowel Syndrome Symptom Severity Score (IBS-SSS) was used to evaluate the primary outcome. Secondary outcomes included adequate relief (AR) rate, Irritable Bowel Syndrome-Quality of Life Questionnaire (IBS-QOL), Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD), and the recurrence rate at follow-ups. Safety indices including the adverse events (AEs) and related laboratory tests were evaluated.@*RESULTS@#Primary outcome: IBS-SSS at baseline, weeks 2, 4, 6 showed no statistical significance in both full analysis set (FAS) and per protocol set (PPS, P>0.05). After 6 weeks of treatment, the total effective rate of IBS-SSS scores in the treatment group (147/171,86.0%) was higher than the control group (143/171, 83.6%) by FAS (P>0.05). In regard to secondary outcomes, after 6-week treatment, there was no significant difference in AR rate, total score of IBS-QOL, improvement of HAMD and HAMA total scores between the two groups (P>0.05). The recurrence rate at 8-week follow-up was 12.35% (10/18) in treatment group and 15.79% (12/76) in control group, respectively (P>0.05). A total of 21 AEs occurred in 15 cases, of which 11 occurred in 8 cases in the treatment group and 10 AEs in 7 cases in the control group. The incidence of AEs had no statistical significance between the two goups (P>0.05).@*CONCLUSION@#Tongxiening Granules could relieve the symptoms of patients with IBS-D and the treatment effect was comparable to pinaverium bromide. (No. ChiCTR-IPR-15006415).

Effect of Zhizhu Pill on Gastric Smooth Muscle Contractile Response and Protein Expression of Growth Hormone Secretagogue Receptor in Functional Dyspepsia Rats / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To study the therapeutic mechanism of Zhizhu Pill (ZP) for treating functional dyspepsia (FD) rats.</p><p><b>METHODS</b>Totally 30 ten-day-old male rats were randomly divided into the normal control group (n =10) and the model group (n = 20). The FD rat model was induced using gastric administration of 0.1% iodoacetamide (IA) combined tail clamping. The model was evaluated when rats were 8-week old. Successfully modeled rats were randomly divided into the model group (n = 10) and the ZP group (n = 10). Rats in the normal group and the model group were administered with normal saline by gastrogavage, while those in the ZP group were administered with ZP Decoction (2 mL/100 g) by gastrogavage. All medication lasted for 7 successive days. The contractile activity in in vitro longitudinal gastric muscle was recorded using Power Lab biological signal collecting system. The expression of growth hormone secretagogue receptor (GHSR) in stomach of FD rats was detected using Western blot and immunohistochemistry (IHC).</p><p><b>RESULTS</b>Compared with the normal group, average frequencies of gastric contraction and changing rates of amplitude obviously decreased in the model group (P < 0.05). Results of Western blot and IHC showed that the expression of GHSR decreased in the model group (P < 0.01). Compared with the model group, average frequencies of gastric contraction and changing rates of amplitude obviously increased in the ZP group (P < 0.05). Results of Western blot and IHC showed that the expression of GHSR increased in the ZP group (P < 0.01).</p><p><b>CONCLUSION</b>ZP could promote the gastric motility in FD rats induced by gastric administration of IA combined tail clamping, and its mechanism might be related to up-regulating GHSR protein level.</p>

Treating non-alcoholic fatty liver disease patients of Gan stagnation Pi deficiency syndrome by tiaogan lidi recipe: a randomized controlled clinical trial / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy and safety of tiaogan Lipi Recipe (TLR) in treating non-alcoholic fatty liver disease (NAFLD) patients of Gan stagnation Pi deficiency syndrome (GSP-DS).</p><p><b>METHODS</b>A randomized, double blind, placebo-controlled clinical trial was performed. Totally 99 NAFLD patients of GSPDS were randomly allocated into two groups, 66 patients in the treatment group (treated with-TLR, one dose per day) and 33 patients in the control group (treated with placebos, one dose per day). The therapeutic course for all was 12 weeks. All patients received lifestyle interventions including moderate aerobic exercise, moderate caloric restriction, and dietary changes. Clinical symptoms, CT indices, liver functions and blood lipids were observed before and after treatment.</p><p><b>RESULTS</b>After 12 weeks of treatment, the total score of clinical symptoms decreased in the two groups (P <0. 01), and it was lower in the treatment group than in the control group (P <0. 05). Liver/spleen CT ratio increased in the treatment group (P <0. 01), and it was higher in the treatment group than in the control group (P <0. 01). After treatment levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT) all decreased in the treatment group (P <0. 05, P <0. 01), while levels of ALT decreased in the control group (P <0. 05). Besides, all the 3 levels mentioned above were lower in the treatment group than in the control group (P <0. 05). Levels of total cholesterol (CHO) and triglyceride (TG) decreased in the two groups (P <0. 05), and they were lower in the treatment group (P <0. 05). Total effective rates of TCM syndrome, abdominal CT, liver functions, and blood lipids were 79. 69% (51/64 cases), 54. 69% (35/64 cases), 67. 65% (23/34 cases), and 67. 39% (31/46 cases) in the treatment group, while they were 56. 25% (18/32 cases), 25. 00% (8/32 cases), 33. 33% (6/18 cases), and 55. 56% (10/18 cases) in the control group. All were superior in the treatment group (P <0.05, P <0.01, respectively).</p><p><b>CONCLUSION</b>TLR combined with lifestyle intervention could safely and effectively improve clinical symptoms of NAFLD patients of GSPDS, elevate liver/spleen CT ratios, and play a role in liver protection, anti-inflammation, and lowering blood lipids.</p>

Study on the mechanism of action of total saponins of Panax notoginseng in ameliorating oxidative stress and insulin resistance in rats fed with high fat diet / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To investigate whether total saponins of Panax notoginseng (tPNS) can ameliorate oxidative stress and insulin resistance (IR) in the high fat induced nonalcoholic fatty liver disease (NAFLD) rat model and to explore the relationship between oxidative stress and IR.</p><p><b>METHODS</b>Totally 50 healthy rats were randomly divided into the normal control group (NC), the model group, the high dose tPNS group (at the daily dose of 160 mg/kg), the low dose tPNS group (at the daily dose of 80 mg/kg), and the bicyclol group (at the daily dose of 100 mg/kg), 10 in each group. Rats in the NC group were fed with standard forage. Those in the rest group were fed with high fat forage. Distilled water was given by gastrogavage to those in the NC group and the model group. Corresponding medication was performed for 4 weeks. Four weeks later Lee's index and body weight were measured. All rats were sacrificed to detect the wet weight of livers. Their sera was isolated and detected to calculate liver functions (serum ALT and AST levels). Levels of fasting blood glucose (FBG) and fasting insulin (FINS) were detected. Insulin sensitive index (ISI) and insulin resistance index (IRI) were calculated. Serum levels of TNF-alpha and malondialdehyde (MDA), contents of total superoxide dismutase (T-SOD), hydroxy radical level (-OH), and total antioxidant capacity (T-AOC) were measured. Pathological changes of livers was observed by HE staining of paraffin section.</p><p><b>RESULTS</b>Compared with the NC group, rats' wet liver weight and Lee's index increased in the model group (P < 0.05), and results of light microscopy showed that obvious fatty degeneration occurred in livers. Compared with the model group, rats' wet liver weight and Lee's index, as well as ALT and AST could be obviously improved by tPNS and bicyclol (P < 0.05, P < 0.01). The fatty deposition of liver cells could also be alleviated. Compared with the NC group, serum levels of-OH, MDA, and TNF-alpha significantly increased, and activities of T-SOD and T-AOC decreased in the model group (P < 0.01), also accompanied with IR. Compared with the model group, concentrations of -OH, MDA, and TNF-alpha decreased after treated by tPNS (P < 0.05, P < 0.01), activities of T-SOD and T-AOC got recovered (P < 0.05, P < 0.01), and IR got obvious improvement (P < 0.01).</p><p><b>CONCLUSION</b>The anti-oxidative stress effect and IR improving effect of tPNS might play partial roles in treating NAFLD.</p>

Efficacy of Gastrosis No.1 compound on functional dyspepsia of spleen and stomach deficiency-cold syndrome: a multi-center, double-blind, placebo-controlled clinical trial / 中国结合医学杂志

<p><b>OBJECTIVE</b>To assess the efficacy and safety of Gastrosis No.1 compound in the treatment of functional dyspepsia with Spleen (Pi) and Stomach (Wei) deficiency-cold syndrome.</p><p><b>METHODS</b>A randomized, double-blind, placebo-controlled trial was performed in 5 centers. Patients with functional dyspepsia (FD) of Spleen-deficiency and qi-stagnation syndrome (162 cases) were randomly assigned to groups given Chinese herbal medicine (CHM) Gastrosis No.1 compound or placebo in a 2:1 ratio. This trial included a 4-week treatment period and a 4-week follow-up period. The outcomes were the dyspepsia symptom scores (measured by total dyspepsia symptom scale and single dyspepsia symptom scale) and syndromes of traditional Chinese medicine score (measured by traditional Chinese medicine syndrome scale). The outcomes were noted at weeks 0, 4 and 8.</p><p><b>RESULTS</b>Compared with patients in the placebo group, patients in the CHM group showed significant improvement in the dyspepsia symptom scores as rated by patients and investigators (P <0.01), and also showed improvement in syndromes of traditional Chinese medicine score (P <0.01). No serious adverse event was reported. Safety tests obtained after 4 weeks of treatment showed no abnormal values.</p><p><b>CONCLUSION</b>CHM Gastrosis No.1 compound was effective and safe in the treatment of functional dyspepsia with Spleen and Stomach deficiency-cold syndrome.</p>

Effects of shugan jianpi recipe on the ion transport of diarrhea predominant irritable bowel syndrome rat colon mucosa induced by 5-HT / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To investigate the mechanism of Shugan Jianpi Recipe (SJR) on the ion transportation of diarrhea predominant irritable bowel syndrome (IBS-D) colon mucosa induced by 5-HT.</p><p><b>METHODS</b>Totally 36 male SD rats were randomly divided into three groups, i. e., the normal group, the model group, and the SJR group, 12 in each group. IBS-D Rat model was induced by intracolonic instillation of acetic acid and restraint stress. After successful modeling, normal saline was given to rats in the normal group and the model group, while SJR was given to those in the SJR group by gastrogavage for 14 days. The short circuit current (lsc) technology was used to measure 5-HT induced lsc changes of the colon mucosa under the actions of drugs and specific blocking agents.</p><p><b>RESULTS</b>There was no difference in basal current (BC), the potential difference (PD), and transmembrane resistance (TR) of the distal colon among the 3 groups (all P > 0.05). The 5-HT induced short circuit current change (delta lsc) was lower in the model group than in the normal group (P < 0.05), and it was higher in the SJR group than in the model group (P < 0.05). When 4,4'-diisothiocyanato-stilbene-2,2'-disulfonic acid (DIDS, 500 micromol/L), an Ca(+)-dependent Cl- channel blocker, was added from the epiphragm of the colonic mucosa, the 5-HT induced delta lsc was lower in the model group than in the normal group (P < 0.05), and it was higher in the SJR group than in the model group (P < 0.05). When Na+ was substituted in the epiphragm solution (Na+ free) or amiloride (100 micromol/L) was added from the epiphragm of the colonic mucosa, an epithelial Na+ channel blocker, the 5-HT induced delta lsc was lower in the model group than in the normal group (P < 0.05), and it was higher in the SJR group than in the model group (P < 0.05).</p><p><b>CONCLUSIONS</b>SJR could affect the transmembrane electrolyte transportation of IBS-D rat induced by 5-HT through regulating the secretion of Cl- and HCO3-. The effects might be achieved by the coordination of apical Cl- channel CFTR, basolateral Na(+)-K+ ATPase, sodium-potassium-chloride cotransporter, sodium-bicarbonate cotransporter, Cl-/HCO3- exchanger, as well as K+ channel.</p>

Clinical study of comprehensive treatment of Chinese medicine in treating ulcerative colitis based on two steps according to the stage of disease / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To observe the clinical efficacy of comprehensive treatment of Chinese medicine in treating ulcerative colitis (UC) according to syndrome differentiation therapy and the stage of disease.</p><p><b>METHODS</b>Fifty-three patients with mild or moderate, initial onset or relapsed active UC of large intestinal dampness-heat syndrome were randomly assigned to two groups, the treatment group (27 cases) and the control group (26 cases). The treatment group was treated with oral Qingchang Huashi Recipe (QHR) and external application of Guanchang Recipe (GR) in the active stage, oral administration of Fuzheng Qingchang Recipe in the remission stage. Symptomatic modification was performed according to the features of the symptoms. Patients in the control group were treated with oral Mesalazine enteric coated tablet (MSRT, 1.0 g, 4 times daily) in the active stage, oral administration of MSRT (0.5 g, three times daily) in the remission stage. The main clinical symptoms, Chinese medicine syndrome, induced remission rate, and changes of quality of life were observed on the 28th, 56th, and 84th day after treatment.</p><p><b>RESULTS</b>After 84 days of treatment, the scores of the symptoms such as diarrhea, passing stool with pus and blood, and the abdominal pain in the treatment group were obviously improved when compared with before treatment (P < 0.05). The scores of the symptoms such as diarrhea, and passing stool with pus and blood in the treatment group were better than those in the control group (P < 0.05). After 28, 56, and 84 days of treatment, the clinical efficacy of Chinese syndromes were 77.78%, 77.78%, and 88. 89%, respectively, and the induced remission rates were 63.0%, 77.8%, and 88.9%, respectively in the treatment group, better than those in the control group of the same phase (P < 0.05). After 84 days of treatment, the scores of the quality of life, the general symptoms, the emotional capacity, and the social capacity, tc. in the treatment group and the control group were improved than before treatment (P < 0.05). Besides, the scores of the quality of life in the treatment group were superior to that in the control group (P < 0.05).</p><p><b>CONCLUSIONS</b>Comprehensive treatment of Chinese medicine in treating ulcerative colitis based on two steps according to the stage of disease can effectively improve the main symptoms of UC patients, improve the Chinese syndromes, elevate the clinical remission rate and patients' quality of life. It showed favorable clinical efficacy.</p>

The current state and prospect of Chinese medicine gastroenterology / 中国中西医结合杂志

The progress and existent problems of Chinese medicine (CM) gastroenterology since the National Eleventh Five-Year Plan were discussed in this article in terms of theory innovation, formulation of clinical pathway and diagnosis-treatment consensus, efficacy assessment, formulation of efficacy assessment scale, advantage diseases, and exploration of the syndrome standardization, progress in science research, academic exchange, and the construction of study platform, and so on. Meanwhile, the development of CM gastroenterology was prospected in the following five aspects: to enhance the theory inheritance and innovation, the construction of discipline standardization; to establish scientific clinical efficacy assessment methods and the standard system; to expend treatment technologies and feature therapies; and to clarify the modern scientific connotation of CM theory and treatment.

A multi-center randomized controlled trial on treatment of diarrhea-predominant irritable bowel syndrome by Chinese medicine syndrome-differentiation therapy / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To verify the clinical efficacy of Chinese Medicine syndrome-differentiation therapy in treating diarrhea-predominant irritable bowel syndrome IBS-D.</p><p><b>METHODS</b>With a blinded randomized controlled design adopted, 360 patients with IBS-D were randomly assigned to two groups, the treated group and the control group, they were treated with Chinese medicine and Pinaverium bromide for four weeks respectively.</p><p><b>RESULTS</b>Comprehensive evaluation showed that the total effective rate in the treated group was higher than that in the control group significantly (93.8% vs 81.3%, P<0.01). Efficacy assessment on symptoms (by scoring) showed that the efficacy in the treated group was better than that in the control group in aspects of improving abdominal pain (86.1% vs 70.3%), defecation coziness (involving the frequency of defecation, incidence of tenesmus in the latest 10 days and Bristol typing of stool characters), living interfering, and total BSS score (P<0.05 or P<0.01).</p><p><b>CONCLUSION</b>Chinese medicine syndrome-differentiation dependent therapy shows good efficacy in treating IBS-D.</p>

Effect of TCM therapy for invigorating Pi, soothing Gan, eliminating dampness and resolving blood stasis on the short-term quality of life in patients with diarrhea type irritable bowel syndrome / 中国中西医结合杂志

<p><b>OBJECTIVE</b>To observe the TCM therapy for invigorating Pi, soothing Gan, eliminating dampness and resolving blood stasis (TCM-T) on the short-term quality of life (stQOL) in patients with diarrhea type irritable bowel syndrome (IBS-D).</p><p><b>METHODS</b>One hundred and twenty-five patients with IBS-D were assigned to 3 groups, Group A was treated with TCM-T; Group B treated with some selected Chinese patent drugs according to patients' syndrome types, such as Changweikang granule, Guben Yichang tablet, Bupi Yichang pill and Shenling Baizhu pill, Group C treated with Western medicines as Dicetel 50 mg, Oryzanol 10 mg, and Bifid triple viable 420 mg, 3 times daily by oral administration. The therapeutic course was 4 weeks for all. The stQOL was evaluated and compared by SF-36 scale before and after treatment.</p><p><b>RESULTS</b>Comparison between groups on the scores for the 8 dimensions of SF-36 scale, i.e., physiological function (PF), role physical (RP), body pain (BP), global health (GH), vitality (VT), society function (SF), emotional effect (RE), and mental health (MH), showed no significant difference before treatment, but scores of all the 8 dimensions were improved significantly in Group A after treatment (P < 0.05), with scores of SF, BP, GH and MH superior to those in Group B (P < 0.05, P < 0.01), and scores of RP, GH, SF, RE, PF and MH superior to those in Group C (P < 0.05, P < 0.01).</p><p><b>CONCLUSION</b>TCM-T has favorable effect in treating IBS-D, it could improve the stQOL of patients.</p>