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This study was conducted to evaluate the efficacy and safety of Simotang Oral Liquid in the treatment of functional dyspepsia in adults. "Simotang Oral Liquid" "Simotang" "Si Mo Tang" "Si Mo Tang Oral Liquid" were used for retrieval of the relevant papers from CNKI, Wanfang, VIP, SinoMed, PubMed, Cochrane Library, Springer Link, and Web of Science from database inception to June 2021. Randomized controlled trial(RCT) of Simotang Oral Liquid in the treatment of functional dyspepsia in adults was screened out for Meta-analysis which was conducted in RevMan 5.3. A total of 16 RCTs were included. Meta-analysis showed that compared with the control group, Simotang Oral Liquid increased the total response rate and lowered the traditional Chinese medicine syndrome scores, serum cholecystokinin(CCK), serum nitric oxide(NO), and incidence of adverse reactions. However, the serum substance P(SP) had no statistical difference between the two groups. Simotang Oral Liquid is effective and safe in the treatment of functional dyspepsia in adults. However, this study has evidence and limitations, so the conclusions need to be further verified by large sample and multicenter clinical studies.
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Adult , Humans , Databases, Factual , Drugs, Chinese Herbal/therapeutic use , Dyspepsia/drug therapy , Medicine, Chinese Traditional , Multicenter Studies as Topic , Randomized Controlled Trials as TopicABSTRACT
OBJECTIVE To explore the improvement effect and mechanism of Simotang oral liquid on functional dyspepsia （FD） model rats by regulating PTEN-induced putative kinase 1 （Pink1）/E3 ubiquitin ligase （Parkin） axis. METHODS SD male rats were subjected to unpredictable chronic stress to establish an FD model， and were randomly grouped into the model group， positive control group （Domperidone tablets， 3.5 mg/kg）， Simo decoction group （Simotang oral liquid， 5.4 mL/kg）， with 20 rats in each group. The blank group without modeling was set up. Administration groups were given relevant medicine intragastrically， blank group and model group were given constant volume of normal saline intragastrically， once a day， for consecutive 14 d. After the last administration， the gastric emptying rate and small intestine propulsion rate of rats were detected. The contents of gastrointestinal hormones [motilin （MTL）， gastrin （GAS） and cholecystokinin （CCK）] in rats were determined； the mitochondrial structure of ICC in gastric antrum tissue of rats was observed； the immunofluorescence co-localization method was applied to observe the expression of cytochrome C oxidase Ⅳ （COX Ⅳ） and Parkin in gastric antrum tissue of rats； the protein expressions of LC3， p62， Pink1 and Parkin in gastric antrum tissue of rats were all detected. RESULTS Compared with the blank group， the gastric emptying rate， small intestinal propulsion rate， the serum contents of MTL and GAS， and protein expression of p62 in model group were all reduced significantly （P＜0.05）； the serum content of CCK， the co-localization expression of COX Ⅳ and Parkin in mitochondria， the protein expressions of LC3， Pink1 and Parkin were all increased significantly （P＜0.05）. The number of ICC mitochondria in gastric antrum tissue decreased， mitochondria became vacuolated， mitochondrial cristae were blurry， and there were more autophagic lysosomes. Compared with the model group， the above indexes of the positive control group and the Simo decoction group were reversed significantly （P＜0.05）； the mitochondrial structure of ICC gradually recovered， with clear mitochondrial cristae and reduced autophagic lysosomes. CONCLUSIONS Simotang oral liquid can improve gastrointestinal motility and gastrointestinal hormone levels in model rats， the mechanism of which may be related to inhibiting Pink1/Parkin axis and blocking autophagy.
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ObjectiveTo evaluate the safety， efficacy， and economy of the four Chinese patent medicines （CPMs）， including Simotang oral liquid， Liuwei Anxiao capsule， Baohe pill， and Jianwei Xiaoshi oral liquid in the treatment of functional dyspepsia （FD） by a rapid health technology assessment （RHTA）， thus providing evidence support for clinical decision making. MethodChina National Knowledge Infrastructure （CNKI）， WanFang Database， VIP Chinese Technology Periodical Database （VIP）， China Biology Medicine disc （CBMdisc）， PubMed， EMBASE， Cochrane Library， and Web of Science were searched by computer from inception to March 2022. After literature screening， data extraction， and quality evaluation， the descriptive analysis of the results combined with visual charts was performed. Nineteen studies were included， involving 18 randomized controlled trials （RCTs） and 1 Meta-analysis. Neither economic studies nor health technology assessment （HTA） reports were retrieved. ResultThe four CPMs were safe and effective in the treatment of FD， but economic research was lacking. Among them， Simotang oral liquid could be used for children with FD and FD caused by qi and food stagnation， liver and spleen disharmony， and liver and spleen stagnation. Liuwei Anxiao capsule could be used for adult patients with FD caused by food stagnation. Baohe pill could be used for the elderly with FD. Jianwei Xiaoshi oral liquid could be used for children with FD caused by spleen and stomach weakness. ConclusionThe four CPMs have their advantages in the treatment of FD. Among them， the clinical universality of Simotang oral liquid is higher. However， the quality of clinical evidence is generally low， and comparative analysis among drug dosage forms is lacking. In the future， it is necessary to improve， apply， and promote RHTA for rapid evidence production while carrying out a more standardized and scientific evidence-based demonstration of the comprehensive clinical efficacy of CPMs.
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Objective:To observe clinical effect of addition and subtraction therapy of Si Junzitang combined with Simotang to outlet obstructive constipation (OOC) after stapled trans-anal rectal resection (STARR). Method:One hundred and twenty-four patients were randomly divided into control group (62 cases) and observation group (62 cases) by random number table. Patients in control group got Qirong Ruichang oral liquid, 20 mL/time, 3 times/day. After operation, patients in observation group got addition and subtraction therapy of Si Junzitang combined with Simotang, 1 dose/day. And courses of treatment in two groups were 4 weeks, and 8 weeks' follow-up was recorded. Before the operation and at the second and fourth week after treatment, and the eighth week of follow-up, scores of main symptoms of constipation and Longo ODS were graded. Before the operation and at the fourth week after treatment, levels of superoxide dismutase (SOD), malondialdehyde (MDA), constipation patients quality of life self-assessment scale (PAC-QOL), anorectal pressure, anal resting pressure (ARP), maximum anal systolic pressure (MSP), rectal defecation pressure (RSP), FSV, CRS and MTV were recorded. And incidence, recurrence, normal defecation, satisfaction at the fourth week after the operation and safety were evaluated. Result:The clinical rate in observation group was better than that in control group (Z=2.096, P<0.05). At the second, fourth after treatment and eigh weeks' for follow-up, score of main symptoms of constipation and Longo ODS were both lower than those in control group (P<0.01). Levels of ARP, FSV, FSV, CRS and MDA were lower than those in control group (P<0.01), levels of MSP, RSP and SOD were higher than those in control group (P<0.01). Incidence and recurrence rate in observation group were 20.97% (13/62) and 4.84% (3/62) were all lower than 39.71% (24/62) and 16.13% (10/62) in control group (P<0.05). Normal defecation rate in observation group was 91.94% (57/62) higher than 80.65% (50/62) in control group, but there was no statistical significance in two groups. And total score of PAC-QOL and scores of each factor were all lower than those in control group (P<0.01). Then there was no adverse reaction related to the traditional Chinese medicine. Conclusion:Addition and subtraction therapy of Si Junzitang combined with Simotang can reduce constipation symptoms and the degree of illness, improve the quality of life, reduce the incidence of postoperative complications and recurrence rate, and improve anorectal dynamic indicators and oxidative stress indicators, improve the clinical efficacy.
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Objective:To observe clinical effect of addition and subtraction therapy of Xiaoyaosan combined with Simotang to irritable bowel syndrome with predominant constipation （IBS-C） and syndrome of stagnation of liver Qi and to study influence to gut-brain axis. Method:One hundred and forty-four patients were randomly divided into control group （72 cases） and observation group （72 cases） by random number table. The 66 patients in control group completed the therapy （2 patients were falling off or missing visit， 5 patients were eliminate）， 65 patients in observation group completed the therapy （4 patients were falling off or missing visit， 2 patients were eliminate）. Patients in control group got Simotang， 20 mL/time， 3 times/day. In control group， patients in observation group added addition and subtraction therapy of Xiaoyaosan combined with Simotang， 1 dose/day. And courses of treatment in two groups were 4 weeks. Before and after treatment， degree of abdominal pain， irritable bowel syndrome （IBS） symptom severity scale （IBS-SSS）， quality of life in irritable bowel syndrome （IBS-QOL）， syndrome of stagnation of liver Qi， scores of Hamilton anxiety scale-14（HAMA-14）， Hamilton depression scale-17（HAMD-17）， complete spontaneous bowel movement （CSBM）， response rate of abdominal pain and defecation， remission rate of IBS-SSS were all recorded. And levels of vasoactive intestinal peptide （VIP）， substance P （SP）， neuropeptide Y （NPY）， 5-hydroxytryptamine （5-HT）， somatostatin （SS） and calcitonin related gene peptide were detected， and safety was evaluated. Result:Degree of abdominal pain， scores of IBS-SSS， syndrome of stagnation of liver Qi ， HAMA-14， HAMD-17 and levels of VIP， NPY， 5-HT， SS and CGRP in observation group were all lower than those in control group （P<0.01）. And times of CSBM， score of IBS-QOL and level of SP were all higher than those in control group （P<0.01）. Besides， response rate of abdominal pain and defecation and remission rate of IBS-SSS in observation group 95.38%（62/65）， 93.85%（61/65） and 90.77%（59/65）were higher than 83.33%（55/66），78.79%（52/66）and 75.76%（50/66） in control group （P<0.05）. And curative effect of traditional Chinese medicine （TCM） syndromes in was better than that in control group （Z=2.1034， P<0.05）. No serious adverse events happened and no adverse reaction caused by TCM. Conclusion:Addition and subtraction therapy of Xiaoyaosan combined with Simotang can significantly ameliorate IBS-C symptoms， reduce bad mood， improve patients' quality of life， regulate a variety of brain gut peptide factors， and improve brain gut axis disorder. It has good clinical efficacy and safety.
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Objective:To observe the efficacy of modified Simotang in treatment of adult functional constipation (Qi-stagnancy constipation), and investigate its effects on serum levels of intestinal neurotransmitter nitric oxide synthase (nNOS), nitric oxide (NO), and vasoactive intestinal peptide (VIP), as well as superoxide dismutase (SOD), malonaldehyde (MDA), and glutathione (GSH) levels. Method:One hundred and ten patients with functional constipation were selected and randomly divided into control group (55 cases) and treatment group (55 cases) by referring to random number table. The patients in control group were given with routine therapy, Domperidone tablet (1 tablet/time, tid), and Phenolphthalein tablets (100 mg/time, bid). The patients in treatment group were treated with modified Simotang, 1 dose/day. Both groups were treated for 4 weeks. Then the scores of main clinical symptoms of functional constipation, scores of Qi-stagnancy constipation and clinical efficacy were compared between two groups. Constipation recurrence rate was compared between two groups after stopping medicine. Serum levels of intestinal neurotransmitters nNOS, NO and VIP as well as SOD, MDA, GSH levels were detected in both groups. Result:After treatment, scores for main clinical symptoms (difficult defecation, abdominal distension, defecation time, number of defecation times) and Bristol scores in treatment group were obviously lower than those in control group (PP PPPPConclusion:Based on routine therapy, modified Simotang in treatment of adult functional constipation (Qi-stagnancy constipation) can improve clinical symptoms and syndrome symptoms, increase the clinical efficacy, decrease recurrence rate, and regulate levels of intestinal neurotransmitters nNOS,NO and VIP as well as SOD, MDA, GSH levels.
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AIM To establish an HPLC method for the simultaneous content determination of five constituents in Simotang Oral Liquid (Aucklandiae Radix,Aurantii Fructus,Arecae Semen,etc.).METHODS The analysis of 50％ methanol extract of this drug was performed on a 35 ℃ thermostatic Agilent Zorbax C18 column (4.6 mm × 250 mm,5 μm),with the mobile phase comprising of acetonitrile-0.1％ formic acid flowing at 1.0 mL/min in a gradient elution manner,and the detection wavelength was set at 283 nm.RESULTS Synephrine,norisoboldine,naringin,hesperidin and neohesperidin showed good linear relationships within the ranges of 5.8-185.6 μg/mL (r =0.999 9),0.829-26.52 μg/mL (r =1.000 0),9.775-312.8 μg/mL (r =1.000 0),0.594-19 μg/mL (r =0.999 5) and 5.2-166.4 μg/mL (r =1.000 0),whose average recoveries were 98.93％,98.95％,102.57％,99.67％ and 103.43％ with the RSDs of 1.85％,1.27％,0.52％,0.89％ and 0.43％,respectively.CONCLUSION This simple,accurate and reproducible method can be used for the rapid quality control of Simotang Oral Liquid.
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Objective To observe the clinical efficacy of Simotang oral liquid combined with compound glutamine enteric capsules in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) belonging to liver depression and spleen deficiency pattern, and to explore its possible mechanism. Methods Sixty patients were randomly divided into two groups. The treatment goup (30 cases) took Simotang oral liquid and compound glutamine enteric capsules, the control group took Cerekinon and Medilac-S. The treatment course was 4 weeks. Clinical symptoms, 5-hydroxytryptamine (5-HT) and substance P (SP) of both groups were evaluated respectively before and after treatment. Recurrence rate and adverse reactions were recorded. Results The total effective rate after treating 1, 2, 4 weeks between the two groups had no significant difference (P>0.05). Four weeks later, in the treatment group, total score of the symptoms, abdominal distension and defecation urgency were apparently lower than that of control group (P0.05). Obvious side effects were not found in the two groups. Conclusion Simotang oral liquid combined with compound glutamine enteric capsules has evident therapeutic effect on IBS-D of liver depression and spleen deficiency pattern, especially good at releasing abdominal distension and defecation urgency. The mechanism may be related with decreasing the levels of 5-HT and SP.
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Objective To explore effect of Simotang on gastrointestinal motility and expression of vasoactive intestinal peptide(VIP) in the hypothalamus, spinal cord and duodenum of chronical stressed mice. Methods Mice were randomly divided into normal, stress and Simotang group( n= 10 in each group), and given a variety of unpredictable chronic mild stress. After 21 days gastric emptying and intestinal propulsion function were measured,the expression of VIP was detected by immunohistochemistry and RT-PCR. Results Compared with mice in normal group( (49.81 ± 8.56)%; (51.02 ± 5.11 )% ), chronic stress increased gastric residual rate( (61.53 ±8.71 ) %; P ＜ 0.05 ) and reduced small intestine propulsion rate ( ( 31.79 ± 2.38 ) %; P ＜ 0. 05 ). There were differences in expressions of VIP positive cells and mRNA in duodenum( (8.8 ± 1.1 )/mm2 and(0. 58 ±0.03) ),hypothalamus ( ( 12.9 ± 1.5 )/mm2 and (0.81 ± 0. 07 ) ) and spinal cord ( ( 12.1 ± 1. 2)/mm2 and (0.76 ± 0.02) )in chronic stress group compared with normal group( (6.5 ± 0. 9)/mm2 and (0.43 ± 0. 04);( 10.8 ± 1.3 )/mm2and (0.57 ± 0.03 ); (9.3 ± 1.5 )/mm2 and (0.53 ± 0. 02 ) respectively). There was not difference in gastric residual rate (52.93 ± 9.15 )%, small intestine rate(48.98 ± 4.38 )% and expressions of VIP positive cells and mRNA in duodenum ( (6.7 ± 0.9)/mm2 and (0.48 ± 0. 05 ) ), hypothalamus ( ( 10. 6 ± 1.4 )/mm2 and ( 0. 61 ± 0. 05 ) )and spinal cord ( (9. 1 ± 1.3)/mm2 and(0.55 ± 0.05 ) ) in Simotang group compared with those in normal group (P ＞ 0.05 ), but there were decreased compared with those in chronic stress group (P ＜ 0.05 ). Conclusion Simotang can regulate expressions of VIP in duodenum, hypothalamusand spinal cord in chronically stressed mice.