Simo Decoction Research Articles

Safety and efficacy evaluation of Simo decoction and Arecae semen in herbal medicine practice

ObjectiveThe traditional Chinese patent medicine (TCPM), Simo decoction (Simo decoction oral solution), with its primary ingredient Arecae semen (Binglang, Areca catechu L.), known for its potential carcinogenic effects, is the subject of this study. The research aims to analyze the effectiveness and potential risks of Simo decoction, particularly as a carcinogen, and to suggest a framework for evaluating the risks and benefits of other herbal medicines. MethodsThe study is based on post-marketing research of Simo decoction and Arecae semen. It utilized a wide range of sources, including ancient and modern literature, focusing on the efficacy and safety of Simo decoction. The research includes retrospective data on the sources, varieties, and toxicological studies of Arecae semen from databases such as Pubmed, Clinical Trials, Chinese Clinical Trial Registry, China National Knowledge Infrastructure, WHO-UMC Vigibase, and China National Center for ADR Monitoring. ResultsCommon adverse drug reactions (ADRs) associated with Simo decoction include skin rash, nausea, vomiting, abdominal pain, and diarrhea. However, no studies exist reporting the severe ADRs, such as carcinogenic effects. Arecae semen is distributed across approximately 60 varieties in tropical Asia and Australia. According to the WHO-UMC Vigibase and the National Adverse Drug Reaction Monitoring System databases, there are currently no reports of toxicity related to Arecae semen in the International System for Classification of ADRs (ISCR) or clinical studies. ConclusionRisk-benefit analysis in TCPM presents more challenges compared to conventional drugs. The development of a practical pharmacovigilance system and risk-benefit analysis framework is crucial for marketing authorization holders, researchers, and regulatory bodies. This approach is vital for scientific supervision and ensuring the safety and efficacy of drug applications, thus protecting public health.

Effectiveness and safety of traditional Chinese medicine decoction for diabetic gastroparesis: A network meta-analysis.

Diabetic gastroparesis (DGP) is a prevalent complication of diabetes that impairs people's quality of life and places a significant financial burden on them. The gastrointestinal symptoms of DGP patients can be improved by several Traditional Chinese Medicine (TCM) decoctions that have been shown to be effective in treating the disease. There are still many unanswered questions regarding the identification of appropriate therapeutic agents for the treatment of DGP in clinical practice. To analyze the efficacy of several TCM decoctions in the treatment of DGP using Bayesian network meta-analysis for reference. PubMed, EMBASE, Cochrane Library, Web of Science, China National Kno-wledge Infrastructure, The China Biology Medicine DVD, Wanfang, and CQVIP were searched from inception to September 17, 2022, to collect randomized controlled trials (RCTs) about TCM decoctions for DGP. Clinical effects and symptom scores were the primary outcomes. Additionally, we assessed motilin (MOT), somatostatin (SS), gastrin (GAS), gastric emptying rate, gastric emptying time, and adverse drug events as secondary outcomes. A total of 67 eligible RCTs involving 4790 DGP patients and 7 TCM decoctions were included. The results of network meta-analysis (NMA) and surface under the cumulative ranking curve showed that with western medicine (WM) as a common control, the Banxia Xiexin Decoction (BXXD) + WM was most effective in clinical effects and enhancing early satiety scores; the Simo decoction (SMD) + WM was most effective in improving nausea and vomiting scores and anorexia scores, bloating scores; the Chaishao Liujunzi Decoction (CSLJD) was most effective in MOT, the Zhishi Xiaopi Decoction (ZSXPD) was most effective in SS and upgrading emptying rate; the Jianpi Xiaozhi Decoction was most effective in GAS; the CSLJD + WM was most effective in improving gastric emptying time. These NMA results suggest that the BXXD + WM and SMD + WM may be one of the potential optimal treatments. Due to various limitations, further large-sample, double-blind, multi-center randomized RCTs are needed.

Simo decoction curing spleen deficiency constipation was associated with brain-bacteria-gut axis by intestinal mucosal microbiota.

Simo decoction (SMD) is a traditional prescription for treating gastrointestinal diseases. More and more evidences prove that SMD can treat constipation by regulating intestinal microbiota and related oxidative stress indicators, but the specific mechanism is still unclear. A network pharmacological analysis was used to predict the medicinal substances and potential targets of SMD to alleviate constipation. Then, 15 male mice were randomly divided into normal group (MN group), natural recovery group (MR group), and SMD treatment group (MT group). Constipation model mice were constructed by gavage of Folium sennae decoction and control of diet and drinking water, and SMD was used for intervention after successful modeling. The levels of 5-hydroxytryptamine (5-HT), vasoactive intestinal peptide (VIP), superoxide dismutase (SOD), malondialdehyde (MDA), and fecal microbial activities were measured, and the intestinal mucosal microbiota was sequenced. Network pharmacology analysis showed that a total of 24 potential active components were obtained from SMD, and 226 target proteins were obtained after conversion. Meanwhile, we obtained 1,273 and 424 disease-related targets in the GeneCards database and the DisGeNET database, respectively. After combination and deduplication, the disease targets shared 101 targets with the potential active components of SMD. When the mice were intervened with SMD, the 5-HT, VIP, MDA, SOD content, and microbial activity in MT group were close to MN group, and Chao 1 and ACE in MT group were significantly higher than that in MR group. In the Linear discriminant analysis Effect Size (LEfSe) analysis, the abundance of beneficial bacteria such as Bacteroides, Faecalibacterium, Alistipes, Subdoligranulum, Lactiplantibacillus, and Phascolarctobacterium in MT group increased. At the same time, there were some associations between microbiota and brain-gut peptides and oxidative stress indicators. SMD can promote intestinal health and relieve constipation through brain-bacteria-gut axis associating with intestinal mucosal microbiota and alleviate oxidative stress.

Effects of Simo decoction on gastric motility of diabetic rats.

To investigate the effects of simo decoction (SMD) on the gastric motility of diabetic rats. Diabetic rats were gavaged with various doses of SMD (0.15, 1.5, and 3.0ml/kg/d) or saline, and their blood glucose levels and body weight were monitored. Gastric emptying and antral motility were assessed by phenol red retention and contractions of antral strips, respectively. The levels of substance P (SP), vasoactive intestinal peptide (VIP), and neurogenic nitric oxide synthase (nNOS) in the gastric antrum were determined by real-time polymerase chain reaction and Western blot. Gastric emptying was delayed in diabetic rats (p< 0.01 vs. non-diabetic controls) but accelerated after SMD administration (p< 0.01). The contractions of antral strips were reduced in diabetic rats (p< 0.01 vs. non-diabetic controls) but improved after SMD intervention (p< 0.05). The mRNA expressions of SP, VIP, and nNOS in diabetic rats were downregulated compared with non-diabetic controls (all p< 0.01). Simo decoction treatment did not affect the expression of these factors in diabetic rats. The protein levels of SP, VIP, and nNOS in diabetic rats were decreased (p< 0.01), increased (p< 0.01), and comparable (p> 0.05), respectively, in comparison with non-diabetic controls. Simo decoction administration increased SP protein expression (p< 0.01) and decreased the levels of VIP (p< 0.01) and nNOS (p< 0.01) in diabetic rats. Simo decoction improved gastric dysmotility of diabetic rats possibly by upregulating SP and downregulating VIP and nNOS.

Rapid Investigation and Screening of Bioactive Components in Simo Decoction via LC-Q-TOF-MS and UF-HPLC-MD Methods.

Simo decoction (SMD), as a traditional medicine, is widely used in the treatment of gastrointestinal dysmotility in China. In this study, a combined method of liquid chromatography quadrupole time-of-flight mass spectrometry (LC-Q-TOF-MS) and ultrafiltration high-performance liquid chromatography molecular docking (UF-HPLC-MD) was efficiently employed to identify and screen bioactive ingredients in SMD. Ninety-four major constituents were identified or tentatively characterized by comparing their retention times and mass spectra with standards or literature data by using LC-Q-TOF-MS, and the ascription of those compounds were classified for the first time. Among them, 13 bioactive ingredients, including norisoboldine, eriocitrin, neoeriocitrin, narirutin, hesperidin, naringin, neohesperidin, hesperitin-7-O-glucoside, linderane, poncirin, costunolide, nobiletin, and tangeretin, were primarily identified as the human serum albumin (HSA) ligands at a range of docking scores from −29.7 to −40.6 kJ/mol by UF-HPLC-MD. The results indicate the systematic identification and screening of HSA ligands from Simo decoction guided by LC-Q-TOF-MS and UF-HPLC-MD represents a feasible and efficient method that could be extended for the identification and screening of other bioactive ingredients from natural medicines.

Comparison of efficacy of simo decoction and acupuncture or chewing gum alone on postoperative ileus in colorectal cancer resection: a randomized trial

To compared the ability of chewing gum or simo decoction (SMD) and acupuncture to reduce incidence of postoperative ileus (POI) after colorectal cancer resection, patients with colorectal cancer undergoing open or laparoscopic resection were randomized to receive SMD and acupuncture (n = 196), chewing gum alone (n = 197) or no intervention (n = 197) starting on postoperative day 1 and continuing for 5 consecutive days. Patients treated with SMD and acupuncture experienced significantly shorter hospital stay, shorter time to first flatus and shorter time to defecation than patients in the other groups (all P < 0.05). Incidence of grade I and II complications was also significantly lower in patients treated with SMD and acupuncture. Patients who chewed gum were similar to those who received no intervention in terms of hospital stay, incidence of complications, and time to first bowel motion, flatus, and defecation (all P > 0.05). The combination of SMD and acupuncture may reduce the incidence of POI and shorten hospital stay for patients with colorectal cancer after resection. In contrast, chewing gum does not appear to affect recovery of bowel function or hospital stay, though it may benefit patients who undergo open resection. (Clinicaltrials.gov registration number: NCT02813278).

Randomized clinical trial of the effect of simo decoction plus acupuncture and chewing gum on postoperative ileus in patients with hepatocellular carcinoma after hepatic resection.

307 Background: Postoperative ileus (POI) is a common complication following hepatic resection that delays recovery of bowel function and increases length of hospital stay. Simo decoction (SMD) and acupuncture tsusanli acupoint are used to enhance bowel hypomotility in China. Chewing gum reducing POI is reported. The aim of study is to evaluate the effect of SMD plus acupuncture tsusanli acupoint and chewing gum alone on POI and length of hospital stay in patients with hepatocellular carcinoma (HCC) after hepatic resection. Methods: Primary HCC patients undergoing hepatic resection were randomized to SMD plus acupuncture, chewing gum, or empty control group. Interventions were started on postoperative day 1 for six consecutive days or until flatus. Primary endpoints were POI and length of hospital stay. Secondary endpoints were surgical complications. Results: Between March 2015 and August 2015, 162 patients were randomized to SMD plus acupuncture (55), chewing gum (53), or empty control (54). SMD plus acupuncture or chewing gum group have significantly shorter first peristalsis, flatus, and defaecation time than empty control group (all P&lt; 0.05). The mean (s.d.) length of hospital stay of the three groups was 14.0 (4.9), 14.7 (6.2), and 16.5 (6.8) days. The difference between SMD plus acupuncture and empty control group was significant (P = 0.014). However, chewing gum cannot significantly shorten hospital stay than empty control (P = 0.147). Interventions groups had less grade I and II complications. Conclusions: SMD plus acupuncture or chewing gum is a safe treatment to reduce POI and shorten hospital stay. Registration number: NCT02438436 (https://clinicaltrials.gov). Clinical trial information: NCT02438436.

Different methods for bowel preparation in elderly patients with constipation before colonoscopy

One hundred and forty six elderly patients with constipation undergoing colonoscopy during March 2012 and August 2013 were randomly assigned to trial and control groups. Seventy patients in trial group received Macrogol electrolytes powder combined with Chinese herb medicine Simo decoction for bowel preparation and 76 patients in control group received macrogol electrolytes powder only. The first defecation, times of defecation and tolerance of patients were compared between two groups. The quality of bowel preparation was evaluated by endoscopists with Boston Bowel Preparation Scale(BBPS). The first defecation time was shorter in trial group than that in control group (55.7±27.9 vs. 72.9±34.8, P<0.05) . However, no statistical significance was found in the times of defecation and tolerance of patients between two groups. The mean BBPS score in trial groups was higher than that in control group (7.87±1.08 vs. 6.97±0.96, P<0.05). Chinese herb medicine Simo decoction combined with conventional method shows satisfactory result for bowel preparation in elderly patients with constipation undergoing colonoscopy. Key words: Constipation; Bowel preparation

Simo Decoction Stimulates Contractions of Antral Longitudinal Smooth Muscle via Multitudinous Mechanisms.

The aim of the study was to investigate Simo decoction-induced contractions of antral smooth muscles of rats and its mechanisms. The contractile responses of longitudinal strips to consecutive concentrations of Simo decoction were characterized by atropine, gallamine, 4-diphenylacetoxy-N-methylpiperidine methiodide, and adrenaline, hexamethonium, L-arginine, and nifedipine and compared with Krebs solution (control) and acetylcholine-induced contractions. Simo decoction dose-dependently increased contractions of antral strips (P = .000 vs control); its maximal effect was higher than acetylcholine (10-3 mol L-1; P < .05); Simo decoction-induced contractions were completely inhibited by atropine, 4-diphenylacetoxy-N-methylpiperidine methiodide, or 4-diphenylacetoxy-N-methylpiperidine methiodide + gallamine (P = .000 for all) but were partly suppressed by gallamine, adrenaline, hexamethonium, L-arginine, and nifedipine (P = .000 for all). Simo decoction promotes the contractions of antral strips mainly through activation of muscarinic M3 receptor, while partly through activation of M2 receptor, Ca2+ channel, nicotinic receptor, and inhibition of adrenergic receptor as well as release of nitric oxide.

Simo decoction promotes contraction of antral circular smooth muscle mainly via muscarinic M3 receptor

Ethnopharmacological relevanceSimo Decoction (SMD), a traditional Chinese medicine, included four elements, such as Fructus aurantii, Radix aucklandiae, Semen arecae and Radix linderae. It has been used to improve gastrointestinal dysmotility in clinical practice for a long history in China. However, the explicit mechanisms are unclear. The aim of this study was to investigate the effect of SMD on contractions of antral circular smooth muscle strips of Sprague-Dawley (SD) rats and its underlying mechanism. Materials and methodsThe antral circular strips were prepared in the organ bath under baseline or to be incubated with muscarinic receptor antagonist atropine (10−6M), muscarinic M3 receptor antagonist 4-diphenylacetoxy-N-methylpiperidine methiodide (4-DAMP) (0.4×10−6M), muscarinic M2 receptor antagonist gallamine (10−6M), adrenergic receptor agonist adrenaline (10−7M), exogenous nitric oxide (NO) donor l-arginine (10−4M), nicotinic receptor antagonist hexamethonium chloride (10−4M) and Ca2+ channel antagonist nifedipine (30nM), and consecutive concentrations of SMD were added to the bath to observe the strip responses. As a control, the responses of strips after administration with the same volume of Krebs solution as SMD were also noted. The strip responses to acetylcholine (10−7–10−3M) were also noted in organ bath to compare with SMD-induced contraction. ResultsSMD dose-dependently evoked hypercontractility of antral circular strips, and the maximal contractile effect of circular smooth muscle induced by SMD was significantly higher than that induced by acetylcholine (10−3M). The responses of antral circular strips to SMD were completely antagonized by atropine, 4-DAMP or 4-DAMP+gallamine, but partly inhibited by gallamine and partly suppressed by adrenaline, l-arginine, hexamethonium chloride and nifedipine. ConclusionsSMD promotes contractions of antral circular strips in rats mainly via activation of muscarinic M3 receptor, but partly via activation of muscarinic M2 receptor, Ca2+ channel and nicotinic receptor, inhibition of adrenergic receptor and releasing of NO.

Effects of Simo decoction on calcitonin gene-related peptide and ghrelin in diabetic rats

Objective To investigate the effects of Simo decoction on ghrelin and calcitonin gene-related peptide (CGRP) in diabetic rats.Methods A total of 48 SD rats were divided into healthy control group,diabetes group (DM),DM treated with low dose Simo decoction group (DMTL),DM treated with medium dose Simo decoction group (DM-TM),DM treated with high dose Simo decoction group (DM-TH) and DM prevented with medium dose Simo decoction group (DMPM) ; there were eight rats in each group.The rats of DM group and other intervention groups were intraperitoneally injected with 1％ streptozotoein (STZ) to establish the model.The rats of healthy control group were injected with solvent.At eight weeks after the model successfully established,the rats of each intervention group were gavaged with low dose of Simo decoction (0.15 ml · kg-1 · d-1 ),medium dose of Simo decoction (1.5 ml · kg-1 · d-1 ) and high dose of Simo decoction (3.0 ml · kg-1 ·d-1 ) for two weeks; the rats of control group and DM groups were gavaged with equal volume of 0.9％NaCl.The rats of DM-PM group were gavaged with Simo decoction at 1.5 ml · kg-1 · d-1 for 10 weeks after the model successfully established.Rats were sacrificed at the end of drug intervention and gastric antrum tissues were dissociated for detecting the expression of ghrelin and CGRP by real time polymerase chain reaction (PCR).The data were analyzed by one way ANOVA and t test.Results There was no significant difference in ghrelin expression at mRNA level in gastric antrum tissues between diabetic rats and control group.However after intervened by low dose and medium dose of Simo decoction,the ghrelin expression increased (1.45 ± 0.34,1.87 ± 0.68 compared with 0.87 ±0.28,Dunnett's T3 test,P＜0.05).There was no effects of high dose Simo decoction on the expression of ghrelin in diabetic rats.There was no significant difference in ghrelin between DM-TM and DM-PM.The expression of CGRP at mRNA level in gastric antrum tissues of diabetic rats was significantly higher than that of control group (4.61 ± 1.67 compared with 1.06 ± 0.40,t =5.843,P＜0.01).There was no effects of low dose Simo decoction on CGRP expression of diabetic rats.The expression of CGRP of diabetic rats was down-regulated by medium and high dose of Simo decoction intervention.There was no significant difference in CGRP expression between DM-TM and DM-PM.Conclusions Simo decoction can promote ghrelin expression in gastric antrum of diabetic rats.The expression of CGRP in gastric antrum of diabetic rats significantly increased,but Simo decoction may down-regulate the expression of CGRP in gastric antrum of diabetic rats. Key words: Simo decoction; Diabetes mellitus; Pyloric antrum; Ghrelin; Calcitonin generelated peptide; Rats, Sprague-Dawley

Clinical observation of simo decoction and mamiai on children with chronic idiopathic conspitation

目的 观察四磨汤口服液联合复方乳酸菌(妈咪爱)散剂治疗小儿慢性特发性便秘的临床疗效.方法对符合慢性特发性便秘诊断的小儿随机分为两组,治疗组予四磨汤口服液联合妈咪爱散剂口服,对照组予常规导泻剂口服.结果治疗组治疗小儿慢性特发性便秘有效率达91%,对照组有效率为65%,明显优于对照组(P＜0.005).结论四磨汤联合妈咪爱治疗小儿慢性特发性便秘疗效佳。

Clinical observation of treatment of hyperbilirubinemia in the newborn by integrated traditional chinese and western medicine

To find a method of treatment for correcting hyperbilirubinemia timely and effectively to prevent bilirubin induced cerebral damage in the newborn. The newborns with hyperbilirubinemia in the treated group were treated with conventional treatment plus Butyribacterial preparation (BBP) and Simo Decoction (SMD, taken orally, and the effect was compared with that in control group A treated with conventional treatment only and that in control group B treated with conventional treatment plus BBP. The mean daily decreasing rate of bilirubin in the treated group was 51.11±25.03 μmol/L, which was higher than that in control groups A (39.36 + 22.44 μmol/L) and B (43.24±24.18 μmol/L), respectively (P<0.01 andP<0.05). The bilirubin decreasing value on the first day and the speed of bilirubin decreasing (to 102. 6 μmol/L) in the treated group were both higher than those in the control groups,P<0.01. The combined therapy of conventional treatment plus BBP and SMD could rapidly reduce the blood bilirubin level in the newborn with hyperbilirubinemia, and shorten the therapeutic course markedly, and the therapeutic effect is superior to that of the conventional treatment alone or that of the conventional treatment plus BBP only.