Effect and Safety of Herbal Medicine Foot Baths in Patients with Diabetic Peripheral Neuropathy:A Multicenter Double-Blind Randomized Controlled Trial

Objective:To evaluate the effect and safety of foot baths with Tangbi Waixi Decoction(TW)in treating patients with diabetic peripheral neuropathy(DPN).Methods:It is a multicenter double-blinded randomized controlled trial.Participants with DPN were recruited between November 18,2016 and May 30,2018 from 8 hospitals in China.All patients received basic treatments for glycemic management.Patients received foot baths with TW herbal granules either 66.9 g(intervention group)or 6.69 g(control group)for 30 min once a day for 2 weeks and followed by a 2-week rest,as a therapeutic course.If the Toronto Clinical Scoring System total score(TCSS-TS)6 points,the patients received a total of 3 therapeutic courses(for 12 weeks)and were followed up for 12 weeks.The primary outcome was change in TCSS-TS score at 12 and 24 weeks.Secondary outcomes included changes in bilateral motor nerve conduction velocity(MNCV)and sensory nerve conduction velocity(SNCV)of the median and common peroneal nerve.Safety was also assessed.Results:Totally 632 patients were enrolled,and 317 and 315 were randomized to the intervention and control groups,respectively.After the 12-week intervention,patients in both groups showed significant declines in TCSSTS scores,and significant increases in MNCV and SNCV of the median and common peroneal nerves compared with pre-treatment(P<0.05).The reduction of TCSS-TS score at 12 weeks and the increase of SNCV of median nerve at 24 weeks in the control group were greater than those in the intervention group(P<0.05).The number of adverse events did not differ significantly between groups(P>0.05),and no serious adverse event was related with treatment.Conclusion:Treatment of TW foot baths was safe and significantly benefitted patients with DPN.A low dose of TW appeared to be more effective than a high dose.(Registry No.Chi CTR-IOR-16009331)

How completely are randomized controlled trials of non-pharmacological interventions following concussion reported? A systematic review

Purpose:The study aimed to examine the reporting completeness of randomized controlled trials(RCTs)of non-pharmacological interventions following concussion.Methods:We searched MEDLINE,Embase,PsycInfo,CINAHL,and Web of Science up to May 2022.Two reviewers independently screened studies and assessed reporting completeness using the Template for Intervention Description and Replication(TIDieR),Consensus on Exercise Reporting Template(CERT),and international Consensus on Therapeutic Exercise aNd Training(i-CONTENT)checklists.Additional information was sought my study authors where reporting was incomplete.Risk of bias(ROB)was assessed with the Cochrane ROB-2 Tool.RCTs examining non-pharmacological interventions following concussion.Results:We included 89 RCTs(n=53 high ROB)examining 11 different interventions for concussion:sub-symptom threshold aerobic exercise,cervicovestibular therapy,physical/cognitive rest,vision therapy,education,psychotherapy,hyperbaric oxygen therapy,transcranial magnetic stimulation,blue light therapy,osteopathic manipulation,and head/neck cooling.Median scores were:TIDieR 9/12(75%;interquartile range(IQR)=5;range:5-12),CERT 17/19(89%;IQR=2;range:10-19),and i-CONTENT 6/7(86%;IQR=1;range:5-7).Percentage of studies completely reporting all items was TIDieR 35%(31/89),CERT 24%(5/21),and i-CONTENT 10%(2/21).Studies were more completely reported after publication of TIDieR(t_(87)=2.08;p=0.04)and CERT(t_(19)=2.72;p=0.01).Reporting completeness was not strongly associated with journal impact factor(TIDieR:rs=0.27;p=0.01;CERT:r_(s)=-0.44;p=0.06;i-CONTENT:r_(s)=-0.17;p=0.48)or ROB(TIDieR:rs=0.11;p=0.31;CERT:rs=0.04;p=0.86;i-CONTENT:rs=0.12;p=0.60).Conclusion:RCTs of non-pharmacological interventions following concussion demonstrate moderate to good reporting completeness,but are often missing key components,particularly modifications,motivational strategies,and qualified supervisor.Reporting completeness improved after TIDieR and CERT publication,but publication in highly cited journals and low ROB do not guarantee reporting completeness.

Efficacy of a Nutritional Cream Intervention to Treat Depression in Rescuers:A Randomized Controlled Trial

Objective To explore the effectiveness of a nutritional intervention in rescuers who screened positive for depression.Methods A randomized controlled trial design was employed.From June to August,2022,4,460 rescuers were screened using the Self-Rating Depression Scale(SDS),and 1,615 positive cases were identified.Thirty-one volunteers were recruited and randomly divided into a nutritional intervention group and a control group.The intervention group received health education and nutritional intervention(a compound paste therapy primarily composed of red roses and Seville orange flowers),while the control group received psychological education.SDS scores were assessed before and after the intervention.Results There was a statistically significant decline in SDS scores in the nutritional intervention group after the intervention(P<0.05).Furthermore,the SDS scores of the intervention group were significantly lower than those of the control group,both before and after the intervention(P<0.05).No severe adverse reactions were observed during safety evaluation.Conclusion The nutritional intervention effectively reduced the depression scores in rescuers.Early nutritional intervention is recommended for rescuers who initially screen positive for depression.

Effect of Jianpi Shengxue Tablet on Iron Metabolism and Nutritional Status in Patients with Renal Anemia:A Prospective,Randomized,Open,Parallel Controlled and Multicenter Clinical Study

Objective This study aimed to analyze the clinical efficacy of the Jianpi Shengxue tablet for treating renal anemia.Methods A total of 200 patients with renal anemia from December 2020 to December 2022 were enrolled and randomly divided into two groups.Patients in the control group were treated with polysaccharide-iron complex,and those in the experimental group were administered Jianpi Shengxue tablet.After 8 weeks of continuous treatment,the therapeutic outcomes regarding anemia were compared between the two groups.Results After treatment,the red blood cell(RBC)count,hematocrit(HCT),reticulocyte percentage(RET),ferritin(SF),serum iron(SI),transferrin saturation(TSAT),and serum albumin(ALB)all increased(P<0.01),and the clinical symptom score and total iron binding capacity decreased(P<0.01)in the experimental group.Moreover,the improvements in RBC,HCT,RET,SF,SI,TAST,ALB,and clinical symptoms(fatigue,anorexia,dull skin complexion,numbness of hands and feet)in the experimental group were significantly greater than those in the control group(P<0.05).The total effective rate for treating renal anemia was significantly higher in the experimental group than in the control group(P<0.01).Conclusion The Jianpi Shengxue tablet demonstrates efficacy in treating renal anemia,leading to significant improvements in the laboratory examination results and clinical symptoms of patients with renal anemia.

Effects of Lycium barbarum polysaccharide on cytokines in adolescents with subthreshold depression:a randomized controlled study

Strong evidence has accumulated to show a correlation between depression symptoms and inflammatory responses.Moreover,anti-inflammatory treatment has shown partial effectiveness in alleviating depression symptoms.Lycium barbarum polysaccharide(LBP),derived from Goji berries,exhibits notable antioxidative and anti-inflammatory properties.In our recent double-blinded randomized placebo-controlled trial,we found that LBP significantly reduced depressive symptoms in adolescents with subthreshold depression.It is presumed that the antidepressant effect of LBP may be associated with its influence on inflammatory cytokines.In the double-blinded randomized controlled trial,we enrolled 29 adolescents with subthreshold depression and randomly divided them into an LBP group and a placebo group.In the LBP group,adolescents were given 300 mg/d LBP.A 6-week follow up was completed by 24 adolescents,comprising 14 adolescents from the LBP group(15.36±2.06 years,3 men and 11 women)and 10 adolescents from the placebo group(14.9±1.6 years,2 men and 8 women).Our results showed that after 6 weeks of treatment,the interleukin-17A level in the LBP group was lower than that in the placebo group.Network analysis showed that LBP reduced the correlations and connectivity between inflammatory factors,which were associated with the improvement in depressive symptoms.These findings suggest that 6-week administration of LBP suppresses the immune response by reducing interleukin-17A level,thereby exerting an antidepressant effect.

Can Tibetan medicine Honghua Ruyi pills relieve endometriosisassociated dysmenorrhea?Protocol for a randomized placebocontrolled trial

Objective:To provide high-quality clinical evidence of the efficacy of Tibetan medicine Honghua Ruyi(HHRY)pills for endometriosis-associated dysmenorrhea.Methods:This study constitutes a multicenter,randomized,double-blind,placebo-controlled trial encompassing a three-menstrual cycle intervention followed by a three-menstrual cycle follow-up period.A total of 164 eligible females with endometriosis-associated dysmenorrhea were randomly divided into HHRY pills and placebo groups in a 1:1 ratio.The primary outcome included dysmenorrhea symptoms assessed using Visual Analog Scale(VAS)scores and quality of life,whereas the secondary outcome measures included the maximum VAS for non-menstrual pelvic pain,duration of pain episodes(in days),frequency and quantity of the consumption of ibuprofen sustained-release capsules(or other non-steroidal anti-inflammatory drugs),and days off work/study for staff/student due to dysmenorrhea,ovarian cyst,and/or pelvic nodule size.The safety was monitored throughout the treatment period.All the analyses were based on the intention-to-treat principle.For continuous outcomes,simple or multiple linear regressions were used to estimate the differences between the HHRY pills and placebo groups,with categorical data expressed as the number and percentage of occurrences.Differences were compared using the chi-square test or Fisher's exact test.The predefined analysis was adjusted for concomitant treatment,a variable considered to be associated with outcomes but unaffected by treatment allocation.Estimates of treatment effects were reported with 95%confidence intervals.Two-tailed P values≤.05 were considered statistically significant.Conclusion:Positive results from this trial,upon completion would provide robust evidence for the efficacy and safety of HHRY pills in treating dysmenorrhea in patients with endometriosis.

Electroacupuncture with different waveforms for primary dysmenorrhea:A randomized controlled trial

Objective:To observe and compare the clinical effects of different electroacupuncture waveforms on primary dysmenorrhea.Methods: This was a prospective,randomized,three-group,parallel-controlled trial.Participants with primary dysmenorrhea were randomly divided into dense-sparse wave,continuous wave,and discontinuous wave groups in a 1:1:1 ratio.Two lateral Ciliao(BL 32)points were used.All three groups started treatment 3–5 days before menstruation,once a day for six sessions per course of treatment,one course of treatment per menstrual cycle,and three menstrual cycles.The primary outcome measure was the proportion with an average visual analog scale(VAS)score reduction of≥50%from baseline for dysmenorrhea in the third menstrual cycle during treatment.The secondary outcome measures included changes in dysmenorrhea VAS scores,Cox Menstrual Symptom Scale scores and the proportion of patients taking analgesic drugs.Results: The proportion of cases where the average VAS score for dysmenorrhea decreased by≥50%from baseline in the third menstrual cycle was not statistically significant(P>.05).Precisely 30 min after acupuncture and regarding immediate analgesia on the most severe day of dysmenorrhea,there was a statistically significant difference in the dense-sparse wave group compared with the other two groups during the third menstrual cycle(P<.05).Additionally,there was a statistically significant difference between the dense-sparse wave and discontinuous wave groups 24 h after acupuncture(P<.05).Conclusions: Waveform electroacupuncture can alleviate primary dysmenorrhea and its related symptoms in patients.The three groups showed similar results in terms of short-and long-term analgesic efficacy and a reduction in the number of patients taking analgesic drugs.Regarding achieving immediate analgesia,the dense-sparse wave group was slightly better than the other two groups.

Can propensity score matching replace randomized controlled trials?

Randomized controlled trials(RCTs)have long been recognized as the gold standard for establishing causal relationships in clinical research.Despite that,various limitations of RCTs prevent its widespread implementation,ranging from the ethicality of withholding potentially-lifesaving treatment from a group to relatively poor external validity due to stringent inclusion criteria,amongst others.However,with the introduction of propensity score matching(PSM)as a retrospective statistical tool,new frontiers in establishing causation in clinical research were opened up.PSM predicts treatment effects using observational data from existing sources such as registries or electronic health records,to create a matched sample of participants who received or did not receive the intervention based on their propensity scores,which takes into account characteristics such as age,gender and comorbidities.Given its retrospective nature and its use of observational data from existing sources,PSM circumvents the aforementioned ethical issues faced by RCTs.Majority of RCTs exclude elderly,pregnant women and young children;thus,evidence of therapy efficacy is rarely proven by robust clinical research for this population.On the other hand,by matching study patient characteristics to that of the population of interest,including the elderly,pregnant women and young children,PSM allows for generalization of results to the wider population and hence greatly increases the external validity.Instead of replacing RCTs with PSM,the synergistic integration of PSM into RCTs stands to provide better research outcomes with both methods complementing each other.For example,in an RCT investigating the impact of mannitol on outcomes among participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial,the baseline characteristics of comorbidities and current medications between treatment and control arms were significantly different despite the randomization protocol.Therefore,PSM was incorporated in its analysis to create samples from the treatment and control arms that were matched in terms of these baseline characteristics,thus providing a fairer comparison for the impact of mannitol.This literature review reports the applications,advantages,and considerations of using PSM with RCTs,illustrating its utility in refining randomization,improving external validity,and accounting for non-compliance to protocol.Future research should consider integrating the use of PSM in RCTs to better generalize outcomes to target populations for clinical practice and thereby benefit a wider range of patients,while maintaining the robustness of randomization offered by RCTs.

Multicenter Clinical Randomized Controlled Trial and Network Pharmacology Analysis of Zhenzhu Qingyuan Granules for the Treatment of Gastroesophageal Reflux Disease

Objective To evaluate the clinical efficacy and safety of Zhenzhu Qingyuan Granules through a clinical randomized controlled trial and to analyze the potential action targets and pathways of this formula using network pharmacology.Methods Patients with gastroesophageal reflux disease(GERD)of liver–stomach stagnant heat pattern who met the inclusion and exclusion criteria were randomly divided into the control group and the observation group.The control group received oral rabeprazole,whereas the observation group were given Zhenzhu Qingyuan Granules in addition to the rabeprazole.The treatment duration was 8 weeks.Clinical efficacy was observed in both groups after 8 weeks.Network pharmacology was used to analyze the action targets of ZhenzhuQingyuanGranules and the genes related to GERD,and core targets were inferred.Gene Ontology and Kyoto Encyclopedia of Genes and Genomes enrichment analyses were conducted to explore the potential mechanisms of this formula.Results The clinical research results showed that the total effective rate in the treatment group was 92.68%,compared with 70.00%in the control group,with a statistically significant difference(p<0.05).After treatment,both Chinese medicine syndrome score and endoscopic score improved in both groups compared with before treatment(p<0.05),and the treatment group showed greater improvement than the control group(p<0.05).Network pharmacology identified effective components of Zhenzhu Qingyuan Granules for treating GERD,including quercetin,luteolin,andβ-sitosterol,with potential action targets such as tumor protein 53(TP53),protein kinase B(AKT1),and tumor necrosis factor.Conclusion Zhenzhu Qingyuan Granules can significantly improve clinical symptoms in patients with GERD of liver–stomach stagnated heat pattern,enhance clinical efficacy,and have high safety.This formula may exert therapeutic effects through multiple targets and pathways.

Clinical study on the treatment of acute pancreatitis with external application of Yi-Dan Therapy based on the method of“stagnation requiring dispersion”:study protocol for a randomized controlled trial

Background:Acute pancreatitis is an unpredictable and potentially lethal disease,causing tremendous pain in patients.The initial treatment of acute pancreatitis in modern medicine is supportive,but it is generally ineffective in relieving abdominal pain and distension.Traditional Chinese medicine has been shown to be more effective in regulating the body’s homeostasis and reducing the clinical symptoms of pancreatitis.Yi-Dan ointment,derived from Dahuang-Mudan Decoction,is an effective external ointment for treating acute pancreatitis.The aim of this trial is to investigate the clinical efficacy of Yi-Dan ointment,providing a valuable complement to existing treatment options for pancreatitis.Methods:This is a randomized controlled clinical trial with two parallel groups.Patients in the control group were given basic treatment and nursing for 7 days;in the treatment group,Yi-Dan ointment was applied externally in addition to basic treatment and nursing.The main indicator is the overall efficacy,serum amylase,acute physiology and chronic health evaluationⅡscore,symptom score,inflammatory markers,and classification of computed tomography.Conclusion:The trial results will provide high-quality evidence for Yi-Dan ointment,and provide a complement to existing treatment options for pancreatitis.

Efficacy and safety of Xinfeng capsule in patients with rheumatoid arthritis:a multi-center parallel-group double-blind randomized controlled trial

OBJECTIVE:To evaluate the efficacy and safety of Xinfeng capsule in patients suffering rheumatoid arthritis(RA).METHODS:A multi-center parallel-group designed,double-blind,randomized,controlled trial was conducted.Totally 304 RA patients were assigned to two groups:one group was administered Xinfeng capsule(XFC) plus the placebo of leflunomide and the other given leflunomide(LEF) plus the placebo of XFC for twelve weeks.The clinical and laboratory parameters were compared at baseline and fourth,eighth,and twelfth weeks.RESULTS:After twelve-week treatment,patients in two groups all showed some trend of effectiveness when compared in terms of American Rheumatism Association(ACR) recommended 20%,50%,70%improvement criteria,but it was insignificant.The validity in ameliorate modified disease activity score(DAS28) and laboratory indexes as erythrocyte sedimentation rate(ESR),C-reactive protein(CRP),rheumatoid factor(RF) were also found no difference.The score of health assessment questionnaire(HAQ),self-rating anxiety scale(SAS),self-rating depression scale(SDS) and quality of life questionnaire with rheumatoid arthritis(RAQOL)both lower than the first week and the changes showed no difference.However,the score of SDS dropped more in XFC group than in the other.A total of 147 adverse reaction cases were reported,which shows no difference between the two groups.The most common adverse reactions were hepatic impairment,anemia,leukocytopenia,epigastric discomfort and phalacrosis.CONCLUSION:XFC demonstrated better improvement in the scores of SDS and compared with those of LEF group.

Efficacy and safety of Yiqi Huoxue Jiedu decoction for the treatment of advanced epithelial ovarian cancer patients: a double-blind randomized controlled clinical trial

OBJECTIVE:To further evaluate the complementary effect of Yiqi Huoxue Jiedu decoction(YHJD)on patients with advanced epithelial ovarian cancer(EOC).METHODS:All 330 enrolled participants diagnosed with stageⅢc EOC were randomly divided into two groups that received YHJD or a placebo.The primary end point was health-related quality of life(HRQL)measured by the functional assessment of cancer therapy-ovary cancer(FACT-O)questionnaire.The secondary end point was progression-free survival(PFS).RESULTS:A total of 299 participants completed the trial with 153 and 146 in YHJD and control groups,respectively.After 6 months of treatment,YHJD increased physical wellbeing(PWB),functional wellbeing(FWB),additional concerns(AC),and the trial outcome index(TOI)(P<0.05)by various degrees compared with the baseline.YHJD also had notable advantages over the placebo at 3 and 6 months in terms of PWB,FWB,AC(P<0.05),and TOI(P<0.01).In addition,YHJD had a significant advantage in terms of PFS compared with the placebo(21 vs18 months,P<0.05).No adverse events were reported.CONCLUSION:YHJD is an effective and safe choice as a complementary therapy to improve HRQL and prolong PFS of stageⅢc EOC patients.

Can moxibustion, an ancient treatment modality, be evaluated in a double-blind randomized controlled trial? —— A narrative review

For thousands of years, moxibustion has been used for various diseases in China and other Asian countries. Despite the recent surge in Chinese herbal studies, few randomized controlled trials have been conducted on this modality, possibly due to the lacking of suitable double blinding methodology. This is a review of extant sham moxa devices and an introduction to a recently developed device that needs further validation.

Efficacy and safety of Xiangsha Liujunzi granules for functional dyspepsia: A multi-center randomized double-blind placebo-controlled clinical study

AIM To assess the efficacy and safety of a Chinese herbal medicine (CHM), Xiangsha Liujunzi granules, in the treatment of patients with functional dyspepsia (FD). METHODS We performed a randomized, double-blind, placebo-controlled trial with patients from three centers. Two hundred and sixteen subjects diagnosed with FD according to ROME. criteria and confirmed by upper gastrointestinal endoscopy and spleen-deficiency and Qi-stagnation syndrome were selected to receive Xiangsha Liujunzi granules or placebo for 4 wk in a 2: 1 ratio by blocked randomization. The subjects also received follow-up after the 4-wk intervention. Herbal or placebo granules were dissolved in 300 mL of water. Participants in both groups were administered 130 mL (45 degrees C) three times a day. Participants were evaluated prior to and following 4 wk of the intervention in terms of changes in the postprandial discomfort severity scale (PDSS) score, clinical global impression (CGI) scale score, hospital anxiety and depression scale (HADS) score, traditional Chinese medicine symptoms score (SS), scores of various domains of the 36-item short form health survey (SF-36), gastric emptying (GE) and any observed adverse effects. RESULTS Compared with the placebo group, patients in the CHM group showed significant improvements in the scores of PDSS, HADS, SS, SF-36 and CGI scale (P < 0.05 or P < 0.01). They also showed the amelioration in the GE rates of the proximal stomach and distal stomach (P < 0.05 or P < 0.01). CONCLUSION Xiangsha Liujunzi granules offered significant symptomatic improvement in patients with FD.

Zishenpingchan granules for the treatment of Parkinson＇s disease：a randomized,double-blind,placebo-controlled clinical trial

Levodopa preparations remain the preferred drug for Parkinson＇s disease.However,long-term use of levodopa may lead to a series of motor complications.Previous studies have shown that the combination of levodopa and Zishenpingchan granules（consisting of Radix Rehmanniae preparata,Lycium barbarum,Herba Taxilli,Rhizoma Gastrodiae,Stiff Silkorm,Curcuma phaeocaulis,Radix Paeoniae Alba,Rhizoma Arisaematis,Scorpio and Centipede） can markedly improve dyskinesia and delay the progression of Parkinson＇s disease,with especially dramatic improvements of non-motor symptoms.However,the efficacy of this combination has not been confirmed by randomized controlled trials.The current study was approved by the Hospital Ethics Committee and was registered in the Chinese Clinical Trial Register（registration number：Chi CTR-INR-1701194）.From December 2014 to December 2016,128 patients（72 males and 56 females,mean age of 65.78 ± 6.34 years） with Parkinson＇s disease were recruited from the Department of Neurology of Longhua Hospital and Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine in China.Patients were equally allocated into treatment and control groups.In addition to treatment with dopamine,patients in treatment and control groups were given Zishenpingchan granules or placebo,respectively,for 24 weeks.Therapeutic efficacy was assessed using the Unified Parkinson＇s Disease Rating Scale,on-off phenomenon,Hoehn-Yahr grade,Scales for Outcomes in Parkinson＇s disease–Autonomic,Parkinson＇s disease sleep scale,Hamilton Anxiety Scale,Hamilton Depression Scale,Mini-Mental State Examination,and the Parkinson＇s Disease Quality of Life Questionnaire.Artificial neural networks were used to determine weights at which to scale these parameters.Our results demonstrated that Zishenpingchan granules significantly reduced the occurrence of motor complications,and were useful for mitigating dyskinesia and non-motor symptoms of Parkinson＇s disease.This combination of Chinese and Western medicine has the potential to reduce levodopa dosages,and no obvious side effects were found.These findings indicate that Zishenpingchan granules can mitigate symptoms of Parkinson＇s disease,reduce toxic side effects of dopaminergic agents,and exert synergistic and detoxifying effects.

Efficacy of the herbal formula of Foeniculum vulgare and Rosa damascena on elderly patients with functional constipation:A double-blind randomized controlled trial

Background:Constipation is a common chronic bowel disorder with an incidence of more than 50%in the elderly population.Complementary and alternative medicine is a cost-effective and satisfactory treatment for constipation used widely by the elderly.Objective:This study evaluates the efficacy of an herbal formula made from Foeniculum vulgare Mill.and Rosa damascena for the treatment of constipation in an elderly population and consequent changes to their quality of life.Design,setting,participants and intervention:This double-blind randomized active controlled clinical trial,with parallel group allocation ratio of 1:1,was conducted in a referral clinic in Afzalipour Hospital,affiliated to Kerman University of Medical Sciences in Kerman,Southeastern Iran.Individuals over 60 years of age,diagnosed with functional constipation(based on the RomeⅣcriteria),were included in this study.Participants received a sachet of 10 g F.vulgare and R.damascena(herbal formula group)or polyethylene glycol 4000(PEG 4000 group)with a glass of warm water two times a day for 4 weeks and were followed up for 4 additional weeks.Main outcome measures:Constipation severity,stool consistency,and the quality of life were used as the primary outcomes.Drug side effects were used as a secondary outcome.The outcomes were assessed using the Constipation Assessment Scale,the Bristol Stool Form Scale,and the Patient Assessment of Constipation Quality of Life questionnaire.Results:A total of 25 participants in each group completed the four-week treatment cycle and the eightweek follow-up.At the end of the four-week treatment cycle,all clinical outcomes had significant improvements in both groups(P<0.05).The analysis of constipation severity(P<0.001),stool consistency(P<0.001),and the quality of life(P<0.001)showed significant improvements with fewer side effects(mild diarrhea)and a longer duration of symptom relief in the herbal formula group compared to the PEG 4000 group.Conclusion:Although both interventions significantly improved the treatment outcomes,constipation severity,stool consistency and the quality of life were improved more effectively by the herbal formula than by PEG 4000;however,the mechanism of action is not yet understood.Trial registration:This trial was registered in the Iranian Registry of Clinical Trials(IRCTID:IRCT20200108046056N1).

Chinese herbal medicine for chronic heart failure:a multicenter,randomized,double-blind,placebo-controlled trial

Objective:The purpose of this study was to assess the efficacy and safety of Chinese herbal medicine(CHM)in the treatment of chronic heart failure(CHF)patients according to syndrome differentiation.Methods:In this multicenter,randomized,double-blind,placebo-controlled clinical trial,a total of 220 CHF patients were assigned to receive CHM or placebo granules without decoction according to syndrome differentiation in addition to their standard western treatment for 4 weeks.The change in the left ventricular ejection fraction(LVEF)was the primary outcome,and the changes in the TCM syndrome scores(TCM-SS)and New York Heart Association functional classification(NYHA-FC)were the secondary outcomes.

Serum metabolic effects of corn oligopeptides with 7-day supplementation on early post-surgery primary liver cancer patients: a double-blind randomized controlled trial

Background:Liver cancer as the main leading cancer has caused heavy burdens globally.The prognosis of liver cancer is closely related with postoperative nutrition support.Corn oligopeptides(COPs)are protein hydrolysates produced by enzymatic treatments,which have shown potential bioactivities,such as inhibiting angiotensin I-converting enzyme,resisting lipid peroxidation and anti-oxidant.However,the correlation between COPs and liver cancer patients is still unknown and the potential mechanism of COPs on liver cancer is unclear as well.The aim of this study was to assess effects of 7-day intervention of COPs after surgery on liver function and serum metabolic profiles of liver cancer patients.Methods:Patients were assigned into COPs intervention group(n=50)and control group(n=91)for 7 days.Investigations were scheduled at 1st day and 7th day after liver resection surgery respectively,mainly including anthropometric,biochemical indexes and liquid chromatography-mass spectrometry(LC/MS)analysis.Results:Seven-day supplementation of COPs on early post-surgery liver cancer patients down-regulated levels of alanine aminotransferase,aspartate aminotransferase,total bilirubin,direct bilirubin and up-regulated prothrombin time activity and prealbumin levels.LC/MS analysis revealed metabolic signatures including regulation of 16 metabolites,which was closely related with two metabolic pathways(nicotinate and nicotinamide metabolism,fatty acid metabolism).Conclusions:COPs supplementation has displayed the potentials on alleviating the injury of liver function and it may be due to regulation of fatty acid metabolism,nicotinate and nicotinamide metabolism,lipid peroxidation and anti-inflammatory action.More researches are warranted in future to confirm the exact mechanisms.

A multicenter randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of rhubarb in treating acute exacerbation of chronic obstructive pulmonary disease of the syndrome type phlegm-heat obstructing the lungs

Objective:To observe the clinical efficacy and safety of oral administration of the traditional Chinese herb rhubarb to treat acute exacerbation of chronic obstructive pulmonary disease(AECOPD).Method:This was a multicenter randomized double-blinded placebo controlled study that took place in 7 provinces of China that enrolled 244 patients(aged 18e80 years)who had acute exacerbation of COPD with the traditional Chinese syndrome pattern of phlegm-heat obstructing lung.Participants were divided into experimental and control groups.The experimental group received 4.5 g of rhubarb granules twice daily and the control group received placebo granules.Both groups also received conventional Western therapy consisting of oxygen therapy,an antibiotic,expectorant,and a bronchodilator.Treatment lasted 10 days.Symptom scores for cough,sputum volume and color,wheezing and chest tightness before treatment and on days 3,5,7,and 10 during the treatment were recorded.Lung function,arterial blood gas and levels of serum inflammatory factors,interleukin-4(IL-4),interleukin-8(IL-8),and interleukin-10(IL-10)and tumor necrosis factor-alpha(TNF-a),before and after treatment were measured.Results:The sample size of the full analysis set(FAS)was 244 participants,and the sample size of per protocol set(PPS)was 235.Following 10 days’treatment,symptom scores of the experimental group were markedly lower than those of the placebo group(FAS:mean difference
1.67,95%CI:e2.66 to
0.69,P Z 0.001;PPS:mean difference
1.55,95%CI:
2.56 to
0.54,P Z 0.003).Lung function in the experimental group was significantly higher than in the placebo group(FEV1,FAS:mean difference 0.12,95%CI:0.06 to 0.18;P<0.001;PPS:mean difference 0.12,95%CI 0.05 to 0.18;P<0.001.FVC:FAS:mean difference 0.16,95%CI:0.06 to 0.26;P Z 0.002;PPS:mean difference 0.16,95%CI 0.05 to 0.26;P Z 0.003.FEV1%,FAS:mean difference 5.95,95%CI:3.36 to 8.53;P<0.001;PPS:mean difference 5.92,95%CI 3.28 to 8.56;P<0.001.).PaO2,PaCO2,as well as serum inflammatory factors were also improved when compared to the placebo group.There were no significant differences in the incidence rate of adverse reaction between the two groups.Conclusions:Compared with placebo,rhubarb granules significantly reduced symptom scores,improved blood oxygen level,controlled systemic inflammatory response,without significant adverse effects.Thus,rhubarb may be a beneficial adjuvant method for treating the phlegm-heat obstructing the lung syndrome pattern of AECOPD.

The Efficacy and Safety of a Patent Pending Combination of Ginger and Goldenrod Extracts on the Management of Cold Symptoms: A Randomized, Double-Blind Controlled Trial

Objective: In a randomized, double-blind, exploratory, active-controlled trial, the efficacy and safety of a patent-pending combination of Ginger and Goldenrod extracts (BDI-630) in alleviating cold symptoms in community-dwelling adults was compared to a combination of standardized amounts of Echinacea (EC) components. Methods: 44 healthy adults, experiencing new onset of cold symptoms were randomly assigned to receive either BDI-630 (900 mg) or EC (500 mg) twice daily for 10 days. The severity of cold symptoms and the quality of life was assessed by self-reporting of subjects using the Wisconsin Upper Respiratory Symptom Survey (WURSS-21? 2004). Results: The intent-to-treat population (ITT) consisted of 44 subjects (n = 22 for BDI-630;n = 22 for EC). The modified ITT (mITT) population consisted of 40 subjects, excluding four subjects with major protocol deviations related to inclusion/exclusion criteria and/or use of prohibited drugs from the efficacy analysis (n = 3 for BDI-630 and n = 1 for EC). Results indicated a sig-nificant difference between the two groups: the superiority of BDI-630 over EC was particularly noticeable between Day 1 and Day 7, as demonstrated by a 14-fold difference of the mean percentage of change of total score from baseline in the mITT population. Adverse events (AEs) following the intake of BDI-630 were mostly limited to mild gastrointestinal intolerance in less than 10% of the subjects. Conclusions: BDI-630 was shown to be more effective than EC in alleviating cold symptoms in the adult population, particularly during the first 7 days of treatment. BDI-630 was very well tolerated by all subjects.