Rupi Sanjie capsule plus surgical operation for the treatment of hyperplasia nodule of mammary gland:A meta-analysis and trial sequential analysis

Objective:To evaluate the efficacy and safety of Rupi Sanjie(RPSJ)capsule plus the conventional surgical operation for treatment of hyperplasia nodule of mammary gland.Methods:A meta-analysis was conducted on randomized controlled trials(RCT)related to RPSJ capsule plus surgical operation in the treatment of hyperplasia nodule of mammary gland.The methodological quality of eligible RCTs was assessed according to the criteria from the Cochrane Handbook for Systematic Reviews of Interventions.RevMan5.3 and Stata14.0 were used for data analyses.Trial sequential analysis was performed to estimate the sample size of systematic review base on TSA software v0.9.Results:Twenty-two RCTs were totally included in this study,involving 2135 patients.The result showed the clinical recurrence rate of RPSJ capsule plus surgical treatment group was significantly lower than surgical treatment alone group(RR:0.25,95%CI[0.17,0.37],P<0.01).The clinical cure rate and total effective rate were higher in RPSJ capsule plus surgical treatment group than the conventional surgical treatment group(RR:1.63,95%CI[1.46,1.82],P<0.01);(RR:1.29,95%CI[1.22,1.37],P<0.01).Application of RPSJ capsule decreased the occurrence of adverse events including nausea,vomiting,irregular menstruation,constipation,dizziness,and headache etc.(RR:0.90,95%CI[0.54,1.49],P=0.68).The results of trial sequential analysis demonstrated that the current available data did not reach the expected value.Conclusion:RPSJ capsule plus the conventional surgical treatment was more effective in reducing the clinical recurrence rate,and improving the total clinical effective rate and clinical cure rate,with a decrease in the occurrence of adverse events.

Hongjin Xiaojie Capsule,a Chinese patent medicine,for treating moderate to severe cyclical breast pain:A single-blind randomized controlled trial

Background Moderate to severe breast pain has major effects on the quality of life for patients.Patent Chinese medicines are widely used in the treatment of breast pain due to their stable dosage form and good efficacy.Objective To evaluate the beneficial effects and safety of Hongjin Xiaojie Capsule(HJXJC),a Chinese patent medicine,for the treatment of cyclical breast pain.Design,setting,participants and intervention This is a multicenter,single-blind randomized controlled trial conducted in 3 medical centers in China from 2019 to 2021.Patients with moderate to severe cyclic breast pain were randomly divided into the intervention group(who took HJXJC,four capsules per dose,three times a day for 12 weeks)and the control group(waiting for the treatment)in a 1:1 ratio.Main outcome measures The primary outcome was pain duration,and the patients recorded measurements at baseline and at the end of weeks 4,8,12 and 16 on a patient log card.Results The full analysis set(FAS)population included 298 participants(intervention group,n=150;control group,n=148),while the per-protocol analysis set(PPS)included 274 participants.After 12 weeks,the duration of breast pain was significantly shorter in the intervention group(FAS:mean difference,–6.69;95%CI,–7.58 to–5.80;P<0.01,vs control.PPS:mean difference,–7.09;95%CI,–8.01 to–6.16;P<0.01,vs control).The Short-form McGill Pain Questionnaire(SF-MPQ)scores were significantly lower in the intervention group(FAS:mean difference,–12.55;95%CI,–13.90 to–11.21;P<0.01,vs control.PPS:mean difference,–13.07;95%CI,–14.48 to–11.66;P<0.01,vs control).The above indicators continued to be significantly different through week 16.Moreover,in the intervention group,breast lumps shrank after 12 weeks and the size of breast lumps was statistically smaller than that in the control group(P<0.05),whereas the sizes of breast nodules and uterine fibroid showed no statistically significant difference compared with the control group(P>0.05).At weeks 8 and 12,the dysmenorrhea scores in the intervention group were lower than those in the control group(P<0.05).No obvious adverse reactions were observed in any group.Conclusion HJXJC can significantly shorten the duration of breast pain,reduce breast pain,reduce the size of breast lumps,and relieve dysmenorrhea.However,it has no significant effect on the size of breast nodules or uterine fibroid.

The Potential Effects and Use of Chinese Herbal Medicine Pine Pollen(Pinus pollen):A Bibliometric Analysis of Pharmacological and Clinical Studies

The objectives of this study are to conduct a comprehensive literature search and bibliometric analysis to identify the breadth and volume of pharmacological and clinical studies on pine pollen(Pinus pollen)and to identify the potential effects and the use of pine pollen.Three Chinese electronic databases and two English electronic databases were searched for pharmacological and clinical studies on pine pollen.Data were extracted and analyzed and included publication year,authors,study type,pharmacological research topics or clinical diseases/conditions,usage and type of preparation,authors’conclusions,and adverse effects.Of 239 publications identified,180 were pharmacological studies,37 were clinical trials,and 22 were reviews.Numbers of publications increased particularly from 2004 onward.The top 10 most frequent topics in pharmacological studies were immune regulation,antisenility,antioxidation,liver protection,inhibiting prostate hyperplasia,inhibiting tumor cell proliferation,lowering blood glucose,lowering blood lipids,antifatigue,and improving intestinal function.The top 10 most frequent clinical diseases treated or where pine pollen was used as an adjuvant were bedsores,diaper dermatitis,hyperlipidemia,oral mucositis,eczema,hyperplasia of prostate,hypertension,prostatitis,type 2 diabetes mellitus,and radiodermatitis.Eight trials reported no adverse events associated with pine pollen,one reported mild gastrointestinal reactions,but symptoms disappeared without special management.There have been an increasing number of publications on pine pollen during the past 20 years.Pharmacological studies have shown many potential benefits,and clinical studies have indicated some positive effects when it is either used as a single herb or as an adjuvant to treat disease.Its use as a topical agent,especially for skin diseases,was notable.

Kangfuxin(Periplaneta americana)Lotion for Adjunctive Treatment of Ulcerative Colitis:A Systematic Review and Meta-Analysis of Randomized Controlled Trials

Objective: The objective of the study is to investigate the effect of Kangfuxin lotion as adjunctive therapy for treating ulcerative colitis(UC) through a systematic review and meta?analysis of randomized controlled trials(RCTs). Materials and Methods: RCTs comparing Kangfuxin lotion with no treatment, placebo, western medications or combination therapy for treatment of UC were included in this study. Two English and three Chinese electronic databases were searched. All searches ended in December 2017. Data and quality assessment carried out respectively. Rev Man 5.2 software(Copenhagen, The Nordic Cochrane Centre, The Cochrane Collaboration, 2014) was used to analyze with effect estimate presented as mean difference(MD), risk ratio(RR) and 95% confidence interval(CI). Results: Fifteen trials with 1050 participants were included in this review. Overall, 13 trials were eligible for meta?analysis. Kangfuxin lotion combined with Mesalazine was better than Mesalazine on clinical cure rate(RR 1.45, 95% CI 1.24–1.70, 7 trials), recurrence rate of UC(RR 0.22, 95% CI 0.07–0.72, 2 trials), or endoscopic mucosal recovery(RR 8.05, 95% CI 2.64–24.57, 2 trials). And Kangfuxin lotion combined with triple live bacteria tablets(Bifidobacterium-Lactobacillus? Streptococcus thermophilus)was superior with regard to symptoms remission rate(RR 5.36, 95% CI 1.73–16.60, 3 trials), endoscopic disease activity score(MD-2.30, 95% CI-2.64–-1.96, 1 trial). There were no reports on the serious adverse events of Kangfuxin lotion. Conclusion: Kangfuxin lotion as adjunctive treatment appears more effective than medications alone on clinical cure rate, recurrence rate, endoscopic mucosal recovery and improvement rate of related symptoms.