Herbal Medicine For Treatment Research Articles

Integrative traditional Korean medicine treatment for children with idiopathic short stature: A STROBE-compliant case series.

Integrative traditional Korean medicine (TKM) treatment including herbal medicine and acupuncture has been used frequently by parents in South Korea for the treatment of children with idiopathic short stature (ISS). We aimed to report the TKM treatments currently being used for children with ISS and explore their therapeutic effects. The medical records of children who met the criteria for ISS and who had been treated with TKM for the management of ISS were retrospectively reviewed. In total, 116 patients (mean [standard deviation] age, 8.07 [3.08] years; 52.6% girls) enrolled in the study. Their mean height percentile was 1.45 and body mass index was 16.19 kg/m2. During the study period of 5 years, participants visited the outpatient clinic an average of 2.93 times; the mean number of days to the next visit was 101 days. All patients received herbal medicine treatment, and the formulation was mainly decoction type. Additional treatments including ear acupuncture and moxibustion were also used. After treatment with TKM, the height percentile and standard deviation scores increased in both girls and boys (P < .001 and P < .01, respectively). Additionally, the predicted adult height, estimated based on bone age, increased in girls (P < .05). This study provided preliminary data for future research in TKM use in children with ISS.

A Case Study of Yulgyuk and Banui Syndrome in a Patient with Systemic Sclerosis

Objectives: This study aimed to report on a systemic sclerosis patient diagnosed with Yulgyuk and Banui syndrome improved by Korean medical treatment.Methods: We treated a 70-year-old woman who had swallowing disorders and frequent vomiting caused by systemic sclerosis with herbal medicine and acupuncture treatment for six months. Treatment was evaluated with a numerical rating scale (NRS).Results: After treatment, swallowing disorders and frequent vomiting decreased. The NRS decreased from 8 to 3.Conclusions: This case suggests that Korean medical treatment was effective for alleviating a swallowing disorder and frequent vomiting caused by systemic sclerosis as a conservative treatment.

Real-World Evidence of Traditional Chinese Medicine (TCM) Treatment on Cancer: A Literature-Based Review.

While randomized controlled trials (RCTs) are the gold standard for evidence-based medicine, they do not always reflect the real condition of patients in the real-world setting, which limits their generalizability and external validity. Real-world evidence (RWE), generated during routine clinical practice, is increasingly important in determining external effectiveness of the tightly controlled conditions of RCTs and is well recognized as a valuable complement to RCTs by regulatory bodies currently. Since it could provide new ideas and methods for clinical efficacy and safety evaluation of traditional Chinese medicine (TCM) and high-quality evidence support, real-world study (RWS) has received great attention in the field of medicine, especially in the field of TCM. RWS has shown desirable adaptability in the clinical diagnosis and treatment practice of traditional Chinese medicine. Consequently, it is increasingly essential for physicians and researchers to understand how RWE can be used alongside clinical trial data on TCM. Here, we discuss what real-world study is and outline the benefits and limitations of real-world study. Furthermore, using examples from TCM treatment on cancer, including Chinese herbal medicine, acupuncture, moxibustion, integrated TCM and Western medicine treatment, and other treatments, we elaborate how RWE can be used to help inform treatment decisions when doctoring patients with cancer in the clinic.

The Potential Complementary Role of Using Chinese Herbal Medicine with Western Medicine in Treating COVID-19 Patients: Pharmacology Network Analysis.

The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) caused a global pandemic in 2019—coronavirus disease (COVID-19). More and more Western medicine (WM) and Chinese herbal medicine (CHM) treatments have been used to treat COVID-19 patients, especially among Asian populations. However, the interactions between WM and CHM have not been studied. This study aims at using the network pharmacology approach to explore the potential complementary effects among commonly used CHM and WM in a clinical setting from a biomolecular perspective. Three well-published and widely used CHM formulas (National Research Institute of Chinese Medicine 101 (NRICM101), Qing-Fei-Pai-Du-Tang (QFPDT), Hua-Shi-Bai-Du-Formula (HSBDF)) and six categories of WM (Dexamethasone, Janus kinase inhibitors (JAKi), Anti-Interleukin-6 (Anti-IL6), anticoagulants, non-vitamin K antagonist oral anticoagulants (NOAC), and Aspirin) were included in the network pharmacology analysis. The target proteins on which these CHM and WM had direct effects were acquired from the STITCH database, and the potential molecular pathways were found in the REACTOME database. The COVID-19-related target proteins were obtained from the TTD database. For the three CHM formulas, QFPDT covered the most proteins (714), and 27 of them were COVID-19-related, while HSBDF and NRICM101 covered 624 (24 COVID-19-related) and 568 (25 COVID-19-related) proteins, respectively. On the other hand, WM covered COVID-19-related proteins more precisely and seemed different from CHM. The network pharmacology showed CHM formulas affected several inflammation-related proteins for COVID-19, including IL-10, TNF-α, IL-6, TLR3, and IL-8, in which Dexamethasone and Aspirin covered only IL-10 and TNF-α. JAK and IL-6 receptors were only inhibited by WM. The molecular pathways covered by CHM and WM also seemed mutually exclusive. WM had advantages in cytokine signaling, while CHM had an add-on effect on innate and adaptive immunity, including neutrophil regulation. WM and CHM could be used together to strengthen the anti-inflammation effects for COVID-19 from different pathways, and the combination of WM and CHM may achieve more promising results. These findings warrant further clinical studies about CHM and WM use for COVID-19 and other diseases.

Korean medicine registry of herbal medicine for weight loss.

Introduction:In South Korea, the prevalence of obesity has continuously increased over the last decade, and the burden of social and economic costs has also increased immensely. The purpose of this study is to investigate the clinical characteristics and current status of patients receiving herbal medicine (HM) treatment for weight loss in Korean medicine (KM) by constructing a multi-institutional prospective registry.Methods and analysis:This is a prospective, observational, multi-center registry, including patients visiting the KM clinics in South Korea for weight loss. This study will collaborate with 15 KM clinics and recruit patients into the registry between October 2021 and October 2022. The study population will include patients visiting the KM clinics for weight loss. A total of 1000 eligible patients visiting the KM clinics for weight loss who decide to undergo HM treatment will be enrolled in the registry. After enrollment, we will collect the individual characteristics of each patient, such as body mass index, body composition test, liver and kidney function tests, and information on prescribed HM. We will also record the adverse events at each visit.Discussion:This study is the first prospective, multicenter registry of HM for weight loss in KM clinics. The results of this registry may show the current status of patients who receive HM treatments for weight loss and provide evidence for reasonable decision-making on KM healthcare policy for obese patients in the future.

Herbal Medicines for the Treatment of Chronic Obstructive Airway Diseases (Asthma or Chronic Obstructive Pulmonary Disease): A Prospective Observational Study.

Background Obstructive airway disease is a major health problem and has a great impact on global socioeconomic burden. Despite therapeutic advances in recent decades, there is still a need for effective and safe therapeutic agents for patients with asthma or chronic obstructive pulmonary disease (COPD). Methods This prospective observational study explored the effects of herbal medicines in patients with asthma and COPD. All participants visited the hospital at least every 4 weeks for 12 weeks to receive their herbal medicines based on their pattern identification and to evaluate safety and efficacy endpoints. We followed the diagnostic criteria used by Korean medicine doctors to prescribe herbal medicines, explored variations in prescribed herbal medicines, and explored a number of clinical features in patients with asthma or COPD. Results A total of 24 patients were enrolled: 14 were diagnosed with asthma and 10 with COPD and 19 completed the study. After 12 weeks of herbal medicine treatment, herbal medicines significantly improved the modified Clinical Asthma Measurement Scale in Oriental Medicine-V in asthma patients and the modified Medical Research Council Dyspnoea Scale and St. George's Respiratory Questionnaire in COPD patients. For all patients, modified Medical Research Council Dyspnoea Scale score and interleukin-13 were found to be significantly different after treatment. Additionally, the majority of patients were satisfied with our herbal medicine treatments, and no severe adverse events were reported during the study. Conclusions Our study provides preliminary clinical data on the safety and efficacy of herbal medicines in patients with asthma and COPD.

Efficacy of Traditional Herbal Medicine Treatment Based on Pattern Identification for Idiopathic Parkinson's Disease: A Protocol for Systematic Review and Meta-Analysis.

Parkinson's disease (PD), the second most common progressive neurodegenerative disease, is characterized by various clinical symptoms and reduced quality of life. The standard dopaminergic therapy for PD has limitations such as drug wear-off, drug-related side effects, and drug-resistant PD symptoms. Traditional oriental medicine, which is a personalized approach based on pattern identification (PI), has been reported to relieve symptoms, halt disease progression, and improve the quality of life in patients with PD. This comprehensive systematic review will be conducted to gather clinical studies related to complementary traditional herbal therapies based on PI for idiopathic PD and assess its effectiveness. Clinical studies, including randomized controlled trials in English, Korean, and Chinese databases related to the efficacy of herbal medicine based on PI for PD will be searched in computer retrieval. In addition, the subdivided PI for each clinical manifestation of PD will be investigated. Two researchers will independently screen and select studies, extract data, and assess bias risk. The risk of bias will be evaluated using the Cochrane risk-of-bias assessment tool. After screening the studies, a meta-analysis will be performed. The primary outcome will be the unified Parkinson's disease rating scale to measure clinical symptom reduction. Secondary outcomes will consist of other validated scales to evaluate the improvement of PD, including improvement of clinical symptoms and quality of life. The quality of evidence will be evaluated through the Grading of Recommendations, Assessment, Development, and Evaluation pro. Complementary traditional medicine is a personalized medicine that classifies individual states based on PI. We expect that the results of this review will provide evidence for the efficacy of traditional herbal medicine based on PI for the treatment of PD. This protocol has been registered in the International Platform of Registered Systematic Review and Meta-Analysis Protocols (INPLASY) 2021 (registration number INPLASY2021100020).

Development of the Korean Medicine Core Outcome Set for Stroke Sequelae: Herbal Medicine Treatment of Elderly Patients With Stroke Sequelae in Primary Clinics.

Objectives: We developed a Korean medicine core outcome set for stroke sequelae (COS-SS-KM) to evaluate the effectiveness and safety of herbal medicine (HM) for stroke sequelae, especially for elderly stroke patients in primary clinics. Methods: We identified previously reported outcomes from a literature review and defined the list of outcomes and effect modifiers for the core outcome set (COS) questionnaire. Three rounds of modified Delphi consensus exercises with experts were conducted online for suitability assessment, and one round of a modified Delphi consensus exercise with primary clinicians was conducted for feasibility assessment. Results: The review identified 17 outcomes and 16 effect modifiers; moreover, six outcomes and one effect modifier were suggested by the experts. The final COS comprised 8 outcomes and 12 effect modifiers for history taking, and experts listed 13 major symptoms of stroke sequelae for symptom assessment. The clinicians agreed on the feasibility of the COS. Conclusion: This COS will help primary care researchers assess the effectiveness of pharmacotherapy, including HM, for elderly patients with stroke sequelae. Future studies should focus on reflecting the opinions of all stakeholders.

A national survey on current clinical practice pattern of Korean Medicine doctors for treating obesity

Given the multifactorial nature of obesity, there is current interest on Korean medicine (KM) for weight loss. This survey aimed to investigate current practice patterns of KM treatment for obesity among doctors. A questionnaire on clinical practice patterns of KM treatment for obesity was constructed and distributed to 21,788 KM doctors (KMDs). The questionnaire was consisted of respondent characteristics, state of treated patient, diagnosis, treatment, and usage pattern of herbal medicine for obesity. A total of 4.9% of KMDs (n = 1,084/21,788) validly completed the survey. Patients with Obesity Class I (25 ≤ Body mass index (BMI) ≤ 29.9) are the most common in KM clinics. Bioelectric impedance and KM Obesity Pattern Identification Questionnaire were routinely used for diagnosis. The average treatment duration was 4.16 weeks, and patients visited on an average 4.25 times per month for treatment. Herbal medicine is the most commonly used for obesity treatment by KMDs, and Taeeumjowui-tang was the most frequently prescribed. Ephedrae Herba, which is identified as the most used herbs for weight loss, was prescribed 5.18 ± 2.7 g/day at minimum and 10.06 ± 4.23 g/day at maximum. A total of 62.9% of responded KMDs had ever a patient with uncomfortable symptoms due to Ephedrae Herba use, neuropsychiatric events were the most common symptoms, followed by gastrointestinal events. Taken together, this study provides information on real clinical practice patterns of KM including patients, diagnosis, treatments, and herbal medicine for obesity.

Advanced Maternal Age with Severely Diminished Ovarian Reserve with Multiple Successful Live Births after Chinese Herbal Medicine Treatment: A Case Report

The fecundity of women decreases significantly beginning approximately at age 35 and decreases more rapidly after age 40. Age affects not only the size of the oocyte pool but also the quality of germ cells. Despite the continuous progress of assisted reproductive technology, infertility is still a problem for advanced maternal age.

Traditional Chinese Herbal Medicine and Corticosteroids in Asthma: A short review.

Asthma is a prevalent chronic inflammatory disease that has gold standard treatment with corticosteroids, but these are associated with important long-term side effects. On this basis, Traditional Chinese Medicine contributes with therapeutic techniques such as the herbal Anti-Asthma Herbal Medicine Intervention (ASHMI). In this context, this study aims to evaluate the effectiveness of treatment with ASHMI compared to conventional therapy, considering the need for new therapeutic approaches. An integrative review was performed, according to the PRISMA methodology. Articles published between 2011 and 2021 that related Herbal Medicines of Traditional Chinese Medicine, asthma and corticosteroids were examined. The searches took place in October and November 2021 in the Scopus, PubMed, Web of Science, Google Scholar, and Scielo databases. The selection comprised steps such as: search, pre-selection and inclusion of articles. The results of the herbal medicine and its isolated components were demonstrated, with three studies being clinical trials with humans and four pre-clinical studies. From the results, the efficacy of the herbal medicine and its components compared to corticosteroids were evaluated. It was reported that ASHMI, unlike corticosteroids, does not suppress the hypothalamic-pituitary-adrenal axis and the immune system, having mild adverse effects

External treatment of herbal medicine with tuina in congenital muscular torticollis: A protocol for systematic review and meta-analysis.

Background:This study is the protocol to evaluate the clinical evidence for external treatments using herbal medicine (ETHM) with tuina as a congenital muscular treatment (CMT) in pediatrics.Methods:Eleven databases will be searched until June 2022, without any language restrictions: four English databases (MEDLINE, Pubmed, EMBASE, and The Cochrane Central Register of Database of Controlled Trials), three Chinese databases (China National Knowledge Infrastructure, Chinese Scientific Journal Database, and Wan Fang Database), and four Korean electronic databases (Oriental Medicine Advanced Searching Integrated System, Korean Studies Information Service System, National Digital Science Links, and Research Information Sharing Service). This review will include randomized clinical trials (RCTs) of ETHM with tuina as an intervention versus the same tuina. All published RCTs for any ETHM for CMT will be included. Non-RCTs, RCT protocol, animal studies, case reports, reviews, and surveys will be excluded. The methodological quality assessment will be performed using the Cochrane risk of bias (ROBs). Review Manager version 5.4. will be used for the data synthesis and quantitative analysis.Results and discussions:The systematic review and meta-analysis will provide evidence for ETHM as a treatment of CMT. The evidence can help clinicians and patients recognize more effective therapeutic and safe inventions.INPLASY registration number:INPLASY202210017.

East Asian Herbal Medicine (EAHM) Alone for the Treatment of Women with Diminished Ovarian Reserve (DOR): A Systematic Review and Meta-analysis

Objectives: The aim of this study was to find out whether east asian herbal medicine (EAHM) treatment alone is effective in improving pregnancy-related indicators compared to conventional medicine in women with Diminished Ovarian Reserve (DOR).Methods: We searched eligible studies from PubMed, Cochrane Library, EMBASE, Chinese National Knowledge Infrastructure Database, CiNii, Korean Medical Database, Korean Studies Information Service System, Oriental Medicine Advanced Searching Integrated System, ScienceOn. GRADE pro was used to evaluate the current evidence of the study.Result: A total of 5 studies, 325 women with DOR were included. EAHM showed a significant effect on improvement of pregnancy rate (n=270, RR 2.13 [95% CI 1.44 to 3.15], Z=3.78, p=0.0002, I2=0%) and Anti-Mullerian Hormone (AMH) level (n=211, SMD 0.82 [95% CI 0.40 to 1.25], Z=3.80, p=0.0001) compared to conventional medicine. In ovulation rate (n=156, RR 0.86 [95% CI 0.70 to 1.06], Z=1.43, p=0.15, I2=0%), Antral Follicle Count (n=245, SMD 0.27 [95% CI -0.25 to 0.79], Z=1.01, p=0.31), and follicle stimulating hormone (n=245, SMD 0.29 [95% CI -0.13 to 0.70], Z=1.36, p=0.17) level, EAHM showed similar effects to conventional medicine. In this study, the most frequently used herbal medicines were Cuscutae Semen, Dipsaci Radix, and Angelicae Gigantis Radix.Conclusion: This meta-analysis showed that EAHM could improve pregnancy rates and AMH levels in women with DOR. However, more well-designed RCTs will have to be performed further in the future.

Comprehensive Korean Medicine Treatment for Benign Essential Blepharospasm in a Patient Responding Poorly to Botulinum Toxin Treatment

Benign essential blepharospasm (BEB) is a condition/disease which involves involuntary muscle contractions causing the eye to repetitively close, making it impossible for the patient to perform daily activities. This study reports Korean medicine treatment of a rare case BEB in a 34-year-old male patient whose symptoms showed minimal improvement following botulinum toxin injection (the standard treatment). Acupuncture, pharmacopuncture, and herbal medicine treatment for 11 days resulted in clinical improvement for all symptoms as assessed by using the Jankovic Rating Scale, Blepharospasm Disability Index, numerical rating scale, duration of spasms lasting more than 1 hour per day, and number of spasms lasting less than 1 minute per day. This case report suggests that comprehensive Korean medicine treatment could be a treatment option for BEB in patients who do not respond well to botulinum toxin injection.

Integrative treatment of herbal medicine with western medicine on coronary artery lesions in children with Kawasaki disease.

Background:Kawasaki disease (KD) is a major cause of coronary artery lesions (CALs) in children. Approximately 10% to 20% of children treated with intravenous immunoglobulin are intravenous immunoglobulin-resistant. This study evaluated the efficacy and safety of adding herbal medicine to conventional western medicines versus conventional western medicines alone for CALs in children with KD.Methods:This study searched 9 electronic databases until August 31, 2021. The inclusion criteria were the randomized controlled trials (RCTs) that assessed the CALs in children with KD and compared integrative treatment with conventional western treatments. Two authors searched independently for RCTs, including eligible articles that fulfilled the inclusion criteria, extracted data, and assessed the methodological quality using the Cochrane risk of bias tool. Meta-analysis was conducted using Cochrane Collaboration's Review Manager 5.4 software. The effect size was presented as the risk ratio (RR), and the fixed-effect models were used to pool the results.Results:The finally selected 12 studies included a total of 1030 KD patients. According to a meta-analysis, the integrative treatment showed better results than the conventional treatment in the CAL prevalence rate (RR = 2.00; 95% confidence interval [CI], 1.49–2.71; P < .00001), CAL recovery rate (RR = 1.27; 95% CI, 1.05–1.54; P = .02), and total effective rate (RR = 1.17; 95% CI, 1.11–1.23; P < .00001). Only 2 studies referred to the safety of the treatment. The asymmetrical funnel plot of the CAL prevalence rate indicated the possibility of potential publication bias.Conclusions:This review found the integrative treatment to be more effective in reducing the CAL prevalence rate and increasing the CAL recovery rate and total effective rate in KD patients than conventional western treatment. However, additional well-designed RCTs will be needed further to compensate restrictions of insufficient trials on safety, methodological quality, and publication bias.

Time-dependent dual beneficial modulation of interferon-γ, interleukin 5, and Treg cytokines in asthma patient peripheral blood mononuclear cells by ganoderic acid B.

Th2 cytokines play a dominant role in the pathogenesis of allergic asthma. Interferon gamma (IFN-γ), a Th1 cytokine, links to therapeutic mechanisms of allergic asthma. Interleukin (IL)-10, a regulatory cytokine, is involved in the induction of immune tolerance. We previously demonstrated that Anti-Asthma Simplified Herbal Medicine Intervention (ASHMI) suppressed Th2 and increased IFN-γ in patients with asthma and in animal models, but its bioactive compound is unknown. Ganoderic acid beta (GAB) was isolated from Ganoderma lucidum (one herb in ASHMI). Human peripheral blood mononuclear cells (PBMCs) from adult patients with asthma were cultured with GAB or dexamethasone (Dex) in the presence of environmental allergens. The cytokine levels of IL-10, IFN-γ, IL-5, transcription factors T-bet, Foxp-3, and GATA3 were measured. Following 3-day culture, GAB, but not Dex, significantly increased IL-10 and IFN-γ levels by allergic patients' PBMCs. Following 6-day treatment, GAB inhibited IL-5 production, but IL-10 and IFN-γ remained high. Dex suppressed production of all three cytokines. GAB suppressed GATA3 and maintained Foxp-3 and T-bet gene expression, while Dex significantly suppressed GATA3 and T-bet expression. GAB simultaneously increased IL-10, IFN-γ associated with induction of T-bet and Foxp3, while suppressing IL-5, which was associated with suppression of GATA3, demonstrating unique beneficial cytokine modulatory effect, which distinguishes from Dex's overall suppression.

Traditional Chinese herbal medicine in treating amenorrhea caused by antipsychotic drugs: Meta-analysis and systematic review

Ethnopharmacological relevanceAmenorrhea caused by antipsychotic drugs is not uncommon in clinical practice, and various treatment strategies are used to treat the condition. Chinese herbal medicine has its own theory for amenorrhea caused by antipsychotic drugs and has developed its own medication methods. Aim of the studyTo review and conduct meta-analysis of the use of traditional Chinese herbal medicine in treatment of amenorrhea caused by antipsychotic drugs. Materials and methodsA search was conducted across seven Chinese electronic databases (the China National Knowledge Infrastructure (CNKI) database, the China Science and Technology Journal Database, the Wanfang Database, the SinoMed, the Foreign Medical Literature Retrieval Service(FMRS), the Chinese University of Hong Kong Library, the Airiti Library), and the following English databases: MEDLINE, PreMEDLINE, OLD MEDLINE、Publisher Supplied Citation in pubmed; JBI EBP Database, EBM Reviews, Embase, OVID Emcare, Ovid MEDLINE(R), Maternity & Infant Care Database(MIDIRS), APA PsycInfo in OVID, and Cochrane Database of Systematic Reviews (Cochrane Reviews), Database of Abstracts of Reviews of Effects (Other Reviews), Cochrane Central Register of Controlled Trials (Clinical Trials),The Cochrane Methodology Register (Method Studies), Health Technology Assessment Database (Technology Assessments), NHS Economic Evaluation Database (Economic Evaluations) in Cochrane Library; and four databases (Science Direct, ProQuest, Web of Science, and Scopus) in official website using common standards and inclusion/exclusion criteria. The remaining reports were used for preliminary studies. Due to inconsistencies in control groups, randomized controlled trials and articles that combined with other drugs were also excluded. This study is a META analysis of a single rate. ResultsInitial screening returned 912 potentially relevant publications in all databases. After subsequent filtering, a total of 18 articles were included in the analysis. The overall effectiveness for treatment amenorrhea caused by antipsychotic drugs using traditional Chinese herbal medicine was 0.91, with 95% confidence interval of 0.89–0.93. Notably in most studies, the time needed to achieve this level of effectiveness was relatively long, usually in excess of three months. Although a satisfactory verification of an improvement in menstrual cycling takes time, the long treatment duration is a downside. Our analysis revealed that the following Chinese herbal remedies were most common: Danggui (Angelica sinensis (Oliv.) Diels), Chuanxiong (Ligusticum striatum DC.), Taoren (Prunus persica (L.) Batsch), Honghua (Carthamus tinctorius L.), Gancao (Glycyrrhiza uralensis Fisch.), Fuling ((Fungus) Poria cocos (Schw.) Wolf), Baizhu (Atractylodes macrocephala Koidz.), Xiangfu (Cyperus rotundus L.), Chaihu (Bupleurum chinense DC.), Shudihuang (Rehmannia glutinosa (Gaertn.) DC.(Processed), Baishao (Cynanchum otophyllum C.K.Schneid.) ConclusionsChinese herbal medicine can effectively treat amenorrhea caused by psychiatric drugs, although it takes a long time to achieve satisfactory effectiveness. More research is needed to better understand different aspects of Chinese herbal medicine use in treatment of this particular medical condition.

Chinese herbal medicine treatment based on subgroup differentiation as adjunct therapy for Parkinson\u2019s disease: study protocol of a pilot add-on, randomised, controlled, pragmatic clinical trial

BackgroundParkinson’s disease (PD) is a prevalent and debilitating condition. Conventional medications cannot control all symptoms and may inflict adverse effects. A survey reported that Chinese herbal medicine (CHM) is frequently sought. Existing CHM trials were contradictory and often of poor quality due to lack of methodological rigor. A national clinical guideline was drafted in China with diagnostic criteria and treatment strategy of Chinese medicine (CM) patterns subgroups of PD. The suggested CHM were found to exhibit neuroprotective effect in in vitro and in vivo studies. This trial aims to preliminarily assess the effect of CHM prescribed based on pattern differentiation on PD symptoms and patients’ quality of life, and evaluate the feasibility of the trial design for a future large-scale trial.MethodsThis trial will be a pilot assessor- and data analyst blind, add-on, randomised, controlled, pragmatic clinical trial. 160 PD patients will be recruited and randomised into treatment or control groups in a 1:1 ratio. The trial will be conducted over 32 weeks. PD patients in the treatment group will be stratified into subgroups based on CM pattern and receive CHM accordingly in addition to conventional medication (ConM). The control group will receive ConM only. The primary outcome will be part II of the Movement Disorder Society Sponsored Revision of Unified Parkinson’s Disease Rating Scale (MDS-UPDRS). Secondary outcomes will include part and total scores of MDS-UPDRS, domain and total scores of Non-motor symptom scale (NMSS). Adverse events will be monitored by monthly follow-ups and questionnaires. Mixed models will be used to analyse data by Jamovi and R.Expected outcomesThe success of our trial will show that the pragmatic design with subgroup differentiation is feasible and can produce reliable results. It will also provide preliminary data of the effect of CHM on improving clinical outcomes and quality of PD patients. Data collected will be used to optimize study design of the future large-scale clinical study.Ethical clearanceEthical clearance of this study was given by the Research Ethics Committee of Hong Kong Baptist University (REC/20-21/0206).Trial registration This trial is registered on ClinicalTrials.gov (NCT05001217, Date: 8/10/2021, https://clinicaltrials.gov/ct2/show/NCT05001217). Type of manuscript: clinical trial protocol (date: 3rd November, 2021, version 1)

Role of traditional herbal medicine in treatment of malaria

Role of traditional herbal medicine in treatment of malaria

Herbal medicine in treatment of dysmenorrhea: a systematic review

Herbal medicine in treatment of dysmenorrhea: a systematic review