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Objective: Chinese herbal medicine (CHM) is quite popular in Asia. The purpose of this study is to investigate the benefits of decreasing the risk of cirrhosis in patients with non-alcoholic fatty liver disease (NAFLD) by using CHM. Design: We performed a 1:3 propensity score-matched cohort study to analyze patients with NAFLD diagnosed between January 1, 1997 and December 31, 2011 through the Taiwanese National Health Insurance Research Database. Patients who received CHM therapy from the initial date of diagnosis of NAFLD to December 31, 2011 were included in the CHM group. Patients who were not treated with CHM during the same interval were categorized in the non-CHM group. Cox regression model was used to adjust for sex, age, comorbidities, and drug use. Hazard ratios were also compared between the two groups. Results: A total of 13,072 patients were identified after 1:3 propensity score matching. The patients had similar basic characteristics. A lower cumulative incidence of cirrhosis was found in the CHM cohort (log-rank test, p < 0.0001). Finally, 176 patients in the CHM cohort (4.66 per 1000 person-years) and 582 patients in the non-CHM cohort (7.92 per 1000 person-years) developed cirrhosis (adjusted hazard ratios 0.63, 95% confidence interval 0.53–0.75). The effect of CHM to lower cirrhosis incidence was independent of sex, drug use, and comorbidities, including diabetes mellitus, hypertension, and cardiovascular diseases. Patients older than 40 years of age and without comorbidities such as chronic obstructive pulmonary disease, hyperlipidemia, alcoholism, tobacco use, or obesity also benefited from CHM. Conclusions: Our study is the first large-scale investigation in Taiwan that shows the association between patients with NAFLD and cirrhosis prevention after CHM intervention. The results may be useful for treatment and for decision making for patients and clinical doctors. Further restricted trials are needed to support our findings. [ABSTRACT FROM AUTHOR]

Background: Patients who have Parkinson's disease (PD) comorbid with dementia is common. With the prolonged life expectancy, dementia is gradually becoming prevalent and affects most patients' life qualities. However, the efficacy of current treatments in dementia of PD is limited. Previous studies indicated the potential roles of Chinese herbal medicine (CHM) in treating dementia, yet the correlation between CHM usage and risk of dementia in PD patients is unclear. Methods: This case–control study was nested within a National Health Insurance database of patients over 50 years with newly diagnosed PD from year 2000 to 2010. Among these PD patients, dementia and nondementia groups were discussed, respectively, in terms of the duration of taking CHM (≥90 vs. <90 days), age (50–64 vs. ≥65 years) and gender. Results: The risk of dementia in patients with PD is lower in CHM users compared with non-CHM users, especially in those taking CHM for more than 90 days (adjusted odds ratio [aOR] 0.58; 95% confidence interval [95% CI] 0.39–0.87). The use of CHM was significantly related to the lower risk of dementia in the subgroups of patients with age ≥65 years for CHM usage <90 days (aOR 0.68; 95% CI 0.53–0.88), patients with age ≥65 years for CHM usage ≥90 days (aOR 0.63; 95% CI 0.42–0.94), female patients using CHM for ≥90 days (aOR 0.43; 95% CI 0.22–0.84), and male patients using CHM for <90 days (aOR 0.62; 95% CI 0.43–0.88). Conclusions: The authors demonstrated the association of CHM usage with lower risk of dementia in patients with PD, especially in women with the usage of CHM for more than 90 days. Since no arbitrary causal conclusions could be drawn from retrospective cohort studies, the finding in this study could be used to generate a hypothesis for a subsequent design of prospective longitudinal study. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the effect of Yugengtongyu granules on reducing the incidence of adverse cardiovascular events and improving quality of life (QOL) in patients with stable coronary artery disease (SCAD). Methods: A double-blind randomized controlled trial was conducted among SCAD population. One hundred fourteen patients were randomly assigned to experimental group (n = 57) and control group (n = 57) following randomized block design. Combined with the basis of standard treatment of SCAD, the experimental group and control group received Yugengtongyu granules or placebo, respectively, twice daily for 6 months and were followed for another 1 year (18 months in total from enrollment). Major outcomes (any occurrence of cardiovascular death, nonfatal myocardial infarction, or coronary revascularization), minor outcomes (any occurrence of all-cause death, ischemic stroke, readmission due to unstable angina, heart failure, or malignant arrhythmia), and composite outcomes (union of major and minor outcomes) were used to evaluate prognosis; Seattle Angina Questionnaire (SAQ) was applied to evaluate QOL, and levels of low density lipoprotein-cholesterol (LDL-C) and high sensitive C reacting protein (HS-CRP) in serum were tested. Results: The incidence of composite outcomes in the experimental group was significantly lower than that in the control group (3 [5.2%] vs. 11 [19.2%], hazard ratio: 0.273, 95% confidence interval: 0.080–0.926, p = 0.022); major outcomes, minor outcomes, and independent events such as nonfatal myocardial infarction showed lowering trend in experimental group. Experimental group scored significantly higher than control group in four dimensions of SAQ: physical limitation, angina frequency, treatment satisfaction, and disease perception at the third- and sixth-month follow-up; there was no significant difference in serum level of LDL or HS-CRP at all scheduled timepoints. Conclusion: The addition of Yugengtongyu granules based on current standard treatment reduced the incidence of composite outcomes and improved QOL in patients with SCAD. The trial was registered in the Chinese Clinical Trial Registry (ChiCTR-TRC-13004370). [ABSTRACT FROM AUTHOR]

Objectives: Acute coronary syndrome (ACS) is an acute disease with high mortality. Although early percutaneous coronary intervention (PCI) is proved to be the practical approach in treating ACS, the incidence of cardiovascular events is still far from satisfactory. The combination of Suxiao Jiuxin Pill (SJP) and Western medicine is one conventional approach in the treatment of ACS. Many elementary and clinical trials have proved the efficacy and safety in the improvement of cardiocerebral vascular conditions. The aim of this project is to evaluate the safety and efficacy of SJP on ACS with early PCI patients. Trial Design: This is a multicenter randomized, double-blind placebo-controlled trial. Trial registration: ChiCTR-TRC-13003053. Settings: Hospitals. Subjects: A total of 200 ACS with early PCI patients were randomly divided into SJP group (n = 100) and placebo group (n = 100). Interventions: The SJP group was treated with routine treatment and SJP (taking eight SJP pills orally each time, three times per day). The placebo group was treated with routine treatment along with equal amounts of SJP placebo. The course of treatment was 6 months and a follow-up visit at 12 months. Outcome Measures: Assessments of major adverse cardiovascular events (MACE), safety assessments, adverse events, left ventricular systolic function (LVEF), Seattle angina questionnaire (SAQ), troponin C (cTNI), C-reactive protein (CRP), fibrinogen (Fib), and cystatin C (cysC). Results: The SJP group had a relatively low incidence of MACE than the placebo (p < 0.05, odds ratio: 1.916, 95% confidence interval [0.999–3.674]). LVEF was significantly higher in the SJP group than the placebo group on the 360-day follow-up (p < 0.01). SJP had a significant increase score in the SAQ subscale of physical limitation, angina frequency, and treatment satisfaction (p < 0.05). There is no significant difference in the cTNI and CRP level between the two groups. The serum concentration of Fib and cysC in the SJP was significantly decreased compared with the placebo (p < 0.05). The numbers of adverse events between the two groups were not statistically different (p > 0.05). Conclusions: SJP is associated with a reduction in MACE, and an improvement of heart function and quality of life in ACS patients with early PCI, and is probably safe to use. [ABSTRACT FROM AUTHOR]

Objectives:Fufang Banmao (FFBM) capsule, a type of Chinese medicinal formulation, has decades of history in treating hepatocellular carcinoma (HCC). This retrospective study aimed to observe the effect of FFBM capsules on the 6-month survival of patients with advanced HCC and Vp3–4 portal vein tumor thrombosis (PVTT) who received supportive therapy alone. Design: In total, 320 HCC/Vp3–4 PVTT patients underwent treatment with supportive therapy, of whom 95 took FFBM capsules and were treated with supportive therapy (FFBM group) and 225 received supportive therapy alone (control group). Comparisons of the 6-month overall survival (OS) rate of the two groups were performed. Propensity score matching (PSM) was used to match the characteristics between individuals in the two groups. A nomogram was built based on independent predictive factors for OS. Results: Cox multivariate analysis revealed that hepatic encephalopathy, aspartate transaminase (AST) and γ-glutamyl transpeptidase levels, Child–Pugh class, prothrombin time, α-fetoprotein level, largest tumor diameter, and use of FFBM capsules were independent predictive factors of OS. Variceal bleeding, alanine transaminase, AST, total bilirubin, and Barcelona Clinic for Liver Cancer stage were different at baseline in the FFBM and control groups. Analysis revealed no significant adverse effects or toxicities relevant to the medications. After PSM (1:1), 95 patient pairs were analyzed as FFBM versus control. The OS probability was remarkably higher for patients in the FFBM group than in those in the control group at 6 months (p < 0.0001). The median survival time was 4 months in the FFBM group and 2.2 months in the control group. Kaplan–Meier analysis showed significant statistical differences in the 6-month OS rates in the patients with total nomogram scores ≥84 (p < 0.0001). Conclusions: Given the satisfying survival outcomes, the results suggested that FFBM capsules should be administered to patients with HCC/Vp3–4 PVTT in the high-risk group (score ≥84). FFBM capsules have the potential for improving patient survival time in those with advanced HCC and Vp3–4 PVTT who receive supportive therapy alone, especially those in the high-risk group (score ≥84). [ABSTRACT FROM AUTHOR]

Background: There is currently no effective treatment against coronavirus disease 2019 (COVID-19). The optimal selection of interventions targeting the virus is unknown. Therefore, evidence from randomized controlled trials (RCTs) to support specific treatment against COVID-19 is urgently needed. The use of Chinese herbal medicines (CHMs) might have a role in the treatment and symptomatic management of patients with COVID-19. It was aimed at providing an overview of the available evidence and ongoing trials concerning the effects of CHMs for the treatment of COVID-19. Methods: This is a narrative review of relevant studies. Searches were conducted to identify documents published till April 22, 2020. Electronic databases, evidence-based collections, websites of relevant organizations, and trial registries were consulted. Results: A total of 25 guidelines on the treatment of patients with COVID-19 were identified. Four guidelines provided recommendations on the use of CHMs; these guidelines were developed in China and South Korea and were based on the consensus of experts exclusively. The remaining 21 guidelines provided no guidance on CHMs. No finished RCTs of CHMs for the treatment of patients with COVID-19 was found. According to the evidence evaluated in this review, a Cochrane review of CHMs for severe acute respiratory syndrome and five uncontrolled observational studies of the effects of CHMs in patients with COVID-19, the effects of CHMs for COVID-19 are unknown. A total of 52 ongoing clinical trials of CHM interventions for the treatment of COVID-19 were found. These trials will be carried out mostly in China (n = 51). Forty (77%) of the ongoing trials will be randomized, whereas 12 (23%) have an unclear sequence generation procedure. Forty-seven trials (90%) will have a sample size <400 participants. Conclusions: To the authors' knowledge, only the Chinese and the South Korean guidelines recommend CHMs as a treatment option for patients with COVID-19. These guidelines base their recommendations on the consensus of experts. Clinical guidelines or health authorities from other countries do not provide advice on CHMs. Due to the absence of RCT, there is currently no reliable evidence on the effects of any specific CHM intervention for the treatment of patients with COVID-19. A high number of clinical trials of different herbal products are being currently conducted in China. [ABSTRACT FROM AUTHOR]

The article presents Synopses of Cochrane Reviews from Cochrane Library. Topics discussed include Polycystic ovarian syndrome (PCOS), a condition in which the ovaries are enlarged and the body produces high levels of androgens and insulin and lower levels of progesterone, can make it difficult for women to become pregnant; and Chinese herbal medicine (CHM) has also been used to treat subfertility in PCOS and this Cochrane review looked at the safety and effectiveness of CHM.

Objectives: Despite the remarkable advances in critical care management of acute brain injury for the past 20 years, the prognoses remain poor. However, numerous reports indicate the efficacy of Traditional Chinese Medicine (TCM) therapy in stroke rehabilitation. This study aimed to determine the efficacy and safety of integrated TCM (Wendan decoction [WDD]) in patients with acute brain injury as a combination therapy in the early stages. Design: Prospective randomized controlled trial. Setting: Single-center study. Subjects: Sixty patients diagnosed with acute brain injury were randomly assigned to intervention and control groups, equally, and 41 patients completed the study. Interventions: All patients were treated by conventional neurologic intensive care. The 23 patients in the intervention group were administered with an integrated WDD in the early stages three times daily; combination treatment was initiated within 14 days and lasted >1 month. Outcome measures: Duration of ventilator use, intensive care unit stays, Glasgow Coma Scale (GCS) scores, motor response, the best muscle power, disability rating scale (DRS) scores, modified Rankin scale (mRS) scores, and the mortality rate for the first month. The other outcome measures were GCS scores, motor response, the best muscle power, DRS, mRS, and Barthel index (BI) scores 6 months later. Results: There was no mortality in the intervention group, but the rate was 39% in the control group for first month. Comparisons between groups showed significant differences (p < 0.05) in GCS, DRS, mRS, and BI scores, indicating improvements in the intervention group after 6 months. Conclusions: In the early stages of acute brain injury, combination treatment with WDD was found to be safe. Furthermore, this treatment may improve neurologic functional outcomes after 6 months. [ABSTRACT FROM AUTHOR]

Objectives: In this pilot study, the effect of 970 mg Chi-Ju-Di-Huang-Wan (CJDHW) plus 30 mg four-substance decoction (Si Wu Tang; CJDHWSWT) was evaluated, in terms of its ability to alleviate dry eye symptoms and its therapeutic mechanism. Methods: This double-masked prospective investigation has recruited dry eye patients who have been randomly selected into two groups, namely treatment (n = 15) versus nontreatment (n = 15). In the treatment group, a daily oral intake of CJDHWSWT plus eye drops systane ultra was given for 90 consecutive days. In the nontreatment group, only defined eye drops were prescribed. The examinations included Schirmer's test, fluorescein-stained superficial punctate keratitis (SPK), artificial tear consumption, tear vascular endothelium growth factor (VEGF) level, and ocular surface disease index. The drug safety tests included liver and kidney functions, and complete blood counts. The candidates were observed during the screening visit and the following three monthly follow-ups. The data were analyzed by unpaired Student's t-test. Results: Compared to no significance in the nontreatment group, CJDHWSWT significantly (p = 0.03) increased the tear secretion after 3 months of intake. Furthermore, in contrast to no significance in the treatment group, there were significant alterations, including (i) increased fluorescein-stained SPK areas (p = 0.03); (ii) increased artificial tear instillation amount (p = 0.03); (iii) elevated tear VEGF protein levels (p = 0.03) in the nontreatment group; and (iv) significant improvement in clinically relevant phenomenon (e.g., reading limit and uncomfortable feeling in windy conditions), after treatment of artificial tear plus oral intake of CJDHWSWT. As shown by the post-treatment normal defined laboratory data, there were no adverse drug effects. Conclusions: This study has supported that CJDHWSWT is safe and effective in relieving dry eye's clinically relevant symptoms/phenomena. CJDHWSWT avoided the tear VEGF upregulation probably induced by dry eye-associated hypoxia/ischemia. [ABSTRACT FROM AUTHOR]

Objectives:Bupleurum chinense (BC; Radix Bupleuri) formulae are widely used in herbal medicine clinical practice for major depressive disorder (MDD). This study provides an up-to-date and comprehensive systematic review and meta-analysis of BC formula for MDD. Design: Randomized controlled trials were retrieved from English and Chinese databases, from their inceptions to March 2019. Included studies compared BC formula alone or as integrative medicine to selective serotonin reuptake inhibitor (SSRI) antidepressants. Studies included adults 18–65 years of age. People with other types of depression or physical comorbidities, such as poststroke depression, bipolar, and other mental or physical disorders, were excluded. Meta-analysis was performed using STATA software. Grading of Recommendations Assessment, Development, and Evaluation was also conducted to assess the quality of evidence. Results: Thirty studies compared BC formula to antidepressants and 25 studies compared BC formula plus antidepressants to antidepressants alone. BC formula was more effective than antidepressants at improving depression severity measured on the Hamilton Rating Scale for Depression (HRSD) (standardized mean difference [SMD] −0.35, 95% confidence interval [CI] −0.52 to −0.18, I2 = 81.2%). Integrative use of BC formula plus SSRIs was also superior to SSRIs alone at improving HRSD scores (SMD −1.03, 95% CI −1.43 to −0.62, I2 = 94.2%). However, heterogeneity of the included studies was high and quality was low. The total number and severity of adverse events in the BC formula groups were less than that in the antidepressant groups. Conclusions: BC formula alone or given as integrative medicine with antidepressants reduced depression severity. However, the evidence is low quality and at risk of bias. Well-designed studies are needed to validate the results we identified in this review. [ABSTRACT FROM AUTHOR]

Objective: Toutongning (TTN) capsule, a Chinese patent medicine, is used as a prophylactic treatment for migraine. The present study was conducted as a postmarketing evaluation of the efficacy and safety of TTN capsule. Design: A randomized, double-blind, placebo-controlled trial. Location: Patients recruited from 14 medical centers in China from May 2014 to August 2015. Subjects: Patients between 18 and 65 years of age with a diagnosis of migraine. Interventions: The patients were randomly assigned to receive either TTN (1200 mg, three times daily) or a matched placebo (1:1) for 4 weeks. Outcome measures: The primary outcome measured was a minimum 50% reduction in the frequency of headaches from the 4-week baseline period to the last 4 weeks of the 12-week trial. Secondary outcomes included duration, days, and visual analog score of headache attack, interval between headache attacks, usage of acute analgesics, and score on the Headache Impact Test-6. In addition, all patients were evaluated for adverse events (AEs). Results: This study initially enrolled 400 patients; a total of 378 participants completed the experiment while fulfilling all study requirements. TTN had a superior effect compared with the placebo on both the primary and secondary outcome measures without any serious AEs or unexpected side effects. Conclusion: TTN can effectively prevent the occurrence of migraine headaches and is well-tolerated and safe. TTN may exhibit a persistent therapeutic effect even after cessation of use. Trial Registration number: ChiCTR-IPR-15007058. [ABSTRACT FROM AUTHOR]

Objectives: Chronic atrophic gastritis (CAG) is the precancerous stage of gastric carcinoma. Traditional Chinese Medicine (TCM) has been widely used in treating CAG. This study aimed to reveal core pathogenesis of CAG by validating the TCM syndrome patterns and provide evidence for optimization of treatment strategies. Design: This is a cross-sectional study conducted in 4 hospitals in China. Hierarchical clustering analysis (HCA) and complex system entropy clustering analysis (CSECA) were performed, respectively, to achieve syndrome pattern validation. Results: Based on HCA, 15 common factors were assigned to 6 syndrome patterns: liver depression and spleen deficiency and blood stasis in the stomach collateral, internal harassment of phlegm-heat and blood stasis in the stomach collateral, phlegm-turbidity internal obstruction, spleen yang deficiency, internal harassment of phlegm-heat and spleen deficiency, and spleen qi deficiency. By CSECA, 22 common factors were assigned to 7 syndrome patterns: qi deficiency, qi stagnation, blood stasis, phlegm turbidity, heat, yang deficiency, and yin deficiency. Conclusions: Combination of qi deficiency, qi stagnation, blood stasis, phlegm turbidity, heat, yang deficiency, and yin deficiency may play a crucial role in CAG pathogenesis. In accord with this, treatment strategies by TCM herbal prescriptions should be targeted to regulating qi, activating blood, resolving turbidity, clearing heat, removing toxin, nourishing yin, and warming yang. Further explorations are needed to verify and expand the current conclusions. [ABSTRACT FROM AUTHOR]

Objectives: This study evaluates the efficacy of Chinese herbal medicines after percutaneous coronary intervention (PCI). Background: PCI is the primary treatment for coronary atherosclerotic heart disease (CHD). However, many patients experience restenosis within 6 months after PCI. Chinese herbal medicines are widely used in patients after PCI. Clinical studies have found that Chinese herbal medicines may prevent restenosis. Methods: Eight databases were searched for randomized controlled trials (RCTs) investigating the use of Chinese herbal medicines after PCI. The search period was from the date of database inception to June 2017. We used the Cochrane risk of bias tool to estimate the methodological quality of the studies. The primary outcome was the restenosis rate, and secondary outcomes were the angina recurrence rate and major adverse cardiac events (MACEs). Data were analyzed with RevMan 5.3, and the quality of evidence was assessed with the GRAD approach. Results: Eleven RCTs with a total of 1,383 patients were included. The major outcome was the restenosis rate, and the results showed a significant effect of Chinese herbal medicines on reduction in the rate of restenosis (risk ratio [RR] = 0.46, 95% CI: 0.35–0.60, p < 0.00001, I2 = 0%). Chinese herbal medicine treatment also decreased the angina recurrence rate (RR = 0.41, 95% CI: 0.29–0.57, p < 0.00001, I2 = 0%). The results revealed a lower rate of MACEs in the Chinese medicine group than in the control group (RR = 0.49, 95% CI: 0.34–0.71, p = 0.0001, I2 = 0%). We evaluated the quality of evidence with the GRADE system; the quality of evidence for the restenosis rate and angina was low, and the quality of evidence for MACEs was estimated to be moderate. Conclusion: According to existing research evidence, the use of Chinese herbal medicines may reduce the incidence of MACEs. Chinese herbal medicines may reduce restenosis and angina recurrence rates after PCI, but the evidence is limited. [ABSTRACT FROM AUTHOR]

Objectives: Patients with Bell's palsy are more likely to develop stroke than the general population. The therapeutic effect of Traditional Chinese Medicine (TCM) on the risk of stroke in patients with Bell's palsy is unknown. We investigated the risk of stroke according to TCM use in Bell's palsy patients. Design: Records obtained from Taiwan's National Health Insurance Research Database identified 9,863 patients with Bell's palsy, 238 of whom met study inclusion criteria and were categorized as TCM users (n = 119) or non-TCM users (n = 119). TCM treatment modalities and Chinese herbal medicine prescription patterns were analyzed. Cox proportional hazards regression analysis determined the risk of stroke. Results: TCM users were at lower risk of stroke compared with non-TCM users (adjusted hazard ratio [aHR] 0.19; 95% confidence interval [CI], 0.06–0.59; p < 0.004). In subgroup analyses, patients treated with both TCM and oral steroids were at significantly lower risk of stroke compared with those who used neither (aHR 0.05; 95% CI, 0.01–0.22; p < 0.001). The risk of stroke was also lower among those treated with TCM only (aHR 0.25; 95% CI, 0.11–0.59; p < 0.001) or oral steroids only (aHR 0.12; 95% CI, 0.03–0.39; p < 0.01), compared with patients using neither. Conclusion: TCM therapy may lower the risk of stroke after Bell's palsy. However, the retrospective nature of this study and characteristics of the database limit these observational findings. Our results deserve further verification in large-scale prospective studies. [ABSTRACT FROM AUTHOR]

Objectives: The study aims to evaluate the therapeutic efficacy and safety of Chinese herbal medicine (Xiaoaiping) injections for chemotherapy-induced thrombocytopenia (CIT) in nonsmall cell lung cancer (NSCLC) and gastric cancer. Design: A randomized, controlled, multicenter study from December 2013 to August 2015. Settings/Location: All patients are from China. Subjects: One hundred forty patients with either NSCLC or gastric cancer were enrolled in this trial. Interventions: The intervention group (n = 70) was given Xiaoaiping injections (1 dose/day for 10 days) with chemotherapy, whereas the control group (n = 70) was given chemotherapy only. The follow up period was 11 days after the final injection. Outcome measures: Platelet (PLT) count was tested at day 0, 7, 14, and 21 as the primary outcome for evaluation. Safety measurements, including red blood cells (RBC), hemoglobin (HBG), white blood cells (WBC), neutrophil (NE)#, aspartate aminotransferase (AST), alanine aminotransferase (ALT), lactate dehydrogenase (LDH), creatine kinase (CK), creatinine (Cr), and blood urea nitrogen (BUN) were tested at day 0 and 21 as the secondary outcomes. Results: (1) Two patients in the intervention group and four patients in the control group were lost upon follow-up. (2) PLT count: there was no significant difference in PLT count between the two groups from baseline (day 0), day 7, and day 14. At day 21, the intervention group indicated an upward trend of PLT count with a statistically significant difference than that of the control group (p < 0.05). (3) NSCLC: there was significant difference in PLT count between the two groups on day 21 (p < 0.01). (4) Gastric cancer: there was no significant difference in PLT count between the two groups during this trial (p > 0.05). (5) There was no statistically significant difference between the intervention group and the control group with the safety figures (secondary outcomes) RBC, HGB, WBC, NE#, AST, ALT, LDH, CK, Cr, and BUN measured (p > 0.05). (6) Adverse events: one gastric cancer patient in the control group was diagnosed with gastrointestinal bleeding on day 3. Conclusions: In conclusion, Xiaoaiping injections may provide a safe and effective option for CIT in patients with NSCLC. [ABSTRACT FROM AUTHOR]

Background: Mild cognitive impairment (MCI) prevalence is estimated at 6%–12% of the population. It is possible that early treatment at the MCI stage could reduce progression to more severe cognitive impairment. The Montreal Cognitive Assessment (MoCA) is a sensitive measure used to assess changes in cognitive function. Various Chinese herbal medicines (CHMs) have been tested for effects on MCI using MoCA. Objectives: To evaluate the clinical evidence for CHMs on MoCA scores in MCI. Design: Five biomedical databases in English and Chinese language were searched for randomized controlled trials that compared orally administered CHMs with a control group and assessed changes in cognition using MoCA. Analyses were based on the comparison, control intervention, and study duration. Mean differences and 95% confidence intervals were calculated to evaluate treatment effects. For each study, risk of bias was assessed according to the Cochrane tool. Results: Nineteen studies were included with 16 contributing to the data analyses. Three studies were placebo controlled. Nine compared a CHM with a pharmacotherapy, three combined a CHM with a pharmacotherapy, and one combined CHM with cognitive training. In the two placebo-controlled studies of 24-week duration, results favored the CHMs at end of treatment. Conclusions: The systematic review suggests that the oral application of certain CHMs improved scores on MoCA by 1.76–2.34 points compared with placebo in people with MCI after 24 weeks of treatment. However, these two studies used different CHM formulations. Two studies that tested the same CHM formulation, Bu Yang Huan Wu Tang, in combination with donepezil, reported improvement in the integrative groups, but the studies were not blind and the durations were only 8–12 weeks. Overall, methodological weaknesses limited the strength of the evidence. The herbal formulae included ingredients that have received considerable research attention for their effects on memory and cognition. PROSPERO international prospective register of systematic reviews protocol registration number: CRD42018099650. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the traditional use of Chinese herbal medicine (CHM) for insomnia in pre-contemporary times. Materials and methods: The Encyclopedia of Traditional Chinese Medicine (fifth edition) was systematically searched using seven Chinese medicine disease nomenclatures to identify insomnia citations. Citations were coded, and frequently used herbal formulae specific for insomnia were analyzed. Results: Insomnia treatments were mentioned in 940 citations, and insomnia diagnosis treated with Chinese herbal formulae was specifically described in 800 citations. The traditional use of CHM appeared to be individualized based on the cause, pathogenesis, phase, phenotype, demographics, and concurrent medical conditions of insomnia. The most common herbal formulae for insomnia included Wen dan tang, Suan zao ren tang, Ban xia shu mi tang, and Gui pi tang. The most frequently cited herb was suan zao ren (Ziziphi spinosae semen). Conclusions: A number of herbal formulae for insomnia were cited in the historical literature. The commonly cited formulae such as Wen dan tang and Suan zao ren tang are consistent with current clinical practice and are good prospects for further therapeutic development. [ABSTRACT FROM AUTHOR]

Background: Acupuncture point (acupoint) injection is a common practice in China. Some trials showed that Chinese herbal extracts and/or conventional medication are injected at the Zusanli (ST36) acupoint for the treatment of diabetic peripheral neuropathy (DPN). The study aimed to assess the effectiveness and safety of acupoint injection for DPN at the ST36 by systematically evaluating the evidence published to date. Methods: Six databases were searched for randomized controlled trials (RCTs) of ST36 injection for DPN with primary outcome of pain, global symptom improvement, and quality of life. Methodological quality was assessed by the Cochrane risk of bias (ROB) tool. Data were analyzed using RevMan 5.3. Results: Fourteen RCTs involving 1,071 participants with DPN were included. All RCTs were assessed as unclear or high ROB. Few RCTs adequately reported methodology-related items and needling details according to Consolidated Standards of Reporting Trials (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) statement. Medications injected at ST36 included conventional medications (11 RCTs) and Chinese herbal extracts (3 RCTs). The authors of this study did not perform any meta-analysis due to the heterogeneity of medications used for injections. Two individual RCTs favored ST36 injection in relieving pain compared with intramuscular injection of the same medication. For global symptom measured by Toronto clinical scoring system, one RCT showed that ST36 injection of Fufang Danggui was more effective than intramuscular injection of vitamin B12, two RCTs demonstrated that ST36 injection of mecobalamin or Danhong with cointervention was superior, while one RCT showed no significant differences between ST36 injection and intramuscular injection of mecobalamin. For improving nerve conduction velocity (NCV), three of four individual RCTs showed that ST36 injection was better than intramuscular or intravenous injection of the same medication, two RCTs favored ST36 injection with cointervention, and one RCT favored ST36 injection without cointervention. Four RCTs reported monitoring adverse events, all of which showed no significant difference between groups. Conclusions: Limited evidence suggests that ST36 injection appears to be safe, and potentially effective in reducing pain score and improving NCV compared with intramuscular injection of the same medication. However, poor methodological and reporting quality reduced confidence in the findings. Rigorously designed and well-reported RCTs evaluating the effectiveness of ST36 injection for DPN are warranted. [ABSTRACT FROM AUTHOR]

Background: Tanreqing injection (TRQ) is often used in the treatment of pulmonary infection in patients with tuberculosis (TB). But its efficacy and safety are still unclear; to further reveal its efficacy and safety, the authors systematically evaluated all relevant trials. Methods: The authors searched published trials using the search strategy as (Tanreqing OR "Tanreqing injection") AND ("Tuberculosis" [MeSH] OR Tuberculosis OR TB) in Embase, PubMed, CNKI, VIP, Wanfang Database, CBM and CENTRAL, and ongoing trials in Chinese and U.S. clinical trials and World Health Organization International Clinical Trials Registry Platform (WHO-ICTRP) (established to January 2017). The authors evaluated the methodological bias risk of all included trials using the Cochrane evaluation handbook of randomized controlled trials (RCTs) (5.1.0), extracted data following the PICO principles, and synthesized the data using meta-analysis. Results: Twenty-six RCTs involving 2404 patients were included. In TRQ alone versus antibiotics, the merged risk ratio (RR) values and their confidence interval (95% CI) of meta-analysis for overall efficacy, lesion absorption, and bacterial clearance were as follows: 1.05 (0.99–1.10), 0.98 (0.89–1.08), and 1.36 (1.09–1.70). All differences were not statistically significant. In TRQ plus antibiotics versus antibiotics, the RR values and their 95% CI of overall efficacy, lesion absorption, and bacterial clearance were as follows: 1.17 (1.10–1.25), 1.24 (1.11–1.38), and 1.61 (1.36–1.90). All differences were statistically significant. Except for the bacterial clearance, sensitivity analyses showed that the overall efficacy had good stability. Conclusions: TRQ may have the same overall efficacy as antibiotics in pulmonary infection in patients with TB. TRQ plus antibiotics may improve the clinical efficacy. TRQ may have synergistic effect to antibiotics through bacteriostatic activity and eliminating inflammatory mediators. Its antibacterial activity may be better than some antibiotics and does not increase adverse drug reaction. But all these need new evidences for further investigation. [ABSTRACT FROM AUTHOR]

Editor's Note: This column continues the JACM commentary series from the Society for Acupuncture Research (SAR). The authors, Claudia Citkovitz, PhD, LAc, from NYU Langone Hospital - Brooklyn and Rosa N. Schnyer, DAOM, LAc, from the University of Texas, are both licensed East Asian Medicine (EAM) clinicians as well as researchers. The dual roles inform this commentary. As clinicians, they respect development over the centuries of strategies toward epidemics by the Chinese and are intrigued by the high use of Chinese herbal medicine to treat COVID-19 in China. As researchers, they are aware of the robust exploration of integrative strategies in China and the dearth of such interest of exploration by most agencies in the West. In their column, Citkovitz and Schnyer highlight what self-respecting clinician researchers are doing to fill the knowledge gap. They provide background on three separate data gathering initiatives that have collaborated to keep their reporting structures comparable in order to "improve clinical practice in real time": one for detailed case reports, a second via a registry, and the third an observational study that provides quantitative and qualitative data regarding clinical reasoning and patient response. At JACM, we look forward to seeing the kinds of reports these initiatives can cast on the widespread patient experience with integrative and EAM COVID-19. —John Weeks, Editor-in-Chief, JACM [ABSTRACT FROM AUTHOR]

The article offers information on the inter-rater agreement in Traditional Chinese Medicine (TCM). Topics discussed include role the symptoms of the patient play in deciding the pattern of diagnosis, arguments for not using the Fleiss Kappa statistic as a test of agreement in TCM, and details of the instrument Popplewell developed to address the problem of low diagnostic agreement in TCM studies.

Objective: Constipation is quite common and has impact on life quality in the elderly diabetic patients; therefore it is important to seek better treatments. The aim of this study is to evaluate the effect of Chang Run Tong (CRT) decoction on constipation in elderly diabetic patients in comparison with the effect of Macrogol 4000 powder (Forlax). Design: This study was designed as a prospective study consisting of two parallel arms: CRT group and Forlax group. Settings/Location: The study was conducted in China-Japan Hospital. Subject interventions: Eighty elderly diabetic patients with constipation were evaluated, among them 52 patients were treated with CRT and 28 patients were treated with Forlax. Outcome measures: The patients were interviewed for Bristol stool scale, spontaneous complete bowel movements (SCBM) and symptoms of defecation feeling, defecation weakness, feeling of incomplete evacuation, bloating, and flatulence at different time points. The changes of all above parameters from treatment for 2 and 4 weeks and follow-up for 1 and 2 months with reference to the baseline (before treatment) were compared between CRT and Forlax treatments. The treatment efficiency was evaluated and compared between two different treatments. Results: For the improvement of Bristol stool scale, SCBM and feeling of incomplete evacuation, CRT was significantly better than Forlax at different time points (p < 0.01, p < 0.001). For the symptoms of defecation feeling, defecation weakness, bloating, and flatulence, CRT was significantly better than Forlax for follow-up improvement (p < 0.01, p < 0.001); whereas no difference was found at other time points of the treatment (p > 0.05). Furthermore, CRT had a significantly better treatment efficiency than Forlax (p < 0.001). Conclusions: Both CRT and Forlax treatment could effectively improve bowel habits and symptoms of constipation in elderly diabetic patients. CRT was better than Forlax to treat constipation in elderly diabetic patients and had better follow-up improvement after stopping drugs. [ABSTRACT FROM AUTHOR]

Objective: The present work aimed to further explore the therapeutic potential of Xing Qi Hua Ying Tang (XQHYT) by conducting a systemic clinical study in patients with goiter. Design: Seventy-two patients with either multinodular or diffuse goiter were enrolled and randomly assigned into treatment group receiving XQHYT (n = 36) and control group receiving Hai Zao Yu Hu Tang (n = 36). Location: Traditional Chinese Medicine Hospital of Shanxi. Subjects: Patients were diagnosed multinodular goiter or diffuse goiter resulting from Qi stagnation. Intervention: All patients took the extract twice a day (100 mL each time) for two courses of treatment, of which a single course lasted for 3 months. Before the treatment was commenced and after the completion of the treatment, general body checks, thyroid function test, and goiter size examination were performed. Outcome measures: Scoring of the clinical symptoms using Chinese medicine symptomatology was also done. Results: The symptom score of the treatment group was significantly lower than that of the control group (treatment group, 8.26 ± 2.62; control group, 10.02 ± 2.62; p < 0.05). Substantial reduction in goiter size was seen in 82.3% of XQHYT-treated patients, whereas in the control group only 67.7% of patients exhibited constricted goiter. When assessed by both the Chinese medicine criteria and goiter size, the overall effective rate of the treatment group was 91.2%, whereas that of the control group was only 67.7%. The difference was statistically significant (p < 0.05). XQHYT did not affect the normal functions of liver, kidney, and heart. For both groups of patients, their levels of thyroid-stimulating hormone, free T4 and free T3 were normal before the treatment, and were not affected by the treatment. Conclusion: XQHYT was shown to be a promising therapeutic regimen for the treatment of goiter. The herbal regimen ameliorated clinical symptoms of patients that were accompanied with reduction in the size of goiter. [ABSTRACT FROM AUTHOR]

Objectives: GuiZhi-ShaoYao-ZhiMu decoction (GSZD), a traditional Chinese herbal medication for the management of rheumatoid arthritis (RA), has a long history of use and modern scientific research support for efficacy, but the studies have not been systematically evaluated. Therefore, this study systematically reviewed the efficacy of GSZD using the available human clinical trials and conducted a meta-analysis. Methods: The available databases were searched using proper languages of English, Korean, and Chinese. The key erms used for searching were 'GSZD,' 'Cassia Twig,' 'Guizhi,' ' Paeonia lactiflora,' 'Shaoyao,' ' Anemarrhena Rhizome,' 'Zhimu,' 'rheumatoid arthritis,' 'randomized,' 'controlled trial,' and 'clinical trial.' Randomized clinical trials (RCTs) using GSZD were included in the review and meta-analysis. According to heterogeneity, odds ratio and confidence intervals in the pooled RCTs were assessed by a fixed or random model in meta-analysis. Risk of bias was evaluated for all included studies. Results: Thirteen RCTs met the inclusion criteria and were included in the meta-analysis. All studies evaluated the efficacy of GSZD for treating RA, but the herbal formulations varied since some studies added herbs to the basic GSZD formulation. However, all formulations contained the essential herbs: Guizhi, Shaoyao, and Zhimu. Each RCT included an experimental group (GSZD with or without Western-style medicine) and a control group (either standard Western-style medicines or placebo). When compared to placebo, the GSZD treatment was found to be three to six times more effective than standard Western drugs for some symptoms. Furthermore, only two studies reported any adverse events associated with the GSZD group, whereas several reported serious adverse events in the control groups. Conclusions: The Traditional Chinese Medicine, GSZD, may have equal or superior effectiveness and safety for treating RA compared to Western RA drugs. It should be considered a viable alternative to Western medicine. However, more long-term research is needed in larger patient groups to better establish its safety and efficacy. [ABSTRACT FROM AUTHOR]

Objective: To analyze the patterns and differences of Chinese herbs in the treatment of coronary heart disease (CHD) in different time periods and different regions in recent 20 years. Design: The literature of controlled clinical trials that focuses on Chinese herbs treating CHD published in China National Knowledge Internet and Wanfang database from January 1, 1996 to December 31, 2015 were screened to analyze the patterns of herb utilization using SPSS 21.0. Results: A total of 1250 articles were enrolled in total covering 29 regions. There were 242 kinds of single herbs, 18 categories, mentioned a total of 11,594 times. In Northeast China, North China, South China, Central China, and Southwest China the most frequently used herb was Radix Salviae Miltiorrhizae, but in East China and Northwest China, the most frequently used herb was Rhizoma Chuanxiong. The most frequently used herb category in North China, Central China, Southwest China, and Northwest China was herbs to invigorate blood, but in Northeast China, East China, and South China the most frequently used herb category was herbs to tonify. Conclusion: Single herbs and herb categories to treat CHD in Traditional Chinese Medicine differed from time to time and from region to region. [ABSTRACT FROM AUTHOR]

Introduction: Patients with psoriasis often use botanical therapies as part of their treatment. It is important for clinicians to be aware of the current evidence regarding these agents as they treat patients. Methods: A systematic literature search was conducted using the PubMed, MEDLINE, and EMBASE database for randomized clinical trials assessing the use of botanical therapeutics for psoriasis. The search included the following keywords: 'psoriasis' and 'plant' or 'herbal' or 'botanical.' Citations within articles were also reviewed to identify relevant sources. The results were then further refined by route of administration, and the oral (systemic) botanical agents are reviewed herein. Results: A total of 12 controlled and uncontrolled clinical trials addressing the use of oral, systemic botanical agents for psoriasis were assessed in this review. While overall evidence is limited in quantity and quality, HESA-A, curcumin, neem extract, and, to a lesser degree, Traditional Chinese Medicine seem to be the most efficacious agents. Conclusion: The literature addresses a large amount of studies in regards to botanicals for the treatment of psoriasis. While most agents appear to be safe, further research is necessary for evidence-based recommendation of oral botanical agents to psoriasis patients. [ABSTRACT FROM AUTHOR]

Objectives: Low back pain (LBP) is a chronic condition. Although Western treatments are available, Kampo (traditional Japanese) medicine is widely prescribed and covered by health insurance in Japan. Goshajinkigan (GJG), a Kampo formula, is commonly used to treat LBP. However, cases we have occasionally been encountered in which GJG did not show the expected effects. Hence, the purpose of this retrospective study was to investigate patient factors important in developing the effects of GJG. Methods: This was a retrospective observational study based at the Center for Kampo Medicine, Keio University Hospital. Data were retrieved from the medical records of 28 patients who visited our hospital between May 2008 and March 2013 and who received GJG for LBP. The patients were divided into responders and non-responders based on whether their LBP improved post treatment. The groups were compared with respect to daily GJG dose, incidence of spine disease, and side effects. Results: Ten patients (responders) reported an improvement in LBP within 6 months. One patient experienced decreased appetite as a side effect. Nine patients reported no improvement (non-responders). The number of patients prescribed the usual daily dose of GJG (7.5 g) was significantly higher among responders than it was among non-responders ( p = 0.023), and the number of patients with spine disease was significantly greater among non-responders than it was among responders ( p = 0.020). The number of patients with spinal stenosis was significantly higher among non-responders than it was among responders ( p = 0.011). Therefore, the usual daily dose of GJG provided significant relief of LBP, particularly in patients without any spine disease. Conclusions: Routine daily administration of GJG in patients without spine disease seems to lead to the effects of the product. However, further investigations using the above-mentioned parameters are needed to confirm these findings. [ABSTRACT FROM AUTHOR]

Objectives: Gastroesophageal reflux disease (GERD) is a prevalent gastrointestinal disease that causes troublesome symptoms and/or complications. The major therapeutic strategy for GERD focuses mainly on symptom alleviation using proton pump inhibitors (PPIs), which does not produce a perfect response in all patients. An approach with new therapeutic agents for GERD seems to be essential. The aim of this study was to review animal and human studies investigating the effect of medicinal plants in GERD as well as mechanisms underlying their therapeutic effects. Methods: Medline, Scopus, and Cochrane Central Register of Controlled Trials were searched for animal or human studies. The data collected covered January 1966-October 2015. Results: A total of 22 studies were included in this review, of which nine were animal studies and 13 were human studies. Ceratonia siliqua as a medicinal plant and rikkunshito as a multicomponent herbal preparation were the most frequently studied herbal medicines in GERD. Antioxidant and anti-inflammatory activities were the main mechanisms demonstrated in animal studies for ameliorating the effects of medicinal plants in GERD. Other mechanisms include downregulation of genes encoding inflammatory proteins, improvement of barrier function and gastric mucus, a decrease in gastric acid, and induction of tonic contractions of the lower esophageal sphincter. All herbal preparations used in human studies have led to the alleviation of symptoms related to GERD. Myrtus communis and Cydonia oblonga showed marked reduction in GERD symptoms comparable to omeprazole. The therapeutic effect of Cydonia oblonga persisted after discontinuation of the drug. Tongjlang and rikkunshito showed therapeutic effects for non-erosive reflux disease (NERD) where PPIs failed to show a promising effect. Studies on Ceratonia siliqua have been solely focused on regurgitation in infants, and a remarkable decrease in the number of regurgitations was demonstrated. Conclusion: The multiple mechanisms of action of medicinal plants in GERD other than anti-secretory properties appear to provide more efficient treatment and helped to manage the histopathological changes associated with this disorder. Further studies are needed to understand the effects of medicinal plants on GERD better. [ABSTRACT FROM AUTHOR]

Objectives: Traditional Chinese Medicine (TCM) applied in the clinic as a complementary and alternative therapy has helped improve immunity and reduce side effects and symptomatic treatment in patients with HIV/AIDS. However, the mechanisms of TCM syndromes are not clear. Transcriptomics enables the study of such TCM syndromes. Design: This study compared the messenger RNA (mRNA) expressions of healthy persons and patients with HIV/AIDS who had two common TCM syndromes, qi-yin deficiency and dampness-heat retention, to find the difference in HIV/AIDS with TCM syndromes. Results: Comparison with healthy persons identified 113 mRNAs-41 enhanced and 72 decreased-in the qi-yin deficiency group. Additionally, 76 mRNAs were found in the dampness-heat retention group: 14 increased and 62 decreased. Functional genetic analysis of the mRNAs indicated that two TCM syndromes were correlated with cell apoptosis, immunoinflammatory responses, and lymphocyte activation. Differentially expressed mRNAs in the qi-yin deficiency group were obviously associated with cellular activity, communication, protein localization, cellular ion homeostasis, and regulation of cell motion, whereas mRNAs in the dampness-heat retention group were associated with sequence-specific DNA binding, cellular response to stress, and hemopoietic or lymphoid organ development. Conclusions: These results suggest that the formation of different TCM syndromes in patients with HIV/AIDS were founded on biological transcriptomics, which reveal mechanisms of the formation of these syndromes in HIV/AIDS. Differentially expressed mRNAs in two TCM syndrome groups tended to normalize after TCM intervention, which indicates that TCM might remit symptoms by changing genetic expression. [ABSTRACT FROM AUTHOR]

Objectives: Patients in Taiwan with allergic rhinitis seek not only Western medicine treatment but also Traditional Chinese Medicine treatment or integrated Chinese-Western medicine treatment. Various studies have conducted pairwise comparison on Traditional Chinese Medicine, Western medicine, and integrated Chinese- Western medicine treatments. However, none conducted simultaneous analysis of the three treatments. This study analyzed patients with allergic rhinitis receiving the three treatments to identify differences in demographic characteristic and medical use and thereby to determine drug use patterns of different treatments. Materials and Methods: The National Health Insurance Research Database was the data source, and included patients were those diagnosed with allergic rhinitis (International Classification of Diseases, Ninth Revision, Clinical Modification codes 470-478). Chi-square test and Tukey studentized range (honest significant difference) test were conducted to investigate the differences among the three treatments. Results: Visit frequency for allergic rhinitis treatment was higher in female than male patients, regardless of treatment with Traditional Chinese Medicine, Western medicine, or integrated Chinese-Western medicine. Persons aged 0-19 years ranked the highest in proportion of visits for allergic rhinitis. Traditional Chinese Medicine treatment had more medical items per person-time and daily drug cost per person-time and had the lowest total expenditure per person-time. In contrast, Western medicine had the lowest daily drug cost per person-time and the highest total expenditure per person-time. The total expenditure per person-time, daily drug cost per person-time, and medical items per person-time of integrated Chinese-Western medicine treatment lay between those seen with Traditional Chinese Medicine and Western medicine treatments. Conclusions: Although only 6.82 % of patients with allergic rhinitis chose integrated Chinese-Western medicine treatment, the visit frequency per person-year of integrated Chinese-Western medicine ranked highest. In addition, multiple-composition medicines were used more frequently than single-composition medicines, and mar huang (Ephedra sinica Stapf) was seldom used to decrease the risk of combining medications. [ABSTRACT FROM AUTHOR]

Objectives: To identify and analyze records of the treatment of dementia and memory disorders in the classical Chinese medical literature that were consistent with the signs and symptoms of Alzheimer's disease (AD), with the aim of determining which traditional medicines have histories of use for these disorders. Methods: Encyclopedia of Traditional Chinese Medicine (Zhong Hua Yi Dian), a database of more than 1000 classical and premodern Chinese medical books, was systematically searched. Search terms were identified from dictionaries, medical nomenclatures, guidelines, and specialist clinical manuals on aging, neurology, or brain disorders. Inclusion and exclusion criteria were used to identify citations of conditions whose signs and symptoms were consistent with the clinical features of AD. Passages of text identified by these terms were copied to Microsoft Excel spreadsheets, together with the identity of the source book and all relevant information on the disorder and the intervention. Each distinct passage of text was considered a citation. The frequencies of the traditional formulas used as interventions and their constituent ingredients were calculated. Results: The selection criteria identified 1498 citations of dementia and memory impairments derived from 277 different books written from circa 363 to 1945 AD. In 91 of these citations, memory impairment was associated with aging and was broadly consistent with the clinical features of AD. Although the interventions varied in name, Poria cocos, Polygala tenuifolia, Rehmannia glutinosa, Panax ginseng, and Acorus species consistently appeared as ingredients in multiple formulas for memory impairment in the context of aging. Conclusions: Memory impairment in older age was a recognized condition in the classical literature. Many of the traditional medicines frequently used as ingredients in classical formulas for memory impairment consistent with clinical features of AD remain in contemporary use, and experimental studies suggest biological activities relevant to AD. [ABSTRACT FROM AUTHOR]

Objectives: Chinese herbal medicine (CHM) use has not been well characterized in persons living in the United States who receive care by Western-trained healthcare providers. The primary objective of this study was to characterize use of CHM taken in the last 12 months by patients seen at a Chinatown public health center. Design: Convenience sample survey. Setting: Data collection occurred over 3 months at a San Francisco Chinatown public health center. Participants: Adult patients visiting their primary care provider. Interventions: Completion of a voluntary 24-question survey on CHM use. Outcome measures: Prevalence, type, and indications for use. Results: Survey response rate was 29% (50/170). Seventy percent (35/50) of respondents had used CHM in the last 12 months and 94% (33/35) were also taking prescription medicines. The three most commonly used CHM were goji berry (37%), Dioscorea (31%), and ginseng (23%). The most common indications for herbs used in the last 12 months were general wellness (34%), cold/flu (25%), and headache (6%). Sixty-four percent of respondents had used Western medicine in combination with CHM within the last 12 months. Sixty-nine percent of respondents who used CHM did not tell their Western provider about this use. No patient had CHM use documented in the electronic medical record. Conclusions: Patients seen at a Chinatown public health center frequently used CHM products in conjunction with Western prescription medicines. Providers should routinely enquire about CHM use for health as a soup, tea, food, or pill and document this use in the medical record. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to evaluate the safety, tolerability, and efficacy of a selective estrogen receptor beta (ERβ) agonist, Dr. Tagliaferri's Menopause Formula (MF102), to treat the symptoms of menopause. Methods: An open-label trial of MF102 taken for 12 weeks by 30 postmenopausal women aged 40-65 years, who experienced a minimum of five moderate to severe hot flushes per day. The primary efficacy outcome was a change in the frequency of moderate to severe hot flushes from baseline to week 12. A change in the frequency of hot flushes that woke participants from their sleep from baseline to 12 weeks was a secondary endpoint. Lipid profile and endometrial thickness were also evaluated. Results: Thirty postmenopausal women with an average of nine moderate to severe hot flushes per day were treated with MF102 4 g/day; 27 participants completed the study. The median percent reduction in moderate to severe hot flushes was 71% ( p < 0.001). The median percent reduction in hot flushes that woke participants from their sleep was 54% ( p < 0.001). Low-density lipoprotein (LDL-C) and total cholesterol both declined significantly from baseline. There were no serious adverse events, reports of abnormal uterine bleeding, or significant changes in double-wall endometrial thickness. Conclusions: Treatment with MF102 resulted in a marked decrease in the frequency of moderate to severe hot flushes, was well-tolerated, and demonstrated no safety concerns. [ABSTRACT FROM AUTHOR]

The article presents a study which reveals that that the Qing Dai therapy induces remission in many cases of active ulcerative colitis (UC). It mentions that the that Qing Dai has anti-inflammatory effects as a radical scavenger. The study concludes that Qing Dai treatment exhibited a remission maintenance effect, and was safe to consume for long periods.

Background: Childhood constipation is a common ailment that in certain cases can lead to encopresis or fecal incontinence. The literature suggests that standard care varies in effectiveness, especially in the long term. Fecal incontinence can lead to frustration, guilt, and shame for both the child and family and has untold long-term psychological and physical consequences. Objective: To address alternative treatment options for pediatric constipation and encopresis by using acupuncture and Chinese medicine. Patient and Setting: This is a case study of a 6-year-old girl seen in a private practice acupuncture clinic in the northwestern United States. Intervention: Treatment involved acupuncture, massage, and Chinese herbal medicine. Results: The patient in this study began to have regular bowel movements on her own, from a type 5 on the modified Bristol Stool Form Scale for Children to a type 3, with no laxative use and few to no fecal accidents. Conclusions: Emotional stability and support seem to play an important role in pediatric constipation and encopresis. Acupuncture may be an effective treatment option in the integrative care model to address both the emotional and physical components of childhood constipation. [ABSTRACT FROM AUTHOR]

Background/Objective: Atopic dermatitis comprises a group of chronic, relapsing inflammatory conditions. Topical steroids (TS) can ameliorate atopic dermatitis but induce skin atrophy and secondary infection. Tzu-Yun ointment (TYO) was used widely for skin ulcers and pus discharges. This study sought to determine whether TYO can replace TS therapy for atopic dermatitis. Methods: This preliminary, randomized, controlled, open-label design compared the therapeutic effects of TS and TYO in patients with atopic dermatitis; 33 patients were randomly assigned to the TS group (17 patients) and the TYO group (16 patients). All patients received an 8-week TS or TYO treatment. Primary outcome measures were assessed by using the Eczema Area and Severity Index (EASI) and Three Item Severity (TIS) before the treatment (baseline, week 0) and 1 week (week 1), 2 weeks (week 2), 4 weeks (week 4), and 8 weeks (week 8) after initiation of the treatment. Results: Of the 33 enrolled patients, 31 (16 in the TS group and 15 in the TYO group) completed the study. Patients in both groups showed decreased EASI and TIS scores, with no significant difference at weeks 0, 1, 2, 4, and 8. Conclusion: TYO may be as effective as TS therapy for atopic dermatitis and has potential as an alternative treatment for this condition. [ABSTRACT FROM AUTHOR]

Background: Psoriasis vulgaris is a chronic disease that significantly affects patient's quality of life and poses an economic burden. Acitretin is a second-generation retinoid used for psoriasis in clinical practice. Orally administered Chinese herbal medicine (CHM), alone or combined with acitretin, has been used for the clinical management of psoriasis vulgaris. This systematic review evaluates the efficacy of oral CHM in comparison with acitretin and the add-on effect of oral CHM to acitretin. Methods: Five English databases and four Chinese databases were searched from their inceptions to May 2014. Included randomized, controlled trials (RCTs) were published in English or Chinese, compared oral CHM or the combination of oral CHM and acitretin with acitretin, and used Psoriasis Area and Severity Index (PASI) as the outcome measure. Results: A total of 25 RCTs were included in this review: 8 studies compared oral CHM with acitretin, 12 compared the combination with acitretin alone, and 5 were three-arm studies that compared both with acitretin. Conclusion: The meta-analysis indicated that oral CHM was effective for psoriasis vulgaris as follows: (1) Oral CHM is neither superior nor inferior to acitretin, and (2) oral CHM could produce add-on effects when combined with acitretin. Oral CHM itself appeared safe for treating psoriasis vulgaris and possibly could reduce the common adverse events seen with acitretin. However, the long-term effect and safety of oral CHM could not be assessed. Further research should consider including a placebo control and using outcome measures according to international guidelines to evaluate CHM, as well as include follow-ups to monitor longer-term efficacy and safety. [ABSTRACT FROM AUTHOR]

Objectives: To investigate the pattern of Traditional Chinese Medicine (TCM) usage for urolithiasis patients in Taiwan and to determine the most common Chinese herbal products used for urolithiasis. Design: Retrospective review of urolithiasis patients treated with TCM treatment. Settings/Location: One million randomly selected samples in the Taiwanese National Health Insurance Research Database between 1997 and 2008. Patients: Eighty-two thousand five hundred and fifty-one newly diagnosed urolithiasis patients. Outcome measures: The correlation between TCM treatment, demographic factors, or medical conditions. Results: A total of 62.6% of urolithiasis patients use TCM treatment. A younger age, female gender, polypharmacy, multiple comorbidities, and stone in the lower urinary tract result in a greater tendency to use TCM, after adjusting for demographic factors. Jia-Wei-Xiao-Yao-San Extract Powder and Ji-Sheng-Shen-Qi-Wan Extract Powder are the most frequently prescribed Chinese medicine formulae. Conclusion: This is the first study to examine the use of and the prescription pattern for TCM in urolithiasis patients using a random, national population-based sample. More than 62% of urolithiasis patients use TCM, and patients with polypharmacy, multiple comorbidities, and stone in the ureter are more likely to use TCM. The most frequently prescribed Chinese medicine formulae were Jia-Wei-Xiao-Yao-San Extract Powder and Ji-Sheng-Shen-Qi-Wan Extract Powder, which were reported to retard the progression of renal failure and alleviate flank pain or tenderness. [ABSTRACT FROM AUTHOR]

Objective: There have been no systematic reviews, let alone meta-analyses, of randomized controlled trials (RCTs) comparing tongxinluo capsule (TXL) and beta-blockers in treating angina pectoris. This study aimed to evaluate the efficacy of TXL and beta-blockers in treating angina pectoris by a meta-analysis of eligible RCTs. Methods: The RCTs comparing TXL with beta-blockers (including metoprolol) in treating angina pectoris were searched and retrieved from databases including PubMed, Chinese National Knowledge Infrastructure, and WanFang Data. Eligible RCTs were selected according to prespecified criteria. Meta-analysis was performed on the odds ratios (OR) of symptomatic and electrocardiographic (ECG) improvements after treatment. Subgroup analysis, sensitivity analysis, meta-regression, and publication biases analysis were conducted to evaluate the robustness of the results. Results: Seventy-three RCTs published between 2000 and 2014 with 7424 participants were eligible. Overall ORs comparing TXL with beta-blockers were 3.40 (95% confidence interval [CI], 2.97-3.89; p<0.0001) for symptomatic improvement and 2.63 (95% CI, 2.29-3.02; p<0.0001) for ECG improvement. Subgroup analysis and sensitivity analysis found no statistically significant dependence of overall ORs on specific study characteristics except efficacy criteria. Meta-regression found no significant except sample sizes for data on symptomatic improvement. Publication biases were statistically significant. Conclusion: TXL seems to be more effective than beta-blockers in treating angina pectoris, on the basis of the eligible RCTs. Further RCTs are warranted to reduce publication bias and verify efficacy. [ABSTRACT FROM AUTHOR]

Objectives: To evaluate the satisfaction, concerns, and preference for Traditional Chinese Medicine (TCM) drugs among guardians of children with acute bronchiolitis, assess the agreement between satisfaction and preference, and explore the factors associated with satisfaction. Design: A cross-sectional study was conducted in three main tertiary hospitals in Kunming, China, from September 2012 to July 2013 by structured questionnaire interviews. The characteristics of children and their guardians and guardians' satisfaction with and preference for TCM drugs were collected and analyzed by using chi-square or Fisher exact test. The agreement of satisfaction and preference was assessed by κ and prevalence-adjusted κ coefficients. Multiple logistic regression was used to identify factors associated with satisfaction. Results: A total of 286 guardians were enrolled in the study. Most children (97.6%) were younger than age 2 years. In total, the rates of satisfaction and preference for TCM drugs were 75.5% and 73.1%, respectively, and preference and satisfaction levels did not significantly differ between TCM and non-TCM hospitals. Guardians with higher socioeconomic status were more satisfied with TCM drugs, and the most common reason for preference for TCM drugs was that they had less toxicity or fewer adverse effects. Guardians were concerned most about safety and least concerned about cost. The agreement between satisfaction and preference was moderate in general (prevalence-adjusted κ=0.42). Conclusions: Three fourths of the Chinese guardians of children with acute bronchiolitis were satisfied with and preferred the TCM drugs. Moderate agreement between satisfaction and preference was shown. [ABSTRACT FROM AUTHOR]

Objectives: This open-label, prospective, phase I/II trial was performed to establish the safety and efficacy of Traditional Chinese Medicine (TCM) herbal products for treating non-anemia-related fatigue in patients with cancer. Although this practice is widespread in China, it has not been confirmed in a prospective clinical study. Design: Thirty-three patients who had completed cancer treatment, had stable disease and no anemia, and reported moderate to severe fatigue (rated ≥4 on a 0-10 scale) were enrolled in a TCM outpatient clinic. Patients took Ren Shen Yangrong Tang (RSYRT) decoction, a soup containing 12 TCM herbs, twice a day for 6 weeks. RSYRT aims to correct qi deficiency. Fatigue was assessed before and after RSYRT therapy, which all patients completed. Results: No discomfort or toxicity was observed. Before the study, all patients had had fatigue for at least 4 months. Fatigue severity decreased significantly from before therapy to 6 weeks after therapy: from 7.06 to 3.30 on a 0-10 scale ( p<0.001). Fatigue category (mild, moderate, severe) shifted significantly ( p=0.024): Of 22 patients with severe fatigue (rated ≥7) before therapy, 11 had mild fatigue and 11 had moderate fatigue after TCM treatment. The time-to-fatigue-alleviation was 2-3 weeks. Conclusion: RSYRT therapy was safe and was associated with fatigue improvement in nonanemic cancer survivors, consistent with historical TCM clinical practice experience. Because of a possible placebo effect in this open-label study, decoction RSYRT warrants further study in randomized clinical trials to confirm its effectiveness for managing moderate to severe fatigue. [ABSTRACT FROM AUTHOR]

The author discusses the white paper on traditional Chinese medicine (TCM) released on December 6, 2016 by the Chinese news agency, Xinhua. Topics discussed include government-sponsored programs related to both TCM and "integrated medicine," cost-savings and other basic principles of TCM and the commitment of the Chinese government to promote the globalization of TCM.

Purpose: This study evaluates published clinical trials of Chinese herbal medicine (CHM) for chronic obstructive pulmonary disease (COPD) that employ a health-related quality of life (HRQoL) outcome measure. Methods: Searches were conducted in April 2011 on MEDLINE®, Embase, the Cochrane Controlled Trials Register, CINAHL, Scopus, and Chinese databases (CNKI, CQVIP, WANFANG). Randomized controlled trials involving oral administration of CHM formulae or single herb, with or without blinding, compared to placebo, no treatment, routine pharmacotherapy control, or CHM plus routine pharmacotherapy versus routine pharmacotherapy, with a HRQoL questionnaire as an outcome measure were identified. The methodological quality was assessed using the Cochrane risk of bias assessment. Results: A total of 27 studies involving 1966 patients were identified. St. George Respiratory Questionnaire (SGRQ) or Cai's QoLQ were used in 13 and 14 studies, respectively. Assessment of the Cochrane risk of bias revealed adequate sequence of generation in 10 studies and adequate allocation concealment in 1 study; double blinding was not described adequately in any studies. Seventeen (17) studies addressed incomplete outcome data, and 17 studies were free of selective reporting. The main results of meta-analysis showed improvement of total HRQoL scores (SGRQ and Cai's QoLQ) when CHM was compared to no treatment (−6.07 [−9.21, −2.93] and −0.20 [−32, −0.07], respectively) and for CHM plus routine pharmacotherapy versus routine pharmacotherapy (−5.15 [−7.26, −3.05]) and (−0.25 [−0.37, −0.13]). Conclusions: While the results of CHM on HRQoL for stable COPD sufferers were promising, they need to be interpreted with caution due to methodological problems, which should be addressed in future trials. [ABSTRACT FROM AUTHOR]

Background: Endometriosis is a common and disabling gynecologic condition affecting between 5% and 15% of women of childbearing age. Conventional medical intervention has unpleasant side-effects, and symptoms frequently return after treatment. Preliminary evidence suggests Chinese herbal medicine (CHM) may contribute to the treatment of endometriosis. Objectives: The aims of this study were to test the feasibility of a novel methodology for investigating individualized decoctions of CHM rigorously and to gather preliminary data on the treatment effect of CHM for a larger definitive trial. Design: This was a 16-week prospective, double blinded, randomized controlled trial of 40 women with laparoscopically confirmed endometriosis. Settings: The trial was conducted at a private CHM clinic in Hove (U.K.) and at a National Health Service outpatient clinic in London (U.K.). Interventions: Participants were initially randomized to either wait-list control (WLC) or treatment groups to receive either individualized CHM decoctions or a therapeutically inert placebo decoction. Outcome measures: Four 10-cm visual analogue scales (VAS) were used to measure menstrual pain, daily pain, and pain on intercourse and bowel movement; these measurements were recorded weekly. The Endometriosis Health Profile-30 (EHP-30) endometriosis-specific quality-of-life questionnaire was completed at the beginning and at the end of the trial. The Measure Yourself Medical Outcomes Profile (MYMOP) a patient-centered health questionnaire was completed monthly. Liver and renal function was measured at 0, 4, 8, and 16 weeks. Results: Twenty-eight (28) women completed the trial. High dropout rates led to the suspension of the WLC. Randomization, double blinding, and allocation concealment was achieved successfully. Adjusted mean differences favored the active treatment in the EHP-30 and MYMOP scores. VAS scores favored the active treatment for relief of menstrual pain and the placebo group for reduction of daily pain. Conclusions: the methodology successfully allowed individualized CHM decoctions to be tested rigorously. There are nonspecific contextual effects from CHM that require further investigation. Provisional data were generated to warrant a larger, more-definitive study. [ABSTRACT FROM AUTHOR]

Objective: This meta-analysis aimed to assess the effectiveness and safety of Chinese herbal medicine (CHM) as an adjunctive method to standard therapy for patients with diabetic foot ulcers (DFU). Methods: Randomized controlled trials (RCTs) of CHM to treat DFU were searched in the following electronic databases: MEDLINE®; EMBASE; Chinese Biomedical Database (CBM); Cochrane Central Register of Controlled Trials (CENTRAL); Allied & Complementary Medicine Resources (AMED); and Cumulative Index to Nursing and Allied Health Literature (CINAHL). Two (2) researchers independently assessed the quality and validity of included trials and extracted outcome data for synthesis. Results: Six (6) trials were included for analysis. Compared to using standard therapy alone, CHM combined with standard therapy significantly increased the number of patients whose ulcers healed (risk ratio [ RR], 0.62, [95% confidence interval (CI), 0.39–0.97]) and number of patients with at least a 30% reduction in the ulcer area ( RR, 0.81 [95%CI, 0.71–0.92]). In addition, the two therapies combined significantly decreased the number of patients without any improvement ( RR, 0.34 [95%CI, 0.21–0.53]). However, with respect to blood flow volume in the dorsal artery of the foot, no significant difference between the two therapies was observed (standardized mean difference, 1.71 [95% CI −1.25–4.67]), but the result favored the CHM combined with standard therapy group. Only 2 of 6 trials reported adverse events, which included nausea, epigastric pain, and dry mouth. Conclusions: CHM may be effective and safe as an adjunctive therapy for treating DFU. However, a firm conclusion could not be reached because of the poor quality of the included trials. Further trials with higher quality are justified. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to develop and evaluate a questionnaire for Cold and Heat pathologic pattern identification in the context of Traditional Chinese Medicine (TCM). This questionnaire was intended to classify subjects into Cold or Heat pattern groups, a distinction that is useful in clinical trials of both herbal and acupuncture treatments. Methods: A questionnaire that had been developed in a previous study was completed by 63 patients (Group A) and 64 patients (Group B) from TCM hospitals. Each patient was diagnosed by a TCM doctor as one of three patterns: Cold, Heat, and Complex. The questionnaire results were analyzed for internal reliability and validity based on the doctor's diagnosis. Results: Cronbach's α coefficients were 0.579 for the 10 Cold items and 0.718 for the 10 Heat items. There were significant differences in the mean questionnaire scores between the Cold and Heat groups. The classification accuracy of this questionnaire for Group A was 94.9%, and for Group B it was 92.3%. Conclusions: Our results suggest that the questionnaire meets certain basic and fundamental requirements and that it may be useful as an adjunct diagnostic tool. Further studies using a greater number and variety of patients will be needed to evaluate its usefulness in clinical trials and in basic physiologic research. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this systematic review was to critically appraise published clinical trials designed to assess the effect of Traditional Chinese Medicine (TCM) on the management of constipation. Methods: Databases searched included both English and non-English articles published in the Cochrane library, MEDLINE,® CINAHL, AMED, EMBASE, China National Knowledge Infrastructure (CNKI), and the Chinese Electronic Periodical Services (CEPS). Studies reviewed included randomized controlled trials and controlled clinical trials. Methodological quality was assessed using the modified Jadad scale. Results: One hundred and thirty-seven (137) studies met the inclusion criteria, of which 21 were high-quality trials ( n = 2449). Eighteen (18) were Chinese herbal medicine (CHM) and 3 were acupuncture trials. The primary outcome measure was total effective rate. CHM was more effective than conventional medicines in eight trials. Of the 10 remaining CHM trials, 9 compared the study CHM with another CHM and the results were significant in 4 trials. The effective rate was significantly higher in the intervention group than in the placebo group in the last CHM study. One (1) of the three acupuncture trials compared acupuncture with a conventional medicine, one trial with Sennae folium, and one trial with deeper acupuncture on Tianshu (ST 25). The therapeutic effect in the treatment group was more effective than that in the control group in all three studies. Conclusions: TCM interventions appear to be useful to manage constipation. Significant positive results were found in 15 high-quality studies. However, only 21 of the 137 publications identified attained high Jadad scores. There was heterogeneity in diagnostic procedures and interventions among the studies. Outcome indicators were also different. Hence, the results should be interpreted cautiously. [ABSTRACT FROM AUTHOR]

Background: The Cochrane Collaboration, an international not-for-profit organization that prepares and maintains systematic reviews of randomized trials of health care therapies, has produced reviews summarizing much of the evidence on Traditional Chinese Medicine (TCM). Our objective was to review the evidence base according to Cochrane systematic reviews. Methods: In order to detect reviews focusing on TCM, we searched the titles and abstracts of all reviews in Issue 4, 2008 of the Cochrane Database of Systematic Reviews. For each review, we extracted data on the number of trials included and the total number of participants. We provided an indication of the strength of the review findings by assessing the reviewers' abstract conclusions statement. We supplemented our assessment of the abstract conclusions statements with a listing of the comparisons and outcomes showing statistically significant meta-analyses results. Results: We identified 70 Cochrane systematic reviews of TCM, primarily acupuncture ( n = 26) and Chinese herbal medicine ( n = 42), and 1 each of moxibustion and t'ai chi. Nineteen (19) of 26 acupuncture reviews and 22/42 herbal medicine reviews concluded that there was not enough good quality trial evidence to make any conclusion about the efficacy of the evaluated treatment, while the remaining 7 acupuncture and 20 herbal medicine reviews and each of the moxibustion and t'ai chi reviews indicated a suggestion of benefit, which was qualified by a caveat about the poor quality and quantity of studies. Most reviews included many distinct interventions, controls, outcomes, and populations, and a large number of different comparisons were made, each with a distinct forest plot. Conclusions: Most Cochrane systematic reviews of TCM are inconclusive, due specifically to the poor methodology and heterogeneity of the studies reviewed. Some systematic reviews provide preliminary evidence of Chinese medicine's benefits to certain patient populations, underscoring the importance and appropriateness of further research. These preliminary findings should be considered tentative and need to be confirmed with rigorous randomized controlled trials. [ABSTRACT FROM AUTHOR]

Objective: This study aims to gain an overview of hot topics related to research focused on Chinese herbal drugs by authors inside China and outside of China in the past 10 years. Methods: PubMed/MEDLINE was utilized in order to investigate and select research that was published on “Chinese herbal drugs” from 1998 to 2007, by authors located both inside and outside of China (MeSH terms were downloaded and ranked). MeSH terms that frequently appeared were identified and co-word analysis was carried out for two groups: (1) authors located in China, and (2) authors based outside of China, respectively. The hot topics concerning research into Chinese herbal drugs were concluded after cluster analysis and related document analysis. Results: For authors in the China group versus those outside the China group, the search results were 4790 versus 2609 citations and approximately 40,000 versus 20,000 MeSH terms, respectively. The threshold value of highly frequent terms was set at 30 versus 20, and the cumulative frequency percentage of these terms was 40.92% versus 36.67%, respectively. Thus, 43 highly frequent MeSH terms were identified and 43 × 43 co-word matrices were acquired for each group. The appearance frequency of MeSH showed that most research focused on pharmacology, therapeutic application, phytotherapy, side-effects of Chinese herbal drugs, and identification of active chemical components in herbs. Conclusion: The hot topics are as follows: (1) anti-inflammatory activity, antioxidant activities, anticancer activity of phytogenic antineoplastic agents, and neuroprotective effects of Chinese herbal drugs; (2) common diseases treated with Chinese herbal drugs include hepatocirrhosis, diabetes, angina, chronic hepatitis B in China, and diabetes, asthma, prostate cancer, and hepatocirrhosis outside of China; (3) Chinese herbal nephropathy and acute hepatitis induced by Chinese herbal drugs; (4) PC-SPES (PDQ®) for the treatment of prostate cancer, which was a hot topic for researchers located outside of China; (5) research on extraction of active components from medicinal plants; and finally (6) research related to the identification of the Chinese herbal drugs component with state-of-the-art technologies in China. [ABSTRACT FROM AUTHOR]

Objective: To investigate whether a training process that focused on a questionnaire-based diagnosis in Traditional Chinese Medicine (TCM), and developing diagnostic consensus, would improve the agreement of TCM diagnoses among 10 TCM practitioners evaluating patients with temporomandibular joint disorder (TMJD). Design and setting: Evaluation of a diagnostic training program at the Department of Family and Community Medicine, University of Arizona, Tucson Arizona, and the Oregon College of Oriental Medicine, Portland, Oregon. Subjects: Screened participants for a study of TCM for TMJD. Practitioners: Ten (10) licensed acupuncturists with a minimum of 5 years licensure and education in Chinese herbs. Methods: A training session using a questionnaire-based diagnostic form was conducted, followed by waves of diagnostic sessions. Between sessions, practitioners discussed the results of the previous round of participants with a focus on reducing variability in primary diagnosis and severity rating of each diagnosis: 3 waves of 5 patients were assessed by 4 practitioner pairs for a total of 120 diagnoses. At 18 months, practitioners completed a recalibration exercise with a similar format with a total of 32 diagnoses. These diagnoses were then examined with respect to the rate of agreement among the 10 practitioners using inter-rater correlations and kappas. Results: The inter-rater correlation with respect to the TCM diagnoses among the 10 practitioners increased from 0.112 to 0.618 with training. Statistically significant improvements were found between the baseline and 18 month exercises ( p < 0.01). Conclusions: Inter-rater reliability of TCM diagnosis may be improved through a training process and a questionnaire-based diagnosis process. The improvements varied by diagnosis, with the greatest congruence among primary and more severe diagnoses. Future TCM studies should consider including calibration training to improve the validity of results. [ABSTRACT FROM AUTHOR]