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Objective: Given the existing evidence for the analgesic effect of acupuncture, the current study aimed to assess whether acupuncture could be feasible and manageable as an adjunctive therapy for cancer pain in a real-world hospital setting. Methods: Thirty patients in an Oncology department with moderate or severe pain were recruited and randomized to an adjunctive acupuncture group or control group, who received pharmacotherapy for pain management without acupuncture. The duration of the treatment course was 1 week with a 2-week follow-up. In total, four acupuncture sessions were administered, on days 1/2/4/6 of the trial. Pain intensity was measured using a numerical rating scale (NRS) and the daily opioid dose was recorded. Results: The overall trends favored acupuncture for both pain intensity and daily opioid consumption. The proportion of participants experiencing at least a 2-point reduction in the NRS at the end of the treatment was 93% (n = 14/15) for the acupuncture group and 57% (n = 8/14) for the control group (risk difference (RD) 36.1%, 95% confidence interval (CI) [7.4%–65.0%]; relative risk (RR) 1.63, 95% CI [1.02–2.62]; p = 0.04). There were no serious adverse events and no dropouts during the treatment. Conclusion: This pilot study showed that adding acupuncture to routine analgesia for patients with cancer pain was feasible and acceptable to patients. The clinical effects of adding acupuncture as an adjunctive therapy need to be further evaluated. Clinical trial registration number: ChiCTR1800017023 (Chinese Clinical Trial Registry)

Introduction. Herbal medicine is commonly used by patients with chronic cough, but the role of herbal medicine for cough variant asthma (CVA) has not yet been clearly defined. For the first time, we performed a meta-analysis to integrate the current evidence of randomized controlled trials (RCTs) on this topic and assess the efficacy of herbal medicine in adults with CVA. Methods. A comprehensive search was conducted in electronic databases to identify RCTs of herbal medicine for adult CVA. Cochrane systematic review methods were followed, and the Grading of Recommendations Assessment, Development, and Evaluation was performed to evaluate the quality of evidence. Results. Twenty-eight RCTs were included. Compared with placebo, moderate-quality evidence from two studies showed that herbal medicine was associated with reduced cough symptom score (CSS) (MD −1.15 points; 95% CI, −1.67 to −0.63) and visual analogue scale (VAS) (MD −1.76 points; 95% CI, −2.66 to −0.86). Compared with montelukast, low- to moderate-quality evidence from 11 studies indicated that herbal medicine was associated with improved Leicester Cough Questionnaire (LCQ) (MD 2.38 points; 95% CI, 1.32 to 3.44), reduced CSS (SMD −0.81 points; 95% CI, −1.09 to −0.53), and VAS (MD −1.34 points; 95% CI, −1.82 to −0.86). There were no significant differences between herbal medicine and ICS plus bronchodilator. Conclusions. In adults with CVA, herbal medicine may result in improved quality of life and reduced cough frequency and severity scores compared with placebo or montelukast. Herbal medicine was not better than ICS plus a bronchodilator but the evidence is very uncertain.

Context People with spasticity that occurred between 30 days and one year after stroke onset with a baseline Modified Ashworth Scale (MAS) ≥1. Objectives To determine the practicality of a pragmatic parallel-group open-labeled randomized controlled trial and to collect preliminary data of effectiveness and safety of electroacupuncture (EA) for poststroke spasticity. Methods Eligible participants were randomly allocated to the intervention group (EA plus usual care) or the control group (usual care alone) at a 1:1 ratio with block sizes of six. Participants received EA three times a week for four weeks, then were followed up for another four weeks. Participants' retention and adherence in the trial were assessed to determine the practicality of trial design. Clinical outcome measures were the change scores of MAS, Fugl-Meyer Assessment of motor performance and Barthel Index, and adverse events. Results Seventy-two people were screened for eligibility, and 30 of them were recruited and randomized. At the end, 25 participants followed the trial protocol and were included in our final data analyses using an intention-to-treat approach. No significant between-group difference was detected for the change scores of MAS, Fugl-Meyer Assessment, or Barthel Index at the end of treatment or end of follow-up. Eighteen participants reported 37 adverse events, but none of the participants was deemed related to EA. Conclusion It is feasible to conduct a full-scale trial to precisely evaluate the effectiveness and safety of EA for treating poststroke spasticity; however, longer treatment and follow-up phases should be considered in the full-scale trial.

Yuanbin Chen,1,* Lin Lin,1,* Lei Wu,1 Yinji Xu,1 Johannah L Shergis,2 Anthony L Zhang,2 Zehuai Wen,1 Christopher Worsnop,3 Cliff Da Costa,4 Frank Thien,5 Charlie C Xue1,2 1The Second Clinical College of Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine and Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, People’s Republic of China; 2School of Health and Biomedical Sciences, RMIT University, Bundoora, Victoria, Australia; 3Institute of Breathing and Sleep, Austin Health, Heidelberg, Victoria, Australia; 4School of Science, RMIT University, Bundoora, Victoria, Australia; 5Department of Respiratory Medicine, Eastern Health, Victoria, Australia, and Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia*These authors contributed equally to this workCorrespondence: Charlie C XueSchool of Health and Biomedical Sciences, PO BOX 71, Bundoora, Victoria 3083, AustraliaTel +61 3 99257360Fax +61 3 99256539Email charlie.xue@rmit.edu.auPurpose: Herbal medicines are commonly used by people with chronic obstructive pulmonary disease (COPD) but high quality randomized controlled trials are limited. This study evaluated the therapeutic value of ginseng capsules in reducing acute exacerbations and improving the quality of life in people with COPD.Patients and Methods: This randomized, double-blind and placebo-controlled trial assessed ginseng’s effects on 200 patients with moderate to very severe COPD. Ginseng capsules (200 mg, twice per day) were compared to placebo over 24 weeks. Patients were followed up for a further 24 weeks after the treatment period. The primary outcome measure was acute COPD exacerbation rate over 12 months. Secondary outcome measures were health-related quality of life, including the St George’s Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT) and the Short Form 36 Health Survey (SF-36). We also assessed lung function, walking distance and use of relief medication.Results: Baseline characteristics were balanced between groups. The rate of COPD exacerbations was not statistically significant between groups after 1 year (62 participants in the ginseng group and 63 in the placebo group). Secondary outcome measures showed improvements after ginseng and placebo but results were not clinically significant. The incidence of adverse events in the two groups was similar and events were unrelated to the intervention.Conclusion: Compared with placebo, ginseng did not reduce the rate of acute COPD exacerbations over 12 months. It was safe and well tolerated by people with moderate to very severe COPD.Keywords: COPD, ginseng, exacerbation, quality of life, randomized controlled trial

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 comprehe...

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.

BackgroundPanax ginseng (ginseng) is a therapeutic herb which might be beneficial in COPD. The study investigated if ginseng, compared with placebo, is effective and safe for people with moderate COPD.MethodsThis multicentre, randomised, double-blind, placebo-controlled trial compared 24 weeks of ginseng capsules (100 mg twice daily) with placebo. Participants were followed up for a further 24 weeks. Participants were aged 40 years and over and had airflow limitation in the moderate (Global Initiative for Chronic Obstructive Lung Disease 2) COPD range. The coprimary endpoints were the St George’s Respiratory Questionnaire, the COPD Assessment Test and the Short Form Health Survey. Secondary outcomes included lung function, exacerbation rate and use of relief medication.Findings168 participants were randomised 1:1 from five centres in Australia and China. Baseline characteristics were balanced between groups. There were no significant differences between ginseng and placebo, with overall results improving in both groups. Ginseng seemed safe for, and well tolerated by, people with COPD.InterpretationThere was no significant difference in improvement in health-related quality of life (primary outcome) between the ginseng and placebo groups.Trial registration numberACTRN12610000768099.

Background Mild‐moderate psoriasis vulgaris is a common dermatological autoimmune condition with limited conventional therapeutic options. Safe and effective adjunct therapies to topical non‐steroidal antipsoriatic therapy are needed. The oral Chinese herbal medicine (CHM) formula PSORI‐CM01 has been evidenced potential antipsoriatic pharmacological activity. This article reports a pilot study which was designed as a double‐blinded, placebo‐controlled randomized controlled trial (RCT) evaluating the effects of PSORI‐CM01 when added to topical calcipotriol cream. Methods People with moderate psoriasis vulgaris were randomized to receive oral PSORI‐CM01 or placebo administered for 12 weeks in combination with calcipotriol. The primary clinical outcome was the change of psoriasis area severity index (PASI) score at week 12 and week 24. Secondary clinical outcomes were PASI75, PASI50, relapse rate, change in body surface area, dermatology life quality index and Skindex29, and adverse events (AEs). Participants’ satisfaction and willingness to repeat were also assessed. Results The pilot study was conducted in Australia and China, 29 participants were randomized with 26 completed the treatment and follow‐up. Participants’ baseline basic characteristics were comparable. No between‐group statistical significance was found on pre‐defined clinical outcome measures, although there seemed a trend of treatment effects favoring the combination of PSORI‐CM01 with calcipotriol. Frequency and severity of AEs were similar between two groups, with no severe AEs reported. Conclusions The design and duration of the study appears feasible. A proper powered RCT with slight adjustments in the methods is needed to reveal the add‐on effects of oral CHM PSORI‐CM01. The experience and results from this pilot study will contribute to the refine of objectives and design of a future study, and assist the sample size calculation for the full‐scale RCT.

Background Chinese medicine has been used to treat diabetes symptoms for thousands of years. Dioscoreae rhizome or Shanyao is a Chinese medicinal herb that is routinely used in the treatment of diabetes mellitus (DM). Objective The purpose of this study is to evaluate the evidence of the added benefits and safety of herbal formulae containing Shanyao in clinical studies and the possible mechanisms of Shanyao in the prevention and treatment of DM in experimental studies. Methods We searched nine databases for randomized controlled trials (RCTs) that included Shanyao in the formulae in the treatment of type 2 DM. Furthermore, experimental studies on the prevention and treatment of DM by Shanyao in English- and Chinese-language databases were identified. Results Fifty-three moderate quality RCTs with herbal formulae containing Shanyao were identified. Results from meta-analysis indicated that Shanyao alone or formulae containing Shanyao in addition to conventional treatments could benefit people with type 2 DM in lowering blood glucose, blood lipids and reducing insulin resistance. Moreover, adverse events were significantly lower in the CHM plus conventional group than those in the conventional group. Shanyao may exert the benefit through various mechanisms including inhibition of α-glucosidase and DPP-IV activity, increase of endogenous GLP-1 and immune regulating activities. Conclusion Evidence from this review suggested that there appeared to be added clinical benefits associated with the use of Shanyao for DM, whether as a food supplement or as a CHM combined with hypoglycemic agents with a good safety profile.

Background. The prophylactic effects of Chinese herbal medicine (CHM) for migraine were examined in numerous clinical trials. This review aimed to analyze the effectiveness and safety of CHM as prophylactic treatment of migraine compared to flunarizine. Methods. Nine databases were searched for randomized controlled trials (RCTs) that evaluated effects of CHM for episodic migraine prophylaxis compared to flunarizine, published before March 2019. Results. Thirty-five RCTs with 2,840 participants met the inclusion criteria, and 31 of them were included in meta-analyses. The overall meta-analysis indicated that, when compared to flunarizine, CHM reduced the frequency of migraine attacks at the end of treatment (EoT) (21 studies, mean difference (MD) −1.23, 95% confidence interval (CI) (−1.69, −0.76)) and at the end of follow-up (EoFU) (five studies, MD −0.96, 95% CI (−1.70, −0.21)). Subgroup analyses based on the treatment duration, follow-up duration, and the dosage of flunarizine showed that CHM was superior to or comparable with flunarizine in reducing migraine frequency. Similar results were also found for secondary outcomes such as the pain visual analogue scale, migraine duration, responder rate, and acute medication usage. In particular, the studies that used CHM containing herb pairs (Chuan Xiong plus Bai Zhi and Chuan Xiong plus Tian Ma) showed promising results. However, the certainty of this evidence was evaluated as “low” or “very low” using the Grading of Recommendations, Assessment, Development and Evaluations approach. Conclusion. CHM appeared to be comparable with flunarizine in reducing the frequency of episodic migraine attacks in adults at EoT and EoFU and well-tolerated by participants, regardless of the treatment duration, follow-up duration, and dosage of flunarizine. Due to the low certainty of the evidence, the suggested promising prophylactic outcomes require higher quality evidence from further rigorous RCTs.

Background and purpose Chinese medicine is increasingly used by women with postpartum depression (PPD). We systematically analyzed randomized controlled trials of acupuncture and Chinese herbal medicine (CHM) for PPD. Methods Studies were retrieved from English and Chinese databases. The Cochrane risk of bias tool was used to assess methodological quality. Results Fifteen CHM, and three acupuncture studies were included. Low quality evidence suggested that CHM alone or combined with antidepressants as add-on therapy may reduce symptoms of depression compared to placebo or antidepressants on the Edinburgh Postnatal Depression Scale (EPDS). There was no statistically significant difference between acupuncture and antidepressants. Adverse events were rare. Conclusions CHM reduced PPD symptoms greater than placebo or antidepressants. Acupuncture was neither superior nor inferior to antidepressants. More rigorously designed studies are required to confirm the effect of CHM and acupuncture for PPD.

Acne vulgaris is a common inflammatory skin condition characterized by comedones. Current pharmacotherapies are effective but are associated with adverse events (AEs) such as mood disorders and antibiotic resistance. The Eriobotrya japonica Formula (EJF) contains six herbs commonly used in traditional Chinese medicine clinical practice. This paper evaluates the experimental evidence and clinical efficacy of EJF for acne vulgaris. Searches of 11 English and Chinese databases were conducted to identify eligible randomized controlled trials (RCTs). PubMed was searched for experimental evidence of herbs included in EJF. Meta-analyses were performed to analyse the clinical effects of EJF compared to pharmacotherapies. Ingredients in EJF were reported to have an effect on inhibiting TNF-α, PPAR-γ and IL-6 cytokines. Some also inhibited P. acnes and had anti-androgenic and anti-lipogenic effects. There were 15 RCTs included in the clinical review. The number of people achieving a clinical improvement based on lesion count was higher with EJF than pharmacotherapies. The effective rate of EJF was greater than antibiotics and benzoyl peroxide (2 studies, RR: 1.47 [1.23, 1.77], I2 = 0%), and antibiotics with topical supplements (2 studies, RR: 1.77 [1.18, 2.67], I2 = 0%). There were 107 mild AEs reported in 7 trials, 33 in the intervention groups and 74 in the control groups. No serious AEs were reported. There is some evidence that EJF can decrease inflammatory lesions in acne vulgaris with fewer AEs in the short-term. However, due to methodological limitations of the included trials, results on clinical efficacy should be interpreted with caution.

The majority of studies of integrative treatment for colorectal cancer (CRC) have been published in Chinese journals. These studies indicate potential benefits, but concerns have been raised over the quality of trials published in Chinese journals. The CONSORT statement provides a guide for study reporting that has been endorsed by more than 400 international journals. Previous studies have used the CONSORT checklist to assess the quality of randomized controlled trials (RCTs).This study focused on RCTs of integrative and traditional medicine for CRC published in Chinese journals and assessed: (1) the overall quality of reporting with a focus on methodological aspects; (2) change over time; and (3) the influence of study funding, level of institution conducting the trial, rank of the journal, and the length of the article.Searches of seven databases identified RCTs. Quality was assessed using CONSORT 2010 with adaptations to facilitate scoring. Additional codes were added for publication year, hospital rank, report length, and status of the journal. Scores of each checklist item, total scores, and scores for eight items associated with RCT methodology were calculated.Eighty-one studies were included in the main analyses. The RCT methodology subgroup scores were significantly higher in studies: with public funding, conducted by authors from university hospitals, published in higher ranked journals, and in longer articles.Few Chinese journals mention CONSORT in their author guidelines. In these RCTs on CRC better reporting of RCT methodology was associated with ranking of the journal as "core," public funding of the RCT, and first or correspondent author from a university hospital but the quality of reporting had not significantly improved in 15 years. As the volume of scientific information produced in China grows, it is imperative that there is growth in the quality of this information.

Objectives This study sought to determine the most common oral herbal formula for menopausal symptoms in classical Chinese medicine textbooks and investigate its clinical effectiveness and potential mechanisms of action. Methods The most common formula used for menopause-like symptoms in past eras was identified from the Encyclopedia of Traditional Chinese Medicine. A systematic review of randomized controlled trials (RCTs) was undertaken and findings from relevant experimental studies were summarized. Results Licorice (Glycyrrhiza spp.) and jujube (Ziziphus jujuba Mill.) formula (LJF) was used in 63 of the 175 citations (36%) in the classical literature. Evidence from four RCTs showed that while LJF may improve sleep symptoms, there is insufficient evidence to provide recommendations for clinical practice. Experimental studies showed sedative, antidepressant-like, estrogenic and antiprogestogenic actions. Conclusions LJF has a long history of use for menopause-like symptoms, but further research is needed to confirm its clinical effects and guide clinical decision-making.

Increasing placebo effect sizes over time have been reported in randomized controlled trials (RCTs) for outcomes related to psychiatric symptoms. The Neuropsychiatric Inventory (NPI) is a key outcome measure in clinical trials of the behavioral and psychological symptoms of dementia (BPSD). Accurate placebo effect size estimates for NPI are needed for sample size calculations in order to adequately power future studies. This study investigated variation in placebo effect sizes for NPI in RCTs testing oral interventions for BPSD. A search of PubMed was conducted in April 2016 for two-armed, double-blinded, placebo-controlled RCTs testing any oral intervention for management of BPSD using the NPI. Meta-analysis was conducted of baseline versus end of treatment placebo group data of included studies. Twenty-five RCTs published from 2000 to 2015 were included. Substantial variation in placebo effect sizes was detected. Participants in placebo groups showed greater improvements in recent studies compared with earlier studies. Subgroup analyses indicated robustness of this finding. From 2000 to 2008 there was no significant change in total NPI scores within placebo groups (12 studies; 1,056 participants), whereas from 2009 to 2015 there was significant improvement (mean difference: −2.68; 95% confidence interval: −4.38, −0.99; z = 3.10; p = 0.002, random effects; I 2 = 76%; 13 studies; 1,170 participants). This increase in NPI effect sizes in placebo groups has important implications for power calculations for future clinical trials of BPSD. Effect size estimates for NPI need to be based on more recent studies.

This study reviewed the biological action of key herbs and evaluated systematically the efficacy and safety of oral Gentiana formula for herpes zoster (HZ). Experimental studies relevant to HZ were identified in PubMed. Randomized controlled trials using Gentiana formula for HZ were identified from nine English and Chinese databases. The primary outcome was evaluation of pain. Potential risk of bias was assessed. Meta-analysis was conducted using mean difference or risk ratio with 95% confidence intervals. Key herbs Gentiana scabra Bunge, Gentiana triflora Pall, Scutellaria baicalensis Georgi, and Gardenia jasminoides Ellis have shown antiinflammatory actions through inhibition of inflammatory cytokines and pro-inflammatory enzymes. Twenty-six clinical studies, involving 2955 participants, were included. Modified Gentiana formula resolved pain earlier than pharmacotherapy when used alone or combined with topical Chinese herbal medicine. Incidence of postherpetic neuralgia was lower (risk ratio 0.14, 95% confidence interval 0.03 to 0.74) with modified Gentiana formula plus topical Chinese herbal medicine. Mild adverse events were reported. Antiinflammatory actions of key herbs of Gentiana formula may explain clinical benefit in hastening pain relief and decreasing postherpetic neuralgia. Few adverse events were reported. Findings were limited by study quality and diversity in intervention and comparator dosage. Copyright © 2017 John Wiley & Sons, Ltd.

Cordyceps sinensis (CS) is a complementary medicine used for Chronic Obstructive Pulmonary Disease (COPD) of Global Initiative for Chronic Obstructive Lung Disease (GOLD) stages 2-3. Many randomized controlled trials have been conducted to evaluate the effect of CS alone or in combination with other herbs on stable COPD. To provide a synthesis of the evidence, we searched nine major electronic databases for randomized controlled trials on CS published before 21st December 2016. Fifteen interventional studies, including 1,238 participants, met the inclusion criteria. Meta-analysis showed that both CS preparations and CS formulae showed the potential benefits in lung function, exercise endurance, life quality, and improvement of symptoms. No serious adverse events were reported. So CS may be a promising treatment for patients with stable COPD of GOLD stages 2-3. No studies were placebo-controlled or of high methodological quality, which limits the conclusions.

Background Depression is common in women during perimenopause and menopause. Complementary therapies such as acupuncture and Chinese herbal medicine (CHM) are often utilized by these women. However, the efficacy and safety of these treatments have not been systematically evaluated. Methods We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs). Nine English and Chinese databases were searched and search terms included perimenopause, menopause, depression, Chinese herbal medicine, acupuncture, RCTs, and their synonyms. Methodological quality was assessed using the Cochrane Risk of Bias Tool. Results A total of 18 RCTs were identified (6 CHM, 11 acupuncture related therapies, 1 combination of CHM and acupuncture). For Hamilton Rating Scale of Depression (HRSD) and Kuppermans Index of Menopause, tuina-massage, combined therapy of CHM plus acupuncture showed significant benefits at end of treatment compared to antidepressants. Either CHM and acupuncture reduced HRSD scores, indicating less severe depression, showing comparable effects to antidepressants. Conclusion CHM and acupuncture treatment in perimenopause and menopausal women resulted in reduced severity of depression. Results should be interpreted with caution given the small number of studies included in this review and further RCTs are warranted to validate findings from this review.

Mild cognitive impairment (MCI) is a condition that may be prodromal to the development of dementia. There remain, as yet, no approved pharmaceutical interventions for MCI. Chinese herbal medicines (CHMs) have a long history of use for cognitive impairments and some plant ingredients have shown neuroprotective actions in experimental studies. This review assesses the current clinical evidence from controlled clinical trials for the effects of CHMs on cognitive outcomes as measured by Mini-mental state examination (MMSE) or Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-Cog). Fifty one studies (4026 participants) were included. These compared CHM with placebo, supportive care, pharmaceutical treatment or combined CHM with a pharmaceutical in an integrative setting. For the eight randomised controlled trials (RCTs) of comparisons with placebo, MMSE was significantly higher in the CHM groups (MD 1.56 [0.78, 2.34] I2 = 85%, n = 503), similarly for eight RCTs of comparisons with supportive care (MD 1.77 [1.33, 2.21] I2 = 0%, n = 555). Benefits were also evident in comparisons with some pharmaceuticals and with integrative treatment. The small size of most studies and methodological weaknesses mean that these results should be interpreted with caution. Further studies employing rigorous methods are required to investigate the potential benefits of these CHMs for MCI. Copyright © 2016 John Wiley & Sons, Ltd.

Importance Research into acupuncture and acupressure and their application for cancer pain has been growing, but the findings have been inconsistent. Objective To evaluate the existing randomized clinical trials (RCTs) for evidence of the association of acupuncture and acupressure with reduction in cancer pain. Data Sources Three English-language databases (PubMed, Embase, and CINAHL) and 4 Chinese-language biomedical databases (Chinese Biomedical Literature Database, VIP Database for Chinese Technical Periodicals, China National Knowledge Infrastructure, and Wanfang) were searched for RCTs published from database inception through March 31, 2019. Study Selection Randomized clinical trials that compared acupuncture and acupressure with a sham control, analgesic therapy, or usual care for managing cancer pain were included. Data Extraction and Synthesis Data were screened and extracted independently using predesigned forms. The quality of RCTs was appraised with the Cochrane Collaboration risk of bias tool. Random-effects modeling was used to calculate the effect sizes of included RCTs. The quality of evidence was evaluated with the Grading of Recommendations Assessment, Development and Evaluation approach. Main Outcomes and Measures The primary outcome was pain intensity measured by the Brief Pain Inventory, Numerical Rating Scale, Visual Analog Scale, or Verbal Rating Scale. Results A total of 17 RCTs (with 1111 patients) were included in the systematic review, and data from 14 RCTs (with 920 patients) were used in the meta-analysis. Seven sham-controlled RCTs (35%) were notable for their high quality, being judged to have a low risk of bias for all of their domains, and showed that real (compared with sham) acupuncture was associated with reduced pain intensity (mean difference [MD], −1.38 points; 95% CI, −2.13 to −0.64 points;I2 = 81%). A favorable association was also seen when acupuncture and acupressure were combined with analgesic therapy in 6 RCTs for reducing pain intensity (MD, −1.44 points; 95% CI, −1.98 to −0.89;I2 = 92%) and in 2 RCTs for reducing opioid dose (MD, −30.00 mg morphine equivalent daily dose; 95% CI, −37.5 mg to −22.5 mg). The evidence grade was moderate because of the substantial heterogeneity among studies. Conclusions and Relevance This systematic review and meta-analysis found that acupuncture and/or acupressure was significantly associated with reduced cancer pain and decreased use of analgesics, although the evidence level was moderate. This finding suggests that more rigorous trials are needed to identify the association of acupuncture and acupressure with specific types of cancer pain and to integrate such evidence into clinical care to reduce opioid use.

Delays in recovery of intestinal function following abdominal surgery are associated with longer hospital stays, increased postoperative complications, and higher costs to the health care system. Studies of acupuncture for postoperative ileus and other postoperative issues have reported improvements. This systematic review and meta-analysis aimed to assess whether acupuncture assisted recovery following surgery for colorectal cancer (CRC). Randomized controlled trials (RCTs) were identified from major English and Chinese language biomedical databases. Participants (aged 18 years plus) had received surgical resection for CRC. 22 studies (1,628 participants) were included. Five were sham-controlled. Outcomes included gastrointestinal function recovery (21 studies), recovery of urinary function (1 study), postoperative abdominal distension (3 studies), and quality of life (1 study). Meta-analyses found significant reductions in time to first bowel sounds, first flatus, and first defecation in both the sham-controlled and nonblinded studies. These results suggested that the addition of acupuncture following CRC surgery improved recovery of gastrointestinal function based on four blinded good quality RCTs (281 participants) and 17 nonblinded lower quality RCTs (1,265 participants). The best available evidence was for interventions that included electroacupuncture at the point ST36 Zusanli and there is supporting evidence for other types of acupuncture therapies that involve stimulation of this point. This review is registered with the following: systematic review registration in PROSPERO: CRD42017079590.

Purpose. To conduct a systematic review and meta-analysis to determine the current best available evidence of the efficacy and safety of acupuncture and related therapies for acne vulgaris. Methods. Eleven English and Chinese databases were searched to identify randomized controlled trials (RCTs) of acne vulgaris compared to pharmacotherapies, no treatment, and sham or placebo acupuncture. Methodological quality was assessed using Cochrane Collaboration’s risk of bias tool. Meta-analysis was conducted using RevMan software. Results. Twelve RCTs were included in the qualitative review and 10 RCTs were included in meta-analysis. Methodological quality of trials was generally low. The chance of achieving ≥30% change in lesion count in the acupuncture group was no different to the pharmacotherapy group (RR: 1.07 [95% CI 0.98, 1.17]; I2=8%) and ≥50% change in lesion count in the acupuncture group was not statistically different to the pharmacotherapy group (RR: 1.07 [95% CI 0.98, 1.17]; I2=50%). Conclusions. While caution should be exercised due to quality of the included studies, acupuncture and auricular acupressure were not statistically different to guideline recommended treatments but were with fewer side effects and may be a treatment option. Future trials should address the methodological weaknesses and meet standard reporting requirements stipulated in STRICTA.

This meta-analysis evaluates the clinical evidence for the addition of traditional medicines (TMs) to oxaliplatin-based regimens for colorectal cancer (CRC) in terms of tumor response rate (TRR). Eight electronic databases were searched for randomized controlled trials of oxaliplatin-based chemotherapy combined with TMs compared to the same oxaliplatin-based regimen. Data on TRR from 42 randomized controlled trials were analyzed using Review Manager 5.1. Studies were conducted in China or Japan. Publication bias was not evident. The meta-analyses suggest that the combination of the TMs with oxaliplatin-based regimens increased TRR in the palliative treatment of CRC (risk ratio [RR] 1.31 [1.20-1.42], I2 = 0%). Benefits were evident for both injection products (RR 1.36 [1.18-1.57], I2 = 0%) and orally administered TMs (RR 1.27 [1.15-1.41], I2 = 0%). Further sensitivity analysis of specific plant-based TMs found that Paeonia, Curcuma, and Sophora produced consistently higher contributions to the RR results. Compounds in each of these TMs have shown growth-inhibitory effects in CRC cell-line studies. Specific combinations of TMs appeared to produce higher contributions to TRR than the TMs individually. Notable among these was the combination of Hedyotis, Astragalus, and Scutellaria.

This systematic review and meta-analysis assessed the efficacy and safety of Dang shen [Codonopsis pilosula (Franch.) Nannf., root] formulae for the treatment of chronic obstructive pulmonary disease (COPD). English and Chinese databases were searched, and 48 randomized controlled trials were included. Dang shen formulae improved lung function forced expiratory volume in 1 s compared with conventional pharmacotherapy (CP) [mean difference (MD) 0.22 L, 95% confidence interval (CI) 0.13-0.31, p < 0.001, I 2 = 5%] and quality of life (St. Georges Respiratory Questionnaire) compared with placebo (MD -7.19, 95% CI -10.82 to -3.56, p < 0.001, I2 = 0%) and when combined with CP versus CP (MD -9.05, 95% CI -12.72 to -5.38, p < 0.001, I2 = 89%). Dang shen formulae also increased distance walked in 6 min when combined with CP versus CP alone (MD 51.43 m, 95% CI 30.06-72.80, p < 0.001, I2 = 27%) and reduced frequency/days with COPD exacerbations. Risk of bias was evaluated using the Cochrane tool. Methodological shortfalls were identified. Adverse events were low and not different between intervention and control groups. Thirty-three events were reported, including gastrointestinal upset, dry mouth, and insomnia. Dang shen formulae appear to improve some aspects of the included COPD outcomes. However, owing to methodological flaws, the current evidence is inadequate to support the routine use of Dang shen formulae outside of Chinese medicine practice. However, these results justify further investigation.

Clinically, oral Chinese herbal medicine (CHM) is widely used in the treatment of psoriasis. This review evaluates the effects of oral CHM in combination with pharmacotherapy for psoriasis vulgaris. The Cochrane Library, PubMed, Embase, CINAHL, CNKI, and CQVIP were searched from their inceptions to November 2012. Randomized controlled trials (RCTs) investigating CHM plus pharmacotherapy compared to pharmacotherapy were included. Data were analyzed using Review Manager 5.1.0. Seventeen RCTs were included, conducted in China, and employed a diversity of both herbal medicines and pharmacotherapies. When the meta-analyses were restricted to studies that used a well-known pharmacotherapy as the comparator with 60% or greater clinical improvement in psoriasis as the outcome, five studies used oral acitretin, one used topical calcipotriol, and one used topical clobetasol propionate as control interventions. At the end of treatment, there was a benefit for the pooled result of the five studies that compared CHM plus acitretin with acitretin alone and no serious adverse events were reported. However, none of these studies was blind, so there is considerable risk of bias in this result. In addition, there was inadequate reporting of longer-term results, so it remains unclear whether the reported effect could be maintained or whether the prolonged use of the CHM in conjunction with acitretin would be safe. The main plants used in these studies, Rehmannia glutinosa root, Salvia miltiorrhiza root, and Lithospermum erythrorhizon root, have shown anti-inflammatory and/or antiproliferative effects in experimental studies. These actions may at least partially explain the observed results.

Background Perennial allergic rhinitis (PAR) has a high and increasing prevalence worldwide. Ear acupressure (EAP) is a noninvasive semi–self-administered form of acupuncture. Previous studies indicated that EAP could be effective and safe for AR symptom management. However, there was insufficient evidence to confirm this. This study investigated whether EAP, a noninvasive clinical alternative to acupuncture, is effective and safe for PAR. Methods This is an international, multicenter, randomized, single-blind, sham-controlled trial. The trial was conducted at two centers: Royal Melbourne Institute of Technology University (Melbourne, Australia) Clinical Trial Clinic and Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China. PAR participants were randomized to receive real or sham EAP treatment once a week for 8 weeks and then were followed-up for 12 weeks. Participants were instructed to administer EAP stimulation three times daily. Symptom severity and quality of life (QoL) were evaluated. Adverse events (AEs) were also monitored. Intention-to-treat analysis on change of symptom scores and QoL was applied. Results Two hundred forty-five participants were randomly assigned to real (n = 124) and sham EAP (n = 121) groups. Twenty-five participants discontinued during treatment and 15 participants dropped out during follow-up. At the end of treatment and follow-up periods, changes of global QoL score were significantly greater in the real EAP group compared with the sham group. At the end of follow-up, scores for total nasal symptom, runny nose, and eye symptoms in the real EAP group had a greater reduction compared with the sham group. Overall, both real and sham EAP were well tolerated. Two severe AEs were reported but were not considered related to the EAP procedures. Conclusion In conclusion, EAP showed short-term and extended benefit for improving PAR symptoms and QoL for PAR patients.

Ear-acupuncture/ear-acupressure (EAP) has been used for a range of health conditions with numerous randomized controlled trials (RCTs) investigating its efficacy and safety. However, the design of sham interventions in these RCTs varied significantly. This study systematically reviewed RCTs on EAP for all clinical conditions involving a number of sham EAPs as a control intervention. The review is guided by the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0 and investigated the types and differences of sham EAP interventions. Four electronic English databases (The Cochrane Library, PubMed, Embase, CINAHL®) and two Chinese databases (CQVIP, CNKI) were searched in December 2012 and 55 published RCTs comparing real and sham EAP for any clinical condition were included. Characteristics of participants, real and sham interventions, and outcomes were extracted. Four types of sham methods were identified. Among the 55 RCTs, 25 studies involved treatment on nonspecific ear acupoints as the sham method; seven studies used nonacupoints on the ear; nine studies selected placebo needles or placebo ear-acupressure on the same ear acupoints for the real treatment; 10 studies employed pseudo-intervention; and five studies combined two of the above methods to be the sham control. Other factors of treatment such as number of points, treatment duration, and frequency also varied greatly. Risk of bias assessment suggests that 32 RCTs were "high risk" in terms of participants blinding, and 45 RCTs were "high risk" in terms of personnel blinding. Meta-analysis was not conducted due to the high clinical heterogeneity across included studies. No relationship was found between the sham designs and efficacy outcomes, or between the sham types and dropout rate. No solid conclusion of which design is the most appropriate sham control of EAP could be drawn in this review.

Ethnopharmacological relevance Historical literature and pharmacological studies both suggest that Astragalus membranaceus (A. membranaceus) holds potential benefits for diabetic kidney disease (DKD), which is a growing burden with limited proven renal protective options. Aim of the study: An updated systematic review was conducted to evaluate the efficacy and safety of A. membranaceus preparations as an adjunctive therapy to conventional therapies for DKD. Methods Nine databases and five clinical trial registries were searched for randomized controlled trials (RCTs) of A. membranaceus preparations added to conventional therapies compared with conventional therapies alone for people with DKD. Study screening, data collection, and quality assessment were performed independently by two reviewers. Estimated effects were pooled as mean differences or standardized mean differences with 95% confidence intervals by using a random-effects model. Results Sixty-six studies, involving 4785 DKD participants, were included. The quality of the included studies was low due to methodological shortfalls. Meta-analysis showed that additional use of A. membranaceus injection reduced more albuminuria (32 RCTs, 2253 participants; SMD: 2.05 [–2.49, −1.61], I2 = 94%), proteinuria (26 RCTs, 1812 participants; SMD: 1.85 [–2.34, −1.37], I2 = 95%), and serum creatinine levels (32 RCTs, 2880 participants; −14.78 μmol/L [–19.22, −10.33], I2 = 97%) than conventional therapies alone did. An anti-albuminuria effect was also observed in the oral A. membranaceus preparation group (four RCTs, 236 participants; SMD: 1.27 [–1.82, −0.73], I2 = 73%). Meta-regression suggested that the treatment effect of A. membranaceus injection was associated with the baseline serum creatinine level. The adverse-events profile was similar between the additional A. membranaceus and control groups. Conclusion The low quality of evidence suggested that adjunctive use of A. membranaceus preparations in addition to conventional therapies may be effective and tolerated for short-term reduction of albuminuria, proteinuria, and serum creatinine in DKD patients. The findings should be considered with caution due to the lack of high-quality RCTs and significant heterogeneity and publication bias. Further RCTs are needed to confirm the long-term efficacy and safety of A. membranaceus preparations, especially of the oral form, in patient-important outcomes.

IntroductionAlthough acupuncture has been recommended for alleviating cancer pain by clinical guidelines, the level of the supporting evidence needs to be improved. A pragmatic randomised controlled trial (pRCT) in a hospital setting would provide real-world assessments of the overall clinical effects of acupuncture. This pilot trial aims to explore the feasibility and provide data for sample size calculations for a pRCT evaluating the effectiveness of acupuncture as an adjunctive therapy to routine medical care for cancer pain.Methods and analysisThirty patients with cancer admitted to the oncology department with moderate or severe pain will be recruited. Participants will be randomised at a ratio of 1:1 to the adjunctive acupuncture group or a control group which receives routine pain management without acupuncture. The standardised section of the acupuncture protocol will be developed based on the results of reviews of the literature, recommendations in clinical guidelines and interviews with clinical experts. The acupuncturist will be allowed to tailor the protocol according to the individual situation of each participant. Primary outcomes relevant to the feasibility of conducting a fully powered trial include: numbers and proportions of participants recruited, screened, consented and randomised; numbers and reasons for withdrawals and dropouts; numbers and types of adverse events; feasibility of implementing the trial procedures; evaluation of the comprehensiveness and ease-of-use of the case report form. Secondary outcomes are clinical measurements of the effectiveness of the treatment that are intended for use in the full-scale trial. Analysis of feasibility will be descriptive and pain intensity measures will be analysed using mixed-effects regression.Ethics and disseminationEthics approval was obtained from the Institutional Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine (approval no: Z2017-184-01) and RMIT University Human Research Ethics Committee (reference no: 21361). Results will be disseminated in a peer-reviewed journal, and trial participants will be informed via email and/or phone calls.Trial registration numberChiCTR1800017023

This systematic review evaluates the clinical evidence for the addition of herbal medicines (HMs) to FOLFOX 4 for advanced colorectal cancer (ACRC) in terms of tumor response rate (tRR), survival, quality of life and reduction in adverse events (AEs). Seven electronic databases were searched for randomized controlled trials (RCTs) of FOLFOX4 combined with HMs compared to FOLFOX4 alone. Outcome data for 13 randomized controlled trials were analysed using Review Manager 5.1. Risk of bias for objective outcomes including tumor response and survival was judged as low. Publication bias was not evident. Meta-analyses found the addition of HMs improved tRR (RR 1.25, 95%CI 1.06-1.47, I2=0%), one year survival (RR 1.51, 95%CI 1.19-1.90, I2=0%) and quality of life in terms of Karnofsky Performance Status (KPS) gained (RR 1.84, 95%CI 1.54-2.19, I2=0%); alleviated grade 3 and 4 chemotherapy-related AEs for neutropenia (RR 0.33, 95%CI 0.18-0.60, I2=0%), nausea and vomiting (RR 0.34, 95%CI 0.17-0.67, I2=0%) and neurotoxicity (RR 0.39, 95%CI 0.15-1.00, I2=0%), compared to FOLFOX4 alone. The most frequently used herbs were Astragalus membranaceus, Panax ginseng, Atractylodes macrocephala, Poria cocos, Coix lachryma-jobi and Sophora flavescens. In experimental studies, each of these herbs has shown actions that could have contributed to improved tumor response.

Background Atopic dermatitis (AD) is a chronic, itching skin disease, and conventional therapies offer inadequate symptom management. Patients with AD are increasingly turning to Chinese medicine. Objective We systematically evaluated the clinical evidence of the efficacy and safety of oral Chinese herbal medicine for AD. Methods Searches were conducted on major electronic databases using the following key words: "randomized controlled trials," "atopic dermatitis," "traditional Chinese medicine," "traditional East Asian medicine," "herbal medicine," "Chinese herbal drugs," "medicinal plants," "phytotherapy," "Kampo medicine," and "Korean traditional medicine." The results were screened to include English/Chinese randomized controlled trials. A metaanalysis was conducted on suitable outcome measures. Results Seven randomized controlled trials were included (1 comparing Chinese herbal medicine and Western medicine with Western medicine alone; 6 comparing Chinese herbal medicine with placebo). Combined Chinese herbal medicine with Western medicine was superior to Western medicine alone. Three placebo controlled trials showed significant treatment efficacy and 2 showed significantly reduced concurrent therapy with Chinese herbal medicine. No abnormalities in safety profile or severe adverse events were reported. Limitations A metaanalysis of all included studies could not be conducted because of study heterogeneity. Conclusions Chinese herbal medicine significantly improved symptom severity of AD and was reported as well tolerated. However, the poor quality of studies did not allow for valid conclusions to support its tolerability and routine use. Additional studies addressing the methodologic issues are warranted to determine the therapeutic benefit of Chinese herbal medicine for AD.

This systematic review and meta-analysis of randomized controlled trials (RCTs) examined the topical use of multi-herbal formulations for the management of psoriasis vulgaris. Studies were identified from PubMed, Cochrane library, EMBASE, and the Chinese databases CNKI and CQVIP. Methods were according to the Cochrane Handbook and meta-analyses used RevMan 5.1. Nine studies met the inclusion/exclusion criteria. The comparisons were with placebo and/or anti-psoriatic pharmacotherapy (APP) with two studies having three arms. The pooled meta-analysis data indicated the topical herbal formulae improved overall clinical efficacy (defined as 50% improvement or greater) when compared with: topical placebo (plus oral herbal co-intervention); topical APP alone; and topical APP (plus pharmaceutical co-intervention). Improvement was evident in Modified Psoriasis Area and Severity Index (PASI) score when topical herbal formula was compared to placebo (plus oral herbal co-intervention). No serious adverse events were reported. The most commonly used herbs were Sophora flavescens root and Lithospermum erythrorhizon root. Experimental studies reported that these herbs and/or their constituents have anti-inflammatory, anti-proliferative, anti-angiogenic, and tissue repair actions. These actions may at least partially explain the apparent benefits of the topical multi-herbal formulations in psoriasis.

Background: Smoking is the largest preventable cause of death and disease worldwide but smokers often fail to quit due to nicotine withdrawal symptoms. Current available pharmaceutical therapies may assist with smoking cessation but may have side effects. Ear acupressure (EAP) and ear acupuncture have been used for smoking cessation, and some positive results have been reported. The aim of the study is to assess the efficacy and safety of EAP in assisting individuals to quit smoking and/or support them in the management of nicotine withdrawal symptoms. Methods: This study will be a randomised, single-blind, sham-controlled study conducted at RMIT University in Melbourne, Australia. Adult smokers will be randomly assigned to receive EAP specifically for smoking cessation or nonspecific EAP treatments. After a 2-week run-in, participants will be treated once a week for 8 weeks and followed up for 12 weeks. The primary outcome measures will be 7 day point-prevalence cessation rate by self-report validated by expired carbon monoxide and nicotine withdrawal symptoms measured by the Mood and Physical Symptoms Score questionnaire. Secondary outcomes will be self-reported usage of nicotine replacement therapies, cigarette consumption, body weight change and quality of life. The safety end point will be self-reported adverse events associated with EAP. Intention-to-treat analysis will be applied. Discussion: Findings from this study will determine if this EAP intervention alone can be an effective and safe therapy to assist with smoking cessation and the management of nicotine withdrawal symptoms.

Panax ginseng is one of the most frequently used herbs in the world. Numerous trials have evaluated its clinical benefits. However, the quality of these studies has not been comprehensively and systematically assessed. We reviewed randomized controlled trials (RCTs) of Panax ginseng to evaluate their quality and risk of bias. We searched four English databases, without publication date restriction. Two reviewers extracted details about the studies' methodological quality, guided by the Consolidated Standards of Reporting Trials (CONSORT) checklist and its extension for herbal interventions. Risk of bias was determined using the Cochrane Risk of Bias tool. Of 475 potentially relevant studies, 58 met our inclusion criteria. In these 58 studies, 48.3% of the suggested CONSORT checklist items and 35.9% of the extended herbal items were reported. The quality of RCTs published after the CONSORT checklist improved. Until 1995 (before CONSORT) (n = 4), 32.8% of the items were reported in studies. From 1996–2006 (CONSORT published and revised) (n = 30), 46.1% were reported, and from 2007 (n = 24), 53.5% were reported (p = 0.005). After the CONSORT extension for herbal interventions was published in 2006, RCT quality also improved, although not significantly. Until 2005 (n = 34), 35.2% of the extended herbal items were reported in studies; and from 2006 onwards (n = 24), 37.3% were reported (p = 0.64). Most studies classified risk of bias as "unclear". Overall, the quality of Panax ginseng RCT methodology has improved since the CONSORT checklist was introduced. However, more can be done to improve the methodological quality of, and reporting in, RCTs.

This study investigated the efficacy and safety of ear acupressure (EAP) as a stand-alone intervention for smoking cessation and the feasibility of this study design. Adult smokers were randomised to receive EAP specific for smoking cessation (SSEAP) or a nonspecific EAP (NSEAP) intervention which is not typically used for smoking cessation. Participants received 8 weekly treatments and were requested to press the five pellets taped to one ear at least three times daily. Participants were followed up for three months. Primary outcome measures were a 7-day point-prevalence cessation rate confirmed by exhaled carbon monoxide and relief of nicotine withdrawal symptoms (NWS). Intention-to-treat analysis was applied. Forty-three adult smokers were randomly assigned to SSEAP (n=20) or NSEAP (n=23) groups. The dropout rate was high with 19 participants completing the treatments and 12 remaining at followup. One participant from the SSEAP group had confirmed cessation at week 8 and end of followup (5%), but there was no difference between groups for confirmed cessation or NWS. Adverse events were few and minor.

Psoriasis vulgaris is a chronic skin condition affecting patients' quality of life. Long-term use of conventional therapy increases risk of unwanted side effects. Compound glycyrrhizin in conjunction with conventional therapy has been used in clinical practice, but the evidence for such practice has not been evaluated systematically.This review aims to evaluate the efficacy and safety of compound glycyrrhizin in combination with conventional therapy for psoriasis vulgaris.PubMed, Excerpta Medica dataBASE (Embase), Cumulative Index to Nursing and Allied Health Literature (CINAHL), Cochrane Central Register of Controlled Trials, Allied and Complementary Medicine Database (AMED), CiNii, Chinese Biomedical Literature, China National Knowledge Infrastructure, Chinese Scientific Journals Full Text Database and Wanfang Data were searched from their respective inceptions to July 2015. Randomized controlled trials comparing compound glycyrrhizin plus conventional therapy to conventional therapy alone for psoriasis vulgaris were included. Data analysis was performed using Review Manager 5.3.Eleven randomized controlled trials were included in this review. Meta-analysis of the 11 randomized controlled trials indicated that the addition of compound glycyrrhizin increased the number of patients achieving Psoriasis Area and Severity Index (PASI) 60 (RR: 1.30 [1.21, 1.40], ICompound glycyrrhizin in conjunction with conventional therapy enhances clinical response, and compound glycyrrhizin as add-on therapy does not appear to pose any additional risk in the treatment of psoriasis vulgaris. However, the findings should be interpreted with caution of methodological flaws in the included studies. PROSPERO registration number: CRD42015027763.

Herpes zoster is an acute inflammatory condition which can have a significant impact on quality of life. Antiviral therapies are effective, but do not meet patients' expectations of symptomatic relief. Acupuncture and moxibustion have been used for herpes zoster; this systematic review evaluated their efficacy and safety. Nine English and Chinese databases were searched from their inceptions to March 2016. Randomized controlled trials evaluating the combination of acupuncture plus moxibustion in adult herpes zoster were included. Outcomes included pain intensity and duration, quality of life and adverse events. Meta-analysis was performed using RevMan software (version 5.3). Nine studies (945 participants) were included. Studies were of low to moderate methodological quality based on risk of bias assessment. Pain intensity (visual analogue scale) was lower among those who received acupuncture plus moxibustion compared with pharmacotherapy (one study; MD -8.25 mm, 95% CI -12.36 to -4.14). The clinical significance of this result is yet to be established. Some benefits were seen for other pain and cutaneous outcomes, and global improvement in symptoms. Mild adverse events were reported in the intervention groups. Acupuncture plus moxibustion may improve pain and cutaneous outcomes, although current evidence is limited by the number of studies and methodological shortcomings.

Supplemental Digital Content is available in the text, Use of Chinese herbal medicines (CHM) in symptom management for cancer palliative care is very common in Chinese populations but clinical evidence on their effectiveness is yet to be synthesized. To conduct a systematic review with meta-analysis to summarize results from CHM randomized controlled trials (RCTs) focusing on symptoms that are undertreated in conventional cancer palliative care. Five international and 3 Chinese databases were searched. RCTs evaluating CHM, either in combination with conventional treatments or used alone, in managing cancer-related symptoms were considered eligible. Effectiveness was quantified by using weighted mean difference (WMD) using random effect model meta-analysis. Fourteen RCTs were included. Compared with conventional intervention alone, meta-analysis showed that combined CHM and conventional treatment significantly reduced pain (3 studies, pooled WMD: −0.90, 95% CI: −1.69 to −0.11). Six trials comparing CHM with conventional medications demonstrated similar effect in reducing constipation. One RCT showed significant positive effect of CHM plus chemotherapy for managing fatigue, but not in the remaining 3 RCTs. The additional use of CHM to chemotherapy does not improve anorexia when compared to chemotherapy alone, but the result was concluded from 2 small trials only. Adverse events were infrequent and mild. CHM may be considered as an add-on to conventional care in the management of pain in cancer patients. CHM could also be considered as an alternative to conventional care for reducing constipation. Evidence on the use of CHM for treating anorexia and fatigue in cancer patients is uncertain, warranting further research.

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.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.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]).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.

Ear-acupuncture/ear-acupressure (EAP) has been used for a range of health conditions with numerous randomized controlled trials (RCTs) investigating its efficacy and safety. However, the design of sham interventions in these RCTs varied significantly. This study systematically reviewed RCTs on EAP for all clinical conditions involving a number of sham EAPs as a control intervention. The review is guided by the Cochrane Handbook for Systematic Reviews of Interventions 5.1.0 and investigated the types and differences of sham EAP interventions. Four electronic English databases (The Cochrane Library, PubMed, Embase, CINAHL®) and two Chinese databases (CQVIP, CNKI) were searched in December 2012 and 55 published RCTs comparing real and sham EAP for any clinical condition were included. Characteristics of participants, real and sham interventions, and outcomes were extracted. Four types of sham methods were identified. Among the 55 RCTs, 25 studies involved treatment on nonspecific ear acupoints as the sham method; seven studies used nonacupoints on the ear; nine studies selected placebo needles or placebo earacupressure on the same ear acupoints for the real treatment; 10 studies employed pseudo-intervention; and five studies combined two of the above methods to be the sham control. Other factors of treatment such as number of points, treatment duration, and frequency also varied greatly. Risk of bias assessment suggests that 32 RCTs were ”high risk” in terms of participants blinding, and 45 RCTs were ”high risk” in terms of personnel blinding. Metaanalysis was not conducted due to the high clinical heterogeneity across included studies. No relationship was found between the sham designs and efficacy outcomes, or between the sham types and dropout rate. No solid conclusion of which design is the most appropriate sham control of EAP could be drawn in this review.

Background: Quality acupuncture influences the outcomes of clinical research, and issues associated with effective administration of acupuncture in randomized controlled trials need to be addressed when appraising studies. Objective: The study objective was to achieve consensus on domains and items for inclusion in a rating scale to assess quality acupuncture administered in clinical research. Study design and subjects: An active group of Australian acupuncture researchers initially identified a pool of items assessing quality. The Delphi consensus process was then used to select and reduce the number of items, and an additional expert panel of 42 researchers were invited to participate. Participants initially ranked items along a five-point scale for the first Delphi round, and indicated an agree or disagree response during the second round. For an item to be retained into the second round, an item had to attain greater than 80% agreement that the item described a dimension of quality acupuncture and related study design. Results: Thirty-two (32) experts agreed to participate in the study. After two rounds of the Delphi process, consensus was reached on 14 domains and 26 items relating to quality acupuncture. Domains, items, and minimum standards related to study design; rationale of the intervention; criteria relating to needling stimulation either manual or electrostimulation; duration and frequency of treatment; and practitioner training. Conclusions: Items for inclusion in an instrument to assess quality acupuncture in clinical research were identified. Further development of the instrument including relative weighting of items and reliability testing is under way. © 2011, Mary Ann Liebert, Inc.

IntroductionSpasticity is a common complication of stroke. Current therapies for poststroke spasticity (PSS) have been reported to be associated with high costs, lack of long-term benefit and unwanted adverse events (AEs). Electroacupuncture (EA) has been used for PSS, however, its efficacy and safety is yet to be confirmed by high-quality clinical studies. This study is designed to evaluate the add-on effects and safety profile of EA when used in combination with usual care (UC).Methods and analysisThis study is a parallel group randomised controlled trial. A total of 136 participants will be included and randomly assigned to either the treatment group (EA plus UC) or the control group (UC alone). Prior to the main trial, a pilot study involving 30 participants will be conducted to assess the feasibility of the trial protocol. EA will be administered by registered acupuncturists for 20min to 30 min, three times per week for 4 weeks. The primary outcome measure (Modified Ashworth Scale) and secondary outcome measures (Fugl-Meyer Assessment and Barthel Index) will be evaluated at baseline, the end of treatment (week 4) and the end of follow-up (week 8). AEs will be monitored, recorded and reported, and their causality will be explored.Ethics and disseminationEthics approval was obtained from the ethics committees of Guangdong Provincial Hospital of Chinese Medicine and RMIT University in December 2016. The results will be disseminated in a peer-reviewed journal, and PhD theses and might be presented at international conferences.Trial registration numberChiCTR-IOR-16010283; Pre-results.

Objective To evaluate the effects and safety of electroacupuncture (EA) for stroke patients with spasticity. Data Sources Five English databases (PubMed, EMBASE, CINAHL, Cochrane Central Register of Controlled Trials, Allied and Complementary Medicine Database) and 4 Chinese databases (Chinese Biomedical Database, Chinese National Knowledge Infrastructure, Chongqing VIP Database, Wanfang Database) were searched from their inception to September 2016. Study Selection Randomized controlled trials were included if they measured spasticity with the Modified Ashworth Scale (MAS) in stroke patients and investigated the add-on effects of electroacupuncture to routine pharmacotherapy and rehabilitation therapies. Data Extraction Information on patients, study design, treatment details and outcomes assessing spasticity severity, motor function, and activities of daily living was extracted. Data Synthesis In total, 22 trials involving 1425 participants met the search criteria and were included. The estimated add-on effects of EA to reduce spasticity in the upper limbs as measured by the MAS (standardized mean difference [SMD]=−.57; 95% confidence interval [CI], −.84 to −.29), and to improve overall motor function as measured by the Fugl-Meyer Assessment of Sensorimotor Recovery (mean difference [MD]=10.60; 95% CI, 8.67–12.53) were significant. Significant add-on effects of EA were also shown for spasticity in the lower limbs, lower-limb motor function, and activities of daily living ([SMD=−.88; 95% CI, −1.42 to −.35;], [MD=4.42; 95% CI, .06–8.78], and [MD=6.85; 95% CI, 3.64–10.05], respectively), although with high heterogeneity. For upper-limb motor function, no significant add-on effects of EA were found. Conclusions EA combined with conventional routine care has the potential of reducing spasticity in the upper and lower limbs and improving overall and lower extremity motor function and activities of daily living for patients with spasticity, within 180 days poststroke. Further studies of high methodological and reporting quality are needed to confirm the effects and safety of EA, and to explore the adequate and optimal protocol of EA for poststroke spasticity, incorporating a group of comprehensive outcome measures in different populations.

This systematic review aimed to assess the effectiveness and safety of herbal medicines (HM) for treating dementia. Databases in English and Chinese were searched from their inceptions to February 2007. References in reviews and randomized controlled trials (RCTs) were screened by hand. Trials comparing orally administered HM with placebo, no intervention or other therapy were considered. Trials on Ginkgo biloba and its extracts were excluded to avoid duplication of existing reviews. Pairs of authors independently applied eligibility criteria, extracted data and assessed methodological quality using the Jadad Scale. Thirteen RCTs met the inclusion criteria of three or above on this scale. Six trials compared herbal medicine with placebo, one with no treatment, and the remainder with pharmaceutical intervention. Meta-analyses were performed on common cognitive performance outcome measures. All studies reported HM had significant effects in improving symptoms. In studies that employed active controls, HM was at least as effective as the pharmaceutical intervention. Meta-analyses found HM more effective than no treatment or placebo and at least equivalent to control interventions, although the overall effect was small. No severe adverse events were reported. These trials provide overall positive evidence for the effectiveness and safety of certain HMs for dementia management. Refereed/Peer-reviewed

Objective Acupuncture is widely used in Asia and increasingly in Western countries. We performed a systematic review and meta-analysis to examine the effects of acupuncture for insomnia. Methods We identified randomized controlled trials from English and Chinese databases. Data were extracted using a predefined form and analysed using RevMan 5.2. We included studies that compared acupuncture to sham/placebo, standard pharmacotherapy or cognitive behavioral therapy. Risk of bias was assessed using the Cochrane risk of bias tool. The primary outcome was sleep quality assessed by the Pittsburgh Sleep Quality Index (PSQI). Results A total of 30 studies involving 2363 participants were included. Acupuncture point combinations included the use of at least one of the recommended points for insomnia, HT7, GV20, SP6. Pharmacotherapy control was used in 27 studies and sham/placebo in three studies. Cognitive behavioral therapy was not used in any of the studies. Pharmacotherapies in all studies were benzodiazepine receptor agonists, except for one that used an antidepressant. Acupuncture was superior to sham/placebo in terms of PSQI (MD −0.79, 95% CI −1.38, −0.19, I 2 =49%). Acupuncture was also more effective than pharmacotherapy (MD −2.76, 95% CI −3.67, −1.85, I 2 =94%). Most studies were at risk of bias. Some mild adverse events were reported but they were not causally related to the acupuncture treatments. Conclusions Acupuncture compared to sham/placebo and pharmacotherapy showed statistically significant results. However, the evidence is limited by bias in the included studies and heterogeneity. Well-designed studies are needed to confirm the results identified in this review.

Objective To systematically evaluate the efficacy and safety of Buzhong Yiqi Tang (BZYQT) for stable chronic obstructive pulmonary disease (COPD). Methods Three electronic English databases (PubMed, EMBASE and CENTRAL) and four Chinese databases (CBM, CNKI, CQVIP and WFMO) were searched from their inceptions until 30th June 2016. Participants were diagnosed with COPD according to the Chinese Medical Association's COPD diagnosis and treatment guidelines or Global Initiative for Chronic Obstructive Lung Disease (GOLD), and were in stable stage. Randomized controlled trials (RCTs) of oral BZYQT, alone or combined with conventional treatment, compared with conventional treatment alone or plus placebo were included in the review. Clinical improvement and the six-minute walking test (6MWT) were the primary outcome measures. The secondary outcome measures were defined as forced expiratory volume in one second (FEV1), forced vital capacity (FVC), respiratory muscle strength index with maximum inspiratory pressure (MIP), COPD Assessment Test (CAT), and frequency of acute exacerbations. To assess risk of bias the Cochrane, Risk of Bias tool was used, and statistical analysis was performed using RevMan 5.3.0 software. Results Sixteen studies (1400 participants) were included. The results of meta-analysis indicated patients receiving BZYQT alone or BZYQT in combination with conventional treatment showed a significant increase in clinical improvement (RR 1.25, 95% CI 1.18 to 1.33, I 2 =0%), enhanced exercise capacity 6MWT (MD 51.22m, 95% CI 45.56 to 56.89, I 2 =44%), improved lung function FVC (L) (MD 0.26 liters, 95% CI 0.18 to 0.33, I 2 =37%), reduced respiratory muscle fatigue MIP (MD 0.46 liters, 95% CI 0.11 to 0.80, I 2 =0%), and improved quality of life CAT (MD −2.56 points, 95% CI −3.40 to −1.72, I 2 =0%) when compared with conventional treatment alone, or plus placebo. BZYQT also showed small but significant improvements in FEV1% and decreased acute exacerbations of COPD. Four studies reported that no adverse events occurred, other studies did not mention adverse events. The finding should be considered with caution because the included studies had methodological shortfalls. Conclusions BZYQT improves clinically important outcomes for patients with stable COPD, such as improved clinical symptoms, exercise capacity, lung function and quality of life. Moreover, it has an excellent safety profile. However further evaluation is needed to validate these preliminary findings in high quality RCTs.

Background Atopic eczema or atopic dermatitis is a chronic inflammatory skin disease. Current conventional medical treatment for moderate and severe atopic eczema is not satisfactory. There is promising evidence derived from randomised clinical trials to support the clinical use of Chinese herbal medicine in the management of atopic eczema. However, the available evidence is compromised by the high risk of bias associated with most of the included trials. Therefore, well-designed and adequately powered randomised clinical trials are needed. The primary aim of this trial is to evaluate the efficacy and safety of oral ingestion of an oral Chinese herbal formula (Pei Tu Qing Xin granules; PTQX) in children aged between 6 and 16 years with moderate to severe atopic eczema. Methods/Design We have designed a randomised, double-blind, placebo-controlled, two-arm, parallel clinical trial with 12 weeks of treatment and a 4-week follow-up period. A pilot study with 30 participants will be conducted at the RMIT University in Australia to determine the feasibility of the full-scale randomised clinical trial (N = 124). Eczema Area and Severity Index score will be the primary outcome. Secondary outcome measures include change in symptoms using the Patient-Oriented Eczema Measure, the Children’s Dermatology Life Quality Index and the use of concomitant medicines. Safety parameters include report of adverse events and pathology tests during the trial period. Discussion Key elements for conducting a high-quality randomised clinical trial have been addressed in this protocol. Findings from the proposed trial will provide critical evidence regarding Chinese herbal medicine treatment for atopic eczema. Trial registration Australian New Zealand Clinical Trials Registry Identifier: ACTRN12614001172695. Date of Registration: 7 November 2014.