Baduanjin Mind-Body Exercise for Cancer-Related Fatigue: Protocol for a Remotely Delivered Randomized Wait-List Controlled Feasibility Study.

BACKGROUND: People living with a cancer diagnosis often experience cancer-related fatigue (CRF). Between 9% and 45% of people report CRF as moderate to severe, negatively impacting their quality-of-life (QOL). The evidence-base for managing CRF recommends exercise-related therapies over pharmaceutical interventions. One such exercise-like therapy is Baduanjin mind-body exercise (MBE), which has additional benefits. A remotely delivered program may further benefit people with CRF. The primary objective of this pilot will test study feasibility of a remotely delivered Baduanjin MBE exercise program for people living with CRF. METHODS: This is a randomized wait-list controlled pilot study and will take place in Sydney, Australia. Subject to informed consent, 40 adults with moderate CRF levels and receiving or previously received adjuvant chemotherapy, will undertake a home-based 8-week Baduanjin MBE program supported by online resources and instructors. The primary feasibility outcomes are recruitment, enrollment, retention, and adherence rates; and safety as measured by tolerance and adverse-event frequency. Clinical outcomes (eg, changes in CRF, QOL, and participant perceptions) are assessed at pre-intervention, week 1, week 4, week 8, and post-intervention. Analyses follows the Intent-to-Treat (all participants as per randomization) and per-protocol (participants adhering to the protocol). Missing data will be imputed from previous data entries and regression models may be tested to predict missing outcomes. DISCUSSION: To our knowledge, this is the first study evaluating the feasibility and effects of Baduanjin MBE on CRF using a remote delivery method. These feasibility data will inform a fully powered future trial investigating evidence of effect on CRF and QOL.Trial registration: Australian and New Zealand Clinical Trials Registry (ANZCTR 12623000177651).Ringgold ID: 651498 Chinese Medicine Centre.

Are Published Cancer Care Trial Protocols With Traditional Chinese Medicine Interventions Concordant With SPIRIT-TCM Extension 2018? A Scoping Review on Published Trial Protocols Between 2019 and 2022.

BACKGROUND: The SPIRIT-TCM Extension 2018 was created to guide the design and reporting of Traditional Chinese Medicine (TCM) clinical trial protocols. This study aims to investigate the extent of concordance with this guideline in the relevant field of cancer care research. METHODS: A scoping review of TCM cancer trial protocols published in English and Chinese since January 2019 was conducted. Five major academic databases (MEDLINE, EMBASE, CINAHL, CENTRAL, and China National Knowledge Infrastructure) were searched. Concordance with the SPIRIT-TCM Extension 2018 was assessed by descriptive analysis. RESULTS: Fifty-three TCM cancer care trial protocols were identified, comprising 23 acupuncture, 26 Chinese herbal medicine (CHM), and 4 Tai Chi/Qigong (TCQ) interventions. The majority of the checklist items had a low rate of concordance, especially in the reporting of quality control and safety, dosage, TCM diagnostic patterns, possible interactions between Western Medicine and TCM interventions, and TCM-related outcome assessments. CONCLUSIONS: Although the SPIRIT-TCM Extension 2018 guideline was established through extensive Delphi consultation, there are low rates of concordance between published TCM cancer care clinical trial protocols with the guideline. Further research is necessary to understand the low rate of concordance and how scientific rigors of reporting can be improved in TCM cancer care research.

Perceptions of Australian Palliative Medicine Specialists Toward Acupuncture for Palliative Care.

Background: With increasing multidisciplinary care strategies, palliative medicine practitioner perceptions toward acupuncture integration are significant. Objective: To evaluate acupuncture availability and acceptability in Australian palliative care. Outcomes: (1) Domains of the survey included participant characteristics, (2) workplace availability, (3) personal attitudes, and (4) recommendation likelihood. Design: An online REDCap survey of Australian palliative medicine practitioners was administered. Results: Acupuncture was mostly not available/permitted at workplaces (45.2%) due to cost/funding (57.1%) and limited evidence (57.1%). When available by workplace (24.2%) or affiliated service (4.8%), doctors mostly administered acupuncture (66.7%). Respondents were not up to date with current research (71.4%). Referral likelihood increased with confidence in provider (80.0%), workplace availability (77.1%), and patient prior/current use (77.1%). Patient acupuncture discussions were rare (62.9%) with barriers of effectiveness uncertainty (71.4%) and limited knowledge of availability (57.1%). Conclusion: Despite available integrative services and acceptability by Australian palliative medicine practitioners, utilization is low. Further research into acupuncture effectiveness for palliative symptoms, feasibility, and patient acceptability is required.

Effects of Electroacupuncture on the Correlation between Serum and Central Immunity in AD Model Animals.

Objective: The goal was to investigate the connection between neuroinflammation in the brain and serum inflammatory markers as Alzheimer's disease progressed. We also sought to determine whether electroacupuncture had an effect on inflammatory markers found in blood and other brain regions. Methods: As an animal model for AD, we used senescence-accelerated mouse prone 8 (SAMP8) mice. To examine the effects and probable mechanism of electroacupuncture, we used HE staining, immunofluorescence staining, western blotting, and enzyme-linked immunosorbent assay. Results: Electroacupuncture therapy protected neurons, significantly downregulated the Iba-1 level in the hippocampus (p value was 0.003), frontal lobe cortex (p value was 0.042), and temporal lobe cortex (p value was 0.013) of the AD animal model, all of which had significantly lower levels of IL-6 (p value was 0.001), IL-1ß (p value was 0.001), and TNF-α (p value was 0.001) in their serum. Conclusion: The amounts of IL-6, IL-1ß, and TNF-α detected in the serum were strongly linked to the levels discovered in the hippocampus and the frontal lobes of the brain, respectively. A better understanding of the electroacupuncture process as well as the course of Alzheimer's disease and the therapeutic benefits of electroacupuncture may be gained by using biomarkers such as serum inflammatory marker biomarkers.

Interactions Between Natural Products and Tamoxifen in Breast Cancer: A Comprehensive Literature Review.

Introduction: Tamoxifen (TAM) is the most commonly used hormone therapeutic drug for the treatment of estrogen receptor-positive (ER+) breast cancer. 30%-70% of clinical breast cancer patients use natural products, which may increase the likelihood of drug interactions. Objective: To evaluate the evidence for the interactions between natural products and TAM in breast cancer. Methods: Electronic databases, including PubMed, CINAHL Plus (via EbscoHost), European PMC, Medline, and Google Scholar, were searched for relevant publications. The search terms include complementary and alternative medicine, natural products, plant products, herbs, interactions, tamoxifen, breast cancer, and their combinations. Results: Various in vitro and in vivo studies demonstrated that the combined use of natural products with TAM produced synergistic anti-cancer effects, including improved inhibition of tumor cell growth and TAM sensitivity and reduced side effects or toxicity of TAM. In contrast, some natural products, including Angelica sinensis (Oliv.) Diels [Apiaceae], Paeonia lactiflora Pall., Rehmannia glutinosa (Gaertn.) DC., Astragalus mongholicus Bunge, and Glycyrrhiza glabra L. [Fabaceae], showed estrogen-like activity, which may reduce the anti-cancer effect of TAM. Some natural products, including morin, silybin, epigallocatechin gallate (EGCG), myricetin, baicalein, curcumin, kaempferol, or quercetin, were found to increase the bioavailability of TAM and its metabolites in vivo. However, three are limited clinical studies on the combination of natural products and TAM. Conclusion: There is evidence for potential interactions of various natural products with TAM in pre-clinical studies, although the relevant clinical evidence is still lacking. Further studies are warranted to evaluate the potential interactions of natural products with TAM in clinical settings.

Zao Ren An Shen capsule for insomnia: a double-blind, randomized, placebo-controlled trial.

STUDY OBJECTIVES: The aim of this study was to test the efficacy and safety of Zao Ren An Shen (ZRAS) capsule, a Chinese herbal medicine product, for the treatment of insomnia. METHODS: We conducted a double-blind randomized placebo-controlled trial. After a one-week placebo run-in, a total of 85 people with insomnia were randomly allocated to receive ZRAS or placebo for 4 weeks. The primary outcomes were insomnia severity assessed with the Insomnia Severity Index (ISI) and the number of participants with adverse events (AEs). Secondary outcomes included objective and subjective sleep parameters, psychological status, fatigue level, quality of life, acceptability, and tolerability. RESULTS: A nonsignificant (p > .05) difference of 0.7 points in ISI in favor of ZRAS capsule was found at the end of the treatment. The number of participants with AEs was not significantly different (p > .05) between the two groups. Except for subjective sleep onset latency, which had a nonsignificant (p > .05) medium effect (Cohen's d = 0.5), the effects in secondary efficacy outcomes were all small (Cohen's d < .4) and nonsignificant (p > .05). The acceptability and tolerability were high in the active group. CONCLUSIONS: ZRAS capsule is safe, acceptable, and tolerable, yet not more effective than placebo in the treatment of insomnia. As previous evidence showed that Chinese herbal medicine was effective for insomnia, these results may be explained by the dose of the product, which was lower than the dose generally used in the clinic.Registration: This clinical trial was registered in Australia New Zealand Clinical Trial Registry (registration number ACTRN12619000140156) under the name "Impact of Zao Ren An Shen (ZRAS) capsule on chronic insomnia patients' insomnia severity: A randomized-controlled trial" (https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376730&isReview=true).

Manual Acupuncture Plus Usual Care Versus Usual Care Alone in the Treatment of Endometriosis-Related Chronic Pelvic Pain: A Randomized Controlled Feasibility Study.

Objective: To determine the acceptability and feasibility of acupuncture for the treatment of endometriosis-related chronic pelvic pain. Design: A prospective, randomized controlled feasibility study. Setting: Outpatient setting in Sydney, Australia. Subjects: Participants who were aged 18-45 years, had a confirmed laparoscopic diagnosis of endometriosis in the past 5 years, and had regular menstrual periods and mean pelvic pain scores ≥4/10. Interventions: Sixteen acupuncture treatments delivered by registered acupuncturists using a standardized point protocol over 8 weeks, twice per week plus usual care compared with usual care alone. Outcome measures: Primary outcome measures were feasibility, safety, and acceptability of the acupuncture intervention. Secondary outcomes were changes in self-reported pelvic pain scores, changes in quality of life as measured by the Endometriosis Health Profile (EHP-30), changes in descending pain modulation, and changes in systemic inflammation (plasma interleukin [IL-6] concentrations). Results: Twenty-nine participants were eligible to participate, with 19 participants completing the trial. There was unequal withdrawals between groups; the acupuncture group had a withdrawal rate of 14% compared with 53% in usual care. Adverse events were uncommon (6.7%) and generally mild. A 1.9 point decrease in median nonmenstrual pain scores and a 2.0 decrease in median menstrual pain scores between baseline and end of trial were observed in the acupuncture group only. Improvements in all domains of the EHP-30 were seen in the acupuncture group, with no changes seen in usual care. There was no difference between baseline and end of treatment in IL-6 concentrations for either group. Conclusions: Acupuncture was an acceptable, well-tolerated treatment and it may reduce pelvic pain and improve quality of life; however, usual care was not an acceptable control group. Trial Registration: anzctr.org.au: ACTRN12617000053325. Prospectively registered January 11, 2017.

RIGHT for acupuncture: An extension of the RIGHT statement for clinical practice guidelines on acupuncture.

OBJECTIVE: In 2017, the International Standard for Reporting Items for practice Guideline in HealThcare (RIGHT) published reporting guidelines to enhance transparency and clarity in the process of developing clinical practice guidelines (CPGs). Given the original tool was developed in 2017 and demanded in developing and reporting high quality of acupuncture CPGs, an extension with a focus on a specific reporting checklist was warranted. STUDY DESIGN AND SETTING: The study was designed based on the methodology recommended by the Enhancing the Quality and Transparency Of Health Research (EQUATOR) Network with modification accordingly. A reporting checklist and its elaboration and explanations for users were developed. RESULTS: A checklist of seven sections (Basic information, Background, Evidence, Recommendations, Funding, Declaration and management of interest, Other information), twenty-three first level items and forty-three second level items was developed. We clarified the rationales of the items and provided explanations and examples of each item for additional guidance. CONCLUSION: The RIGHT for Acupuncture checklist identifies a set of items to be reported when reviewing clinical practice guidelines on acupuncture. This extension can be expected to improve the reporting quality of CPGs on acupuncture.

Exploring the Safety, Effectiveness, and Cost-Effectiveness of a Chinese Patent Medicine (Fufang E'jiao Syrup) for Alleviating Cancer-Related Fatigue: A Protocol for a Randomized, Double-Blinded, Placebo-Controlled, Multicenter Trial.

OBJECTIVE: To provide higher level evidence on the benefits of a Chinese patent medicine (CPM) (Fufang E'jiao Syrup, FFEJS) for alleviating cancer-related fatigue (CRF), this article describes a protocol for a randomized controlled trial. METHODS/DESIGN: We designed a double-blind, placebo-controlled stratified permuted block randomization clinical trial on CRF among 3 types of cancer in China. Participants will be equally allocated to FFEJS group or placebo group according to the randomization sequence and the hospitals they were enrolled at. Each patient will receive 20 ml of either the study formula FFEJS or a placebo formula, 3 times a day for 6 weeks. The follow-up period will be another 4 weeks for safety evaluation. The primary outcome is the difference in improvement of fatigue as measured with the Revised Piper Fatigue Scale-Chinese Version (RPFS-CV). Secondary outcomes include change in fatigue (measured by routine blood panel and hormones in peripheral blood) and QoL (measured by Edmonton symptom assessment scale and Functional Assessment of Cancer Therapy). Patient safety will be measured by liver, renal or cardiac damage, and the risk of FFEJS having a tumor promotion and progression effect will be monitored throughout this study. Cost-effectiveness will also be evaluated mainly by incremental cost per each quality-adjusted life year gained. DISCUSSION: This article describes the study design of a CPM for CRF in patients with advanced cancer through exploring the effectiveness, safety, and cost-effectiveness of FFEJS. TRIAL REGISTRATION: ClinicalTrials.gov, NCT04147312. Registered on 1 Sep 2019.

Drug-herb interactions between Scutellaria baicalensis and pharmaceutical drugs: Insights from experimental studies, mechanistic actions to clinical applications.

Whilst the popular use of herbal medicine globally, it poses challenges in managing potential drug-herb interaction. There are two folds of the drug-herb interaction, a beneficial interaction that may improve therapeutic outcome and minimise the toxicity of drug desirably; by contrast, negative interaction may evoke unwanted clinical consequences, especially with drugs of narrow therapeutic index. Scutellaria baicalensis Georgi is one of the most popular medicinal plants used in Asian countries. It has been widely used for treating various diseases and conditions such as cancer, diabetes, inflammation, and oxidative stress. Studies on its extract and bioactive compounds have shown pharmacodynamic and pharmacokinetic interactions with a wide range of pharmaceutical drugs as evidenced by plenty of in vitro, in vivo and clinical studies. Notably, S. baicalensis and its bioactives including baicalein, baicalin and wogonin exhibited synergistic interactions with many pharmaceutical drugs to enhance their efficacy, reduce toxicity or overcome drug resistance to combat complex diseases such as cancer, diabetes and infectious diseases. On the other hand, S. baicalensis and its bioactives also affected the pharmacokinetic profile of many drugs in absorption, distribution, metabolism and elimination via the regulatory actions of the efflux pumps and cytochrome P450 enzymes. This review provides comprehensive references of the observed pharmacodynamic and pharmacokinetic drug interactions of Scutellaria baicalensis and its bioactives. We have elucidated the interaction with detailed mechanistic actions, identified the knowledge gaps for future research and potential clinical implications. Such knowledge is important for the practice of both conventional and complementary medicines, and it is essential to ensure the safe use of related herbal medicines. The review may be of great interest to practitioners, consumers, clinicians who require comprehensive information on the possible drug interactions with S. baicalensis and its bioactives.

Acupuncture for Cancer Related Pain: Protocol for a Pragmatic Randomised Wait-List Controlled Trial.

BACKGROUND: Acupuncture has been proved effective for cancer related pain (CRP) in China, America and some other countries. However, there is relative lack of evidence to support the use of acupuncture for CRP in Australia. OBJECTIVES: To assess the effectiveness and safety of acupuncture for management of CRP in a real-world setting and to understand cancer patients' experience of undergoing acupuncture for CRP. METHODS: A pragmatic randomised controlled trial will be conducted in South Western Sydney Local Health District (SWSLHD) in NSW, Australia. Adults with cancer related pain (n = 106) will be randomised in a 1:1 ratio to receive the acupuncture intervention up front versus after a wait list period of 4 weeks. Pain level (by Numerical Rating Scale), analgesic use, auricular acupressure frequency and adverse events will be assessed at baseline, mid-treatment and post-treatment. Expectancy on trial outcome (by Credibility and Expectancy questionnaire) will be assessed at baseline. The perspective of the participants (by an interview) will be recorded after the last intervention. EXPECTED OUTCOMES: We hypothesise that acupuncture will relieve cancer related pain at mid-treatment and post-treatment. We also hypothesise that few adverse events will be provoked by acupuncture. TRIAL REGISTRATION: Australia New-Zealand Clinical Trial Registry (ACTRN12620000325909).

Effects of Nonpharmacological Interventions in Chemotherapy-Induced Peripheral Neuropathy: An Overview of Systematic Reviews and Meta-Analyses.

INTRODUCTION: Chemotherapy-induced peripheral neuropathy (CIPN) is one of the prevalent and disabling side effects of cancer treatment. However, management strategies for CIPN currently remain elusive, with treatment restricted to neuropathic pain medications, supportive care, and chemotherapy dosing adjustments. This overview explores evidence on the potential benefits and safety of nonpharmacological interventions in preventing and treating CIPN in cancer patients. METHODS: Seven databases were searched for systematic reviews of randomized controlled trials (RCTs). The methodological quality of the selected reviews was assessed by AMSTAR 2, and the quality of evidence was judged by GRADE. Twenty-eight systematic reviews were considered eligible for this review. RESULTS: It was found that nonpharmacological interventions (acupuncture, exercise, herbal medicine, nutritional supplements) provided potential benefits for patients with CIPN. Furthermore, Chinese herbal medicine, administered orally or externally, significantly prevented and/or relieved the incidence and severity of CIPN in comparison to control groups (no additional treatment, placebo, and conventional western medicine). However, the quality of evidence and strength of recommendations were compromised by the inconsistencies and imprecision of included studies. The main concerns regarding the quality of systematic reviews included the lack of sufficiently rigorous a priori protocols, and the lack of protocol registration adopted in the included studies. CONCLUSIONS: Though looking across reviews, Chinese herbal medicine appear generally effective in CIPN, uncertainty remains about the effects of many other nonpharmacological interventions. The evidence on what works was particularly compromised by reporting and methodological limitations, which requires further investigation to be more certain of their effects.

Zao Ren An Shen for insomnia: a systematic review with meta-analysis.

OBJECTIVE: To assess the effectiveness and safety of Zao Ren An Shen (ZRAS), a Chinese herbal medicine formula, for the treatment of insomnia. METHODS: Seven databases (ie, EMBASE, PubMed, the Cochrane library, and PsycINFO, Chinese National Knowledge Infrastructure, Wanfang and Chongqing VIP) were searched from their inception to 6 November 2018. Controlled trials comparing the effectiveness or safety of ZRAS to conventional treatments, a placebo or no-treatment in an insomnia population were selected. Primary outcomes were: sleep quality (assessed with the Pittsburgh Sleep Quality Index, PSQI), and the number of adverse events at post-treatment. The risk of bias was assessed with the Cochrane Collaboration's tool and meta-analyses were performed using RevMan 5.3. RESULTS: A total of 19 studies (1780 participants) were included. The effect of ZRAS on sleep quality (mean difference) was found to be superior compared to placebo in the sole placebo-controlled study located [-0.90 (-1.56, -0.24; 95% CI), p = 0.007] and similar to Benzodiazepine Receptor Agonists (BzRAs) [0.17 (-0.29, 0.64); 95% CI, p = 0.46]. The number of adverse events (relative risk) was lower for ZRAS than BzRAs [0.16 (0.12, 0.23; 95% CI), p < 0.001]. An overall high risk of bias was found in the selected studies. CONCLUSIONS: The results favor ZRAS against BzRAs and placebo for the treatment of insomnia. However, the poor methodology of the studies prevents strong recommendations for ZRAS. Clinical trials with higher quality designs are required.

Efficacy and safety of Jianpishengsui for chemotherapy-related fatigue in patients with non-small cell lung cancer: study protocol for a randomized placebo-controlled clinical trial.

BACKGROUND: Chemotherapy-related fatigue (CRF) is a common symptom in non-small cell lung cancer (NSCLC) patients. A Chinese herbal formula cream for oral application, called Jianpishengsui (JPSS), is extensively used in the First Affiliated Hospital of Guangzhou University of Chinese Medicine as an internal preparation for CRF and is associated with a promising response. Due to the lack of high-quality clinical evidence, a randomized placebo-controlled trial is required to assess the efficacy and safety of JPSS. METHODS/DESIGN: The efficacy and safety of JPSS herbal formula cream will be evaluated through a prospective, randomized, placebo-controlled trial conducted in the First Affiliated Hospital of Guangzhou University of Chinese Medicine. NSCLC patients with CRF will be randomized into two groups at a ratio of 1:1. Each group will receive either 15 g of the oral JPSS herbal formula cream or placebo twice a day from day 6 to day 20 during two courses of paclitaxel + platinum/docetaxel + platinum/pemetrexed + platinum (TP/DP/AP) chemotherapy. The primary endpoint is the difference in the degree of fatigue between baseline (the day before the start of the intervention) and day 42, which will be assessed by the Revised Piper Fatigue Scale score. The secondary endpoints are quality of life (measured by the 43-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer C43), Eastern Cooperative Oncology Group Performance Status, and Traditional Chinese Medicine syndrome score. The toxicity of the treatments will also be evaluated at the same time. All outcomes will be measured at baseline, day 6, day 21, and day 42 of the treatment. DISCUSSION: This randomized trial will investigate the efficacy and safety of JPSS applied for CRF in patients with NSCLC. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1900023451. Registered on 28 May 2019.

Modified Liujunzi Decoction () Alleviates Chemotherapy-Induced Anorexia in Advanced Non-Small Cell Lung Cancer: A Propensity Score Matched Case-Control Study.

OBJECTIVE: To evaluate the effect of Chinese herbal medicine formula, modified Liujunzi Decoction (, MLJZT), for anorexia, utilized as adjunct therapy during chemotherapy treatment for patients with advanced non-small cell lung cancer (NSCLC). METHODS: The study adopted a propensity score-matched design based on a prospective database. From February 2016 to September 2017, patients with advanced NSCLC that received both cisplatin-based chemotherapy and MLJZT (IM group) were 1:1 propensity score-matched to patients that received the cisplatin-based chemotherapy alone (control group). Changes in anorexia and weight, as well as side effects were evaluated per week within 4-cycle chemotherapy. RESULTS: Overall, 156 patients with advanced NSCLC that had received chemotherapy from our database were identified and 53 pairs were matched successfully. In total, 48.6% (50/53) of patients in the IM group had anorexia-improvement compared to 28.3% (15/53) of patients in the control group, and a total of 39.6% (21/53) of patients in the control group had a worsening of anorexia compared to only 7.8% (8/53) of patients in the IM group (P<0.01). The weight reduced significantly over time in the control group (-2.36 ± 2.53 kg) as compared to the IM group (-0.62 ± 3.89 kg, P<0.01). CHM didn't reduce the efficacy of chemotherapy in shrinking tumor size, and didn't increase the incidence of side effects such as hematological and hepatorenal toxicity. CONCLUSION: MLJZT is effective and safe for alleviating anorexia in patients with NSCLC. These findings warrant the conduct of a randomized controlled trial.

Zao Ren An Shen capsule for chronic insomnia: Study protocol for a randomized, placebo-controlled trial.

BACKGROUND: Zao Ren An Shen (ZRAS), a Chinese Herbal Medicine product, has been proposed as an alternative to recommended treatments for chronic insomnia. There is a lack of strong evidence supporting this proposition. AIMS: To assess the efficacy and safety of ZRAS capsule for chronic insomnia compared to placebo. METHODS: A parallel-group, double-blind, randomized-controlled trial will be performed in Western Sydney University, Australia. After a 1-week placebo run-in, adults with chronic insomnia (n = 90) will be randomized in a 1:1 ratio to receive either ZRAS capsule or placebo for 4 weeks. Insomnia severity (Insomnia Severity Scale score), sleep parameters (measured with the Consensus Sleep Diary and actigraphy), fatigue levels (Fatigue Severity Scale score), psychological status (Depression Anxiety Stress Scale score), quality of life (Assessment of Quality of Life score), and adverse events will be assessed at baseline, mid-treatment, post-treatment and at a 1-month follow-up. EXPECTED OUTCOMES: We hypothesize that ZRAS capsule will improve insomnia severity, sleep parameters, fatigue levels, psychological status, and quality of life better than placebo at mid-treatment, post-treatment, and follow-up. We also hypothesize that the number of adverse events provoked by ZRAS capsule will be similar to placebo at these time-points. TRIAL REGISTRATION: Australia New-Zealand Clinical Trial Registry (Registration number ACTRN12619000140156).

Traditional Chinese medicine for management of recurrent and refractory Crohn disease: A case report.

INTRODUCTION: Crohn disease (CD) is a chronic relapsing systemic inflammatory disease afflicting the gastrointestinal system with a high morbidity. There has been increasing clinical interest in traditional Chinese medicine (TCM) treatment for CD. This report aims to present patient outcome of therapeutic management using TCM in combination with pharmacologic therapy. PATIENT CONCERNS: A 53-year-old woman with a more than 23-year history of chronic indigestion, reflux, abdominal pain, and excessive diarrhea, and a more than 21-year history of recurrent refractory CD. The condition had been managed for 21 years with ongoing pharmacologic therapy, and surgical intervention; however, with poor therapeutic effect. DIAGNOSIS: In this study, the diagnosis of CD was based on integrating patient symptoms and radiologic findings and biopsy results. The patient had no differential diagnosis. INTERVENTIONS: The patient received acupuncture treatment at an approximate frequency of once per week for a total of 21 sessions until November 5, 2018. The patient also received Chinese herbal medicine (CHM) on an as-needed basis to manage her symptoms. OUTCOMES: Patient reported symptoms of chronic indigestion, reflux, abdominal pain, and excessive diarrhea were substantially improved by combined TCM and pharmacologic therapy intervention, while the dosage of her medication was reduced. CONCLUSION: Following acupuncture treatment, improvements of subjective symptoms: chronic indigestion, reflux, abdominal pain, and excessive diarrhea, were observed. CHM provided immediate relief of indigestion, reflux, and abdominal pain. TCM may be a potential therapeutic strategy to manage clinical symptoms of CD, if this is proven useful in future RCT studies.

Investigation on Advanced Non-Small-Cell Lung Cancer among Elderly Patients Treated with Chinese Herbal Medicine versus Chemotherapy: A Pooled Analysis of Individual Data.

PURPOSE: Many patients with advanced non-small-cell lung cancer (NSCLC) seek help from Chinese herbal medicine (CHM). The purpose of this study was to investigate the survival between CHM and chemotherapy (CT) treatment of patients aged ≥60 years with advanced Epidermal Growth Factor Receptor (EGFR) wild type NSCLC and Karnofsky Performance Status (KPS) ≥ 60. METHODS: We extracted individual data of all eligible patients from 1 randomized control trial and 2 cohort studies and performed a pooled analysis. Survival outcomes of patients were compared between CHM group and CT group using Cox regression model stratified for study. RESULTS: A total of 486 patients were included in the study, including 262 patients in the CHM group and 224 patients in the CT group. The median overall survival time was 10.9 (95% confidence intervals [CI]: 8.9-13.0) months in CHM group and 9.8 (95% CI: 8.1-11.5) days in CT group (p=0.592). The adjusted hazard ratio (HR) and 95% CI for CHM compared to CT are 0.98 (0.87, 1.10, p=0.751) in the stratified Cox regression model. Stratified analysis showed a trend that previously treated elderly patients with EGFR wild type advanced NSCLC probably gain greater survival benefit from CHM (adjusted HR:0.83, 95% CI: 0.68-1.01, p=0.063). CONCLUSIONS: There might be no significant difference in survival for elderly patients with advanced EGFR wild type NSCLC between the CHM and CT groups in the current study. And previously treated elderly patients with advanced NSCLC probably receive greater benefit from CHM. However, limited by the design and unpreplanned study hypothesis, the results must be confirmed by randomized control trial before making a conclusion.

Clinical massage therapy for patients with cancer-related fatigue protocol of a systematic review.

BACKGROUND: Cancer-related fatigue (CRF) is a prevalent and debilitating symptom experienced by cancer survivors, one that severely compromises functional independence and quality of life. Clinical massage therapy (CMT), as an important part of complementary and alternative medicine, is widely employed among massage therapists, physical therapists, nurses, and physicians when managing CRF. Clinical research indicates that CMT produced relief of CRF. In this systematic review, we aim to evaluate the effectiveness and safety of CMT for patients with CRF. METHODS: We will search the following electronic databases for randomized controlled trials to evaluate the effectiveness and safety of CMT for CRF in cancer patients: CENTRAL, Embase, MEDILINE, CINAHL and China National Knowledge Infrastructure. Each database will be searched from inception to October 2018. The entire process will include study selection, data extraction, risk of bias assessment and meta-analyses. RESULTS: This proposed study will evaluate the effectiveness and safety of CMT for CRF. The outcomes will include change in quality of life, fatigue relief and adverse effect. CONCLUSIONS: This proposed systematic review will evaluate the existing evidence on the effectiveness and safety of CMT for patients with CRF. DISSEMINATION AND ETHICS: The results of this review will be disseminated through peer-reviewed publication. Because all of the data used in this systematic review and meta-analysis has been published, this review does not require ethical approval. Furthermore, all data will be analyzed anonymously during the review process.

Chinese herbal medicine for opioid induced constipation in cancer patients: Protocol for a systematic review.

BACKGROUND: Opioid induced constipation (OIC) is a symptom that is commonly encountered in cancer pain management. Chinese herbal medicine (CHM) has been widely used to improve OIC in China. Many clinical trials indicate that CHM could improve OIC. In this systematic review, we aim to evaluate the effectiveness and safety of CHM for OIC in cancer patients. METHODS: We will search the following electronic databases for randomized controlled trials to evaluate the effectiveness and safety of CHM for OIC in cancer patients: CENTRAL, EMBASE, MEDILINE, CINAHL and China National Knowledge Infrastructure. Each database will be searched from inception to June 2018. The entire process will include study selection, data extraction, risk of bias assessment and meta-analyses. RESULTS: This proposed study will evaluate the effectiveness and safety of CHM for OIC. The outcomes will include change in bowel movements, quality of life and adverse events. CONCLUSIONS: This proposed systematic review will evaluate the existing evidence on the effectiveness and safety of CHM for OIC in cancer patients. DISSEMINATION AND ETHICS: The results of this review will be disseminated through peer-reviewed publication. Because all of the data used in this systematic review and meta-analysis has been published, this review does not require ethical approval. Furthermore, all data will be analyzed anonymously during the review process.