Metabolic impairments associated with type 2 diabetes mellitus and the potential effects of exercise therapy: An exploratory randomized trial based on untargeted metabolomics.

BACKGROUND: Type 2 diabetes mellitus (T2DM) is a common condition that is characterized by metabolic impairments. Exercise therapy has proven effective in improving the physiological and psychological states of patients with T2DM; however, the influence of different exercise modalities on metabolic profiles is not fully understood. This study first aimed to investigate the metabolic changes associated with T2DM among patients and then to evaluate the potential physiological effects of different exercise modalities (Tai Chi and brisk walking) on their metabolic profiles. METHODS: This study included 20 T2DM patients and 11 healthy subjects. Patients were randomly allocated to either the Tai Chi or walking group to perform Dijia simplified 24-form Tai Chi or brisk walking (80-100 m/min), with 90 minutes each time, three times per week for 12 weeks, for a total of 36 sessions. The healthy group maintained daily living habits without intervention. Glycemic tests were conducted at the baseline and after 12 weeks. Serum and urine samples were collected for untargeted metabolomic analyses at baseline and 12 weeks to examine the differential metabolic profiles between T2DM and healthy subjects, and the metabolic alterations of T2DM patients before and after exercise therapy. RESULTS: Compared to the healthy group, T2DM patients exhibited metabolic disturbances in carbohydrates (fructose, mannose, galactose, glycolysis/gluconeogenesis), lipids (inositol phosphate), and amino acids (arginine, proline, cysteine, methionine, valine, leucine, and isoleucine) metabolism, including 20 differential metabolites in the serum and six in the urine. After exercise, the glycemic results showed insignificant changes. However, patients who practiced Tai Chi showed significant improvements in their post-treatment metabolic profiles compared to baseline, with nine serum and six urine metabolites, including branch-chained amino acids (BCAAs); while those in the walking group had significantly altered nine serum and four urine metabolites concerning steroid hormone biosynthesis and arachidonic acid metabolism compared to baseline. CONCLUSION: T2DM patients displayed impaired carbohydrate, lipid, and amino acid metabolism, and exercise therapy improved their metabolic health. Different modalities may act through different pathways. Tai Chi may improve disrupted BCAAs metabolism, whereas brisk walking mainly regulates steroid hormone biosynthesis and arachidonic acid metabolism.

Acupuncture versus sham acupuncture and usual care for Antiandrogen-Induced hot fLashes in prostate cancer (AVAIL): study protocol for a randomized clinical trial.

BACKGROUND: Hot flashes are the common and debilitating symptom among prostate cancer (PCa) patients undergoing androgen deprivation therapy (ADT). Strong evidence from multiple rigorously designed studies indicated that pharmacological option such as venlafaxine provides partial relief, but the tolerability is poor when dose is not tapered. Hence, alternative therapy is needed. Previous studies reported that acupuncture may be helpful in the management of hot flashes. However, the insufficient randomized controlled trial limited the quality of evidence. METHODS: Five hospitals will recruit 120 acupuncture naïve patients with moderate-to-severe hot flashes after prostate cancer received ADT in China from February 2023 to December 2024. Participants will be randomly 2:1:1 allocated to the 18 sessions of verum acupuncture at true acupuncture points plus usual care, 18 sessions of non-penetrating sham acupuncture at non-acupuncture points plus usual care, or usual care alone over 6 weeks. The primary outcome measure is the change of mean weekly hot flashes symptom severity score (HFSSS) at the end of treatment compared with baseline. EXPECTED RESULTS AND CONCLUSION: We will be able to measure the effectiveness of acupuncture for patients with PCa suffering from ADT-induced hot flashes and whether acupuncture is superior to sham acupuncture and usual care. The proposed acupuncture treatment might provide an alternative option for those patients. TRIAL REGISTRATION: Clinicaltrials.gov (NCT05069467).

COMT Val158Met Affects the Analgesic Response to Acupuncture Among Cancer Survivors With Chronic Pain.

Catechol-O-methyltransferase (COMT) is the major enzyme involved in the catabolism of dopamine, a neurotransmitter in the brain's reward system. The common COMT polymorphism Val158Met (rs4680 G>A) modulates pain response to opioids through a reward-motivated mechanism; however, its role in nonpharmacological pain medicine has not been clinically characterized. We genotyped 325 participants from a randomized controlled trial of cancer survivors with chronic musculoskeletal pain. We found that carrying methionine at position 158 (158Met) of COMT, encoded by the A allele, significantly increased the analgesic response to electroacupuncture (74% vs 50%; odds ratio [OR]: 2.79; 95% confidence interval [CI]: 1.31, 6.05; P < .01), but not to auricular acupuncture (68% vs 60%; OR: 1.43; 95% CI: .65, 3.12; P = .37) or usual care (24% vs 18%; OR: 1.46; 95% CI: .38, 7.24; P = .61) compared to Val/Val. These findings raise the possibility that COMT Val158Met might be an important predictor of analgesic response to electroacupuncture, providing novel insights into precision nonpharmacologic pain management tailored to individual genetic backgrounds. PERSPECTIVE: This work suggests the modulating effects of the polymorphism in COMT Val158Met on the response to acupuncture. Further research needs to validate these findings, increase the mechanistic understanding of acupuncture, and guide further development of acupuncture as a precision pain management strategy.

The Herbal Medicine Suanzaoren (Ziziphi Spinosae Semen) for Sleep Quality Improvements: A Systematic Review and Meta-analysis.

BACKGROUND: Sleep disturbances are common and bothersome among cancer and noncancer populations. Suanzaoren (Ziziphi Spinosae Semen) is commonly used to improve sleep, yet its efficacy and safety are unclear. METHODS: We systematically searched PubMed, Cochrane Library, and EMBASE from inception through October 5, 2021, to identify randomized trials of Suanzaoren. We included randomized trials comparing Suanzaoren to placebo, medications, cognitive behavioral therapy (CBT), or usual care for improving sleep outcomes in cancer and noncancer patients with insomnia or sleep disturbance. We performed a risk of bias analysis following Cochrane guidelines. Depending on heterogeneity, we pooled studies with similar comparators using fixed- and random-effects models. RESULTS: We included participants with insomnia disorder (N = 785) or sleep disturbance (N = 120) from 9 trials. Compared with placebo, Suanzaoren led to significant subjective sleep quality improvements in participants with insomnia and patients with sleep disturbance combined (standard mean difference -0.58, 95% CI -1.04, -0.11; P < .01); Compared with benzodiazepines or CBT, Suanzaoren was associated with a significant decrease in insomnia severity (mean difference -2.68 points, 95% CI -5.50, -0.22; P = .03) at 4 weeks in the general population and cancer patients. The long-term effects of Suanzaoren were mixed among trials. Suanzaoren did not increase the incidence of major adverse events. The placebo-controlled studies had a low risk of bias. CONCLUSION: Suanzaoren is associated with short-term patient-reported sleep quality improvements among individuals with insomnia or sleep disturbance. Due to the small sample size and variable study quality, the clinical benefits and harms of Suanzaoren, particularly in the long term, should be further assessed in a sufficiently powered randomized trial. REGISTRATION: PROSPERO CRD42021281943.

Effect of acupuncture versus usual care on sleep quality in cancer survivors with chronic pain: Secondary analysis of a randomized clinical trial.

BACKGROUND: Chronic pain negatively affects sleep; it is unclear whether pain relief from acupuncture contributes to sleep quality improvements in cancer survivors. This study aimed to evaluate the effect of acupuncture versus usual care on sleep quality among cancer survivors with comorbid sleep disturbance and chronic musculoskeletal pain. METHODS: Sleep outcome data from the Personalized Electroacupuncture Versus Auricular Acupuncture Comparative Effectiveness (PEACE) randomized clinical trial were analyzed. Electroacupuncture or auricular acupuncture was compared with usual care for sleep quality improvement over 10 weeks of treatment among cancer survivors with clinically significant sleep disturbance and chronic musculoskeletal pain at baseline. Sleep quality was measured with the Pittsburgh Sleep Quality Index (PSQI) global score. RESULTS: Among 268 participants (mean [standard deviation (SD)] age, 61.4 [12.6] years; 191 women [71.3%]; mean [SD] baseline PSQI global score, 10.3 [3.3] points), electroacupuncture and auricular acupuncture resulted in greater reductions in the PSQI global score from baseline to 10 weeks in comparison with usual care: 1.42 points (95% confidence interval [CI], 0.45-2.38; p = .004) and 1.59 points (95% CI, 0.62-2.55; p = .001), respectively. The improvement in sleep quality for the acupuncture groups was sustained for 24 weeks from randomization. Furthermore, a greater proportion of patients in the electroacupuncture and auricular acupuncture groups had clinically meaningful improvement in sleep quality compared to the usual care group (41.0% and 42.9% vs. 21.4%; p = .044). CONCLUSIONS: Among cancer survivors with comorbid sleep disturbance and chronic pain, electroacupuncture and auricular acupuncture produced a clinically relevant and persistent improvement in sleep quality. These findings suggest that acupuncture may be an evidence-based nonpharmacologic intervention to improve sleep health for cancer survivors with pain. PLAIN LANGUAGE SUMMARY: This study analyzed the sleep quality data from a published randomized clinical trial that evaluated the effect of electroacupuncture or auricular acupuncture versus usual care on pain relief among people who survived cancer. This analysis included a prespecified subgroup of 268 participants with co-occurring sleep disturbance and chronic musculoskeletal pain at baseline and found that patients who used acupuncture for pain relief demonstrated greater improvements in sleep quality compared with patients who received usual care. Sleep quality improvement by acupuncture was sustained after the treatment ended.

Ginseng and Ginseng Herbal Formulas for Symptomatic Management of Fatigue: A Systematic Review and Meta-Analysis.

Objectives: Ginseng has been widely used in fatigue management. However, its efficacy on fatigue remains unclear. This study aimed to assess the efficacy and safety of ginseng and ginseng herbal formulas for fatigue in randomized clinical trials (RCTs). Methods: The authors searched PubMed, Embase, Cochrane, Web of Science, and Allied and Complementary Medicine Database (AMED) databases from inception to July 6, 2022. Outcomes included fatigue severity, quality of life (QoL), and adverse events (AEs). Quality of evidence was assessed using the Cochrane Risk of Bias Tool. They pooled all included data and performed subgroup analysis by fatigue type, assessment instrument, and ginseng type. Results: The authors included 19 RCTs. Pooled analyses found no significant reduction in fatigue severity with ginseng versus controls (standardized mean difference [SMD]: -0.36, 95% confidence interval [CI]: -0.82 to 0.11, p = 0.13). In subgroup analysis, there was significant fatigue reduction with the ginseng herbal formula (SMD: -0.39, 95% CI: -0.66 to -0.13, p = 0.004) and chronic fatigue (CF) (SMD: -0.30, 95% CI: -0.56 to -0.03, p = 0.03) compared to controls. Ginseng produced significant reductions in general (i.e., non-disease-specific) fatigue compared to controls (SMD: -0.48, 95% CI: -0.71 to -0.25, p < 0.0001). Ginseng was associated with a trend toward QoL improvement (p = 0.05) and did not increase AEs compared with controls. Effect sizes were small. Conclusion: Ginseng herbal formulas improved fatigue severity compared to controls, especially among patients with CF, but with a small effect size. Rigorous RCTs as well as guidelines for standard ginseng usage are needed to further evaluate the effects of ginseng for fatigue and ensure proper use.

Effect of Acupuncture on Blood Pressure and Metabolic Profile Among Patients With Essential Hypertension: Protocol of a Randomized Clinical Trial.

Essential hypertension is a polygenic cardiovascular disease that is associated with maladaptive metabolic changes. Acupuncture as a non-pharmacologic intervention is used to lower blood pressure and improve metabolic dysfunction. However, such effects have not been clinically characterized. We will conduct a randomized clinical trial to evaluate the antihypertensive effect of acupuncture among patients with essential hypertension and determine the associated metabolic improvements. This study is a phase II, two-arm, randomized, sham-controlled trial (Trial registration: ChiCTR2100043737), in which biospecimens will be collected for metabolic profiling. A total of 64 patients with a clinical diagnosis of essential hypertension will be randomly assigned to either the acupuncture or the sham acupuncture group in a 1:1 ratio. All participants will receive 10 treatments over 4 weeks, with three sessions per week for the first 2 weeks and two sessions per week for the remaining weeks. The primary outcome is the change of the systolic and diastolic blood pressure measured by the 24-h ambulatory blood pressure monitoring from baseline to 4 weeks. Secondary outcomes include the circadian rhythm of blood pressure, sleep quality measured by the Insomnia Severity Index, cognitive function measured by the Montreal Cognitive Assessment, and others. Fasting blood serum and urine samples will be collected at baseline and 4 weeks for targeted and untargeted metabolomics analysis. We will use the mixed-effects model and other related bioinformatics approaches to analyze the clinical and metabolome data. This metabolomic-based trial will provide important clinical data regarding the efficacy of acupuncture for essential hypertension to better inform evidence-based care delivery for hypertension patients. Moreover, the findings will offer important insights into the mechanism of action of acupuncture for hypertension by revealing its effect on metabolism. The results of this study will be used to inform the design of a statistically powered, multicenter, randomized trial. We will publish the study findings in peer-reviewed journals. The ethical approval of this study has been reviewed and approved by the Sichuan Regional Ethics Review Committee on Traditional Chinese Medicine (ID: 2021KL-006). The outcomes of the trial will be disseminated through peer-reviewed publications.

Tibetan Herbal Pain-Relieving Plaster for Chronic Musculoskeletal Pain Among Cancer Survivors: Study Protocol of a Randomized, Double-Blind, Placebo-Controlled Trial.

Chronic pain is common and debilitating in cancer survivors. Tibetan herbal pain-relieving plaster is used as an external analgesic to treat musculoskeletal pain in China; however, its safety and efficacy have not been evaluated via clinical trials in cancer survivors. We designed this Phase II randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov Identifier: NCT04916249) to assess the efficacy and safety of the pain-relieving plaster for temporary pain relief among cancer survivors with chronic musculoskeletal pain. Under ethical approval from the Institutional Review Board at the Memorial Sloan Kettering Cancer Center, we will enroll eligible cancer survivors who have a clinical diagnosis of moderate to severe chronic musculoskeletal pain in this study. We use a central randomization system to allocate the eligible participants to either the treatment or the control group in a 1:1 ratio, with stratification by baseline opioid use. We will instruct the participants to apply the herbal patch (Tibetree Pain-Relieving Plaster, Tibet Cheezheng Tibetan Medicine Co. Ltd., Tibet, China) or placebo patch daily at the focal area with worst pain for 14 consecutive days. Study physician, participant, outcome assessor, and biostatistician are blinded to the group allocation. The primary outcome is pain severity measured by the Brief Pain Inventory on Days 2-7. Secondary outcomes include changes in insomnia, anxiety, depression, fatigue, pressure pain threshold, pain medication use, and global impression of change. We will also monitor the adverse events throughout the study period. Statistical analysis will follow the intention-to-treat principle and linear mixed modeling will be used. With rigorous design and implementation, this randomized, placebo-controlled trial will provide the initial evidence on the efficacy and safety of the pain-relieving plaster for pain relief among cancer survivors with chronic musculoskeletal pain.

Herbal Formula Shenling Baizhu San for Chronic Diarrhea in Adults: A Systematic Review and Meta-analysis.

BACKGROUND: Shenling Baizhu San (SBS), a well-known Chinese medicine herbal formula, has been widely used for treating chronic diarrhea for thousands of years. However, the efficacy and safety of SBS in treating chronic diarrhea have not been fully assessed. OBJECTIVE: This study evaluates the efficacy and safety of the herbal formula SBS in symptomatic relief of chronic diarrhea. METHODS: English and Chinese language databases (PubMed, Cochrane Library, China National Knowledge Infrastructure, China Science and Technology Journal Database, Wanfang Data, and SinoMed electronic databases) were searched through April 2020 for relevant randomized controlled trials (RCTs). The outcomes in these RCTs included stool frequency, stool consistency, patient-reported satisfaction of chronic diarrhea treatment, quality of life and adverse events. Paired reviewers independently extracted data and conducted qualitative and quantitative analyses. The Cochrane revised risk of bias RoB-2 tool was applied to assess the risk of bias for each trial whereas the RevMan 5.3 software was used for outcomes data synthesis and meta-analysis. Mean difference (MD) and the 95% confidence interval (CI) were used to measure continuous data. The dichotomous data were analyzed via the relative risk (RR) with 95% CIs. RESULTS: Fourteen RCTs including 1158 participants (54% males) with chronic diarrhea were included. Shenling Baizhu San combined with or without conventional medicine (CM) was associated with greater patient-reported satisfaction than CM alone. There was no increased risk of adverse events (AEs) during treatment. CONCLUSION: Treatment with SBS was associated with significant improvement in patient-reported satisfaction, irrespective of conventional medicine use. Rigorous and powered RCTs with objective outcome measures are needed to confirm the effects of SBS in specific gastrointestinal disease populations with chronic diarrhea symptoms. SYSTEMATIC REVIEW REGISTRATION NUMBER (PROSPERO): CRD42020178073.

Guideline Acupuncture for low back pain: a clinical practice guideline from the Hong Kong taskforce of standardized acupuncture practice.

OBJECTIVE: To develop a clinical practice guideline to guide the treatment of low back pain by acupuncture. METHODS: An integrative approach of systematic review of literature, clinical evidence classification, expert opinion surveying, and consensus establishing via a Delphi program was utilized during the developing process. Both evidence-based practice standards and the personalized features of acupuncture were taken into considerations. RESULTS: Based on clinical evidence and expert opinions, we developed a clinical practice guideline for the treatment of low back pain with acupuncture. These recommendations have a wide coverage spanning from Western Medicine diagnosis and Traditional Chinese Medicine syndrome differentiation, to acupuncture treatment procedures, as well as post treatment care for rehabilitation and follow-ups. The recommendations for acupuncture practice included treatment principles, therapeutic regimens, and operational procedures. The levels of evidence and strength of recommendation were rated for each procedure of practice. CONCLUSION: A clinical practice guideline for acupuncture treating low back pain was developed based on contemporary clinical evidence and experts' consensus to provide best currently agreeable practice guideline for domestic and international stakeholders.

Patient-centred, self-administered acupressure for Chinese advanced cancer patients experiencing fatigue and co-occurring symptoms: A pilot randomised controlled trial.

OBJECTIVES: To evaluate the feasibility and potential effects of patient-centred self-administered acupressure for alleviating fatigue and co-occurring symptoms among Chinese advanced cancer patients receiving treatment. METHODS: Thirty advanced cancer patients who screened positive for moderate/severe fatigue with symptoms of insomnia and/or pain were recruited from a hospital in Hong Kong. They were randomly assigned (1:1) to receive a 4-week patient-centred self-administered acupressure intervention or health education. Fatigue (primary outcome) and secondary outcomes (sleep quality, pain, fatigue-sleep disturbance-pain symptom cluster severity, anxiety, depression and quality of life) were measured by questionnaires and actigraphy. RESULTS: Twenty-four participants (80%) completed the study. Adherence to self-administered acupressure practice was satisfactory, with all retained participants attending all sessions and 90.9% practising acupressure daily. All completers rated the class as very enjoyable or quite enjoyable. Fatigue, pain, symptom cluster severity, anxiety, depression and quality of life appeared to improve from baseline to post-intervention in the intervention group. Among these outcomes, only the between-group difference in anxiety post-intervention was significant. The group × time interaction effect was nonsignificant for all outcomes. CONCLUSIONS: Patient-centred self-administered acupressure appears to be feasible and acceptable among advanced cancer patients. A fully powered trial is warranted to confirm the intervention effect.

Acupuncture for menstrual migraine: a systematic review.

BACKGROUND AND OBJECTIVE: In clinical practice, the evidence of acupuncture used as a treatment for migraine without aura is employed interchangeably to guide treatment for menstrual migraine. However, its effect and safety are not substantiated. This study aimed to assess the efficacy of acupuncture on the frequency and pain intensity of menstrual migraine. METHODS: We searched PubMed, Cochrane Library, China National Knowledge Infrastructure (CNKI) and other two Chinese databases from their inception to 1 May 2019. This study included randomised controlled trials of women with menstrual migraine receiving acupuncture or a valid control. Two reviewers independently completed study selection, data extraction and risk of bias assessment. We combined data with a fixed-effect model in RevMan. Clinical outcomes included migraine frequency and duration, headache intensity, and adverse events. RESULTS: Thirteen studies with 826 subjects were included, 9 of which had data suitable for meta-analyses. Current evidence showed that acupuncture was not superior to sham acupuncture in reducing monthly migraine frequency and duration, average headache intensity, and analgesic use at completion of treatment or follow-up. Pooled data demonstrated a significant improvement in mean headache intensity in the acupuncture group compared with drugs. However, all studies were underpowered and associated with moderate to high risk of bias. No serious adverse event was related to acupuncture treatment. CONCLUSIONS: There is no convincing evidence to support the use of acupuncture in treating menstrual migraine. Acupuncture cannot yet be recommended to patients with menstrual migraine until more solid evidence is produced. TRIAL REGISTRATION NUMBER: CRD42019119337.

Acupuncture versus cognitive behavioral therapy for pain among cancer survivors with insomnia: an exploratory analysis of a randomized clinical trial.

Pain and insomnia often co-occur and impair the quality of life in cancer survivors. This study evaluated the effect of acupuncture versus cognitive behavioral therapy for insomnia (CBT-I) on pain severity among cancer survivors with comorbid pain and insomnia. Using data from the CHOICE trial that compared acupuncture versus CBT-I for insomnia among cancer survivors, we analyzed the effect of interventions on pain outcomes in 70 patients with moderate to severe baseline pain. Interventions were delivered over eight weeks. We assessed average pain severity (primary outcome) and pain interference at baseline, week 8, and week 20. We further defined insomnia and pain responders as patients who achieved clinically meaningful improvement in insomnia and pain outcomes, respectively, at week 8. We found that compared with baseline, the between-group difference (-1.0, 95% CI -1.8 to -0.2) was statistically significant favoring acupuncture for reduced pain severity at week 8 (-1.4, 95% CI -2.0 to -0.8) relative to CBT-I (-0.4, 95% CI-1.0 to 0.2). Responder analysis showed that 1) with acupuncture, insomnia responders reported significantly greater pain reduction from baseline to week 4, compared with insomnia non-responders (-1.5, 95% CI -2.7 to -0.3); 2) with CBT-I, pain responders reported significantly greater insomnia reduction at week 8, compared with pain non-responders (-4.7, 95% CI -8.7 to -1.0). These findings suggest that among cancer survivors with comorbid pain and insomnia, acupuncture led to rapid pain reductions, which contributed to a decrease in insomnia, whereas CBT-I had a delayed effect on pain, possibly achieved by insomnia improvement.

Electroacupuncture Plus Auricular Acupressure on Chemotherapy-Related Insomnia in Patients With Breast Cancer (EACRI): Study Protocol for a Randomized, Sham-Controlled Trial.

OBJECTIVE: Insomnia is a highly prevalent and disturbing symptom in breast cancer patients under or post chemotherapy. If not appropriately treated, it can persist for years after the completion of cancer treatments. Acupuncture has been widely used for alleviating insomnia. The aim of this study is to examine the feasibility, efficacy and safety of acupuncture for chemotherapy-related insomnia among patients with breast cancer. MATERIALS AND METHODS: This is a trial protocol for a randomized, sham-controlled, subject- and assessor-blinded clinical trial. A total of 138 eligible participants will be assigned randomly to acupuncture or sham control group at a ratio of 1:1. Participants in acupuncture group will receive electroacupuncture (EA) plus auricular acupressure (AA) treatment, while subjects in sham acupuncture group will receive sham EA plus sham AA. Both acupuncture and sham treatments will be given twice weekly for 6 weeks, followed by maintenance treatments once every 4 weeks for 12 weeks (15 sessions totally). The primary outcome is the change of Insomnia Severity Index score between baseline and the end of 6-week treatment. Secondary outcome measurements include Actiwatch, sleep diary, Pittsburgh Sleep Quality Index, Functional Assessment of Cancer Therapy-Breast Cancer, Hospital Anxiety and Depression Scale, Brief Pain Inventory-Short Form, Brief Fatigue Inventory, Acupuncture Expectancy Scale, credibility, and adverse events. Participants will be followed up to 42 weeks. CONCLUSIONS: This trial will expand our understanding of the feasibility, efficacy, and safety of acupuncture as a treatment for alleviating chemotherapy-related insomnia in patients with breast cancer. EA plus AA, if proven to be effective, can be implemented into routine settings to play a role in insomnia management for patients with breast cancer.

Tibetan herbal pain-relieving plaster for low back pain: A systematic review and meta-analysis.

ETHNOPHARMACOLOGICAL RELEVANCE: Tibetan traditional medicine CheeZheng Pain-Relieving Plaster (CZPRP) is frequently used as an over-the-counter external analgesic for musculoskeletal pain; however, its evidence for low back pain (LBP) has not been evaluated. AIM OF THE STUDY: This study aims to assess the efficacy and safety of CZPRP for both acute, subacute and chronic LBP through a systematic review and meta-analysis of clinical trials. MATERIALS AND METHODS: PubMed, CENTRAL, CNKI, CQVIP, and Wanfang databases were searched through April 20, 2020 for randomized controlled trials of CZPRP for LBP. Eligible comparators were placebo, active treatment, or usual care. Clinical outcomes included pain severity, lower back function score, pain-free rate, and adverse events (AEs). Qualitative evaluations were conducted using the Cochrane risk of bias assessment tools. Quantitative analyses were conducted using a random-effects model. RESULTS: This study includes 1674 LBP patients from nine clinical studies. Pooled analyses among subjects with acute LBP show 1) significant pain reductions (mean difference -0.84, 95% confidence interval[CI] -1.31, -0.37) in CZPRP plus diclofenac versus diclofenac, 2) significant improvements in lower back function (standard mean difference -1.50, 95% CI -2.16, -0.85) in CZPRP versus diclofenac, and 3) a higher pain-free rate in CZPRP alone (risk ratio 1.48, 95% CI 1.16, 1.89; I2 = 61%) or CZPRP plus nonsteroidal anti-inflammatory drugs (NSAIDs) (risk ratio 1.66, 95% CI 1.14, 2.40; I2 = 0%) versus NSAIDs. However, in a heterogeneous population with mixed LBP subtypes, there was no significant difference in pain outcomes between CZPRP and diclofenac. Additionally, CZPRP use did not increase AEs compared with no CZPRP (p = 0.40). All nine studies are associated with moderate to high risk of bias. CONCLUSIONS: The use of CZPRP is associated with improved acute LBP outcomes compared to diclofenac. However, due to the moderate to high risk of bias of the studies, future rigorous randomized controlled trials are needed to evaluate the effects of CZPRP for acute and chronic LBP.

Genetic Predictors of Response to Acupuncture or Cognitive Behavioral Therapy for Insomnia in Cancer Survivors: An Exploratory Analysis.

CONTEXT: Insomnia is a common problem affecting cancer survivors. While effective nonpharmacological treatments are available, it is unknown whether individual genetic characteristics influence treatment response. OBJECTIVES: We conducted an exploratory analysis of genetic associations with insomnia treatment response in a randomized trial of cognitive behavioral therapy for insomnia (CBT-I) vs. acupuncture in a heterogeneous group of cancer survivors. METHODS: We successfully genotyped 136 participants for 11 genetic variants. Successful treatment response was defined as a reduction in Insomnia Severity Index score of at least eight points from baseline to week 8. We used Fisher exact tests to evaluate associations between genotype and treatment success for each treatment arm, for an alpha level of 0.05 with unadjusted and Holm-Bonferroni-adjusted P-values. RESULTS: We found that more carriers of COMT rs4680-A alleles responded to acupuncture compared to the GG carriers (63.6% vs. 27.8%, P = 0.013). More carriers of the NFKB2 rs1056890 CC genotype also responded to acupuncture compared to TT or CT carriers (72.2% vs. 38.9%, P = 0.009). There were no significant differences found between any of the tested gene variants and CBT-I response. None of the results remained statistically significant after adjustment for multiple testing. CONCLUSION: In cancer survivors, specific variants in the COMT and NFKB2 genes are potentially associated with response to acupuncture but not to CBT-I. Confirming these preliminary results will help inform precision insomnia management for cancer survivors.

Herbal formula MaZiRenWan (Hemp Seed Pill) for constipation: A systematic review with meta-analysis.

BACKGROUND: There is growing interest in using herbal supplements to treat constipation; however, little evidence exists for their use. PURPOSE: This study evaluates the efficacy and safety of herbal formula MaZiRenWan (Hemp Seed Pill, HSP) in patients with functional or non-functional constipation. STUDY DESIGN: Systematic review and meta-analysis METHODS: PubMed, CENTRAL, Embase, CNKI, and Wanfang were searched through April 20, 2020 for randomized trials of HSP versus placebo or medications for all types of constipation. The primary outcomes were complete response rate, complete spontaneous bowel movement (CSBM), patient-reported satisfactory treatment rate (prSTR), and adverse events (AEs). Clinical data were analyzed using a random-effects model, and the quality of evidence was evaluated with the GRADE system. RESULTS: This review includes 1681 constipation patients from 17 moderate-to-high risk of bias trials that were conducted in east Asia. Two high-quality trials showed that HSP compared with placebo significantly increased weekly CSBM (mean difference, 0.95; 95% CI: 0.56, 1.35) and had a higher complete response rate (risk ratio [RR], 1.43; 95% CI: 1.20, 1.71) in patients with functional constipation. Low-quality evidence showed significant improvement in prSTR in HSP compared with conventional medications (RR, 1.79; 95% CI: 1.42, 2.25). Additionally, HSP use did not increase AEs compared with no HSP (p = 0.99). CONCLUSIONS: This study found that HSP was effective among Asian patients with functional constipation. Rigorous trials need to be conducted in clinical populations outside of east Asia and in those with non-functional constipation to increase the generalizability of the evidence.

Improvement of intestinal flora: accompany with the antihypertensive effect of electroacupuncture on stage 1 hypertension.

BACKGROUND: Increasing evidence have indicated the relationship between intestinal dysbiosis and hypertension. We aimed to evaluate the effect of the electroacupuncture (EA) on intestinal microbiota in patients with stage 1 hypertension. METHODS: 93 hypertensive patients and 15 healthy subjects were enrolled in this study. Applying a highly accurate oscillometric device to evaluate the antihypertensive effect of EA. 16S rRNA sequencing was used to profile stool microbial communities from Healthy group, Before treatment (BT) group and After treatment (AT) group, and various multivariate analysis approaches were used to assess diversity, composition and abundance of intestinal microbiota. RESULTS: In this study, EA significantly decreased the blood pressure (BP) of hypertensive patients. Higher abundance of Firmicutes and lower Bacteroidetes abundance were observed in the BT group compared to the Healthy group. And EA treatment significantly decreased the Firmicutes/Bacteroidetes ratio compared to the BT group. Moreover, at the genus level, there was an increased abundance of Escherichia-Shigella in patients with hypertension, while Blautia were decreased, and EA reversed these changes. CONCLUSIONS: Our study indicates that EA can effectively lower BP and improve the structure of intestinal microbiota which are correlate with the alteration of blood pressure by electroacupuncture. TRIAL REGISTRATION: Clinicaltrial.gov, NCT01701726. Registered 5 October 2012, https://clinicaltrials.gov/ct2/show/study/NCT01701726.

The efficacy of acupuncture for stable angina pectoris: A systematic review and meta-analysis.

OBJECTIVE: The aim of this study was to assess the efficacy and safety of acupuncture in the treatment of patients with stable angina pectoris. METHODS: A literature search was performed in nine databases, including PubMed and the Cochrane Library, from their inception to 30 August 2018. Randomized controlled trials that compared acupuncture therapy with sham acupuncture or no treatment were included. Two reviewers under the guidance of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines assessed the eligibility of each record and extracted essential information independently. The data were merged using a fixed-effect model. RESULTS: Pooled analysis of 17 eligible trials with 1516 participants showed that acupuncture was associated with reduced angina attack frequency (-4.91; 95% confidence interval, -6.01- -3.82; p < 0.00001) and improved depression (-1.23; 95% confidence interval, -1.47- -1.00; p < 0.00001) and anxiety level (-0.96; 95% confidence interval, -1.16- -0.75; p < 0.00001) relative to sham treatment or standard care alone. No increased risk of adverse events was observed during treatment (relative risk, 0.70; 95% confidence interval, 0.33-1.48; p = 0.35). No significant improvement was shown in nitroglycerin use or angina intensity. The included studies were associated with unclear to high risk of selection or performance bias, and the quality of evidence was low to moderate. CONCLUSIONS: Acupuncture may safely and effectively improve physical restrictions, emotional distress, and attack frequency in patients with stable angina pectoris. However, angina intensity and medication use were not reduced. Studies with adequate blinding and a valid sham control group are still warranted due to the current low quality of evidence.

Effect and Safety of CX-DZ-II Intelligent Electroacupuncture Therapeutic Instrument for Neck Pain Caused by Cervical Spondylos: Study Protocol for A Randomized Controlled Trial.

BACKGROUND: Neck pain caused by cervical spondylosis (CS) is a chronic pain condition, with an increasingly high incidence in the general population. Electroacupuncture is a common analgesic modality that has been widely applied in neck pain treatment. However, current electroacupuncture instruments used in the clinic have low intelligence levels and obscure parameter standards. We here designed this study for assessing the effect and safety of a new, intelligent electroacupuncture instrument, the CX-DZ-II, in treating neck pain. METHODS: The present study is a prospective, two-center, randomized, controlled, open-label, non-inferiority trial for CX-DZ-II on treating neck pain caused by CS. Totally 160 eligible patients will be included in this trial and randomly assigned to an experimental group and a control group in a 1:1 ratio. A semi-standard acupoint selection strategy will be employed. In the experimental group, selected acupoints will be stimulated by CX-DZ-II. Electroacupuncture treatment will be accomplished by a pre-existing electroacupuncture instrument in the control group. The duration of treatment will be 2 weeks. The primary outcome is the change of Visual Analog Scale (VAS) score after one course of treatment. The secondary outcomes include the VAS scores after each treatment, the responder rate, drug-usage rate of non-steroidal antipyretic analgesics, the rate of adverse events occurrence, and the performance of instrument. DISCUSSION: This study will evaluate the effect and safety of the CX-DZ-II intelligent electroacupuncture therapeutic instrument in comparison with a pre-existing non-intelligent instrument in the treatment of neck pain caused by CS. The results will hopefully demonstrate a more optimal electroacupuncture instrument for the treatment of neck pain. (Trial registration No. gov NCT03005301).