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JAMA Network Open Nov 2023Pain is challenging for patients with advanced cancer. While recent guidelines recommend acupuncture and massage for cancer pain, their comparative effectiveness is... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Pain is challenging for patients with advanced cancer. While recent guidelines recommend acupuncture and massage for cancer pain, their comparative effectiveness is unknown.
OBJECTIVE
To compare the effects of acupuncture and massage on musculoskeletal pain among patients with advanced cancer.
DESIGN, SETTING, AND PARTICIPANTS
A multicenter pragmatic randomized clinical trial was conducted at US cancer care centers consisting of a northeastern comprehensive cancer center and a southeastern cancer institute from September 19, 2019, through February 23, 2022. The principal investigator and study statisticians were blinded to treatment assignments. The duration of follow-up was 26 weeks. Intention-to-treat analyses were performed (linear mixed models). Participants included patients with advanced cancer with moderate to severe pain and clinician-estimated life expectancy of 6 months or more. Patient recruitment strategy was multipronged (eg, patient database queries, mailings, referrals, community outreach). Eligible patients had English or Spanish as their first language, were older than 18 years, and had a Karnofsky score greater than or equal to 60 (range, 0-100; higher scores indicating less functional impairment).
INTERVENTIONS
Weekly acupuncture or massage for 10 weeks with monthly booster sessions up to 26 weeks.
MAIN OUTCOMES AND MEASURES
The primary end point was the change in worst pain intensity score from baseline to 26 weeks. The secondary outcomes included fatigue, insomnia, and quality of life. The Brief Pain Inventory (range, 0-10; higher numbers indicate worse pain intensity or interference) was used to measure the primary outcome. The secondary outcomes included fatigue, insomnia, and quality of life.
RESULTS
A total of 298 participants were enrolled (mean [SD] age, 58.7 [14.1] years, 200 [67.1%] were women, 33 [11.1%] Black, 220 [74.1%] White, 46 [15.4%] Hispanic, and 78.5% with solid tumors). The mean (SD) baseline worst pain score was 6.9 (1.5). During 26 weeks, acupuncture reduced the worst pain score, with a mean change of -2.53 (95% CI, -2.92 to -2.15) points, and massage reduced the Brief Pain Inventory worst pain score, with a mean change of -3.01 (95% CI, -3.38 to -2.63) points; the between-group difference was not significant (-0.48; 95% CI, -0.98 to 0.03; P = .07). Both treatments also improved fatigue, insomnia, and quality of life without significant between-group differences. Adverse events were mild and included bruising (6.5% of patients receiving acupuncture) and transient soreness (15.1% patients receiving massage).
CONCLUSIONS AND RELEVANCE
In this randomized clinical trial among patients with advanced cancer, both acupuncture and massage were associated with pain reduction and improved fatigue, insomnia, and quality of life over 26 weeks; however, there was no significant different between the treatments. More research is needed to evaluate how best to integrate these approaches into pain treatment to optimize symptom management for the growing population of people living with advanced cancer.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT04095234.
Topics: Female; Humans; Male; Middle Aged; Acupuncture Therapy; Fatigue; Massage; Musculoskeletal Pain; Neoplasms; Quality of Life; Sleep Initiation and Maintenance Disorders; Adult; Aged
PubMed: 37962891
DOI: 10.1001/jamanetworkopen.2023.42482 -
JAMA Internal Medicine Jul 2023Previous research has suggested that Xuebijing injection (XBJ), an herbal-based intravenous preparation, may reduce mortality among patients with sepsis.
IMPORTANCE
Previous research has suggested that Xuebijing injection (XBJ), an herbal-based intravenous preparation, may reduce mortality among patients with sepsis.
OBJECTIVE
To determine the effect of XBJ vs placebo on 28-day mortality among patients with sepsis.
DESIGN, SETTING, AND PARTICIPANTS
The Efficacy of Xuebijing Injection in Patients With Sepsis (EXIT-SEP) trial was a multicenter, randomized double-blind, placebo-controlled trial conducted in intensive care units at 45 sites and included 1817 randomized patients with sepsis (sepsis 3.0) present for less than 48 hours. Patients aged 18 to 75 years with a Sequential Organ Failure Assessment score of 2 to 13 were enrolled. The study was conducted from October 2017 to June 2019. The final date of follow-up was July 26, 2019. Data analysis was performed from January 2020 to August 2022.
INTERVENTIONS
The patients were randomized to receive either intravenous infusion of XBJ (100 mL, n = 911) or volume-matched saline placebo (n = 906) every 12 hours for 5 days.
MAIN OUTCOMES AND MEASURES
The primary outcome was 28-day mortality.
RESULTS
Among the 1817 patients who were randomized (mean [SD] age, 56.5 [13.5] years; 1199 [66.0%] men), 1760 (96.9%) completed the trial. In these patients, the 28-day mortality rate was significantly different between the placebo group and the XBJ group (230 of 882 patients [26.1%] vs 165 of 878 patients [18.8%], respectively; P < .001). The absolute risk difference was 7.3 (95% CI, 3.4-11.2) percentage points. The incidence of adverse events was 222 of 878 patients (25.3%) in the placebo group and 200 of 872 patients (22.9%) in the XBJ group.
CONCLUSIONS AND RELEVANCE
In this randomized clinical trial among patients with sepsis, the administration of XBJ reduced 28-day mortality compared with placebo.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT03238742.
Topics: Male; Humans; Middle Aged; Female; Double-Blind Method; Sepsis; Drugs, Chinese Herbal; Organ Dysfunction Scores
PubMed: 37126332
DOI: 10.1001/jamainternmed.2023.0780 -
JAMA Network Open Sep 2023When sham acupuncture is set as a control in evaluating acupuncture, the sham needling technique is usually different from acupuncture. However, the sham procedure is... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
When sham acupuncture is set as a control in evaluating acupuncture, the sham needling technique is usually different from acupuncture. However, the sham procedure is conducted either at the same points that are used for the acupuncture group or at nonindicated points.
OBJECTIVE
To assess whether the outcome of sham acupuncture varies according to the needling points in sham-controlled trials of acupuncture for chronic nonspecific low back pain (CLBP) as an example.
DATA SOURCES
Searches of MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and the Allied and Complementary Medicine Database were conducted on February 12, 2023.
STUDY SELECTION
Randomized clinical trials (RCTs) assessing the outcomes of acupuncture in sham acupuncture-controlled or waiting list-controlled trials on CLBP were included.
DATA EXTRACTION AND SYNTHESIS
Two researchers independently extracted data on study characteristics and outcomes and assessed quality. Sham acupuncture was classified according to whether it was conducted at the same acupuncture points used in the acupuncture group, referred to as sham acupuncture therapy (verum) (SATV) or at different points, referred to as sham acupuncture therapy (sham) (SATS). Clinical similarity, transitivity, and consistency tests were conducted, followed by a random-effects frequentist network meta-analysis (NMA).
MAIN OUTCOMES AND MEASURES
The primary outcome was pain, and the secondary outcome was back-specific function. The first assessment after the end of treatment was chosen for analysis. Effect sizes are reported as standardized mean differences (SMD) with 95% CIs. The risk of bias was assessed using the Cochrane risk of bias tool, and the certainty of evidence for findings was evaluated using the Grading of Recommendations Assessment, Development, and Evaluation approach.
RESULTS
Ten RCTs involving 4379 participants were included. In comparison with SATS, acupuncture was significantly associated with improvements in both pain (SMD, -0.33; 95% CI, -0.52 to -0.15) and function outcomes (SMD, -0.13; 95% CI, -0.25 to -0.02); however, there were no differences between acupuncture and SATV. In comparison with SATS, SATV was significantly associated with better pain (SMD, -0.45; 95% CI, -0.88 to -0.03) and function outcomes (SMD, -0.30; 95% CI, -0.56 to -0.05). The risk of bias that could affect the interpretation of the results was usually low, and the certainty of evidence was moderate to low.
CONCLUSIONS AND RELEVANCE
In this NMA, sham acupuncture needling at the same points as those in acupuncture was not a true placebo control for assessing the efficacy of acupuncture for CLBP and might underestimate the outcome of acupuncture in clinical settings.
Topics: Humans; Low Back Pain; Network Meta-Analysis; Acupuncture Therapy; Vascular Surgical Procedures; Databases, Factual
PubMed: 37672270
DOI: 10.1001/jamanetworkopen.2023.32452 -
JAMA Network Open Nov 2023Depression is a leading cause of disability worldwide, and there is increasing interest in nonpharmacological treatments. Auricular acupuncture (AA) is a simple,... (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Depression is a leading cause of disability worldwide, and there is increasing interest in nonpharmacological treatments. Auricular acupuncture (AA) is a simple, low-cost, and well-tolerated option, but further studies are needed to establish its efficacy and safety.
OBJECTIVE
To estimate the efficacy and safety of auricular acupuncture as a treatment for depression.
DESIGN, SETTING, AND PARTICIPANTS
This randomized clinical trial was conducted at 4 university research centers in Brazil, from March to July 2023. Eligible patients were adults aged 18 to 50 years whose score on the Patient Health Questionnaire-9 (PHQ-9) indicated moderate depression (score 10-14) or moderately severe depression (score 15-19). Exclusion criteria included previous application of AA, risk of suicidal ideation, or severe depression (PHQ-9 score >20). An intent-to-treat analysis and modified intent-to-treat analysis were conducted.
INTERVENTION
Participants were randomized into 2 treatment groups, which included specific AA (SA) and nonspecific AA (NSA). Both groups received 12 sessions of AA with semipermanent needles with daily stimulation twice a week over 6 weeks and were followed-up for 3 months. All participants continued with their usual care for ethical reasons. The SA group's treatment protocol consisted of 6 acupuncture points on the auricular pavilion chosen according to the diagnosis of depression by traditional Chinese medicine (Shenmen, subcortex, heart, lung, liver, and kidney). The NSA group's acupuncture points were the external ear, the cheek and face area, and 4 nonspecific points in the helix region unassociated with mental health symptoms. A locator device was used to confirm which areas had neuroreactive points.
MAIN OUTCOMES AND MEASURES
The primary outcome was a reduction of at least 50% in the PHQ-9 score (ie, depression recovery) at 3 months. Secondary outcomes included depression recovery at 4 and 6 weeks; depression remission (PHQ-9 score < 5) at 4 weeks, 6 weeks, and 3 months); and adverse events.
RESULTS
A total of 304 participants were screened, and 74 participants (62 women [84%]; median [IQR] age, 29 [23-27] years) were included in the intention-to-treat analysis, with 37 participants randomized to each group (SA and NSA). A total of 47 participants (64%) were followed-up through 3 months. The results showed no statistically significant difference in depressive recovery between the groups at 3 months (14 of 24 participants in the SA group [58%] vs 10 of 23 participants in the NSA group [43%]; risk ratio [RR], 1.34; 95% CI, 0.76-2.45; P = .38). The proportions of depression recovery and remission at 4 and 6 weeks based on the PHQ-9 were higher in the SA group (except for depression recovery at 6 weeks) with no statistically significant differences. However, a statistically significant difference was observed in symptom remission at 3 months (11 of 24 participants in the SA group [46%] vs 3 of 23 participants in the NSA group [13%]; RR, 1.99; 95% CI, 1.16-3.34; P = .02) in favor of SA. There were no significant differences in adverse event rates between the groups, evidencing the intervention's safety. Most participants reported mild pain at the needle application site (33 patients [94%] in the SA group vs 32 patients [91%] in the NSA group). Five participants dropped out of the study due to adverse events.
CONCLUSIONS AND RELEVANCE
The results of this randomized clinical trial suggest that SA over 6 weeks is safe. Although there was no statistically significant difference between groups for the primary efficacy outcome, patients receiving SA did experience greater symptom remission at 3 months. A larger sample size and longer intervention are needed to further evaluate the efficacy of SA for depression.
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT05855421.
Topics: Adult; Humans; Female; Acupuncture, Ear; Depression; Acupuncture Therapy; Brazil; Depressive Disorder
PubMed: 38032640
DOI: 10.1001/jamanetworkopen.2023.45138 -
Advances in Nutrition (Bethesda, Md.) Sep 2023Resistant starch (RS) has become a popular topic of research in recent years. Most scholars believe that there are 5 types of RS. However, accumulating evidence... (Review)
Review
Resistant starch (RS) has become a popular topic of research in recent years. Most scholars believe that there are 5 types of RS. However, accumulating evidence indicates that in addition to starch-lipid complexes, which are the fifth type of RS, complexes containing starch and other substances can also be generated. The physicochemical properties and physiologic functions of these complexes are worth exploring. New physiologic functions of several original RSs are constantly being discovered. Research shows that RS can provide health improvements in many patients with chronic diseases, including diabetes and obesity, and even has potential benefits for kidney disease and colorectal cancer. Moreover, RS can alter the short-chain fatty acids and microorganisms in the gut, positively regulating the body's internal environment. Despite the increase in its market demand, RS production remains limited. Upscaling RS production is thus an urgent requirement. This paper provides detailed insights into the classification, synthesis, and efficacy of RS, serving as a starting point for the future development and applications of RS based on the current status quo.
Topics: Humans; Resistant Starch; Starch; Obesity
PubMed: 37276960
DOI: 10.1016/j.advnut.2023.06.001 -
JAMA Network Open Jan 2024Motor aphasia is common among patients with stroke. Acupuncture is recommended as an alternative therapy for poststroke aphasia, but its efficacy remains uncertain. (Randomized Controlled Trial)
Randomized Controlled Trial
IMPORTANCE
Motor aphasia is common among patients with stroke. Acupuncture is recommended as an alternative therapy for poststroke aphasia, but its efficacy remains uncertain.
OBJECTIVE
To investigate the effects of acupuncture on language function, neurological function, and quality of life in patients with poststroke motor aphasia.
DESIGN, SETTING, AND PARTICIPANTS
This multicenter, sham-controlled, randomized clinical trial was conducted in 3 tertiary hospitals in China from October 21, 2019, to November 13, 2021. Adult patients with poststroke motor aphasia were enrolled. Data analysis was performed from February to April 2023.
INTERVENTIONS
Eligible participants were randomly allocated (1:1) to manual acupuncture (MA) or sham acupuncture (SA) groups. Both groups underwent language training and conventional treatments.
MAIN OUTCOMES AND MEASURES
The primary outcomes were the aphasia quotient (AQ) of the Western Aphasia Battery (WAB) and scores on the Chinese Functional Communication Profile (CFCP) at 6 weeks. Secondary outcomes included WAB subitems, Boston Diagnostic Aphasia Examination, National Institutes of Health Stroke Scale, Stroke-Specific Quality of Life Scale, Stroke and Aphasia Quality of Life Scale-39, and Health Scale of Traditional Chinese Medicine scores at 6 weeks and 6 months after onset. All statistical analyses were performed according to the intention-to-treat principle.
RESULTS
Among 252 randomized patients (198 men [78.6%]; mean [SD] age, 60.7 [7.5] years), 231 were included in the modified intention-to-treat analysis (115 in the MA group and 116 in the SA group). Compared with the SA group, the MA group had significant increases in AQ (difference, 7.99 points; 95% CI, 3.42-12.55 points; P = .001) and CFCP (difference, 23.51 points; 95% CI, 11.10-35.93 points; P < .001) scores at week 6 and showed significant improvements in AQ (difference, 10.34; 95% CI, 5.75-14.93; P < .001) and CFCP (difference, 27.43; 95% CI, 14.75-40.10; P < .001) scores at the end of follow-up.
CONCLUSIONS AND RELEVANCE
In this randomized clinical trial, patients with poststroke motor aphasia who received 6 weeks of MA compared with those who received SA demonstrated statistically significant improvements in language function, quality of life, and neurological impairment from week 6 of treatment to the end of follow-up at 6 months after onset.
TRIAL REGISTRATION
Chinese Clinical Trial Registry: ChiCTR1900026740.
Topics: United States; Adult; Male; Humans; Middle Aged; Aphasia, Broca; Quality of Life; Acupuncture Therapy; Communication; Stroke
PubMed: 38252438
DOI: 10.1001/jamanetworkopen.2023.52580 -
Journal of Clinical Medicine Aug 2023Chemotherapy, as well as opioid and antiemetic drugs, can contribute to constipation in oncological patients. This systematic review aims to analyse the potential of... (Review)
Review
BACKGROUND
Chemotherapy, as well as opioid and antiemetic drugs, can contribute to constipation in oncological patients. This systematic review aims to analyse the potential of specific rehabilitation strategies and alternative strategies for improving constipation symptoms, with the goal of incorporating these strategies into a dedicated protocol for managing cancer-related constipation. This could potentially reduce the dosages of or eliminate the need for constipation medications.
METHODS
A systematic search was conducted on PubMed, Scopus and Web of Science. The review included studies analysing constipation complaints in cancer patients treated with rehabilitation, acupuncture and osteopathy.
RESULTS
The review included 16 studies in line with PRISMA and PICOS criteria. Most studies showed that physical exercise, abdominal massage, TENS, acupuncture and education on the correct defecation position positively impacted the management of constipation and quality of life in oncological patients. A physiotherapy program involving massages as well as aerobic and resistance training improved constipation in oncological women, regardless of age, sex and frailty. A combination of abdominal massage, abdominal muscle stretching and education on proper defecation position alleviated the severity of constipation and related depression. However, the outcomes regarding TENS were yet inconsistent. Another technique, becoming increasingly common for constipation, and demonstrating positive results, involved stimulating trigger points through acupressure and acupuncture. Conversely, osteopathic and superficial manipulations more frequently required constipation medications than did the other alternative approaches. However, no existing studies have proposed a specific protocol to manage cancer-related constipation.
CONCLUSIONS
The results of the studies confirm the positive influences of rehabilitation, osteopathy and acupuncture on constipation and pain in oncological patients. Nevertheless, further studies are required to establish the best type, timing and duration of treatment, as well as how the stage and location of the cancer and the cause of constipation (drug-induced or functional) impact the results.
PubMed: 37568485
DOI: 10.3390/jcm12155083