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JMIR Research Protocols Jun 2024Vascular cognitive impairment (VCI) persistently impairs cognition and the ability to perform activities of daily living, seriously compromising patients' quality of... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Vascular cognitive impairment (VCI) persistently impairs cognition and the ability to perform activities of daily living, seriously compromising patients' quality of life. Previous studies have reported that disorders of serum iron metabolism and iron deposition in the brain can lead to inflammation, abnormal protein aggregation and degeneration, and massive neuronal apoptosis in the central nervous system, which in turn leads to a progressive decline in cognitive processes. Our previous clinical studies have found acupuncture to be a safe and effective intervention for treating VCI, but the specific mechanisms require further exploration.
OBJECTIVE
The objective of the trial is to evaluate the clinical efficacy of Tongdu Xingshen acupuncture and to investigate whether it can improve VCI by regulating brain iron deposition and body iron metabolism.
METHODS
In total, 42 patients with VCI and 21 healthy individuals will participate in this clinical trial. The 42 patients with VCI will be randomized into acupuncture and control groups, while the 21 healthy individuals will be in the healthy control group. Both the control and acupuncture groups will receive conventional medical treatment and cognitive rehabilitation training. In addition, the acupuncture group will receive electroacupuncture treatment with Tongdu Xingshen for 30 minutes each time, 6 times a week for 4 weeks. Meanwhile, the healthy control group will not receive any intervention. All 3 groups will undergo baseline assessments of brain iron deposition, serum iron metabolism, and neuropsychological tests after enrollment. The acupuncture and control groups will be evaluated again at the end of 4 weeks of treatment, as described earlier. By comparing neuropsychological test scores between groups, we will examine the efficacy of Tongdu Xingshen acupuncture in treating VCI. Additionally, we will test the correlations between neuropsychological test scores, brain iron deposition, and body iron metabolism indexes to explore the possible mechanisms of Tongdu Xingshen acupuncture in treating VCI.
RESULTS
Participants are currently being recruited. The first participant was enrolled in June 2023, which marked the official start of the experiment. As of the submission of the paper, there were 23 participants. The recruitment process is expected to continue until June 2025, at which point the processing and analysis of data will begin. As of May 15, 2024, up to 30 people have been enrolled in this clinical trial.
CONCLUSIONS
This study will provide data on the effects of Tongdu Xingshen acupuncture on cerebral iron deposition as well as somatic iron metabolism in patients with VCI. These results will help to prove whether Tongdu Xingshen acupuncture can improve VCI by regulating brain iron deposition and body iron metabolism, which will provide the clinical and theoretical basis for the wide application of acupuncture therapy in VCI rehabilitation.
TRIAL REGISTRATION
China Clinical Registration Agency ChiCTR2300072188; https://tinyurl.com/5fcydtkv.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID)
PRR1-10.2196/56484.
Topics: Humans; Acupuncture Therapy; Iron; Brain; Cognitive Dysfunction; Male; Female; Middle Aged; Aged; Adult
PubMed: 38885500
DOI: 10.2196/56484 -
Frontiers in Endocrinology 2024Graphene-based warm uterus acupoint paste (GWUAP) is an emerging non-drug alternative therapy for the treatment of primary dysmenorrhea (PD), but the underlying...
Graphene-based warm uterus acupoint paste (GWUAP) is an emerging non-drug alternative therapy for the treatment of primary dysmenorrhea (PD), but the underlying mechanism is still unclear. SD female rats were randomly divided into control group, model group and treatment group to explore the mechanism of GWUAP in the treatment of PD. Combined with 16S rDNA and fecal metabolomics, the diversity of microbiota and metabolites in each group was comprehensively evaluated. In this study, GWUAP reduced the torsion score of PD model rats, improved the pathological morphology of uterine tissue, reduced the pathological damage score of uterine tissue, and reversed the expression levels of inflammatory factors, pain factors and sex hormones. The 16 S rDNA sequencing of fecal samples showed that the abundance of Lactobacillus in the intestinal flora of the model group decreased and the abundance of Romboutsia increased, while the abundance of Lactobacillus in the intestinal flora of the treatment group increased and the abundance of Romboutsia decreased, which improved the imbalance of flora diversity in PD rats. In addition, 32 metabolites related to therapeutic effects were identified by metabolomics of fecal samples. Moreover, there is a close correlation between fecal microbiota and metabolites. Therefore, the mechanism of GWUAP in the treatment of PD remains to be further studied.
Topics: Animals; Female; Dysmenorrhea; Rats; Rats, Sprague-Dawley; Metabolomics; Acupuncture Points; Gastrointestinal Microbiome; RNA, Ribosomal, 16S; Feces; DNA, Ribosomal
PubMed: 38872962
DOI: 10.3389/fendo.2024.1397402 -
Frontiers in Neurology 2024Drawing on the principles of wrist-ankle acupuncture (WAA), our research team has developed a portable device for WAA point compression, termed the acupressure...
BACKGROUND
Drawing on the principles of wrist-ankle acupuncture (WAA), our research team has developed a portable device for WAA point compression, termed the acupressure wrist-ankle strap (AWA). The current study aims to evaluate the efficacy of the AWA in alleviating pain associated with primary dysmenorrhea.
METHODS
A single-blind, randomized clinical trial was conducted from April 1, 2019, to December 31, 2019. 78 participants with primary dysmenorrhea were recruited from Shanghai University of Traditional Chinese Medicine. All participants were treated on the first day of menstruation for 30 min. Participants in the AWA group used the AWA, the internal side of which is equipped with a tip compression component, while participants in the non-acupressure wrist-ankle acupuncture(NAWA)group used the NAWA, with the inside tip pressing parts removed. The main outcome was the difference in visual analogue scale (VAS) score between baseline and 30 minutes after randomization.
RESULTS
A total of 78 participants aged 18 to 30 years were included in the intention-to-treat analyses. The VAS scores (mean [standard deviation]) in the AWA group were significantly lower than those in the NAWA group at each time point of intervention (5 minutes: 95% CI, [-1.27 to -0.68], < 0.001; 10 minutes: 95% CI, [-2.34 to -1.51], < 0.001; 30 minutes: 95% CI, [-3.74 to -2.72], < 0.001). In the AWA group, 16 participants reported "obvious relief" of dysmenorrhea pain while 23 did not; the average onset time of analgesia they reported were (21.50 ± 3.65) min, while no subjects in NAWA group reported obvious pain relief. The pain threshold (mean [standard deviation]) at SP9 of both sides in AWA group decreased significantly after intervention that in NAWA group (Left: 95% CI, [-5.02 to -1.81], < 0.001; Right: 95% CI, [-7.67 to -4.24], < 0.001). There was no significant change in the temperature at CV4 in either group (95% CI, [-0.63 to -0.66], = 0.970).
CONCLUSION
This trial substantiates our hypothesis that the AWA provides immediate analgesic effects. The AWA represents an effective and safe non-invasive physical therapy option, which patients can self-administer to alleviate abdominal pain.
PubMed: 38872824
DOI: 10.3389/fneur.2024.1362586 -
BMJ Open Jun 2024Primary dysmenorrhoea (PD) is a common menstrual concern with significant physical and psychosocial impacts. The effectiveness and safety of transcutaneous electrical... (Randomized Controlled Trial)
Randomized Controlled Trial
INTRODUCTION
Primary dysmenorrhoea (PD) is a common menstrual concern with significant physical and psychosocial impacts. The effectiveness and safety of transcutaneous electrical acupoint stimulation (TEAS) in alleviating PD symptoms remain uncertain due to insufficient evidence. This single-centre, parallel, randomised controlled study intends to evaluate the efficacy and safety of TEAS for PD management.
METHODS AND ANALYSIS
60 participants aged 18-40 years diagnosed with moderate to severe PD will be recruited from Tai'an Hospital of Traditional Chinese Medicine (TCM) and randomly assigned to either a TEAS group or a TEAS-sham group (1:1). The TEAS group will undergo 12 sessions of TEAS treatment over two menstrual cycles, with 30 min per session, three sessions weekly. Participants in the TEAS-sham group will receive TEAS stimulation using identical devices and protocols but without current output. The primary outcome is the Visual Analogue Scale (VAS) for pain assessment. Secondary outcomes are Short-Form McGill Pain Questionnaire, total effective rate, uterine artery haemodynamics, prostaglandin and β-endorphin level, mental well-being and quality of life. Adverse events and their potential reasons and the use of analgesics will also be recorded.
ETHICS AND DISSEMINATION
This study was approved by the Medical Ethics Committee of Tai'an Hospital of TCM. Written informed consent will be obtained from each participant. The results will be submitted for publication in a peer-reviewed journal.
TRIAL REGISTRATION NUMBER
ChiCTR2300071686.
Topics: Humans; Dysmenorrhea; Female; Transcutaneous Electric Nerve Stimulation; Acupuncture Points; Adult; Young Adult; China; Adolescent; Pain Measurement; Treatment Outcome; Randomized Controlled Trials as Topic; Quality of Life
PubMed: 38866569
DOI: 10.1136/bmjopen-2023-078895 -
Frontiers in Neurology 2024Post-stroke dysphagia (PSD) affects the efficacy and safety of swallowing, causing serious complications. Acupuncture is a promising and cost-effective treatment for...
BACKGROUND
Post-stroke dysphagia (PSD) affects the efficacy and safety of swallowing, causing serious complications. Acupuncture is a promising and cost-effective treatment for PSD; however, as the number of randomized controlled trials increases, scientific analysis of the parameters and acupoint prescription is required. Therefore, this study aimed to explore the effects of acupuncture on parameters related to post-stroke dysphagia (PSD).
METHODS
We searched the Cochrane Library, PubMed, Embase, Web of Science, China National Knowledge Infrastructure, Wanfang Database, Chinese Biomedical Literature, and Chongqing VIP Database for randomized controlled trials of acupuncture for PSD in the last 15 years and relevant parameters were analyzed using data mining techniques.
RESULTS
In total, 3,205 records were identified, of which 3,507 patients with PSD were included in 39 studies. The comprehensive analysis demonstrated that the closest parameter combinations of acupuncture on PSD were 0.25 mm × 40 mm needle size, 30 min retention time, five treatments per week, and a 4-week total course of treatment. Additionally, the gallbladder and nontraditional meridians, crossing points, and head and neck sites are the most commonly used acupoint parameters. The core acupoints identified were GB20, RN23, EX-HN14, Gongxue, MS6, SJ17, EX-HN12, EX-HN13, and the commonly used combination of EX-HN12, EX-HN13, GB20, and RN23.
CONCLUSION
This study analyzed the patterns of PSD-related needling and acupoint parameters to provide evidence-based guidelines for clinical acupuncturists in treating PSD, potentially benefitting affected patients.
PubMed: 38854959
DOI: 10.3389/fneur.2024.1394348 -
Medical Science Monitor : International... Jun 2024BACKGROUND This study embarked on an innovative exploration to elucidate the effects of integrating electroacupuncture (EA) with motor training (MT) on enhancing...
BACKGROUND This study embarked on an innovative exploration to elucidate the effects of integrating electroacupuncture (EA) with motor training (MT) on enhancing corticospinal excitability and motor learning. Central to this investigation is the interplay between homeostatic and non-homeostatic metaplasticity processes, providing insights into how these combined interventions may influence neural plasticity and motor skill acquisition. MATERIAL AND METHODS The investigation enrolled 20 healthy volunteers, subjecting them to 4 distinct interventions to parse out the individual and combined effects of EA and MT. These interventions were EA alone, MT alone, EA-priming followed by MT, and MT-priming followed by EA. The assessment of changes in primary motor cortex (M1) excitability was conducted through motor-evoked potentials (MEPs), while the grooved pegboard test (GPT) was used to evaluate alterations in motor performance. RESULTS The findings revealed that EA and MT independently contributed to enhanced M1 excitability and motor performance. However, the additional priming with EA or MT did not yield further modulation in MEPs amplitudes. Notably, EA-priming was associated with improved GPT completion times, underscoring its potential in facilitating motor learning. CONCLUSIONS The study underscores that while EA and MT individually augment motor cortex excitability and performance, their synergistic application does not further enhance or inhibit cortical excitability. This points to the involvement of non-homeostatic metaplasticity mechanisms. Nonetheless, EA emerges as a critical tool in preventing M1 overstimulation, thereby continuously fostering motor learning. The findings call for further research into the strategic application of EA, whether in isolation or with MT, within clinical settings to optimize rehabilitation outcomes.
Topics: Humans; Electroacupuncture; Male; Motor Cortex; Learning; Female; Evoked Potentials, Motor; Adult; Healthy Volunteers; Transcranial Magnetic Stimulation; Neuronal Plasticity; Young Adult; Motor Skills; Pyramidal Tracts
PubMed: 38853414
DOI: 10.12659/MSM.943748 -
Medicine Jun 2024Since ancient times, acupuncture has been utilized in the treatment of lots of diseases, as a part of Traditional Chinese Medicine. Acupoint embedding (AEM) therapy,... (Review)
Review
Since ancient times, acupuncture has been utilized in the treatment of lots of diseases, as a part of Traditional Chinese Medicine. Acupoint embedding (AEM) therapy, known as catgut embedding, is a development of acupuncture that consists of inserting catgut or surgical threads into specific acupoints to produce continuous acupoint stimulation based on the theory of Traditional Chinese Medicine. The remaining thread in the acupoint works as a semi-permanent acupuncture needle that results in decreasing the total time of the treatment which is required for continuous manual acupuncture sessions and increasing the treatment efficacy and patients' satisfaction. In each session of AEM about twenty 1 to 2 cm-long threads-natural origin, synthetic polymer, or bioactive threads-will be inserted at the target acupoints and this process will be repeated every 3 to 4 weeks. Indications of AEM are somehow similar to manual acupuncture including obesity, pain, musculoskeletal inflammations, infertility, etc, and it cannot be performed on pregnant women and pediatrics. AEM demonstrates its therapeutic effects via modulating immune system function, alleviating body inflammatory conditions, affecting the neurohormonal system, and other mechanisms. Subcutaneous indurations, redness, bleeding, hematoma, and bruising are some adverse events reported following the AEM. In conclusion, the scientific literature suggests that AEM is a relatively safe and convenient therapy if performed by a professional skilled practitioner.
Topics: Humans; Acupuncture Therapy; Acupuncture Points; Catgut; Medicine, Chinese Traditional
PubMed: 38847703
DOI: 10.1097/MD.0000000000038314 -
Heliyon Jun 2024The goal of the research is to investigate the link between serum potassium levels and death after 28 days in sepsis patients, utilizing an extensive sample of patients...
OBJECTIVE
The goal of the research is to investigate the link between serum potassium levels and death after 28 days in sepsis patients, utilizing an extensive sample of patients from the multi-center Medical Information Mart for Intensive Care IV (MIMIC-IV) database. Current research on serum potassium levels and 28-day mortality in sepsis patients is questionable. This study adds to the growing body of evidence linking serum potassium levels to the 28-day possibility of death in patients with sepsis.
METHODS
We collected 349,08 patients with sepsis from the retrospective cohort MIMIC-IV database, using serum potassium level on the first day of admission to the intensive care unit as the exposure variable and mortality at 28 days as the outcome variable. And controlled for confounding characteristics including gender, age, ethnicity, and vital signs during admission.
RESULTS
Serum potassium has a U-shaped connection with 28-day mortality in patients suffering from sepsis. The turning point was 4.10 mmol/L (95 % confidence interval: 4.03 to 4.22). Serum potassium and 28-day mortality were negatively linked on the inflection point's left side (OR: 0.72; 95 % CI: 0.63 to 0.83, P < 0.0001); on the opposing side of the point of inflexion, serum potassium was enthusiastically attached to 28-day mortality. (OR: 1.13; 95 % CI: 1.06 to 1.21, P < 0.0001).
CONCLUSION
The research conducted found that too high or too low potassium levels were linked to a 28-day risk of mortality in humans with sepsis.
PubMed: 38845906
DOI: 10.1016/j.heliyon.2024.e31753 -
Integrative Medicine Research Jun 2024Acupuncture shows promise as an effective nonpharmacologic option for reduction of acute pain in the emergency department (ED). Following CONSORT and STRICTA guidelines,...
Fidelity to the acupuncture intervention protocol in the ACUpuncture In The EmergencY department for pain management (ACUITY) trial: Expanding the gold standard of STRICTA and CONSORT guidelines.
BACKGROUND
Acupuncture shows promise as an effective nonpharmacologic option for reduction of acute pain in the emergency department (ED). Following CONSORT and STRICTA guidelines, randomized controlled trials (RCTs) generally report intervention details and acupoint options, but fidelity to acupuncture interventions, critical to reliability in intervention research, is rarely reported.
METHODS
ACUITY is an NCCIH-funded, multi-site feasibility RCT of acupuncture in 3 EDs (Cleveland, Nashville, and San Diego). ACUITY acupuncturists were trained in study design, responsive acupuncture manualization protocol, logistics and real-time recording of session details via REDCap forms created to track fidelity.
RESULTS
Across 3 recruiting sites, 79 participants received acupuncture: 51 % women, 43 % Black/African American, with heterogeneous acute pain sites at baseline: 32 % low back, 22 % extremity, 20 % abdominal, 10 % head. Pragmatically, participants were treated in ED common areas (52 %), private rooms (39 %), and semi-private rooms (9 %). Objective tracking found 98 % adherence to the six components of the acupuncture manualization protocol: staging, number of insertion points ( = 13.2, range 2-22), needle retention time ( = 23.5 min, range 4-52), session length ( = 40.3 min, range 20-66), whether general recommendations were provided and completion of the session form.
CONCLUSION
To the best of our knowledge, this is the first RCT to assess and report fidelity to an acupuncture protocol. Fidelity monitoring will be fundamental for ACUITY2, which would be a future definitive, multi-site RCT. Furthermore, we recommend that fidelity to acupuncture interventions be added to CONSORT and STRICTA reporting guidelines in future RCTs.
PROTOCOL REGISTRATION
The protocol of this study is registered at clinicaltrials.gov: NCT04880733.
PubMed: 38841077
DOI: 10.1016/j.imr.2024.101048 -
Medical Science Monitor : International... Jun 2024Uterine fibroids, benign tumors originating from uterine smooth muscle cells, vary in prevalence depending on patient ethnicity, hormonal exposure, and genetics. Due to... (Review)
Review
Uterine fibroids, benign tumors originating from uterine smooth muscle cells, vary in prevalence depending on patient ethnicity, hormonal exposure, and genetics. Due to their high incidence, these neoplasms pose a significant burden on healthcare systems. Current treatment strategies range from routine monitoring in asymptomatic cases to surgical procedures such as myomectomy or hysterectomy in symptomatic patients, with an increasing trend toward uterus-preserving or non-surgical alternatives. This review examines the existing medical treatments for uterine fibroids and delves into the potential of emerging therapies. A scoping review of the literature was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews. Medical therapies are divided into hormonal and non-hormonal treatments; however, long-term, safe, and effective treatments in the treatment of uterine fibroids are limited. In addition to established therapies, there is an increasing number of studies investigating the effect of substances such as vitamin D or green tea extract on uterine fibroids. Some studies investigate acupuncture as a possible alternative therapy. While existing treatments offer symptomatic relief and preparation for surgery, our findings point to a significant need for further research into long-term solutions, especially owing to recent limitations in the use of ulipristal acetate due to risk of liver damage. Initial studies involving vitamin D and epigallocatechin gallate are encouraging; however, additional research is required to establish definitive therapeutic roles.
Topics: Humans; Leiomyoma; Female; Uterine Neoplasms; Vitamin D; Uterine Myomectomy; Acupuncture Therapy; Hysterectomy; Norpregnadienes
PubMed: 38837949
DOI: 10.12659/MSM.943614