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BACKGROUND: The effectiveness of acupuncture for patients with chronic spontaneous urticaria (CSU), reported in a few small-scale studies, is not convincing. OBJECTIVE: To investigate whether acupuncture leads to better effects on CSU than sham acupuncture or waitlist control. DESIGN: A multicenter, randomized, sham-controlled trial. (Chinese Clinical Trial Registry: ChiCTR1900022994). SETTING: Three teaching hospitals in China from 27 May 2019 to 30 July 2022. PARTICIPANTS: 330 participants diagnosed with CSU. INTERVENTION: Participants were randomly assigned in a 1:1:1 ratio to receive acupuncture, sham acupuncture, or waitlist control over an 8-week study period (4 weeks for treatment and another 4 weeks for follow-up). MEASUREMENTS: The primary outcome was the mean change from baseline in the Weekly Urticaria Activity Score (UAS7) at week 4. Secondary outcomes included itch severity scores, self-rated improvement, and Dermatology Life Quality Index scores. RESULTS: The mean change in UAS7 (range, 0 to 42) for acupuncture from baseline (mean score, 23.5 [95% CI, 21.8 to 25.2]) to week 4 (mean score, 15.3 [CI, 13.6 to 16.9]) was -8.2 (CI, -9.9 to -6.6). The mean changes in UAS7 for sham acupuncture and waitlist control from baseline (mean scores, 21.9 [CI, 20.2 to 23.6] and 22.1 [CI, 20.4 to 23.8], respectively) to week 4 (mean scores, 17.8 [CI, 16.1 to 19.5] and 20.0 [CI, 18.3 to 21.6], respectively) were -4.1 (CI, -5.8 to -2.4) and -2.2 (CI, -3.8 to -0.5), respectively. The mean differences between acupuncture and sham acupuncture and waitlist control were -4.1 (CI, -6.5 to -1.8) and -6.1 (CI, -8.4 to -3.7), respectively, which did not meet the threshold for minimal clinically important difference. Fifteen participants (13.6%) in the acupuncture group and none in the other groups reported adverse events. Adverse events were mild or transient. LIMITATION: Lack of complete blinding, self-reported outcomes, limited generalizability because antihistamine use was disallowed, and short follow-up period. CONCLUSION: Compared with sham acupuncture and waitlist control, acupuncture produced a greater improvement in UAS7, although the difference from control was not clinically significant. Increased adverse events were mild or transient. PRIMARY FUNDING SOURCE: The National Key R&D Program of China and the Science and Technology Department of Sichuan Province.
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Terapia por Acupuntura , Urticaria Crónica , Urticaria , Humanos , Terapia por Acupuntura/efectos adversos , Urticaria Crónica/terapia , Urticaria Crónica/etiología , China , Resultado del Tratamiento , Urticaria/terapia , Urticaria/etiologíaRESUMEN
The purpose of this study was to observe and compare the clinical efficacy of active acupuncture and placebo acupuncture in the treatment of insomnia and mood disorders. 96 patients with insomnia in Chengdu were randomly divided into two groups (1:1). The active acupuncture group (AA group n = 48) received the tube of Park sham device with deep needle insertion. The placebo acupuncture group (PA group n = 48) received the tube of Park sham device with a retractable needle shaft and a blunt tip. The same acupuncture points and treatment cycles were used in both groups. The overall score for the Pittsburgh Sleep Quality Index (PSQI) is the primary outcome. Secondary outcomes recorded sleep rate, self-reported depression scale (SDS), self-assessment anxiety scale (SAS), the 'six component' scores of PSQI, and 'Deqi' scale scores. Eventually, 90 patients completed the study. After 2 weeks of treatment, the total score of PSQI in the AA group was 4.6 ± 2.4 and in the PA group was 12.9 ± 1.8 (ES = 3.91, p < .1). The SAS, SDS score in the AA group were 39.9 ± 5.6/39.9 ± 5.9 and in the PA group were 59.7 ± 6.1/61.2 ± 4.4 (ES = 3.38/4.9, p < .1). The sleep rate were 93.8% and 25.0% (p < .1). During the 1 month follow-up period, the PSQI total score in the AA group (5.2 ± 1.9) was superior to the PA group (13.1 ± 1.8) (ES = 4.27, p < .1). The SAS, SDS score in the AA group were 40.4 ± 5.1/42.7 ± 6.6 and in the PA group were 63.7 ± 6.6/63.5 ± 4.8 (ES = 3.95/3.60, p < .1). Throughout the study period, the 'six component' scores of PSQI in the AA group was superior to the PA group (each p < .1). Except for tingling and cooling, other acupuncture sensations were significant differences (each p < .1). Compared to the placebo acupuncture, active acupuncture can significantly improve insomnia, and clinical efficacy is maintained for at least 6 weeks.
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Terapia por Acupuntura , Evaluación de Resultado en la Atención de Salud , Trastornos del Inicio y del Mantenimiento del Sueño/terapia , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , PlacebosRESUMEN
BACKGROUND: Primary insomnia is a common health issue in the modern world. We conducted a systematic review of the auricular therapy, aiming to evaluate whether there are advantages of auricular acupuncture with seed or pellet attachments for the treatment of primary insomnia. METHODS: A search of relevant literatures was performed on major medical databases, including Medline, Embase, CENTRAL, CBM, CNKI, VIP, Wanfang Data and so on. Risk of bias evaluation, meta-analysis, sensitivity analysis and evidence rating of all extracted information were conducted also. RESULTS: A total of 1381 records were identified, with 15 studies deemed eligible for the present review. Meta-analyses were conducted in two comparisons separately: participants received auricular acupuncture were more likely to make an improvement in clinical effective rate (RR = 1.40, 95% CI 1.07 to 1.83), sleep duration (MD = 56.46, 95% CI 45.61 to 67.31), sleep efficiency(MD = 12.86, 95% CI 9.67 to 16.06), global score on PSQI (MD = -3.41, 95% CI -3.93 to -2.89), number of awakenings( MD = -3.27, 95% CI -6.30 to -0.25) and sleep onset latency(MD = -10.35, 95% CI -14.37 to -6.33) when compared to sham auricular acupuncture or placebo; while in auricular acupuncture VS medications comparison, a better effective rate (RR = 1.24, 95% CI 1.15 to 1.34), better sleep efficiency(MD = 21.44, 95% CI 16.30 to 26.58), lower PSQI score (MD = -3.62, 95% CI -4.59 to -2.65) and less adverse effect (RR = 0.11, 95% CI 0.04 to 0.26) can be seen also in auricular acupuncture group. Although these results suggested benefits of auricular acupuncture, the overall quality of evidence rated by the GRADE system was low. CONCLUSION: Statistical analyses of the outcomes revealed a positive effect of auricular acupuncture for primary insomnia. Nonetheless, considering the poor methodological quality, insufficient sample size and possible publication bias, current evidence is not yet adequate to provide a strong support for the use of auricular acupuncture in the treatment of primary insomnia. More strictly designed clinical studies will be needed to obtain a more explicit conclusion.
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Acupuntura Auricular/métodos , Trastornos del Inicio y del Mantenimiento del Sueño/terapia , Sueño , Implantes de Medicamentos , Humanos , SemillasRESUMEN
BACKGROUND: Fu's subcutaneous needling (FSN) is an acupuncture technique for the treatment of soft tissue diseases. Knee osteoarthritis often involves lower limb muscles. This study aimed to observe and compare the clinical efficacy of Fu's subcutaneous acupuncture and electroacupuncture in the treatment of patients with knee osteoarthritis. METHODS: 62 patients with early or medial stage of knee osteoarthritis were randomly divided into the FSN therapy group or the electroacupuncture(EA) therapy group (1:1). The Lysholm score, range of motion, and equilibrium function were observed over a 3-month follow-up period. A total of 60 participants completed the study. RESULTS: Over the 3 months of follow-up, both treatment regimens showed equally favorable results on all prognostic measures compared with their respective baseline data (P<0.05). Compared with the EA group, the FSN group had a significantly greater improvement in claudication, joint stability, swelling, pain, and ROM after treatment (P<0.05). At 3 months after treatment, the FSN group revealed better scores of claudication, joint stability, swelling, walking up stairs, squatting, pain, ROM, and equilibrium function (forward and backward movement speed, left and right movement speed, movement ellipse area, movement length) compared to the EA group (all P<0.05). CONCLUSIONS: This study showed that FSN can significantly improve the pain symptoms, joint stability, and joint function of patients with knee osteoarthritis, and the clinical efficacy can be maintained at least 3 months after treatment.
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Terapia por Acupuntura , Osteoartritis de la Rodilla , Rango del Movimiento Articular , Humanos , Osteoartritis de la Rodilla/terapia , Femenino , Masculino , Persona de Mediana Edad , Anciano , Terapia por Acupuntura/métodos , Resultado del Tratamiento , Electroacupuntura/métodos , Articulación de la RodillaRESUMEN
Uremic pruritus (UP) is a chronic disease that can seriously affect the quality of life of dialysis patients. Acupuncture is a non-medication therapy that has been used to treat pruritus disorders. This systematic review aimed to evaluate the efficacy and safety of acupuncture for the treatment of UP. A total of nine Chinese and English databases were searched from their inception to December 31, 2021, and 214 studies were retrieved. Finally, seven randomized controlled trials (n=504) were included in the meta-analysis performed using RevMan V.5.3. Results included effective rate, recurrence rates, and adverse events. Compared with conventional treatment, acupuncture was more effective in treating UP (risk ratio [RR]=1.28, 95% confidence interval [CI]=1.09 to 1.50, P=0.003). The results were consistent after sensitivity analysis (RR=1.38, 95% CI=1.21 to 1.57, P<0.00001). In subgroup analysis, the efficacy rates of acupuncture and medications (oral and topical) were comparable (RR=1.20, 95% CI=0.98 to 1.47, P=0.07). Acupuncture combined with hemodialysis was more effective than hemodialysis alone in relieving pruritus (RR=1.42, 95% CI=1.18 to 1.72, P=0.0002). Adverse events were reported in only three studies, including one case of hyperphosphatemia in the medications group (RR=0.29, 95% CI=0.01 to 7.06, P=0.45). None of the studies reported recurrence rates. In conclusion, acupuncture is a safe treatment modality for patients with UP receiving hemodialysis that can effectively improve UP symptoms, and acupuncture in combination with hemodialysis has more efficacy than hemodialysis alone in improving the UP symptoms.
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Terapia por Acupuntura , Calidad de Vida , Humanos , Diálisis Renal , Terapia por Acupuntura/efectos adversos , Terapia por Acupuntura/métodos , Prurito/etiología , Prurito/terapiaRESUMEN
Introduction: Chronic spontaneous urticaria (CSU) is a common skin condition that can significantly impact patients' quality of life. Although studies have demonstrated the efficacy of acupuncture in treating CSU, the underlying mechanisms remain unclear. Dysfunction within the brain's default mode network (DMN) represents a fundamental characteristic of central pathological changes associated with CSU. Therefore, it is hypothesized that improving brain network dysfunction could serve as a key mechanism through which acupuncture exerts its therapeutic effects. This study aims to provide evidence supporting this hypothesis. Methods and analysis: This study, a parallel, randomized, sham-controlled functional neuroimaging investigation will be conducted in China. We aim to enroll 50 patients with CSU and 25 healthy controls, distributing them evenly between the acupuncture and sham acupuncture groups in a 1:1 ratio. The total observation period will span 6 weeks, including 2 weeks designated for the baseline phase and 4 weeks allocated for the clinical treatment phase. Prior to treatment, all participants will undergo magnetic resonance scanning, clinical index detection, and microbiota collection. Following treatment, the patients with CSU will be retested for these indicators. Using resting-state functional connectivity (rsFC) analysis, dynamic Functional Connection (dFC) analysis, and brain microstate extraction technology combined with correlation analysis of microbiota and clinical indicators, the regulatory mechanism of acupuncture on the brain network of CSU will be evaluated from multiple dimensions. Ethics and dissemination: This trial was approved by the Biomedical Ethics Review Committee of the West China Hospital, Sichuan University (No. 2022-1255). Each participant will provide written informed consent to publish any potentially identifiable images or data.Clinical trial registrationhttps://www.chictr.org.cn/, identifier: ChiCTR2200064563.
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Background: With societal and economic development, the annual incidence of chronic kidney disease (CKD) is increasing. Current treatments for CKD are limited, and once patients progress to the uraemic stage, it places a significant economic burden on families and society. Based on the "gut-kidney axis" theory and real-world research, this study aims to evaluate the clinical efficacy, safety, and potential mechanism of high-position colon dialysis combined with traditional Chinese medicine (TCM) retention enema in treating stage 3-5 chronic kidney disease (non-dialysis). Additionally, it seeks to identify new therapeutic targets and approaches for CKD treatment. Methods: The TCM decoction was analyzed using Ultra-Performance Liquid Chromatography-Quadrupole-Orbitrap-High Resolution Mass Spectrometry (UPLC-Q-Orbitrap-HRMS). Participants meeting the inclusion criteria were divided into a control group (n = 153) and a treatment group (n = 159) based on their preferences and physicians' recommendations. Both groups adhered to a high-quality low-protein, low-salt, low-phosphorus, and low-fat diet supplemented with essential amino acids, and were monitored for blood pressure, blood glucose, and blood lipids. The treatment group received high-position colon dialysis combined with TCM retention enemas (administered at least 12 times every other day). Results: Thirteen compounds were identified from the herbs by UPLC-Q-Orbitrap-HRMS. The CKD3-5 treatment group exhibited improvements in blood biochemistry and other laboratory indices, with significant enhancements in renal function-related indices for CKD4 and CKD5 stages (p < 0.05). Following treatment, indoxyl sulfate (IS), endotoxin, and D-lactic acid levels decreased to a certain extent in both groups, with a statistically significant difference observed within the treatment group (p < 0.05). The treatment group displayed a significant reduction in aerobic bacterial colonies, an increase in anaerobic bacterial colonies, a decrease in Escherichia coli colonies, and an increase in Bifidobacterium and Lactobacillus colonies (p < 0.05). No significant changes in colony numbers were observed in the control group. Conclusion: High-position colon dialysis combined with TCM retention enema may serve as an adjuvant treatment for CKD4-5 (non-dialysis), and its mechanism may be related to the reduction of uraemic toxins, improvement of intestinal mucosal barrier function, and regulation of intestinal microecology. Clinical Trial Registration: https://www.chictr.org.cn/, identifier ChiCTR2200062852.
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OBJECTIVE: To determine the feasibility of conducting a full-scale randomized controlled trial (RCT) and investigate the basic information and safety of acupuncture for patients with chronic spontaneous urticaria (CSU). METHODS: A total of 80 participants with CSU from July 2018 to July 2019 were randomly assigned to receive active acupuncture (n=41) on a fixed prescription of acupoints or sham acupuncture (n=39) with superficial acupuncture on non-acupuncture points through the completely randomized design. Patients in both groups received 5 sessions per week for 2 weeks, and participants were followed for a further 2 weeks. Feasibility was assessed by recruitment and randomization rates, retention of participants, treatment protocol adherence, and the incidence of adverse events (AEs). The clinical primary outcome was the changes from baseline weekly urticaria activity scores (UAS7) after treatment at 2 weeks. Secondary outcomes included the Visual Analogue Scale (VAS) score of itching intensity, Dermatology Life Quality Index (DLQI), Hamilton Depression Scale (HAMD), and Hamilton Anxiety Scale (HAMA). RESULTS: A total of 80 participants were enrolled. The recruitment rate of 24.02%, randomization rate of 100%, a loss rate of 6.25%, and no obvious AEs were observed in either group. The decrease from baseline in the mean UAS7 total score at week 2 in the active acupuncture group was -8.63 (95%CI, -11.78 to -5.49) and -6.21 (95%CI, -9.43 to -2.98) in the sham acupuncture group for a between-group difference of -2.42 (95% CI, -6.93 to 2.07). The change in the DLQI, VAS of itching intensity, HAMA, and HAMD were a slightly better improvement trend in the active acupuncture group than the sham acupuncture group, but the between-group difference was not significant. CONCLUSIONS: Active acupuncture had a better improvement trend in alleviating symptoms, improving quality of life and regulating the mood of anxiety and depression in patients with CSU than sham acupuncture. (Registration Nos. AMCTR-ICR-18000190 and ChiCTR2100054776).
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BACKGROUND: Standard doses of second-generation H1-antihistamines (sgAHs) as first-line treatment are not always effective in treating chronic spontaneous urticaria (CSU), and hence an increase in the dose of sgAHs is recommended. However, literature evaluating the efficacy and safety of this treatment remains inconclusive, highlighting the need for a systematic review and meta-analysis. The aim of this systematic review and meta-analysis was to evaluate the efficacy and safety of high-dose sgAHs compared with standard-dose sgAHs in treating CSU. METHODS: A systematic literature search of double-blind, randomized controlled trials (RCT) utilizing multiple doses of sgAHs was performed by searching the electronic databases Medline, Embase, PsycInfo, Cochrane databases, and Web of Science. Bibliographies were also manually searched. The Cochrane Risk of Bias Tool for assessing risk of bias was used to assess the quality of randomized controlled trials (RCTs). Two reviewers screened studies, extracted data, and evaluated the risk of bias independently. The response rate, the number of adverse events, somnolence, and withdrawal due to adverse events were extracted from each article. The data were combined and analyzed to quantify the safety and efficacy of the treatment. RevMan (V5.3) software was used for data synthesis. RESULTS: A total of 13 studies were identified, seven of which met the eligibility criteria for the meta-analysis. Our pooled meta-analyses showed that high-dose sgAHs was associated with a significantly higher response rate than standard-dose (RR 1.13, 95% CI 1.02 to 1.26; P = 0.02). Conversely, high doses of sgAHs were associated with significantly higher somnolence rates than standard dose (RD 0.05, 95% CI 0.01 to 0.09; P = 0.02). There was no significant difference in adverse events or withdrawal due to adverse events between standard- and high-dose treatments. CONCLUSIONS: Our analyses showed that a high dose of sgAHs (up to two times the standard dose) might be more effective than a standard dose in CSU treatment. High-dose and standard-dose sgAHs showed similar adverse events, except for somnolence, where incidence was found to be dose-dependent in some studies. However, given the limited number of studies, our meta-analysis results should be interpreted with caution.
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Urticaria Crónica , Antagonistas de los Receptores Histamínicos H1 no Sedantes , Humanos , Somnolencia , Ensayos Clínicos Controlados Aleatorios como Asunto , Urticaria Crónica/tratamiento farmacológico , Antagonistas de los Receptores Histamínicos/uso terapéuticoRESUMEN
Introduction: The purpose of this review is to evaluate the effectiveness and safety of acupuncture in the treatment of patients with gastrointestinal urticaria (GU) and to provide a clinician's guide to GU treatment options. Methods and analysis: We plan to search multiple databases (i.e., PubMed, EMBASE, Springer, Web of Science, Cochrane Library, China National Knowledge Infrastructure, Chinese Biomedical Literature Database and Wanfang Database) for studies published before September 1, 2022. We will electronically search for all relevant studies concerning clinical acupuncture treatments of GU, including unpublished conference articles and other gray literature. The language limit of this systematic review is Chinese and English. Any reports of clinical randomized controlled trials of acupuncture for the treatment of GU will be included in the study. Two researchers will perform independent data extraction to increase the quality of the data extraction. The primary outcome was the Urticaria Activity Score 7 (UAS7). Abdominal visual analog scale (VAS) for abdominal pain, dermatological life quality index (DLQI), the total effective rate, recurrence rate, and occurrence of adverse events were secondary outcomes. We will use RevMan V.5.3 statistical software for pairwise meta-analysis and ADDIS V.1.16.8 software for Bayesian network meta-analysis. If feasible, meta-regression and subgroup analyses will also be performed to address the potential causes of inconsistency and heterogeneity. We will conduct a GRADE assessment of the quality of evidence for the interventions included in this review. Discussion: This study may validate acupuncture as an alternative therapy for the effective treatment of GU. Trial registration number: PROSPERO CRD42022333977.
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The aim of this study was to observe the clinical effects and brain electrical potential changes following acupuncture in the treatment of insomnia patients with mood disorders. Ninety patients with insomnia who met the inclusion criteria were randomly divided into the active acupuncture group (AA group, n = 44) and sham acupuncture group (SA group, n = 46) at a ratio of 1:1. The primary outcome was the total score of the Pittsburgh Sleep Quality Index (PSQI), and the secondary outcomes were the total effective rate, Self-Rating Anxiety Scale (SAS), Self-Rating Depression Scale (SDS) scores, and values of steady-state visual evoked potentials (SSVEP). The two groups received acupuncture or sham acupuncture 10 times (2 weeks). Finally, the total PSQI scores of the AA group and SA group were significantly different (p < 0.05) at 2 weeks (6.11 ± 2.33 vs. 10.37 ± 4.73), 6 weeks (6.27 ± 1.39 vs. 11.93 ± 3.07), 18 weeks (6.32 ± 2.84 vs. 11.78 ± 2.95) and 42 weeks (8.05 ± 3.14 vs. 12.54 ± 2.81). Further analysis found that AA group patients received acupuncture treatment at any age after the same effect (p > 0.05). The SAS and SDS scores of the AA group were also significantly different from those of the SA group at each assessment time point (p < 0.05). The total effective rate of the AA group was 81.82%, while that of the SA group was 30.43% (p < 0.05). There was no significant difference between the AA group and SA group only in the brain potential of the parietal lobe (F4), left temporal lobe (C3) and right temporal lobe (T8) (P > 0.05), but there was a significant difference between other brain regions (P < 0.05). In addition, correlation analysis showed that there was a certain positive correlation between the total PSQI score, SAS score, efficacy level, and SSVEP value in the AA group as follows: C4 and the total PSQI score (r = 0.595, P = 0.041), F3 and SAS score (r = 0.604, P = 0.037), FPz and efficiency level of the frontal lobe (r = 0.581, P = 0.048), and O2 and efficiency level of the occipital lobe (r = 0.704, P = 0.011). Therefore, acupuncture have a good clinical effect on patients with insomnia and emotional disorders and have a significant regulatory effect on abnormally excited brain potentials.
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INTRODUCTION: Postmenopausal osteoporosis, caused by ageing and oestrogen deficiency, seriously threatens women's physical and mental health. Postmenopausal osteopenia is the transition from healthy bone to osteoporosis, and it may be the key period for preventing bone loss. Moxibustion, a physical therapy of Traditional Chinese Medicine, has potential benefits for osteoporosis treatment and prevention, but it has not been adequately studied. This study aims to explore the clinical effects and safety of moxibustion in delaying bone loss in postmenopausal women. METHODS AND ANALYSIS: In this parallel-design, randomised, patient-blind and assessor-blind, controlled clinical study, 150 women with osteopenia at low fracture risk will be randomly assigned to a moxibustion treatment (MT) group or a placebo-moxibustion control (PMC) group in a 1:1 ratio. In addition to the fundamental measures (vitamin D3 and calcium) as recommended by the guidelines, participants of the two groups will receive MT or PMC treatment for 42 sessions over 12 months. The primary outcome will be the bone mineral density (BMD) of the lumbar spine at the end of the 12-month treatment, and secondary outcomes will be the BMD of the femoral neck and total hip, T-scores, bone turnover markers, serum calcium levels, serum magnesium levels, serum phosphorus levels, serum parathyroid hormone levels and 25-hydroxyvitamin D levels, intensity of bone pain, quality of life, incidence of osteoporosis and fractures, usage of emergency drugs or surgery, participant self-evaluation of therapeutic effects and the rate of adverse events. All statistical analyses will be performed based on the intention-to-treat and per-protocol principle. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the Ethics Committee on Biomedical Research, West China Hospital of Sichuan University (permission number: 2021-1243). The results are expected to be published in peer-reviewed journals. TRIAL REGISTRATION NUMBER: ChiCTR2100053953.
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Enfermedades Óseas Metabólicas , Fracturas Óseas , Moxibustión , Osteoporosis Posmenopáusica , Osteoporosis , Humanos , Femenino , Posmenopausia , Calidad de Vida , Calcio , Osteoporosis Posmenopáusica/prevención & control , Osteoporosis Posmenopáusica/tratamiento farmacológico , Enfermedades Óseas Metabólicas/prevención & control , Enfermedades Óseas Metabólicas/tratamiento farmacológico , Densidad Ósea , Fracturas Óseas/prevención & control , Método Doble Ciego , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Background: Severe chronic constipation (SCC) is a common functional gastrointestinal (GI) disorder associated with disruptions in GI motility. Abnormalities between gut microbiota and microRNAs (miRNAs) are implicated in the pathogenesis of GI motility in SCC. Acupuncture has been shown to improve constipation-related symptoms and rebalance the gut microbiota. This protocol proposed a plan to explore the hypothesis that the efficacy of acupuncture is associated with the crosstalk between gut microbes and miRNAs in patients with SCC. Methods: This trial is designed as a randomized, sham-controlled trial involving 80 patients and 40 healthy volunteers. A total of 80 patients with SCC (≤2 mean spontaneous, complete bowel movements per week [CSBMs]) will be randomly allocated to receive either 16-session acupuncture at true acupoints or non-penetrating sham acupuncture at non-acupoints for 4 weeks. The primary outcome will be the proportion of patients with ≥3 mean weekly CSBMs over weeks 1-4 and 5-8. Secondary efficacy endpoints include bowel movements, stool consistency, degree of straining, and the quality of life. Healthy volunteers will not receive any clinical intervention. Fasting plasma and fecal samples will be analyzed by 16S rRNA third-generation sequencing and miRNA high-throughput sequencing technologies. Finally, a tripartite network analysis will be used to investigate the interactions among clinical efficacy, miRNAs, and intestinal microbiota. Discussion: From the perspective of microRNA-gut microbiota regulatory mechanisms, our results will partially illuminate the crucial role of fecal miRNAs and intestinal microbiota to understand how acupuncture exerts its anti-constipation role. Trial registration: This trial is registered with ChiCTR2100048831, registered 18 July 2021; ethical approval has been obtained from the Sichuan Regional Ethics Review of Committee on Traditional Chinese Medicine, approval ID: 2021KL-023.
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Background: Gender differences in hippocampal and parahippocampal gyrus (HIP/PHG) volumes have been reported in sleep disorders. Therefore, this study investigated the moderating effect of gender on the relationship between chronic insomnia disorder (CID) and the HIP/PHG functional connectivity (FC) network. Methods: For this study, 110 patients diagnosed with CID (43 men and 67 women) and 60 matched good sleep control (GSC) (22 men and 38 women) were recruited. These participants underwent resting-state functional magnetic resonance imaging scans, after which a 2 × 2 (diagnosis × gender) analysis of variance was used to detect the main and interactive effect of insomnia and gender on their HIP/PHG FC networks. Results: Although the main effect of insomnia on the HIP FC network was observed in the bilateral cerebellar tonsil, superior frontal gyrus, and the medial orbitofrontal cortex, effects on the PHG FC network were observed in the bilateral HIP and amygdala. In contrast, the main effect of gender on the HIP FC network was observed in the right cerebellum posterior lobe, the dorsolateral prefrontal cortex (DLPFC), and the supplemental motor area. Of note, the interactive effect of both insomnia and gender was observed in FCs between the right HIP and the dorsal anterior cingulate cortex, and then between the right PHG and DLPFC. Moreover, the FC between the right PHG and left DLPFC was positively associated with anxiety scores in the female patients with CID. Conclusion: Our study identified that gender differences in brain connectivity existed between the HIP/PHG and executive control network in patients diagnosed with CID, these results will eventually extend our understanding of the important role that gender plays in the pathophysiology of CID.
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Pruritus of chronic spontaneous urticaria (CSU) is one of the most common and irritating sensations that severely affects the quality of life. However, the changes in the functional connectivity (FC) between thalamic subregions and other brain regions have not been fully elucidated. This study aimed to explore the potential changes in brain neural circuits by focusing on various subregions of the thalamus in patients with CSU pruritus to contribute to the understanding of chronic pruritus from the perspective of central mechanisms. A total of 56 patients with CSU and 30 healthy controls (HCs) completed the data analysis. Urticaria Activity Score 7 (UAS7), pruritus visual analog score (VAS-P), Dermatological Life Quality Index (DLQI), and immunoglobulin E (IgE) values were collected to assess clinical symptoms. Seed-based resting-state functional connectivity (rs-FC) analysis was used to assess relevant changes in the neural circuits of the brain. Compared to HCs, seeds within the caudal temporal thalamus (cTtha) on the right side of patients with CSU showed increased rs-FC with the cerebellum anterior lobe (CAL). Seeds within the lateral prefrontal thalamus (lPFtha) on the right side showed increased rs-FC with both CAL and pons, while those within the medial prefrontal thalamus (mPFtha) on the right side showed increased rs-FC with both CAL and the dorsal lateral prefrontal cortex (dlPFC) on the right side. Seeds within the posterior parietal thalamus (PPtha) on the right side showed increased rs-FC with the cerebellum posterior lobe (CPL) on the left side. The UAS7 values and IgE levels were positively correlated with the rs-FC of the right dlPFC. Our results suggest that patients with CSU may exhibit stronger rs-FC alterations between certain thalamic subregions and other brain regions. These changes affect areas of the brain involved in sensorimotor and scratching. Trial registration number: [http://www.chictr.org.cn], identifier [ChiCTR1900022994].
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Background: Chronic urticaria (CU) can severely impair the quality of life. Acupuncture and related therapies have been widely used in the treatment of CU in China. This study aimed to summarize and critically evaluate the methodological and reporting quality of relevant systematic reviews (SRs) and present objective and comprehensive evidence on the effectiveness and safety of acupuncture and related therapies for CU. Methods: Eight electronic databases were searched from inception to October 2021 for SRs examining acupuncture and related therapies for CU, and gray literature was manually searched. Two authors independently identified SRs and extracted data. The methodological and reporting quality of these SRs were assessed by the Assessment of Multiple Systematic Reviews 2 (AMSTAR 2) tool and preferred reporting items for SRs and meta-analyses (PRISMA, 2020), respectively. In addition, the risk of bias in systematic reviews (ROBIS) was used to evaluate the risk of bias. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) framework was applied to evaluate the quality of evidence for outcome measures. Results: In total, 23 SRs, including a total of 11 outcome indicators, were published before October 2021. The AMSTAR-2 results showed that the methodological quality of all SRs was critically low; items 2, 3, 7, 9, 10, and 16 were found to have particularly low quality. For PRISMA, the reporting quality of the included SRs was unsatisfactory, and major reporting flaws were observed in the search strategy, synthesis method, certainly assessment, reporting biases, registrations, and financial support of the included SRs. For ROBIS, 22 SRs (95.65%) had a high risk of bias. Among the 55 outcomes assessed using the GRADE framework, there were 3 (5.45%) outcomes with moderate-quality evidence, 6 (10.91%) outcomes with low-quality evidence, and 46 (83.64%) outcomes with very low-quality evidence. We found the moderate quality of evidence indicating that the total effective rate and curing rate of the acupuncture group were higher than those of the western medicine group, and the recurrence rate was lower than that of the western medicine group. Conclusions: Acupuncture and related therapies for the treatment of CU are supported by low-quality evidence-based medicine. However, considering the poor quality of these SRs, we suggest that studies with more rigorous designs, larger sample sizes, and higher methodological and reporting quality are necessary to provide stronger evidence. Registration. The protocol for this study has been registered (PROSPERO registration number: CRD42021259131).
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OBJECTIVE: To determine whether electroacupuncture (EA) could alleviate visceral hypersensitivity in diarrhea-predominant irritable bowel syndrome (IBS-D) rats by inhibiting EGCs activity via the BDNF/TrkB signaling pathway. METHODS: Sprague Dawley rats were randomly divided to a control group (n = 8) and a model preparation group (n = 32), which received Senna solution by gavage and CUMS (chronic unpredictable mild stress) for 14 consecutive days and was further divided to a Model group, an EA group (only electroacupuncture), an EA + TrkB agonist group (electroacupuncture and TrkB), and an EA + DMSO group (electroacupuncture and DMSO, n = 8 for each). Rats in the three EA groups were acupunctured at ST25, ST36, and LR3 for 20 min every day for 14 days. Abdominal withdrawal reflex (AWR) was used to quantify visceral sensitivity; reverse transcription polymerase chain reaction (RT-PCR) and double immunofluorescent staining were used to detect the colocalized expression of GFAP/BDNF and GFAP/TrkB. Western Blot (WB) was used to detect the expression of PLC and SP in the colon. Flow cytometry was used to detect the expression of Ca2+. RESULTS: EA effectively alleviated visceral hypersensitivity in IBS-D rats (P < 0.05). Compared to the control group, the expression of BDNF, TrkB, PLC, SP, and Ca2+ and the colocalized expression of GFAP/BDNF and GFAP/TrkB increased in the Model group (P < 0.05), while all these parameters decreased in the EA group following EA intervention (P < 0.05). In addition, no significant difference was found between the EA + TrkB agonist group and the control group (P > 0.05). CONCLUSIONS: EA alleviates visceral hypersensitivity of IBS-D rats possibly by inhibiting the activity of EGCs through the BDNF/TrkB-PLC-Ca2+ signaling pathway in the colon.
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INTRODUCTION: Chronic spontaneous urticaria (CSU) is a troublesome dermatological problem that can have a significant impact on quality of life. Previous studies have indicated that acupuncture may be beneficial for patients with CSU. However, well-designed studies determine the effects of acupuncture on CSU are rare. The aim of this study is to investigate the efficacy and safety of acupuncture treatment for patients with CSU. METHODS AND ANALYSIS: This study is designed as a multicentre, parallel, three-arm, randomised, sham-controlled trial. A total of 330 patients diagnosed as CSU will be randomly allocated into three groups: the verum acupuncture group, the sham acupuncture group and the waiting-list control group in a 1:1:1 ratio. Patients in the verum and sham acupuncture groups will receive 16 treatment sessions over 4 weeks, while patients in the waiting-list control group will not receive any acupuncture treatment. The primary outcome is the changes of weekly urticaria activity scores at the end of treatment. Secondary outcomes include itching severity measurement, Dermatology Life Quality Index, Hamilton Depression Scale, Hamilton Anxiety Scale, Pittsburgh Sleep Quality Index and serum total IgE level. Adverse events will be recorded during the study observation period. All patients who are randomised in this study will be included in the intention-to-treat analysis. ETHICS AND DISSEMINATION: Ethical approval of this study has been granted by the Sichuan Regional Ethics Review of Committee on Traditional Chinese Medicine (TCM) (ID: 2019 kl-006), the Medical Ethic Committee of the First Hospital of Wuhan (ID: (2019) number 7)) and the Medical Ethics Committee of the First Hospital of Hunan University of TCM (ID: HN-LLKY-2019-017-01/03) in three clinical centres in China, respectively. The results will be disseminated through peer-reviewed journals. TRIAL REGISTRATION NUMBER: ChiCTR1900022994.
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Terapia por Acupuntura , Urticaria Crónica , Terapia por Acupuntura/métodos , Urticaria Crónica/terapia , Humanos , Medicina Tradicional China , Estudios Multicéntricos como Asunto , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como Asunto , Resultado del TratamientoRESUMEN
BACKGROUND: Many patients with chronic insomnia disorder (CID) have gastrointestinal (GI) symptoms. First-line insomnia medications do not treat GI problems. Acupuncture has a comprehensive regulative action on both CID and GI disorder and is receiving increasing attention. Recent studies indicate that both CID and GI diseases may cause abnormal brain activity. However, the neurological mechanism underlying the effect of acupuncture on such diseases is still unclear. The aim of this study is to explore the pathological mechanisms of CID with GI discomfort, as well as the main response characteristics of acupuncture treatment from multiple perspectives using multimodal magnetic resonance imaging (MRI). METHODS: A total of 60 participants with CID and GI disorders will be randomly divided into two groups (real acupuncture group and sham acupuncture group; ratio of 1:1). Patients will receive 20 sessions (five sessions per week) of real acupuncture treatment or sham acupuncture treatment. The primary outcome is the aggregate score on the Pittsburgh Sleep Quality Index. Secondary outcomes are scores on the Gastrointestinal Symptom Rating Scale, Self-Rating Anxiety Scale, and Self-Rating Depression Scale. Multimodal MRI scans and clinical assessments will be performed both at baseline and post-treatment. Another 30 age-, sex-, and education-matched healthy subjects will be recruited as controls and will receive MRI scans and clinical evaluations. DISCUSSION: This study aims to provide scientific evidence for the mechanism of acupuncture in treating CID with GI disorder using multimodal MRI imaging data on brain structure, function, and metabolism. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1800017092 (URL: http://www.chictr.org.cn/showproj.aspx?proj=27173 ). Registered on July 11, 2018.
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Terapia por Acupuntura , Enfermedades Gastrointestinales , Trastornos del Inicio y del Mantenimiento del Sueño , Encéfalo/diagnóstico por imagen , Enfermedades Gastrointestinales/diagnóstico por imagen , Enfermedades Gastrointestinales/terapia , Humanos , Imagen por Resonancia Magnética , Ensayos Clínicos Controlados Aleatorios como Asunto , Trastornos del Inicio y del Mantenimiento del Sueño/diagnóstico por imagen , Trastornos del Inicio y del Mantenimiento del Sueño/terapia , Resultado del TratamientoRESUMEN
BACKGROUND: The aim of this systematic review with meta-analysis is to determine the efficacy and security of acupuncture in treatment of ocular myasthenia gravis and find out whether or not the quick short-term efficacy of acupuncture exists. METHODS: The following electronic databases will be searched by 2 independent reviewers: PubMed, Cochrane Library, EMBASE, Springer, China National Knowledge Infrastructure, Wanfang, and Chinese Biomedical Literature Database. All randomized controlled trials on acupuncture for ocular myasthenia gravis published in electronic databases from inception to March 1, 2020, with language restricted in Chinese and English will be included in the study.Methodologic quality is assessed by 2 blinded reviewers independently screen and score the articles using the PEDro scale and the Cochrane Collaboration risk of bias tool. A meta-analysis was performed when there is sufficient clinical homogeneity in at least 2 studies. The Grading of Recommendations Assessment, Development and Evaluation approach is used to rate the body of evidence in each meta-analysis. When the quantitive evaluation is not available, a qualitative description of the results of single study is provided. RESULTS: An evidence of variety of acupuncture treatment methods for treating ocular myasthenia gravis will be illustrated using subjective reports and objective measures of performance. The primary outcomes consisted of effective rate, MGFA PIS, QMG, and MG-composite. Secondary outcomes involve clinical absolute and relative score, titers of AchR antibodies, and the side effects. The treatment frequency and courses will be measured. CONCLUSION: This protocol will present the evidence of whether acupuncture is an effective and safe intervention for ocular myasthenia gravis. TRIAL REGISTRATION NUMBER: CRD42019141325.