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INTRODUCTION: Benign prostatic hyperplasia (BPH) is a condition commonly seen among men aged over 40, significantly affecting their quality of life and typically accompanied by lower urinary tract symptoms (LUTS). Acupuncture presents a potentially effective treatment option; however, the exact effects remain uncertain. Therefore, we design this multicentre randomised trial to evaluate the efficacy and safety of electroacupuncture (EA) for relieving LUTS in men with BPH. METHODS AND ANALYSIS: A two-arm, sham-controlled, subject-blinded and assessor-blinded trial will be conducted in 11 hospitals in China to compare EA with sham electroacupuncture (SA) in treating moderate to severe LUTS of BPH among men aged 40-80. A total of 306 eligible male patients will be recruited and assigned at a 1:1 ratio to receive either EA or SA for 24 sessions over a succession of 8 weeks, with 24 weeks of follow-up. The primary outcome will be the proportions of participants with at least 30% reduction in the International Prostate Symptom Score total score from baseline at weeks 8 and 20. All statistical analyses will be conducted in accordance with the intention-to-treat principle, and a two-tailed p value less than 0.05 will be considered statistically significant. ETHICS AND DISSEMINATION: The trial has been approved by the institutional review board of Guang'anmen Hospital (2022-203-KY), as well as other recruitment centres. Each participant will receive the detailed information of the trial, and sign the written informed consent. The results of the trial are expected to be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT05585450.
Subject(s)
Electroacupuncture , Lower Urinary Tract Symptoms , Prostatic Hyperplasia , Quality of Life , Humans , Male , Electroacupuncture/methods , Prostatic Hyperplasia/complications , Prostatic Hyperplasia/therapy , Lower Urinary Tract Symptoms/therapy , Lower Urinary Tract Symptoms/etiology , Middle Aged , Aged , Randomized Controlled Trials as Topic , Treatment Outcome , Adult , Aged, 80 and over , China , Multicenter Studies as TopicABSTRACT
BACKGROUND: Acupuncture may improve degenerative lumbar spinal stenosis (DLSS), but evidence is insufficient. OBJECTIVE: To investigate the effect of acupuncture for DLSS. DESIGN: Multicenter randomized clinical trial. (ClinicalTrials.gov: NCT03784729). SETTING: 5 hospitals in China. PARTICIPANTS: Patients with DLSS and predominantly neurogenic claudication pain symptoms. INTERVENTION: 18 sessions of acupuncture or sham acupuncture (SA) over 6 weeks, with 24-week follow-up after treatment. MEASUREMENTS: The primary outcome was change from baseline in the modified Roland-Morris Disability Questionnaire ([RMDQ] score range, 0 to 24; minimal clinically important difference [MCID], 2 to 3). Secondary outcomes were the proportion of participants achieving minimal (30% reduction from baseline) and substantial (50% reduction from baseline) clinically meaningful improvement per the modified RMDQ. RESULTS: A total of 196 participants (98 in each group) were enrolled. The mean modified RMDQ score was 12.6 (95% CI, 11.8 to 13.4) in the acupuncture group and 12.7 (CI, 12.0 to 13.3) in the SA group at baseline, and decreased to 8.1 (CI, 7.1 to 9.1) and 9.5 (CI, 8.6 to 10.4) at 6 weeks, with an adjusted difference in mean change of -1.3 (CI, -2.6 to -0.03; P = 0.044), indicating a 43.3% greater improvement compared with SA. The between-group difference in the proportion of participants achieving minimal and substantial clinically meaningful improvement was 16.0% (CI, 1.6% to 30.4%) and 12.6% (CI, -1.0% to 26.2%) at 6 weeks. Three cases of treatment-related adverse events were reported in the acupuncture group, and 3 were reported in the SA group. All events were mild and transient. LIMITATION: The SA could produce physiologic effects. CONCLUSION: Acupuncture may relieve pain-specific disability among patients with DLSS and predominantly neurogenic claudication pain symptoms, although the difference with SA did not reach MCID. The effects may last 24 weeks after 6-week treatment. PRIMARY FUNDING SOURCE: 2019 National Administration of Traditional Chinese Medicine "Project of building evidence-based practice capacity for TCM-Project BEBPC-TCM" (NO. 2019XZZX-ZJ).
Subject(s)
Acupuncture Therapy , Intermittent Claudication , Lumbar Vertebrae , Spinal Stenosis , Humans , Spinal Stenosis/complications , Spinal Stenosis/therapy , Male , Female , Middle Aged , Intermittent Claudication/therapy , Aged , Treatment Outcome , Disability EvaluationABSTRACT
BACKGROUND: Premature Ventricular Complexes (PVCs) are very common in clinical practice, with frequent PVCs (more than 30 beats per hour) or polymorphic PVCs significantly increasing the risk of mortality. Previous studies have shown that vagus nerve stimulation improves ventricular arrhythmias. Stimulation of the auricular distribution of the vagus nerve has proven to be a simple, safe, and effective method to activate the vagus nerve. Transcutaneous au ricular vagus nerve stimulation (taVNS) has shown promise in both clinical and experimental setting for PVCs; however, high-quality clinical studies are lacking, resulting in insufficient evidence of efficacy. METHODS: The study is a prospective, randomized, parallel-controlled trial with a 1:1 ratio between the two groups. Patients will be randomized to either the treatment group (taVNS) or the control group (Sham-taVNS) with a 6-week treatment and a subsequent 12-week follow-up period. The primary outcome is the proportion of patients with a ≥ 50% reduction in the number of PVCs monitored by 24-hour Holter. Secondary outcomes include the proportion of patients with a ≥ 75% reduction in PVCs, as well as the changes in premature ventricular beats, total heartbeats, and supraventricular premature beats recorded by 24-hour Holter. Additional assessments compared score changes in PVCs-related symptoms, as well as the score change of self-rating anxiety scale (SAS), self-rating depression scale (SDS), and 36-item short form health survey (SF-36). DISCUSSION: The TASC-V trial will help to reveal the efficacy and safety of taVNS for frequent PVCs, offering new clinical evidence for the clinical practice. TRIAL REGISTRATION: Clinicaltrials.gov: NCT04415203 (Registration Date: May 30, 2020).
Subject(s)
Vagus Nerve Stimulation , Ventricular Premature Complexes , Humans , Ventricular Premature Complexes/therapy , Vagus Nerve Stimulation/methods , Prospective Studies , Adult , Male , Middle Aged , Female , Transcutaneous Electric Nerve Stimulation/methods , Randomized Controlled Trials as TopicABSTRACT
OBJECTIVE: Chronic neck pain, a prevalent health concern characterized by frequent recurrence, requires exploration of treatment modalities that provide sustained relief. This systematic review and meta-analysis aimed to evaluate the durable effects of acupuncture on chronic neck pain. METHODS: We conducted a literature search up to March 2024 in six databases, including PubMed, Embase, and the Cochrane Library, encompassing both English and Chinese language publications. The main focus of evaluation included pain severity, functional disability, and quality of life, assessed at least 3 months post-acupuncture treatment. The risk of bias assessment was conducted using the Cochrane Risk of Bias 2.0 tool, and meta-analyses were performed where applicable. RESULTS: Eighteen randomized controlled trials were included in the analysis. Acupuncture as an adjunct therapy could provide sustained pain relief at three (SMD: - 0.79; 95% CI - 1.13 to - 0.46; p < 0.01) and six (MD: - 18.13; 95% CI - 30.18 to - 6.07; p < 0.01) months post-treatment. Compared to sham acupuncture, acupuncture did not show a statistically significant difference in pain alleviation (MD: - 0.12; 95% CI - 0.06 to 0.36; p = 0.63). However, it significantly improved functional outcomes as evidenced by Northwick Park Neck Pain Questionnaire scores 3 months post-treatment (MD: - 6.06; 95% CI - 8.20 to - 3.92; p < 0.01). Although nine studies reported an 8.5%-13.8% probability of adverse events, these were mild and transitory adverse events. CONCLUSION: Acupuncture as an adjunct therapy may provide post-treatment pain relief lasting at least 3 months for patients with chronic neck pain, although it is not superior to sham acupuncture, shows sustained efficacy in improving functional impairment for over 3 months, with a good safety profile.
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Background: Acupuncture may be effective in treating tension-type headache (TTH). The durability of its effects after treatment completion remains inconclusive. Methods: We searched multiple databases and references from previous reviews for randomized controlled trials (RCTs) which investigated the effectiveness of acupuncture for TTH. We assessed the methodological quality of RCTs using the Cochrane Risk of Bias 2.0 (RoB 2) tool. Primary outcome was response rate, defined as the proportion of participants who reported at least a 50% reduction in monthly headache days from baseline after completion of treatment. Secondary outcomes included headache days, headache intensity, and analgesic use. Safety outcomes were also evaluated. Results: A total of seven RCTs involving 3,221 participants with frequent episodic and chronic TTH were included. Individuals receiving acupuncture reported a significantly higher response rate versus sham acupuncture (SA) immediately and at 1-6 months after completion of treatment (P<0.05). Compared with SA, post-treatment results of headache days and headache intensity appeared consistent on the whole, showing associations favoring acupuncture. However, no significant reduction in analgesic use was found post-treatment. Acupuncture showed no superiority over physical training or relaxation training in headache days and headache intensity. Moreover, no serious adverse events associated with acupuncture were reported. Conclusion: Limited evidence suggested that acupuncture might provide durable post-treatment effects in the management of frequent episodic and chronic TTH for up to 6 months compared with SA,with no severe treatment-related adverse events reported.
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Professor LIU Zhishun's clinical experience of electroacupuncture (EA) for pediatric neurogenic bladder of lower motor neuron type in children is summarized. Considering the unique physiological and pathological characteristics of children, with the strategy of combining "disease-symptom-location" in the selection of acupoints, professor LIU Zhishun proposes that the main disease location is the bladder and kidney, with the involvement of the conception vessel, governor vessel, kidney meridian of foot-shaoyin and the bladder meridian of foot-taiyang. The primary acupoint prescription-1 (bilateral Zhongliao [BL 33], Ciliao [BL 32] and Huiyang [BL 35]) and primary acupoint prescription-2 (Guanyuan [CV 4], Zhongji [CV 3] and bilateral Sanyinjiao [SP 6]) are selected to promote the yang of the governor vessel, stimulate the yin of the conception vessel, and invigorate the bladder's qi transformation. Before acupuncture, the four-step method is applied to precisely locate Ciliao (BL 32) and Zhongliao (BL 33). During acupuncture, the importance of achieving deqi is emphasized, with deep insertion in the sacral area to reach the disease location. Based on the tolerance characteristics of children, low-frequency EA and gentle moxibustion treatment are applied.
Subject(s)
Acupuncture Points , Electroacupuncture , Urinary Bladder, Neurogenic , Child , Child, Preschool , Female , Humans , Male , Meridians , Motor Neurons/physiology , Urinary Bladder/innervation , Urinary Bladder, Neurogenic/therapyABSTRACT
INTRODUCTION: Acupuncture is one of primary treatment options for chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), but its efficacy varies among patients. This study aimed to develop and validate a nomogram for predicting the efficacy of acupuncture in CP/CPPS. METHODS: This study enrolled 220 patients with CP/CPPS who received acupuncture. Patients were divided into a responder group and nonresponder group based on the reduction in the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI). Potential variables were selected using the least absolute shrinkage and selection operator regression, and a nomogram was established using the multivariable logistic regression model. The performance of the nomogram was assessed by the receiver operating characteristic curves and calibration curves. RESULTS: Two Hundred Twenty men were randomly assigned to the training cohort (n = 154) and the internal test cohort (n = 66). The developed nomogram included age, current drinking status, sedentary lifestyle, habit of staying up late, expectations for acupuncture, comorbidities, NIH-CPSI pain subscale and total scores. The area under the curve of the prediction model was 0.777 (95% CI: 0.702-0.851) in the training cohort, 0.752 (95% CI: 0.616-0.888) in the internal test cohort, demonstrating satisfactory discriminative ability as indicated by the calibration curve. CONCLUSIONS: The nomogram accurately identified CP/CPPS patients who would benefit from acupuncture. Factors such as youth, abstention from alcohol, avoiding sedentary habits and staying up late, having high expectations for acupuncture, being free from comorbidities, and baseline high scores on both the NIH-CPSI pain subscale and total scores may positively affect the efficacy of acupuncture. Further validation of our findings requires multicenter and large-sample prospective studies.
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Background: Medication overuse headache (MOH) is a secondary headache disorder that leads to pronounced disability and decreased quality of life. Available therapeutic options for MOH are limited, and many are only effective in a subset of individuals. Although the existing evidence is limited, acupuncture may be an effective treatment option for MOH. Case presentation: A 45-year-old Chinese woman presented to the Medical Acupuncture Department of Sanming Integrated Traditional Chinese and Western Medicine Hospital on April 11, 2022. Thirty-five years ago, she had episodic migraines. The frequency increased over time, however, and for the past 10 years she has had daily headaches. These headaches were characterized by daily persistent throbbing pain on the left side of the patient's head, accompanied by photophobia, phonophobia, neck stiffness, dizziness, and fatigue. Without painkillers, the patient rated her headache intensity as 9 out of 10 on a visual analog scale (0 = no pain, 10 = intolerable pain), and reported that the headaches lasted for up to 7 days or more. With painkillers, the headaches had a reduced intensity (5 of 10), but persisted. The patient had taken 1-3.5 compound aminopyrine phenacetin tablets daily for more than 5 years. Standard conservative therapy (patient education, medication withdrawal, and behavioral intervention) for MOH had failed to improve her symptoms. Before her visit, the patient had headache and engaged in short-term medication use on 30 days per month. The total monthly headache intensity score was 90. The patient's Migraine-Specific Quality of Life Questionnaire (MSQ) score was 33 points, her Hamilton Depression Scale (HAMD) score was 24 points, and her Hamilton Anxiety Scale (HAMA) score was 20 points. Results: After 48 acupuncture sessions over 24 weeks, the patient completely discontinued short-term analgesic use and the monthly number of headache days and headache intensity score were both reduced by 96.67 % (from 30 to 1 and 90 to 3, respectively), with no adverse effect. Compared with baseline, the MSQ, HAMD, and HAMA scores improved by 45, 17, and 16 points, respectively. At 12 months, the patient's condition remained stable and her MOH had not relapsed. Conclusion: In the context of the current literature and the present case, electroacupuncture shows promise for the long-term relief of chronic migraine with MOH when other treatments fail.
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Background: Chronic urinary retention (CUR) resulting from lower motor neuron lesions (LMNL) is a medical condition secondary to pelvic or lumbosacral tumor resection surgeries. Electroacupuncture (EA) is proved to be effective and safe in treating certain lower urinary tract disorders. However, the clinical benefit and optimal duration of EA treatment for CUR following LMNL remain unknown. Methods: Using a retrospective cohort design, 20 eligible patients diagnosed with CUR resulting from LMNL secondary to pelvic or lumbosacral tumor resection surgeries were included from March 1, 2017, to June 30, 2020. The patients were treated by EA three times a week for 2 to 12 weeks and followed up for 24 weeks after treatment. The electric stimulators with a 5-Hz continuous wave (5-10 mA intensity) were separately connected to bilateral Ciliao (BL32), bilateral Zhongliao (BL33), and bilateral Huiyang (BL35), and stimulators with a 10-Hz continuous wave (1-2 mA intensity) were connected to bilateral Sanyinjiao (SP6). Current intensity was adjusted according to the patients' individual tolerance. The median follow-up was 32 weeks (range, 26-36 weeks). Responders were defined as patients whose post-void residuals (PVR) reduced by 50% or more from baseline. Adverse event was recorded. Results: Totally 20 patients [mean (standard deviation) age, 48.1 (15.5) years; 9 men (45.0%); 11 women (55.0%)] were included. Of the 20 patients, 14 (70.0%) had responded to EA treatment and stopped catheterization for achieving satisfactory spontaneous urination (PVR <100 mL without complications), 7 (35.0%) had complete resolution (90-100% reduction in PVR from baseline), and 13 (65.0%) scored 1 (much better) or 2 (moderately better) in the Patient Global Impression of Improvement (PGI-I) assessment. Moreover, 6 (30.0%) patients had responded within 4 weeks of EA treatment. According to Kaplan-Meier survival curve, we found that more than 50% patients could respond to EA treatment within 8 weeks or longer. None of the responders had ever experienced relapse in 24 weeks after EA treatment ended. None of the patients manifested urinary tract infection (UTI), newly diagnosed hydroureter or hydronephrosis. One patient diagnosed with hydronephrosis at baseline recovered after 12-week EA treatment. Two patients with UTI at baseline were prescribed antibiotics and did not present UTI again during the follow-up. Conclusions: EA could be a promising treatment option for CUR caused by LMNL following pelvic or lumbosacral tumor resection surgeries, with long-term effects and a good safety profile. The optimal duration of EA should be of 8 weeks at least. But this was a retrospective cohort study of a small sample size, so future studies are needed to investigate EA in larger populations in randomized controlled trials.
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PURPOSE OF REVIEW: Knee osteoarthritis (KOA) is a degenerative joint disease which can result in chronic pain and disability. The current interventions available for KOA often fail to provide long-lasting effects, highlighting the need for new treatment options that can offer durable benefits. Previous studies have suggested the efficacy of acupuncture for knee osteoarthritis (KOA) with its durability remaining uncertain. In this review, we aimed to investigate the durability of the efficacy after completion of treatment. RECENT FINDINGS: We performed thorough searches of PubMed, EMBASE, Web of Science, and Cochrane Central Register of Controlled Trials from inception to November 4, 2023. The outcomes were assessed at all available time points after completion of treatment. Primary outcomes were changes from baseline in pain and function measured using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function subscales. Secondary outcomes included response rate, overall pain, the WOMAC stiffness subscale, total WOMAC index, and physical and mental health components of 12/36-item Short-Form Health Survey. A total of 10 randomized controlled trials (RCTs) involving 3221 participants were included. Pooled estimates suggested that acupuncture may offer potential improvements in function and overall pain for 4.5 months post-treatment versus sham acupuncture (SA). Acupuncture may provide durable clinically important pain relief and functional improvement up to 5 months post-treatment versus usual care, and up to 6 months post-treatment versus diclofenac. For acupuncture versus no treatment, one trial with large sample size indicated that improvements in pain and function persisted for 3 months post-treatment, while the other trial reported that significant pain reduction and functional improvement were only observed at the end of the treatment, not at 9 months post-treatment. However, acupuncture as adjunct to exercise-based physical therapy (EPT) showed no superiority to SA as an adjunct to EPT or EPT alone up to 11.25 months after completion of treatment. Acupuncture may provide pain alleviation and functional improvements in KOA patients for 3 to 6 months after completion of treatment with a good safety profile.
Subject(s)
Acupuncture Therapy , Osteoarthritis, Knee , Humans , Acupuncture Therapy/methods , Osteoarthritis, Knee/therapy , Randomized Controlled Trials as Topic , Treatment OutcomeABSTRACT
PURPOSE: Acupuncture has been recommended as an effective therapy to improve symptoms of chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). We conducted this secondary analysis to explore the factors that may influence the response of patients with CP/CPPS to acupuncture. METHODS: This secondary analysis was based on a randomized controlled trial demonstrating the efficacy of acupuncture among patients with CP/CPPS. Responder is defined as a patient with a decrease of ≥ 6 points in National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score from baseline at the 32 week. 206 patients who received acupuncture treatment and completed 32-week follow-up were included in this secondary analysis. Descriptive statistics were used to describe the demographic and clinical characteristics of both responders and non-responders in acupuncture group. Logistic regression analysis with bootstrapping was made to identify potential factors that contributed to the effectiveness of acupuncture for treating CP/CPPS. Responders and non-responders were listed as dependent variables. RESULTS: In this study, 130 (63.11%) patients were assessed as responders. The results showed that men with non-sedentariness (OR 4.170 [95%CI 1.837 to 9.463; P = 0.001]), non-smoking habit (OR 2.824 [95%CI 1.453 to 5.487; P = 0.002]), without comorbidity (OR 8.788 [95%CI 1.912 to 40.295; P = 0.005]), and severe NIH-CPSI total score (OR 0.227 [95%CI 0.114 to 0.450; P < 0.0001]) benefited more from acupuncture intervention. CONCLUSION: CP/CPPS patients who are active, non-smokers, without comorbidity, and had severe symptoms may be more likely to respond to acupuncture.
Subject(s)
Acupuncture Therapy , Chronic Pain , Prostatitis , Male , Humans , Chronic Pain/therapy , Prostatitis/complications , Chronic Disease , Acupuncture Therapy/methods , Pelvic Pain/therapyABSTRACT
BACKGROUND: Chronic severe functional constipation is a common disease that requires novel and effective treatment strategies. Acupuncture might constitute a promising therapeutic approach for chronic constipation, but it reportedly engenders an enhanced placebo response. Herein, we aimed to determine the magnitude of the placebo responses to electroacupuncture for constipation and identify its influencing factors. METHODS: In this secondary analysis of a multicenter randomized trial, patients were randomized to a sham electroacupuncture group, which was administered for 8 weeks in 24 sessions of superficial needling at nonacupoints. The placebo response rates were assessed using three responder criteria: ≥3 complete spontaneous bowel movements per week (CSBMs/week), overall CSBM, and sustained CSBM. Logistic regression with backward selection method was employed to identify the potential factors that affected the placebo response. KEY RESULTS: Overall, 539 patients were included in the study. The placebo response rate was 10.58%, 9.46%, and 9.09% according to the three aforementioned criteria, respectively. Those who exhibited more CSBMs/week at baseline were more likely to respond to sham electroacupuncture. Among patients with more than one CSBM per week at baseline, the response rates for achieving the criteria of ≥3 CSBMs per week, overall CSBM, and sustained CSBM were 25.40%, 30.16%, and 22.22%. CONCLUSIONS AND INFERENCE: Electroacupuncture did not demonstrate a large placebo response in functional constipation treatment. The number of CSBMs at baseline may be a moderator of the placebo response to sham electroacupuncture. Thus, superficial needling sham acupuncture may be considered an ideal sham control for clinical trials of chronic constipation.