Electroacupuncture for lower urinary tract symptoms in men with benign prostatic hyperplasia: study protocol for a randomised controlled trial.

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.

Effect of Acupuncture on Neurogenic Claudication Among Patients With Degenerative Lumbar Spinal Stenosis : A Randomized Clinical Trial.

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).

Durable effects of acupuncture for tension-type headache: A systematic review and meta-analysis.

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.

Durable Effect of Acupuncture for Chronic Neck Pain: A Systematic Review and Meta-Analysis.

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.

[LIU Zhishun's clinical experience of electroacupuncture for pediatric neurogenic bladder of lower motor neuron type in children].

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.

Predicting Acupuncture Efficacy in Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Study on Model Development and Result Visualization.

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.

Effects of electroacupuncture on treatment-resistant chronic migraine with medication overuse headache: A 12-month follow-up case report.

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.

Durable Effects of Acupuncture for Knee Osteoarthritis: A Systematic Review and Meta-analysis.

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.

Effects of electroacupuncture on chronic urinary retention after pelvic or lumbosacral tumor resection surgeries: a retrospective cohort study.

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.

Factors related to acupuncture response in patients with chronic prostatitis/chronic pelvic pain syndrome: secondary analysis of a randomized controlled trial.

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.

Placebo response to sham electroacupuncture in patients with chronic functional constipation: A secondary analysis.

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.

The durable effect of acupuncture for episodic migraine: a systematic review and meta-analysis.

Background: Migraine is a common and recurrent type of headache. Avoiding trigger factors is not often successful in reducing headache frequency, duration, and severity. Prophylactic medications may be effective but are limited by strict indications and daily medication intake. This review aimed to investigate the durable effect of acupuncture on episodic migraine. Methods: Seven databases including Medline, Embase, PubMed, etc., were searched for English and Chinese literature from their inception to 23 November 2022. Two independent reviewers screened the retrieved studies and extracted the data. Primary outcomes were monthly migraine days, monthly migraine attacks, and VAS score at 3 months post-treatment. The risk of bias in included studies was assessed using the Cochrane Risk of Bias 2.0 tool. Meta-analysis was conducted where applicable. Results: Fifteen studies were included in this review. Acupuncture reduced the number of migraine attacks (MD -0.68; 95% CI -0.93, -0.43; p < 0.001), the number of days with migraine (MD -0.86; 95% CI -1.18, -0.55; p < 0.001), and VAS score (MD -1.01; 95% CI -1.30, -0.72; p < 0.001) to a greater degree than sham acupuncture at 3 months after treatment. Significant differences in reducing pain intensity of migraine in favor of acupuncture compared with waitlist (MD -1.84; 95% CI -2.31, -1.37; p < 0.001) or flunarizine (MD -2.00; 95% CI -2.35, -1.65; p < 0.001) at 3 months after treatment were found, and the differences reached the minimal clinically important difference (MCID). Conclusion: This review found that the durable effect of acupuncture for episodic migraine lasted at least 3 months after treatment. More high-quality studies with longer follow-up periods in the future are needed to confirm the findings.

Effects of electroacupuncture on pediatric chronic urinary retention: a case-series study.

Objectives: This study aims to preliminarily evaluate the effect and safety of electroacupuncture (EA) in treating pediatric chronic urinary retention (CUR) following lumbosacral surgeries, with treatment duration evaluated. Methods: This prospective case-series study was performed from August 5, 2017, to July 31, 2022. Pediatric patients diagnosed with CUR following lumbosacral surgeries were included and treated by EA for 2-16 weeks. Responders were defined as participants achieving a reduction of 50% or more in post void residuals (PVR) from baseline. Time-to-event analysis was applied to explore the association between EA treatment duration and response rate. Adverse event was recorded. Results: Totally 14 participants (mean [SD] age, 12 [4] years) completed EA treatment. Response rate was 71% (10/14) at the 12th week. 50% (7/14) of participants removed catheters at the 12th week, and none of them experienced re-catheterization in the 24-week follow-up. No serious adverse event was reported. Time-to-event analysis estimated that over 50% patients could respond to EA of more than 8 weeks. Subgroup analysis showed that participants with baseline PVR ≥300 ml and CUR duration ≥12 months experienced longer EA duration to reach the response rate of 50%, compared with those whose PVR <300 ml and CUR duration <12 months (median value: 12 weeks vs. 8 weeks, 12 weeks vs. 4 weeks, respectively). Conclusions: EA could reduce PVR for pediatric patients suffering from CUR following lumbosacral surgeries, with long-term efficacy and safety. EA treatment of more than 8 weeks was reasonable. Further study of a larger sample and controlling is needed. Clinical Trial Registration: www.chictr.org.cn, identifier, ChiCTR1800020222.

Acupuncture and Doxylamine-Pyridoxine for Nausea and Vomiting in Pregnancy : A Randomized, Controlled, 2 × 2 Factorial Trial.

BACKGROUND: An effective and safe treatment for nausea and vomiting of pregnancy (NVP) is lacking. OBJECTIVE: To assess the efficacy and safety of acupuncture, doxylamine-pyridoxine, and a combination of both in women with moderate to severe NVP. DESIGN: Multicenter, randomized, double-blind, placebo-controlled, 2 × 2 factorial trial. (ClinicalTrials.gov: NCT04401384). SETTING: 13 tertiary hospitals in mainland China from 21 June 2020 to 2 February 2022. PARTICIPANTS: 352 women in early pregnancy with moderate to severe NVP. INTERVENTION: Participants received daily active or sham acupuncture for 30 minutes and doxylamine-pyridoxine or placebo for 14 days. MEASUREMENTS: The primary outcome was the reduction in Pregnancy-Unique Quantification of Emesis (PUQE) score at the end of the intervention at day 15 relative to baseline. Secondary outcomes included quality of life, adverse events, and maternal and perinatal complications. RESULTS: No significant interaction was detected between the interventions (P = 0.69). Participants receiving acupuncture (mean difference [MD], -0.7 [95% CI, -1.3 to -0.1]), doxylamine-pyridoxine (MD, -1.0 [CI, -1.6 to -0.4]), and the combination of both (MD, -1.6 [CI, -2.2 to -0.9]) had a larger reduction in PUQE score over the treatment course than their respective control groups (sham acupuncture, placebo, and sham acupuncture plus placebo). Compared with placebo, a higher risk for births with children who were small for gestational age was observed with doxylamine-pyridoxine (odds ratio, 3.8 [CI, 1.0 to 14.1]). LIMITATION: The placebo effects of the interventions and natural regression of the disease were not evaluated. CONCLUSION: Both acupuncture and doxylamine-pyridoxine alone are efficacious for moderate and severe NVP. However, the clinical importance of this effect is uncertain because of its modest magnitude. The combination of acupuncture and doxylamine-pyridoxine may yield a potentially larger benefit than each treatment alone. PRIMARY FUNDING SOURCE: The National Key R&D Program of China and the Project of Heilongjiang Province "TouYan" Innovation Team.

Efficacy and Safety of Acupuncture for Cyclic Mastalgia: Study Protocol for a Randomized, Sham-Controlled Trial.

Purpose: Cyclic mastalgia is prevalent among women and negatively impairs their daily life and work. There is still a lack of effective therapies for mastalgia, and acupuncture may be a promising method. We design this multicenter randomized trial to evaluate the efficacy and safety of acupuncture on cyclic mastalgia. Study Design and methods: Sixty participants with moderate-to-severe cyclic breast pain (with a duration of 5-21 days and the worst pain scoring 5 points or more on Numerical Rating Scale [NRS]) will be recruited at three hospitals in China. They will be randomly assigned to acupuncture group or sham-acupuncture group at 1:1 ratio to receive 16-session treatment during 3 consecutive menstrual cycles, and follow-up for 6 menstrual cycles after treatment. The primary outcome is the change from baseline in the NRS score on the worst breast pain during the third cycle of treatment period. All statistical tests will be two-sided and P value <0.05 will be considered statistically significant.

[Functional dyspepsia treated with acupuncture of different frequencies: a randomized controlled trial].

OBJECTIVE: To compare the clinical efficacy of acupuncture with different frequencies in the treatment of patients with functional dyspepsia (FD). METHODS: A total of 90 patients with FD were randomly divided into a 3-time acupuncture treatment per week group (3-A group, 31 cases, 2 cases dropped off), a 1-time acupuncture treatment per week group (1-A group, 30 cases, 2 cases dropped off) and a control group (29 cases, 2 cases dropped off). In the two acupuncture groups, the acupoints were Zhongwan (CV 12) and bilateral Tianshu (ST 25), Neiguan (PC 6), Liangqiu (ST 34), Yanglingquan (GB 34), Zusanli (ST 36) and Taichong (LR 3), stimulated 3 times a week and once a week, respectively; and the treatment was given consecutively for 4 weeks. In the control group, no intervention was adopted, but the compensatory therapy was provided after the end of follow-up. The scores of the symptom index of dyspepsia (SID), self-rating anxiety scale (SAS) and self-rating depression scale (SDS) were compared among the 3 groups before treatment, after 4 weeks of treatment and in 4 and 8 weeks after treatment completion separately. The score of Nepean dyspepsia life quality index (NDLQI) was evaluated before treatment, after 2 and 4 weeks of treatment and in 4 and 8 weeks after treatment completion. RESULTS: After 4 weeks of treatment and in 4 and 8 weeks after treatment completion, the scores of SID, SAS and SDS were all reduced in the 3-A group and the 1-A group when compared with the scores before treatment (P<0.000 1, P<0.05). After 4 weeks of treatment, the scores of SID, SAS and SDS in the two acupuncture groups were lower than those in the control group (P<0.000 1). After 2 and 4 weeks of treatment, the increased values of NDLQI score in the two acupuncture groups were all higher than those in the control group (P<0.05). In 4 and 8 weeks after treatment completion, the scores of SID, SAS and SDS in the 3-A group were lower than those in the 1-A group (P<0.001, P<0.05), and the increased values of NDLQI score in the 3-A group were higher than those in the 1-A group (P<0.000 1). CONCLUSION: Acupuncture given 3 times per week is superior to the treatment given once per week in the aspects of relieving the clinical symptoms, improving the quality of life and regulating the emotional state in patients with FD. This efficacy is persistent for 8 weeks after treatment completion.

Impact of ejaculation upon effect of acupuncture on chronic prostatitis/chronic pelvic pain syndrome: Secondary analysis of a randomized controlled trial.

Background: Acupuncture can improve chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS). Ejaculation frequencies might impact the conditions of CP/CPPS. The present study aimed to explore the impact of different ejaculation frequencies on the effect of acupuncture among men with CP/CPPS. Methods: This was a secondary analysis of the data from a multicenter, randomized, clinical trial. Eligible participants were patients with moderate to severe CP/CPPS, who had taken 8-week acupuncture treatment, and followed until week 32. Participants fell into the category of 0-3, 4-7, or at least 8 according to their monthly ejaculation frequencies reported at baseline. The primary outcome was the proportion of responders, defined as men who reported at least 6 points reduction from baseline in the National Institute of Health-Chronic Prostatitis Symptom Index (NIH-CPSI) total score at weeks 8 and 32. Results: 214 participants were included in this secondary analysis, of whom 42 reported a monthly ejaculation frequency of 0-3, 89 reported a frequency of 4-7, and 83 reported a frequency of at least 8. At week 8, 52.20% participants with an ejaculation frequency of 0-3 responded to the acupuncture treatment, 65.38% participants with a frequency of 4-7 responded, and 63.09% participants with a frequency of at least 8 responded. At week 32, 56.14%, 59.57%, and 68.36% participants responded in the three groups, respectively. No significant differences were observed between three groups (all P>0.05). Conclusion: Acupuncture can improve symptoms of CP/CPPS, regardless of ejaculation frequencies. Ejaculation frequencies may not affect the efficacy of acupuncture on CP/CPPS among Chinese men. Trial registration: ClinicalTrials.gov, NCT03213938.

Efficacy and safety of acupuncture for hand osteoarthritis: study protocol for a multi-center, randomized, sham-controlled clinical trial.

BACKGROUND: Hand osteoarthritis (OA) is a prevalent disorder in the general population. Patients with hand OA often report symptoms of pain, stiffness, and functional limitations, which cause clinical burden and impact on quality of daily life. However, the efficacy of current therapies for hand OA is limited. Other therapies with better effects and less adverse events are in urgent need. Acupuncture is well known for analgesia and has been proved effective in treating basal thumb joint arthritis. This study aims to clarify the efficacy and safety of acupuncture treatment for clinical symptomatic improvement of hand OA. METHODS: This will be a sham-controlled, randomized, multi-center clinical trial. A total of 340 participants will be recruited and randomly allocated to either traditional acupuncture group or sham acupuncture group. All participants will receive 12 treatment sessions over 4 weeks and 2 follow-up assessments in the following 3 months at week 8 and week 16. The primary outcome will be the proportion of responders at week 5. Secondary outcomes will include visual analog scale, Australian Canadian Osteoarthritis Hand Index, Functional Index for hand OA, the number of symptomatic joints, hand grip strength and pinch strength, global assessment, the World Health Organization Quality of Life abbreviated version and expectations. Safety will be evaluated during the whole process of the trial. All outcomes will be analyzed following the intention-to-treat principle. DISCUSSION: This prospective trial will provide high-quality evidence on evaluating the efficacy and safety of acupuncture treatment for hand OA. Results of this trial might contribute in offering a new option to clinical recommendations. Trial registration ClinicalTrials.gov Identifier: NCT05267093. Registered 23 February 2022.

Effects of Electroacupuncture for Opioid-Induced Constipation in Patients With Cancer in China: A Randomized Clinical Trial.

Importance: Opioid-induced constipation (OIC) is prevalent among patients treated with opioids for cancer pain. Safe and effective therapies for OIC in patients with cancer remain an unmet need. Objective: To determine the efficacy of electroacupuncture (EA) for OIC in patients with cancer. Design, Setting, and Participants: This randomized clinical trial was conducted at 6 tertiary hospitals in China among 100 adult patients with cancer who were screened for OIC and enrolled between May 1, 2019, and December 11, 2021. Interventions: Patients were randomized to receive 24 sessions of EA or sham electroacupuncture (SA) over 8 weeks and then were followed up for 8 weeks after treatment. Main Outcomes and Measures: The primary outcome was the proportion of overall responders, defined as patients who had at least 3 spontaneous bowel movements (SBMs) per week and an increase of at least 1 SBM from baseline in the same week for at least 6 of the 8 weeks of the treatment period. All statistical analyses were based on the intention-to-treat principle. Results: A total of 100 patients (mean [SD] age, 64.4 [10.5] years; 56 men [56.0%]) underwent randomization; 50 were randomly assigned to each group. Among them, 44 of 50 patients (88.0%) in the EA group and 42 of 50 patients (84.0%) in the SA group received at least 20 (≥83.3%) sessions of treatment. The proportion of overall responders at week 8 was 40.1% (95% CI, 26.1%-54.1%) in the EA group and 9.0% (95% CI, 0.5%-17.4%) in the SA group (difference between groups, 31.1 percentage points [95% CI, 14.8-47.6 percentage points]; P < .001). Compared with SA, EA provided greater relief for most OIC symptoms and improved quality of life among patients with OIC. Electroacupuncture had no effects on cancer pain and its opioid treatment dosage. Electroacupuncture-related adverse events were rare, and, if any, all were mild and transient. Conclusions and Relevance: This randomized clinical trial found that 8-week EA treatment could increase weekly SBMs with a good safety profile and improve quality of life for the treatment of OIC. Electroacupuncture thus provided an alternative option for OIC in adult patients with cancer. Trial Registration: ClinicalTrials.gov Identifier: NCT03797586.