Acupuncture versus sham acupuncture and usual care for Antiandrogen-Induced hot fLashes in prostate cancer (AVAIL): study protocol for a randomized clinical trial.

BACKGROUND: Hot flashes are the common and debilitating symptom among prostate cancer (PCa) patients undergoing androgen deprivation therapy (ADT). Strong evidence from multiple rigorously designed studies indicated that pharmacological option such as venlafaxine provides partial relief, but the tolerability is poor when dose is not tapered. Hence, alternative therapy is needed. Previous studies reported that acupuncture may be helpful in the management of hot flashes. However, the insufficient randomized controlled trial limited the quality of evidence. METHODS: Five hospitals will recruit 120 acupuncture naïve patients with moderate-to-severe hot flashes after prostate cancer received ADT in China from February 2023 to December 2024. Participants will be randomly 2:1:1 allocated to the 18 sessions of verum acupuncture at true acupuncture points plus usual care, 18 sessions of non-penetrating sham acupuncture at non-acupuncture points plus usual care, or usual care alone over 6 weeks. The primary outcome measure is the change of mean weekly hot flashes symptom severity score (HFSSS) at the end of treatment compared with baseline. EXPECTED RESULTS AND CONCLUSION: We will be able to measure the effectiveness of acupuncture for patients with PCa suffering from ADT-induced hot flashes and whether acupuncture is superior to sham acupuncture and usual care. The proposed acupuncture treatment might provide an alternative option for those patients. TRIAL REGISTRATION: Clinicaltrials.gov (NCT05069467).

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.

Efficacy of Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome : A Randomized Trial.

BACKGROUND: Acupuncture has promising effects on chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS), but high-quality evidence is scarce. OBJECTIVE: To assess the long-term efficacy of acupuncture for CP/CPPS. DESIGN: Multicenter, randomized, sham-controlled trial. (ClinicalTrials.gov: NCT03213938). SETTING: Ten tertiary hospitals in China. PARTICIPANTS: Men with moderate to severe CP/CPPS, regardless of prior exposure to acupuncture. INTERVENTION: Twenty sessions of acupuncture or sham acupuncture over 8 weeks, with 24-week follow-up after treatment. MEASUREMENTS: The primary outcome was the proportion of responders, defined as participants who achieved a clinically important reduction of at least 6 points from baseline on the National Institutes of Health Chronic Prostatitis Symptom Index at weeks 8 and 32. Ascertainment of sustained efficacy required the between-group difference to be statistically significant at both time points. RESULTS: A total of 440 men (220 in each group) were recruited. At week 8, the proportions of responders were 60.6% (95% CI, 53.7% to 67.1%) in the acupuncture group and 36.8% (CI, 30.4% to 43.7%) in the sham acupuncture group (adjusted difference, 21.6 percentage points [CI, 12.8 to 30.4 percentage points]; adjusted odds ratio, 2.6 [CI, 1.8 to 4.0]; P < 0.001). At week 32, the proportions were 61.5% (CI, 54.5% to 68.1%) in the acupuncture group and 38.3% (CI, 31.7% to 45.4%) in the sham acupuncture group (adjusted difference, 21.1 percentage points [CI, 12.2 to 30.1 percentage points]; adjusted odds ratio, 2.6 [CI, 1.7 to 3.9]; P < 0.001). Twenty (9.1%) and 14 (6.4%) adverse events were reported in the acupuncture and sham acupuncture groups, respectively. No serious adverse events were reported. LIMITATION: Sham acupuncture might have had certain physiologic effects. CONCLUSION: Compared with sham therapy, 20 sessions of acupuncture over 8 weeks resulted in greater improvement in symptoms of moderate to severe CP/CPPS, with durable effects 24 weeks after treatment. PRIMARY FUNDING SOURCE: China Academy of Chinese Medical Sciences and the National Administration of Traditional Chinese Medicine.

Efficacy of acupuncture versus sham acupuncture or waitlist control for patients with chronic plantar fasciitis: study protocol for a two-centre randomised controlled trial.

INTRODUCTION: Plantar fasciitis (PF) is reported to be the most common cause of plantar heel pain. Acupuncture has been used for patients experiencing PF, but evidence of the efficacy of acupuncture on PF is limited. The primary objective of this trial is to compare combined acupuncture and sham acupuncture (SA) versus waitlist control for improving the level of pain experienced by patients suffering from chronic PF. METHODS AND ANALYSIS: This will be a two-centre, parallel-group, sham and no-treatment controlled, assessor-blinded randomised trial. We will randomly allocate 120 participants with chronic PF to acupuncture, SA and waitlist control groups at a ratio of 2:1:1. Participants in the acupuncture and SA groups will receive a 30 min acupuncture or SA treatment for a total of 12 sessions over 4 weeks, with a 12-week follow-up. Participants in the waitlist control group will not undergo treatment for a period of 16 weeks but instead will have the option of 4 weeks (12 sessions) of acupuncture free of charge at the end of the follow-up period. The primary outcome will be the treatment response rate 4 weeks after randomisation, assessed as a minimum of 50% improvement in the worst pain intensity during the first steps in the morning compared with the baseline. All analyses will be performed with a two-sided p value of <0.05 considered significant following the intention-to-treat principle. ETHICS AND DISSEMINATION: The study has been approved by the Ethical Committee of the Guang'anmen Hospital, China Academy of Chinese Medical Sciences (approval no. 2019-210-KY). The results will be disseminated through presentation at a peer-reviewed medical journal, the relevant conferences and scientific meetings. TRIAL REGISTRATION: NCT04185259.

Electroacupuncture Versus Pelvic Floor Muscle Training Plus Solifenacin for Women With Mixed Urinary Incontinence: A Randomized Noninferiority Trial.

OBJECTIVE: To evaluate the efficacy and safety of electroacupuncture vs pelvic floor muscle training (PFMT) plus solifenacin for women with mixed urinary incontinence (MUI). PATIENTS AND METHODS: This randomized controlled noninferiority trial was conducted at 10 hospitals in China between March 1, 2014, and October 10, 2016. Participants were randomized 1:1 to receive electroacupuncture (36 sessions) over 12 weeks with 24 weeks of follow-up or PFMT-solifenacin (5 mg/d) over 36 weeks. The primary outcome was percentage change from baseline to week 12 in mean 72-hour incontinence episode frequency (IEF) measured by the 72-hour bladder diary. It was analyzed in the per-protocol set with a prespecified noninferiority margin of 15%. RESULTS: Of 500 women with MUI who were randomized, 467 (239 in the electroacupuncture group and 228 in the PFMT-solifenacin group) completed treatment per protocol and were included in the primary outcome analysis. At weeks 1 through 12, the percentage of reduction from baseline in mean 72-hour IEF was 37.83% in the electroacupuncture group and 36.49% in the PFMT-solifenacin group (between-group difference, -1.34% [95% CI, -9.78% to 7.10%]; P<.001 for noninferiority), which demonstrates noninferiority; the treatment effect persisted throughout follow-up. Statistically significant improvements were found for secondary outcomes in both groups, with no meaningful difference between treatments. CONCLUSION: In women with moderate to severe MUI, electroacupuncture was not inferior to PFMT-solifenacin in decreasing the 72-hour IEF and shows promise as an effective alternative for the treatment of MUI. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT02047032.

Acupuncture for symptoms in menopause transition: a randomized controlled trial.

BACKGROUND: Acupuncture has been used for women during menopause transition, but evidence is limited. OBJECTIVE: We sought to evaluate the efficacy of electroacupuncture on relieving symptoms of women during menopause transition. STUDY DESIGN: We conducted a prospective, multicenter, randomized, participant-blinded trial in China mainland. Subjects were randomized to receive 24 treatment sessions of electroacupuncture at traditional acupoints or sham electroacupuncture at nonacupoints over 8 weeks with 24 weeks' follow-up. Primary outcome was the change from baseline in the total score of Menopause Rating Scale at week 8. Secondary outcomes included the changes from baseline in the average 24-hour hot flash score, the Menopause Rating Scale subscale scores, the total score of Menopause-Specific Quality of Life Questionnaire and its subscales, and serum female hormones. All analyses were performed with a 2-sided P value of < .05 considered significant based on the intention-to-treat principle. RESULTS: A total of 360 women (180 in each group) with menopause-related symptoms during menopause transition were enrolled from June 9, 2013, through Dec 28, 2015. At week 8, the reduction from baseline in the Menopause Rating Scale total score was 6.3 (95% confidence interval, 5.0-7.7) in the electroacupuncture group and 4.5 (95% confidence interval, 3.2-5.8) in the sham electroacupuncture group with a between-group difference of 1.8 (95% confidence interval, 0.9-2.8; P = .0002), less than the minimal clinically important difference of 5 points' reduction. For secondary outcomes, the between-group differences for the decrease in the mean 24-hour hot flash score were significant at weeks 8, 20, and 32, but all were less than the minimal clinically important difference in previous reports. Interestingly, the between-group differences for the Menopause-Specific Quality of Life Questionnaire total score reduction were 5.7 at week 8, 7.1 at week 20, and 8.4 at week 32, greater than the minimal clinically important difference of 4 points. Changes from baseline in follicle-stimulating hormone, luteinizing hormone, and estradiol levels at weeks 8 and 20 (P > .05 for all), with the exception of follicle-stimulating hormone/luteinizing hormone ratios (P = .0024 at week 8 and .0499 at week 20), did not differ between groups. CONCLUSION: Among women during menopause transition, 8 weeks' electroacupuncture treatment did not seem to relieve menopausal symptoms, even though it appeared to improve their quality of life. Generalizability of the trial results may be limited by mild baseline menopausal symptoms in the included participants.

Acupuncture for Chronic Prostatitis/Chronic Pelvic Pain Syndrome: A Randomized, Sham Acupuncture Controlled Trial.

PURPOSE: We investigated the effectiveness of acupuncture in patients with chronic prostatitis/chronic pelvic pain syndrome. MATERIALS AND METHODS: We performed this 32-week randomized, controlled trial with 8 weeks of treatment followed by 24 weeks of followup to compare acupuncture with sham acupuncture. Participants with chronic prostatitis/chronic pelvic pain syndrome were randomly assigned to acupuncture or noninvasive sham acupuncture. The primary outcome was the change in the NIH-CPSI (National Institutes of Health Chronic Prostatitis Symptom Index) total score from baseline to week 8. Secondary outcomes were the NIH-CPSI subscale scores, pain severity, the I-PSS (International Prostate Symptom Score), the global response rate and satisfaction assessment. RESULTS: A total of 68 participants 18 to 50 years old were enrolled and included in intent to treat analyses. Baseline characteristics were comparable in the 2 groups. The reduction in the NIH-CPSI total score differed significantly between the 2 groups at weeks 8, 20 and 32 with a difference of -5.7 (95% CI -7.8--3.7), -6.7 (95% CI -8.9--4.5) and -7.4 (95% CI -9.8--5.1), respectively (each p <0.001). All differences were greater than the 4-point minimal clinically important difference. No significant difference was found between the groups in NIH-CPSI pain and quality of life subscale scores or in I-PSS at week 4 (each p >0.05). For all other secondary outcomes the acupuncture group was statistically better than the sham acupuncture group. CONCLUSIONS: Acupuncture showed clinical and long-lasting benefits compared with sham acupuncture for chronic prostatitis/chronic pelvic pain syndrome. Randomized controlled trials with larger sample sizes are needed in the future.

Efficacy of acupuncture for chronic prostatitis/chronic pelvic pain syndromes: study protocol for a randomized, sham acupuncture-controlled trial.

BACKGROUND: Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) affects many adult men worldwide. The currently available therapies offer little or no proven benefit for CP/CPPS. We designed this study to assess the efficacy of acupuncture therapy for the treatment of CP/CPPS. METHODS: This study is designed as a randomized, sham acupuncture-controlled trial. We will compare patients with CP/CPPS in an acupuncture group and a sham acupuncture group. Sixty-eight patients will be randomly allocated to receive acupuncture or sham acupuncture. The treatments will consist of 30-min sessions, three times weekly, for 8 weeks. The primary outcome measure is change in the weekly mean National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) total score from baseline through the 8-week treatment period. Secondary measures include the NIH-CPSI subscale scores, the total International Prostate Symptom Score (IPSS), patients' response rate, and patient satisfaction after treatment. We will also assess changes in the NIH-CPSI total score from baseline at the 20th and 32nd week of follow-up. DISCUSSION: This is a randomized, sham-controlled trial of acupuncture treatment for CP/CPPS. The results of this trial will provide more evidence on whether acupuncture is efficacious for treating CP/CPPS. TRIAL REGISTRATION: Clinical Trials.gov NCT02588274.

[Effectiveness of Electroacupuncture of Zigong (EX-CA 1), etc. in Treatment of Perimenopausal Syndrome Women].

OBJECTIVE: To evaluate the curative effect of electroacupuncture(EA) of Zigong (EX-CA 1) and Tianshu (ST 25) and acupuncture of Sanyinjiao (SP 6) and Guanyuan (CV 4) for perimenopausal syndrome(PMS). METHODS: Fifty-eight PMS patients were equally and randomized into acupuncture group and medication group. EA (10 Hz/50 Hz, 30 min in duration) was applied at Zigong (EX-CA 1) and Tianshu (ST 25) in combination with manual acupuncture stimulation of Sanyinjiao (SP 6) and Guanyuan (CV 4) by twirling the acupuncture needles with small amplitude and till deqi. The treatment was conducted once every other day, three times a week, 8 weeks altogether. The patients of the medication group were asked to take estradiol valerate (1 mg/time, qd) for 3 weeks, then, to have one week's rest and continuously took estradiol valerate(1 mg/d) and medroxyprogesterone 17-acetate (8 mg/d) for 10 days. The therapeutic effects were assessed by Menopause Rating Scale Questionnaire[MRS, composing of 3 areas:somatic (4 items), psychological(4 items) and urogenital (3 items) domain]. Serum estradiol (E2), follicle stimulating hormone(FSH) and luteotrophic hormone (LH) contents were assayed using ELISA. RESULTS: After the treatment, the scores of the MRS and the contents of serum FSH and LH were significantly decreased in both the acupuncture and medication groups (P<0.01), and serum E2 contents significantly increased in the two groups (P<0.01). No significant differences were found between the two groups in the total effective rates (P>0.05). Eight weeks' follow-up showed that the MRS score of the acupuncture group was significantly lower than that of the medication group (P<0.05). Of the two 29 PMS patients in the medication and acupuncture groups, 3 (10.3%) and 2 (6.9%) cases were under control, 22 (75.9%) and 21 (72.4%) experienced a marked improvement in their symptoms, 3 (10.3%) and 4(13.8%) were effective, 1 (3.4%) and 2(6.9%) invalid, with the effective rates being 96.6% and 93.1%, respectively. Eight weeks' follow-up showed that the long-term effect of the acupuncture therapy was obviously superior to that of the medication (P<0.05) according to MRS score. CONCLUSIONS: Acupuncture therapy is effective in relieving clinical symptoms of PMS women by regulating endocrine hormones, being similar to medication.