Effect of Adjunctive Acupuncture on Pain Relief Among Emergency Department Patients With Acute Renal Colic Due to Urolithiasis: A Randomized Clinical Trial.

Importance: Renal colic is described as one of the worst types of pain, and effective analgesia in the shortest possible time is of paramount importance. Objectives: To examine whether acupuncture, as an adjunctive therapy to analgesics, could accelerate pain relief in patients with acute renal colic. Design, Setting, and Participants: This single-center, sham-controlled, randomized clinical trial was conducted in an emergency department in China between March 2020 and September 2020. Participants with acute renal colic (visual analog scale [VAS] score ≥4) due to urolithiasis were recruited. Data were analyzed from October 2020 to January 2022. Interventions: After diagnosis and randomization, all patients received 50 mg/2 mL of diclofenac sodium intramuscular injection immediately followed by 30-minute acupuncture or sham acupuncture. Main Outcomes and Measures: The primary outcome was the response rate at 10 minutes after needle manipulation, which was defined as the proportion of participants whose VAS score decreased by at least 50% from baseline. Secondary outcomes included response rates at 0, 5, 15, 20, 30, 45, and 60 minutes, rescue analgesia, and adverse events. Results: A total of 115 participants were screened and 80 participants (66 men [82.5%]; mean [SD] age, 45.8 [13.8] years) were enrolled, consisting of 40 per group. The response rates at 10 minutes were 77.5% (31 of 40) and 10.0% (4 of 40) in the acupuncture and sham acupuncture groups, respectively. The between-group differences were 67.5% (95% CI, 51.5% to 83.4%; P < .001). The response rates of acupuncture were also significantly higher than sham acupuncture at 0, 5, 15, 20 and 30 minutes, whereas no significant difference was detected at 45 and 60 minutes. However, there was no difference between the 2 groups in rescue analgesia rate (difference 2.5%; 95% CI -8.8% to 13.2%; P > .99). No adverse events occurred during the trial. Conclusions and Relevance: These findings suggest that acupuncture plus intramuscular injection of diclofenac is safe and provides fast and substantial pain relief for patients with renal colic compared with sham acupuncture in the emergency setting. However, no difference in rescue analgesia was found, possibly because of the ceiling effect caused by subsequent but robust analgesia of diclofenac. Acupuncture can be considered an optional adjunctive therapy in relieving acute renal colic. Trial Registration: Chinese Clinical Trial Registry: ChiCTR1900025202.

Efficacy and Safety of Acupuncture in Renal Colic Caused by Urinary Calculi in Adults: A Systematic Review and Meta-Analysis.

Background: Acute renal colic caused by urinary calculi has a considerable impact on the quality of life. Pain relief is the primary goal in the management of patients with acute renal colic caused by urinary calculi. At present, there is no systematic evaluation of the efficacy and safety of manual acupuncture in the treatment of acute renal colic caused by urinary calculi in adults. Objective: To evaluate the efficacy and safety of manual acupuncture in the treatment of acute renal colic caused by urinary calculi in adults. Methods: Databases of PubMed, EMBASE, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang Medical, VIP Database for Chinese Technical Periodicals (VIP), and China Biomedical Literature (SinoMed) were searched for literature and other randomized controlled registration platforms. We searched to identify the relevant randomized controlled trials from the establishment of the database to February 9, 2022. Only randomized controlled trials (RCTs) of manual acupuncture as the therapy for acute renal colic caused by urinary calculi in adults were included, whether or not the blind method is used. The patients were adults diagnosed with urinary calculi and renal colic. The control group was treated with commonly used analgesics and antispasmodics. The experimental group was treated with acupuncture as a monotherapy or as an adjuvant therapy (manual acupuncture combined with analgesics and antispasmodics). Two review authors independently assessed titles and abstracts for relevance and extracted data on study design, participants, interventions, and outcomes from potentially relevant articles. Cochrane risk bias assessment tool was used to evaluate the quality of the included study, and RevMan5.4 software was used for meta-analysis. Our primary outcomes were response rate and time duration before pain remission. Secondary outcomes were the time of complete pain relief, pain variation, need for rescue analgesia, and adverse events. Results: Out of 1123 records identified, 15 were found to be of relevance to this study, and 1210 participants were included in the meta-analysis. The meta-analysis of the results shows that, in terms of response rate, compared with the control group, acupuncture as a monotherapy seems to have a slight advantage (RR = 1.10 (95% CI: 1.03, 1.18), I 2 = 28%, P=0.004), while acupuncture as an adjuvant therapy has no advantage (RR = 1.06 (95% CI: 0.95, 1.20), I 2 = 77%, P=0.30). In terms of duration before pain relief, acupuncture as a monotherapy had an advantage over the control group (MD = -10.28(95% CI: -14.40, -6.17), I 2 = 93%, P < 0.00001). Acupuncture as a monotherapy was similar to positive medication in terms of complete pain relief (MD = -7.13 (95% CI: -20.19, 5.94), I 2 = 95%, P=0.28). Pain variation: VAS scores at 10 min, acupuncture as a monotherapy (MD = -2.47 (95% CI: -3.40, -1.53), I 2 = 84%, P < 0.00001) or as an adjuvant therapy (MD = -3.38 (95% CI: -4.33, -2.43), I 2 = 60%, P < 0.00001) was better than the control group. VAS scores at 30 min, compared with the control group, there was no difference between acupuncture as a monotherapy (MD = -0.27 (95% CI: -1.43, 0.88), I 2 = 88%, P=0.64) and acupuncture as an adjuvant therapy (MD = -1.17 (95% CI: -3.15, 0.81), I 2 = 96%, P=0.25). VAS scores at 60 min, compared with the control group, there was no difference in the acupuncture as a monotherapy (MD = 0.58 (95% CI: -0.28, 1.45), I 2 = 77%, P=0.19), while acupuncture as an adjuvant therapy was better (MD = -1.22 (95% CI: -1.93, -0.51), I 2 = 72%, P=0.0007). VAS scores at 120 min, there was no difference in acupuncture as a monotherapy compared to the control group (MD = -0.24 (95% CI:-1.22, 0.75), I 2 = 0, P=0.64). One study reported on rescue analgesia. Fewer adverse events occurred in the experimental group compared to the control group. Conclusion: In the course of manual acupuncture treatment of acute renal colic caused by urinary calculi in adults, available evidence suggests that manual acupuncture is as effective as positive treatment drugs, either as a monotherapy or as an adjunctive therapy, with the advantage of acupuncture being its rapid onset of action. However, the number of existing clinical studies is small, and the quality of evidence is generally low, so it is recommended to use it with caution. In order to further verify the above conclusions, more high-quality clinical RCTs need to be carried out. Trial Registration. The present review protocol was registered with the International Prospective Register of Systematic Reviews (CRD42019134900).

Acupuncture as adjunctive therapy for acute renal colic caused by urinary calculi: study protocol for a randomized controlled trial.

BACKGROUND: Acute renal colic caused by urinary calculi (ARCUC) has a considerable impact on the quality of life. Acupuncture might be a potential treatment option. However, the evidence is limited. We will conduct this trial to evaluate the efficacy and safety of acupuncture as adjunctive treatment to diclofenac for ARCUC. METHODS/DESIGN: A total of 80 eligible patients who are diagnosed with urinary stone renal colic will be randomly allocated to the acupuncture group or the sham acupuncture group. Each patient will receive 1 session of acupuncture or sham acupuncture. The primary outcome will be the response rate of patients achieving a reduction of > 50% on visual analog score (VAS) from baseline to 10 min after treatment. Secondary outcomes will include the VAS, remedial analgesia, re-visit and admission rate, blinding assessment, credibility and expectancy, and adverse event. All patients who receive randomization will be included in the intent-to-treat analysis. DISCUSSION: The finding of this trial will provide evidence on the efficacy and safety of acupuncture for the treatment of ARCUC. The results of this study will be published in peer-reviewed journals. TRIAL REGISTRATION: ClinicalTrials.gov ChiCTR 1900025202 . Registered on August 16, 2019.

Effects of warm needling therapy on symptoms of benign prostatic hyperplasia: A protocol for a systematic review and meta-analysis.

BACKGROUND: Benign prostatic hyperplasia (BPH) is the term for a type of non-malignant prostate enlargement that is most often diagnosed in men of middle age and older. Lower urinary tract symptoms (LUTS) are commonly observed in men afflicted with BPH. Evidence suggests that warm needling therapy could be applied clinically to relieve the LUTS associated with BPH, particularly in China, where experienced practitioners are readily available. In this review, the safety and effects of warm needling therapy are assessed in the context of treatment for LUTS associated with BPH. METHODS: First, data for relevant randomised controlled trials and the initial periods of randomised cross-over trials will be obtained from four English databases (MEDLINE, Cochrane Central Register of Controlled Trials, EMBASE, and Allied and Complementary Medicine Database) and six Chinese databases (China National Knowledge Infrastructure, Wanfang Database, SinoMed, Chongqing VIP Chinese Science and Technology Periodical Database, China Master's Theses Full-text Database and China Doctoral Dissertations Full-text Database). The primary outcomes analysed in this protocol are improvements in urological symptoms as measured by recognized urological symptom scores, while secondary outcomes include improvement of urine flow rate measures, residual urine volume, nocturia, prostate size, and quality-of-life score. In addition, safety outcomes will be analysed by assessing incidences of adverse events. Two reviewers will independently assess and select studies, extract data and assess the risk of bias. Data synthesis and risk bias assessment will be performed with Review Manager software (version 5.3). RESULTS: This systematic review provides a synthesis to assess the therapeutic efficacy of warm needling therapy for LUTS associated with BPH. CONCLUSION: The present study will provide a clinically relevant evaluation of the current state of evidence regarding the therapeutic efficacy of warm needling therapy for LUTS associated with BPH. ETHICS AND DISSEMINATION: Ethical approval is not required for this review, because private information will not be collected from the included participants. The results of the study will be published in a peer-reviewed journal. REGISTRATION NUMBER: PROSPERO CRD42020198360.

Effect of fire needle therapy on mild-moderate benign prostatic hyperplasia: Protocol for a randomized controlled pilot trial.

BACKGROUND: Benign prostatic hyperplasia (BPH) is the most common non-cancerous disease of the prostate and leads to lower urinary tract symptoms in middle-aged and elderly males. Fire needle therapy could improve the lower urinary tract symptoms associated with mild-moderate BPH in clinical practice. The aim of the present pilot study is to assess the preliminary effects of fire needle therapy on mild-moderate BPH. METHODS: The present study is a prospective parallel randomized controlled pilot trial. A total of 60 eligible participants will be randomly assigned to a treatment or control group at a 1:1 ratio. The treatment group will receive fire needle therapy and the control group will receive watchful waiting with lifestyle advice and education regarding BPH. Participants will receive intervention for 4 weeks, with a follow-up period of 4 additional weeks. Adverse events will be recorded to assess the safety and tolerability of fire needle therapy for mild-moderate BPH. The primary outcome will be the change in the International Prostate Symptom Score. The secondary outcomes will include the change in the mean number of nightly urinations, the maximum urinary flow rate, the average flow rate, and the prostate volume as measured by a B-mode ultrasound device. All outcome measures will be observed at baseline and at 4 and 8 weeks following the beginning of treatment. DISCUSSION: The present study will provide evidence of the preliminary effects of fire needle therapy on mild-moderate BPH and indicate an optimal sample size for future studies.