Background: The number of randomized controlled trials using auricular stimulation (AS) such as transauricular vagus nerve stimulation, or other auricular electrostimulation or auricular acupuncture or acupressure, in experimental and clinical settings, has increased markedly over the last three decades. This systematic review focusses on cardiovascular effects of auricular stimulation.Methods and analysis: The following databases were searched: MEDLINE (PubMed), EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), ISI Web of Science, and Scopus Database. RCTs were reviewed that had been published in English and European languages. Data collection and analysis was conducted by two reviewers independently. Quality and risk assessment of included studies was performed and the meta-analysis of the effect of the most frequently assessed biomarkers.Results: Altogether, 78 trials were included. 38 studies assessed heart rate (HR), 19 studies analyzed heart rate variability (HRV), 31 studies analyzed blood pressure (BP) and 7 studies were identified that measured oxygen saturation (O2), 2 studies on baroreflex sensitivity and 2 studies on skin conductance were evaluated in this review. 26 studies contained continuous data and were eligible for meta-analysis, 50 trials reported non continuous data and were evaluated descriptively. The overall quality of the studies was moderate to low. AS leads to a significant reduction of HR, the changes though were not considered an adverse reaction. Furthermore, when looking at HRV, AS was able to reduce the LF/HF ratio significantly compared to control procedures. No other cardiovascular parameters (blood pressure, oxygen saturation, baroreflex sensitivity) were changed significantly. AS produced only minor side effects in all trials.Conclusion: AS can lead to clinically safe reduction of HR and changes in the LF/HF ratio of the HRV, which is presumably via an increase in vagal activity. More research is needed to clarify whether AS can be used to modulate tachycardia or indications with autonomic imbalance.Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=231885 PROSPERO, ID CRD42021231885.

Background: Diabetic polyneuropathy (DPN) is a common complication of diabetes, which presents with a loss of sensorimotor function or pain. This study assessed the effectiveness and safety of acupuncture as a treatment for DPN-related complaints. Methods: In this randomized controlled trial, patients with type II diabetes and symptoms of neuropathy in the lower limbs were included. A total of 12 acupuncture treatments were administered over 8 weeks. The waitlist control group received the same acupuncture treatment starting at week 16 (after baseline). Results: A total of 62 patients were randomized (acupuncture group n = 31; control group n = 31). The primary outcome was overall complaints, and it was reduced with a significant difference of 24.7 on a VAS (CI 95% 14.8;34.7, p < 0.001) between both groups in favor of acupuncture. Reductions were recorded for the secondary outcomes VAS pain, neuropathic pain symptom inventory (NPSI), emotional dimensions of pain, SF-12, and diabetic peripheral neuropathic pain impact (DPNPI) after the intervention and at the follow-ups in the acupuncture group. Adverse reactions were minor and transient. Conclusions: Acupuncture leads to a significant and lasting reduction in DPN-related complaints when compared to routine care and is well tolerated, with minor side effects.

BACKGROUND Diabetic peripheral neuropathy (DPN) is a common complication of diabetes mellitus and can lead to serious complications. Therapeutic strategies for pain control are available but there are few approaches that influence neurological deficits such as numbness. AIM To investigate the effectiveness of acupuncture on improving neurological deficits in patients suffering from type 2 DPN. METHODS The acupuncture in DPN (ACUDPN) study was a two-armed, randomized, controlled, parallel group, open, multicenter clinical trial. Patients were randomized in a 1:1 ratio into two groups: The acupuncture group received 12 acupuncture treatments over 8 wk, and the control group was on a waiting list during the first 16 wk, before it received the same treatment as the other group. Both groups received routine care. Outcome parameters were evaluated after 8, 16 and 24 wk and included neurological scores, such as an 11-point numeric rating scale (NRS) 11 for hypesthesia, neuropathic pain symptom inventory (NPSI), neuropathy deficit score (NDS), neuropathy symptom score (NSS); nerve conduction studies (NCS) were assessed with a handheld point-of-care device. RESULTS Sixty-two participants were included. The NRS for numbness showed a difference of 2.3 (P < 0.001) in favor of the acupuncture group, the effect persisted until week 16 with a difference of 2.2 (P < 0.001) between groups and 1.8 points at week 24 compared to baseline. The NPSI was improved in the acupuncture group by 12.6 points (P < 0.001) at week 8, the NSS score at week 8 with a difference of 1.3 (P < 0.001); the NDS and the TNSc score improved for the acupuncture group in week 8, with a difference of 2.0 points (P < 0.001) compared to the control group. Effects were persistent in week 16 with a difference of 1.8 points (P < 0.05). The NCS showed no meaningful changes. In both groups only minor side effects were reported. CONCLUSION Study results suggest that acupuncture may be beneficial in type 2 diabetic DPN and seems to lead to a reduction in neurological deficits. No serious adverse events were recorded and the adherence to treatment was high. Confirmatory randomized sham-controlled clinical studies with adequate patient numbers are needed to confirm the results.

The number of randomized controlled trials (RCTs) using auricular stimulation (AS) techniques, such as transauricular vagus nerve stimulation, auricular electrostimulation, auricular acupuncture, and acupressure in experimental and clinical settings has increased markedly over the last three decades. This systematic review evaluates the effects of AS on biomarkers of inflammation and stress responses. The following data bases were searched: MEDLINE (PubMed), EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), ISI Web of Science, and Scopus Data base. Data collection and analysis were conducted independently by two reviewers. Quality and risk assessments of the included studies were performed, and a meta-analysis of the effects of the most frequently assessed biomarkers was conducted using RevMan statistical software. A total of 1122 patients and healthy volunteers from 27 RCTs were included in this systematic review; 81% of the participants were female, with a median age of 51 years. Pooled data of 18 studies showed a significant effect of AS regarding a reduction of serum C-reactive protein, tumor necrosis factor-α, interleukin (IL)-6, and IL-10. Although IL-4, IL1β, cortisol, substance P and calcitonin gene-related peptide, and adrenocorticotropic hormone did not show any changes, salivary amylase increased under AS. The influence of inflammatory cytokines seems to be mediated by AS. More research is needed to investigate the effects of AS on the immunologic system in addition to its clinical significance in high-quality RCT.

Background: Acupuncture is used to treat patients with diabetic peripheral neuropathy; however, the evidence is unclear. We present the design and methodology of the ACUDPN (ACUpuncture in Diabetic Peripheral Neuropathy) trial, which investigates the effectiveness of acupuncture for the treatment of diabetic peripheral neuropathy (DPN) symptoms. The aim of this study is to investigate whether acupuncture is effective for the treatment of DPN symptoms. Methods: This study is a two-armed, randomized, controlled, parallel group, open-label, confirmatory, multicenter trial (8-week intervention period plus 16 weeks of follow-up). Physicians in outpatient units in Germany who specialize in acupuncture treatment will treat 110 diabetes type II patients with clinical symptoms of peripheral neuropathy in the feet and legs with signs of neuropathy according to nerve conduction testing. The patients will be randomized in a 1:1 ratio to one of the following two groups: (a) semi-standardized acupuncture plus routine care or (b) routine care alone. Acupuncture will consist of 12 treatments per patient over 8 weeks. The primary outcome will be the overall DPN-related complaints in the extremities after 8 weeks as measured by the Visual Analog Scale (VAS). Further outcome measures will include DPN-related pain, the Neuropathic Pain Symptom Inventory (NPSI), Diabetic Peripheral Neuropathic Pain Impact (DPNPI) scores, and nerve conduction parameters of the sural nerve at weeks 8, 16, and 24. Discussion: The results of this trial will be available in 2021 and will help clarify whether acupuncture can be considered effective for the treatment of DPN with regard to the subdimensions of the neuropathic clinical picture. Trial registration: ClinicalTrials.gov NCT03755960. Registered on 11 August 2018.

Background: Over the last three decades, the number of randomized controlled trials (RCTs) using stimulation of auricular vagal sensory nerves by means of electrical stimulation, auricular acupuncture, or acupressure to support weight loss has increased markedly. This systematic review focuses on the effects of auricular stimulation (AS) on anthropometric parameters and obesity-related blood chemistry.Methods and analysis: The following databases were searched until November 2021: MEDLINE (PubMed), EMBASE, Cochrane Central Register of Controlled Trials (CENTRAL), ISI Web of Science, and Scopus Database. Data collection and analysis were conducted by two reviewers independently. Quality and risk assessment of included studies was performed using the risk of bias tool of the Cochrane Handbook, and the meta-analysis of the effect of the most frequently assessed biomarkers was conducted using the statistical software RevMan.Results: The full texts of 1,274 studies were screened; 22 contained data on obesity-related outcomes, and 15 trials with 1,333 patients were included in the meta-analysis. The overall quality of the included trials was moderate. AS significantly reduced body mass index (BMI) (mean difference (MD) = −0.38 BMI points, 95% CI (−0.55 to −0.22), p < 0.0001), weight (MD = −0.66 kg, 95% CI (−1.12 to −0.20), p = 0.005), waist circumference (MD = −1.44 cm, 95% CI (−2.69 to −0.20), p = 0.02), leptin, insulin, and HOMA insulin resistance compared to controls. No significant reduction was found in body fat, hip circumference, ratio of waist/hip circumference, cholesterol, LDL, triglycerides, adiponectin, ghrelin, and glucose levels. The AS was safe throughout the trials, with only minor adverse reactions.Conclusion: The study results suggest that a reduction of weight and BMI can be achieved by AS in obese patients; however, the size of the effect does not appear to be of clinical relevance. The effects might be underestimated due to active sham trials.Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021231885.