Manual Acupuncture or Combination with Vitamin B to Treat Diabetic Peripheral Neuropathy: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.
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ABSTRACT: Methods
Randomized controlled trials on manual acupuncture treatment of DPN were retrieved from the Medline, Web of Science, PubMed, Cochrane Library, EMBASE, CNKI, WanFang, and VIP databases. Extracted research data were summarized in the tables, and methodological assessment was performed using the risk-of-bias assessment tool of Cochrane. Meta-analysis was performed by Revman 5.3, Stata 14.0, and TSA 0.9.5.10 Beta software.Results
A total of 18 randomized clinical trials (RCTs) were recruited: (1) 11 RCTs were acupuncture alone compared with vitamin B; (2) 7 RCTs were acupuncture combined with vitamin B compared with vitamin B, involving 1200 participants. Acupuncture alone improved clinical efficacy (P < 0.05) and nerve conduction velocity of the four peripheral nerves: peroneal nerve, tibial nerve, median nerve, and ulnar nerve (P < 0.05), but there was no significant difference between the group of acupuncture alone and the group of vitamin B (P = 0.36 > 0.05) in improving median nerve SCV (sensory nerve conduction velocity). Acupuncture combined with vitamin B improved clinical efficacy and nerve conduction velocity of the three peripheral nerves, peroneal nerve, tibial nerve, and median nerve (P < 0.05), and decreased the scores of the Toronto clinical scoring system (TCSS) (P < 0.05).Conclusion
Acupuncture alone and vitamin B combined with acupuncture are more effective in treating DPN compared to vitamin B. However, more high-quality RCTs on vitamin B combined with acupuncture are required to confirm our results.
SUBMITTER: Jiang HL
PROVIDER: S-EPMC8067773 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveManual acupuncture has commonly been used in China, either alone or in combination with conventional medicine, to treat diabetic peripheral neuropathy (DPN). The objective of this study was to perform a systematic review to evaluate the potential benefits and harms of manual acupuncture for DPN to justify its clinical use.MethodsWe searched for published and unpublished randomized controlled trials of manual acupuncture for DPN till 31 March 2013. Revman 5.2 software was used for data analysis with effect estimate presented as relative risk (RR) and mean difference (MD) with a 95% confidence interval (CI).ResultsA total of 25 trials involving 1649 participants were included. The methodological quality of included trials was generally poor. Meta-analysis showed that manual acupuncture had better effect on global symptom improvement compared with mecobalamin (RR 1.31, 95%CI 1.21 to 1.42), vitamin B1 and B12 (RR 1.55, 95%CI 1.33 to 1.80), and no treatment (RR 1.56, 95%CI 1.31 to 1.85), and that the combination of manual acupuncture and mecobalamin had better effect compared with mecobalamin alone on global symptom improvement (RR 1.56, 95%CI 1.28 to 1.90). Adverse events were not reported in any trials. The asymmetric funnel plot suggested publication bias.ConclusionsDespite the number of trials of manual acupuncture for DPN and their uniformly positive results, no clinically relevant conclusions can be drawn from this review due to the trials' high risks of bias and the possibility of publication bias. Clearly defined and internationally acknowledged outcome measures are required for future study. There remains an urgent need for training Chinese researchers in conducting unbiased trials as well as prospectively registering all initiated Chinese trials to avoid publication bias.
| S-EPMC3771980 | biostudies-literature
Project description:BackgroundTo evaluate the reports' qualities which are about randomized controlled trials (RCTs) of acupuncture treatment on Diabetic Peripheral Neuropathy (DPN).Methodology/principal findingsEight databases including The Cochrane Library(1993-Sept.,2011), PubMed (1980-Sept., 2011), EMbase (1980-Sept.,2011), SCI Expanded (1998-Sept.,2011), China Biomedicine Database Disc (CBMdisc, 1978-Sept., 2011), China National Knowledge Infrastructure (CNKI, 1979-Sept., 2011 ), VIP (a full text issues database of China, 1989-Sept., 2011), Wan Fang (another full text issues database of China 1998-Sept., 2011) were searched systematically. Hand search for further references was conducted. Language was limited to Chinese and English. We identified 75 RCTs that used acupuncture as an intervention and assessed the quality of these reports with the Consolidated Standards for Reporting of Trials statement 2010 (CONSORT2010) and Standards for Reporting Interventions Controlled Trials of Acupuncture 2010(STRICTA2010). 24 articles (32%) applied the method of random allocation of sequences. No article gave the description of the mechanism of allocation concealment, no experiment applied the method of blinding. Only one article (1.47%) could be identified directly from its title as about the Randomized Controlled Trials, and only 4 articles gave description of the experimental design. No article mentioned the number of cases lost or eliminated. During one experiment, acupuncture syncope led to temporal interruption of the therapy. Two articles (2.94%) recorded the number of needles, and 8 articles (11.76%) mentioned the depth of needle insertion. None of articles reported the base of calculation of sample size, or has any analysis about the metaphase of an experiment or an explanation of its interruption. One (1.47%) mentioned intentional analysis (ITT).Conclusions/significanceThe quality of the reports on RCTs of acupuncture for Diabetic Peripheral Neuropathy is moderate to low. The CONSORT2010 and STRICTA2010 should be used to standardize the reporting of RCTs of acupuncture in future.
| S-EPMC3388075 | biostudies-literature
Project description:BackgroundAcupuncture 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.MethodsThis 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.DiscussionThe 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 registrationClinicalTrials.gov NCT03755960 . Registered on 11 August 2018.
| S-EPMC7907791 | biostudies-literature
Project description:BACKGROUND:Diabetic peripheral neuropathy (DPN) is the most common chronic complication of diabetes mellitus that has a considerable impact on quality of life, but there are few effective therapeutic strategies. The aim of this trial is to determine the efficacy and safety of manual acupuncture (MA) versus sham acupuncture (SA) for DPN. METHODS/DESIGN:This is a study protocol for a randomized, placebo-controlled clinical trial. A total of 118 patients with DPN will be recruited and randomly assigned in a 1:1 ratio to either the MA group or SA group. All patients will receive 24 sessions over 12?weeks. Participants will complete the trial by visiting the research center at month 6 for a follow-up assessment. The primary outcome is peroneal motor nerve conduction velocity (peroneal MNCV) at week 12 compared with baseline. Secondary outcomes include peroneal motor nerve action potential amplitude (peroneal MNAP) and latent period (peroneal MNLP), sural sensory nerve conduction velocity (sural SNCV), action potential amplitude (sural SNAP) and latent period (sural SNLP), fasting plasma glucose (FPG), 2-h postprandial blood glucose (2hPG), glycated hemoglobin (HbAlc) at week 12 compared with baseline, Michigan Neuropathy Screening Instrument (MNSI) score and Diabetes Specific Quality of Life scale (DSQL) at week 12 and month 6 compared with baseline. Safety will be assessed during the whole trial. Masking effectiveness will be assessed by patients. DISCUSSION:This trial may provide high-quality evidence for evaluating the efficacy and safety of MA treatment for DPN compared with SA treatment. Results of this study will be published in peer-reviewed journals. TRIAL REGISTRATION:Chinese Clinical Trials Registry ChiCTR1800020444. First registered on 29 December 2018, retrospectively registered, http://www.chictr.org.cn/showproj.aspx?Proj=31063 .
| S-EPMC7586683 | biostudies-literature
Project description:Diabetic peripheral neuropathy (DPN), the most common chronic complication of diabetes, has become an important public health crisis worldwide. Given that DPN is extremely difficult to treat, determining its risk factors and controlling it at an early stage is critical to preventing its serious consequences and the burden of social disease. Current studies suggest that the risk factors for diabetic peripheral neuropathy are the duration of diabetes, age, glycosylated hemoglobin A1c (HbA1c), diabetic retinopathy (DR), smoking, and body mass Index (BMI). However, most of the aforementioned studies are cross-sectional, and the sample sizes are very limited, so the strength of causal reasoning is relatively low. The current study systematically evaluated DPN's influencing factors in patients with type 2 diabetes using evidence-based medicine. Overall, 16 included studies (14 cross-sectional studies and 2 case-control studies including 12,116 cases) that conformed to the present criteria were included in the final analysis. The results suggested that the duration of diabetes (MD 2.5, 95% CI 1.71~3.29), age (MD 4.00, 95% CI 3.05~4.95), HbA1c (MD 0.48, 95% CI 0.33~0.64), and DR (OR 2.34, 95% CI 1.74~3.16) are associated with significantly increased risks of DPN among diabetic patients, while BMI, smoking, total triglyceride (TG), and total cholesterol (TC) did not indicate any risks of increasing DPN. The findings provide a scientific basis for a further understanding of the causes of type 2 diabetes complicated with peripheral neuropathy and the improvement of preventive strategies. The next step is to conduct further high-quality prospective cohort studies to validate this paper's findings.
| S-EPMC6382168 | biostudies-literature
Project description:BackgroundCurrently, diabetic peripheral neuropathy (DPN) is one of the most severe complications of diabetes mellitus (DM). Despite the seriousness of this problem, limited evidence is available on the prevalence of diabetic peripheral neuropathy among patients with diabetes mellitus in Ethiopia. In Ethiopia, there were no updated studies that estimate the national prevalence of DPN. Hence, this systematic review and meta-analysis provided a national prevalence of diabetic peripheral neuropathy among patients with diabetes mellitus in Ethiopia.MethodsThis study was submitted for registration with the International Prospective Register of Systematic Reviews (PROSPERO) in March 2020 and accepted with the registration number CRD42020173831. Different database searching engines were searched online to retrieve related articles, including PubMed, Scopus, Google Scholar, African Journals Online, World Health Organization (WHO) Afro Library, and Cochrane Review. The reviewers used the Preferred Reporting Items for Systematic Review and Meta-Analysis (PRISMA) guideline in the reviewing process. In this systematic review and meta-analysis, all published and unpublished articles were analyzed. The reviewers used the random effects model to estimate the pooled prevalence of diabetic peripheral neuropathy among diabetes mellitus patients. The reviewers conducted the statistical analysis using the R version 3.5.3 and RStudio version 1.2.5033 software for Windows. The reviewers evaluated the heterogeneity across the included studies by the inconsistency index (I 2). The reviewers examined the publication bias by the funnel plot.ResultsThe search of the databases produced 245 papers. After checking the inclusion and exclusion criteria, 38 articles with 14029 total patients with diabetes mellitus were found suitable for the review. Except for three (retrospective cohort study), all studies were cross-sectional. The overall pooled prevalence of diabetic peripheral neuropathy was 22% (95% CI 18% to 26%). The subgroup analysis of diabetic peripheral neuropathy among patients with diabetes in the different regions was 23% (95% CI 17% to 29%) in Addis Ababa, 27% (95% CI 16% to 38%) in Oromia, 16% (95% CI 14% to 18%) in South nation and nationalities, and 15% (95% CI 6% to 24%) in Amhara.ConclusionsMore than one-fifth of patients with diabetes have diabetic peripheral neuropathy. According to this study, the prevalence of diabetic peripheral neuropathy in Ethiopia is considerably high. This evidence suggests that attention should be given to patients with diabetes in monitoring patients' blood glucose.
| S-EPMC7880716 | biostudies-literature
Project description:Background: Chemotherapy-induced peripheral neuropathy (CIPN) has no cure, but acupuncture may provide relief through its known neuromodulation or neuroendocrine adjustment. This review aimed to assess the efficacy of acupuncture in treating CIPN. Method: A literature review following the PRISMA Statement was performed, searching 7 databases from inception through August 2019. All studies were clinical trials of the effect of acupuncture on CIPN. The methodological quality of these trials was assessed using Cochrane criteria; meta-analysis software (RevMan 5.2) was used to analyze the data. Data Sources: The databases searched were the following: MEDLINE (Ovid), Embase, Cochrane CENTRAL, Scopus, World Health Organization International Clinical Trials Registry Platform, CNKI (China National Knowledge Infrastructure), and Wanfang Med Online. Results: We examined 386 cancer patients from 6 randomized control trials, which had high quality, based on the modified Jadad scale. Meta-analysis showed that acupuncture led to significant improvements in pain scores (-1.21, 95% confidence interval [CI] = -1.61 to -0.82, P < .00001) and nervous system symptoms based on Functional Assessment of Cancer Therapy/Neurotoxicity questionnaire scores (-2.02, 95% CI = -2.21 to -1.84, P < .00001). No significant change was noted in nerve conduction velocity (1.58, 95% CI = -2.67 to 5.83, P = .47). Conclusion: Acupuncture can effectively relieve CIPN pain and functional limitation. The limited number of subjects warrants a larger scale study.
| S-EPMC7242803 | biostudies-literature
Project description:IntroductionStudies have shown that acupuncture has significant therapeutic effects on painful diabetic peripheral neuropathy (PDPN) yet the precise mechanism of action underpinning these effects remains controversial. Resting-state functional MRI (rs-fMRI) is an advanced imaging technique that can be used to monitor changes in the activity of the brain, particularly in PDPN. However, the data from several studies remain inconclusive and there is currently no systematic review and meta-analysis for the use of rs-fMRI in PDPN.Methods and analysisIn this study, we will select all eligible studies published on or before 30 June 2021. Four English and four Chinese databases will be searched, specifically, PubMed, Embase, Web of Science, Cochrane Library, China National Knowledge Infrastructure, WanFang database, China Science Technology Journal Database (VIP) and China Doctor/Master Dissertations Full-text Database. Only clinical trials and the first cycle of a cross-over trial linked to acupuncture for PDPN will be included in the analysis. The main outcomes include the amplitude of low-frequency fluctuation, regional homogeneity, functional connectivity of the brain, bilateral superficial peroneal nerve sensory nerve conduction velocity, bilateral dorsal current perception threshold values and the degree of subjective pain. The secondary outcomes include biochemical indicators, the degree of depression and anxiety and changes in efficiency. The study selection, data extraction and risk of bias assessment will be performed by two investigators. For statistical analyses, Review Manager V.5.4 software will be used. If necessary, heterogeneity testing, data synthesis, and subgroup analysis will be performed.Ethics and disseminationOur systematic review and meta-analysis will be based on published literature for data extraction and will not include the use of individual patient data and so no ethical approval required.Prospero registration numberCRD42021211644.
| S-EPMC8388266 | biostudies-literature
Project description:Monochromatic infrared energy (MIRE) or phototherapy has been used to improve plantar sensitivity and pain in lower limbs of patients with diabetic sensorimotor peripheral neuropathy (DSPN), but the available primary results are inconsistent.To review systematically the effects of MIRE on plantar sensitivity and neuropathic pain in patients with DSPN.Medline, EMBASE, Cochrane CENTRAL, and Google Scholar were searched up to September 2016. Randomized controlled trials addressing the effects of MIRE on plantar sensitivity and neuropathic pain in patients with DSPN were selected. Study inclusion, risk of bias and quality assessment, and data extraction were completed by two independent reviewers.Of 2549 records identified, six studies met the selection criteria, with 304 patients (594 feet) randomized. MIRE was not associated with improvement in plantar tactile sensitivity (SMD=0.22, 95%CI -0.07 to 0.51, low quality of evidence). Subgroups of studies with short-term (up to 2 weeks) follow-up showed significant improvement in plantar sensitivity (SMD=0.41, 95% CI 0.18-0.64). Neuropathic pain increased significantly in patients who received MIRE (MD=0.49, 95% CI 0.30-0.68, low quality of evidence).There was limited evidence that MIRE results in short-term improvement of tactile sensitivity probably not sustained over time. Limited evidence also suggested that MIRE does not provide relief for neuropathic pain. As quality of evidence is low, further studies are likely to change the estimated effect.
| S-EPMC5537484 | biostudies-other
Project description:Background: Vitamin E has been increasingly used to prevent chemotherapy-induced peripheral neuropathy (CIPN) in recent years. However, it is still unclear whether vitamin E can effectively prevent CIPN. Methods: We searched all clinical studies in the Embase, Cochrane Library, Clinicaltrials.gov, and PubMed databases from inception to December 2020. We performed a meta-analysis of 9 randomized controlled trials (RCTs) with 486 patients that compared the vitamin E group with the control group. Outcomes of the study were incidence of all-grade CIPN, incidence of severe CIPN, and the total neuropathy scores (TNS). Random effect models were used to make the meta-analysis results more cautious. Results: Notably, vitamin E significantly reduced the incidence of all-grade CIPN (overall risk ratio (RR) = 0.55, 95% CI: 0.36, 0.85, I2 = 77.3%, p = 0.007), and TNS (overall standard mean difference (SMD) = -0.64, 95% CI: -1.03, -0.25, I2 = 42.7%, p = 0.001). However, the results of the subgroup analysis, which included only double-blind RCTs, suggested that vitamin E did not significantly reduce the incidence of all-grade CIPN (overall RR = 0.52, 95% CI: 0.07, 4.06, I2 = 77.5%, p = 0.531). Moreover, there was no significant difference in the incidence of severe CIPN between these two arms (p = 0.440). Conclusion: The results of our meta-analysis suggests that vitamin E has a beneficial effect on the incidence and symptoms of CIPN. However, routine prophylactic use of vitamin E is still not recommended. Moreover, more high-quality double-blind RCTs are needed to further validate the effects of vitamin E in prevention of CIPN.
| S-EPMC8155355 | biostudies-literature