Performance analysis of noninvasive electrophysiological methods for the assessment of diabetic sensorimotor polyneuropathy in clinical research: a systematic review and meta-analysis with trial sequential analysis

Fahmida Haque,Sawal Hamid Md Ali,Mamun Bin Ibne Reaz,Muhammad Enamul Hoque Chowdhury,Norhana Arsad

doi:10.1038/s41598-020-78787-0

Fahmida Haque, Sawal Hamid Md Ali + Show 3 more

Open Access

https://doi.org/10.1038/s41598-020-78787-0

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Abstract

Despite the availability of various clinical trials that used different diagnostic methods to identify diabetic sensorimotor polyneuropathy (DSPN), no reliable studies that prove the associations among diagnostic parameters from two different methods are available. Statistically significant diagnostic parameters from various methods can help determine if two different methods can be incorporated together for diagnosing DSPN. In this study, a systematic review, meta-analysis, and trial sequential analysis (TSA) were performed to determine the associations among the different parameters from the most commonly used electrophysiological screening methods in clinical research for DSPN, namely, nerve conduction study (NCS), corneal confocal microscopy (CCM), and electromyography (EMG), for different experimental groups. Electronic databases (e.g., Web of Science, PubMed, and Google Scholar) were searched systematically for articles reporting different screening tools for diabetic peripheral neuropathy. A total of 22 studies involving 2394 participants (801 patients with DSPN, 702 controls, and 891 non-DSPN patients) were reviewed systematically. Meta-analysis was performed to determine statistical significance of difference among four NCS parameters, i.e., peroneal motor nerve conduction velocity, peroneal motor nerve amplitude, sural sensory nerve conduction velocity, and sural sensory nerve amplitude (all p < 0.001); among three CCM parameters, including nerve fiber density, nerve branch density, and nerve fiber length (all p < 0.001); and among four EMG parameters, namely, time to peak occurrence (from 0 to 100% of the stance phase) of four lower limb muscles, including the vastus lateralis (p < 0.001), tibialis anterior (p = 0.63), lateral gastrocnemius (p = 0.01), and gastrocnemius medialis (p = 0.004), and the vibration perception threshold (p < 0.001). Moreover, TSA was conducted to estimate the robustness of the meta-analysis. Most of the parameters showed statistical significance between each other, whereas some were statistically nonsignificant. This meta-analysis and TSA concluded that studies including NCS and CCM parameters were conclusive and robust. However, the included studies on EMG were inconclusive, and additional clinical trials are required.

Highlights

Despite the availability of various clinical trials that used different diagnostic methods to identify diabetic sensorimotor polyneuropathy (DSPN), no reliable studies that prove the associations among diagnostic parameters from two different methods are available
Diabetic sensorimotor polyneuropathy (DSPN) is a common and costly complication that is experienced by patients with diabetes; this complication, which involves disruption in the anatomy of the nerve and blood vessels that subsequently leads to the dysfunction of the motor, sensory, and autonomic nerves, has an estimated prevalence of 50%1–3
The evaluation of DSPN by using clinical assessment instruments is simple and inexpensive, but the obtained results vary during reproduction

Summary

Introduction

Despite the availability of various clinical trials that used different diagnostic methods to identify diabetic sensorimotor polyneuropathy (DSPN), no reliable studies that prove the associations among diagnostic parameters from two different methods are available. A systematic review, meta-analysis, and trial sequential analysis (TSA) were performed to determine the associations among the different parameters from the most commonly used electrophysiological screening methods in clinical research for DSPN, namely, nerve conduction study (NCS), corneal confocal microscopy (CCM), and electromyography (EMG), for different experimental groups. Abbreviations ADA American Diabetic Association BMI Body Mass Index CCM Corneal confocal microscopy CI Confidence interval DN Diabetic neuropathy DSPN Diabetic sensorimotor polyneuropathy EMG Electromyography FL Fibularis longus GM Gastrocnemius medialis HbA1c Glycated hemoglobin IENF Intra-epidermal nerve fiber LG Lateral gastrocnemius NCV Nerve conduction velocity NCS Nerve conduction studies NA Nerve amplitude NFD Nerve fiber density NBD Nerve branch density NFL Nerve fiber length PM Peroneal motor PMNCV Peroneal motor nerve conduction velocity PMNamp Peroneal motor nerve amplitude QST Quantitative sensory testing RIS Required information size SD Standard deviation SMD Standard mean difference SS Sural sensory SSNCV Sural sensory nerve conduction velocity SSNamp Sural sensory nerve amplitude TA Tibialis anterior TSA Trial sequential analysis VPT Vibration perception threshold VL Vastus lateralis. Diabetic neuropathy leads to the progressive loss of somatosensory sensitivity, especially in the lower limbs; this effect may cause functional gait variations and is predominantly related to Scientific Reports | (2020) 10:21770 |

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