Prevention of Peripheral Distal Polyneuropathy in Patients with Diabetes: A Systematic Review
Abstract
:1. Introduction
2. Materials and Methods
2.1. Protocol and Registration
2.2. Eligibility Criteria
- Participants: Patients with DM, aged ≥ 18 years.
- Interventions: Any strategy that entailed prevention or delay of DPN onset.
- Comparisons: Placebo substances, any other alternative or natural progression of the disease in the control group.
- Outcomes or results: The effectiveness of the intervention in terms of the prevention of DPN at the end of the studies in patients who did not present this condition at the beginning, or the improvement of this condition if they presented it at the beginning of the study, should be evaluated. Other outcomes may include quality of life measurements, adverse events, related costs, changes in neuropathic pain symptoms, presence of foot ulcerations and/or amputations, and events that prevented continuation of clinical trials.
2.3. Sources and Search
2.4. Study Selection
2.5. Data Extraction and Synthesis of Results
2.6. Risk of Bias Assessment
3. Results
3.1. Risk of Biases among the Studies Included
3.2. Statistical Analysis of the Quality of the Included Studies
3.3. Limitations of Included Studies
Authors | Limitations |
---|---|
Ismail-Beigi et al., 2010 | Early termination of the RCT due to increased mortality among participants. |
Charles et al., 2011 | Not all patients were evaluated with all measurements. Patients in the CASE IV subgroup were younger than the rest, so microvascular complications may have been lower in this group. |
Gong et al., 2011 | No results were obtained for 25% of the participants who died. Low incidence of nephropathy and neuropathy due to short duration of diabetes in participants. |
Pop-Busui et al., 2013 | Study not designed to detect an effect of the groups on DPN. A lower incidence of neuropathy was found in the IS group; however, the authors were unable to identify whether the benefit was specific to biguanides or thiazolidinediones. Small fiber neuropathy was not evaluated, as only the Michigan Neuropathy Screening Instrument (MNSI), which evaluates large fibers, was used. Subjectivity of the MNSI. |
Dixit et al., 2014 | The effect of aerobic exercise to halt or interrupt the natural course of DPN was not studied. The study had a large number of dropouts. |
Martin et al., 2014 | Intentional exclusion at the start of Diabetes Control and Complications Trial (DDCT) of participants with severe neuropathy. Patients in the conventional insulin therapy (CON) group were switched to intensive insulin therapy (INT) group because of the benefits of intensive glycemic control in patients with TIDM. |
Diabetes Prevention Program Research Group et al., 2015 | The combination of three different microvascular outcomes in the aggregate microvascular outcome. |
Look AHEAD Research Group et al., 2017 | Relationship of biguanide use with vitamin B12 depletion and the development of DPN. Levels of this vitamin were not recorded. Diagnosis of DPN by questionnaire, MNSI physical examination and Semmes-Weinstein (SW) monofilament. |
Gholami et al., 2018 | Small sample size, large number of dropouts, and only male participation. |
Brock et al., 2019 | Severe irreversible neuropathy, more male representation. |
Gholami et al., 2020 | Small sample size. |
3.4. Synthesis of Results
3.4.1. Studies Included
3.4.2. Participants
3.4.3. Interventions and Comparisons
3.4.4. Analysis of Results
3.4.5. Summary of Results
4. Discussion
4.1. Intensive Glycemic Control
4.2. Use of Drugs
4.3. Lifestyle Modification
4.4. Practice of Physical Exercise
4.5. Limitations of the Study
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Appendix A. Search Strategy
Appendix A.1. PubMed
Appendix A.1.1. Clinical Trials
Appendix A.1.2. Cohort Studies
Appendix A.2. Scopus
Appendix A.3. The Cochrane Library
Appendix A.4. CINAHL
Appendix A.4.1. Clinical Trials
Appendix A.4.2. Cohort Studies
Appendix B. Individual Characteristics of the Studies Included in the Review
- Study 1: Brock et al., 2019 [53]
- Study 2: Charles et al., 2011 [62]
- Study 3: Diabetes Prevention Program Research Group et al., 2015 [57]
- Study 4: Dixit et al., 2014 [54]
- Study 5: Gholami et al., 2018 [61]
- Study 6: Gholami et al., 2020 [59]
- Study 7: Gong et al., 2011 [58]
- Study 8: Ismail-Beigi et al., 2010 [55]
- Study 9: Look AHEAD Research Group et al., 2017 [56]
- Study 10: Martin et al., 2014 [15]
- Study 11: Pop-Busui et al., 2013 [60]
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Reason for Exclusion | Authors |
---|---|
RCTs that specifically address treatment rather than prevention of DPN | Farvid et al., 2011 [27] Song et al., 2011 [28] Rizzo et al., 2012 [29] Lavery et al., 2012 [30] Mueller et al., 2013 [31] Ulbrecht et al., 2014 [32] Dixit et al., 2016 [33] Ziegler et al., 2016 [34] Sharoni et al., 2018 [35] Venkataraman et al., 2019 [36] López-Moral et al., 2019 [37] Stubbs et al., 2019 [38] Ahmad et al., 2019 [39] Shu et al., 2019 [40] Sari et al., 2020 [41] |
Cohort studies not from RCTs | Müller-Stich et al., 2013 [42] Hur et al., 2013 [43] Cho et al., 2014 [44] Ishibashi et al., 2018 [45] O’Brien et al., 2018 [46] Yang et al., 2020 [47] Cárdenas et al., 2019 [48] |
Cohort studies that do not specifically address the prevention of DPN, but from RCTs | Aroda et al., 2016 [49] |
Gaede et al., 2016 [50] | |
Abraham et al., 2018 [51] | |
Braffett et al., 2020 [52] |
Intraclass Correlation a | 95% Confidence Interval | F Test with True Value 0 | |||||
---|---|---|---|---|---|---|---|
Lower Bound | Lower Bound | Value | df1 | df2 | Sig. | ||
Single Measures | 0.997 b | 0.995 | 0.995 | 687.400 | 10 | 10 | 0.000 |
Average Measures | 0.999 c | 0.995 | 1.000 | 687.400 | 10 | 10 | 0.000 |
Authors | Scale | Review 1 | Review 2 |
---|---|---|---|
Ismail-Beigi et al., 2010 | CASpe | 10/11 | 10/11 |
Charles et al., 2011 | CASpe | 6/11 | 6/11 |
Gong et al., 2011 | STROBE | 16/22 | 16/22 |
Pop-Busui et al., 2013 | STROBE | 17/22 | 17/22 |
Dixit et al., 2014 | CASpe | 11/11 | 11/11 |
Martin et al., 2014 | STROBE | 16/22 | 16/22 |
Diabetes Prevention Program Research Group et al., 2015 | STROBE | 17/22 | 17/22 |
Look AHEAD Research Group et al., 2017 | CASpe | 9/11 | 9/11 |
Gholami et al., 2018 | CASpe | 9/11 | 9/11 |
Brock et al., 2019 | CASpe | 11/11 | 11/11 |
Gholami et al., 2020 | CASpe | 9/11 | 9/11 |
Authors | Design | Participants (N) | Groups | Diabetes Type | Average Age (Years) | Duration of the Study | Interventions | Measured Results |
---|---|---|---|---|---|---|---|---|
Brock et al. (2019) | RCT, double-blind, placebo-controlled | 39 | IG (Liraglutide) N = 19 CG (placebo) N = 20 | TIDM | 50.4 | 32 weeks | Liraglutide Placebo | Changes in nerve potentials, proinflammatory cytokines, autonomic function and peripheral neurophysiological tests. MNSI |
Charles et al. (2011) | RCT with parallel groups | 1161 | Routine Care (RC) N = 459 Intensive multifactorial treatment (IT) N = 702 | TIIDM | 59.9 | 6 years | IT: Education, medication and promotion of healthy lifestyle. CR: Danish recommendations for diabetes care. | AAI Vibration detection threshold (tuning fork) Light touch (SW) |
Diabetes Prevention Program Research Group et al. (2015) | Cohort study of a parallel-group placebo-controlled RCT | 2776 | Placebo N = 935 Metformin N = 926 Lifestyle N = 915 | TIIDM | 51 | 15 years | Metformin Placebo Lifestyle | Diagnosis of diabetes HbA1c Albuminuria (Nephropathy) Fundus evaluation (Retinopathy) SW light touch (Neuropathy) |
Dixit et al. (2014) | RCT of parallel groups | 87 | CG N = 47 (10 lost) EG N = 40 (11 lost) | TIIDM | CG: 59.45 EG: 54.40 | 8 weeks | EG: Moderate aerobic exercise, foot care education, healthy diet CG: Standard medical care, education | Motor and sensory nerve conduction studies in peroneal and sural nerves MDNS |
Gholami et al. (2018) | RCT of parallel groups | 24 | Exercise N = 12 Control N = 12 | TIIDM | CG: 43 ± 6.4 EG: 42 ± 4.6 | 12 weeks | Exercise: Running, walking or treadmill 3 times/week for 20–45 min. Control: Maintain usual level of physical activity. | Weight, BMI, % fat HbA1c Nerve conduction velocity (NCV) and nerve action potential amplitude (APAN) peoneal, tibial and sural nerves |
Gholami et al. (2020) | RCT of parallel groups | 31 | CG N = 15 EG N = 16 | TIIDM | 52.8 ± 9.6 | 12 weeks | EG: Cycling exercises CG: Maintaining the usual level of physical activity | HbA1c Fasting glucose Flow mediated dilation (FMD), changes in intima-media thickness and basal diameter in superficial femoral artery, MDNS |
Gong et al. (2011) | Cohort study of parallel-group RCTs | 577 | CG = N = 136 (42 lost) EG = N = 441 (135 lost) | TIIDM | CG 66.7 ± 9.2 EG 64.7 ± 9.3 | 20 years | EG: diet, exercise or diet + exercise CG: Regular medical care | Plasma glucose HbA1c, oral glucose tolerance test, Examination ocular fundus Inspection extremity lower limb AAI Light touch (SW) |
Ismail-Beigi et al. (2010) | RCT of parallel groups | 10,251 | Intensive therapy N = 5128 Standard therapy N = 5123 | TIIDM | 62.2 ± 6 | 3.5 years | Intensive therapy: HbA1c < 6.0% Standard therapy: HbA1c 7.0–7.9% | Albuminuria Creatinine Fundus examination MNSI Vibratory sensitivity (tuning fork), light touch (SW) |
Look AHEAD Research Group et al. (2017) | RCT of parallel groups | 5145 | Intensive lifestyle intervention (ILI) N = 2570 Diabetes support and education (DSE) N = 2575 | TIIDM | 58.7 | 11 years | ILI: 7% weight loss, reduced caloric intake, and increased physical activity DSE: Diabetes education focused on diet and exercise | MNSI Light touch (SW) |
Martin et al. (2014) | Cohort study of a parallel-group RCT | 1345 | Intensive insulin therapy (INT) N = 687 Conventional insulin therapy (CON) N = 688 | TIDM | 33.6 ± 7 | 14 years | INT: insulin treatment aimed at near-normal glycemia. CON: insulin treatment according to current standards | Vibratory sensitivity Light touch (SW) MNSI Nerve conduction studies HbA1c |
Pop-Busui et al. (2013) | Cohort study of a parallel-group RCT | 2159 | Insulin-sensitizing treatments (IS) N = 1080 Insulin-providing treatments (IP) N = 1079 | TIIDM | 62 ± 9 | 4 years | Insulin-sensitizing treatments Insulin-providing treatments | HbA1c, Duration of DM, Albuminuria Retinopathy Alcohol and tobacco consumption Blood lipids, Blood pressure, MNSI Prevalence of DPN |
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Carvajal-Moreno, L.; Coheña-Jiménez, M.; García-Ventura, I.; Pabón-Carrasco, M.; Pérez-Belloso, A.J. Prevention of Peripheral Distal Polyneuropathy in Patients with Diabetes: A Systematic Review. J. Clin. Med. 2022, 11, 1723. https://doi.org/10.3390/jcm11061723
Carvajal-Moreno L, Coheña-Jiménez M, García-Ventura I, Pabón-Carrasco M, Pérez-Belloso AJ. Prevention of Peripheral Distal Polyneuropathy in Patients with Diabetes: A Systematic Review. Journal of Clinical Medicine. 2022; 11(6):1723. https://doi.org/10.3390/jcm11061723
Chicago/Turabian StyleCarvajal-Moreno, Lidia, Manuel Coheña-Jiménez, Irene García-Ventura, Manuel Pabón-Carrasco, and Ana Juana Pérez-Belloso. 2022. "Prevention of Peripheral Distal Polyneuropathy in Patients with Diabetes: A Systematic Review" Journal of Clinical Medicine 11, no. 6: 1723. https://doi.org/10.3390/jcm11061723