Meta AnalysisID 7259
在糖尿病周围神经病变治疗中α-硫辛酸与γ-亚麻酸有效性和安全性的排序：一项系统评价与网状Meta分析
CRD42023456959
The purpose of this paper is to summarize the available evidence about the efficacy and safety of ALA and GLA in the management of DN or PDN. It also aims to statistically combine the outcomes of each intervention agains
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Record Fields
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- Meta Analysis Id
- 7259
- Evidence Id
- 15817
- Core Evidence Id
- 15817
- Source Meta Analysis Id
- 7243
- Herb2 Meta Analysis Id
- HBMA007243
- Crd Id
- CRD42023456959
- Title
- Ranking Alpha Lipoic Acid and Gamma Linolenic Acid in terms of Efficacy and Safety in the management of Diabetic Peripheral Neuropathy: A Systematic Review and Network Meta- Analysis
- Review Question
- The purpose of this paper is to summarize the available evidence about the efficacy and safety of ALA and GLA in the management of DN or PDN. It also aims to statistically combine the outcomes of each intervention against placebo using the conventional meta-analysis; and rank the 1) different doses of ALA and 2) different interventions (ALA vs GLA vs Placebo) using network meta-analysis in terms of efficacy and safety parameters.
- Study Type Included
- Only randomized placebo-controlled trials will be included in this systematic review with conventional and network meta-analysis
- Condition Being Studied
- Diabetic Neuropathy (DN) contributes to 32 to 53% of peripheral neuropathies. Hyperglycemia, whether in overt or prediabetic patients may cause DN. While glycemic control is effective in preventing and slowing the progression of DSPN and PDN among type 1 DM patients, its effect among T2DM patients is only modest and reversal of neuronal loss is generally not achievable.At most, symptomatic relief of pain with the use of gabapentinoids like pregabalin and gabapentin; serotonin and norepinephrine reuptake inhibitors (SNRI) such as duloxetine and venlafaxine; tricyclic antidepressants (TCA) like amitriptyline and nortriptyline; and sodium channel blockers like carbamazepine and valproic acid, is recommended by the most recent guidelines for the management of DN by the American Diabetes Association (ADA) and American Academy of Neurology (AAN). As these medications don’t address the pathologic process of denervation among DN patients, ancillary treatments such as aldose reductase inhibitor, or ROS scavengers may be needed.
- Participant
- Studies involving adult Diabetes Mellitus Type 1 or 2 patients suffering from Diabetic Polyneuropathy for at least a year will be considered.
- Animal
- Human Disease Modelled
- Intervention
- Alpha-Lipoic Acid (ALA) and Gamma Linolenic Acid (GLA) no matter what the dose, frequency, mode and duration of administration are the interventions of the studies that will be included.
- Comparator Control
- Placebo or standard of care or ALA or GLA will serve as comparators especially in the network meta-analysis.
- Main Outcome
- Primary efficacy outcomes will include change in Total Symptom Score (TSS) from baseline to end of the study. Secondary efficacy outcomes will include proportion of patients with improved outcomes, change in Visual Analog Scale (VAS) score from baseline to end of the study, change in Neuropathy Impairment Score (NIS) from baseline to end of the study, change in Neuropathy Disability Score (NDS) from baseline to end of the study and electrophysiological markers for improvement like change in sural sensory and peroneal and tibial motor nerve parameters. Safety outcomes will include proportion of patients who develops adverse events (AE), severe adverse events (SAE) and tolerability per intervention group. Measures of effect Studies with similar outcomes will be assessed for appropriateness to do conventional meta-analysis. Proportion outcomes such as adverse events, severe adverse events, tolerability and proportion of patients with improved outcomes between intervention and control will have risk ratio as their measure of effect while variables with continuous outcomes such as change in TSS from baseline to end of study will utilize standard mean difference (SMD), particularly Hedges’ g as their summary measure of effect with corresponding standard deviation and confidence interval. Z test p value of less than 0.05 implies statistically significant difference between intervention and control.
- Outcome Measure
- Additional Outcome
- None.
- Study Method
- Intervention, Meta-analysis, Network meta-analysis, Systematic review
- Keyword
- Antioxidants; Diabetes Mellitus; Diabetic Neuropathies; Humans; Network Meta-Analysis; Thioctic Acid; dioctadecylamidospermine; gamma-Linolenic Acid
- Contact
- Mario Prado Jr. [email protected]
- Organisational Affiliation
- University of the Philippines Manila
- Funding Source
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- Philippines
- Review Stage
- Review Ongoing
- First Submission Date
- 2023-08-23
- Registration Date
- 2023-09-02
- Anticipated Start Date
- 2023-09-01
- Anticipated Completion Date
- 2023-09-30
- Title Cn
- 在糖尿病周围神经病变治疗中α-硫辛酸与γ-亚麻酸有效性和安全性的排序：一项系统评价与网状Meta分析
- Title En
- Ranking Alpha Lipoic Acid and Gamma Linolenic Acid in terms of Efficacy and Safety in the management of Diabetic Peripheral Neuropathy: A Systematic Review and Network Meta- Analysis
- Bilingual Status
- complete