Benfotiamine Versus Vitamin B1-6-12 for Diabetic Peripheral Neuropathy

Официальное название

A 12-Week Double-blind Randomized Controlled Study; Comparing the Efficacy of Benfotiamine and Vitamin b1-6-12 in Alleviating Numbness, Sensory Neuropathy Symptoms and Pain in Patients With Diabetic Peripheral Neuropathy

Обзор

The purpose of this clinical trial is to compare the efficacy of benfotiamine with vitamin B1-6-12 in reducing sensory neuropathy symptoms, numbness and pain in patients with diabetic peripheral neuropathy. The main questions this study aims to answer are: * Does benfotiamine reduce overall sensory neuropathy symptoms more effectively than vitamin B1-6-12? * Does benfotiamine reduce numbness more effectively than vitamin B1-6-12? * Does benfotiamine reduce pain more effectively than vitamin B1-6-12? Researchers will compare benfotiamine with vitamin B1-6-12 in a double-blind study. Both treatments will be manufactured as visually identical study medications to maintain blinding. The study will evaluate whether benfotiamine provides greater improvement in sensory neuropathy symptoms, numbness, and pain than vitamin B1-6-12 in patients with diabetic peripheral neuropathy. Participants will: * undergo screening for vitamin B12 deficiency before enrollment. Patients with vitamin B12 deficiency will not be eligible for participation. * randomly assigned to receive either benfotiamine or vitamin B1-6-12, taken orally twice daily for 3 months. * attend two on-site clinic visits (baseline and the end of the study) and complete two telephone follow-up assessments during the study. * continue their usual medications throughout the study, provided that no new neuropathic pain medications are initiated and the dose of existing neuropathic pain medications remains unchanged.

Вмешательства

• Препарат Benfotiamine
  Benfotiamine arm - participants receive benfotiamine 150 mg orally twice daily for 3 months. Benfotiamine is provided as blinded study medication that is visually identical to the comparator to maintain double blinding.
• Препарат Vitamin B1-6-12
  Vitamin B1-6-12 arm- participants receive vitamin B1-6-12 (B1 100 mg, B6 5 mg, B12 65 mcg per tablet) orally twice daily for 3 months. The study medication is manufactured to be visually identical to benfotiamine to maintain double blinding.

Первичные конечные точки

• Mean change NTSS-6 [Срок оценки: From enrollment to 4, 8 and 12 weeks of treatment.]

Вторичные конечные точки (3)

• Mean change of numbness score [Срок оценки: From enrollment to the end of treatment at 12 weeks]
• Mean change numerical rating scale for pain [Срок оценки: From enrollment to 4, 8 and 12 weeks of treatment at]
• The proportion (%) of participants who achieved a Patient Global Impression of Change (PGIC) score of 1-2 [Срок оценки: From enrollment to the end of treatment at 12 weeks]

Критерии участия

Критерии включения

• Age ≥18 years.
• Diagnosis of diabetic peripheral neuropathy confirmed by a physician based on the following ICD-10 codes: E11.42: Type 2 diabetes mellitus with diabetic polyneuropathy; or E11: Type 2 diabetes mellitus, combined with either:

M79.2: Neuralgia and neuritis, unspecified; or G62.9: Polyneuropathy, unspecified.

• Presence of sensory neuropathy symptoms assessed using the Neuropathy Total Symptom Score-6 (NTSS-6), with: Total NTSS-6 score ≥1; and Numbness symptom score (NTSS-6 item 6) ≥1.
• No evidence of vitamin B12 deficiency, defined as a serum vitamin B12 level ≥200 pg/mL (148 pmol/L).
• provide informed consent and participate in the study.

Критерии исключения

• Presence of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltose malabsorption.
• Adjustment of doses of medications used for neuropathic pain control within 6 weeks prior to study enrollment, including tricyclic antidepressants (TCAs), selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), gabapentinoids, or other neuropathic pain medications.
• Presence of other conditions that may affect diabetic peripheral neuropathy or neuropathic pain, including:

• Chemotherapy-induced peripheral neuropathy due to neurotoxic agents within 6 months prior to enrollment, including vinca alkaloids, taxanes, platinum-based agents, proteasome inhibitors, thalidomide, brentuximab vedotin, or ado-trastuzumab emtansine.
• HIV/AIDS with any of the following: Current or previous treatment with didanosine, stavudine, or zalcitabine; CD4 count <200 cells/mm³; or HIV viral load >1,000 copies/mL.
• Drug-induced polyneuropathy (ICD-10: G62.0).
• Polyneuropathy due to other toxic agents (ICD-10: G62.2).
• Alcoholic polyneuropathy (ICD-10: G62.1).
• Fibromyalgia (ICD-10: M79.7).
• Planned surgery within 3 months prior to or during the study period.
• Previous pain-relief procedures, including:
• Transcutaneous electrical nerve stimulation (TENS) or temporary peripheral nerve stimulation (PNS) within 1 year prior to enrollment;
• Permanent PNS;
• Pulsed radiofrequency or radiofrequency ablation within 6 months prior to enrollment;
• Botulinum toxin injection for neuropathic pain relief within 12 weeks prior to enrollment.
• Adjustment of glucose-lowering medication doses or HbA1c >8% within 3 months prior to study enrollment.
• Pregnancy, planned pregnancy within 3 months, or currently breastfeeding.
• Inability to attend scheduled study visits in person or through telemedicine follow-up as required by the study protocol.
• Known allergy or hypersensitivity to benfotiamine or any component of benfotiamine, vitamin B1, vitamin B6, or vitamin B12.
• Previous use of benfotiamine and/or vitamin B1-6-12 discontinued less than 7 days before study enrollment.
• Current use of vitamin B6 supplementation or medications containing vitamin B6 at a dose >100 mg/day.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Таиланд · 1 центр

• Thammasat University Hospital — Pathumthani

Публикации

• Management of peripheral neuropathy symptoms with a fixed dose combination of high-dose vitamin B1, B6 and B12: A 12-week prospective non-interventional study in Indonesia. (2018). Asian Journal of Medical Sciences, 9(1), 32-40. https://doi.org/10.3126/ajms.v9i1.18510
• The Role of Vitamins B Complex in the Management of Diabetic Peripheral Neuropathy: an Electrophysiological Study. (2024). The Review of Diabetic Studies , 19(3). https://diabeticstudies.org/index.php/RDS/article/view/370
• Sathienluckana T, Palapinyo S, Yotsombut K, Wanothayaroj E, Sithinamsuwan P, Suksomboon N. Expert consensus guidelines for community pharmacists in the management of diabetic peripheral neuropathy with a combination of neurotropic B vitamins. J Pharm Policy Pract. 2024 Feb 7;17(1):2306866. doi: 10.1080/20523211.2024.2306866. eCollection 2024. PMID 38333576
• Gerould H, Mangrum R, Robinson RL, Schantz K, Bryant A, Delbecque L, Behrend B, Price KL, Stauffer VL, Secinti E. Evaluating the Content Validity of the Modified Neuropathy Total Symptom Score-6 Self-Administered (mNTSS-6-SA) in a Painful Diabetic Peripheral Neuropathy Population. J Pain Res. 2025 Nov 12;18:6045-6055. doi: 10.2147/JPR.S539056. eCollection 2025. PMID 41257214
• Bastyr EJ 3rd, Price KL, Bril V; MBBQ Study Group. Development and validity testing of the neuropathy total symptom score-6: questionnaire for the study of sensory symptoms of diabetic peripheral neuropathy. Clin Ther. 2005 Aug;27(8):1278-94. doi: 10.1016/j.clinthera.2005.08.002. PMID 16199253
• Ziegler D, Tesfaye S, Spallone V, Gurieva I, Al Kaabi J, Mankovsky B, Martinka E, Radulian G, Nguyen KT, Stirban AO, Tankova T, Varkonyi T, Freeman R, Kempler P, Boulton AJ. Screening, diagnosis and management of diabetic sensorimotor polyneuropathy in clinical practice: International expert consensus recommendations. Diabetes Res Clin Pract. 2022 Apr;186:109063. doi: 10.1016/j.diabres.2021.109063 PMID 34547367
• Balakumar P, Rohilla A, Krishan P, Solairaj P, Thangathirupathi A. The multifaceted therapeutic potential of benfotiamine. Pharmacol Res. 2010 Jun;61(6):482-8. doi: 10.1016/j.phrs.2010.02.008. Epub 2010 Feb 25. PMID 20188835
• Bozic I, Lavrnja I. Thiamine and benfotiamine: Focus on their therapeutic potential. Heliyon. 2023 Nov 7;9(11):e21839. doi: 10.1016/j.heliyon.2023.e21839. eCollection 2023 Nov. PMID 38034619

Идентификаторы

NCT: NCT07708233 · 68PH174

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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