Treatment of chronic painful diabetic neuropathy with isosorbide dinitrate spray: A double-blind placebo-controlled cross-over study

Kevin C J Yuen, Neil R. Baker, Gerry Rayman

Research output: Contribution to journalArticle

117 Citations (Scopus)

Abstract

OBJECTIVE - Considerable evidence implicates impaired nitric oxide (NO) generation in the pathogenesis of diabetic neuropathic pain. We therefore conducted a pilot study to examine the effects of isosorbide dinitrate (ISDN), a NO donor with local vasodilating properties, in spray form in the management of chronic neuropathic pain. RESEARCH DESIGN AND METHODS - The study was of double-blind, randomized, placebo-controlled, and two-period cross-over design. After a 2-week run-in period, 22 diabetic patients (13 men, 20 with type 2 diabetes, age [mean ± SE] 63.7 ± 1.8 years, duration of diabetes 9.1 ± 1.5 years, duration of painful neuropathy 2.6 ± 0.4 years) were randomized to receive ISDN or placebo sprays for 4 weeks, exchanging their treatment for a further 4 weeks after a 2-week wash-out period. The patients administered the spray to both feet before bedtime. Biweekly pain and other sensory symptoms were assessed using a visual analog scale (VAS) and the Lickert scale, respectively. RESULTS - ISDN spray reduced overall neuropathic pain (P = 0.02) and burning sensation (P = 0.006). No treatment difference was observed with other sensory modalities (hot/cold sensation, tingling, numbness, hyperesthesia, and jabbing-like sensation). At study completion, 11 patients (50%) reported benefit and wished to continue using the ISDN spray, 4 (18%) preferred the placebo spray, and the remaining 7 (32%) were undecided. CONCLUSIONS - ISDN spray offers an alternative and effective pharmacological option in relieving overall pain and burning sensation in the management of painful diabetic neuropathy. The potential of ISDN spray in alleviating other specific sensory symptoms associated with diabetic peripheral neuropathy merits further study.

Original languageEnglish (US)
Pages (from-to)1699-1703
Number of pages5
JournalDiabetes Care
Volume25
Issue number10
DOIs
StatePublished - Oct 2002
Externally publishedYes

Fingerprint

Isosorbide Dinitrate
Diabetic Neuropathies
Cross-Over Studies
Placebos
Neuralgia
Therapeutics
Hyperesthesia
Pain
Nitric Oxide Donors
Hypesthesia
Peripheral Nervous System Diseases
Visual Analog Scale
Double-Blind Method
Chronic Pain
Type 2 Diabetes Mellitus
Foot
Nitric Oxide
Research Design
Pharmacology

ASJC Scopus subject areas

  • Internal Medicine
  • Endocrinology, Diabetes and Metabolism

Cite this

Treatment of chronic painful diabetic neuropathy with isosorbide dinitrate spray : A double-blind placebo-controlled cross-over study. / Yuen, Kevin C J; Baker, Neil R.; Rayman, Gerry.

In: Diabetes Care, Vol. 25, No. 10, 10.2002, p. 1699-1703.

Research output: Contribution to journalArticle

Yuen, Kevin C J ; Baker, Neil R. ; Rayman, Gerry. / Treatment of chronic painful diabetic neuropathy with isosorbide dinitrate spray : A double-blind placebo-controlled cross-over study. In: Diabetes Care. 2002 ; Vol. 25, No. 10. pp. 1699-1703.
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abstract = "OBJECTIVE - Considerable evidence implicates impaired nitric oxide (NO) generation in the pathogenesis of diabetic neuropathic pain. We therefore conducted a pilot study to examine the effects of isosorbide dinitrate (ISDN), a NO donor with local vasodilating properties, in spray form in the management of chronic neuropathic pain. RESEARCH DESIGN AND METHODS - The study was of double-blind, randomized, placebo-controlled, and two-period cross-over design. After a 2-week run-in period, 22 diabetic patients (13 men, 20 with type 2 diabetes, age [mean ± SE] 63.7 ± 1.8 years, duration of diabetes 9.1 ± 1.5 years, duration of painful neuropathy 2.6 ± 0.4 years) were randomized to receive ISDN or placebo sprays for 4 weeks, exchanging their treatment for a further 4 weeks after a 2-week wash-out period. The patients administered the spray to both feet before bedtime. Biweekly pain and other sensory symptoms were assessed using a visual analog scale (VAS) and the Lickert scale, respectively. RESULTS - ISDN spray reduced overall neuropathic pain (P = 0.02) and burning sensation (P = 0.006). No treatment difference was observed with other sensory modalities (hot/cold sensation, tingling, numbness, hyperesthesia, and jabbing-like sensation). At study completion, 11 patients (50{\%}) reported benefit and wished to continue using the ISDN spray, 4 (18{\%}) preferred the placebo spray, and the remaining 7 (32{\%}) were undecided. CONCLUSIONS - ISDN spray offers an alternative and effective pharmacological option in relieving overall pain and burning sensation in the management of painful diabetic neuropathy. The potential of ISDN spray in alleviating other specific sensory symptoms associated with diabetic peripheral neuropathy merits further study.",
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