Glyceryl trinitrate spray in the management of painful diabetic neuropathy: a randomized double blind placebo controlled cross-over study. 2007

R P Agrawal, and Ramdev Choudhary, and Poornima Sharma, and Srikant Sharma, and R Beniwal, and K Kaswan, and D K Kochar
Department of Medicine, S.P. Medical College, Bikaner 334003, India. rpagrawal@sancharnet.in

OBJECTIVE Various drugs are effective in the management of painful diabetic neuropathy, but none is completely satisfactory. The objective of this study is to test the effectiveness and safety aspect of glyceryl trinitrate (GTN) in the management of painful diabetic neuropathy as a nitric oxide (NO) donor with local vasodilating properties in spray form. METHODS Randomized double blind placebo controlled cross-over study. METHODS Fifty patients with painful diabetic neuropathy (type 2) were screened consecutively, out of which two were excluded (1 with HbA(1)c>11 and one withdrew his consent). The remaining 48 were given either drug (group A) or placebo (group B) in the first phase. After thorough clinical assessment in the first phase, quantitative assessment of pain was done by McGill Pain Questionnaire, Visual Analogue Score, Present Pain Intensity and 11 point Lickerts Scale, at the beginning and after 4 weeks, followed by 2 weeks wash out period and thereafter receiving 4 weeks of cross-over regimen. Adverse drug effects were assessed periodically. RESULTS Of the 48 patients, five dropped out, two in group A and three in group B. Both groups A and B experienced significant improvement in pain score in their drug phase of trial, when compared to placebo phase of other group (p<0.001). After crossing over the treatment arm, patients of group B observed significant improvement in all pain scores compared to group A (p<0.001). The numbers needed to treat (NNT) calculated on VAS as pain parameters came out to be 4. The drug was well tolerated by all the patients except palpitation and headache for some days in five patients. CONCLUSIONS GTN spray, a well tolerated drug, provides significant improvement in painful diabetic neuropathy. These data provide a basis for future trials for longer duration in a larger group of patients.

UI MeSH Term Description Entries
D008875 Middle Aged An adult aged 45 - 64 years. Middle Age
D001786 Blood Glucose Glucose in blood. Blood Sugar,Glucose, Blood,Sugar, Blood
D003929 Diabetic Neuropathies Peripheral, autonomic, and cranial nerve disorders that are associated with DIABETES MELLITUS. These conditions usually result from diabetic microvascular injury involving small blood vessels that supply nerves (VASA NERVORUM). Relatively common conditions which may be associated with diabetic neuropathy include third nerve palsy (see OCULOMOTOR NERVE DISEASES); MONONEUROPATHY; mononeuropathy multiplex; diabetic amyotrophy; a painful POLYNEUROPATHY; autonomic neuropathy; and thoracoabdominal neuropathy. (From Adams et al., Principles of Neurology, 6th ed, p1325) Diabetic Amyotrophy,Diabetic Autonomic Neuropathy,Diabetic Neuralgia,Diabetic Polyneuropathy,Neuralgia, Diabetic,Asymmetric Diabetic Proximal Motor Neuropathy,Diabetic Asymmetric Polyneuropathy,Diabetic Mononeuropathy,Diabetic Mononeuropathy Simplex,Diabetic Neuropathy, Painful,Mononeuropathy, Diabetic,Symmetric Diabetic Proximal Motor Neuropathy,Amyotrophies, Diabetic,Amyotrophy, Diabetic,Asymmetric Polyneuropathies, Diabetic,Asymmetric Polyneuropathy, Diabetic,Autonomic Neuropathies, Diabetic,Autonomic Neuropathy, Diabetic,Diabetic Amyotrophies,Diabetic Asymmetric Polyneuropathies,Diabetic Autonomic Neuropathies,Diabetic Mononeuropathies,Diabetic Mononeuropathy Simplices,Diabetic Neuralgias,Diabetic Neuropathies, Painful,Diabetic Neuropathy,Diabetic Polyneuropathies,Mononeuropathies, Diabetic,Mononeuropathy Simplex, Diabetic,Mononeuropathy Simplices, Diabetic,Neuralgias, Diabetic,Neuropathies, Diabetic,Neuropathies, Diabetic Autonomic,Neuropathies, Painful Diabetic,Neuropathy, Diabetic,Neuropathy, Diabetic Autonomic,Neuropathy, Painful Diabetic,Painful Diabetic Neuropathies,Painful Diabetic Neuropathy,Polyneuropathies, Diabetic,Polyneuropathies, Diabetic Asymmetric,Polyneuropathy, Diabetic,Polyneuropathy, Diabetic Asymmetric,Simplex, Diabetic Mononeuropathy,Simplices, Diabetic Mononeuropathy
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005996 Nitroglycerin A volatile vasodilator which relieves ANGINA PECTORIS by stimulating GUANYLATE CYCLASE and lowering cytosolic calcium. It is also sometimes used for TOCOLYSIS and explosives. Glyceryl Trinitrate,Anginine,Dynamite,Gilustenon,Nitrangin,Nitro-Bid,Nitro-Dur,Nitrocard,Nitroderm,Nitroderm TTS,Nitroglyn,Nitrol,Nitrolan,Nitrong,Nitrospan,Nitrostat,Perlinganit,Susadrin,Sustac,Sustak,Sustonit,Transderm Nitro,Tridil,Trinitrin,Trinitrolong,Nitro Bid,Nitro Dur,NitroBid,NitroDur,Trinitrate, Glyceryl
D006442 Glycated Hemoglobin Products of non-enzymatic reactions between GLUCOSE and HEMOGLOBIN (occurring as a minor fraction of the hemoglobin of ERYTHROCYTES.) It generally refers to glycated HEMOGLOBIN A. Hemoglobin A1c (Hb A1c) is hemoglobin A with GLYCATION on a terminal VALINE of the beta chain. Glycated hemoglobin A is used as an index of the average blood sugar level over a lifetime of erythrocytes. Fructated Hemoglobins,Glycohemoglobin,Glycohemoglobin A,Glycohemoglobins,Glycosylated Hemoglobin A,Hb A1c,HbA1,Hemoglobin A(1),Hemoglobin A, Glycosylated,Glycated Hemoglobin A,Glycated Hemoglobin A1c,Glycated Hemoglobins,Glycosylated Hemoglobin A1c,Hb A1,Hb A1a+b,Hb A1a-1,Hb A1a-2,Hb A1b,Hemoglobin, Glycated A1a-2,Hemoglobin, Glycated A1b,Hemoglobin, Glycosylated,Hemoglobin, Glycosylated A1a-1,Hemoglobin, Glycosylated A1b,A1a-1 Hemoglobin, Glycosylated,A1a-2 Hemoglobin, Glycated,A1b Hemoglobin, Glycated,A1b Hemoglobin, Glycosylated,Glycated A1a-2 Hemoglobin,Glycated A1b Hemoglobin,Glycosylated A1a-1 Hemoglobin,Glycosylated A1b Hemoglobin,Glycosylated Hemoglobin,Hemoglobin A, Glycated,Hemoglobin A1c, Glycated,Hemoglobin A1c, Glycosylated,Hemoglobin, Glycated,Hemoglobin, Glycated A1a 2,Hemoglobin, Glycosylated A1a 1,Hemoglobins, Fructated,Hemoglobins, Glycated
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000287 Administration, Topical The application of drug preparations to the surfaces of the body, especially the skin (ADMINISTRATION, CUTANEOUS) or mucous membranes. This method of treatment is used to avoid systemic side effects when high doses are required at a localized area or as an alternative systemic administration route, to avoid hepatic processing for example. Drug Administration, Topical,Administration, Topical Drug,Topical Administration,Topical Drug Administration,Administrations, Topical,Administrations, Topical Drug,Drug Administrations, Topical,Topical Administrations,Topical Drug Administrations
D016896 Treatment Outcome Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series. Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes
D018579 Patient Selection Criteria and standards used for the determination of the appropriateness of the inclusion of patients with specific conditions in proposed treatment plans and the criteria used for the inclusion of subjects in various clinical trials and other research protocols. Patient Recruitment,Research Subject Recruitment,Selection Criteria,Research Subject Selection,Selection for Treatment,Selection of Research Volunteers,Selection of Subjects,Criteria, Selection,Recruitment, Patient,Recruitment, Research Subject,Recruitments, Research Subject,Research Subject Recruitments,Research Subject Selections,Research Volunteers Selection,Research Volunteers Selections,Selection for Treatments,Selection, Patient,Selection, Research Subject,Selections, Research Subject,Subject Recruitment, Research,Subject Recruitments, Research,Subject Selection, Research,Subject Selections, Research,Subjects Selection,Subjects Selections,Treatment, Selection for,Treatments, Selection for,Volunteers Selection, Research

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