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Research ArticleOriginal Article
Open Access

Evaluation of the efficacy and safety of pregabalin, venlafaxine, and carbamazepine in patients with painful diabetic peripheral neuropathy

A randomized, double-blind trial

Nazanin Razazian, Maryam Baziyar, Nasrin Moradian, Daryoush Afshari, Arash Bostani and Marziyeh Mahmoodi
Neurosciences Journal July 2014, 19 (3) 192-198;
Nazanin Razazian
From the Department of Neurology (Razazian, Baziyar, Moradian, Afshari, Bostani), Imam Reza Hospital, College of Medicine, Kermanshah University of Medical Sciences, Kermanshah, and the Department of Biostatistics & Epidemiology (Mahmoodi), Hamadan University of Medical Science, Hamadan, Islamic Republic of Iran
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Maryam Baziyar
From the Department of Neurology (Razazian, Baziyar, Moradian, Afshari, Bostani), Imam Reza Hospital, College of Medicine, Kermanshah University of Medical Sciences, Kermanshah, and the Department of Biostatistics & Epidemiology (Mahmoodi), Hamadan University of Medical Science, Hamadan, Islamic Republic of Iran
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Nasrin Moradian
From the Department of Neurology (Razazian, Baziyar, Moradian, Afshari, Bostani), Imam Reza Hospital, College of Medicine, Kermanshah University of Medical Sciences, Kermanshah, and the Department of Biostatistics & Epidemiology (Mahmoodi), Hamadan University of Medical Science, Hamadan, Islamic Republic of Iran
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  • For correspondence: [email protected]
Daryoush Afshari
From the Department of Neurology (Razazian, Baziyar, Moradian, Afshari, Bostani), Imam Reza Hospital, College of Medicine, Kermanshah University of Medical Sciences, Kermanshah, and the Department of Biostatistics & Epidemiology (Mahmoodi), Hamadan University of Medical Science, Hamadan, Islamic Republic of Iran
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Arash Bostani
From the Department of Neurology (Razazian, Baziyar, Moradian, Afshari, Bostani), Imam Reza Hospital, College of Medicine, Kermanshah University of Medical Sciences, Kermanshah, and the Department of Biostatistics & Epidemiology (Mahmoodi), Hamadan University of Medical Science, Hamadan, Islamic Republic of Iran
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Marziyeh Mahmoodi
From the Department of Neurology (Razazian, Baziyar, Moradian, Afshari, Bostani), Imam Reza Hospital, College of Medicine, Kermanshah University of Medical Sciences, Kermanshah, and the Department of Biostatistics & Epidemiology (Mahmoodi), Hamadan University of Medical Science, Hamadan, Islamic Republic of Iran
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Article Figures & Data

Figures

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  • Figure 1
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    Figure 1

    Distribution of diabetic peripheral neuropathy patients. Ec/MoH - European Commission/Ministry of Health

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    Figure 2

    Comparisons of pain severity scores (VAS) between the treatment groups across time among diabetic peripheral neuropathy patients.

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    Figure 3

    Change in pain severity in the treatment groups among diabetic peripheral neuropathy patients. Improved and worse categories includes cases with VAS reduction and increase. VAS - visual analogue scale

Tables

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    Table 1

    Baseline demographic and clinical characteristics of diabetic peripheral neuropathy patients.

    Baseline characteristicsCarbamazepine groupPregabalin group (mean±SD)Venlafaxine groupTotalP-value*
    Age (year)58.3±10.455.4±11.155.1±9.656.3±10.40.083
    Female, n (%)44 (51.8)57 (66.3)55 (64.0)156 (60.7)0.114
    Type 2, n (%)78 (91.8)79 (91.9)79 (91.9)239 (93)1.000
    Duration of diabetes (years)13.7±5.614.2±6.112.7±6.013.5±5.90.256
    FBS (mg/dl)174±63.8191±86197±69187.5±74.40.123
    HbA1C (%)8.8±2.19.1±2.38.3±1.88.7±2.10.107
    BMI (kg/m2)27.0±3.426.3±3.327±7.626.7±5.20.586
    Duration of pain (months)23±2.422.8±3.323.9±2.923.5±2.50.112
    VAS, mm74.5±12.982.3±13.474.5±12.977.1±13.60.0001*
    Score of sleep interference4.45±1.24.80±0.984.48±1.24.58±1.10.087
    Score of mood interference2.60±0.72.68±0.632.53±0.622.60±0.70.335
    Score of work interference3.52±1.13.81±0.963.5±1.033.62±1.00.106
    • ↵* Differences between pregabalin and other drugs are statically significant (p=0.0001), but not significant between carbamazepine and venlafaxine (p≥0.09). FBS - fasting blood sugar, BMI - body mass index, HbA1C - glycated hemoglobin, VAS - visual analogue scale

    • View popup
    Table 2

    Means of VAS scores in treatment groups of diabetic peripheral neuropathy patients during the follow-up period.

    TimeBaseline2nd day7th day14th day35th dayP-value†
    Carbamazepine74.569.463.440.239.60.0001
    Pregabalin82.380.269.735.633.40.0001
    Venlafaxine74.570.265.548.046.60.0001
    P-value*0.00010.00010.0070.00010.0001
    • ↵* One-Way ANOVA,

    • ↵† repeated measurement ANOVA

    • View popup
    Table 3

    Change in pain severity among diabetic peripheral neuropathy patients.

    P-valueVenlafaxinePregabalinCarbamazepineVariable
    n (%)
    Reduction of VAS ≥50%,35 (41.2)66 (76.7)36 (41.9)0.001
    Reduction of VAS<50-≥30%39 (45.5)14 (16.2)20 (23.3)0.02
    Reduction of VAS<30%2 (2.4)2 (2.3)5 (5.8)0.06
    No change in VAS4 (4.7)3 (3.7)19 (22.1)0.004
    Increase in VAS5 (5.9)1 (1.2)6 (7.0)0.01
    Total85 (100)86 (100)86 (100)
      • View popup
      Table 4

      Mean scores of sleep, mood, and work interference in the treatment groups during the follow-up period.

      VariableMean score of sleep interference (1st day)Mean score of sleep interference (35th day)P-value*Mean score of mood interference (1st day)Mean score of mood interference (35th day)P-value*Mean score of work interference (1st day)Mean score of work interference (35th day)P-value*
      Carbamazepine4.45±1.12.40±0.9≤0.0012.60±0.72.40±0.6≤0.0013.52±1.02.12±1.10.0001
      Pregabalin4.80±0.91.77±0.8≤0.0012.68±0.61.41±0.5≤0.0013.81±0.9 1.55±0.760.0001
      Venlafaxine4.48±1.22.66±1.4≤0.0012.53±0.61.63±0.8≤0.0013.52±1.02.38±1.20.0001
      P-value†0.0870.00010.3350.00010.1060.0001
      • ↵* Paired sample t-test,

      • ↵† One-way ANOVA

      • View popup
      Table 5

      Reported adverse events during and at the end of follow-up among diabetic peripheral neuropathy patients.

      Adverse eventsCarbamazepine n=85Pregabalin n=86 n (%)Venlafaxine n=86
      Agitation0 (0.0)0 (0.0)4 (4.7)
      Dizziness10 (11.8)63 (73.2)36 (41.9)
      Vomiting0 (0.0)0 (0.0)3 (3.5)
      Impotency1 (1.2)1 (1.2)4 (4.7)
      Somnolence3 (3.5)46 (53.3)20 (23.3)
      Asthenia1 (1.2)5 (5.8)11 (12.7)
      Headache0 (0.0)0 (0.0)18 (20.9)
      Nausea1 (1.2)0 (0.0)30 (34.9)
      Bulimia2 (2.4)0 (0.0)2 (2.4)
      Dyspepsia1 (1.2)2 (2.3)2 (2.4)
      Edema0 (0.0)2 (2.3)2 (2.3)
      Weight changes1 (1.2)4 (4.6)2 (2.4)
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    Evaluation of the efficacy and safety of pregabalin, venlafaxine, and carbamazepine in patients with painful diabetic peripheral neuropathy
    Nazanin Razazian, Maryam Baziyar, Nasrin Moradian, Daryoush Afshari, Arash Bostani, Marziyeh Mahmoodi
    Neurosciences Journal Jul 2014, 19 (3) 192-198;

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    Evaluation of the efficacy and safety of pregabalin, venlafaxine, and carbamazepine in patients with painful diabetic peripheral neuropathy
    Nazanin Razazian, Maryam Baziyar, Nasrin Moradian, Daryoush Afshari, Arash Bostani, Marziyeh Mahmoodi
    Neurosciences Journal Jul 2014, 19 (3) 192-198;
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