Research Article
Clinical Trial Assessing the Efficacy of Gabapentin Plus B Complex (B1/B12) versus Pregabalin for Treating Painful Diabetic Neuropathy
Table 1
Demographics characteristics and per group treatment characteristics (
).
| Demographics characteristics and per group treatment baselines, per protocol population | | Pregabalin |
Combined gabapentin | value | | | % | | % |
| Gender | | | | | | Female | 74 | 60.2 95% CI (51.4–68.9) | 100 | 68.0 95% CI (60.4–75.7) | 0.179 | Male | 49 | 39.8 95% CI (31.1–48.6) | 47 | 32.0 95% CI (24.3–39.6) | Age (years) | | | | | | Average | 53.6 | | 52.5 | | 0.344 | Std. deviation | 9.4 | | 10.5 | | Minimum–maximum | 25.0–71.0 | | 19.0–70.0 | |
| Risk factors |
| Smoking | | | | | | Yes | 8 | 6.5 95% CI (2.1–10.9) | 13 | 8.8 95% CI (4.2–13.5) | 0.475 | Arterial hypertension | | | | | | History | 42 | 34.1 95% CI (25.6–42.6) | 58 | 39.4 95% CI (31.5–47.4) | 0.369 | Hypothyroidism | | | | | | History | 1 | 0.8 95% CI (0.0–2.4) | 1 | 0.7 95% CI (0.0–2.0) | 0.900 | Cholesterol (baseline measure) | | | | | | Average | 198.3 | | 195.2 | | 0.560 | Std. deviation | 47.5 | | 38.3 | | Minimum–maximum | 101.0–542.0 | | 71.0–366.0 | | Triglycerides (baseline measure) | | | | | | Average | 207.7 | | 189.9 | | 0.352 | Std. deviation | 183.4 | | 116.3 | | Minimum–maximum | 53.0–1390.0 | | 63.0–952.0 | | BMI (Kg/m2) | | | | | | Average | 28.2 | | 27.9 | | 0.610 | Std. deviation | 3.9 | | 4.1 | | Minimum–maximum | 18.4–39.4 | | 17.4–39.4 | | Diabetes duration | | | | | | Average | 9.8 | | 9.5 | | 0.765 | Std. deviation | 5.9 | | 6.5 | | Minimum–maximum | 1.5–25.5 | | 1.4–32.0 | | With diabetic neuropathic | | | | | | Average | 2.9 | | 2.8 | | 0.603 | Std. deviation | 1.1 | | 1.1 | | Minimum–maximum | 0.6–5.9 | | 1.0–5.9 | | Diabetes treatment | | | | | | Oral | 100 | 81.3 95% CI (74.3–88.3) | 112 | 76.2 95% CI (69.2–83.2) | | Insulin | 3 | 2.4 95% CI (0.0–5.2) | 5 | 3.4 95% CI (0.4–6.2) | 0.333 | Both | 20 | 16.3 95% CI (9.7–22.9) | 30 | 20.4 95% CI (13.8–27.0) | | Glucose (baseline) | | | | | | Average | 126.9 | | 128.9 | | 0.603 | Std. deviation | 53.0 | | 51.2 | | Minimum–maximum | 44.0–410.0 | | 64.0–325.0 | | HbA1c | | | | | | Average | 7.4 | | 7.4 | | 0.603 | Std. deviation | 1.3 | | 1.4 | | Minimum–maximum | 5.2–10.2 | | 4.9–10.0 | |
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