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Gabapentin vs. amitriptyline in painful diabetic neuropathy: an open-label pilot study.
J Pain Symptom Manage. 2000 Oct; 20(4):280-5.JP

Abstract

The objective of this study was to compare the efficacy and tolerability of gabapentin and amitriptyline monotherapy in painful diabetic neuropathy. This was a 12-week, open-label, prospective, randomized trial. Twenty-five type-II diabetic patients with pain attributed to diabetic neuropathy and a minimum score of 2 on a pain intensity scale ranging from 0 (no pain) to 4 (excruciating pain) were randomized to receive either gabapentin, titrated from 1,200 mg/day to a maximum of 2,400 mg/day, or amitriptyline, titrated from 30 mg/day to a maximum of 90 mg/day. Both drugs were titrated over a 4-week period and maintained at the maximum tolerated dose for 8 weeks. The main outcome measures were weekly pain intensity and paresthesia intensity, measured on two categorical scales. Thirteen patients received gabapentin and 12 received amitriptyline. All 25 patients completed the trial. Gabapentin produced greater pain reductions than amitriptyline (mean final scores were 1.9 vs. 1.3 points below baseline scores; P = 0.026). Decreases in paresthesia scores also were in favor of gabapentin (1.8 vs. 0.9 points; P = 0. 004). Adverse events were more frequent in the amitriptyline group than in the gabapentin group: they were reported by 11/12 (92%) and 4/13 (31%) of patients, respectively (P = 0.003). Side effects were the main limiting factor preventing dose escalation. Gabapentin produced greater improvements than amitriptyline in pain and paresthesia associated with diabetic neuropathy. Additionally, gabapentin was better tolerated than amitriptyline. Further controlled trials are needed to confirm these preliminary results.

Authors+Show Affiliations

Department of Neurology and Rehabilitative Medicine, S. Giacomo Hospital, Novi Ligure, Italy.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Controlled Clinical Trial
Journal Article

Language

eng

PubMed ID

11027910

Citation

Dallocchio, C, et al. "Gabapentin Vs. Amitriptyline in Painful Diabetic Neuropathy: an Open-label Pilot Study." Journal of Pain and Symptom Management, vol. 20, no. 4, 2000, pp. 280-5.
Dallocchio C, Buffa C, Mazzarello P, et al. Gabapentin vs. amitriptyline in painful diabetic neuropathy: an open-label pilot study. J Pain Symptom Manage. 2000;20(4):280-5.
Dallocchio, C., Buffa, C., Mazzarello, P., & Chiroli, S. (2000). Gabapentin vs. amitriptyline in painful diabetic neuropathy: an open-label pilot study. Journal of Pain and Symptom Management, 20(4), 280-5.
Dallocchio C, et al. Gabapentin Vs. Amitriptyline in Painful Diabetic Neuropathy: an Open-label Pilot Study. J Pain Symptom Manage. 2000;20(4):280-5. PubMed PMID: 11027910.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Gabapentin vs. amitriptyline in painful diabetic neuropathy: an open-label pilot study. AU - Dallocchio,C, AU - Buffa,C, AU - Mazzarello,P, AU - Chiroli,S, PY - 2000/10/12/pubmed PY - 2001/2/28/medline PY - 2000/10/12/entrez SP - 280 EP - 5 JF - Journal of pain and symptom management JO - J Pain Symptom Manage VL - 20 IS - 4 N2 - The objective of this study was to compare the efficacy and tolerability of gabapentin and amitriptyline monotherapy in painful diabetic neuropathy. This was a 12-week, open-label, prospective, randomized trial. Twenty-five type-II diabetic patients with pain attributed to diabetic neuropathy and a minimum score of 2 on a pain intensity scale ranging from 0 (no pain) to 4 (excruciating pain) were randomized to receive either gabapentin, titrated from 1,200 mg/day to a maximum of 2,400 mg/day, or amitriptyline, titrated from 30 mg/day to a maximum of 90 mg/day. Both drugs were titrated over a 4-week period and maintained at the maximum tolerated dose for 8 weeks. The main outcome measures were weekly pain intensity and paresthesia intensity, measured on two categorical scales. Thirteen patients received gabapentin and 12 received amitriptyline. All 25 patients completed the trial. Gabapentin produced greater pain reductions than amitriptyline (mean final scores were 1.9 vs. 1.3 points below baseline scores; P = 0.026). Decreases in paresthesia scores also were in favor of gabapentin (1.8 vs. 0.9 points; P = 0. 004). Adverse events were more frequent in the amitriptyline group than in the gabapentin group: they were reported by 11/12 (92%) and 4/13 (31%) of patients, respectively (P = 0.003). Side effects were the main limiting factor preventing dose escalation. Gabapentin produced greater improvements than amitriptyline in pain and paresthesia associated with diabetic neuropathy. Additionally, gabapentin was better tolerated than amitriptyline. Further controlled trials are needed to confirm these preliminary results. SN - 0885-3924 UR - https://www.unboundmedicine.com/medline/citation/11027910/Gabapentin_vs__amitriptyline_in_painful_diabetic_neuropathy:_an_open_label_pilot_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0885-3924(00)00181-0 DB - PRIME DP - Unbound Medicine ER -