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Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus: a randomized controlled trial.

Abstract

CONTEXT

Pain is the most disturbing symptom of diabetic peripheral neuropathy. As many as 45% of patients with diabetes mellitus develop peripheral neuropathies.

OBJECTIVE

To evaluate the effect of gabapentin monotherapy on pain associated with diabetic peripheral neuropathy.

DESIGN

Randomized, double-blind, placebo-controlled, 8-week trial conducted between July 1996 and March 1997.

SETTING

Outpatient clinics at 20 sites.

PATIENTS

The 165 patients enrolled had a 1- to 5-year history of pain attributed to diabetic neuropathy and a minimum 40-mm pain score on the Short-Form McGill Pain Questionnaire visual analogue scale.

INTERVENTION

Gabapentin (titrated from 900 to 3600 mg/d or maximum tolerated dosage) or placebo.

MAIN OUTCOME MEASURES

The primary efficacy measure was daily pain severity as measured on an 11-point Likert scale (0, no pain; 10, worst possible pain). Secondary measures included sleep interference scores, the Short-Form McGill Pain Questionnaire scores, Patient Global Impression of Change and Clinical Global Impression of Change, the Short Form-36 Quality of Life Questionnaire scores, and the Profile of Mood States results.

RESULTS

Eighty-four patients received gabapentin and 70 (83%) completed the study; 81 received placebo and 65 (80%) completed the study. By intent-to-treat analysis, gabapentin-treated patients' mean daily pain score at the study end point (baseline, 6.4; end point, 3.9; n = 82) was significantly lower (P<.001) compared with the placebo-treated patients' end-point score (baseline, 6.5; end point, 5.1; n = 80). All secondary outcome measures of pain were significantly better in the gabapentin group than in the placebo group. Additional statistically significant differences favoring gabapentin treatment were observed in measures of quality of life (Short Form-36 Quality of Life Questionnaire and Profile of Mood States). Adverse events experienced significantly more frequently in the gabapentin group were dizziness (20 [24%] in the gabapentin group vs 4 [4.9%] in the control group; P<.001) and somnolence (19 [23%] in the gabapentin group vs 5 [6%] in the control group; P = .003). Confusion was also more frequent in the gabapentin group (7 [8%] vs 1 [1.2%]; P = .06).

CONCLUSION

Gabapentin monotherapy appears to be efficacious for the treatment of pain and sleep interference associated with diabetic peripheral neuropathy and exhibits positive effects on mood and quality of life.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Department of Neurology, University of Wisconsin, Madison 53792, USA. backonja@neurology.wisc.edu

    , , , , , ,

    Source

    JAMA 280:21 1998 Dec 02 pg 1831-6

    MeSH

    Acetates
    Amines
    Analgesics
    Anticonvulsants
    Cyclohexanecarboxylic Acids
    Diabetic Neuropathies
    Double-Blind Method
    Female
    Gabapentin
    Humans
    Male
    Middle Aged
    Pain
    Pain Measurement
    Quality of Life
    gamma-Aminobutyric Acid

    Pub Type(s)

    Clinical Trial
    Journal Article
    Multicenter Study
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    9846777

    Citation

    Backonja, M, et al. "Gabapentin for the Symptomatic Treatment of Painful Neuropathy in Patients With Diabetes Mellitus: a Randomized Controlled Trial." JAMA, vol. 280, no. 21, 1998, pp. 1831-6.
    Backonja M, Beydoun A, Edwards KR, et al. Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus: a randomized controlled trial. JAMA. 1998;280(21):1831-6.
    Backonja, M., Beydoun, A., Edwards, K. R., Schwartz, S. L., Fonseca, V., Hes, M., ... Garofalo, E. (1998). Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus: a randomized controlled trial. JAMA, 280(21), pp. 1831-6.
    Backonja M, et al. Gabapentin for the Symptomatic Treatment of Painful Neuropathy in Patients With Diabetes Mellitus: a Randomized Controlled Trial. JAMA. 1998 Dec 2;280(21):1831-6. PubMed PMID: 9846777.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus: a randomized controlled trial. AU - Backonja,M, AU - Beydoun,A, AU - Edwards,K R, AU - Schwartz,S L, AU - Fonseca,V, AU - Hes,M, AU - LaMoreaux,L, AU - Garofalo,E, PY - 1998/12/10/pubmed PY - 2001/8/14/medline PY - 1998/12/10/entrez SP - 1831 EP - 6 JF - JAMA JO - JAMA VL - 280 IS - 21 N2 - CONTEXT: Pain is the most disturbing symptom of diabetic peripheral neuropathy. As many as 45% of patients with diabetes mellitus develop peripheral neuropathies. OBJECTIVE: To evaluate the effect of gabapentin monotherapy on pain associated with diabetic peripheral neuropathy. DESIGN: Randomized, double-blind, placebo-controlled, 8-week trial conducted between July 1996 and March 1997. SETTING: Outpatient clinics at 20 sites. PATIENTS: The 165 patients enrolled had a 1- to 5-year history of pain attributed to diabetic neuropathy and a minimum 40-mm pain score on the Short-Form McGill Pain Questionnaire visual analogue scale. INTERVENTION: Gabapentin (titrated from 900 to 3600 mg/d or maximum tolerated dosage) or placebo. MAIN OUTCOME MEASURES: The primary efficacy measure was daily pain severity as measured on an 11-point Likert scale (0, no pain; 10, worst possible pain). Secondary measures included sleep interference scores, the Short-Form McGill Pain Questionnaire scores, Patient Global Impression of Change and Clinical Global Impression of Change, the Short Form-36 Quality of Life Questionnaire scores, and the Profile of Mood States results. RESULTS: Eighty-four patients received gabapentin and 70 (83%) completed the study; 81 received placebo and 65 (80%) completed the study. By intent-to-treat analysis, gabapentin-treated patients' mean daily pain score at the study end point (baseline, 6.4; end point, 3.9; n = 82) was significantly lower (P<.001) compared with the placebo-treated patients' end-point score (baseline, 6.5; end point, 5.1; n = 80). All secondary outcome measures of pain were significantly better in the gabapentin group than in the placebo group. Additional statistically significant differences favoring gabapentin treatment were observed in measures of quality of life (Short Form-36 Quality of Life Questionnaire and Profile of Mood States). Adverse events experienced significantly more frequently in the gabapentin group were dizziness (20 [24%] in the gabapentin group vs 4 [4.9%] in the control group; P<.001) and somnolence (19 [23%] in the gabapentin group vs 5 [6%] in the control group; P = .003). Confusion was also more frequent in the gabapentin group (7 [8%] vs 1 [1.2%]; P = .06). CONCLUSION: Gabapentin monotherapy appears to be efficacious for the treatment of pain and sleep interference associated with diabetic peripheral neuropathy and exhibits positive effects on mood and quality of life. SN - 0098-7484 UR - https://www.unboundmedicine.com/medline/citation/9846777/Gabapentin_for_the_symptomatic_treatment_of_painful_neuropathy_in_patients_with_diabetes_mellitus:_a_randomized_controlled_trial_ L2 - https://jamanetwork.com/journals/jama/fullarticle/vol/280/pg/1831 DB - PRIME DP - Unbound Medicine ER -