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      Randomised controlled trial of gabapentin in Complex Regional Pain Syndrome type 1 [ISRCTN84121379]

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          Abstract

          Background

          Complex Regional Pain Syndrome type one (CRPS I) or formerly Reflex Sympathetic Dystrophy (RSD) is a disabling syndrome, in which a painful limb is accompanied by varying symptoms. Neuropathic pain is a prominent feature of CRPS I, and is often refractory to treatment. Since gabapentin is an anticonvulsant with a proven analgesic effect in various neuropathic pain syndromes, we sought to study the efficacy of the anticonvulsant gabapentin as treatment for pain in patients with CRPS I.

          Methods

          We did a randomized double blind placebo controlled crossover study with two three-weeks treatment periods with gabapentin and placebo separated by a two-weeks washout period. Patients started at random with gabapentin or placebo, which was administered in identical capsules three times daily. We included 58 patients with CRPS type 1.

          Results

          Patients reported significant pain relief in favor of gabapentin in the first period. Therapy effect in the second period was less; finally resulting in no significant effect combining results of both periods. The CRPS patients had sensory deficits at baseline. We found that this sensory deficit was significantly reversed in gabapentin users in comparison to placebo users.

          Conclusions

          Gabapentin had a mild effect on pain in CRPS I. It significantly reduced the sensory deficit in the affected limb. A subpopulation of CRPS patients may benefit from gabapentin.

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          Most cited references41

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

          Pain is the most disturbing symptom of diabetic peripheral neuropathy. As many as 45% of patients with diabetes mellitus develop peripheral neuropathies. To evaluate the effect of gabapentin monotherapy on pain associated with diabetic peripheral neuropathy. Randomized, double-blind, placebo-controlled, 8-week trial conducted between July 1996 and March 1997. Outpatient clinics at 20 sites. 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. Gabapentin (titrated from 900 to 3600 mg/d or maximum tolerated dosage) or placebo. 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. 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). 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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            Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial.

            Postherpetic neuralgia (PHN) is a syndrome of often intractable neuropathic pain following herpes zoster (shingles) that eludes effective treatment in many patients. To determine the efficacy and safety of the anticonvulsant drug gabapentin in reducing PHN pain. Multicenter, randomized, double-blind, placebo-controlled, parallel design, 8-week trial conducted from August 1996 through July 1997. Sixteen US outpatient clinical centers. A total of 229 subjects were randomized. A 4-week titration period to a maximum dosage of 3600 mg/d of gabapentin or matching placebo. Treatment was maintained for another 4 weeks at the maximum tolerated dose. Concomitant tricyclic antidepressants and/or narcotics were continued if therapy was stabilized prior to study entry and remained constant throughout the study. The primary efficacy measure was change in the average daily pain score based on an 11-point Likert scale (0, no pain; 10, worst possible pain) from baseline week to the final week of therapy. Secondary measures included average daily sleep scores, Short-Form McGill Pain Questionnaire (SF-MPQ), Subject Global Impression of Change and investigator-rated Clinical Global Impression of Change, Short Form-36 (SF-36) Quality of Life Questionnaire, and Profile of Mood States (POMS). Safety measures included the frequency and severity of adverse events. One hundred thirteen patients received gabapentin, and 89 (78.8%) completed the study; 116 received placebo, and 95 (81.9%) completed the study. By intent-to-treat analysis, subjects receiving gabapentin had a statistically significant reduction in average daily pain score from 6.3 to 4.2 points compared with a change from 6.5 to 6.0 points in subjects randomized to receive placebo (P<.001). Secondary measures of pain as well as changes in pain and sleep interference showed improvement with gabapentin (P<.001). Many measures within the SF-36 and POMS also significantly favored gabapentin (P< or =.01). Somnolence, dizziness, ataxia, peripheral edema, and infection were all more frequent in the gabapentin group, but withdrawals were comparable in the 2 groups (15 [13.3%] in the gabapentin group vs 11 [9.5%] in the placebo group). Gabapentin is effective in the treatment of pain and sleep interference associated with PHN. Mood and quality of life also improve with gabapentin therapy.
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              Signs and symptoms of reflex sympathetic dystrophy: prospective study of 829 patients.

              The pathogenesis of reflex sympathetic dystrophy--variously known as Sudeck's atrophy, causalgia, algodystrophy, and peripheral trophoneurosis--is not yet understood, and diagnosing and treating patients is difficult. We have prospectively studied 829 patients, paying particular attention to early signs and symptoms. In its early phase, reflex sympathetic dystrophy is characterised by regional inflammation, which increases after muscular exercise. Pain was present in 93% of patients, and hypoaesthesia and hyperpathy were present in 69% and 75% respectively. With time, tissue atrophy may occur as well as involuntary movements, muscle spasms, or pseudoparalysis. Tremor was found in 49% and muscular incoordination in 54% of patients. Sympathetic signs such as hyperhidrosis are infrequent and therefore have no diagnostic value. We found no evidence consistent with the presence of three consecutive phases of the disease. Early symptoms are those of an inflammatory reaction and not of a disturbance of the sympathetic nervous system. These data support the concept of an exaggerated regional inflammatory response to injury or operation in reflex sympathetic dystrophy.
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                Author and article information

                Journal
                BMC Neurol
                BMC Neurology
                BioMed Central (London )
                1471-2377
                2004
                29 September 2004
                : 4
                : 13
                Affiliations
                [1 ]Pain Management and Research Centre, Dept. of Anesthesiology, *Dept. of Clinical Epidemiology and Medical Technology Assessment, Dept. of Neurology, University Hospital Maastricht, Maastricht, The Netherlands
                Article
                1471-2377-4-13
                10.1186/1471-2377-4-13
                523854
                15453912
                e31a0d30-f990-4717-bbb9-515dfddff864
                Copyright © 2004 van de Vusse et al; licensee BioMed Central Ltd.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 6 April 2004
                : 29 September 2004
                Categories
                Research Article

                Neurology
                Neurology

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