[Randomized controlled trial of medical and medico-surgical treatment of Hansen's neuritis]. Comparative trial of steroids and surgical intervention in the management of ulnar neuritis. A randomized controlled trial of surgery vs steroid injection for carpal tunnel syndrome. Direct decompressive surgical resection in the treatment of spinal cord compression caused by metastatic cancer: a randomised trial. Treatment with corticosteroids of long-standing nerve function impairment in leprosy: a randomized controlled trial (TRIPOD 3). The perioperative use of corticosteroids and bupivacaine in the management of lumbar disc disease. Surgical or medical decompression as a first-line treatment of optic neuropathy in Graves' ophthalmopathy? A randomized controlled trial. Effect of epicondylectomy in early ulnar neuritis treated with steroids. The prognostic importance of detecting mild sensory impairment in leprosy: a randomized controlled trial (TRIPOD 2).
The aim of the study was to compare the results of the medical treatment alone and of the medico-surgical treatment on leprous neuritis. The patients were followed-up during 2 years, with regular neurological evaluations. The statistical study was performed using the Tukey test. Ninety-three nerves (ulnar, median, common peroneal and posterior tibial) with a deficit of less than 6 months duration have been studied in 31 leprosy patients. All the patients were treated by steroids but in some of them a nerve surgical decompression was performed. An improvement of the sensitive and motor deficit was observed in both groups. No significant statistical differences appeared between the 2 groups according to the nerve involved, the duration of the deficit, the form of leprosy and the type of antibacillary treatment. However, the medico-surgical treatment had a significant better result on pain and on major but incomplete nervous involvement. This study included a limited number of nerves, thus, it would be useful to perform others randomized assays to better define the indications of surgical decompression in the management of leprous neuritis. Fifty-seven ulnar nerves in 39 patients with early neuritis were studied to assess the benefits offered by medial epicondylectomy and external decompression in addition to steroid therapy. The patients were randomly allocated to the surgical or medical group. In those cases where there was bilateral involvement, surgery was carried out on only one side. All cases were assessed prior to treatment and after the first and second years following treatment. The improvement in motor and sensory functions attained at the end of the first year was sustained into the second year. The improvement sustained in both groups was similar even in the second year, and medial epicondylectomy with external decompression seems to have no added benefit as compared to steroid therapy alone in the early treatment of ulnar neuritis. Early diagnosis and treatment, especially in borderline lepromatous cases, seem to offer some hope of nerve function recovery. Decompressive surgery and steroid injection are widely used forms of treatment for carpal tunnel syndrome (CTS) but there is no consensus on their effectiveness in comparison to each other. The authors evaluated the efficacy of surgery vs steroid injection in relieving symptoms in patients with CTS.
                The authors conducted a randomized, single blind, controlled trial. Fifty patients with electrophysiologically confirmed idiopathic CTS were randomized and assigned to open carpal tunnel release (25 patients) or to a single injection of steroid (25 patients). Patients were followed up at 6 and 20 weeks. The primary outcome was symptom relief in terms of the Global Symptom Score (GSS), which rates symptoms on a scale of 0 (no symptoms) to 50 (most severe). Nerve conduction studies and grip strength measurements were used as secondary outcome assessments.
                At 20 weeks after randomization, patients who underwent surgery had greater symptomatic improvement than those who were injected. The mean improvement in GSS after 20 weeks was 24.2 (SD 11.0) in the surgery group vs 8.7 (SD 13.0) in the injection group (p < 0.001); surgical decompression also resulted in greater improvement in median nerve distal motor latencies and sensory nerve conduction velocity. Mean grip strength in the surgical group was reduced by 1.7 kg (SD 5.1) compared with a gain of 2.4 kg (SD 5.5) in the injection group.
                Compared with steroid injection, open carpal tunnel release resulted in better symptomatic and neurophysiologic outcome but not grip strength in patients with idiopathic carpal tunnel syndrome over a 20-week period. The standard treatment for spinal cord compression caused by metastatic cancer is corticosteroids and radiotherapy. The role of surgery has not been established. We assessed the efficacy of direct decompressive surgery.
                In this randomised, multi-institutional, non-blinded trial, we randomly assigned patients with spinal cord compression caused by metastatic cancer to either surgery followed by radiotherapy (n=50) or radiotherapy alone (n=51). Radiotherapy for both treatment groups was given in ten 3 Gy fractions. The primary endpoint was the ability to walk. Secondary endpoints were urinary continence, muscle strength and functional status, the need for corticosteroids and opioid analgesics, and survival time. All analyses were by intention to treat.
                After an interim analysis the study was stopped because the criterion of a predetermined early stopping rule was met. Thus, 123 patients were assessed for eligibility before the study closed and 101 were randomised. Significantly more patients in the surgery group (42/50, 84%) than in the radiotherapy group (29/51, 57%) were able to walk after treatment (odds ratio 6.2 [95% CI 2.0-19.8] p=0.001). Patients treated with surgery also retained the ability to walk significantly longer than did those with radiotherapy alone (median 122 days vs 13 days, p=0.003). 32 patients entered the study unable to walk; significantly more patients in the surgery group regained the ability to walk than patients in the radiation group (10/16 [62%] vs 3/16 [19%], p=0.01). The need for corticosteroids and opioid analgesics was significantly reduced in the surgical group.
                Direct decompressive surgery plus postoperative radiotherapy is superior to treatment with radiotherapy alone for patients with spinal cord compression caused by metastatic cancer. Some leprosy patients with long-standing nerve function impairment (NFI) appear to have responded favourably to treatment with corticosteroids. This study investigated whether patients with untreated NFI between 6 and 24 months duration and who are given standard regimen corticosteroid therapy, will have a better treatment outcome than a placebo group. A multicentre, randomized, double-blind placebo-controlled trial was conducted in Nepal and Bangladesh. Subjects were randomised to either prednisolone treatment starting at 40 mg/day, tapered by 5 mg every 2 weeks, and completed after 16 weeks, or placebo. Outcome assessments were at 4, 6, 9, and 12 months from the start of treatment. 92 MB patients on MDT were recruited, of whom 40 (45%) received prednisolone and 52 (55%) placebo treatment. No demonstrable additional improvement in nerve function, or in preventing further leprosy reaction events was seen in the prednisolone group. Overall, improvement of nerve function at 12 months was seen in about 50% of patients in both groups. Analysis of subgroups according to nerve (ulnar and posterior tibial), duration of NFI, and sensory and motor function, also did not reveal any differences between the treatment and placebo groups. There was however, indication of less deterioration of nerve function in the prednisolone group. Finally, there was no difference in the occurrence of adverse events between both groups. The trial confirms current practice not to treat long-standing NFI with prednisolone. Spontaneous recovery of nerve function appears to be a common phenomenon in leprosy. Leprosy reactions and new NFI occurred in a third of the study group, emphasizing the need to keep patients under regular surveillance during MDT, and, where possible, after completion of MDT. The introduction of microdiscectomy to lumbar spine surgery has resulted in a significant decrease in postoperative pain and length of hospital stay. Intraoperative application of long-acting local anesthetic agents has been used for many general and neurosurgical procedures for the management of postoperative pain. In addition, many surgeons routinely use intraoperative corticosteroids during lumbar discectomy to reduce traumatic nerve root inflammation. However, the efficacy of intraoperative long-acting local anesthetic agents and corticosteroids for reduction of postoperative discomfort has not been reported for lumbar discectomy. This study evaluated 32 patients at a university-based Veterans Administration hospital undergoing lumbar microdiscectomy. All 32 patients presented with radicular symptoms and had radiographic confirmation of a herniated nucleus pulposus. These patients were divided into three groups. Group 1 (12 patients) received 160 mg intramuscular Depo-Medrol (methylprednisolone acetate) and 250 mg intravenous Solu-Medrol (methyl-prednisolone sodium succinate) at the start of the operation. A macerated fat graft soaked in 80 mg Depo-Medrol was placed over the affected nerve root following discectomy. In addition, 30 ml of 0.25% bupivacaine was infiltrated into the paraspinal musculature at skin incision and during closure. Group 2 (10 patients) received 30 ml of 0.25% bupivacaine infiltrated into the paraspinal musculature at skin incision and at closure. In this group of patients, a saline-soaked fat graft was placed over the affected nerve root. Group 3 (10 patients) acted as a control group, undergoing lumbar microdiscectomy without corticosteroids or bupivacaine. Patients receiving bupivacaine and corticosteroids (Group 1) had a statistically significantly shorter hospital stay (1.4 days) compared to the control group (4.0 days) (p = 0.0004, Mann-Whitney U-test). Patients in Group 1 required less postoperative narcotic analgesia than the other groups. Finally, a larger percentage of patients in Group 1 reported complete relief of back and radicular pain on postoperative Day 1 compared to other groups. Postoperative complications and functional outcome were not different between the groups. These results indicate that the combination of long-acting anesthetic agents and corticosteroids can reduce postoperative discomfort and subsequently the length of postoperative hospital stay. Only a small percentage of Graves' ophthalmopathy (GO) patients develop optic neuropathy with impending loss of visual acuity. Therapy with methylprednisolone pulses is the treatment of first choice in severe and active GO patients. When the effect is insufficient, patients are usually treated with surgical decompression. We investigated whether surgery could become the first-line treatment, thus preventing treatment with steroids.
                We performed a randomized trial in 15 patients with very active GO and optic neuropathy. Six patients were treated with surgical decompression, and nine with methylprednisolone i.v. pulses for 2 weeks, followed by oral prednisone for 4 months. The primary outcome was determined by changes in visual acuity. If the eye disease deteriorated despite treatment or did not improve sufficiently, patients were switched to the other treatment arm.
                The severity and activity of GO in both groups were similar at baseline. The Clinical Activity Score (CAS) was 6.3+/- 0.8 in the surgical group vs. 6.0+/- 0.5 in the steroids group and the Total Eye Score was 24+/- 6 vs. 25+/- 6. In the surgery group, 5/6 patients (82%) did not respond because of insufficient improvement in vision (n=3) or persistent chemosis (n=2), and all needed further immunosuppression. In the steroids group, 4/9 patients (45%) did not improve in visual acuity (P=0.132 vs. surgery group), and these needed decompressive surgery. All patients in whom therapy failed were switched to the other treatment arm and visual acuity improved in almost all patients. Visual acuity improved from 0.36 (0.02--0.40) to 0.90 (0.63--1.0) in the surgery group and from 0.50 (0.32--0.63) to 0.75 (0.32--1.0) in the steroids group at 52 weeks. At long-term follow-up in the surgery group 3/6 patients required squint surgery and 5/9 patients in the steroids group. Eyelid surgery was performed in 5/6 patients in the surgery group and in 4/9 patients in the steroids group.
                Immediate surgery does not result in a better outcome and therefore methylprednisolone pulse therapy appears to be the first-choice therapy. Sixty-two ulnar nerves belonging to 44 patients with early neuritis were studied to assess the benefits offered by medial epicondylectomy and external decompression in addition to steroid therapy. The patients were randomly allocated to the surgical or the medical group. In those cases where there was bilateral involvement, surgery was carried out only on one side. All cases were assessed prior to treatment, and at predetermined intervals following treatment. This study presents the results after a 12-month follow-up. There was statistically significant improvement in both groups following treatment as assessed by improvement in motor and sensory functions and in the reduction of pain and tenderness. The study, however, failed to demonstrate any added benefit with surgical intervention as compared to steroid therapy alone in the treatment of early ulnar neuritis. This study was designed to investigate whether leprosy patients diagnosed with mild sensory impairment have a better prognosis when treated with steroids than similarly impaired patients treated with placebo. A multi-centre, randomized, double-blind, placebo-controlled trial was conducted in Nepal and Bangladesh. Patients were eligible if they had a confirmed leprosy diagnosis, were between 15 and 50 years old, had mild sensory impairment of the ulnar or posterior tibial nerve of less than 6 months duration and did not require steroids for other reasons. 'Mild impairment' was defined as 'impaired on the Semmes-Weinstein monofilament test, but testing normal on the ballpen sensory test'. Subjects were randomized to either prednisolone treatment starting at 40 mg per day, tapering over 4 months, or placebo. Nerve function was monitored monthly. Any patient who deteriorated was taken out of the trial and was put on full-dose steroid treatment. Outcome assessment was done at 4, 6, 9 and 12 months from the start of the treatment. Outcome measures were the proportion of patients needing full-dose prednisolone and the Semmes-Weinstein sum scores. Each patient contributed only one nerve to the analysis. Seventy-five patients had nerves eligible for analysis, of whom 41 (55%) and 34 (45%) were allocated to the prednisolone and placebo arms, respectively. At 4 months, three patients in the prednisolone arm (7%) and six in the placebo arm (18%) had an outcome event requiring full dose steroids. At 12 months, these proportions had almost reversed, 11 (27%) and 6 (18%) in the treatment and placebo arms, respectively. In the latter group, 75% had recovered spontaneously after 12 months. Prednisolone treatment of sensory impairment of the ulnar and posterior tibial nerves detectable with the monofilament test, but not with the ballpen test, did not improve the long-term outcome in terms of recovery of touch sensibility, not did it reduce the risk of leprosy reactions or nerve function impairment beyond the initial 4-month treatment phase. Two unexpected main findings were the strong tendency of mild sensory impairment to recover spontaneously and the fact that patients with mild sensory impairment without any other signs or symptoms of reaction or nerve function impairment are relatively rare.
Decompressive surgery is used for treating nerve damage in leprosy but the available evidence from RCTs is of very low quality and does not show a significant added benefit of surgery over steroid treatment alone. Well-designed RCTs are needed to establish the effectiveness of the combination of surgery and medical treatment compared to medical treatment alone.