Evaluation of eperisone hydrochloride in the treatment of acute musculoskeletal spasm associated with low back pain: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: Eperisone hydrochloride is a centrally acting muscle relaxant inhibiting the pain reflex pathway, having a vasodilator effect. AIMS: To evaluate the efficacy and tolerability of eperisone in patients with acute musculoskeletal spasm associated with low back pain. SETTINGS AND DESIGN: Prospective, randomized, double-blind, placebo-controlled, multicentric trial conducted at five tertiary care orthopedic centers across India. MATERIALS AND METHODS: It was planned to enroll 240 patients of either sex between 18-60 years with acute musculoskeletal spasm (AMSP) with low back pain (LBP) due to spondylosis deformans, prolapsed disc or muscle sprain. Patients with other associated unrelated spasm conditions were excluded. Assessments were done for finger-to-floor distance (FFD), lumbar pain, Lasegue's sign, tenderness of vertebral muscles, need for rescue medication and response to therapy for efficacy and tolerability. STATISTICAL ANALYSIS: Parametric data were analyzed by 't' test and ANOVA, and non-parametric data were analyzed using Mann-Whitney 'U' test and Kruskall-Wallis test. Proportions were compared using Fischer's (Chi-square) test. RESULTS: Two hundred and forty patients were randomized to receive eperisone 150 mg/day in three divided doses (n=120) or placebo (n=120) for 14 days, of which 15 patients did not complete and 225 patients completed the study (eperisone, 112 and placebo, 113). Significantly greater improvement in FFD (P<0.001) from baseline on Day 14 was seen with eperisone (150.66 to 41.75) compared to placebo (138.51 to 101.60). Improvements in other parameters were greater with the eperisone group. For 89 (79.46%) patients the therapy was rated as good-excellent with eperisone compared to 43 (38.05%) patients with placebo. Nausea, abdominal pain, headache and dizziness were the common adverse events with both therapies. Rescue drug was needed by 40 (35.71%) eperisone patients and 83 (73.45%) placebo patients. CONCLUSIONS: Eperisone hydrochloride was effective and well tolerated for the treatment of patients with AMSP with LBP.

Aceclofenac-tizanidine in the treatment of acute low back pain: a double-blind, double-dummy, randomized, multicentric, comparative study against aceclofenac alone.

Tizanidine and aceclofenac individually have shown efficacy in the treatment of low back pain. The efficacy and tolerability of the combination have not yet been established. The objective of the study was to evaluate the efficacy and safety of aceclofenac-tizanidine fixed dose combination against aceclofenac alone in patients with acute low back pain. This double-blind, double-dummy, randomized, comparative, multicentric, parallel group study enrolled 197 patients of either sex in the age range of 18-70 years with acute low back pain. The patients were randomized to receive either aceclofenac (100 mg)-tizanidine (2 mg) b.i.d or aceclofenac (100 mg) alone b.i.d for 7 days. The primary efficacy outcomes were pain intensity (on movement, at rest and at night; on VAS scale) and pain relief (on a 5-point verbal rating scale). The secondary efficacy outcomes measures included functional impairment (modified Schober's test and lateral body bending test) and patient's and investigator's global efficacy assessment. aceclofenac-tizanidine was significantly superior to aceclofenac for pain intensity (on movement, at rest and at night; P < 0.05) and pain relief (P = 0.00) on days 3 and 7. There was significant increase in spinal flexion in both the groups from baseline on days 3 and 7 with significant difference in favour of the combination group (P < 0.05). There were significantly more number of patients with excellent to good response for the aceclofenac-tizanidine treatment as compared to aceclofenac alone (P = 0.00). Both the treatments were well tolerated. In this study, aceclofenac-tizanidine combination was more effective than aceclofenac alone and had a favourable safety profile in the treatment of acute low back pain.

Intra-operative somatosensory-evoked potential monitoring.

PURPOSE: To evaluate the usefulness of intra-operative somatosensory-evoked potentials (SSEPs) in monitoring spinal cord status via the posterior tibial nerve. METHODS: 84 men and 28 women aged 16 to 66 years (72% were aged 20 to 40 years) with spinal trauma (63 in the lumbar and 49 in the thoracic spine) underwent posterior instrumentation and fusion using bone grafts. All 63 patients with lumbar spinal injury and 35 of the patients with thoracic spinal injury were treated with pedicular screws. The remaining 14 patients had their thoracic spinal injury fixed with sublaminar wires. Cortical scalp recordings were used. Baseline tracings were obtained prior to surgical intervention and after establishment of anaesthesia. If changes persisted for more than 15 to 20 minutes or if they did not show definite signs of resolution, event reversal was considered. RESULTS: Of the 112 patients, 74 (66%) had no changes in Cz-Fpz patterns and neurological status, whereas 14 (13%) showed improved patterns (2 of them had the same neurological status postoperatively) and 24 (21%) displayed deteriorated patterns prompting intervention. Of the 24 patients prompting intervention, 20 improved substantially (19 had no new neurological deficits and one had deteriorated neurological status) and 4 improved minimally (2 had no new deficit and 2 had new deficits), with 88% sensitivity and 78% specificity. 15 patients were true-positives with an identifiable cause; 21 were false-positives with no neurological deterioration or recognisable cause. CONCLUSION: Intra-operative SSEP monitoring helps identify acute neurological and systemic (hypoxia or hypotension) impairment and enables prompt correction. This makes surgery available to high-risk patients and enables surgeons to carry out more extensive procedures. It also provides valuable documentation in the event of medico-legal dispute.

Comparison of Different Dosing Protocols of Anti-Snake Venom (ASV) in Snake Bite Cases.

INTRODUCTION: Considering the cost of Anti-Snake Venom (ASV) and irregularity in its supply, there is often a need to curtail doses of ASV, despite guidelines for management of snake bite. During June 2013 to September 2013, when ASV was in short supply, our institutional committee reviewed the overall hospital statistics of snake bite cases as well as scientific literature and formulated a working modified protocol that used low dose of ASV in snake bite cases. AIM: To retrospectively analyse and compare the modified ASV protocol versus conventional ASV protocol with respect to outcome, number of ASV vials required, duration of stay in the hospital/ ICU, and additional supportive interventions needed. MATERIALS AND METHODS: This was a retrospective study conducted at a tertiary care teaching hospital, Maharashtra, India. Hospital records of inpatients admitted for snake bite during June 2013 to September 2013 (since introduction of the modified protocol) as well as during June 2012 to September 2012, (when patients received conventional protocol-historical controls) were retrospectively analysed to assess the number of ASV vials received by the patients during the stay, need for supportive therapy, duration of stay and outcome of the patients. RESULTS: There was a significant reduction in average number of ASV vials per patient, required vide the modified protocol compared to their historical controls (10.74±0.95 vs 28.17±2.75 p<0.001). There was no significant difference in outcome, need for dialysis, fresh frozen plasma requirement, need for ICU stay and duration of hospitalization of snake bite patients. Yet, the average cost of management of each patient reduced by approximately 11974.41 INR per treated patient, based on the requirement of ASV. CONCLUSION: The modified ASV protocol used in this study is more cost effective as compared to the conventional protocol, deserves prospective evaluation and may be followed at least during prime time of scarcity of ASV.

Efficacy and safety of aceclofenac in the treatment of osteoarthritis: a randomized double-blind comparative clinical trial versus diclofenac - an Indian experience.

OBJECTIVE: Osteoarthritis is one of the most common forms of arthritis seen in primary care. Non-steroidal anti-inflammatory drugs (NSAIDs) play an important role in the management of osteoarthritis. However, gastrointestinal (GI) side effects limit their use. Cyclooxygenase-2 (COX-2) selective inhibitors exhibit better GI tolerability than conventional NSAIDs, but their cardiovascular safety is controversial. An NSAID with high efficacy, high GI tolerability and devoid of adverse cardiovascular effects is therefore a profile preferred by physicians. Aceclofenac is an anti-inflammatory and analgesic drug with preferential COX-2 inhibition. The objective of this study was to assess the efficacy and safety of aceclofenac in the treatment of osteoarthritis in an Indian population. RESEARCH DESIGN AND METHODS: The trial was controlled, comparative, randomized, and double-blind. The study included 247 patients (82 males and 165 females, 40-82 years), suffering from osteoarthritis. Patients were randomized to receive either aceclofenac (100 mg twice daily) or diclofenac (75 mg twice daily). MAIN OUTCOME MEASURES: Clinical assessment was done at screening, randomization, and at 2 weeks, 4 weeks and 8 weeks of treatment by calculating Western Ontario MacMaster (WOMAC) scores, time taken to walk 100 feet, visual analogue scores for pain, investigator's assessment on a Likert scale and joint tenderness. Tolerability assessment was based on adverse events. Patient compliance was also assessed. RESULTS: Aceclofenac was found to be statistically superior to diclofenac in efficacy parameters of WOMAC scores, investigator's assessment and joint tenderness. Aceclofenac was found to be statistically superior to diclofenac in terms of epigastric discomfort, dyspepsia and abdominal pain. Compliance was also better with aceclofenac. The overall response of patients' osteoarthritis to aceclofenac was found to be statistically superior to diclofenac by both physician and patient. CONCLUSIONS: Aceclofenac is an effective and well-tolerated drug in osteoarthritis in the Indian setting.