Low Back Pain (LBP) is a common human condition with 60-80% of the world population experiencing pain at some point of time in their life. 1 Low back pain is second only to the common cold as the most frequent reason for visiting a physician and is most common chronic pain syndrome in individual countries. 2 Low back pain is a common musculoskeletal symptom that may be either acute or chronic. It may be caused by a variety of diseases & disorders that affect the lumbar spine. The most frustrating aspect in the treatment of low back pain is that there is "no magic bullets". 3 Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most frequently prescribed medications worldwide and are widely used for patients with low back pain. 4 Flupirtine maleate is a non-opioid drug without antipyretic and anti-inflammatory properties which is approved by European Medical Agency for acute & chronic pain especially of musculoskeletal origin. 5 It has ABSTRACT Background: Low back pain is a common musculoskeletal symptom caused by a variety of disorders that affect the lumbar spine. The most frustrating aspect in the treatment of low back pain is that there is "no magic bullets". The objective of the study was to compare the efficacy and safety of flupirtine versus piroxicam in patients with back pain. Methods: This was prospective, open labeled, randomized, comparative clinical study conducted by the Departments Orthopedics and Pharmacology, BMC&H, Chitradurga. Study was conducted on 60 patients of either sex, aged above 18 years with low back pain. Assessments were done for Finger-to-Floor Distance (FFD), lumbar pain, Lasegue's sign, tenderness of vertebral muscles, pain & sensory disturbance in lower limbs and response to therapy for efficacy. Parametric data was analyzed by t-test and proportions were compared using Chi-square test. Results: 74 patients were randomized to 2 groups of 37 each. Group I patients received flupirtine maleate 100 mg twice daily and Group II patients received piroxicam 20 mg twice daily for 14 days. 30 patients in each group completed the study and were analysed. On intergroup comparison, there was no statistical difference (p>0.05) in the efficacy parameters of finger-to-floor distance (FFD), lumbar pain, Lasegue's sign, tenderness of vertebral muscles, sensory disturbance in lower limbs, VAS scores & global assessment of response to therapy. 13.3% in flupirtine group and 16.6% in piroxicam group reported adverse events. Conclusions: Both flupiritine and piroxicam were equally effective but flupirtine was better tolerated than piroxicam.
Background: Bronchodilators are essential for symptomatic management of all stages of chronic obstructive pulmonary disease (COPD). For patients whose COPD is not sufficiently controlled by monotherapy, combining a ß2-agonist with either inhaled steroid or anticholinergic drug is a convenient way of delivering treatment. Currently, there is no documentation to say that one drug is superior to other or the contrary, but a combination of two drugs is more effective than giving single drug alone in patients suffering from COPD.Methods: The study was prospective, open labelled, randomized, comparative interventional clinical study conducted by the Departments of Pharmacology and Medicine, Basaveshwara Medical College and Hospital, Chitradurga in 60 moderates to severe COPD patients.Results: Both the treatments i.e. Salmeterol/Fluticasone and Tiotropium/Formoterol were equally effective as far as the improvement of the lung functions and Borg dyspnoea score are concerned. The difference in improvement with the combination of Salmeterol/Fluticasone was not statistically significant (p>0.05) compared to the combination of Tiotropium/Formoterol. However, Salmeterol/Fluticasone was found to be better than Tiotropium/Formoterol in improving the lung function of moderate to severe COPD patients.Conclusions: Salmeterol/Fluticasone is efficacious and better than Tiotropium /Formoterol combination for maintenance therapy in moderate to severe COPD patients.
Background: As per GOLD (Global initiative for chronic obstructive lung disease) guidelines bronchodilators are required for symptomatic treatment of chronic obstructive pulmonary disease (COPD) patients. Currently there is no evidence to say about the safety of fixed dose combinations used in COPD patients. Since the drugs are to be taken for longer period, it is essential to know the safety aspects of these drugs. Moreover we don’t have adequate studies and documentation to say that a particular drug combination is better and safer for COPD patients.Methods: Prospective, open labelled, randomized, comparative, interventional clinical study conducted by the Departments of Pharmacology and Pulmonary Medicine of Basaveshwara Medical College and Hospital, Chitradurga in 40 COPD patients.Results: The fixed dose combinations of drugs used in both the treatment groups i.e. salmeterol/fluticasone and tiotropium/formoterol were equally safer and well tolerated. Some side effects noticed during the course of treatment were statistically significant when compared between the 2 groups, however they were milder and predictable adverse drug reactions.Conclusions: Systemic and severe adverse drug reactions were not observed during 8 week treatment period and the local side effects observed were mild in both the treatment groups. Hence the fixed dose combinations of salmeterol or fluticasone and tiotropium or formoterol are found to be safer for maintenance therapy in COPD patients.
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