E-ISSN 2231-3206 | ISSN 2320-4672
 

Original Research
Online Published: 16 Apr 2024
 


A comparative study on safety and efficacy of tablet thiocolchicoside 4 mg + aceclofenac 100 mg versus tablet paracetamol 500 mg + aceclofenac 100 mg in treatment of patients with acute lower back pain: A randomized double-blind study

Naga Nandini Bokka, Surendra Kumar Gondi, Deepthi Rani Bodda, Siva Prasad K V.


Abstract
Background: Lower backache is a highly prevalent condition among middle-aged individuals and is often caused by muscle spasms. It is one of the most common reasons why people seek medical assistance from a primary care physician.

Aims and Objectives: The aims and objectives of the study are to evaluate the safety and efficacy of the drug combinations thiocolchicoside 4 mg and aceclofenac 100 mg versus aceclofenac 100 mg and paracetamol 500 mg.

Materials and Methods: The study was conducted using a prospective, randomized, double-blind, comparative, and parallel group design. A total of 80 patients who met the specified criteria were selected to participate in the trial over a period of 3 months. A total of 30 cases were selected for each group, with consideration given to excluding outliers. The patients were allocated randomly into two groups: Group A, consisting of 30 individuals, and Group B, consisting of 30 individuals. The primary efficacy assessments include the visual analog scale, muscle spasm assessment by finger-to-floor distance, and Lasegue’s maneuver. The secondary efficacy measures were assessed using a 4-point scale global assessment, which included ratings of excellent, good, average, and poor.

Results: The majority of study participants were in the age group 39–48 years and above 48 years consisting of 25 patients and 33, respectively. Males constituted 51.6% and females were 48.3%. On day 28, results were calculated on 26 patients in Group A and 24 patients in Group B as 10 patients discontinued the treatment after 3rd week.

Conclusions: It is concluded that the best possible medical intervention to treat acute low back pain is to use drug combinations of analgesics and skeletal muscle relaxants. The combination of tablet thiocolchicoside and aceclofenac proved to be more efficacious and safer when compared to the combination of tablet aceclofenac and paracetamol.

Key words: Low Backache; Muscle Relaxants; Fixed-dose Combinations; Non-steroidal Anti-inflammatory Drugs; Visual Analog Scale; Comparative; Efficacy; Aceclofenac; Thiocolchicoside


 
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How to Cite this Article
Pubmed Style

Bokka NN, Gondi SK, Bodda DR, V SPK. A comparative study on safety and efficacy of tablet thiocolchicoside 4 mg + aceclofenac 100 mg versus tablet paracetamol 500 mg + aceclofenac 100 mg in treatment of patients with acute lower back pain: A randomized double-blind study. Natl J Physiol Pharm Pharmacol. 2024; 14(9): 1858-1864. doi:10.5455/njppp.2024.14.04146202404042024


Web Style

Bokka NN, Gondi SK, Bodda DR, V SPK. A comparative study on safety and efficacy of tablet thiocolchicoside 4 mg + aceclofenac 100 mg versus tablet paracetamol 500 mg + aceclofenac 100 mg in treatment of patients with acute lower back pain: A randomized double-blind study. https://www.njppp.com/?mno=196099 [Access: October 03, 2024]. doi:10.5455/njppp.2024.14.04146202404042024


AMA (American Medical Association) Style

Bokka NN, Gondi SK, Bodda DR, V SPK. A comparative study on safety and efficacy of tablet thiocolchicoside 4 mg + aceclofenac 100 mg versus tablet paracetamol 500 mg + aceclofenac 100 mg in treatment of patients with acute lower back pain: A randomized double-blind study. Natl J Physiol Pharm Pharmacol. 2024; 14(9): 1858-1864. doi:10.5455/njppp.2024.14.04146202404042024



Vancouver/ICMJE Style

Bokka NN, Gondi SK, Bodda DR, V SPK. A comparative study on safety and efficacy of tablet thiocolchicoside 4 mg + aceclofenac 100 mg versus tablet paracetamol 500 mg + aceclofenac 100 mg in treatment of patients with acute lower back pain: A randomized double-blind study. Natl J Physiol Pharm Pharmacol. (2024), [cited October 03, 2024]; 14(9): 1858-1864. doi:10.5455/njppp.2024.14.04146202404042024



Harvard Style

Bokka, N. N., Gondi, . S. K., Bodda, . D. R. & V, . S. P. K. (2024) A comparative study on safety and efficacy of tablet thiocolchicoside 4 mg + aceclofenac 100 mg versus tablet paracetamol 500 mg + aceclofenac 100 mg in treatment of patients with acute lower back pain: A randomized double-blind study. Natl J Physiol Pharm Pharmacol, 14 (9), 1858-1864. doi:10.5455/njppp.2024.14.04146202404042024



Turabian Style

Bokka, Naga Nandini, Surendra Kumar Gondi, Deepthi Rani Bodda, and Siva Prasad K V. 2024. A comparative study on safety and efficacy of tablet thiocolchicoside 4 mg + aceclofenac 100 mg versus tablet paracetamol 500 mg + aceclofenac 100 mg in treatment of patients with acute lower back pain: A randomized double-blind study. National Journal of Physiology, Pharmacy and Pharmacology, 14 (9), 1858-1864. doi:10.5455/njppp.2024.14.04146202404042024



Chicago Style

Bokka, Naga Nandini, Surendra Kumar Gondi, Deepthi Rani Bodda, and Siva Prasad K V. "A comparative study on safety and efficacy of tablet thiocolchicoside 4 mg + aceclofenac 100 mg versus tablet paracetamol 500 mg + aceclofenac 100 mg in treatment of patients with acute lower back pain: A randomized double-blind study." National Journal of Physiology, Pharmacy and Pharmacology 14 (2024), 1858-1864. doi:10.5455/njppp.2024.14.04146202404042024



MLA (The Modern Language Association) Style

Bokka, Naga Nandini, Surendra Kumar Gondi, Deepthi Rani Bodda, and Siva Prasad K V. "A comparative study on safety and efficacy of tablet thiocolchicoside 4 mg + aceclofenac 100 mg versus tablet paracetamol 500 mg + aceclofenac 100 mg in treatment of patients with acute lower back pain: A randomized double-blind study." National Journal of Physiology, Pharmacy and Pharmacology 14.9 (2024), 1858-1864. Print. doi:10.5455/njppp.2024.14.04146202404042024



APA (American Psychological Association) Style

Bokka, N. N., Gondi, . S. K., Bodda, . D. R. & V, . S. P. K. (2024) A comparative study on safety and efficacy of tablet thiocolchicoside 4 mg + aceclofenac 100 mg versus tablet paracetamol 500 mg + aceclofenac 100 mg in treatment of patients with acute lower back pain: A randomized double-blind study. National Journal of Physiology, Pharmacy and Pharmacology, 14 (9), 1858-1864. doi:10.5455/njppp.2024.14.04146202404042024





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