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

doi:10.5455/njppp.2024.14.04146202404042024

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Online Publishing Date:
16 / 04 / 2024

Natl J Physiol Pharm Pharmacol. 2024; 14(9):

doi: 10.5455/njppp.2024.14.04146202404042024

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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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. Online First: 16 Apr, 2024. 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: April 19, 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. Online First: 16 Apr, 2024. 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, [cited April 19, 2024]; Online First: 16 Apr, 2024. 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, Online First: 16 Apr, 2024. 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, Online First: 16 Apr, 2024. 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 Online First: 16 Apr, 2024. doi:10.5455/njppp.2024.14.04146202404042024

MLA (The Modern Language Association) Style

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, Online First: 16 Apr, 2024. doi:10.5455/njppp.2024.14.04146202404042024

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