Therapeutic efficacy and safety of oral tranexamic acid 250 mg once a day versus 500 mg twice a day: a comparative study

Abstract

Oral tranexamic acid (TXA) 250 mg twice daily has been used effectively for 4 weeks to 6 months to treat melasma. As relapses are frequent on discontinuation, a minimum effective dose of TXA that can be used safely for long time remains unknown. We compared the efficacy of oral TXA 250 mg once daily and 500 mg twice daily given for 16 weeks in 132 (m:f 23:109) adults with melasma. 42 patients in Group-A (TXA 250 mg/d) and 46 patients in Group-B (TXA 500 mg twice/d) completed the study. They were followed up at 4-week interval for percentage reduction in baseline Melasma Area Severity Index (MASI) and at 24 and 28 weeks for relapse. Therapeutic response, for both as per-protocol and intention-to-treat analysis, was scored as very good (> 75% reduction), good (51–75% reduction), moderate (25–50% reduction), mild (< 25% reduction) or no improvement. Reduction in mean MASI score at 4 weeks was not statistically significant in Group-A but it decreased significantly 8 weeks onwards and was comparable with that in Group-B. The relapse rate was higher in Group-B (10.8%) than Group-A (4.7%) at the end of 28 weeks. Oligomenorrhoea and abdominal discomfort in few patients did not necessitate treatment discontinuation. TXA 500 mg twice daily showed early reduction in mean MASI score compared to 250 mg given once daily with comparable safety and therapeutic efficacy at 16 weeks. Open-label cross-sectional design, no control arm, small number of patients in each group, MASI score being subjective assessment tool, short duration of treatment and follow-up are study limitations.

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Abbreviations

bFGF:

Basic fibroblast growth factor

IL-8:

Interleukin-8

MASI:

Melasma Area Severity Index

NSAIDS:

Non-steroidal anti-inflammatory drugs

VEGF:

Vascular endothelial growth factor

SD:

Standard deviation

TXA:

Tranexamic acid

UV:

Ultraviolet

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Acknowledgements

Mr. Sushant Sharma of Community Medicine (Biostatistics) Dr. R. P. Govt. Medical College, Kangra (Tanda), H.P. (India), helped in the statistical analysis of the data. His erudite association throughout the study is gratefully acknowledged. The authors also thank their patients/subjects who volunteered for the study.

Funding

The study was not funded by any agency. The clinical data form part of the thesis submitted to Himachal Pradesh University, Shimla, (H.P.) for the degree of M.D. (DVL).

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Contributions

BC obtained compiled, analyzed all data, and prepared initial draft. VKM analyzed and interpreted data, drafted, and critically evaluated the manuscript for important intellectual content. KSM, PSC, VS, AS, SV, and PK helped in obtaining, compiling and interpretation of data, and literature search. KSM evaluated clinical response and PSC assessed pre- and post-treatment photographs. All authors were involved in the drafting and revision of the manuscript and have agreed to the final content.

Corresponding author

Correspondence to Vikram K. Mahajan.

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Conflict of interest

All authors declare that they have no competing interest and therefore nothing else to declare, and have contributed significantly and take full responsibility for the manuscript. The authors of the paper are obliged to confirm that it has not been previously published.

Ethical approval

The study was approved by Institutional Ethics Committee (Rgn no ECR/490/Inst/HP/2013/RR-16) and registered with Clinical Trial Registry of India (CTRI No. REF/2018/03/018038).

Informed consent

Informed consent was obtained from study subjects for enrollment and publication of material with the understanding that their names and initials will not be published and due efforts will be made to conceal their identity but anonymity cannot be guaranteed. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki declaration of 1975 as revised in 1983

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Chowdhary, B., Mahajan, V.K., Mehta, K.S. et al. Therapeutic efficacy and safety of oral tranexamic acid 250 mg once a day versus 500 mg twice a day: a comparative study. Arch Dermatol Res 313, 109–117 (2021). https://doi.org/10.1007/s00403-020-02078-x

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Keywords

  • MASI score
  • Melasma treatment
  • Oligomenorrhea
  • Pigmentary disorders
  • Tranexamic acid