Dergiler / European Journal of Breast Health / 2022 / Cilt: 18 - Sayı: 3

Open-Label Three Arm Trial Comparing Ormeloxifene, Gamma Linolenic Acid With Methylcobalamine + Vitamin C and Placebo in Mastalgia

Sayfa
248–251
Yayın Tarihi
2022-10-18
DOI
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⚡ TL;DR(1 Cümlede Hızlı Çıkarım)

The role of Ormeloxifene in mastalgia needs further evaluation before recommending it as preferred therapy

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Amaç & Hipotez:Objective: We evaluated the beneficial effect of Ormeloxifene (Centchroman) versus a combination of Gamma Linolenic acid (GLA), methylcobalamine and vitamin C on mastalgia in a three-arm, open-label, placebo-controlled trial.
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Temel Bulgular & Veri:Materials and Methods: Patients aged above 18 years with mastalgia were recruited between January 2019 and July 2021.
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Sonuç & Katkı:The role of Ormeloxifene in mastalgia needs further evaluation before recommending it as preferred therapy
🔬Tür:Araştırma Makalesi
📍Kapsam:2019 Verileri
⚙️Değişkenler:Alan Parametreleri

Abstract

Objective: We evaluated the beneficial effect of Ormeloxifene (Centchroman) versus a combination of Gamma Linolenic acid (GLA), methylcobalamine and vitamin C on mastalgia in a three-arm, open-label, placebo-controlled trial. Materials and Methods: Patients aged above 18 years with mastalgia were recruited between January 2019 and July 2021. Patients were divided in three arms: Ormeloxifene arm, GLA arm and Placebo arm. Response was evaluated using visual analogue scale (VAS) and score below 3/10 was defined as complete relief. Results: A total of 113 consecutive women with mastalgia were randomized to the GLA group (Group 1, n = 39 women), Ormeloxifene (Group 2, n = 36) and Placebo (Group 3, n = 38). Complete response was observed in 94% patient in Group 1, 96% in Group 2 and 87% in Group 3 at the end of 12 weeks and it was not significant (p = 0.49). Adverse events were reported by eleven patients taking Ormeloxifene, compared to none in the other two groups. Conclusion: In this study Ormeloxifene and GLA were not superior to placebo for pain relief in mastalgia. Furthermore, there were concerning side effects associated with Ormeloxifene therapy. The role of Ormeloxifene in mastalgia needs further evaluation before recommending it as preferred therapy

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Bu Makaleye Atıf Yap

VERMA, A., SHARMA, D. B., YADAV, S. K., SHARMA, D. (2022). Open-Label Three Arm Trial Comparing Ormeloxifene, Gamma Linolenic Acid With Methylcobalamine + Vitamin C and Placebo in Mastalgia. European Journal of Breast Health, Cilt: 18 - Sayı: 3, 248–251. https://ajindex.com/articles/510628

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Kaynakça (14)

  1. Santen RJ, Mansel R. Benign breast disorders. N Engl J Med 2005
  2. (PMID: 16034013) [Crossref] 2. Smith RL, Pruthi S, Fitzpatrick LA. Evaluation and management of breast pain. Mayo Clin Proc 2004
  3. (PMID: 15008609) [Crossref] 3. Hafiz SP, Barnes NLP, Kirwan CC. Clinical management of idiopathic mastalgia: a systematic review. J Prim Health Care 2018
  4. (PMID: 31039960) [Crossref] 4. Horrobin DF. The effects of gamma-linolenic acid on breast pain and diabetic neuropathy: possible non-eicosanoid mechanisms. Prostaglandins Leukot Essent Fatty Acids 1993
  5. (PMID: 8380930) [Crossref] 5. Pasta V, Dinicola S, Giuliani A, Harrath AH, Alwasel SH, Tartaglia F, et al. A Randomized Pilot Study of Inositol in Association with Betaine and Boswellia in the Management of Mastalgia and Benign Breast Lump in Premenopausal Women. Breast Cancer (Auckl) 2016
  6. (PMID: 27127407) [Crossref] 6. Jaiswal G, Thakur GS. An alternative yogic approach for cyclical mastalgia-A narrative review. J Family Med Prim Care 2021
  7. (PMID: 34041048) [Crossref] 7. Faiz O, Fentiman IS. Management of breast pain. Int J Clin Pract. 2000
  8. (PMID: 10912311) [Crossref] 8. Dhar A, Srivastava A. Role of centchroman in regression of mastalgia and fibroadenoma. World J Surg 2007
  9. (PMID: 17431715) [Crossref] 9. Tejwani PL, Nerkar H, Dhar A, Kataria K, Hari S, Thulkar S, et al. Regression of Fibroadenomas with Centchroman: a Randomized Controlled Trial. Indian J Surg 2015
  10. (PMID: 26730050) [Crossref] 10. Rathi J, Chawla I, Singh K, Chawla A. Centchroman as First-line Treatment for Mastalgia: Results of an Open-label, Single-arm Trial. Breast J 2016
  11. (PMID: 27059808) [Crossref] 11. Kumar S, Rai R, Agarwal GG, Dwivedi V, Kumar S, Das V. A randomized, double-blind, placebo-controlled trial of ormeloxifene in breast pain and nodularity. Natl Med J India 2013
  12. (PMID: 24093978) [Crossref] 12. Tejwani PL, Srivastava A, Nerkar H, Dhar A, Hari S, Thulkar S, et al. Centchroman regresses mastalgia: a randomized comparison with danazol. Indian J Surg 2011
  13. (PMID: 22654331) [Crossref] 13. Barros AC, Mottola J, Ruiz CA, Borges MN, Pinotti JA. Reassurance in the Treatment of Mastalgia. Breast J 1999
  14. (PMID: 11348279) [Crossref] 14. Ngô C, Seror J, Chabbert-Buffet N. Syndrome douloureux mammaire: recommandations Breast pain: Recommendations. J Gynecol Obstet Biol Re