CELLMED (셀메드)

Cellmed Orthocellular Medicine and Pharmaceutical Association (셀메드 세포교정의약학회)
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A Randomized Comparative Study of Unani Formulations in Abnormal Uterine Bleeding due to Endometrial Hyperplasia

  • Abothu Suhasini (Department of Ilmul Qabalat wa Amraze Niswan (Gynaecology and Obstetrics), Govt. Nizamia Tibbi College) ;
  • Wasia Naveed (Department of Ilmul Qabalat wa Amraze Niswan (Gynaecology and Obstetrics), Govt. Nizamia Tibbi College) ;
  • Arshiya sultana (Department of Ilmul Qabalat wa Amraze Niswan (Gynaecology and Obstetrics), National Institute of Unani Medicine) ;
  • Shahzadi Sultana (In-Charge Principal & HoD, Department of Ilmul Qabalat wa Amraze Niswan (Gynaecology and Obstetrics), Govt. Nizamia Tibbi College)
  • Received : 2023.10.06
  • Accepted : 2023.11.22
  • Published : 2023.11.30
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Abstract

Objectives: To compare the efficacy of polyherbal Unani formulations in heavy menstrual bleeding due to endometrial hyperplasia. Methodology: A prospective, randomized comparative trial was conducted at Govt. Nizamia Tibbi College. Group A (n=20) received Itrifal Aftimoon 5g orally BID from menstruation day 3 to day 21 plus suprapubic Marham Dakhilyun application and per vaginally Marham Dakhilyun (5g) and Roghan Gul (10ml) application from menstruation day 5 to day 14. Group B (n=20) received Gulnar Farsi (2g), Phitakri Biryan (0.25g), Dammul Aqwain (0.25g), and Geru (2g), 2.5g powder orally BID, menstruation day 3 for 20 days plus Douche Bargh Sambhalu then Ḥamūl of Safuf Mazu (2g), Kalijiri (2g) and Roghan Gul (10ml) from menstruation day 3 to day 12 for 3 consecutive cycles. The primary outcome was pelvic ultrasound findings of endometrial thickness. The secondary outcome measures were improvement in haemoglobin percentage, change in menstrual flow and menstrual pattern. The level of significance was 5%. Results and conclusion: The intragroup comparison showed that the mean endometrial thickness at baseline and after treatment in groups A and B was extremely significantly different (P<0.0001). The intragroup comparison showed the mean haemoglobin percent at baseline and after treatment in group, A was significantly different (P<0.0001). After treatment, 50% and 60% of participants had normal duration and menstrual blood loss after treatment from baseline in Groups A and B respectively. However, further, phase II and III randomized standard controlled trials in larger samples are recommended to assess the efficacy of these group medicines.

Keywords

Acknowledgement

The authors are thankful to the patients and staff of Govt. Nizamia Tibbi College for their support in carrying out this work.

References

  1. Chandra V, Kim JJ, Benbrook DM, Dwivedi A, Rai R. Therapeutic options for management of endometrial hyperplasia. J Gynecol Oncol 27, 1-25 (2016).  https://doi.org/10.3802/jgo.2016.27.e8
  2. Sajitha K, Padma SK, K JS, Hl KP, Permi HS, Hegde P. Study of histopathological patterns of endometrium in abnormal uterine bleeding. CHRISMED J Heal Res 1, 76-81 (2014).  https://doi.org/10.4103/2348-3334.134265
  3. Goldstein SR. Menorrhagia and abnormal bleeding before the menopause. Best Pract Res Clin Obs Gynecol 18, 59-69 (2004).  https://doi.org/10.1016/j.bpobgyn.2003.10.003
  4. Sanderson PA, Critchley HOD, Williams ARW, Arends MJ, Saunders PTK. New concepts for an old problem : the diagnosis of endometrial hyperplasia. Hum Reprod Update 23, 232-54 (2017). 
  5. Preethi RKS. Analysis of clinical and histomorphological features of endometrium in abnormal uterine bleeding- e with special stain application. Dr MGR Medical University [Dissertation]; 2020. 
  6. Khan A. Iksir-i-A'zam. (Idarae Kitabus Shifa: New Delhi, 2011) 781-6 p. 
  7. Qarshi M. Jamu al-Hikmat. (Idarae Kitabus Shifa New Delhi, 2011) 1121-23 p. 
  8. Anonymous. Govt. Unani Pharmacopoeia. (Govt. Central Press: Andhra Pradesh, 1988) 62, 64 p. 
  9. Ghani, N. Khazainul Advia. (Idarae Kitabus Shifa New Delhi, YNM) 999-1002 p. 
  10. Giri SK, Nayak BL, Mohapatra J. Thickened Endometrium : When to Intervene ? A Clinical Conundrum. J Obstet Gynecol India 71, 216-25 (2021).  https://doi.org/10.1007/s13224-020-01415-4
  11. Fraser, I. S.; Mc Carron G. Randomized trial of 2 hormonal and 2 prostaglandin- inhibiting agents in women with a complaint of menorrhagia. Aust N Z J Obs Gynaecol (1991) 31(1):66-70.  https://doi.org/10.1111/j.1479-828X.1991.tb02769.x
  12. Fathima A, Sultana A. Clinical efficacy of a Unani formulation "Safoof Habis" in menorrhagia: Arandomized controlled trial. Eur J Integr Med 4, (2012). 
  13. Sina I. Al-Qanun fi'l Tibb. (Idarae Kitabus Shifa New Delhi, 2010) 1095 p. 
  14. Khare CP. Indian Medicinal Plants: An Illustrated Dictionary (Google eBook) [Internet]. (Springer:Berlin Heidelberg 2007). 900 p. Available from: http://books.google.com/books?id=gMwLwbUwtfkC&pgis=1 
  15. Nadkarni KM. Indian plants and drugs. (Srishti Book Distributors: New Delhi, 2004). 9,10,11,311,312 p. 
  16. Kirtikar and Basu B. Indian Medicinal Plants. Vol I. 2nd ed. (International Book Distributors Dehradun, 2012) 1289-92 p. 
  17. De Jesus NZ, Falcao HS, Gomes, IF, Leite TJA. LG, Barbosa-Filho JM, Tavares JF, Silva MS AF, PF BL. Tannins, peptic ulcers and related mechanisms. Int J Mol Sci 13, 3203-28 (2012).  https://doi.org/10.3390/ijms13033203
  18. Mandal A, Bhatia D, Bishayee A. Anti-Inflammatory mechanism involved in pomegranate-mediated prevention of breast cancer. Nutrients 436, 1-13 (2017). 
  19. Kim ND, Mehta R, Yu W, Neeman I, Livney T, Poirier D, et al. Chemopreventive and adjuvant therapeutic potential of pomegranate ( Punica granatum ) for human breast cancer. Breast Cancer Res Treat 71, 203-17 (2002).  https://doi.org/10.1023/A:1014405730585
  20. Sturgeon, S.R.; Ronnenberg AG. Pomegranate and breast cancer: Possible mechanisms of prevention. Nutr Rev 68, 122-128 (2010).  https://doi.org/10.1111/j.1753-4887.2009.00268.x
  21. Jivrajani M, Ravat N, Anandjiwala S, Nivsarkar M. Antiestrogenic and anti-inflammatory potential of n -hexane fraction of Vitex negundo linn leaf extract : a probable mechanism for blastocyst implantation failure in Mus musculus. International Scholarly Research Notices 2014 (2014). 
  22. Mahboubi M. Quercus infectoria fruit hulls and galls and female genital disorders. Clin Phytoscience 6, 1-6 (2020).  https://doi.org/10.1186/s40816-020-00194-9
  23. Sultana Arshiya; Rahman Khaleequr; MUZN Farzana\;Farzana\; Mudarsang (Plumbi oxidum): A Mineral with medicinal properties. Ayurveda Sameekshawa 2, 11-5 (2013). 
  24. Gibson DA SP. Estrogen dependent signaling in reproductive tissues - a role for estrogen receptors and estrogen related receptors. Mol Cell Endocrinol 348, 361-372 (2012).  https://doi.org/10.1016/j.mce.2011.09.026
  25. Yamashita Y, Kawada S NH. Induction of mammalian topoisomerase II dependent DNA cleavage by nonintercalative flavonoids, genistein and orobol. Biochem Pharmacol 39,737-44 (1990).  https://doi.org/10.1016/0006-2952(90)90153-C
  26. Lian Z, Niwa K, Tagami K, Hashimoto M, Gao J, Yokoyama Y et al. Preventive effects of isoflavones, genistein and daidzein, on estradiol-17 beta-related endometrial carcinogenesis in mice. Jpn J Cancer Res 92, 726-34 (2001).  https://doi.org/10.1111/j.1349-7006.2001.tb01154.x
  27. Hussain T, Murtaza G, Metwally E, Kalhoro DH, Kalhoro MS, Rahu BA, et al. The role of oxidative stress and antioxidant balance in pregnancy. Mediators Inflamm 2021, (2021). 
  28. Agnieszka, G, Skrzydlewska E. Antioxidative and anti-inflammatory activity of ascorbic acid. Antioxidants 11, (2022). 
  29. Safari VZ, Kamau JK, Nthiga PM, Ngugi MP, Orinda G, Njagi EM. Antipyretic, antiinflammatory and antinociceptive activities of aqueous bark extract of Acacia nilotica (L.) Delile in Albino Mice. J Pain Manag Med 02, (2016). 
  30. Abdulhamid A, Sani I, Kankiya IH, Fakai IM. Phytochemical Screening, Analgesic effect and anti-inflammatory activity of crude methanolic stem bark extract of Acacia nilotica (Linn.). Asian J Biol Sci 12, 450-6 (2019).  https://doi.org/10.3923/ajbs.2019.450.456
  31. Baria AH, Patel RP, Suthar AM PR. Formulation development and evaluation of sustained release aceclofenac suppository. Int J Pharm Sci Drug Res 1, 71-3 (2009). 
  32. Ansari S, Zeenat F, Ahmad W, Ahmad I, Syed Ziaul Hasan Govt H. Therapeutics and pharmacology of Gul-e-Surkh (Rosa damascena Mill): An important Unani drug. Int J Adv Pharm Med Bioallied Sci 5, 195-205 (2017). 
  33. Afrin Z, Siddiqui A, Jafri MA, Vohora D, Asif M. Preliminary screening of a classical unani formulation Majoon Najah for anticonvulsant activity. Int J Pharm Res 11, 142-53 (2019) 
  34. Bansod M. Vitex negundo L : Phytochemical constituents , traditional uses and pharmacological properties: Comprehensive Review Pharmacologyonline 1 : 286-302 ( 2009 ) Newsletter Bansod and Harle. 2016;(January 2009). 
  35. Bonaterra GA, Bronischewski K, Hunold P, Schwarzbach H, Heinrich EU, Fink C, et al. Anti-inflammatory and Anti-oxidative Effects of Phytohustil® and Root Extract of Althaea officinalis L. on Macrophages in vitro. Front Pharmacol 11, 1-14 (2020).  https://doi.org/10.3389/fphar.2020.00001
  36. Al-Snafi AE. The Pharmaceutical importance of Althaea officinalis and Althaea rosea: A review. Int J PharmTech Res 5, 1378-85 (2013). 
  37. Shaygannia E, Bahmani M, Zamanzad B, Rafieian-Kopaei M. A review study on Punica granatum L. J Evid Based Complementary Altern Med 21, 2016 
  38. Kotagasti T. Efficacy of Geru (red ochre) in controlling the bleeding in patients of adolescent menorrhagia. TANG [Humanitas Med] 5, 12.1-12.3. (2015).  https://doi.org/10.5667/tang.2015.0002
  39. Bartels DA, Johnson R, Bayor MT, Ainooson GK, Ossei PPS, Etuaful RK, et al. Formulation of Suppositories of Alum Produced from Bauxite Waste in Ghana for the Treatment of Hemorrhoid. Sci World J 2021; 2021. 
  40. Seo H sik. An Experimental Study of the Antioxidant and the anti-inflammatory effects of alumand burnt alum. J Pharmacopuncture 15, 11-4 (2012).  https://doi.org/10.3831/KPI.2012.15.2.011
  41. Wen Y, Shi Y. Alum: an old dog with new tricks. Emerg Microbes Infect 5, 1-5 (2016).  https://doi.org/10.1038/emi.2016.40
  42. Al-Fatimi M. Ethnobotanical survey of Dracaena cinnabari and investigation of the pharmacognostical properties, antifungal and antioxidant activity of its resin. Plants 7, 1-13 (2018).  https://doi.org/10.3390/plants7040091
  43. Naveed W, Shameem I, Tabassum K. Clinical Study of mutlazima qabl haiz (premenstrual syndrome) and its management with Unani formulation - a randomized controlled trial. Int J Cur Res Rev 6, 51-7 (2014). 
  44. Forouzanfar F, Fazly Bazzaz BS, Hosseinzadeh H. Black cumin (Nigella sativa) and its constituent (thymoquinone): A review on antimicrobial effects. Iran J Basic Med Sci17, 929-38 (2014). 
  45. Boskabady MH, Shafei MN, Saberi Z, Amini S. Pharmacological effects of Rosa damascena. Iran J Basic Med Sci 14, 295-37 (2011). 
  46. Sultana A, Rahman K, Begum M, Rahman S. Views of Ibn Sina (Avicenna) on ifraat haiz (Menorrhagia). J Int Soc Hist Islam Med (JISHIM) (2011-2012).