31.9.41 Assessment of the Effect of Evening Primrose Oil Therapy in the Management of Breast Fibroadenoma

Original Article

 

Effect of Primrose Oil in  Breast Fibroadenoma  

Assessment of the Effect of Evening Primrose Oil Therapy in the Management of Breast Fibroadenoma

Shamaila Ayub1, Yabinda Sahrish2, Omer Bin Khalid Jamil1, Aafia Maqsood3, Summaya Saeed3 and Aun Ali Khowaja1

ABSTRACT

Objective: To assess the effect of evening primrose oil usage on reduction in size of breast fibroadenoma in Pakistani female population.

Study Design: Experimental study.

Place and Duration of Study: This study was conducted at the Quasi experimental study conducted at Creek General Hospital Karachi during February 2018 to March 2020.

Materials and Methods: One hundred and eighty females with fibroadenoma as in breasts were administered evening primrose oil daily for 6 months. Pre therapy and post therapy size of the fibroadenoma was compared via ultrasound. The finding of ultrasound and lab investigation and demographic record was entered in design Performa. Written informed consent was taken before history and examination. The permission of Ethical Committee was taken before start of study and get publishing in Medical Journal. The data was analyzed for results by SPSS
version 27.

Results: A total of 180 patients were able to complete the trial. There was no decrease in the size of fibroadenoma after therapy.

Conclusion: Evening primrose oil has no established role in management of breast fibroadenoma.

Key Words: Evening primrose oil, Fibroadenoma, Breast neoplasms.

Citation of article: Assessment of the effect of Evening primrose oil therapy in the management of breast Fibroadenoma. Med Forum 2020;31(9):178-180.

 

 

INTRODUCTION

Evening primrose oil is herbal medication extracted from seeds of a medicinal plant Oenothera biennis1.Evening primrose oil contains linoleic acid,
γ -linoleic acid, stearic acid, oleic acid, palmitic acid, and steroids campesterol and β-sitosterol. The basic indications of evening primrose oil described in literature are mastalgia2,3 and atopic dermatitis4. Evening primrose oil is rich in essential fatty acids which decreases the effect of estrogen on breast tissueand therefore help alleviating the mastalgia associated with menstrual cycle5.

 

 

1. Department of Surgery, United Medical & Dental College, Creek General Hospital, Karachi.

2. Department of General Surgery, Liaquat College of Medicine and Dentistry, Karachi.

3. Department of Surgery, Civil Hospital, Karachi.

 

 

Correspondence: Dr. Shamaila Ayub, Assistant Professor of Surgery, United Medical & Dental College, Creek General Hospital, Karachi.

Contact No: 0333-3756359

Email: drshama_ilaayub@hotmail.com

 

 

Received:    June, 2020

Accepted:    August, 2020

Printed:        September, 2020

 

 

 

 

 

 

Fibroadenoma is a fairly common disorder of the breast with a reported incidence of 25% in asymptomatic women6. A local study showed that 45% of women presenting to clinic with history of breast lump had fibroadenoma7. Being a benign pathology most fibroadenomas are left alone without treatment, surgical resection is the most common intervention carried out if lump become enlarged, suspicious or if patient desires8. Other treatment modalities include cryoablation9, and high intensity focused ultrasound10. Fibroadenomas are found to have estrogen receptors and may lead to periodic growth of these swellings11. Evening primrose oil may have a beneficial role in this context on fibroadenoma and hence preventing its further growth or even reduction in size. Our study evaluates the same hypothesis after administration of oral evening primrose oil for 6 months in female patients with fibroadenomas.

MATERIALS AND METHODS

This research was conducted under full accordance with the declaration of Helsinki. All the patients were kept anonymous, and data utilized only after obtaining informed consent.

This was a Quasi experimental study conducted at Creek General Hospital Karachi between February 2018 to March 2020. Approval from ethical review board was taken, and patients were enrolled in the trial only after obtaining informed consent. All females presenting with breast fibroadenoma of size 5 cm or less (confirmed on ultrasound) were for non-surgical management were included in the study.

Inclusion criteria

All females between the age of 16 and 45 years presenting with breast fibroadenoma of size 5 cm or less (confirmed on ultrasound) who were selected for non-surgical management were included in the study.

Exclusion criteria

-           Age less than 16 years or more than 45 years

-           Multiple swellings in breasts or bilateral         swellings

-           Patients having menstrual irregularities

-           Pregnancy and lactation

-           Post-menopausal females with fibroadenoma

-           Any comorbidities such as diabetes or           hypertension

-           Patients on oral contraceptives

All patients underwent ultrasound examination of breasts before commencing evening primrose oil therapy and size of the fibroadenoma was recorded. Patients were then prescribed evening primrose oil4gm orally daily in divided dose for the period of 6 months. After the completion of therapy, a repeat ultrasound was carried out to assess the response of evening primrose oil. Paired t test was used to compare the significance of difference between the size reduction. The data was analyzed for results by SPSS version 27.

RESULTS

A total of 218 patients enrolled in the trial initially, however only 180 patients were available that were eligible for analysis. Out of the 38 dropped patients, 16 (42.10%) opted out for surgical excision, 8 (21.05%) patients had discontinued therapy on their own, 4(10.52%) patients conceived pregnancy and the remaining 10 (26.31%) patients were lost to follow up.

The average size as noted on ultrasound prior to administering evening primrose oil was 2.76 cm (see figure – I). All of the patients had noticed the swelling as an incidental finding in duration of 8 months or less. Most of these patients had no pain associated with the swelling. Thirty percent (30%) of the ladies reported that they have taken self-medication (mostly multivitamins) in the past (see Table – I).

Table No.1: Patient data and comparison of size of the swelling 

Patient Characteristic

Value (N = 180)

Age

26.33±7.9 years

Weight

69.0±8.70 kg

BMI

23.6 ± 3.2 kg/m²

Duration of swelling

11.12±7.09 weeks

Pre-therapy size

2.77±0.86 cm

P = 0.531*

Post-therapy size

2.71±0.74 cm

* = Paired t test

Figure No.1: Some history queries of the patients included in the study

No decrease in size of swelling was noted at the end of evening primrose oil therapy (P=0.531), in fact there were 21(11.66%) cases where there was increase in size of the swelling and 3(1.66%) case where a new swelling was noted in the same breast.

DISCUSSION

Fibroadenoma is the most common diagnosis in females presenting to surgical clinics with palpable breast masses12. Although significant number of these females experience uncertainty and anxiety prior to the definitive diagnosis because of dread of having malignancy13, most after diagnosis of benign disease opt for conservative management as theyare also afraid of cosmetic disfigurement and scar formation14. Although two thirds of fibroadenomas tend to resolve within five years without any sequelae15, medical treatment have been tried to manage these swellings. Danazol has been used in treatment of fibroadenoma but with disappointing results16.

Evening primrose oil has been used in treatment of various disorders such as mastalgia, attention deficit hyperactivity disorder, osteoporosis, rheumatoid arthritis, hypertension, diabetic neuropathy and weight loss17. Via animal trials evening primrose oil has also been found to be effective as an anticoagulant and anti-platelet agent18,19. Evening primrose oil although found to reduce the effect of estrogen on breast tissue11, in our study it showed no value in significant reduction in size or resolution of fibroadenoma. The reason why evening primrose oil was not able to reduce estrogen regulated growth of fibroadenoma is unclear and needs to be confirmed via conducting more scientific trials.

Our study was initially targeted for a study group that would be more than 500 patients but due to large number of drop outs and no ambiguity in the obtained results from study, we concluded our study early. Similar study has been done in international literature by Kollias J. et al20. Their study had a prospective comparative design which is better than ours but their study inclusion and exclusion criteria were not well defined. No exclusion of patients on oral contraceptives, any other hormonal therapy or any other comorbidities is mentioned. This may have affected the outcome of their study however their results also showed no benefit of evening primrose oil use for fibroadenoma.

CONCLUSION

Evening primrose oil although used frequently in cyclical mastalgia patients with good results, it has no role in medical management of breast fibroadenoma patients.

Author’s Contribution:

Concept & Design of Study:

Shamaila Ayub

Drafting:

Yabinda Sahrish, Omer bin Khalid Jamil

Data Analysis:

Aafia Maqsood, Summaya Saeed, Aun Ali Khowaja

Revisiting Critically:

Shamaila Ayub, Yabinda Sahrish

Final Approval of version:

Shamaila Ayub

Conflict of Interest: The study has no conflict of interest to declare by any author.

REFERENCES

1.      Blumenthal M, Brinckmann J, Wollschlaeger B. The ABC Clinical Guide to Herbs. Austin, Tex: American Botanical Council; 2003.

2.      Pruthi S, Wahner-Roedler DL, Torkelson CJ, Cha SS, Thicke LS, Hazelton JH, Bauer BA. Vitamin E and evening primrose oil for management of cyclical mastalgia: a randomized pilot study. Altern Med Rev 2010;15(1):59-67.

3.      Asma Muhammad Hanif, Shahid Rasool, Muhammad Tariq Abdullah, Asadullah Khan. Presentation management and outcome of Mastalgia. J Surg Pak 2005;10(4):15-7.

4.      Williams HC. Evening primrose oil for atopic dermatitis. BMJ 2003;27(7428):1358–1359.

5.      Gateley CA, Maddox PR, Pritchard GA, Sheridan W, Harrison BJ, Pye JK, Webster DJ, Hughes LE, Mansel RE. Plasma fatty acid profiles in benign breast disorders. Br J Surg 1992;79(5):407-9.

6.      El-Wakeel H, Umpleby HC. Systematic review of fibroadenoma as a risk factor for breast cancer. Breast 2003;12(5):302-307.

7.      Ali K, Abbas MH, Aslam S, Aslam M, Abid KJ, Khan AZ. Frequency of benign breast diseases in female patients presenting with breast lumps - a study at Sir Ganga Ram Hospital, Lahore. Annals KEMU 2016;11(4).

8.      Sainsbury RC. The breast. In: Williams NS, O’Connell PR, McCaskie AW, editors. Bailey and Love’s Short Practice of Surgery. 27th ed. Boca Raton FL: CRC Press;2017. p. 870.

9.      Kaufman CS, Littrup PJ, Freeman-Gibb LA, et al. Office-based cryoablation of breast fibroadenomas with long-term follow-up. Breast J 2005;11(5):344-350.

10.  Imankulov S, Tuganbekov T, Razbadauskas A, Seidagaliyeva Z. HIFU treatment for fibroadenoma - a clinical study at National Scientific Research Centre, Astana, Kazakhstan. J Pak Med Assoc 2018;68(9):1378-1380.

11.  Nardelli GB, Lamaina V, Siliotti F. Steroid receptors in benign breast disease, gross cystic disease and fibroadenomas. Clin Exper Obstet Gynaecol 1987;14:10–15.

12.  Amr SS, Sa'di AR, Ilahi F, Sheikh SS. The spectrum of breast diseases in Saudi Arab females: A 26 year pathological survey at Dhahran Health Center. Ann Saudi Med 1995;15(2):125-32.

13.  Liao, Chen, Miin-Fu, Chen, Shin-Cheh. MPH Uncertainty and Anxiety During the Diagnostic Period for Women With Suspected Breast Cancer, Cancer Nursing 2008;31(4):274-283.

14.  Ajmal M, Van Fossen K. Breast Fibroadenoma. 2019 Nov 11. Stat Pearls [Internet]. Treasure Island (FL): Stat Pearls Publishing;2019.

15.  Carty NS, Carter C, Rubin C, Ravichandran D. Management of fibroadenoma of the breast. Ann R Coll Surg Engl 1995;77:127–30.

16.  Gateley C A, Maddox P R, Courtney S P, Mansell R E. The effect of danazol on discrete benign breast lumps. J R Coll Surg Edin 1995;40:371–373.

17.  Stonemetz D. A review of the clinical efficacy of evening primrose. Holist Nurs Pract 2008;22(3):171-4.

18.  Riaz A, Khan RA, Ahmed SP. Assessment of anticoagulant effect of evening primrose oil. Pak J Pharm Sci 2009;22(4):355-359.

19.  Abo-Gresha NM, Abel-Aziz EZ, Greish SM. Evening primrose oil ameliorates platelet aggregation and improves cardiac recovery in myocardial-infarct hypercholesterolemic rats. Int J Physiol Pathophysiol Pharmacol 2014;6(1):23-36.

20.  Kollias J, Macmillan RD, Sibbering DM, Burrell H, Robertson JF. Effect of evening primrose oil on clinically diagnosed fibroadenomas. Breast 2000; 9(1):35-6.