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Print ISSN : 2231-7007      Online ISSN : 2462-246X


EFFECTS OF THE EVENING PRIMROSE OIL ON WOMEN'S MASTALGIA: A SYSTEMATIC REVIEW OF RANDOMIZED CONTROLLED TRIALS

Volume-9, Issue 2, 2017, Pages 28 - 35

Khadijeh Sarayloo ; Khadigeh Mirzaii Najmabadi ; Masoomeh Ghazanfarpour ;

Department of Midwifery, School of Nursing and Midwifery, Mashhad University of Medical Sciences, Mashhad, Iran

Abstract :

Paying attention to women's health is important. The majority of women usually suffer from mastalgia. Herbal medicine is more compatible with human body and has fewer side effects because the drugs are natural. Evening Primrose Oil is a novel treatment for the relief of cyclic (premenstrual) and non-cyclic breast pain. The aim of the review is to assess the efficacy of evening prime rose oil (EPO) on mastalgia. Electronic databases (Google scholar, PubMed, Scopus, the Cochrane Library, SID, Iran Medex, Magiran, Medlib and Irandoc) were searched from 1990 up to January 2015 for published randomized controlled Trials (RCTs). Only randomized controlled trials involving Evening Primrose Oil and other drugs agents for mastalgia were included. Background information of the study, participants’ characteristics, and study outcomes were collected out of 143 relevant publication trials, 10 RCTs met the inclusion criteria. Evening Primrose oil showed beneficial effects on Mastalgia in comparison with other drugs used for treatment, which had side effects. It seems that evening Primrose oil can be first line of treatment in mild mastalgia without any side effects. However, efficacy of EPO for moderate to severe mastalgia remains doubtful. Therefore, further studies are required to improve our understanding of management of patients with symptoms of mastalgia.

Keywords : Evening Primrose Oil, Randomized controlled trials, Mastalgia

Introduction :

Mastalgia or breast pain is the most common symptom among patients visiting the breast clinic (Mansel et al., 2004). The majority of women usually suffer from mastalgia. It may occur at monthly intervals (cyclical) or may not follow any patterns (noncyclical). A cyclic pain is the most common type of breast pain. It may be caused by normal monthly changes in hormones (Rosolowich et al., 2006) and has been reported in 50% of women who visit surgical clinics for breast symptoms (Hughes, Mansel & Webster, 1989). The management of mastalgia consists of classification into various patterns, re-assurance, drug therapy in severe cases and, rarely, surgery. Differentiation of cyclical and non cyclical pattern on a simple pain chart is useful for objective assessment of pain severity, selection of approved drug therapy, and subsequent monitoring of response is necessary (Maddox & Mansel 1981). A large number of agents have tried for the treatment of cyclical and non-cyclical breast pain. Since drugs had side effects, people became interested in herbal medicine used in mastalgia which are non-steroidal anti-inflammatory gels, iodides and plant derivatives like Evening Primrose Oil (EPO). There is a considerable debate about the choice of best agent for initial management of mastalgia (Halaska et al., 1999).  

EPO is omega-fatty-acid-rich oil containing both linolenic acid (LA) and gamma-linolenic acid (GCA). EPO contains 74% linoleic acid, 11% oleic acid, 6% palmitic acid, 2% stearic acid and 9% GLA (Maddox, 1981). According to research, women with breast pain have low levels of gamma-linolenic acid (GLA) and its metabolites dihomogammalinolenic acid and arachidonic acid. Efamol Pure Evening Primrose Oil contains GLA-gamma-linolenic acid. Treatment with Efamol Pure Evening Primrose Oil raises levels of GLA and its metabolites towards normal and probably relieves breast pain by attenuating the effects of ovarian hormones and prolactin without changing their levels in blood (Horrobin & Manku, 1989). It seems that Pure Efamol Evening Primrose Oil is a novel treatment for the relief of cyclic (premenstrual) and non-cyclic breast pain (Mansel, 1990). Many discussions have already taken place about the choice of best agent for initial management of mastalgia. So far no systematic review has evaluated the effects of EPO on mastalgia, except a meta-analysis by Srivastava et al., (2007). He conducted a meta-analysis on randomized controlled trials comparing Bromocriptine, Danazol, Evening primrose oil (EPO) and Tamoxifen with placebo on mastalgia. This meta-analysis consisted 8 articles and the part related to EPO was updated. Therefore this review has been done to investigate published randomized trials of EPO which is used in the treatment of mastalgia. The result of this study indicates that Bromocriptine, Danazol and Tamoxifen all offer significant relief from mastalgia. Reliable data regarding direct comparison of above medicine is not available. Tamoxifen is associated with least side effects, so it should be the drug of first choice. According to Srivastava et al., (2007), EPO is ineffective and should not be used. Moreover it must be noted that breast pain may or may not be related to menstruation or hormone use. As, the most women experience breast pain and tenderness before their menstruation or after hormone use, this review focused on mastalgia accompanied with menstrual or hormone use. Since it was more commonly observed in women and no systematic review had been conducted on the effects of EPO on mastalgia, therefore the aim of this study is to assess the efficacy of Evening Primrose Oil (EPO) on mastalgia.

Research Methodology :

Study selection:

Studies which met the following criteria were included in the systematic review:

  1. Randomised Controlled Trials (RCTs)
  2.  Evaluating efficacy of Evening Primrose Oil (EPO) on mastalgia

Trials on agents other than EPO were excluded.

Data extraction

For each study, the authors extracted the following data according to a pre-defined first author, year of publication, age of participants, study design, study duration, and sample size. In crossover trials the result on initial phase (i.e. before cross-over) was used for the analysis of reports.

Methodological quality assessment:

The quality of randomized controlled trials was independently assessed by two authors using Oxford Centre for Evidence- Based Medicine Checklist for RCTs quality.

Results : Search results:

The search of the electronic databases identified 143 articles for screening. A total of 10 papers met the inclusion criteria. The process of the search and selection of RCTs is described in Figure 1.


Figure 1. Search strategy of thestudy

Characteristics of the selectedstudies:

A total of 143 studies wereidentified. About 120 studies were excluded because the titles and abstractswere not relevant to our systematic review and 10 studies were included in thesystematic review. Quantitative analysis was carried out to determine theeffect on mastalgia. The characteristics of the selected studies are summarizedin Table I.

Table 1 Summary of trials of fouron EPO vs. placebo

Age of participants

Study design

Treatment duration(month)

Drop out%

Randomization technique

Treatment Blinding

 Type of Intervention N=

 Type of control N=

Cyclic and non-cyclic mastalgia

conclusion

Blommers et al . Nederland (2002)

37

 RCTS (parallel

factorial)

6

10 %

Yes

Double-blind

evening

primrose oil

N=30

Fish oil

N=30

Cyclic

All groups showed a decrease in pain. Neither Evening Primrose Oil (P = .73);nor fish oil (P = .28) offered clear benefit over control oils in the treatment of mastalgia.

Colling et al. Sweden 1993

 

30-45

RCTS

(Crossover)

10

28

Yes

double-blind,

Evening primrose oil

N=27

Placebo(paraffin oil)N=22

Cyclic

Treatment with essential fatty acids is ineffective tharapy for PMS.

No statistically significant differences between groups (p > 0.05).

Fathizadeh et al,Iran,2008

18-40

RCTS

(semi-experimental study)

3

7.5

Yes

single-blind

Evening primrose oil

N=31

 

Vitamin E

N=30

Cyclic

Evening Primrose Oil decrease the severity of pain and it is more effective and better than the known and common vitamin E medicine  (p < 0.001).

Gateley et al, CARDIFF-UK (1992)

 

RCTS

4

 

15 %

NO

No blinding

 

Evening

primrose oil 

N=85

 

Danazol:N=145

Bromocriptine:

N=94

Cyclic

Overall 92% of patients with cyclical mastalgia and 64% of patients with non-cyclical mastalgia can obtain a clinically

useful response using a combination of danazol, bromocriptine or Evening Primrose Oil. unless the severity of symptoms requires a rapid response, Evening Primrose Oil should be considered as first line treatment

Goyal and

Mansel. UK.2005

18-55

RCTS

(parallel, multicenter study)

8

-

Yes

double-blind,

4 arm

multicentre

555 women in44 centres

placebo-controlled

non-cyclic

Gamolenic acid was not shown to be superior to placebo. (P = .850 in blinded phase (P = .217)in open phase).

 GLA was shown to be safe in long-term use.

Katiyar et al, Singhpur, (2012)

15  – 55

 

RCTS

(Crossover)

12

23 %

NO

No blinding

Evening Primrose Oil  N=26   

 IN CYCLICAL MASTALGIA, N=12

IN NON CYCLICAL MASTALGIA

 

 

danazol N=37

Tamoxifen N=24

Bromocriptine

N= 19

Cyclic

Danazol seems to be best available drug for both cyclical and non cyclical mastalgia. However, Tamoxifen approaches the same efficacy in both groups; in fact it has a better response in non cyclical mastalgia group. EPO is better drug for young and for women who do not want their period to be disturbed.

 Mohammed K Mohammed, Iraq,2010

17-48

RCTS

 

3

-

NO

No blinding

Group1 (Evening Primrose Oil)

N=35

Group2 (Diclofenac Sodium (Olfen) N=35

non-cyclic

Topical NSAI Diclofenac Sodium gel is safe, relatively quick in action with reliable patient compliance and compares favourably with an established recommended first-line treatment for mastalgia; namely EPO.

(P- value= 0.000001 )

Sughra  Parveen et al,2007

18-35

An open, non-randomized, comparative study

3

-

NO

No blinding

Evening primrose oil

N=50

 

danazol       N=50

non-cyclic

Danazol offers good pain control in mastalgia but with distressing side effects, where as Oil of Evening Primrose (OEP) also showed good pain control but without much distressing side effects.

Pruthi et al. USA (2010)

 40

RCTS

6

51 %

Yes

Double-blind

evening

primrose oil 

N=11

 

Vitamin E N=11

Vitamin E+EPO N=9

Cyclic

Vitamin E, EPO , and EPO in combination with vitamin E may improve cyclical mastalgia. (EPO:P=0.18,VIT E:P=0.10, EPO+VIT E: P= 0.16)

Thakur et al. Srinagar. (2009)

17-40

prospective study ,

6

12.35

NO

No blinding

Evening Primrose Oil

N=89

 

-

Cyclic

Cap. Evening Primrose oil can be used as first line of treatment in mild to moderate mastalgia; however, its efficacy for moderate to severe mastalgia remains doubtful.