Abnormalities in Plasma Essential Fatty Acid Levels in Women with Premenstrual Syndrome and with Non-malignant Breast Disease

Horrobin, David F.; Manku, M.S.; Brush, M. G.; Callender, Kay; Preece, P. E.; Mansel, Robert Edward

doi:10.3109/13590849109084123

Cited by 8 publications

(4 citation statements)

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“…A very large (555 participants) and well-designed study failed to find GLA, with or without antioxidants, any more effective than placebo. [21][22][23][24] • GLA: Gamolenic acid is an essential polyunsaturated fatty acid [25][26][27] which is the main active component in evening primrose oil. In subjects with cyclical mastalgia low-plasma levels of GLA metabolites have been identified.…”

Section: Management (Graph 3)mentioning

confidence: 99%

A Prospective Study to study the Efficacy and Side Effects of Ormeloxifene in Regression of Mastalgia and Fibroadenoma: Is It the Ideal Drug?

Gupta¹

2016

Journal of South Asian Federation of Obstetrics and Gynaecology

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Ormeloxifene (Centchroman) is a novel nonsteroidal, selective estrogen receptor modulator birth control pill which has also been used recently for the treatment of mastalgia and fibroadenoma. Fibroadenomas are the most common benign breast tumors in women but worrisome for women fearing cancer. Mastalgia whether cyclic or noncyclic may be severely incapacitating for women. This study aims to analyze the effect of this new drug on the regression of mastalgia and fibroadenoma as an alternative to presently available steroid-based drugs with significant side effects. Materials and methods This was a prospective study involving 100 women of reproductive age group (up to 35 years of age) attending the outpatient department (OPD) in Malhotra Nursing Home, Agra and Rainbow Hospital Pvt Ltd., Agra, India, from August 2011 to August 2014, complaining of mastalgia and/ or fibroadenoma and fulfilling the inclusion criteria. After informed consent, these women were divided into a mastalgia group who had mastalgia with or without nodularity and a fibroadenoma group having sizes 1.5 to 2 cm, single or multiple in one or both breasts. Ormeloxifene 30 mg on alternate days was administered for 3 months in both the groups. Patients were followed at 1, 2, 4, 8, 12 and 24 weeks to assess response to therapy. Clinical examination, change in nodularity by palpation, breast lump size by ultrasonography, change in visual analog score (VAS) and breast tenderness were monitored. Results were analyzed using ‘t’ test. Results A total of 100 patients were included in this study. Eighty percent women belonged to the age group 25 to 35 years with a mean age of 28, 31.2 and 27.2 years in groups IA, IB and group B respectively. Mean interval between drug therapy and onset of response was 6 ± 2 days in mastalgia group and 15 ± 2 days in fibroadenoma group. 97.6 to 100% of women in the mastalgia group reported complete relief at 12 weeks of therapy with a decrease in VAS score from 10 to 3 in the first week of therapy itself while 28% of fibroadenoma group reported complete relief at 12 weeks of therapy, partial relief in 31% and equivocal response in 41%. Side effects observed were allergic rash development (2%) and a delay in menstruation of 7 to 10 days (14%) during therapy. Conclusion Ormeloxifene is a novel nonsteroidal drug found to be effective in treatment of mastalgia and partially in treatment of fibroadenoma in a short period of 3 months. As compared to the drugs presently in use namely danazol and bromocriptine, ormeloxifene is safer as suggested by its side-effect profile and is cost-effective too. There is need for prospective large randomized studies to compare this low-cost drug with the standard but costly drugs being prescribed at present. How to cite this article Gupta N. A Prospective Study to Study the Efficacy and Side Effects of Ormeloxifene in Regression of Mastalgia and Fibroadenoma: Is it the Ideal Drug? J South Asian Feder Obst Gynae 2016;8(1):48-56.

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Section: Management (Graph 3)mentioning

confidence: 99%

A Prospective Study to study the Efficacy and Side Effects of Ormeloxifene in Regression of Mastalgia and Fibroadenoma: Is It the Ideal Drug?

Gupta¹

2016

Journal of South Asian Federation of Obstetrics and Gynaecology

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“…GLA is an essential polyunsaturated fatty acid (PUFA), present in large quantities in evening primrose oil. Women with cyclical mastalgia have been shown to have low plasma levels of the metabolites of GLA and treatment with GLA corrects this biochemical deficiency and is accompanied by a clinical improvement in symptoms (4,5). However, PUFAs are highly susceptible to denaturation by oxidizing systems in the body (6).…”

mentioning

confidence: 99%

A Randomized Multicenter Study of Gamolenic Acid (Efamast) with and without Antioxidant Vitamins and Minerals in the Management of Mastalgia

Goyal

Mansel

2005

Breast Journal

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In a double-blind, placebo-controlled, parallel group, multicenter study, 555 women with moderate to severe mastalgia were randomized to one of the four treatment groups to receive (a) gamolenic acid (GLA) and antioxidants, (b) placebo fatty acids and antioxidants, (c) GLA and placebo antioxidants, or (d) placebo fatty acids and placebo antioxidants, for four menstrual cycles. This was followed by a further eight menstrual cycles of open treatment in which all patients received GLA, but continued to be randomized to active or placebo antioxidants as in the preceding parallel phase. Diary pain cards and linear analog charts were used for assessment of response. A reduction in breast pain was seen in all four treatment groups during the blinded treatment phase. There was a substantial improvement in the placebo fatty acids groups (response rate of 40%), and there were no significant differences among the four treatment groups. During the open treatment phase, a further reduction in breast pain was seen in all groups, with no statistically significant differences between groups. This study showed that GLA (Efamast) efficacy did not differ from that of placebo fatty acids, regardless of whether or not antioxidant vitamins were present.

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“…The GLA is believed to restore the saturated/unsaturated fatty acid balance and decrease sensitivity to steroidal hormones (7). In addition, it has been showed that in women with cyclic mastodynia who have low plasma levels of GLA, the replacement treatment was effective (15,16).…”

Section: Discussionmentioning

confidence: 99%

Vitamin E and Omega-3, 6 and 9 Combinations Versus Vitamin E in the Treatment of Mastodynia

Delfan

Zarei

Iravani

et al. 2015

Jundishapur J Nat Pharm Prod

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Background: Breast pain or mastodynia is moderate to severe pain, which affects around 22-41% of women. If no anomaly is found and other causes, like nutritional changes, are excluded, many drugs, including herbal supplements, are recommended for the treatment of mastodynia. Objectives: This study was performed to evaluate the effects of vitamin E and omega-3, 6 and 9 free fatty acids combinations versus Vitamin E in women with mastodynia. Patients and Methods: A double blind, randomized clinical trial was conducted in Shohada Ashayer Hospital in Khorramabad Lorestan province, in the vest of Iran. A total of 88 women with symptoms of mastodynia, aged between 20-55 years old, were divided to two groups. The patients were randomly assigned to receive vitamin E (400 U/day) and vitamin E (400 U/day) plus omega-3, 6 and 9 (1200 mg/day) orally, for 3 months. Results: Vitamin E plus omega free fatty acids are more effective than the use of vitamin E alone in decreasing mastodynia. Significant difference was seen between the Cardiff Breast Score (CBS) of the vitamin E group compared to vitamin E-omega group (P < 0.05) at the end of the first, second and third months after treatment. Conclusions: Our results showed that vitamin E plus omega free fatty acids decrease the severity of mastodynia better than vitamin E alone.

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Abnormalities in Plasma Essential Fatty Acid Levels in Women with Premenstrual Syndrome and with Non-malignant Breast Disease

Cited by 8 publications

References 10 publications

A Prospective Study to study the Efficacy and Side Effects of Ormeloxifene in Regression of Mastalgia and Fibroadenoma: Is It the Ideal Drug?

A Prospective Study to study the Efficacy and Side Effects of Ormeloxifene in Regression of Mastalgia and Fibroadenoma: Is It the Ideal Drug?

A Randomized Multicenter Study of Gamolenic Acid (Efamast) with and without Antioxidant Vitamins and Minerals in the Management of Mastalgia

Vitamin E and Omega-3, 6 and 9 Combinations Versus Vitamin E in the Treatment of Mastodynia

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