Table 2. Clinical trials on evening primrose oil (EPO) in management of mastalgia.
Trial/ailments | Intervention | Results |
---|---|---|
Prospective clinical trial [18] | 6 EPO capsule (240 mg/d GLA) | Overal response 97% |
For 6 mo | ||
Double blind placebo controlled parallel multicenter clinical trial (n = 555) [21] | 4 g daily EPO plus antioxidant, EPO plus placebo antioxidant, placebo EPO plus antioxidant, placebo EPO plus placebo antioxidant | No effectiveness of EPO in mastalgia |
Randomized double blind [24] | Piroxicam gel 0.5%, twice a day or 1 g daily EPO | Piroxicam gel: excellent response (56%), substantial response (35%), poor response (8%) |
For 3 mo | EPO capsule: substantial response (64%), poor response (32%) | |
Open non-randomized comparative clinical study [15] | 1 g EPO/d, 100 mg danazol | Excellent response |
For 3 mo | 4 wk (36% vs. 44%) | |
12 wk (68% vs. 76%) | ||
Adverse effects (20% vs. 24%) | ||
Randomized clinical study [20] | 5 mg/d bromocriptine plus 2 g/d EPO (n = 36), LILT (n = 40) | Response to treatment |
63.9% vs. 82.5% | ||
Single-blind clinical study [16] | 3 g EPO/d (n = 31), 600 mg vitamin E (n = 30) | Reduction in pain severity |
For 1 mo | 61.3% vs. 26.7% | |
Double-blind randomized placebo controlled trial [17] | 1,200 IU vitamin E (n = 21), 3 g/d EPO (n = 21), vitamin E + EPO (n = 21), placebo (n = 22) | No significant effect |
For 6 mo | ||
Double-blind randomized placebo controlled trial [19] | 2 g/d EPO (n = 25), 400 IU vitamin E, EPO plus vitamin E, placebo | A significant difference between intervention groups with placebo |
For 6 mo | ||
Double-blind randomized placebo controlled trial, cyclical mastalgia [26] | 2 g/d EPO (n = 86) | 23% vs. 68% response to treatment |
Centchroman (n = 67) | ||
A randomized, double-blind factorial controlled trial [22] | 3 g; 1) fish oil- control oil, 2) EPO–control oil, 3) fish oil–EPO, 4) both control oils (wheat germ oil plus corn oil) | No priority of EPO or fish oil than that of wheat germ oil or corn oil in treatment of mastalgia |
GLA: γ-linolenic acid, LILT: low-intensity laser therapy.