A Double-Blind Placebo Controlled Trial of Efamol Marine on Skin and Joint Symptoms of Psoriatic Arthritis

Abstract

Fish oil may be beneficial in the treatment of psoriasis and in RA. We examined the potential benefit of Efamol Marine, a combination of evening primrose oil and fish oil in the treatment of 38 patients with PsA. Patients with PsA were entered in a double-blind placebo controlled study and received either 12 Efamol Marine capsules or 12 placebo capsules daily for 9 months. All patients received placebo capsules for a further 3 months. At month 3 of the study patients were asked to reduce their intake of NSAIDs and maintain that decrease provided there was no worsening of their joint symptoms. Clinical assessments of skin and joint disease severity and activity were performed at 0, 1, 3, 6, 9 and 12 months. All measures of skin disease activity including severity, percentage body affected and itch were unchanged by Efamol Marine. The NSAID requirement remained the same between both treatment groups. In addition, there was no change demonstrated in the activity of arthritis as measured by duration of morning stiffness. Ritchie articular index, number of active joints, ESR and CRP. However, a rise in serum TXB2 was observed in the active group during the placebo phase; in addition a fall in leukotriene B4 production occurred during the active phase period followed by a marked rise during the placebo phase suggesting some laboratory documented anti-inflammatory effect. In conclusion, this study suggests that Efamol Marine may alter prostaglandin metabolism in patients with PsA, although it did not produce a clinical improvement and did not allow reduction in NSAID requirement. A larger dose of essential fatty acid may be needed to produce a clinical benefit.

Effect of omega‐3 fatty acids on disease severity in patients with psoriasis: A systematic review

“…Mayser et al 16 also found a more than 40-fold increase of LTB5, evidenced from day 3 to day 15, but there was only a slight decrease of chemotactic LTB4 in both intervention and control groups with no significant difference. However, Veale et al 6 did not find any significant improvement by giving n-3 PUFA. LTB4 was found to have significantly decreased in the treatment group (P < 0.03) but not in the control group.…”

“…Gupta et al 5 reported the mean time period elapsed before the psoriasis worsened to pre-therapy severity was 4.9 AE 0.5 weeks in the intervention group and 4.5 AE 0.6 weeks in the control group (P = 0.4). Veale et al 6 reported no significant changes in articular index or skin itch at the end of the study, yet the subjects in the active treatment group had significantly more skin itch at the beginning (P = 0.03), thus suggesting the implementation of n-3 PUFA may be helpful for skin itch. Although Bjorneboe et al 14 did not find any significant difference between both groups, the total n-3 PUFA in serum phospholipids was significantly increased as compared to pre-treatment values while causing a significant fall in the AA and linoleic acid content of serum phospholipids.…”

“…LTB4 was found to have significantly decreased in the treatment group (P < 0.03) but not in the control group. The other six studies 5,6,14,15,17,18 reported no significant reduction in scaling, erythema, area involved or thickness. Gupta et al 5 reported the mean time period elapsed before the psoriasis worsened to pre-therapy severity was 4.9 AE 0.5 weeks in the intervention group and 4.5 AE 0.6 weeks in the control group (P = 0.4).…”

“…A total of 720 articles were excluded because they were not randomized controlled trials or observational studies (427 articles), did not involve dietary or pharmacologic interventions with n-3 fatty acids (210 articles), did not perform a comparison (65 articles), or did not include the outcome of interest (18 articles). Eleven randomized controlled trials [4][5][6][11][12][13][14][15][16][17][18] and one open-label controlled observational study 19 were included, and the data of all 12 studies were extracted. The characteristics of the extracted studies are outlined in Table 1.…”

“…5 The n-3 PUFA family includes eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), which modulate inflammatory responses by multiple mechanisms. 6 Based on these mechanisms, multiple randomized controlled trials have been conducted to show the clinical effectiveness of n-3 PUFAs. Although most of the results seemed promising, some have been contradictory.…”