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Clinical trial: marine lipid suppositories as laxatives.

Ormarsson OT, Geirsson T, Bjornsson ES, Jonsson T, Moller P, Loftsson T, Stefansson E - Mar Drugs (2012)

Bottom Line: Our purpose was to evaluate the safety of marine lipid suppositories and ointment in healthy volunteers and to explore the laxative effect of the suppositories.No serious toxic effects or irritation were observed.The marine lipid suppositories and ointment were well tolerated with no significant toxic side effects observed during the study period.

View Article: PubMed Central - PubMed

Affiliation: Department of Pediatric Surgery, Children's Hospital, Landspitali-University Hospital, 101 Reykjavik, Iceland.

ABSTRACT

Unlabelled: Cod-liver oil and other marine products containing polyunsaturated fatty acids have anti-inflammatory, anti-bacterial and anti-viral effects and may be useful in the treatment of various inflammatory and infectious diseases. We developed suppositories and ointment with 30% free fatty acid (FFA) extract from omega-3 fish oil. Our purpose was to evaluate the safety of marine lipid suppositories and ointment in healthy volunteers and to explore the laxative effect of the suppositories. Thirty healthy volunteers were randomized either to a study group administrating 30% FFA suppositories and applying 30% FFA ointment to the perianal region twice per day for two weeks, or to a control group using placebo suppositories and ointment in a double blinded manner.

Results: No serious toxic effects or irritation were observed. In the study group 93% felt the urge to defecate after administration of the suppositories as compared to 37% in the control group (P = 0.001). Subsequently 90% in the study group defecated, compared to 33% in the control group (P = 0.001).

Conclusion: The marine lipid suppositories and ointment were well tolerated with no significant toxic side effects observed during the study period. The suppositories have a distinct laxative effect and we aim to explore this effect in further clinical trials.

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Related in: MedlinePlus

The self reported urge to defecate is shown on the left side and bowel movement after application of suppositories over the 2-week trial period is on the right side. The mean of the one and two week scores is shown. The black columns indicate the study group, which received marine lipid suppositories and ointment and the white columns show the placebo control group. The error bars stretch one standard error of the mean to each side. *** p < 0.001.
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marinedrugs-10-02047-f001: The self reported urge to defecate is shown on the left side and bowel movement after application of suppositories over the 2-week trial period is on the right side. The mean of the one and two week scores is shown. The black columns indicate the study group, which received marine lipid suppositories and ointment and the white columns show the placebo control group. The error bars stretch one standard error of the mean to each side. *** p < 0.001.

Mentions: In the study group 93% felt the urge to defecate, most within 10 min after administration of suppositories. In the placebo group 37% felt the urge for defecation after administration of suppositories (P = 0.001) (Figure 1, Table 1). In the study group 90% had bowel movement, most within 10 min, after administration of suppositories as compared to 33% in the control group (P = 0.001) (Figure 1, Table 1). The smell was more troublesome in the study group (67%) as compared to the placebo group (7%) (P = 0.001).


Clinical trial: marine lipid suppositories as laxatives.

Ormarsson OT, Geirsson T, Bjornsson ES, Jonsson T, Moller P, Loftsson T, Stefansson E - Mar Drugs (2012)

The self reported urge to defecate is shown on the left side and bowel movement after application of suppositories over the 2-week trial period is on the right side. The mean of the one and two week scores is shown. The black columns indicate the study group, which received marine lipid suppositories and ointment and the white columns show the placebo control group. The error bars stretch one standard error of the mean to each side. *** p < 0.001.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3475272&req=5

marinedrugs-10-02047-f001: The self reported urge to defecate is shown on the left side and bowel movement after application of suppositories over the 2-week trial period is on the right side. The mean of the one and two week scores is shown. The black columns indicate the study group, which received marine lipid suppositories and ointment and the white columns show the placebo control group. The error bars stretch one standard error of the mean to each side. *** p < 0.001.
Mentions: In the study group 93% felt the urge to defecate, most within 10 min after administration of suppositories. In the placebo group 37% felt the urge for defecation after administration of suppositories (P = 0.001) (Figure 1, Table 1). In the study group 90% had bowel movement, most within 10 min, after administration of suppositories as compared to 33% in the control group (P = 0.001) (Figure 1, Table 1). The smell was more troublesome in the study group (67%) as compared to the placebo group (7%) (P = 0.001).

Bottom Line: Our purpose was to evaluate the safety of marine lipid suppositories and ointment in healthy volunteers and to explore the laxative effect of the suppositories.No serious toxic effects or irritation were observed.The marine lipid suppositories and ointment were well tolerated with no significant toxic side effects observed during the study period.

View Article: PubMed Central - PubMed

Affiliation: Department of Pediatric Surgery, Children's Hospital, Landspitali-University Hospital, 101 Reykjavik, Iceland.

ABSTRACT

Unlabelled: Cod-liver oil and other marine products containing polyunsaturated fatty acids have anti-inflammatory, anti-bacterial and anti-viral effects and may be useful in the treatment of various inflammatory and infectious diseases. We developed suppositories and ointment with 30% free fatty acid (FFA) extract from omega-3 fish oil. Our purpose was to evaluate the safety of marine lipid suppositories and ointment in healthy volunteers and to explore the laxative effect of the suppositories. Thirty healthy volunteers were randomized either to a study group administrating 30% FFA suppositories and applying 30% FFA ointment to the perianal region twice per day for two weeks, or to a control group using placebo suppositories and ointment in a double blinded manner.

Results: No serious toxic effects or irritation were observed. In the study group 93% felt the urge to defecate after administration of the suppositories as compared to 37% in the control group (P = 0.001). Subsequently 90% in the study group defecated, compared to 33% in the control group (P = 0.001).

Conclusion: The marine lipid suppositories and ointment were well tolerated with no significant toxic side effects observed during the study period. The suppositories have a distinct laxative effect and we aim to explore this effect in further clinical trials.

Show MeSH
Related in: MedlinePlus