Clinical Trial: Marine Lipid Suppositories as Laxatives

Marine Drugs

Orri Thor Ormarsson¹  Thormodur Geirsson²  Einar Stefan Bjornsson²  Tomas Jonsson²  Pall Moller²  Thorsteinn Loftsson² 

[1] Department of Pediatric Surgery, Children’s Hospital, Landspitali-University Hospital, 101 Reykjavik, IcelandSchool of Health Science, University of Iceland, 101 Reykjavik, Iceland;

关键词: suppositories;    ointment;    laxative;    omega-3 fatty acid;    clinical trial;   

DOI  :  10.3390/md10092047

来源: mdpi

【 摘 要 】

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.

【 授权许可】

CC BY   
© 2012 by the authors; licensee MDPI, Basel, Switzerland.