We read the article entitled “Effects of simvastatin in prevention of pain recurrences after surgery for endometriosis” [1] with considerable interest. In this article simvastatin was introduced as being an option that is comparable to triptorelin for medical treatment after conservative endometriosis surgery for pain control. The study is certainly novel and remarkable; however, there are some points about the methods of the study that we think may be worth mentioning. In the first line of the discussion, the authors mentioned the study design as a “prospective, randomized, double-blind trial”. However, in the methods section of the article, the details of blinding were not described. Since two different pharmaceutical dosage forms (simvastatin oral tablet and triptorelin injection) were used in this study, the blinding of patients and physicians must have been quite challenging and a description would have been helpful and informative. Another point is about the allocation of the treatment modalities. “The major reason for laparoscopy in the simvastatin group was infertility (40%)”, which might be due to the allocation process. The authors mentioned that “… in patients who wanted to become pregnant immediately, we had the obligation to prescribe simvastatin rather than GnRHa”. According to the FDA, triptorelin is contraindicated during pregnancy [2], so it was a wise decision not to expose women willing to become pregnant to the unnecessary risk. However, simvastatin is not a safer or better option in cases of pregnancy. Statins are classified as category X drugs, and even in diabetic women with hyperlipidemia, the American Diabetes Association recommends that these drugs should be discontinued before conception [3]. Fortunately, none of the study patients in the simvastatin group became pregnant while they were under treatment; however, the decision regarding allocation needs more description.
Footnotes
Source of support: None
References
- 1.Almassinokiani F, Mehdizadeh A, Sariri E, et al. Effects of simvastatin in prevention of pain recurrences after surgery for endometriosis. Med Sci Monit. 2013;19:534–39. doi: 10.12659/MSM.883967. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2.Highlights of prescribing information, FDA label for triptorelin (Trelstar) available online at: http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020715s030,021288s027,022437s007lbl.pdf viewed on 13.08.2013.
- 3.American Diabetes Association. Standards of Medical Care in Diabetes. Diabetes Care. 2013:S11–66. doi: 10.2337/dc13-S011. [DOI] [PMC free article] [PubMed] [Google Scholar]