Commentary on: The Effect of Oral Psyllium Herbal Laxative Powder in Prevention of Hemorrhoids and Anal Fissure during Pregnancy, a Randomized Double Blind Clinical Trial

Abstract

We read with interest the article published by Ghahramani, et al. (1). The research has been well-planned and blinded. The results are impressive. However, there is a discrepancy between the outcome measures of the study and the outcome measured mentioned in the title. It would be better if constipation as an outcome is also included in the title because constipation alone without haemorrhoids and fissures is also a cause of concern in pregnancy. Further, I found that the results of the study are more reliable with respect of beneficial effects on constipation than haemorrhoids. I would like to make the following remarks in good faith regarding this study: A) It was not clear whether the subjects followed the same life style as usual during the study or they were free to change whenever necessary. Lack of activity and lowfiber and water diet can be considerd as the risk factors for constipation (2). Also it is not clear whether they were advised to refrain from using additional measures to soften stools when they felt constipated or they were free to follow additional measures to prevent constipation. B) It is also not clear how many of them actually sought medical attention for their disease during the follow up period; this is a better parameter than routine clinical examinations because only symptomatic patients need treatment. One study has reported 82% prevalence of haemorrhoids in asymptomatic population (3). It is also taught in medical schools that haemorrhoids are the normal vascular cushions in the anal canal and is a disease only when they give rise to problems like bleeding and prolapse. This aspect has not been addressed in this study. C) The article does not say clearly how haemorrhoids was diagnosed and excluded at the beginning and at the end of the study. The study had not tried to assess the severity of the disease. Further it can be understood from the article that the prevalence of haemorrhoids in the placebo group was 1%. This has to be equivalent to the prevalence of haemorrhoids in the general population in the third trimester of pregnancy. However this figure is much less than the reported prevalence of haemorrhoids in the third trimester of pregnancy, which is as high as 11%-38% (4). Therefore the results with respect to haemorrhoids are not reliable in this study. D) In this study the incidence of constipation in the placebo group was 18%. This can be taken as the prevalence of constipation in the population in the third trimester of pregnancy. The results here seem to be reliable because the figure is comparable with the other published studies (5). Looking at the results the incidence of constipation had come down from 18% to 5% after treating with Psyllium. This is a good achievement. But still 5% continue to carry the problem. This means constipation remains a significant problem among pregnant women even after using this medicine. Accordingly this article showed that Psyllium can be used effectively in pregnancy to prevent constipation but its efficacy in preventing haemorrhoids cannot be concluded without further evaluation.