The Effect of Oral Psyllium Herbal Laxative Powder in Prevention of Hemorrhoids and Anal Fissure during Pregnancy, a Randomized Double Blind Clinical Trial
Annals of Colorectal Research: June 01, 2013, 1 (1); 23-7
June 30, 2013
Article Type: Research Article
February 25, 2013
March 15, 2013
April 8, 2013
S V, Rahimikazerooni
A M, Namavar Jahromi
B, et al. The Effect of Oral Psyllium Herbal Laxative Powder in Prevention of Hemorrhoids and Anal Fissure during Pregnancy, a Randomized Double Blind Clinical Trial,
Ann Colorectal Res.
Pregnancy and delivery make susceptible women to hemorrhoidal disease and fissure during pregnancy because of an increase in abdominal pressure and constipation.
We aimed to determine the preventative effect of psyllium powder (herbal laxative) on constipation, anal fissure and hemorrhoidal diseases during pregnancy.
Patients and Methods:
Regarding the properties of oral psyllium powder, in this study, we aimed to determine the preventative effect of psyllium powder on constipation, anal fissure and hemorrhoidal diseases during pregnancy. This is a randomized clinical trial. All primigravid women, aging 20-30, at the onset of 3rd trimester who referred to OB clinic of Shiraz university of medical sciences were divided into two groups. Treatment group received psyllium powder twice daily while control group received placebo. All cases were evaluated two times before delivery and occurrence of constipation and fissure and hemorrhoid were assessed by a single team.
The mean and SD of age in group A (psyllium consumption group) was 29.9 ± 2.24 and in group B (placebo group) was 29.5 ± 2.48. Comparison between three outcome variables (hemorrhoid, fissure and constipation) revealed significant difference in group A and group B in compare with group B, p < 0.001).
According to our study psyllium powder consumption during the third trimester of pregnancy could significantly prevent constipation, hemorrhoid anal fissure.
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Hemorrhoidal disease and anal fissure are known as one of the prevalent clinical problems in women (
1). The prevalence is different in various places and the level of its outbreak was reported 24.8% ( 2). Pregnancy and delivery make susceptible women to hemorrhoidal disease and fissure during pregnancy because of an increase in abdominal pressure and constipation ( 2).
It was shown that hemorrhoidal diseases may be caused by a backflow of venous blood in order to transient increase in intra abdominal pressure (
3, 4). Constipation in pregnancy results from a change in diet, a decline in physical activity, hormonal alterations, and a decrease in digestive system function ( 5, 6). In different studies, the prevalence of anorectal diseases (hemorrhoidal diseases and anal fissure) and constipation in the third gestational period was reported 11% to 38% (2, 5).Thus, using therapeutic measures without any side effects for the patients and the fetus are clinically important ( 7) . Recently, the use of some herbal medicines like flovonoic acid extracted from the citrous has been taken into account. Plantago psyllium (psyllium as the seed of fleawort) is also one of these herbs whose remedial effect appears by absorption of water by chelating agent in the crust of its seed ( 8). When powder is used with adequate water, it will result into an additional bulk in the stool, increase the water content, and trap it in the mucin within the stool. So psyllium granule would increase the peristalsism movement ( 5, 7, 9).
Regarding the properties of psyllium, in this study, we aimed to determine the preventative effect of psyllium powder on constipation, anal fissure and hemorrhoidal diseases during pregnancy.
3. Patients and Methods
This study was a prospective randomized control trial to compare the effect of psyllium powder on preventing constipation and its’ associated diseases with placebo in pregnant women who referred to Pregnancy Care Clinics of Shiraz University of Medical Sciences from July 1, 2010 to July 1, 2011.The study was submitted to Iranian Registry of Clinical Trials and its’ approval code is 201212119936N3.
All (3136) primigravid women ageing between 20 and 30, at the onset of third trimester of pregnancy were asked to take part in the program and 2412 of them accepted our invitation (724, declined) and signed the written consent form. The inclusion criteria were first pregnancy, being at the beginning of third trimester of gestational period and age between 20 and 30. At the same time, positive medical history of anorectal diseases and signs of current anorectal disease were determined as exclusion criteria. As a consequence 303 participants were excluded from the study. The remaining 2109 participants were divided randomly into two groups. The random sequence was assigned by Blocked Randomization Method and use of standard random number tables. We lost 17 participants during follow-up after allocation.
A package containing 180 small packs of 10 mg powder was delivered to each participant. They were requested to mix a pack in a glass of water and drink it twice daily. In the follow-up under such circumstances, group A with 1015 participants received Psyllium Powder and group B with 1077 participants received placebo. Both placebo powder and Psyllium Powder were provided by Shiraz School of Pharmacy and were just labeled A and B. We arranged two follow up sessions for all cases. The first, 45 days after intervention and the second, seven days before expected delivery date. A surgeon with two assistants who were general practitioners (GP) evaluated the participants in follow-up sessions and recorded information in prepared questionnaires.
All of the persons involved in the study were blinded to intervention including both participants and care providers such as physicians, nurses and the clerks.
Constipation which was the primary outcome was defined as feelings of incomplete or uncomfortable defecation as well as defecation less than three times per week. Obviously, these pieces of data were acquired through the subjective history of participants. Hemorrhoid and anal fissures were regarded as secondary outcomes. They were diagnosed on the basis of history and Physical Examination. The entire process was completed by the same team including a surgeon and two GP assistances.
Statistical analyses were performed with SPSS 20.0 software (SPSS, Chicago, IL, USA). Comparisons between treatment and placebo groups on outcome variables were conducted using chi-square tests for categorical variables. P values below 0.05 were considered significant (
Figure 1 ).
Figure 1 CONSORT 2010 Flow Diagram
The mean and SD of age in group A (treatment group) was 29.9 ± 3.24 and in group B (placebo group) the mean ± SD was 29.5 ± 3.48. In group A 14 participants had less than three times defecation per week, 12 of them had hard stool and 26 had positive history of uncomfortable defecation. Consequently, 52 patients were classified as cases of constipation which eight of them were suffering from fissure and two of them were diagnosed as hemorrhoid cases.
In group B, 92 patients had less than three times defecation per week, 62 of them had hard stool and 56 women had positive history of uncomfortable defecation. As a result all of them (190) classified as cases of constipation. The evaluating team diagnosed 127 of them as fissure cases while 11 of them were suffered from hemorrhoid. Chi-square test for independence indicated significant association between consumption of psyllium powder and decrease rates of constipation, hemorrhoid and fissure, in group B compare with group A ( p < 0.001).
Constipation in pregnancy is related to change in life style, poor oral fluid intake because of nausea and vomiting, hormonal alteration (especially progesterone), some medication such as iron supplement. About 11% to 38% of pregnant women have suffering of constipation. Treatment has to leased on softy without incontinency risk of congenital malformation (9) .Some drugs like senna PEG use for treatment of constipation and related complication sally during pregnancy. Although, some laxative usage like castor oil and mineral oil should be limited. There is no evidence to use prophylactic any laxative agents in pregnancy (
However, some data have shown similarity of prevalence for constipation during pregnancy among women from the same geo graphic area (
13). Our results showed that in the case group, psyllium powder could significantly decrease the number of surgeries resulting from anorectal complications, hemorrhoidal diseases, anal fissure and constipation. It is in concordance of several other studies which emphasized the effect of fiber in diet on preventing constipation in the course of pregnancy (1). Considering the type of delivery, psyllium powder led to the significantly decrease in surgical complications, constipation and fissure in women who had normal delivery. However this decline was observed only for constipation and fissure in women who underwent cesarean section. In other words, psyllium powder had a significant effect on reducing the anorectal complications in normal deliveries, which is justifiable in regard to the additional pressure on the true pelvis during the normal delivery and the effect of psyllium laxative against the increase of pressure in internal anal sphincter. Several studies have already done hemorrhoidal diseases and anal fissures during pregnancy. In one study in Spain by 'Alonso Coello' et al on the effect of laxatives during pregnancy in seven subjects, it was shown that fiber could decrease the hemorrhoidal symptoms and bleeding (7). In another study in France in women during pregnancy until delivery, anal fissure was visible in 15.2% of the subjects and hemorrhoidal diseases in 20% ( 14).
In Thailand, trihydroxy ethyl rothoside was used for treatment of hemorrhoidal diseases during pregnancy and the patients' signs were evaluated two weeks after medication (
15). In another study in Indonesia, the effect of Hydroxy ethyl rothoside in treatment of hemorrhoidal diseases during pregnancy was studied that shown pain, bleeding, secretion and itching ( 16). In another study in Italy, the effect of betahydroxy ethyl rothoside to treat hemorrhoidal diseases during pregnancy was studied and a considerable clinical recovery was noticed ( 17).
In another study in Argentina, conservative measures were practiced for hemorrhoidal diseases during pregnancy such as changes in food habits and the effect of hydroxyl ethyl rothoside in decreasing of hemorrhoidal symptoms was studied during pregnancy showing, however more attention needed to ensure the safety of this drug during pregnancy (
18). In another study in India, micronized flavonoic was used for treatment of hemorrhoidal diseases during pregnancy which resulted into a significant decline in symptoms, bleeding, pain and anal discharge in patients ( 19). During pregnancy anal sphincter pressure is slightly higher than normal level and laxative medications like psyllium can not reduce the resting pressure of the anal sphincter checked by manometry. The laxatives can prevent the rise of pressure in internal anal sphincter only ( 20, 21). We can conclude that psyllium powder consumption during the third trimester of pregnancy could significantly prevent constipation, hemorrhoid anal fissure.