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Ispaghula

Classification: A

Drug products: Husk, Lunelax®, Metamucil, Metamucil kalorienarm Orange, Vi-Siblin®, Vi-Siblin® S

ATC code: A06AC01

Substances: ispaghula, ispaghula seed

Summary

No studies regarding sex differences in effect on constipation have been found.

Several studies have shown that daily doses of 10 g psyllium or more reduce total cholesterol levels in men and women with mild-to-moderate hypercholesterolemia. One study showed a more pronounced decrease in men below 60 years. Another study found increased triglyceride levels in men, decreased levels in postmenopausal women, but no difference in premenopausal women.
 
In our opinion, the described differences do not motivate differentiated dosing or treatment in men and women.

Additional information

Ispaghula husk is also known as psyllium and is used as a dietary fiber in constipation.

Pharmacokinetics and dosing

Psyllium is not absorbed when administrated orally. No studies with a clinically relevant sex analysis regarding the pharmacokinetics or dosing of psyllium have been found.

Effects

A meta-analysis has shown that psyllium 10.2 g daily reduce serum total and LDL-cholesterol concentrations over 8 weeks of treatment in men and women with mild-to-moderate hypercholesterolemia (347 men, 309 women). Treatment differences were consistent between sexes; serum LDL-cholesterol concentrations was reduced by 0.269 mmol/L in women and by 0.243 mmol/L in men, compared with placebo [3]. Also, a study in patients with hyperlipidemia showed that there were no differences in the effect of psyllium on blood lipids between men and women [4].

A crossover trial examined the effects of a psyllium supplement (15 g daily) in men, pre- and postmenopausal women (24 men, 23 premenopausal women, 21 postmenopausal women). Psyllium decreased plasma triacylglycerol concentrations by 17% in men, but was increased by 16% in postmenopausal women. There was no significant effect on this variable in premenopausal women, which might indicate a potential beneficial effect of estrogen in reducing plasma triacylglycerol concentrations. There were no significant sex differences in LDL-cholesterol [5]. Another study in the same cohort of patients found that psyllium intake increased mononuclear cell LPL mRNA abundance by 24% in men, while postmenopausal women experienced a 23% decrease. The difference between men and postmenopausal women may be explained by LPL gene expression and LPL activity [6]. The clinical relevance of this finding is unclear.

A randomized, double-blind, controlled study investigated long-term efficacy of three doses of psyllium, but did not observe significant sex differences in LDL-cholesterol response [7].

In the Swedish physicians’ desk reference (PDR), it’s stated that studies in patients with mild-to-moderate hypercholesterolemia, daily doses of 10 g psyllium resulted in lowering of total cholesterol by 5%. The decrease was more pronounced in men below 60 years [8] .

Adverse effects

No studies with a clinically relevant sex analysis regarding adverse effects of psyllium have been found.

Reproductive health issues

Regarding teratogenic aspects, please consult the Drugs and Birth Defects Database (in Swedish, Janusmed fosterpåverkan).

Other information

The palatability of the bulk additives sterculia gum, psyllium and methylcellulose has been studied in patients and hospital personnel (74 men, 106 women). Each volunteers received a single dose of each of two of the bulk additives. Women preferred sterculia gum while men preferred psyllium [1].In a large British registry study (82450 men, 153264 women), the prevalence of constipation was almost twice as high among women up to the age of 75 years, but higher in men than women among patients aged over 75 years. There was no difference between men and women in choice of laxative (macrogol, lactulose, senna or other laxatives including ispaghula).  The most commonly prescribed laxative in pregnant patients with constipation were lactulose followed by macrogol [2].

Updated: 2019-02-26

Date of litterature search: 2015-08-13

References

  1. Flaherty EV, O'Doherty J, Fielding JF. The palatability of colloidal bulk forming agents. J Int Med Res. 1980;8:262-4. PubMed
  2. Shafe AC, Lee S, Dalrymple JS, Whorwell PJ. The LUCK study: Laxative Usage in patients with GP-diagnosed Constipation in the UK, within the general population and in pregnancy An epidemiological study using the General Practice Research Database (GPRD). Therap Adv Gastroenterol. 2011;4:343-63. PubMed
  3. Anderson JW, Allgood LD, Lawrence A, Altringer LA, Jerdack GR, Hengehold DA et al. Cholesterol-lowering effects of psyllium intake adjunctive to diet therapy in men and women with hypercholesterolemia: meta-analysis of 8 controlled trials. Am J Clin Nutr. 2000;71:472-9. PubMed
  4. Wolever TM, Jenkins DJ, Mueller S, Patten R, Relle LK, Boctor D et al. Psyllium reduces blood lipids in men and women with hyperlipidemia. Am J Med Sci. 1994;307:269-73. PubMed
  5. Vega-López S, Vidal-Quintanar RL, Fernandez ML. Sex and hormonal status influence plasma lipid responses to psyllium. Am J Clin Nutr. 2001;74:435-41. PubMed
  6. Vega-López S, Freake HC, Fernandez ML. Sex and hormonal status modulate the effects of psyllium on plasma lipids and monocyte gene expression in humans. J Nutr. 2003;133:67-70. PubMed
  7. Davidson MH, Maki KC, Kong JC, Dugan LD, Torri SA, Hall HA et al. Long-term effects of consuming foods containing psyllium seed husk on serum lipids in subjects with hypercholesterolemia. Am J Clin Nutr. 1998;67:367-76. PubMed
  8. LUNELAX (ispaghula). Summary of Product Characteristics. Medical Products Agency; 2016.
  9. Conicse. Stockholm: eHälsomyndigheten. 2015 [cited 2016-03-23.] länk

Authors: Linnéa Karlsson Lind, Desirée Loikas

Reviewed by: Mia von Euler

Approved by: Karin Schenck-Gustafsson