Trip Answers

Question answered:12/10/07 Warning! this question is over two years old.

An e-Medicine article on lactose intolerance states:

 

“Lactase derived from yeast can be added to milk products as drops or ingested as chewable tablets prior to ingestion of lactose-containing substances. Studies demonstrate varying success. Digestive supplementations are apparently limited in their ability to digest large quantities of lactose.” [1]

 

We searched the TRIP, Cochrane and Medline databases and found a number of small and mainly non-randomised studies of lactase tablets.

 

Xenos et al examined the efficacy of exogenous beta-D-galactosidase in pellet form for lactose intolerance.

 

“…the effectiveness of the new lactase formulation on glucose absorption was studied in 8 lactose intolerant subjects in a randomized, double blind, crossover trial. After fasting, the subjects were given one capsule containing 100 u/ml beta-galactosidase (i.e. 10 pellets of 10 u/ml each) or one capsule containing placebo pellets, followed by 100 g lactose dissolved in water. The washout period between lactose challenges was one week. Plasma glucose concentrations were measured before and at intervals after the challenges and the subjects completed symptom questionnaires every eight hours for 24 hours. Results showed a statistically significant increase in plasma glucose levels 30, 60, 90 and 120 min after lactose ingestion (repeated measures analysis of variance, p<0.01). Subjective ratings of the severity of abdominal cramping, belching, flatulence, vomiting and diarrhoea were significantly decreased following ingestion of the lactase pellets and lactose (no incidence of diarrhoea) compared with after ingestion of placebo and lactose…” [2]

 

Medow et al report on a study of beta-galactosidase tablets in the treatment of lactose intolerance in a paediatric population:

 

“Lactose-intolerant children manifest diminished or nonexistent intestinal lactase activity, resulting in flatulence, abdominal pain, and diarrhea. To assess the hydrolytic capability of lactase-containing tablets taken immediately before oral lactose challenge, we studied 18 children previously identified as being lactose intolerant and having no underlying organic gastrointestinal disease. Subjects had a mean (+/- SEM) age of 11.4 +/- 3.4 years; 72% were male. At time of the study, lactase-containing tablets or placebo tablets were ingested (double-blind) immediately before drinking a solution of lactose. Breath samples were obtained for hydrogen analysis at 30-minute intervals during a 2-hour period, and clinical symptoms were monitored. In lactose-intolerant patients, hydrogen production was significantly greater following placebo (maximum hydrogen excretion, approximately 60 ppm) compared with lactase-containing tablets (maximum hydrogen excretion, 7 ppm). Increased hydrogen production was associated with clinical symptoms including abdominal pain (89% of subjects following placebo ingestion), bloating (83%), diarrhea (61%), and flatulence (44%). These results indicate, therefore, that coingestion of lactose and lactase-containing tablets significantly reduces both breath hydrogen excretion and clinical symptoms associated with lactose intolerance.” [3]

 

In a second study, Sanders et al observed:

 

“After fasting, the subjects were given three chewable lactase tablets (total lactase dose, 9900 FCC units) or placebo tablets in a randomized, double-blind, crossover manner. The subjects also consumed 8 oz of whole milk in which 37.5 g of lactose powder was dissolved (total lactose content, 50 g). The washout period between lactose challenges was at least one week. Breath hydrogen and plasma glucose concentrations were measured before and at intervals after the challenges, and the subjects completed symptom-evaluation questionnaires every eight hours for four days. Twenty-four subjects completed the study. The maximum mean breath hydrogen concentration was significantly lower after lactase treatment than after placebo treatment. In 21 subjects, the area under the hydrogen concentration-time curve (AUC) was lower after lactase than after placebo; three subjects had hydrogen AUCs more than 300 ppm.hr lower. There were no significant differences in plasma glucose levels. Subjective ratings of the severity of abdominal cramping, belching, flatulence, and diarrhea were lower during the first eight hours after challenge in lactase-treated subjects; ratings for bloating were lower during the next eight hours. Single doses of a chewable lactase tablet reduced the concentration of expired hydrogen and symptoms of lactose intolerance after a lactose challenge.” [4]

 

In a review article, published in 2006, Montalto et al noted:

 

“Solid lactase preparations, in capsules and tablets, are commercially available alternatives for enzyme-replacement therapy. Several studies have investigated and confirmed their efficacy [However, comparative studies have shown that these preparations are more expensive and significantly less effective than prehydrolyzed milk probably due to the enzyme gastric inactivation. Their use can be suggested for solid dairy products.” [5]

 

Concerning the availability of lactase tablets on the NHS, we checked the BNF and although we saw Colief a lactase liquid we found no reference to lactase tablets. In addition, we could not find an SPC for lactase tablets which suggests they are not available on an NHS prescription.

 

The NHS Direct leaflet on lactose intolerance states:

 

“For adults, lactase enzyme is available in tablet form as a food supplement from many health food shops. It can be taken before a meal and may be effective in helping your digestive system to digest the lactose in the meal.
For babies and infants only, lactase enzyme is available from pharmacies in drop form. It can be added to breast milk or formula and can prevent the digestive discomfort, bloatedness and wind that lactose intolerance can cause.” [6]

 

References
1. Guandalini S. Lactose intolerance. e-Medicine. October 2006. (http://www.emedicine.com/ped/topic1270.htm)
2. Xenos K, Kyroudis S, Anagnostidis A et al.Treatment of lactose intolerance with exogenous beta-D-galactosidase in pellet form. Eur J Drug Metab Pharmacokinet. 1998 Apr-Jun;23(2):350-5. (http://www.hubmed.org/display.cgi?uids=9725505)
3. Medow MS, Thek KD, Newman LJ, Berezin S, Glassman MS, Schwarz SM. Beta-galactosidase tablets in the treatment of lactose intolerance in pediatrics. Am J Dis Child. 1990;144 :1261 –1264. (http://www.hubmed.org/display.cgi?uids=2122719)
4. Sanders SW, Tolman KG, Reitberg DP et al. Effect of a single dose of lactase on symptoms and expired hydrogen after lactose challenge in lactose-intolerant subjects. Clin Pharm. 1992 Jun;11(6):533-8. (http://www.hubmed.org/display.cgi?uids=1534729)
5.  Montalto M, Curigliano V, Santoro L et al. Management and treatment of lactose malabsorption. World J Gastroenterol. 2006 Jan 14;12(2):187-91. (http://www.wjgnet.com/1007-9327/12/187.asp)
6. NHS Direct/CKS. Lactose intolerance. (http://cks.library.nhs.uk/patient_information_leaflet/lactose_intolerance)

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