A Partially Blind Study

PEDIATRICS ◽  
1983 ◽  
Vol 71 (4) ◽  
pp. 667-668
Author(s):  
BRIAN FORSYTH
Keyword(s):  
Adverse Reaction ◽  
Blind Study ◽  
Cow’S Milk ◽  
Milk Formula ◽  
Double Blind Study ◽  
Infantile Colic ◽  
Double Blind ◽  
Cow's Milk ◽  
Blinded Study

To the Editor.— I would like to suggest that the article entitled: "Cow's Milk Formula as a Cause of Infantile Colic: A Double-Blind Study"1 would be better entitled: Infantile Colic and Confusion with Milk Formulas: A Partially Blinded Study. The authors of the article suggest that their results demonstrate that infantile colic was "cow's milk dependent in 71% of the infants in the study" and "53% of these infants also showed an adverse reaction to soy." With this, I disagree.

Cow's Milk Formula as a Cause of Infantile Colic: A Double-Blind Study

PEDIATRICS ◽  
1982 ◽  
Vol 70 (1) ◽  
pp. 7-10 ◽  
Author(s):  
Lasse Lothe ◽  
Tor Lindberg ◽  
Irene Jakobsson
Keyword(s):  
Gastrointestinal Symptoms ◽  
Dietary Treatment ◽  
Blind Study ◽  
Cow’S Milk ◽  
Milk Formula ◽  
Double Blind Study ◽  
Infantile Colic ◽  
Double Blind ◽  
Cow's Milk

The role of cow's milk in infantile colic in formula-fed infants was estimated in a double-blind study. Sixty colicky infants were given a cow's milk-containing formula (Enfamil) and a cow's milk-free formula based on soy (ProSobee). Eleven infants (18%) were free of symptoms while receiving soy formula. Symptoms of 32 infants (53%) were unchanged or worse when they were fed cow's milk formula and soy formula, but symptoms disappeared when they were fed a formula containing hydrolyzed casein (Nutramigen). Symptoms of 17 infants (29%) could not be related to the diet; these infants were permitted to continue on a cow's milk-based formula. A challenge with cow's milk-based formula after one month (at approximately age 3 months) produced symptoms of infantile colic in 22 infants (36%). At age 6 months, a challenge with cow's milk was positive in 11 infants (18%) with epidermal and gastrointestinal symptoms. Eight infants (13%) at 12 months of age and five infants (8%) at 16 months of age were still intolerant to cow's milk. Cow's milk seems to be a major cause of infantile colic in formula-fed infants. A dietary treatment is suggested for moderate or severe forms of the colic. Cow's milk protein intolerance is common later in infancy in these infants.

Cow's Milk Formula and Infantile Colic

PEDIATRICS ◽  
1989 ◽  
Vol 84 (6) ◽  
pp. 1124-1125
Author(s):  
WILLIAM B. CAREYMD
Keyword(s):  
Milk Proteins ◽  
Cow’S Milk ◽  
Milk Formula ◽  
Double Blind Study ◽  
Milk Allergy ◽  
Infantile Colic ◽  
Double Blind ◽  
Cow's Milk ◽  
Young Infants ◽  
Excessive Crying

No experienced pediatric clinician doubts the existence of cow's milk allergy in infants. The controversy concerns how often cow's milk proteins cause excessive crying or "colic" in otherwise well young infants. Three interesting papers from our colleagues in Malmö, Sweden, leave the question unanswered despite the considerable sophistication in their research design. In their first report in 1982, they concluded that in a double-blind study "cow's milk seems to be a major cause of infantile colic in formula-fed infants." However, in the only part that was double-blind, fewer infants improved while receiving soy formula (18%) than did those receiving cow's milk formula (29%).

In Reply: Cow's Milk Formula and Infantile Colic

PEDIATRICS ◽  
1989 ◽  
Vol 84 (6) ◽  
pp. 1125-1125
Author(s):  
LASSE LOTHE ◽  
TOR LINDBERG
Keyword(s):  
Adverse Reaction ◽  
Cow’S Milk ◽  
Milk Formula ◽  
Infantile Colic ◽  
Double Blind Trial ◽  
Double Blind ◽  
Cow's Milk ◽  
Blind Trial ◽  
Definition Of ◽  
Dose Dependent

In reply to Dr Carey, we want to emphasize that the criterion for entering a study was that our definition of colic (as quoted by Dr Carey) was fulfilled (ie, "crying of about 3 hours or longer per day. . ."). In our report, an unfortunate misprint occurred. On page 264, first paragraph of the "Results" section, line 5, is written "infants receiving cow's milk-based formula cried 1.5 hours per day or more." It should have been "3 hours per day or more." In the double-blind trial, we decided to reduce the time of crying to > 1.5 hours per day to accept the reaction as positive for the following reasons: Experienced pediatricians know that the adverse reaction to food in a food-allergic (intolerant) infant is dose dependent.

A Partially Blind Study

PEDIATRICS ◽  
1983 ◽  
Vol 71 (4) ◽  
pp. 668-668
Author(s):  
L. LOTHE ◽  
T. LINDBERG ◽  
I. JAKOBSSON
Keyword(s):  
Blind Study ◽  
Cow’S Milk ◽  
Infantile Colic ◽  
Double Blind ◽  
Blind Test ◽  
Cow's Milk

In Reply.— In reply to Forsyth we want to refer to our recent publication in this journal. Once again we emphasize that our conclusion that cow's milk seems to be one major factor in causing infantile colic is based on the results of the whole study (ie, not only the double-blind test, but also the outcome of the cow's milk challenges at follow-up). Concerning the 18% (11 infants) who did not react adversely to soy formula, seven infants received it as the first challenge and four as the second.

Soy Formula Doesn't Help Colic

PEDIATRICS ◽  
1983 ◽  
Vol 71 (2) ◽  
pp. 299-300
Author(s):  
LASSE LOTHE ◽  
TOR LINDBERG ◽  
IRÉNE JAKOBSSON
Keyword(s):  
Adverse Reaction ◽  
Soy Protein ◽  
Milk Proteins ◽  
Cow’S Milk ◽  
Milk Formula ◽  
Cow's Milk ◽  
Cow’S Milk Proteins

In Reply.— We fully agree with LeBlanc that there was no significant improvement when infants with colic were given a soy protein-based formula. As pointed out in the "Discussion," as many as 53% of the infants showed an adverse reaction to soy (corresponding figure for cow's milk formula was 71%). We also emphasized that these figures must be interpreted with caution. In fact, soy protein-based formula was a bad choice as placebo. A placebo substance should be a substance of no importance as an allergen in infancy and soy protein has been shown to be as antigenic as cow's milk proteins (Eastham EJ, et al: J Pediatr 1978;93:561).

Cow's Milk Proteins Cause Infantile Colic in Breast-Fed Infants: A Double-Blind Crossover Study

PEDIATRICS ◽  
1983 ◽  
Vol 71 (2) ◽  
pp. 268-271 ◽  
Author(s):  
Iréne Jakobsson ◽  
Tor Lindberg
Keyword(s):  
Whey Protein ◽  
Sequential Analysis ◽  
Protein A ◽  
Milk Proteins ◽  
Cow’S Milk ◽  
Infantile Colic ◽  
Double Blind ◽  
Milk Whey ◽  
Cow's Milk ◽  
Breast Fed

Sixty-six mothers of 66 breast-fed infants with infantile colic were put on a diet free from cow's milk. The colic disappeared in 35 infants; it reappeared on at least two challenges (cow's milk to mother) in 23 infants (35%). A double-blind crossover trial with cow's milk whey protein was performed in 16 of these 23 mothers and infants. Six infants had to be taken out of the study for various reasons; of the remaining ten infants, nine reacted with colic after their mothers' intake of whey protein-containing capsules. Sequential analysis showed a high correlation between infantile colic in breast-fed infants and their mothers' consumption of cow's milk protein. A diet free of cow's milk is suggested for the mothers as a first trial of treatment of infantile colic in breast-fed infants.

Cow's Milk Whey Protein Elicits Symptoms of Infantile Colic in Colicky Formula-Fed Infants: A Double-Blind Crossover Study

PEDIATRICS ◽  
1989 ◽  
Vol 83 (2) ◽  
pp. 262-266 ◽  
Author(s):  
Lasse Lothe ◽  
Tor Lindberg
Keyword(s):  
Crossover Study ◽  
Whey Protein ◽  
Cow’S Milk ◽  
Infantile Colic ◽  
Double Blind ◽  
Milk Whey ◽  
Cow's Milk ◽  
The Mean ◽  
Blind Crossover Study ◽  
Double Blind Crossover Study

There are several causes of infantile colic. The aim of this study was to evaluate, under controlled conditions, whether bovine whey proteins can elicit symptoms of infantile colic in colicky formula-fed infants. The mean age for entering the study was 6.4 weeks and the mean age for colic debut was 3.7 weeks. In 24 of 27 infants with severe colic, the symptoms disappeared when they were given a cow's milk-free diet (Nutramigen). These 24 infants were entered into a double-blind crossover study. The infants (receiving cow's milk-free diet) were given the contents of identical capsules with each meal during day 6. The same procedure was repeated on day 10. The capsules contained either whey protein powder (with Nutramigen added) or human albumin powder (with Nutramigen added). Eighteen infants receiving the whey protein-containing capsules reacted with colic, two infants receiving placebo reacted with colic (P< .001), and four infants did not react at all. Crying hours per day for the 24 infants were 5.6 hours for formula-fed infants and 0.7 hour for cow's milk-free diet-fed infants (P< .001). Crying hours per day were 3.2 hours for the infants receiving whey protein capsules and 1.0 hour for those receiving placebo (P< .001). In conclusion, bovine whey protein can elicit symptoms of infantile colic in colicky formula-fed infants.

ERRATA

PEDIATRICS ◽  
1989 ◽  
Vol 84 (1) ◽  
pp. 17-17
Keyword(s):  
Crossover Study ◽  
Whey Protein ◽  
Cow’S Milk ◽  
Infantile Colic ◽  
Double Blind ◽  
Milk Whey ◽  
Cow's Milk ◽  
Blind Crossover Study ◽  
Milk Whey Protein ◽  
Double Blind Crossover Study

In the article, "Cow's Milk Whey Protein Elicits Symptoms of Infantile Colic in Colicky Formula-Fed Infants: A Double-Blind Crossover Study," by Lothe and Lindberg (Pediatrics 1989;83:262-266), there was an error on page 264. The second sentence in "Results" should have read: Infants receiving cow's milkbased formula cried 3 h/d or more.

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