Colic in infants causes excessive crying in an otherwise healthy and thriving baby. Colic is a common but poorly understood and often frustrating problem for caregivers. The objective of this trial was to study whether osteopathic treatments of infants with infantile colic / excessive crying (IC/EC) have an impact on the subjectively perceived psychological stress of caregivers compared to usual care.
The study was designed as a prospective, multicenter, randomized controlled trial. Infants aged 1 week to 3 months and who met Rome IV criteria for IC/EC were included. By means of external randomization, infants were allocated to an intervention group or a control group. Infants in the intervention group received three osteopathic treatments at intervals of one week. The treatments were custom-tailored and based on osteopathic principles. Controls received their osteopathic treatment after a 3 week untreated period. The primary outcome parameter was the assessment of parental psychological stress (three questions), measured using a numeric rating scale (NRS; 0-10). Furthermore, the average daily crying time (measured using the Likert scale), the crying intensity (measured using the NRS) and the parents’ self-confidence (measured using the Karitane Parenting Confidence Scale) were assessed.
A total of 103 infants (average age 39.4 ±19.2 days) were included, 52 in the intervention group and 51 in the control group. An inter-group comparison of changes revealed clinically relevant improvements in favor of the intervention group for the main outcome – parameter psychological stress – for all 3 questions (e.g., for question 2 respectively 3, NRS: between group difference of means 3.5; 95% CI: 2.6 to 4.4; p < 0.001). For the secondary outcome parameters of crying intensity and crying time/day, the changes were of similar magnitude.
The authors concluded that three osteopathic treatments given over a period of two weeks led to statistically significant and clinically relevant positive changes of parental psychological stress.
This is a cleverly designed study. I say ‘cleverly’ because the casual reader might not even notice that it compared osteopathic treatments with doing nothing. It is well-documented that just hadling babies with IC/EC has an effect on outcomes. Thus the positive effect may not have anything to do with osteopathy and be due simply to the extra attention given to the child. In other words, the positive result of the study was sure even before the 1st baby was entered into the trial.
I am impressed!
Perhaps this study should be in the textbook entitled:
HOW TO CHEAT WITH SEEMINGLY RIGOROUS CLINICAL TRIALS?
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