Arch Dis Child. 2001 (Feb); 84 (2): 138–141 ~ FULL TEXT
Olafsdottir E, Forshei S, Fluge G, Markestad T.
Department of Paediatrics,
University of Bergen,
5021 Bergen, Norway.
AIMS: To investigate the efficacy of chiropractic spinal manipulation in the management of infantile colic.
METHODS: One hundred infants with typical colicky pain were recruited to a randomised, blinded, placebo controlled clinical trial.
RESULTS: Nine infants were excluded because inclusion criteria were not met, and five dropped out, leaving 86 who completed the study. There was no significant effect of chiropractic spinal manipulation. Thirty two of 46 infants in the treatment group (69.9%), and 24 of 40 in the control group (60.0%), showed some degree of improvement.
CONCLUSION: Chiropractic spinal manipulation is no more effective than placebo in the treatment of infantile colic. This study emphasises the need for placebo controlled and blinded studies when investigating alternative methods to treat unpredictable conditions such as infantile colic.
From the Full-Text Article:
Infantile colic presents during the first three
months of life as excessive crying in an
otherwise healthy, thriving infant who has a
normal weight gain. Most studies on infantile
colic apply the diagnostic criteria ofWessel and
colleagues,  which define infantile colic as paroxysms
of uncontrollable crying or fussing in a
healthy infant less than 3 months of age; duration
of crying is more than three hours per day
and more than three days per week for more
than three weeks. Typically the crying in infantile
colic starts at the same time each day and is
most intense in the afternoon, evening, and at
Studies of crying in western infants have
shown that there is an expected increase in the
amount of crying from birth to reach a peak
around 6 weeks of age. Thereafter a decline is
observed until 12 weeks of age. There is an
evening clustering of crying in the first three
months of life; this pattern of crying is identical
to the pattern in infants with colic. [3-5]
A multitude of approaches to treatment
reflects the fact that the mechanisms underlying
infantile colic are not known. The main
hypotheses postulate that crying is a result of
behavioural disturbances or organic pain. [6-10]
Some infants with colic respond favourably
to a cow’s milk free diet for the mothers who
breast feed, or to cow’s milk free formula in
formula fed infants. [11-14]
Oral sucrose has an analgesic effect in
newborn infants  and has been shown to have
a significant ameliorating effect on infant
colic.  The anticholinergic drugs dicyclomine
hydrochloride and dicycloverine have been
effective in treating colic,  but are no longer
used because of serious side effects.  Simethicone
is often used, but controlled trials have
failed to show benefits. 
In Scandinavia, chiropractic treatment is frequently
used in infantile colic and both parents
and chiropractors have reported a favourable
effect. [20, 21] However, until recently the effect of
this treatment modality has been impossible to
evaluate because of lack of properly performed
controlled studies. In a study by Klougart et al,
chiropractic treatment seemed to have a
positive effect, but the trial did not include a
control group.  A recent randomised controlled
clinical trial with a blinded observer
concluded that spinal manipulation had a positive
short term effect, measured as a reduction
in hours of crying. 
The purpose of the present study was to
evaluate the efficacy of chiropractic spinal
manipulation in the treatment of infantile colic
in a randomised, blinded, and placebo controlled
Subjects and methods
From April 1998 to December 1999, 100 colicky infants were recruited in Bergen from public health care clinics, the paediatric outpatient clinic at the University Hospital, general practitioners, chiropractors, and from direct referrals from parents who were informed about the project at the maternity units in Bergen and by the media.
Before entering the study, all the following criteria had to be met.
Typical infantile colic as defined by Wessel et al (minimum of three hours of crying per day, three days per week for the last three weeks).  The infants were aged 3–9 weeks.
No benefit from cow's milk free diet to the mother for four days in breast fed infants, or casein hydrolysed formula for four days in bottle fed infants.
No signs of lactose intolerance, as examined by pH and reducing substances in the stools.
Insufficient effect of sucrose on crying.
No previous chiropractic treatment.
Appropriate gain in weight, length, and head circumference and a normal psychomotor development on paediatric physical examination.
Born at term with a birth weight of more than 2500 g.
Written informed consent from the parents before entering the study.
The parents were given written information about the study, and were interviewed by one of the investigators (EO). They were asked to keep a 24 hour diary of the infant's crying. The registration started two days before their first visit, and continued until the last visit at the hospital.
At the first visit the infant was randomised (sealed envelopes) to whether spinal manipulation should be given or not. At each visit the parents described the effect of the last visit on a scale of five categories — “getting worse”, “no improvement”, “some improvement”, “marked improvement”, “completely well” — which were defined as the main outcome measure. One paediatrician (EO) was in contact with all the parents at each visit and filled in the scoring system. Neither doctor nor parents knew whether the infant received treatment or not. A nurse brought the infant to the chiropractor. The infants who did not get spinal manipulation were just held by the nurse for 10 minutes (the approximate time of treatment) after being partially undressed in a similar way as treated infants. In the treatment group the chiropractor palpated the infant's spinal articulations with respect to areas of dysfunction. Dysfunctional articulations were manipulated and mobilised using light fingertip pressure. Before commencing the study the method of chiropractic treatment was agreed by a reference group of 14 chiropractors. The treatment was given three times, at intervals of two to five days, for a period of eight days.
At the repeated visits the infant was examined clinically, and the parents received counselling and support on feeding, baby care, and family interaction as usually given to families with colicky infants. After the last visit there was an observation period of eight to 14 days. At the end of the observation period, the parents were contacted by telephone and interviewed according to the same categorical scale, by a blinded observer.
The study was approved by the regional committee on medical research ethics.
All statistic calculations and graphic designs were performed using commercially available software (SPSS for Windows, version 9.0.0, 1998, SPSS Inc., Chicago, Illinois).
Categorical variables with responses on a nominal scale were analysed with Fischer's two tailed exact test; ordinal variables were analysed with the Mann–Whitney test. The amount of crying from the infants' crying diaries (mean group differences) were analysed with Student's t test. Two tailed p values were employed, and a p value of less than 0.05 was considered significant; 95% confidence intervals (CI) and relative risks (RR) were given whenever appropriate.
One hundred infants were recruited to the trial and randomised to either receive treatment with spinal manipulation or not. Of these 100 infants, nine were excluded because of transient lactose intolerance (n = 6), hypogalactia (n = 2), or not fulfilling Wessel's criteria when interviewed on the second visit (n = 1). There were five dropouts: four did not come to the second visit (one in the treatment group and three in the control group), and one dropped out later from the control group.
All 86 infants who completed the study were born at term. They were healthy, had gained appropriately in weight, length, and head circumference, and psychomotor development was normal (table 1). The mean duration of colic was 3.9 weeks, and most of the infants had a consistent diurnal pattern of crying (86.9%). Many of the parents had tried various treatments before entry to the trial. There were no differences between the groups treated and not treated with regard to entry data, except for number of boys and girls: there were fewer girls in the control group than in the treatment group (p = 0.031; table 1).
There was no difference in outcome between those treated and not treated when analysed according to the parents' report (Mann–Whitney test, p = 0.743; table 2), or according to hours of crying based on the diaries for 42 infants in the treatment group and 33 infants in the control group (Student's t test, p = 0.982; table 3). In both the treatment and control group there was a reduction in crying hours per day during the study, from a mean of 5.1 to 3.1 hours per day in the treatment group (41 diaries) and from a mean of 5.4 to 3.1 hours per day in the control group (31 diaries; table 3). In the treatment group, 32 of 46 infants (69.9%) showed some degree of improvement according to the parents' report, whereas in the control group 24 of 40 infants (60.0%) improved. The difference is not statistically significant (Ficher's exact test, p = 0.374).
When analysing data according to “intention to treat” to take into account the infants that dropped out from the study, we found no significant difference between the groups on the parent's report, when using either Fischer's test (p = 0.656) or the Mann–Whitney test (p = 0.861).
This is the first study that we are aware of,
which investigates the effect of chiropractic
spinal manipulation in the treatment of infantile
colic in a randomised, blinded, placebo
controlled clinical trial. In addition to a blinded
observer, the parents were blinded as well and
did not know whether the infant received treatment
with spinal manipulation or not.
In our study we used the parents’ final scoring
on a scale of 1–5 as a main measure of outcome.
Applying the Mann–Whitney test there
was no significant difference between the treatment
and the placebo group. We also used a
crying diary before and during the study in
most of the infants; both groups showed a
reduction in hours of crying per day during the
study, but again there was no significant difference
between the treated group and the control
As reported in previous, controlled studies,
our study shows a strong placebo effect, and
also an effect of counselling and support to the
parents of colicky infants. [23, 24]
One controlled study that validated spinal
manipulation as a treatment of infantile colic
has been published previously.  It showed a
significant difference between hours of crying
per day in two groups of infants, one treated
with spinal manipulation and the other with
dimethicone. The reduction in hours of crying
from pretreatment to days 8–11, was 2.7 hours
versus 1.0 hour respectively in the two groups.
Although this study was randomised and
controlled with a blinded observer, the parents
were not blinded, and there is thus a possibility
for bias. The parents of infants in the manipulation
group might have had higher expectations
about a cure for their infants than parents
of infants who were given dimethicone. In previous
studies this drug has shown no benefits
when compared to placebo treatment. 
In our study all infants were treated by the
same chiropractor, who has treated colicky
infants with spinal manipulation for many
years. The infants and their families were seen
by the same doctor and nurse. In order to
ensure general agreement, the method of chiropractic
treatment was agreed by a reference
group of 14 chiropractors before commencing
the study. The type of spinal manipulation used
in this study was a form of modified fingertip
mobilisation; a very light manipulation was performed.
This procedure is somewhat different
from the manipulative procedures commonly
employed by chiropractors when treating
adults. Characteristically a controlled force is
delivered to spinal joints in a specific direction
with high velocity, often accompanied by joint
“crack” or vacuum phenomenon.  In this study
the typical joint “cracks” were not heard in any
of the infants. Spinal manipulation is commonly
used in the treatment of back and neck
disorders,  but it is controversial whether this
treatment has any effect on other disorders,
especially in children. [27, 28]
Entry data for infants in our study showed a
significant difference in the number of girls and
boys in the groups, with fewer girls in the control
than in the treatment group. This finding
should not influence the results of our study as
previous studies on infantile colic have not
shown any sexual predilection. [29-31]
We adhered strictly to the inclusion criteria,
and excluded those children with colic that
responded favourably to a cow’s milk free diet
in the mothers who breast fed their infants or
cow’s milk free formula in formula fed infants.
Studies have shown that some infants benefit
from this change in their diet. [11-14]
It is reasonable to expect that infants with
colic who responded to general measures such
as guidance and sugar water were not referred
to the study. Sugar water was introduced in this
area in 1997  and is widely used.
In conclusion, our findings indicate that
there are no benefits from treating infantile
colic with chiropractic spinal manipulation.
Improvement occurred in both the treatment
and control groups. This may reflect an effect
of general counselling and support from the
professional team or a natural spontaneous
improvement as a result of increasing age. The
study emphasises the need to investigate
similar alternative methods of treatment by
placebo controlled and blinded studies in order
to document whether these treatment regimens
are effective or not. This is important in order
to establish appropriate advice and counselling
to parents of colicky infants, and as a
cost–benefit analysis of the treatments used in