Abstract
Introduction
Colic in infants causes one in six families (17%) with children to consult a health professional. One systematic review of 15 community-based studies found a wide variation in prevalence, which depended on study design and method of recording.
Methods and outcomes
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for colic in infants? We searched: Medline, Embase, The Cochrane Library, and other important databases up to September 2009 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Results
We found 27 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
Conclusions
In this systematic review we present information relating to the effectiveness and safety of the following interventions: advice to increase carrying, advice to reduce stimulation, casein hydrolysate milk, cranial osteopathy, crib vibrator device, focused counselling, gripe water, infant massage, low-lactose milk, simethicone, soya-based infant feeds, spinal manipulation, and whey hydrolysate milk.
Key Points
Colic in infants is defined as excessive crying in an otherwise healthy and thriving baby. The crying typically starts in the first few weeks of life and ends by age 4 to 5 months.
It causes one in six families with children to consult a health professional.
We found insufficient RCT evidence to judge whether replacing cows' milk or breast milk with casein hydrolysate milk, low-lactose milk, soya-based infant feeds, or whey hydrolysate formula is effective in reducing crying time.
Breastfeeding mothers should generally be encouraged to continue breastfeeding.
Soya milk is associated with possible long-term harmful effects on reproductive health.
The RCTs examining the effects of reducing stimulation (by not patting, lifting, or jiggling the baby, or by reducing auditory stimulation), crib vibration, infant massage, focused counselling, or spinal manipulation were too small for us to draw reliable conclusions.
We found no good RCT evidence assessing cranial osteopathy or gripe water for treating colic in infants.
Despite a lack of evidence from well-conducted trials, gripe water is commonly used by parents for their colicky infants.
Increasing the time spent carrying the infant (by at least 3 hours) does not seem to reduce the time spent crying, and may increase anxiety and stress in the parents.
RCTs identified assessing the effects of simethicone are of insufficient quality to draw reliable conclusions on the effectiveness of simethicone in treating colic.
About this condition
Definition
Colic in infants is defined as excessive crying in an otherwise healthy and thriving baby. The crying typically starts in the first few weeks of life and ends by age 4 to 5 months. Excessive crying is defined as crying that lasts at least 3 hours a day, for 3 days a week, for at least 3 weeks. Because of the natural course of infant colic, it can be difficult to interpret trials that do not include a placebo or have no treatment group for comparison.
Incidence/ Prevalence
Infant colic causes one in six families (17%) with children to consult a health professional. One systematic review of 15 community-based studies found a wide variation in prevalence, which depended on study design and method of recording. Two prospective studies identified by the review yielded prevalence rates of 5% and 19%. One prospective study (89 breast- and formula-fed infants) found that, at 2 weeks of age, the prevalence of crying over 3 hours a day was 43% among formula-fed infants and 16% among breastfed infants. The prevalence at 6 weeks was 12% among formula-fed infants and 31% among breastfed infants. A national survey of 3345 infants found that maternal smoking was potentially associated with colic (OR 1.34, 95% CI 0.88 to 2.04).
Aetiology/ Risk factors
The cause is unclear and, despite its name, infant colic may not have an abdominal cause. It may reflect part of the normal distribution of infantile crying. Other possible explanations are painful intestinal contractions, lactose intolerance, wind, or parental misinterpretation of normal crying.
Prognosis
Infant colic improves with time. One self-reporting parent questionnaire on crying patterns found that 29% of infants aged 1 to 3 months cried for more than 3 hours a day, but that by 4 to 6 months of age the prevalence had fallen to 7% to 11%.
Aims of intervention
To reduce infant crying and distress, and the anxiety of the family, with minimal adverse effects of treatment.
Outcomes
Presence and duration of colic, as determined by frequency and duration of crying, measured on dichotomous, ordinal, or continuous scales or by parents' perceptions of severity and duration of colic recorded in a diary.
Methods
Clinical Evidence search and appraisal September 2009. The following databases were used to identify studies for this systematic review: Medline 1966 to September 2009, Embase 1980 to September 2009, and The Cochrane Library (all databases) Issue 3, 2009. Additional searches were carried out using these websites: NHS Centre for Reviews and Dissemination (CRD) (all databases), Turning Research into Practice (TRIP), and National Institute for Health and Clinical Excellence (NICE). Abstracts of the studies retrieved from the initial search were assessed by an information specialist. Selected studies were then sent to the author for additional assessment, using predetermined criteria to identify relevant studies. Study design criteria for inclusion in this review were: published systematic reviews and RCTs in any language, and containing at least 20 individuals of whom more than 80% were followed up. There was no minimum length of follow-up required to include studies. We excluded all studies described as "open", "open-label", or not blinded unless blinding was impossible. We searched for all comparisons for included interventions, including comparisons against placebo or between included interventions, and reported any RCTs of sufficient quality that we found. We excluded RCTs in infants with normal crying patterns, infants older than 6 months, in interventions lasting less than 3 days, trials with no control groups, or trials with low scores on the Jadad scale. In addition, we use a regular surveillance protocol to capture harms alerts from organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA), which are added to the reviews as required. To aid readability of the numerical data in our reviews, we round many percentages to the nearest whole number. Readers should be aware of this when relating percentages to summary statistics such as relative risks (RRs) and odds ratios (ORs). We have performed a GRADE evaluation of the quality of evidence for interventions included in this review (see table ). The categorisation of the quality of the evidence (high, moderate, low, or very low) reflects the quality of evidence available for our chosen outcomes in our defined populations of interest. These categorisations are not necessarily a reflection of the overall methodological quality of any individual study, because the Clinical Evidence population and outcome of choice may represent only a small subset of the total outcomes reported, and population included, in any individual trial. For further details of how we perform the GRADE evaluation and the scoring system we use, please see our website (www.clinicalevidence.com).
Table 1.
GRADE evaluation of interventions for colic in infants
| Important outcomes | Duration of crying caused by colic, adverse effects | ||||||||
| Number of studies (participants) | Outcome | Comparison | Type of evidence | Quality | Consistency | Directness | Effect size | GRADE | Comment |
| What are the effects of treatments for colic in infants? | |||||||||
| 1 (66) | Duration of crying | Advice to carry infant v general advice | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and incomplete reporting of results |
| 1 (42) | Duration of crying | Advice to reduce stimulation v no advice | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and uncertain validity of outcome measure |
| 1 (122) | Duration of crying | Casein hydrolysate milk or hypoallergenic diet for breastfeeding mother v cows' milk or control diet for mother | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and incomplete reporting of data. Directness point deducted for inclusion of different interventions |
| 1 (38) | Duration of crying | Counselling plus reassurance v crib vibrator device plus reassurance v reassurance alone | 4 | –2 | 0 | –1 | 0 | Very low | Quality point deducted for sparse data and incomplete reporting of results. Directness point deducted for range of interventions advised as part of counselling |
| 1 (20) | Duration of crying | Counselling v elimination of cows' milk or soya milk with casein hydrolysate | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for range of interventions advised as part of counselling |
| 1 (58) | Duration of crying | Infant massage v crib vibrator device | 4 | –1 | 0 | –1 | 0 | Low | Quality point deducted for sparse data. Directness point deducted for inclusion of babies without colic |
| 1 (53) | Duration of crying | Low-lactose milk v standard milk | 4 | –2 | 0 | –1 | 0 | Very low | Quality points deducted for sparse data and methodological flaws. Directness point deducted for uncertain lactose intolerance in babies |
| 3 (136) | Duration of crying | Simethicone v placebo | 4 | –2 | –1 | 0 | 0 | Very low | Quality points deducted for sparse data and methodological flaws. Consistency point deducted for conflicting results |
| 1 (41) | Duration of crying | Simethicone v spinal manipulation | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and lack of blinding |
| 1 (86) | Duration of crying | Spinal palpation v holding | 4 | –1 | 0 | 0 | 0 | Moderate | Quality point deducted for sparse data |
| 1 (43) | Duration of crying | Whey hydrolysate milk v cows' milk formula | 4 | –2 | 0 | 0 | 0 | Low | Quality points deducted for sparse data and flawed blinding |
Type of evidence: 4 = RCT; 2 = Observational; 1 = Non-analytical/expert opinion. Consistency: similarity of results across studies Directness: generalisability of population or outcomes Effect size: based on relative risk or odds ratio
Glossary
- Casein hydrolysate milk
is a hypoallergenic milk made of cows' milk and containing predominantly casein proteins.
- Cranial osteopathy
Involves gentle manipulation of the tissues of the head by an osteopath.
- Crib vibrator device/car ride simulators
These attempt to sooth crying infants, and involve attaching a small motor underneath the crib to vibrate it, and a box to the side of the crib to produce white noise. are a type of crib vibrator device designed to simulate the sound and motion of a car travelling at 55 miles an hour.
- Jadad scale
This measures factors that have an impact on trial quality. Poor description of the factors, rated by low figures, is associated with greater estimates of effect. The scale includes three items: was the study described as randomised? (0–2); was the study described as double blind? (0–2); was there a description of withdrawals? (0–1).
- Low-quality evidence
Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
- Moderate-quality evidence
Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
- Reassurance
Informing the parent that infantile colic is a self-limiting condition resolving by 3–4 months of age, and is not caused by disease or any fault in parental care.
- Simethicone (activated dimeticone [dimethicone])
This has defoaming properties, which can aid dispersion of wind in the gastrointestinal tract.
- Soya-based infant feeds
Contain proteins from soya beans; the feeds are used as lactose-free vegetable milks for those with lactose or cows' milk protein intolerance.
- Very low-quality evidence
Any estimate of effect is very uncertain.
- Whey hydrolysate milk
is a hypoallergenic milk made from cows' milk and containing predominantly whey proteins.
Disclaimer
The information contained in this publication is intended for medical professionals. Categories presented in Clinical Evidence indicate a judgement about the strength of the evidence available to our contributors prior to publication and the relevant importance of benefit and harms. We rely on our contributors to confirm the accuracy of the information presented and to adhere to describe accepted practices. Readers should be aware that professionals in the field may have different opinions. Because of this and regular advances in medical research we strongly recommend that readers' independently verify specified treatments and drugs including manufacturers' guidance. Also, the categories do not indicate whether a particular treatment is generally appropriate or whether it is suitable for a particular individual. Ultimately it is the readers' responsibility to make their own professional judgements, so to appropriately advise and treat their patients.To the fullest extent permitted by law, BMJ Publishing Group Limited and its editors are not responsible for any losses, injury or damage caused to any person or property (including under contract, by negligence, products liability or otherwise) whether they be direct or indirect, special, incidental or consequential, resulting from the application of the information in this publication.
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