Lay Summary

What is infantile colic?
Crying is a baby's normal response to discomfort, such as being hungry, tired or needing a diaper change. Infantile colic is defined as excessive crying for no apparent reason, in an otherwise healthy baby. Crying is considered excessive when it lasts for more than 3 hours per day for at least 3 days per week, and for more than 3 weeks. Colic is common (up to 25% of all infants) and can be very frustrating and concerning for parents. The cause is not known, but colic usually goes away on its own by the time babies are 3 months old.

How is colic treated conventionally?
Colic is treated many different ways in conventional medicine, often starting with soothing techniques. These include swaddling, rocking or other movements, music and "white noise". There are many over-the-counter medications available to treat colic but none have a consistent effect and they should not be used routinely. Colic eventually improves with or without treatment in all babies.

What is Complementary and Alternative Medicine (CAM)?
Complementary and alternative medicine (CAM) is a group of diverse health care systems, practices and products that are not presently considered to be part of conventional medicine. Examples of CAM practices include massage therapy and acupuncture. Examples of CAM products (also known as natural health products) include Echinacea and St. John's wort.

What kinds of CAM are used to treat colic?
There are many CAM therapies used to treat colic. Many treatments have not been well studied in children, especially regarding effectiveness and safety. There are very few high-quality studies, and this can make it difficult to give good evidence-based advice. The information presented here is based on published research. In particular, randomized, controlled trials (RCTs) of commonly used CAM and studies involving children were searched. For colic, the focus will be on 5 kinds of CAM:

- Natural health products (NHPs)
- Massage
- Chiropractic
- Osteopathy
- Educational and behavioural interventions

Natural Health Products (NHPs)
NHPs are widely used for prevention and treatment of various conditions and to maintain health. Examples include herbals, homeopathic remedies, vitamins, minerals, probiotics, amino acids, and traditional medicines. Dosing and quality of products can vary significantly. NHPs commonly used to treat colic include fennel, chamomile, peppermint, ginger, catnip and thyme. Fennel seed oil, some herbal concoctions, sucrose (sugar water) and hypoallergenic baby formula have been found to be effective in studies.

Fennel seed oil
3 randomized controlled trials (RCTs) looked at the effect of fennel (Foeniculum vulgare) on infantile colic. Fennel seed oil was used in a 2003 Russian study. The second study used an herbal tea containing fennel, chamomile, vervain, licorice and balm-mint in a 1993 trial from Israel. The third study was an Italian RCT from 2005 that used an extract of fennel, chamomile and lemon-balm. All 3 studies showed improvement of colic symptoms with the products.

Safety of fennel
No side effects were reported in these studies, and long-term effects are unknown. However, fennel has been known to cause allergic reactions such as rashes and asthma attacks, and seizures have also been reported. Also, the second study involving the herbal tea used significant volumes of tea (up to 450mL per day) that could potentially affect growth and nutrition.

Sucrose
Sucrose (sugar water) is known to prevent pain in very young infants, usually less than one month old, when given just before procedures such as blood tests and circumcisions. A very small 1997 study of colicky Norwegian infants reported positive effect of sucrose compared to distilled water.

Safety of sucrose
No side effects were reported in this study. Many larger studies have shown sucrose to be very safe, although safety of frequent or long-term dosing is unknown.

Soy and hypoallergenic formulas
Most infant formulas are based on cow's milk, so other types of formulas are sometimes tried to see if they help colic. A systematic review published in 1998 looked at 5 studies investigating the effectiveness of substituting cow's milk formula with soy milk formula (3 studies) or hypoallergenic formula (2 studies) for 6-8 days.

The hypoallergenic formula was a casein hydrolysate. It was found to be effective in treating colic. The effect of soy formula was unclear once lower quality studies were excluded from the analysis.

Safety of soy and hypoallergenic formulas
No side effects were reported in this study. Hypoallergenic formulas can be more expensive than regular cow's milk formulas, but are very safe. Soy formulas are also safe unless there is a known allergy to soy.

Massage therapy
One randomized controlled trial published in 2000 showed no difference between massage performed by parents compared with crib vibrator for colicky Finnish infants.

Safety of massage therapy
Massage therapy is very safe, and this study showed no side effects. There are 2 cases of stroke reported in adults after shiatsu-type neck massage.

Chiropractic
The World Federation of Chiropractic (WFC) defines chiropractic care as the diagnosis, treatment and prevention of mechanical disorders of the musculoskeletal system, and the effects of these disorders on the function of the nervous system and general health. It uses manipulation of the spine, joints and soft tissues to treat various conditions and to maintain and restore health.

There is very little pediatric evidence for chiropractic therapy in general, but the evidence of effectiveness for the treatment of colic is not strong. The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) looked at 3 randomized controlled trials of spinal manipulation therapy (SMT) for treatment of infant colic, but they were not high quality studies. 2 studies were published in 1999. The first was an Australian trial comparing SMT and non-functional ultrasound, and the second was a Danish study looking at SMT versus dimethicone (also known as simethicone). Both studies showed improvement of colic symptoms with SMT. The third study was published in 2001, and no difference was found between SMT and 10 minutes of cuddling by a nurse.

Safety of chiropractic
Safety of chiropractic therapy in children is not known due to limited research. Children's bodies and spines are immature and they are more vulnerable to potential injury from rapid and forceful manipulations, especially young children and infants. Less forceful techniques may be less likely to cause spinal injuries. Serious events requiring hospitalization or resulting in permanent loss of function seem to be rare. Financial costs may be a barrier for some families.

Osteopathy
The World Osteopathy Health Organization defines osteopathy as a health care system that relies on manual contact for diagnosis and treatment. Osteopathic medicine varies according to the country. For instance, osteopathy in the United States is similar to conventional medicine in training and practice, and in Canada it has more in common with chiropractic. Various manipulative techniques are generally less forceful than chiropractic. Osteopathy emphasizes the structural and functional integrity of the body and the body's intrinsic tendency for self-healing.

There is very little pediatric evidence for osteopathic treatments. One small 2006 study from England showed that treatment relieved colic symptoms.

Safety of osteopathy
Safety of osteopathic therapy in children is not known due to limited research. Adverse events have generally not been reported, but spinal manipulation may cause injury. Financial costs may be a barrier for some families.

Education and Behavioural Interventions
Although behavioural management techniques may not be considered as CAM to some parents and practitioners, information is included here to provide a broader range of non-medical interventions for colic. Interventions consist of several therapies, such as parental education about colic, parental counseling, infant soothing techniques, and ways to reduce stimulation.

2 small older studies looked at the effects of counseling and behavioural management in the treatment of colic. One 1993 study from Canada found no effect of the interventions, compared with a car-ride simulator and a control group. The second study was a 1994 trial from United Kingdom and it showed a small benefit, although it involved older infants up to 5 months old who may not represent typical colic.

Safety of mind-body techniques
There are no well-established tools to assess side effects of mind-body therapies, but studies suggest that 5-54% of people may experience some forms of anxiety, unpleasant sensations or thoughts, or muscle spasms. Factors associated with such experiences include fear of letting go or losing control, restlessness, and feelings of vulnerability. These side effects may cause some people to stop therapy. In other cases, the feelings are used to therapeutically to explore and cope with these fears. Adequate preparation and supervision of therapy may help minimize and prevent such effects.

Conclusions

There is research showing that CAM can help infants with colic. However, many of the studies have significant limitations that make it difficult to offer advice with confidence based on their conclusions, whether positive or negative. These limitations include lack of safety information (especially long-term side effects), flaws in methodology, and small numbers of patients recruited. Evidence from a single trial of any specific CAM should encourage further study and confirmation of conclusions, and the use of such therapies should be supervised with caution by health care providers. Pediatric dosing is often unknown and the quality of some natural health products is unreliable, making safety a further concern. Adults respond to therapies in ways that children may not, therefore assumptions based on adult experience can be inaccurate or even harmful. Also, some therapies and products can be costly and add financial stress for families.

The following figure shows how the evidence for each CAM can be organized according to safety and effectiveness.

Green
Herbal concoctions containing fennel, chamomile, mint and other herbs
Sucrose (sugar water)
Hypoallergenic baby formula
Osteopathy

Blue
Soy milk
Massage
Education and behavioural interventions

Yellow
Chiropractic

The CAM therapies are organized into colour-coded categories for clarity. Conventional medications can also be categorized similarly. For instance, many over-the-counter medications would fall into the blue area, and many prescription medications would fall into the yellow area. Some pediatric health issues can be potentially serious, especially if the condition is chronic, or multiple therapies, NHPs and medications are used together. The decision to use CAM should be based on each child's health and include discussion with the child's physician.

The natural course of colic is that it gets better with time, regardless of therapy. Each child is unique, and families must weigh the risks and benefits of all interventions as objectively as possible. This is especially important for therapies and products in which good evidence is limited or unknown. The information provided here is intended to promote discussion among parents and health care providers of infants with colic and is not meant to replace medical advice. More high-quality studies are needed to guide recommendations about effectiveness and safety of CAM for treatment of colic, and to assist caregivers and families in making informed decisions about treatment options.

Funding: Partial funding support for this review was received from Passeport Santé.

Lay summaries: For more information in French, please see Passeport Santé.

Clinician summaries: Full scientific review article will be published in Pediatrics in Review.

Disclaimer: The information available on this website is intended to provide general information about complementary and alternative medicine (CAM). This website does not provide specific medical advice and the information provided should not be used as a substitute for seeking medical advice from a registered health practitioner. The opinions expressed on this website are not necessarily reflective of the opinion of the Stollery Children's Hospital, Capital Health Authority,Passeport Santé or Pediatrics in Review.