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Three Part Question

In [an 8-week-old baby with frequent crying] does [cranio-sacral therapy] result [in reduced crying]?

Clinical Scenario

An 8-week-old baby is admitted with bronchiolitis. His parents mention that he has always cried a lot and that he is having a course of cranio-sacral therapy to try and improve things. You wonder whether there is any evidence for this.

Search Strategy

Primary sources Medline, Cinahl, AMED, BNID and TRIP databases were searched Secondary sources - 0 results
"cranio-sacral therapy" and "osteopathic medicine" and "infant" and "children".

Search Outcome

Over 2000 article abstracts were scanned resulting in eight individual articles. There was one controlled trial.

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Hayden et al, 2006,	28 infants with colic	Open controlled prospective study	Hours of "colicky" crying per 24 h	Difference between treated and non-treated group in mean reduction in crying time of 1.0 h, 95% CI 0.14 to 2.19, p<0.02	Groups similar in other characteristics
			Hours of sleeping per 24 h	Difference in mean increase in sleep between treated and non-treated groups of 1.17 h, 95% CI 0.29 to 2.27, p<0.05

Comment(s)

We could only find one controlled trial investigating cranio-sacral therapy in crying babies. Despite this apparent lack of evidence, it is a therapy which is which known about and used by parents of young babies. Anecdotally, parents in clinic tell us it is something they turn to in desperation, and there are many articles in the lay press which suggest it as a possible solution for sleepless nights.

Cranio-sacral therapists believe that birth trauma can underlie many common childhood conditions ranging from minor ailments such as glue ear to more severe problems such as cerebral palsy, autism and epilepsy. They believe that even in a relatively straightforward delivery, restrictions or compressions may persist and inhibit proper growth or development (Turney). This is the rationale for treating babies with persistent crying with cranio-sacral therapy.

Treatment consists of the practitioner placing their hands very gently on the body and identifying areas of restriction or tension, and following the subtle internal twists and pulls of the cranio-sacral system until points of resistance are encountered and released, enabling the tissues to return to proper healthy functioning (Atlee). Treatment is said to be generally soothing and comfortable. Babies can be treated while cradled in their mother’s arms, and even while asleep.

The study by Hayden et al is the only controlled trial reported in the literature investigating whether cranio-sacral therapy produces significant benefit to crying infants. The authors asked the parents to complete crying and sleep diaries over a 4-week period while their child underwent weekly therapy and compared the results to those of a control group. Each child was seen weekly by the therapist, but only the intervention group received treatment. The parents were not blinded, so there is potential for observer bias. The results show a statistically significant reduction in hours crying (by 1.5 h per day in the treated group and 0.5 h in the control group) and also a small increase in hours of sleeping per day (1.35 h vs 0.18 h). Although these are small reductions in crying and increases in sleep, they may be perceived as worthwhile changes for sleep deprived parents.

It is not clear from this study how these improvements are brought about. Releasing tensions in the dura is the proposed mechanism. However, the natural history of crying and sleep in small infants is that it tends to improve with time and the small scale of this study makes this difficult to eliminate as a confounding factor.

The placebo effect is common in alternative therapies and a recent single blind randomised study showed that adults with irritable bowel syndrome improved with sham acupuncture, and even more so with sham acupuncture plus a supportive interview with their therapist(Kaptchuk).

In theory, the placebo effect of the clinical encounter can be divided into the responses to three main components: assessment/observation, therapeutic ritual (placebo) and the patient–physician relationship. The three components of the encounter can be progressively added to produce incremental improvements in symptoms. A therapeutic ritual (placebo treatment) has a modest benefit beyond no treatment, but the patient–physician relationship is the most robust component of the placebo effect. Placebo effects produce statistically and clinically significant improvements (Kaptchuk). This study went some way to addressing the placebo effect, but the lack of blinding may have made it difficult for the parents in the control group to fully engage with the therapist.

It may be that for parents with crying babies, having a cranio-sacral therapist to whom they can voice their concerns is the outlet by which they become more able to cope with their baby’s crying and also become more relaxed, leading to the baby picking up less anxiety from their parents.

Finally, no mention is made of the cost of treatment and inconvenience to families visiting a cranio-sacral therapist. While the treatment may have been provided at no cost in this trial, in most cases families would have to pay as this is not something generally provided by the NHS. The cost may be £30–40 per treatment, with most babies requiring more than one treatment. It is well recognised that people attribute a value to things which they personally pay for. In addition, the more expensive something is, the greater the value that may be put on it. A recent trial which looked at results when people were told a placebo analgesic was a "novel" preparation worth either $2.50 or 10 cents, found a significant improvement in analgesic effect with the more expensively labelled placebo preparation (85.4% vs 61%)(Waber). Cranio-sacral therapy is very expensive relative to prescription charges (currently £7.10 per item, though free for children) and as such one would expect a significant expectation of positive results to be placed upon it, particularly in the context of "desperate" parents.

Clinical Bottom Line

There is extremely limited evidence for the use of cranial osteopathy in infants, and this is restricted to the results of one small open controlled trial. (Grade C) A lot of parents turn to cranio-sacral therapy in desperation. Discussions with families about this therapy, and whether it may be appropriate for them, need to include the fact that no trial has adequately excluded the placebo effect. It cannot be recommended and should only be discussed in the context of an overview of the natural history of crying in babies and with reference to the financial costs with uncertain benefits.

References

1. Hayden C, Mullinger B. A preliminary assessment of the impact of cranial osteopathy for the relief of infantile colic. Complement Ther Clin Pract 2006;12:83–90.
2. Turney J. Tackling birth trauma with cranio-sacral therapy. Pract Midwife 2002;5:17–19.
3. Atlee T. Cranio-sacral therapy and the treatment of common childhood conditions. Health Visitor 1994;67:232–4.
4. Kaptchuk TJ, Kelley JM, Conboy LA, et al. Components of placebo effect: randomised controlled trial in patients with irritable bowel syndrome. BMJ 2008;336:999–1003.
5. Waber RL, Shiv B, Carmon Z, et al. Commercial features of placebo and therapeutic efficacy. JAMA 2008;299:1016–17.