Does osteopathy help in infantile colic? Evidence review

Date Last Updated: 03/08/06
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Does osteopathy help in infantile colic?

1.         Abstract
2.               Treatment
3.         Background
4.         Objectives
5.         Criteria for including studies
6.         Search strategy
7.         Data collection and evaluation of studies
8.         Description of studies
9.         Methodological quality
10.       Results
11.       Discussion of findings
12.       Conclusions
13.       References
14.      Further Resources

1. Abstract
Infantile colic has been commonly defined as inconsolable crying during at least 3 hours per day on at least 3 days a week for at least 3 weeks, in otherwise healthy, thriving infants under 6 months of age. There may be other symptoms present that suggest a gut problem. The cause of it is unclear and prevalence is estimated between 5 and 19%. Most infants are free of symptoms by the age of 6 months.

Osteopathy is a system of diagnosis and treatment that mainly focuses on the neuromusculoskeletal system. Practitioners perform manipulations to treat a wide range of problems. The practice of osteopathic medicine may involve massage, mobilization and spinal manipulation.

Some osteopaths also practice a technique known as cranial osteopathy or craniosacral therapy. Gentle pressure applied to parts of the skull and sacrum is thought to restore the patients’ health. (Green, Martin et al. 1999; Lesho 1999; Vickers and Zollman 1999)

The most important potential serious adverse effects are stroke and spinal cord injury after manipulation of the cervical spine (Vickers and Zollman 1999) how ever they are uncommon. (Lesho 1999) Adverse events have been reported in head-injured patients following craniosacral therapy.(Green, Martin et al. 1999)

There is level three evidence that cranial osteopathy may decrease the amount of inconsolable crying and increase the amount of sleep in infants with colic. Also there is evidence that the time spent holding and rocking the infant is reduced. No adverse events were reported.

2. Treatment
Type of treatment: Osteopathy

3. Background
There is no standard definition of infantile colic; however it has been defined as excessive crying in an otherwise healthy and thriving baby. A common definition of excessive crying is crying that lasts at least 3 hours a day, on at least three days a week, for at least 3 weeks. The crying typically starts in the first few weeks of life and ends by 6 months. There may be other symptoms; including pulling feet up to their stomach, flatulence, a bloated abdomen after feeding or inconsolable high pitched crying. (Lucassen, Assendelft et al. 1998; Lucassen, Assendelft et al. 2001; Wade and Kilgour 2001)

The reported prevalence of infantile colic ranges from 10-40%. The studies on prevalence vary in their definitions of infantile colic and their methodological quality varied considerably and was generally low; even the two most sound studies in a recent systematic review found the cumulative incident rates were between 5-19%.(Lucassen, Assendelft et al. 2001)

The cause of this condition is unclear. Four main causes are proposed in the literature:(Lucassen, Assendelft et al. 1998)

A gut problem with excessive crying due to painful gut contractions caused by lactose intolerance, allergy to cow’s milk or excess gas
a behavioural problem resulting from parental reactions to an infant with a difficult temperament
the extreme end of normal crying or
a collection of different, separate conditions.

Infantile colic improves with time; most infants are free of symptoms by the age of 4-5 months.(Lucassen, Assendelft et al. 1998; Lucassen, Assendelft et al. 2001; Wade and Kilgour 2001)

Osteopathy was systematised in the late 19^th century by Andrew Taylor Still in the United States. Its roots can be found in the folk traditions of “bone setting”.(MacLaren 1872; Radhika 2000)

Osteopathy is a system of diagnosis and treatment that mainly focuses on the neuromusculoskeletal system and osteopaths perform manipulations to treat a wide range of problems. Practitioners work with bones, muscles, and connective tissue, using their hands for diagnosis and treatment. Historically differs from chiropractic in its underlying theory that it is impairment of blood supply and not nerve supply that leads to problems.

The practice of osteopathic medicine may involve massage, mobilization and spinal manipulation. Osteopaths believe that body has an inherent ability to heal itself, that the structure and function of the body are closely related and that problems in one organ affect other parts of the body. The traditional osteopathic view is that perfect alignment of the musculoskeletal system eliminates obstructions in blood and lymphatic flow, which in turn maximizes health. To ensure perfect alignment, a range of manipulative techniques have been developed. Examples include high-velocity thrusts, myofascial (muscle tissue) release, muscle energy techniques, counter strain, craniosacral therapies and lymphatic drainage stimulation. (Vickers and Zollman 1999) For a more detailed description of various techniques, see Lesho 1999.(Lesho 1999)

Some osteopaths also practice a technique known as cranial osteopathy or craniosacral therapy. It is based on the idea that subtle rhythmic pulsations of the cerebrospinal fluid can be felt in the cranial bones and sacrum and that this gives the practitioner information about the patients’ health. Gentle pressure applied to parts of the cranium and sacrum is thought to affect these pulsations and restore the patients’ health. (Green, Martin et al. 1999; Lesho 1999; Vickers and Zollman 1999)

There is a low incidence of serious adverse effects from osteopathic manipulations.(Lesho 1999) The most important potential ones are stroke and spinal cord injury after manipulation of the cervical spine.(Vickers and Zollman 1999) Adverse events have also been reported in head-injured patients following craniosacral therapy.(Green, Martin et al. 1999) More common adverse events (25-50% of all patients) are mild pain, discomfort, or headache and fatigue. Three quarters of these resolve in 24 hours.(Vickers and Zollman 1999)

4. Objectives
The aim of this review is to assess the potential benefits and harms of osteopathy for the treatment of infantile colic.

5. Criteria for including studies
Types of study: Published systematic reviews or randomised controlled trials of osteopathy versus no treatment, placebo/sham osteopathic treatment or other therapeutic interventions, limited to the English language.

Types of participants: Infants (≤ 12 weeks) with infantile colic

Types of intervention: Osteopathic or cranial-sacral osteopathic treatment versus no treatment, placebo/sham osteopathic treatment or other treatments.

Types of outcome measure: Amount and/or intensity of symptoms including inconsolable crying, time spent sleeping, time spent rocking/being held/ walked or being soothed in any way, knees drawn up to chest, fists clenched, loud gurgling noises from abdomen and backward bending of head or trunk.

Exclusions: No previous osteopathic treatment and no signs or symptoms of other diseases.

6. Search strategy
We searched the following databases in May 2006: AMED, The Cochrane Library, MEDLINE, and CINAHL. We also checked the reference lists of publications retrieved by the search for further relevant studies. We also searched the World Wide Web for any other relevant studies.

7. Data collection and evaluation of studies
We used the above search strategy to obtain titles and abstracts of studies that were potentially relevant to this review. Where studies met the criteria for inclusion, they were assessed in full text. The quality of each study was evaluated using the GATE criteria (http://www.health.auckland.ac.nz/population-health/epidemiology-biostats/epiq/) for the evaluation of RCTs and systematic reviews. Where primary studies were included in a good quality systematic review, the systematic review was included rather than the individual primary studies.

The overall quality of the body of evidence (including all the included studies) was graded according to the NZGG CAM levels of evidence system (reference).

Relevant data were extracted from the studies selected for inclusion.

8. Description of studies
An RCT(Hayden and Mullinger 2006), published in 2006 was identified. Two other studies(Gludovatz 2003; Heber and Senger 2005) were identified from a web search with positive results but only their abstracts could be accessed. The abstracts did not contain enough information to accurately assess their quality so they were excluded.

Summary details of the RCT are as follows:

Study

Participants

Intervention & Comparison

Outcomes measured

Comment

Hayden

2006

United Kingdom

28 infants with infantile colic

22 male and 6 female

Age range 10-83 days old

Individualised cranial osteopathy as required

vs no treatment

weekly treatment for 4 weeks

· amount of inconsolable crying per 24 hours

· total time spent sleeping

· time infant was being held or rocked

Randomised using randomised number table

Allocation concealment not reported

Participants and staff unblinded to exposure or comparison

14% drop-out rate in control group (2/14)

Gludovatz

2003

Austria

[abstract]

10 infants with infantile colic

Comparison group: “equally large control group with similar initial situation”

Sex not reported

Age range 0-120 days

Osteopathic treatment

Comparison not reported

Treatment in intervals of two to three weeks

· frequency, duration and intensity of crying attacks

· intervals between breastfeeding

Case-control study

Undergraduate project

Not enough details to assess quality

Heber

2003

Germany

[abstract]

1. 46 infants with 3-month-colic for RCT

2. 90 patients for “explorative study”

Sex not reported

Age not reported

1. Osteopathic treatment vs conventional treatment

2. Questionnaire

· Duration and intensity of crying

· Evaluation of questionnaire

Randomised but method not reported

Not enough details to assess quality

German language

9. Methodological quality
The included study was evaluated using the GATE criteria. The first RCT was of fair quality. The other two studies were not appraised because only the abstracts could be obtained and one was in German.

10. Results
The RCT reported a significant reduction in mean time spent crying and a significant increase of mean total sleeping hours between weeks 1 and 4 in the treatment group.

In the treatment group all 14 infants improved; 4 (29%) required no more treatment after week two and 6 (43%) more did not need treatment after week three. The remaining 4 (29%) showed mild symptoms of colic at the end of the study.

In the control group, 2 (14%) infants improved within the first two weeks. Two infants (14%) withdrew from the study (one because of developing pneumonia and the other because of worsening symptoms of colic). Of the remaining 10, one improved by week three, another 4 by week four but the other 5 had continuing colic symptoms.

There was a significant reduction in hours spent crying of 1.5hrs between week 1 and week 4 in the treatment group and a non-significant reduction of 0.5hrs in the control group. There was a significant increase in hours spent sleeping of 1.35hrs between week 1 and week 4 in the treatment group and a non-significant increase of 0.18hrs in the control group. There was a significant reduction in hours holding and rocking (between week 1 and week 4) of 1.3hrs in the treatment group and a non-significant difference of 2.0hrs in the control group.

The difference between the two groups in the mean reduction of crying time was 1.0 (95% CI: 0.14, 2.19) hours per 24 hours (p<0.02)

The difference between the two groups in mean increase in sleeping time was 1.17 (95% CI: 0.29, 2.27) hours per 24 hours (p<0.05).

No adverse events were reported.

Summary of results:

Difference between the two groups (hours per 24 hrs)

95% confidence interval

P value

Mean reduction of crying time

1.0

0.14 to 2.19

p<0.02

Mean increase in sleeping time

1.17

0.29 to 2.27

p<0.05

11. Discussion of findings
There is some evidence that cranial osteopathy has a beneficial effect for infants with infantile colic over a 4 week period. A significant reduction in inconsolable crying and significant increase in the total hours sleeping was seen in those infants treated with cranial osteopathy. There were no significant changes in crying or sleeping in the untreated group. Although the effect itself seems small (crying decreasing by 1½ hours and sleep increasing by about 1hr 20 mins), most infants treated with osteopathy (71%) did not need any treatment after week 3 and the remaining 4 (29%) had only mild symptoms of colic at the end of the study. There were no adverse events from treatment reported in the study. A larger, double-blind study is recommended.

12. Conclusion
There is level three evidence that cranial osteopathy may decrease the amount of inconsolable crying and increase the amount of sleep in infants with colic. Also there is some evidence that the time spent holding and rocking the infant is reduced

13. References

Gludovatz, P. (2003). Effects of osteopathic treatments on onfantile colic. 2006: Undergraduate Project.

Green, C., C. W. Martin, et al. (1999). A systematic review and critical appraisal of the scientific evidence on craniosacral therapy. Vancouver, British Columbia Office of Health Technology Assessment.

Hayden, C. and B. Mullinger (2006). "A preliminary assessment of the impact of cranial osteopathy for the relief of infantile colic." Complement Ther Clin Pract 12(2): 83-90.

Heber, A. and U. Senger (2005). Osteopathic treatment of infantile colic. 2006: Thesis/Dissertation, Randomized Controlled Trial.

Lesho, E. P. (1999). "An overview of osteopathic medicine." 477-84.

Lucassen, P. L., W. J. Assendelft, et al. (1998). "Effectiveness of treatments for infantile colic: systematic review.[see comment][erratum appears in BMJ 1998 Jul 18;317(7152):171]." Bmj 316(7144): 1563-9.

Lucassen, P. L., W. J. Assendelft, et al. (2001). "Systematic review of the occurrence of infantile colic in the community. [Review] [47 refs]." Archives of Disease in Childhood 84(5): 398-403.

MacLaren, A. (1872). "Hood on bone-setting." Nature: 22-23.

Radhika, M. (2000). A tradition of bone setting.

Vickers, A. and C. Zollman (1999). "ABC of complementary medicine. The manipulative therapies: osteopathy and chiropractic. [Review] [0 refs]." Bmj 319(7218): 1176-9.

Wade, S. and T. Kilgour (2001). "Extracts from "clinical evidence": Infantile colic.[erratum appears in BMJ 2001 Sep 22;323(7314):674]. [Review] [25 refs]." Bmj 323(7310): 437-40.

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