Table 1.
Characteristics of the included studies.
| Author Year (Ref.) | n/Characteristics of Participants/ Age or Age Range |
Experimental Intervention (Duration/Frequency/Intensity) |
Control | Outcome Measure |
Main Result (Between-Group Differences) |
Effect Estimate | Authors’ Conclusions |
AEs/COI | Main Limitations |
|---|---|---|---|---|---|---|---|---|---|
| Accorsi 2014 [18] | 28/Children aged 5 to 15 years with attention-deficit/hyperactivity disorder | OMT + UC (6 sessions, 40 min each) | UC only (drug therapy and psychosocial intervention) | Biancardi-Stroppa Modified Bell Cancellation Test: a. accuracy and b. rapidity scores |
a. p = 0.04 §§ b. p = 0.03 §§ |
1.a. β = 7.948, 95% CI 0.18 to 15.71; 1.b. β = 9.090, 95% CI 0.82 to 17.35 |
“Participants who received OMT had greater improvement in Biancardi- Stroppa Test scores than participants who received conventional care only” |
None reported/not reported | Univariate analyses for post-interventions are missing; very small sample, significant baseline differences; possible confounding effects of UC |
| Castejón-Castejón 2019 [30] | 58/infants aged 0–84 days/infantile colic | OMT (craniosacral therapy) (1–3 sessions, 30–40 min each) | No treatment | 1. Crying hours 2. Sleep hours 3. Colic (pain) severity |
1. p < 0.0005) 2. p < 0.0005) 3. p < 0.0005) |
1. MD = −3.2 (95% CI −3.7, −2.6) at day 24 2. MD = 3.13 (95% CI 2.2, 3.9) at Day 24 3. −18.55 95% CI 21.4, −15.6) at day 24 |
“Craniosacral therapy appears to be effective and safe for infantile colic by reducing the number of crying hours, the colic severity and increasing the total hours of sleep.” | None reported/not reported | Small sample, no control for placebo effects, no blinding of parents |
| Cerritelli 2013 [19] | 110/preterm infants (34 weeks) * | OMT + UC (20 min) | UC only | 1. Length of stay 2. Daily weight gain 3. Costs |
1. p < 0.03 2. p = 0.06§ 3. p < 0.001§ |
MD = −5.20; 95% CI −12.08 to 1.68 (in days) ^ | “The present study suggests that OMT may have an important role in the management of preterm infants hospitalization.” | None reported/none declared | Unequal distribution of loss to follow-up; unclear why newborns transferred from another hospital were ineligible |
| Cerritelli 2015 [20] | 695/preterm infants (range: 29 to 37 weeks) * | OMT + UC (30 min/for the entire hospitalization, twice a week) | UC only (20 min) | 1. Length of stay 2. Daily weight gain 3. Costs |
1. p < 0.001 2. n.s. 3. p < 0.001 |
ES = 0.31 | “Osteopathic treatment reduced significantly the number of days of hospitalization and is cost-effective on a large cohort of preterm infants” | None reported/none declared | Well-designed and adequately powered, unequal distribution of loss to follow-up, missing details of the OMT |
| Danielo Jouhier 2021 [24] | 128/infants (range 38–42 weeks) | OMT (two sessions) | No OMT | Exclusive breast milk feeding at 1 month | 1. n.s. | OR = 0.55; 95% CI 0.26 to 1.17 | “OMT did not improve exclusive breast feeding at 1 month.” |
None reported/none declared | No control for placebo effects |
| Haiden 2015 [21] | 41/preterm infants (32 weeks) * | Visceral OMT (3 times during their first week of life) | No treatment | 1. Time to enteral feedings 2. Length of hospital stay |
1. p = 0.02 2. n.s. |
n.r. | “Infants in the OMT group had a longer time to full enteral feedings and a longer hospital stay what must be interpreted as negative side effect. |
None reported/none reported | Small sample, no control for placebo effects, no blinding |
| Herzhaft-Le Roy 2017 [22] | 97/infants with biomechanical impairments to suckling (mean = 15 days) |
OMT + UC (4 treatments, once a week for 4 weeks) | UC | LATCH score | p = 0.001 | MD = 1.04 | “Findings support the hypothesis that the addition of osteopathy to regular lactation Consultations is beneficial and safe” |
None reported/none declared | Lack of objective outcome measures, treatment protocol not standardized, small sample, underpowered |
| Jones 2021 [23] | 58/children with asthma (mean = 10.8 years) |
OMT + UC (single session 15–20 min) | UC | 1. FEF 25–75% 2. FVC 3. FEV1 4. FEV-1/FVC ^^ |
1. p = 0.05 2. p = 0.26 3. p = 0.06 4. p = 0.51 |
1. Mean change + 4.4% 2. Mean change + 2.4% 3. Mean change 2.4% 4. Mean change = 0% |
“The benefits of OMT on short term spirometry results in pediatric asthma patients remain unclear” |
Not reported/none declared | Small sample, lack of follow-up, long-term benefits/harms unknown, selection bias, baseline differences in pulmonary function |
| Manzotti 2020 [25] | 96/preterm infants (mean (SD) 33.5 (4.3) weeks)) | OMT + UC (single session 20 min) | Static touch + UC | 1. Heart rate 2. Oxygen saturation |
1. n.s. 2. p = 0.04 |
1. Mean change (SD) = 1.2 (13.1) 2. Mean change (SD) = 0.3 (2.4) |
“Results from the present study suggest that a single osteopathic intervention may induce beneficial effects on preterm physiological parameters.” |
Not reported/none declared | Lack of follow-up; poor biological plausibility, underpowered |
| Pizzolorusso 2014 [26] | 110/preterm infants (range 33.8 and 34.3 weeks) * | OMT (twice per week, 20 min sessions) + UC | UC | Length of stay | p < 0.01 | Mean = −2.03; 95% CI −3.15 to −0.91 | “This study shows evidence that the sooner OMT is provided, the shorter their hospital stay is.” | None reported/none declared | Selection bias; lack of standardized treatment, poor generalizability |
| Raith 2016 [27] | 30/preterm infants (range: 25 and 33 weeks) * | OMT (20 min/twice a week over three weeks) | UC | General movements | p > 0.05 | n.r. | The primary outcome showed no difference between groups. Craniosacral therapy seems to be safe in preterm infants. |
Not reported/none declared | Very small sample, insufficiently powered, high drop-out rate |
| Rossi 2019 [28] | 18/teenagers with pediatric headache | OMT (5 sessions over 2 months) | Light Touch Therapy | Headache frequency, analgesic use, quality of life and adverse events |
n.r. | n.r. | “The results are still partial and we need to recruit more patients to have a statistical significance. |
Not reported/not declared | Abstract only; no results |
| Steele 2014 [29] | 52/young children with otitis media (range: 6 months to 2 years) |
OMT (3 weekly visits) | UC | Change in middle ear effusion over four weeks | n.r. ** | OR = 2.98; 95% CI 1.16 to 7.62 | “A standardized OMT protocol administered adjunctively with standard care for patients with acute otitis media may result in faster resolution of middle ear effusion […] than UC alone” | None reported/none declared | 17.3% drop-out rate; small sample, lack of power calculation, high risk of reporting bias, no control for placebo effects |
* = Refers to gestational age; ** = within-group differences reported; ^ = recalculated with RevMan 5.4.; ^^ = all spirometry measures were reported as change scores; § = based on regression analysis; §§ = based on multivariate regression analysis. AE = adverse effect; CI = confidence interval; COI = conflict of interest; ES = effect size; FEF = forced expiratory flow; FEV-1= forced expiration volume in 1st second; FVC = forced vital capacity; MD = mean difference; n.r. = not reported; n.s. = not significant; OMT= osteopathic manipulative treatment; OR = odds ratio; SD = standard deviation; UC = usual care.