Efficacy and safety of osteopathic manipulative treatment: an overview of systematic reviews

May combine two claims.

In Cerritelli and colleagues, evidence for tension-type headache was reported only when within-group analysis was performed, and intergroup analyses reported conflicting results.

“Similarly, evidence has been reported for the tension-type headache only when within-group analysis was performed; intergroup analyses reported conflicting results.”

• cites [31] Cerritelli, 2017, Osteopathy for primary headache patients: a systematic review, J Pain Res sourceDisputed

  The Results section (“Outcomes reported”; page not available) reports a significantly lower headache frequency in the OMT group than in the control group in Rolle et al.’s tension-type headache trial. That between-group finding contradicts the claim that evidence was reported only from within-group analyses. The section also reports nonsignificant between-group results for some outcomes in another trial, so the comparative findings were mixed. (LLM, conf=0.86)

  Checked by a reasoning model — may be wrong.

  Experimental — accuracy not yet measured

May combine two claims.

Four reviews with 34 RCTs (41 comparators) and 3369 participants assessed the efficacy of OMT on low back pain; taking into account overlapping, there were 22 effective trials with a total of 2053 participants.

“Four reviews24–27 with 34 RCTs (41 comparators) and 3369 participants assessed the efficacy of OMT on LBP, including acute LBP, chronic LBP (CLBP), LBP with sciatica, CLBP with menopause symptoms, LBP in obese patients, acute non-specific LBP (ANSLBP), chronic non-specific LBP (CNSLBP) and/or LBP and pelvic girdle pain in pregnancy and postpartum (PP). Taking into account overlapping, there were 2”

• cites [24] de Oliveira Meirelies, 2013, A eficácia da osteopatia sobre a lombalgia: uma revisão sistemática, Man Ther Posturology Rehabil JNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [25] sourcePartly supported

  Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  Experimental — accuracy not yet measured
• cites [26] sourcePartly supported

  The Effect of interventions section (page unavailable) reports five studies with seven comparison groups and 677 participants for low back pain during pregnancy. The postpartum analysis (page unavailable) reports three studies with three comparisons and 180 participants. This source supports the pregnancy and postpartum portion of the citing sentence, but does not establish the aggregate figures for four reviews, 34 RCTs, 41 comparators, 3369 participants, or 22 effective trials involving 2053 participants. (LLM, conf=0.88)

  Experimental — accuracy not yet measured
• cites [27] sourcePartly supported

  Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing).

The overview was reported following the PRISMA statement.

“reported following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement.8–10”

• cites [8] Becker LA , Oxman AD . Chapter 22 : Overviews of reviews. In: Higgins JPT , Green S , eds. Cochrane Handbook for systematic reviews of interventions. Version 5.1.0. The Cochrane Collaboration, 2011. www.cochrane-handbook.orgNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [9] The Cochrane Collaboration . Chapter 9: Analysing data and undertaking meta-analyses(editors).. In: Deeks JJ , Higgins JPT , Altman DG , eds. Cochrane Handbook for systematic reviews of interventions. Version 5.1.0. The Cochrane Collaboration, 2011. https://training.cochrane.org/handbookNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [10] Liberati A , Altman DG , Tetzlaff J . The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration 2009;62. sourceSupported

Classified as probably not a substantial claim.

RCTs are the gold standard for evaluating the efficacy of an intervention.

“randomised controlled trials (RCTs), which are well known to be the gold standard for evaluating the efficacy of an intervention.11”

• cites [11] sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

The agreement on the eligibility of the included studies between the two authors resulted in a 0.78 kappa value.

“The agreement on the eligibility of the included studies, performed by the two authors (DB and DR), resulted in a 0.78 kappa value.23”

• cites [23] sourceCould not verify

  The Methods section explains that Fleiss’ K can measure agreement between two or more raters. The case-study Results concern breast-cancer assessments, not eligibility decisions by DB and DR. A search for the eligibility assessment and 0.78 found no passage reporting the claimed result. (LLM, conf=0.76)

  Experimental — accuracy not yet measured

Classified as probably not a substantial claim.

The AMSTAR-2 tool was used to assess the methodological quality of the included SRs and MAs.

“The AMSTAR-2 tool was used to assess the methodological quality of the SRs and MAs.”

• Also stated in: § Assessment of the methodological quality of included SRs and MAs · plain

  “The methodological quality of the included SRs and MAs was assessed using the AMSTAR-2 tool”

• cites [10] Liberati A , Altman DG , Tetzlaff J . The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate health care interventions: explanation and elaboration 2009;62. sourceCould not verify

  The Abstract identifies this paper as an explanation of PRISMA, a reporting guideline for systematic reviews and meta-analyses. The risk-of-bias discussion addresses assessments of studies included in reviews, not AMSTAR-2 assessments of the reviews themselves. Searches for “AMSTAR-2” and “AMSTAR” found no passage supporting the attributed use of that tool. (LLM, conf=0.76)

  Experimental — accuracy not yet measured

May combine two claims.

In the systematic review by Franke and colleagues (2014), the authors using the CBRG reported low risk of bias for 13 RCTs and high risk of bias for 2 RCTs.

“The methodological quality of all RCTs, evaluated by the authors using the RoB from the CBRG,18 reported a low and a high RoB for 13 and 2 RCTs, respectively.”

• cites [25] sourcePartly supported

  The Methods say the authors used the Cochrane Back Review Group Risk of Bias tool. The Results report 13 studies at low risk and name two at high risk, but also rate Licciardone et al. (2009) at high risk; the Discussion says three of 15 studies had high risk. Thus the claim's count of only two high-risk RCTs does not reflect the paper's full account. (LLM, conf=0.88)

  Experimental — accuracy not yet measured
• cites [18] sourceNot checked — no full text of the source

May combine two claims.

In the three trials of OMT for NSLBP in pregnant women, considerable heterogeneity was found for pain and substantial heterogeneity for functional status.

“Considerable (pain) and substantial (functional status) heterogeneity were found.”

• cites [25] sourcePartly supported

  The Results section on pregnant women reports three studies and says the evidence for both pain and functional status was downgraded for inconsistency. The Methods defines “considerable” and “substantial” heterogeneity, but the available passages do not give outcome-specific heterogeneity values establishing considerable heterogeneity for pain and substantial heterogeneity for functional status. No page numbers are provided in our copy. (LLM, conf=0.82)

  Experimental — accuracy not yet measured

May combine two claims.

Considering the CBN Group, the overview authors rated all RCTs in Franke and colleagues (2017) at high risk of bias, with high-risk domains including patient blinding (100%), care provider blinding (100%), outcome assessor blinding (100%), dropouts described and acceptable (25%), groups similar at baseline (25%), intention to treat analysis (25%), similar timing outcome assessment (25%), and

“Considering the CBN Group,19 we rated all RCTs as at high RoB [domains at high RoB (% of RCTs): patient binding (100%), care provider binding (100%), outcome assessor blinding (100%), dropouts described +acceptable (25%), group similar at the baseline (25%), intention to treat analysis (25%), similar timing outcome assessment (25%) and compliance acceptable (12%)].”

• cites [19] sourceSupported

May combine two claims.

In Rehman and colleagues, the authors using a modified version of the Handbook of Cochrane with six domains reported high risk of bias, with high-risk domains including patient blinding (100%), care provider blinding (100%), outcome assessor blinding (57%), random sequence generation (29%), participant allocation concealment (29%), and dropout >20% (43%).

“The methodological quality of the included studies was performed by the authors using a modified version of the Handbook of Cochrane33 where only six domains were considered (random sequence generation, allocation concealment, blinding of participants, healthcare provider, outcome assessors and dropout rates). According to this modified version, the quality of the RCTs was reported by the authors”

• cites [29] sourcePartly supported

  Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  Experimental — accuracy not yet measured
• cites [33] Higgins JPT GS , ed. Cochrane Handbook for Systematic Reviews of Interventions. Version 5.0.0, 2008. sourceNot checked — no full text of the source

May combine two claims.

Franke and colleagues (2017) identified eight RCTs with 850 participants evaluating OMT on NSLBP and pelvic girdle pain in pregnancy (five RCTs, seven comparisons) and on NSLBP in postpartum women (three trials, three comparisons).

“In another SR, Franke and colleagues26 identified eight RCTs with 850 participants evaluating the efficacy of OMT on NSLBP and pelvic girdle pain in pregnancy (five RCTs, seven comparisons) and on NSLBP in PP women (three trials and three comparisons)”

• cites [26] sourceSupported

May combine two claims.

In Rehman and colleagues, a pooled analysis of two trials with 210 participants found that OMT versus standard care improved quality of life, with a medium effect, moderate quality of evidence, and no heterogeneity.

“Similarly, the pooled analysis of the other two trials with 210 participants found that OMT versus standard care improved the quality of life (medium effect, moderate quality of evidence and no heterogeneity).”

• cites [29] sourcePartly supported

  The Quality of life section reports that two studies found improved quality of life with OMTh versus standard care (SMD 0.67), with moderate-quality evidence, but their pooled sample was 120 participants, not 210. Table 4 lists low inconsistency for this outcome; it does not establish the claimed absence of heterogeneity. (LLM, conf=0.92)

  Experimental — accuracy not yet measured

May combine two claims.

In Rehman and colleagues, another pooled analysis including two trials with 486 participants revealed efficacy of OMT versus standard care in improving disability, with a large effect size, moderate quality of evidence, and no heterogeneity.

“Moreover, another pooled analysis including two trials with 486 participants revealed the efficacy of OMT versus standard care in improving disability (large ES, moderate quality of evidence and no heterogeneity).”

• cites [29] sourcePartly supported

  Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  Experimental — accuracy not yet measured

May combine two claims.

Considering the last version of the CBN Group, the overview authors rated all RCTs in Franke and colleagues (2014) at high risk of bias, with high-risk domains including care provider (100%), patient blinding (67%), outcome assessor blinding (67%), groups similar at baseline (27%), lack of intention to treat analysis use (27%), free of selective outcome report (13%), dropouts described and 7%, and

“However, considering the last version of the CBN Group,19 we rated all RCTs at high RoB [domains at high RoB (% of RCTs): care provider (100%), patient blinding (67%), outcome assessor blinding (67%), groups similar at baseline (27%), lack of intention to treat analysis use (27%), free of selective outcome report (13%), dropouts described+acceptable (7%), similar timing outcome assessment (7%) and”

• cites [19] sourceSupported

May combine two claims.

Three trials (four comparators) with 242 participants evaluated OMT versus obstetric care, sham ultrasound and untreated for NSLBP in pregnant women, identifying a large effect in reducing pain and a medium effect in improving functional status.

“Three trials (four comparators) with 242 participants evaluated the effectiveness of OMT versus obstetric care, sham ultrasound and untreated, for NSLBP in pregnant women. A large and a medium effects in reducing pain and improving functional status, respectively, were identified.”

• cites [25] sourceSupported

May combine two claims.

In Franke and colleagues (2017), meta-analysis including three studies with 173 postpartum participants revealed a significant effect favouring OMT in reducing pain and improving functional status, with a large effect and substantial/considerable heterogeneity, and GRADE found low quality of evidence.

“The meta-analysis including three studies with 173 PP participants revealed a significant effect in favour of OMT in reducing pain and improving functional status, although a large effect and substantial/considerable heterogeneity for both outcomes were reported. The GRADE performed by the authors also found a low quality of evidence.”

• cites [26] sourceSupported

May combine two claims.

In the systematic review by Franke and colleagues (2014), GRADE revealed moderate quality of evidence for pain and high quality of evidence for functional status.

“The GRADE performed by the authors revealed both a moderate quality of evidence for pain and a high quality of evidence for functional status.”

• cites [25] sourcePartly supported

  The Methods (Data synthesis; page unavailable) confirm that the authors used GRADE to assess each outcome. A Results (Effect of interventions; page unavailable) table row reports MODERATE-quality evidence for a pain comparison, but the retrieved passages do not establish the claimed HIGH-quality rating for functional status. (LLM, conf=0.76)

  Experimental — accuracy not yet measured

Classified as probably not a substantial claim. May combine two claims.

The systematic review by Rehman and colleagues identified 16 RCTs, but the overview considered pooled analyses in which trials were only performed by osteopaths.

“The SR by Rehman and colleagues29 evaluated the efficacy of osteopathic interventions performed by manual therapists in chronic non-cancer pain. Sixteen RCTs were identified; however, we considered pooled analyses in which the trials were only performed by osteopaths”

• cites [29] sourceSupported

May combine two claims.

Dal Farra and colleagues revealed a significant effect, clinically relevant according to the CBN Group, of OMT in reducing pain (medium effect) and improving functional status (small effect), with substantial heterogeneity and low quality of evidence for both outcomes.

“The authors revealed a significant effect, clinically relevant according to the CBN Group,19 of OMT in reducing pain (medium effect) and improving functional status (small effect). However, substantial heterogeneity and a low quality of evidence (GRADE) were reported for both outcomes.”

• cites [27] sourceSupported
• cites [19] sourceCould not verify

  Split into 2 atoms — 0 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 2 unverifiable. Expand the claim to see per-atom verdicts.

  Experimental — accuracy not yet measured

May combine two claims.

In Rehman and colleagues, a pooled analysis including 6 RCTs with 728 participants found efficacy of OMT versus standard care in reducing pain severity, with a small effect size, moderate quality of evidence, and low heterogeneity.

“A pooled analysis, including 6 RCTs with 728 participants (six comparators), found the efficacy of OMT versus standard care in reducing pain severity (small ES, moderate quality of evidence and low level of heterogeneity).”

• cites [29] sourcePartly supported

  The Pooled Analysis section reports six studies comparing OMTh with standard care and a significant reduction in pain severity, with a small standardized effect (−0.37) and moderate-quality evidence. The Strengths and Limitations section describes low heterogeneity. The participant count is incorrect: the Pooled Analysis and Table 4 both report 710, not 728; page numbers are unavailable in our copy. (LLM, conf=0.92)

  Experimental — accuracy not yet measured

May combine two claims.

In the systematic review by Franke and colleagues (2014), considerable heterogeneity was found for pain and moderate heterogeneity for functional status.

“Moreover, considerable (pain) and moderate (functional status) heterogeneities were found.”

• cites [25] sourcePartly supported

  The Discussion (page not provided) reports considerable heterogeneity in many forest plots, supporting the claim that the review found considerable heterogeneity. It does not assign that description specifically to pain or report moderate heterogeneity specifically for functional status. The Methods define moderate heterogeneity but do not establish that finding for functional status. (LLM, conf=0.79)

  Experimental — accuracy not yet measured

May combine two claims.

In Dal Farra and colleagues, the authors using the CBN Group reported high risk of bias for all RCTs, with high-risk domains including care provider (100%), patient blinding (50%), outcome assessor blinding (17%), participant allocation (33%), and reporting bias (17%).

“The methodological quality of the primary studies, evaluated by the authors using the CBN Group,19 reported a high RoB for all RCTs [domains at high RoB (% of RCTs): high RoB for care provider (100%), patient blinding (50%), outcome assessor blinding (17%), participant allocation (33%) and reporting bias (17%)].”

• cites [27] sourcePartly supported

  Section 3.4 reports risk-of-bias concerns in all 10 included studies, with high risk for personnel blinding in all trials and participant blinding in 50%. But it reports only one of 10 trials at high risk for allocation concealment and outcome reporting, not 33% and 17%; Section 4.3 describes assessor blinding as low or unclear risk, not high risk in 17%. Section 2.6 names a 13-item tool based on the Cochrane Risk of Bias tool, not a CBN Group tool. (LLM, conf=0.90)

  Experimental — accuracy not yet measured
• cites [19] sourceSupported

May combine two claims.

Considering the CBN Group, the overview authors rated all RCTs in Franke and colleagues (2015) at high risk of bias, with high-risk domains including patient blinding (67%), care provider (100%), outcome assessor blinding (67%), dropouts described and acceptable (33%), and intention to treat analysis (100%).

“Considering the CBN Group,19 we rated all RCTs at high RoB [domains at high RoB (% of RCTs): patient blinding (67%), care provider (100%), outcome assessor blinding (67%), dropouts described+acceptable (33%) and intention to treat analysis (100%)].”

• cites [19] sourceSupported

May combine two claims.

In Franke and colleagues (2017), one study reported occasional tiredness after OMT, two studies did not find adverse events, and the remaining five studies did not analyse adverse events.

“Concerning the adverse events, one study reported occasional tiredness in some patients after OMT, two studies (personal communications to authors SR) did not find adverse events and the remaining five studies did not analyse adverse events.”

• cites [26] sourceSupported

May combine two claims.

In Dal Farra and colleagues, a subgroup analysis of OMT performed only by osteopaths identified six trials (eight comparisons) with 739 participants; five trials were also reported in two further systematic reviews.

“A subgroup analysis evaluating the effectiveness of OMT performed only by osteopaths identified six trials (eight comparisons) with 739 participants; five trials were also reported in other two further SRs”

• cites [27] sourceCould not verify

  Split into 2 atoms — 0 confirmed, 0 partially supported, 0 disputed, 0 misattributed, 1 unverifiable, 1 not checked. Expand the claim to see per-atom verdicts.

  Experimental — accuracy not yet measured

May combine two claims.

In Dal Farra and colleagues, a subanalysis including two trials (three comparisons) with 548 participants did not find evidence of OMT efficacy on functional status after long-term treatment (12 weeks follow-up), with low quality of evidence and no heterogeneity.

“A further subanalysis, including two trials (three comparisons) with 548 participants, did not find evidence of OMT efficacy on functional status after a long-term treatment (12 weeks follow-up). Low quality of evidence and no heterogeneity were reported.”

• cites [27] sourcePartly supported

  Split into 2 atoms — 0 confirmed, 2 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  Experimental — accuracy not yet measured

May combine two claims.

In Franke and colleagues (2014), adverse events were evaluated in only 4 out of 15 primary studies; two RCTs reported minor adverse events such as stiffness and tiredness, one reported no adverse event, and one reported adverse events not related to the treatment intervention.

“Adverse events were evaluated in only 4 out of the 15 primary studies. Two RCTs reported minor adverse events such as stiffness and tiredness, one no adverse event and the last one evidenced adverse events not related to the treatment intervention.”

• cites [25] sourcePartly supported

  Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  Experimental — accuracy not yet measured

May combine two claims.

Two RCTs with 119 participants evaluated OMT for NSLBP in postpartum women, identifying a large effect in reducing pain and improving functional status, no heterogeneity, and moderate quality of evidence for both outcomes.

“Two RCTs with 119 participants evaluated the effectiveness of OMT for NSLBP in PP women. A large effect of OMT in reducing pain and improving functional status was identified. No heterogeneity was found. However, a moderate quality of evidence for both outcomes was revealed.”

• cites [25] sourcePartly supported

  The Results section on postpartum women (page unavailable) reports two studies and moderate-quality evidence of substantial improvements in pain and functional status with OMT. Our copy does not establish the claimed total of 119 participants or explicitly report no heterogeneity for the postpartum comparison; searches for those figures and the postpartum heterogeneity result did not resolve them. (LLM, conf=0.83)

  Experimental — accuracy not yet measured

May combine two claims.

In the systematic review by Franke and colleagues (2014), the meta-analysis revealed a medium effect in reducing pain and a small effect in improving functional status, with moderate quality of evidence downgraded due to inconsistency.

“The meta-analysis revealed a medium and small effect in reducing pain and improving functional status, respectively, and a moderate quality of evidence (downgraded due to inconsistency).”

• cites [25] sourceSupported

May combine two claims.

In Franke and colleagues (2017), pooled analysis of five RCTs with 677 pregnancy participants reported efficacy of OMT in reducing pain and improving functional status, with a medium effect and considerable heterogeneity, and GRADE indicated moderate quality of evidence.

“The pooled analysis of five RCTs with 677 pregnancy participants reported the efficacy of OMT in reducing pain and improving functional status; however, a medium effect and a considerable heterogeneity were revealed. The GRADE performed by the authors indicated a moderate quality of evidence.”

• cites [26] sourcePartly supported

  Split into 2 atoms — 1 confirmed, 1 partially supported, 0 disputed, 0 misattributed, 0 unverifiable. Expand the claim to see per-atom verdicts.

  Experimental — accuracy not yet measured

May combine two claims.

The systematic review by Cerritelli and colleagues included five RCTs with 235 participants, evaluating migraine (two RCTs, 147 participants) and tension-type headache (three RCTs, 88 participants).

“The SR of Cerritelli and colleagues,31 including five RCTs with a total of 235 participants, evaluated two different types of primary headache: migraine (two RCTs, 147 participants) and tension-type headache (three RCTs, 88 participants).”

• cites [31] Cerritelli, 2017, Osteopathy for primary headache patients: a systematic review, J Pain Res sourcePartly supported

  The Results describe five included randomized trials involving migraine and tension-type headache. But Results > Sample size and length of study reports 265 participants, not 235; the passages do not establish the claimed 147/88 participant breakdown. (LLM, conf=0.90)

  Experimental — accuracy not yet measured

Probably not a substantial claim: may not pass S3 (load-bearing).

In Muller and colleagues, the authors using the CBRG reported low risk of bias for all RCTs.

“The methodological quality of all RCTs, evaluated by the authors using the CBRG,18 reported a low RoB for all RCTs.”

• cites [32] sourceSupported
• cites [18] sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

Inter-rater agreement between the two overview authors on the ranking of quality achieved a 0.89 kappa value.

“Inter-rater agreement between the two overview authors (DB and FB) on the ranking of quality achieved a 0.89 kappa value.23”

• cites [23] sourceCould not verify

  The Methods discuss kappa as a measure of agreement, and the case-study Results report estimates for clinical measures, not quality rankings by overview authors. Searches for “0.89 kappa” and “ranking of quality” found no passage reporting the claimed agreement between DB and FB. (LLM, conf=0.77)

  Experimental — accuracy not yet measured

May combine two claims.

The systematic review by Muller and colleagues included five primary studies involving 204 participants and evaluated the efficacy of OMT in the treatment of irritable bowel syndrome.

“In a SR, Muller and colleagues,32 including five primary studies and involving 204 participants, evaluated the efficacy of OMT in the treatment of irritable bowel syndrome (IBS).”

• cites [32] sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

Five systematic reviews reported justification for the exclusion of primary studies.

“five SRs reported justification for the exclusion of primary studies.25 26 28 31 32”

• cites [25] sourceSupported
• cites [26] sourceSupported
• cites [28] sourceNot checked — no full text of the source

May combine two claims.

In Muller and colleagues, although high heterogeneity in outcome measures and follow-up period was evidenced, the results indicated that OMT was effective in irritable bowel syndrome.

“Although high heterogeneity (in outcome measures and follow-up period) was evidenced, the results indicated that OMT was effective in IBS.”

• cites [32] sourceSupported

Classified as probably not a substantial claim.

In Cerritelli and colleagues, due to high heterogeneity (different types of primary headaches, different outcome measures, and variable length of follow-up), a meta-analysis was not conducted by the authors.

“Due to high heterogeneity (different types of primary headaches, different outcome measures and variable length of follow-up), a meta-analysis was not conducted by the authors.”

• cites [31] Cerritelli, 2017, Osteopathy for primary headache patients: a systematic review, J Pain Res sourceSupported

Probably not a substantial claim: may not pass S3 (load-bearing).

Two of the nine systematic reviews registered a protocol before beginning the study.

“Two of the nine SRs registered a protocol before beginning the study.27 29”

• cites [27] sourcePartly supported

  Section 2.1 (Protocol registration; page unavailable) states that this systematic review’s protocol was approved and recorded on PROSPERO, supporting its identification as a review with a registered protocol. It does not state when registration occurred, so the claim that it happened before the study began is not established by this source. (LLM, conf=0.82)

  Experimental — accuracy not yet measured
• cites [29] sourcePartly supported

  The Methods section says this review’s protocol was registered with PROSPERO. It does not establish that registration occurred before the study began, and this source alone does not substantiate the count of two among nine reviews. (LLM, conf=0.83)

  Experimental — accuracy not yet measured

May combine two claims.

Considering the CBN Group, the overview authors rated all RCTs in Muller and colleagues at high risk of bias, with high-risk domains including care provider blinding (100%), outcome assessor blinding (60%), randomisation (20%), patient blinding (20%), groups similar at baseline (20%), and intention to treat analysis (20%).

“Considering the CBN Group,19 we rated all RCTs at high RoB [domains at high RoB (% of RCTs): care provider blinding (100%), outcome assessor blinding (60%), randomisation (20%), patient blinding (20%), groups similar at the baseline (20%) and intention to treat analysis (20%)].”

• cites [19] sourceSupported

May combine two claims.

In Cerritelli and colleagues, the two RCTs evaluating efficacy in migraine reported positive results in favour of OMT (mainly in pain intensity reduction), but intergroup analysis was performed only in one RCT.

“Although the two RCTs evaluating efficacy in migraine reported positive results in favour of OMT (mainly in pain intensity reduction), intergroup analysis was performed only in one RCT.”

• cites [31] Cerritelli, 2017, Osteopathy for primary headache patients: a systematic review, J Pain Res sourcePartly supported

  The Results > Outcomes reported section (page not provided) describes positive OMT findings in two migraine trials, including improved pain scores, and explicitly compares the treated group with control and sham groups in one trial. It does not say that intergroup analysis was performed in only one of the two trials, so that limitation is not established by our copy. (LLM, conf=0.84)

  Experimental — accuracy not yet measured

May combine two claims.

According to the critical domain established in Shea et al, seven systematic reviews were rated low quality and two were rated critically low quality.

“According to the critical domain established in Shea et al,12 seven25–29 31 32 and two SRs 24 30 were rated as low and critically low quality, respectively.”

• cites [12] sourceSupported
• cites [24] de Oliveira Meirelies, 2013, A eficácia da osteopatia sobre a lombalgia: uma revisão sistemática, Man Ther Posturology Rehabil JNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

• cites [25] sourceCould not verify

  The Methods > Data synthesis passage assesses evidence from included trials using GRADE, and Methods > Assessment of risk of bias evaluates those trials. Neither passage reports a Shea critical-domain assessment of systematic reviews or the claimed counts of seven low-quality and two critically low-quality reviews; searches for those terms found no supporting passage in our copy. (LLM, conf=0.72)

  Experimental — accuracy not yet measured
• cites [26] sourceSupported
• cites [27] sourceSupported
• cites [28] sourceNot checked — no full text of the source
• cites [29] sourceCould not verify

  The Quality of Evidence section describes a GRADE assessment of evidence from trials, not quality ratings of systematic reviews using Shea et al’s critical domains. The Strengths and Limitations section calls this review’s GRADE assessment moderate, but does not report seven reviews rated low and two rated critically low. Searches for those ratings and Shea’s critical domains found no supporting passage in our copy. (LLM, conf=0.75)

  Experimental — accuracy not yet measured
• cites [30] sourceNot checked — no full text of the source
• cites [31] Cerritelli, 2017, Osteopathy for primary headache patients: a systematic review, J Pain Res sourceSupported
• cites [32] sourceSupported

May combine two claims.

In Cerritelli and colleagues, the RCTs were reported to be at high risk of bias, with high-risk domains including care provider blinding (100%), participant blinding (60%), and allocation concealment (20%).

“The RCTs were reported by the authors to be at high RoB [domains at high RoB (% of RCTs): care provider blinding (100%), participant blinding (60%) and allocation concealment (20%)].”

• cites [31] Cerritelli, 2017, Osteopathy for primary headache patients: a systematic review, J Pain Res sourcePartly supported

  The Results > Allocation section rates one of five trials at high risk of bias for allocation concealment, supporting 20%. Results > Blinding of participants and personnel reports three trials with unblinded therapists and two with no information—not 100% rated high risk for care-provider blinding. It also does not establish that 60% were rated high risk for participant blinding. (LLM, conf=0.88)

  Experimental — accuracy not yet measured

May combine two claims.

Five systematic reviews carried out a meta-analysis and used appropriate methods for the statistical combination of findings.

“five SRs25–29 carried out a meta-analysis and used appropriate methods for the statistical combination of findings.”

• cites [25] sourceSupported
• cites [26] sourceSupported
• cites [27] sourceSupported
• cites [28] sourceNot checked — no full text of the source
• cites [29] sourceSupported

Probably not a substantial claim: may not pass S2 (checkable), S3 (load-bearing). May combine two claims.

Although these findings have already been reported by Cerritelli and colleagues, to date, these suggestions have not been followed.

“It is important to note that, although these findings have already been reported by Cerritelli and colleagues,38 to date, these suggestions have not been followed.”

• cites [38] sourceSupported

May combine two claims.

The lack of solid evidence stems from a small sample size, the presence of conflicting results, and high heterogeneity in participants, outcome measures, interventions, and comparison interventions.

“The lack of solid evidence stems from a small sample size,26 28–32 the presence of conflicting results24 30 31 and a high heterogeneity in participants,25 31 outcomes measures,31 32 interventions25–27 31 and comparison interventions.25–27 32”

• cites [26] sourcePartly supported

  The Discussion (page unavailable) attributes limited confidence to small studies, inconsistent results, and statistical heterogeneity; it also identifies differing comparison groups. The paper describes different outcome measures and pregnant versus postpartum groups, but does not establish high heterogeneity in participants or outcome measures as causes of weak evidence. It says the osteopathic techniques used across studies were similar, while their comparability was uncertain. (LLM, conf=0.84)

  Experimental — accuracy not yet measured
• cites [28] sourceNot checked — no full text of the source
• cites [29] sourcePartly supported

  The Strengths and Limitations section (page unavailable) identifies small sample sizes as a limitation and says that pooling studies by similar interventions and comparators reduced heterogeneity. The paper also discusses variation in outcomes, but it reports low heterogeneity in its own pooled analyses; it does not establish that high heterogeneity across every listed category caused the lack of solid evidence. (LLM, conf=0.85)

  Experimental — accuracy not yet measured
• cites [30] sourceNot checked — no full text of the source
• cites [31] Cerritelli, 2017, Osteopathy for primary headache patients: a systematic review, J Pain Res sourcePartly supported

  The Results (Description of heterogeneity) report wide variation in participants, outcomes, interventions, and comparison interventions. The Results (Sample size and length of study) report 265 participants across five trials, and the Discussion describes the evidence as preliminary and of low methodological quality. The passages do not identify conflicting results as a reason for the lack of solid evidence. (LLM, conf=0.85)

  Experimental — accuracy not yet measured
• cites [32] sourcePartly supported

  The Conclusion cautions that the favorable results rest on few studies with small sample sizes. The Discussion reports marked heterogeneity in primary outcome measures and control interventions. The passages do not establish conflicting results or high heterogeneity in participants and treatment interventions. (LLM, conf=0.85)

  Experimental — accuracy not yet measured
• cites [24] de Oliveira Meirelies, 2013, A eficácia da osteopatia sobre a lombalgia: uma revisão sistemática, Man Ther Posturology Rehabil JNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

In the overview, seven systematic reviews evaluated adverse events, and from these reviews, no severe incident involving musculoskeletal, neurological, visceral, or paediatric disorders occurred after OMT.

“In our overview, we found that seven SRs25–28 30–32 evaluated adverse events, and from these SRs, it emerges that no severe incident involving musculoskeletal, neurological, visceral or paediatric disorders occurred after OMT.”

• cites [25] sourcePartly supported

  The Results > Adverse events section evaluates adverse events in this review of low back pain studies and says that none of the reported serious events appeared related to treatment. It does not say that no serious events occurred after OMT, or address neurological, visceral, or paediatric disorders. The count of seven reviews is the citing overview’s own finding, not a finding of this source. (LLM, conf=0.87)

  Experimental — accuracy not yet measured
• cites [26] sourcePartly supported

  The Adverse events section reports that one study found no serious adverse events and that authors of two other studies reported none in personal communications. It also says no other study reported on adverse events. This review concerns low back and pelvic girdle pain during and after pregnancy; it does not establish that no severe incidents occurred across neurological, visceral, or paediatric disorders. (LLM, conf=0.84)

  Experimental — accuracy not yet measured
• cites [27] sourcePartly supported

  The Description of results (page unavailable) reports no adverse effects in seven included studies and only increased pain or back-muscle spasticity in two others. This supports the absence of reported severe incidents in this review’s chronic low-back-pain studies, but the seven were studies, not systematic reviews; one study collected no adverse-event data, and this paper does not establish the claim across neurological, visceral, or paediatric disorders. (LLM, conf=0.87)

  Experimental — accuracy not yet measured
• cites [28] sourceNot checked — no full text of the source
• cites [30] sourceNot checked — no full text of the source
• cites [31] Cerritelli, 2017, Osteopathy for primary headache patients: a systematic review, J Pain Res sourceSupported
• cites [32] sourceSupported

May combine two claims.

In manual therapy, blinding is an issue, as patients tend to be aware of the manual treatment and therapists cannot be blinded to the treatment intervention they deliver.

“In manual therapy, blinding is an issue, as patients tend to be aware of the manual treatment and therapists cannot be blinded to the treatment intervention they deliver.37”

• cites [37] sourcePartly supported

  The Introduction says blinding in nonpharmacological trials can be difficult, and the Results describe situations in which participants or providers could not be blinded to treatment. But the Results also describe hands-on sham manipulation used to blind participants, so the paper does not establish that manual-therapy patients generally know which treatment they receive. It does not state that therapists delivering manual therapy categorically cannot be blinded. (LLM, conf=0.85)

  Experimental — accuracy not yet measured

May combine two claims.

Meta-analyses reported that OMT is more effective than comparators in reducing pain and improving functional status in acute/chronic non-specific low back pain, chronic non-specific neck pain and chronic non-cancer pain, although with different effect size and quality of evidence.

“Although with a different effect size and quality of evidence, MAs reported that OMT is more effective than comparators in reducing pain and improving functional status in acute/chronic NSLBP, CNSNP and CNCP.”

The quote only partly states this claim.

The SRs included 71 primary studies with 5577 participants before accounting for overlap.

“The SRs included 71 primary studies with 5577 participants.”

May combine two claims.

The included SRs reported a wide range of conditions including acute and chronic non-specific low back pain (four SRs), chronic non-specific neck pain (one SR), chronic non-cancer pain (one SR), paediatric (one SR), neurological (primary headache, one SR) and irritable bowel syndrome (one SR).

“The SRs reported a wide range of conditions including acute and chronic non-specific low back pain (NSLBP, four SRs), chronic non-specific neck pain (CNSNP, one SR), chronic non-cancer pain (CNCP, one SR), paediatric (one SR), neurological (primary headache, one SR) and irritable bowel syndrome (IBS, one SR).”

• Also stated in: § Description of included reviews · plain

  “Six SRs focused on musculoskeletal conditions24–29 and one each on paediatric,30 neurological31 and visceral conditions.32”

May combine two claims.

The literature search yielded 13,128 potentially relevant articles, and after eliminating duplicates, 8,350 were screened; 44 full texts were assessed and 9 SRs were included.

“The literature search yielded 13 128 potentially relevant articles, and after eliminating duplicate articles (4778), 8350 articles were screened (see figure 1). After reading the titles and abstracts, 44 full texts were selected for eligibility of which 35 were excluded (see online supplemental table 1) and 9 SRs were considered relevant and included in this overview.”

May combine two claims.

No serious adverse events occurred in any RCTs in Franke and colleagues (2015), with data reported in one RCT and as personal communications to SR authors in the other two studies.

“No serious adverse events occurred in any RCTs (data reported in an RCT and as personal communications to SR authors in the other two studies).”

• cites [28] sourceNot checked — no full text of the source

Probably not a substantial claim: may not pass S3 (load-bearing).

In the systematic review by De Oliveira and colleagues, the methodological quality of the five RCTs was classified as fair to excellent (PEDro range 5 to 9 out of 11 points).

“Using the PEDro tool, the methodological quality of the five RCTs was classified by the authors as fair to excellent (PEDro range: from 5 to 9 out of 11 points).”

• cites [24] de Oliveira Meirelies, 2013, A eficácia da osteopatia sobre a lombalgia: uma revisão sistemática, Man Ther Posturology Rehabil JNot matched

  Couldn’t be matched to a paper in Crossref, so it can’t be checked.

May combine two claims.

Franke and colleagues (2015) evaluating 3 RCTs (three comparators) with 123 participants provided evidence that OMT exerted beneficial effects on chronic non-specific neck pain, with a medium effect size in reducing pain, moderate quality of evidence on pain, low heterogeneity, but no significant effect on functional status.

“Franke and colleagues28 evaluating 3 RCTs (three comparators) with 123 participants, provided evidence that OMT exerted beneficial effects on chronic non-specific neck pain (CNSNP). Specifically, a medium ES in reducing pain and a moderate quality of evidence on pain outcome were reported. A low level of heterogeneity was found. However, the meta-analysis did not show a significant effect on”

• cites [28] sourceNot checked — no full text of the source

May combine two claims.

In Posadzky and colleagues, no significant effects of OMT on idiopathic scoliosis, obstructive apnoea, or temporomandibular disorders compared with various control interventions were evidenced by the single RCTs.

“By contrast, no significant effects of OMT on idiopathic scoliosis, obstructive apnoea or temporomandibular disorders compared with various control interventions have been evidenced by the single RCTs.”

• cites [30] sourceNot checked — no full text of the source

May combine two claims.

From the Posadzky and colleagues systematic review, low-quality RCTs favoured OMT, while moderate and high-quality RCTs failed to find OMT effectiveness.

“From the SR, it emerges that low-quality RCTs favoured OMT, while moderate and high-quality RCTs failed to find OMT effectiveness.”

• cites [30] sourceNot checked — no full text of the source

May combine two claims.

In Posadzky and colleagues, adverse events were not analysed in 11 RCTs; no adverse events or serious adverse events following OMT were reported in four trials; adverse events occurred in one RCT but were not related to OMT; and one trial reported aggravation of vegetative symptoms in four patients.

“In 11 RCTs, adverse events were not analysed. No adverse events or serious adverse events following OMT were reported in four trials. Adverse events occurred in one RCT, but they were not related to OMT. One trial reported the aggravation of vegetative symptoms in four patients.”

• cites [30] sourceNot checked — no full text of the source

May combine two claims.

In Posadzky and colleagues, single trials provided evidence that OMT exerted beneficial effects on congenital nasolacrimal duct obstruction (post-treatment), daily weight gain and length of hospital stay, dysfunctional voiding, infantile colic, and postural asymmetry.

“The single trials provided evidence that OMT exerted beneficial effects on congenital nasolacrimal duct obstruction (post-treatment), daily weight gain and length of hospital stay, dysfunctional voiding, infantile colic and postural asymmetry.”

• cites [30] sourceNot checked — no full text of the source

May combine two claims.

The overview identified nine systematic reviews on the use of osteopathic care for the management of musculoskeletal, paediatric, visceral, and neurological disorders, with different effects and clinical relevance depending on the conditions.

“We identified nine SRs on the use of osteopathic care for the management of musculoskeletal, paediatric, visceral and neurological disorders with different effects and clinical relevance depending on the conditions.”

May combine two claims.

The overview excluded 11 systematic reviews, and considering overlapping, 17 RCTs were lost.

“In this regard, 11 systematic reviews were excluded and, considering the overlapping, 17 RCTs were lost”

May combine two claims.

Other issues that emerge from the overview are the lack of treatment description and timing of measuring outcomes (short term and long term) in the systematic reviews as well as in primary trials.

“Other issues that emerge from our overview are the lack of treatment description and timing of measuring outcomes (short term and long term) in the SRs as well as in primary trials.”

May combine two claims.

The overview excluded seven systematic reviews, and considering overlapping, five RCTs were lost.

“In this regard, we excluded seven SRs, and, therefore, considering the overlapping, five RCTs were lost”

Probably not a substantial claim: may not pass S3 (load-bearing).

Data were independently extracted by two authors.

“The data were independently extracted by two authors.”

• Also stated in: § Data collection and analysis · plain

  “Two authors (DB and FB) independently extracted data using an Excel spreadsheet.”

Classified as probably not a substantial claim.

Since only RCTs in which OMT was performed by osteopathic physicians or osteopaths were included, some relevant systematic reviews could have been missed.

“Since only randomised controlled trials in which OMT was performed by osteopathic physicians or osteopaths were included, some relevant systematic reviews could have been missed.”

May combine two claims.

Limited and inconclusive evidence occurs for paediatric conditions, primary headache and IBS.

“Limited and inconclusive evidence occurs for paediatric conditions, primary headache and IBS.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Weighted kappa statistics were calculated to measure agreement between the authors.

“Weighted kappa statistics were calculated to measure agreement between the authors.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The selection of studies was performed independently by two authors.

“The selection was performed independently by two authors (DB and DR).”

Probably not a substantial claim: may not pass S3 (load-bearing).

The overview was conducted according to the Cochrane Handbook for the Systematic Review of Interventions.

“The overview was conducted according to the Cochrane Handbook for the Systematic Review of Interventions (Cochrane Book)”

Classified as probably not a substantial claim.

When more than one SR investigated the same research question and used the same primary studies, only the latest one was selected if it used the most rigorous criteria.

“When more than one SR (which investigated the same research question and used the same primary studies) was identified, only the latest one was selected if it used the most rigorous criteria (eg, followed the PRISMA criteria, used the more recent SR/MA guidelines) to evaluate the methodological quality of the studies.”

Probably not a substantial claim: may not pass S3 (load-bearing).

The protocol of the overview was registered on PROSPERO (CRD42020170983).

“PROSPERO CRD42020170983.”

• Also stated in: § Methods · plain

  “The protocol of the overview has been registered on PROSPERO (CRD42020170983).”

Probably not a substantial claim: may not pass S3 (load-bearing).

The quality assessment of included SRs and MAs was evaluated independently by two authors.

“The quality assessment was evaluated independently by two authors (DB and FB), with any disagreements resolved through discussion with the third author (DR).”

Classified as probably not a substantial claim.

Primary studies present in more than one SR were counted only once.

“we decided to count the primary studies present in more than one SR only once.”

• cites [13] sourceNot checked — no full text of the source
• cites [14] Ballard, 2017, Risk of bias in overviews of reviews: a scoping review of methodological guidance and four-item checklist, Res Synth Methods sourceNot checked — no full text of the source

May combine two claims.

In Posadzky and colleagues, the vast majority of RCTs were reported to be at high risk of bias (15 RCTs), with high-risk domains including allocation concealment (67%), patient blinding (67%), care provider blinding (100%), outcome assessor blinding (50%), addressing incomplete data (33%), selective outcome reporting (33%), and adequate sequence generation (28%), with unclear or low risk of bias

“The vast majority of the RCTs were reported by the authors to be at high RoB (15 RCTs) [domains at high RoB (% of RCTs): allocation concealment (67%), patient blinding (67%), care provider blinding (100%), outcome assessor blinding (50%), addressing of incomplete data (33%), selective outcome reporting (33%), adequate sequence generation (28%)] with unclear or low RoB for the remaining two RCTs.”

• cites [30] sourceNot checked — no full text of the source

May combine two claims.

From the overview, questionable problems emerge related to the lack of appropriate guidelines for assessing the methodological quality of trials in manual therapy and problems due to inadequate reporting of trial methodology and results.

“From our overview, some relevant questionable problems emerge related to the lack of appropriate guidelines for assessing the methodological quality of trials in manual therapy and problems due to inadequate reporting of trial methodology and results.”

Probably not a substantial claim: may not pass S3 (load-bearing).

Considering that in most countries osteopathy is often conducted in the private sector, the participants included in the primary studies might not be generalisable to the population.

“Considering that in most countries osteopathy is often conducted in the private sector (eg, the UK, France and Italy), the participants included in the primary studies might not be generalisable to the population.”

Probably not a substantial claim: may not pass S2 (checkable).

The idea that manual therapies are safe could only be demonstrated if adverse events are defined and assessed in each clinical trial.

“The idea that manual therapies are safe could only be demonstrated if adverse events are defined and assessed in each clinical trial.”

Classified as probably not a substantial claim. May combine two claims.

For participant-reported outcomes such as pain and functional status, blinding of patients is mandatory, and it is necessary to use sham procedures that simulate manipulation as a control group.

“For participant-reported outcomes, for which the patient is the outcome assessor, such as for pain and functional status outcomes, blinding of patients is mandatory, and, therefore, it is necessary to use, as a control group, sham procedures (including light touch therapy) that simulate manipulation.”

May combine two claims.

Manual therapies have been reported to be well tolerated, and manual therapy-related adverse events are short lived and mild or moderate in intensity.

“In general, manual therapies have been reported to be well tolerated, and manual therapy-related adverse events are short lived and mild or moderate in intensity.43”

• cites [43] sourceNot checked — no full text of the source

May combine two claims.

The overview highlights that evidence on the efficacy of OMT is limited and contradictory in the treatment of paediatric conditions, with some conditions evaluated by only one trial, some of low methodological quality, and contradictory results for conditions with two RCTs (OTLE: red).

“(2) limited and contradictory in the treatment of paediatric conditions (some conditions were evaluated by only one trial, some of which were of low methodological quality, and contradictory results were obtained for conditions in which two RCTs were performed, OTLE: red)”

May combine two claims.

The overview highlights that evidence on the efficacy of OMT is promising in musculoskeletal disorders, mainly in reducing pain and improving functional status in acute and chronic NSLBP patients and NSLBP in pregnancy or postpartum (OTLE: yellow).

“our overview highlights that evidence on the efficacy of OMT is: (1) promising in musculoskeletal disorders, mainly in reducing pain and improving functional status in acute and chronic NSLBP patients, NSLBP in pregnancy or PP (OTLE: yellow)”

May combine two claims.

This overview suggests that OMT could be effective in the management of musculoskeletal disorders, specifically with regard to CNSLBP patients and LBP in pregnant or postpartum women.

“This overview suggests that OMT could be effective in the management of musculoskeletal disorders, specifically with regard to CNSLBP patients and LBP in pregnant or PP women.”

May combine two claims.

Although not all RCTs have investigated the safety of OMT, considering that no serious adverse events have been reported, OMT can be considered safe.

“Although not all RCTs have investigated the safety of OMT, considering that no serious adverse events have been reported, OMT can be considered safe.”

• AssumptionRests on an assumption: Absence of reported serious adverse events in the included systematic reviews implies that OMT is safe.