Adverse events from spinal manipulations in the pregnant and postpartum periods: a systematic review and update.
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ABSTRACT: Background
The purpose of this study is to update a previous critical review of adverse events in pregnant and postpartum populations.Methods
The following databases were searched: PubMed, CINAHL, Index to Chiropractic Literature, Cochrane Database of Systematic Reviews/Cochrane Central Register of Controlled Trials and MEDLINE. We included all study design types as it was determined a priori that there would not be enough high-quality research on spinal manipulative therapy (SMT) in these populations to make any determinations. The Scottish Intercollegiate Guidelines Network (SIGN) and CARE (CAse REport) checklists were used for quality rating.Results
This update found one case study that demonstrated a serious adverse event in the cervical spine following SMT and a handful of minor and transient adverse events in the low back following SMT.Conclusions
There was limited evidence of adverse events following SMT in these populations. Although we are calling for improved reporting of such events in future studies, it may be that such injuries are rare.
SUBMITTER: Weis CA
PROVIDER: S-EPMC8128327 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe safety of spinal manipulation during pregnancy and the postpartum periods has been a matter of debate among manual therapists. Spinal manipulative therapy during these periods is a commonly performed intervention as musculoskeletal pain is common in these patients. To date there has not been an evaluation of the literature on this topic exclusively.MethodsA literature search was conducted on PubMed, CINAHL and the Index to Chiropractic Literature along with reference searching for articles published in English and French in the peer-reviewed literature that documented adverse effects of spinal manipulation during either pregnancy or postpartum. Case reports, case series, and any other clinical study designs were deemed acceptable for inclusion, as were systematic reviews. The appropriate Scottish Intercollegiate Guidelines Network (SIGN) tools were used to rate included articles for quality when applicable.ResultsFive articles identifying adverse events in seven subjects following spinal manipulation were included in this review, along with two systematic reviews. The articles were published between 1978 and 2009. Two articles describing adverse effects from spinal manipulation on two postpartum patients were included, while the remaining three articles on five patients with adverse effects following spinal manipulation were on pregnant patients. Injury severity ranged from minor injury such as increasing pain after treatment that resolved within a few days to more severe injuries including fracture, stroke, and epidural hematoma. SIGN scores of the prospective observational cohort study and systematic reviews indicated acceptable quality.ConclusionsThere are only a few reported cases of adverse events following spinal manipulation during pregnancy and the postpartum period identified in the literature. While improved reporting of such events is required in the future, it may be that such injuries are relatively rare.
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Project description:Objectives: Spinal manipulative therapy (SMT) is widely used by manual therapists to manage spinal complaints. Notwithstanding the perceived relative safety of SMT, instances of severe thoracic adverse events (AE) have been documented. An evidence synthesis is required to understand the nature, severity and characteristics of thoracic AE following all SMT. The primary objective of this study was to report thoracic AE following SMT and secondly to report patient characteristics to inform further research for safe practice. Methods: A systematic review and data synthesis were conducted according to a registered protocol (PROSPERO CRD42019123140). A sensitive topic-based search strategy for key databases, gray literature and registers used study population terms and keywords, to search to 12/6/19. Two reviewers were involved at each stage. Using the Oxford Center for Evidence-based Medicine (CEBM) the level evidence was evaluated with grade presented for each AE. Results were reported in the context of overall quality. Results: From 1013 studies identified from searches, 19 studies (15 single case studies and 4 case series) reporting 21 unique thoracic AE involving the spinal cord tissues [nonvascular (n = 7), vascular (n = 6)], pneumothorax or hemothorax (n = 3), fracture (n = 3), esophageal rupture (n = 1), rupture of thoracic aorta (n = 1), partial pancreatic transection (n = 1). Reported outcomes included fully recovery (n = 8), permanent neurological deficit (n = 5), and death (n = 4). Conclusion: Although causality cannot be confirmed, serious thoracic AE to include permanent neurological deficit and death have been reported following SMT. Findings highlight the importance of clinical reasoning, including pre-thrust examination, as part of best and safe practice for SMT.
| S-EPMC7733904 | biostudies-literature
Project description:ObjectivesTo describe if there has been a change in the reporting of adverse events associated with spinal manipulation in randomised clinical trials (RCTs) since 2016.DesignA systematic literature review.Data sourcesDatabases were searched from March 2016 to May 2022: MEDLINE (Ovid), Embase, CINAHL, ICL, PEDro and Cochrane Library. The following search terms and their derivatives were adapted for each platform: spinal manipulation; chiropractic; osteopathy; physiotherapy; naprapathy; medical manipulation and clinical trial.MethodsDomains of interest (pertaining to adverse events) included: completeness and location of reporting; nomenclature and description; spinal location and practitioner delivering manipulation; methodological quality of the studies and details of the publishing journal. Frequencies and proportions of studies reporting on each of these domains were calculated. Univariable and multivariable logistic regression models were fitted to examine the effect of potential predictors on the likelihood of studies reporting on adverse events.ResultsThere were 5399 records identified by the electronic searches, of which 154 (2.9%) were included in the analysis. Of these, 94 (61.0%) reported on adverse events with only 23.4% providing an explicit description of what constituted an adverse event. Reporting of adverse events in the abstract has increased (n=29, 30.9%) while reporting in the results section has decreased (n=83, 88.3%) over the past 6 years. Spinal manipulation was delivered to 7518 participants in the included studies. No serious adverse events were reported in any of these studies.ConclusionsWhile the current level of reporting of adverse events associated with spinal manipulation in RCTs has increased since our 2016 publication on the same topic, the level remains low and inconsistent with established standards. As such, it is imperative for authors, journal editors and administrators of clinical trial registries to ensure there is more balanced reporting of both benefits and harms in RCTs involving spinal manipulation.
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Project description:BackgroundFecal microbiota transplantation (FMT) is a microbiota-based therapy that shows therapeutic potential in recurrent or refractory Clostridium difficile infections and other intestinal or extra-intestinal disorders. Nonetheless, adverse events (AEs) remain a major challenge in the application of FMT.AimTo review the AEs of FMT and to address the concerns of safety during the procedure.MethodsPublications were retrieved in the databases of Medline, Embase and Cochrane Library. AEs were classified according to their causality with FMT or their severity.ResultsA total of 7562 original articles about FMT were identified in this study, 50 of them fulfilled the inclusion criteria. Totally 78 kinds of AEs were revealed enrolled in these 50 selected publications. The total incidence rate of AEs was 28.5%. Among the 42 publications, 5 kinds were definitely and 38 kinds were probably related to FMT. The commonest FMT-attributable AE was abdominal discomfort, which was reported in 19 publications. For upper gastrointestinal routes of FMT, 43.6% (89/204) patients were compromised by FMT-attributable AE, while the incidence dropped to 17.7% (76/430) for lower gastrointestinal routes. In contrast, the incidences of serious adverse events (SAEs) were 2.0% (4/196) and 6.1% (40/659) for upper and lower gastrointestinal routes, respectively. A total of 44 kinds of SAEs occurred in 9.2% patients, including death (3.5%, 38/1089), infection (2.5%, 27/1089), relapse of inflammatory bowel diseases (0.6%, 7/1089) and Clostridium difficile infection (0.9%, 10/1089).ConclusionConsequently, both AEs and SAEs are not rare and should be carefully monitored throughout FMT. However, high quality randomized controlled trials are still needed for the more definite incidence of AEs of FMT.
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Project description:BackgroundMetamizole is used to treat pain in many parts of the world. Information on the safety profile of metamizole is scarce; no conclusive summary of the literature exists.ObjectiveTo determine whether metamizole is clinically safe compared to placebo and other analgesics.MethodsWe searched CENTRAL, MEDLINE, EMBASE, CINAHL, and several clinical trial registries. We screened the reference lists of included trials and previous systematic reviews. We included randomized controlled trials that compared the effects of metamizole, administered to adults in any form and for any indication, to other analgesics or to placebo. Two authors extracted data regarding trial design and size, indications for pain medication, patient characteristics, treatment regimens, and methodological characteristics. Adverse events (AEs), serious adverse events (SAEs), and dropouts were assessed. We conducted separate meta-analyses for each metamizole comparator, using standard inverse-variance random effects meta-analysis to pool the estimates across trials, reported as risk ratios (RRs). We calculated the DerSimonian and Laird variance estimate T2 to measure heterogeneity between trials. The pre-specified primary end point was any AE during the trial period.ResultsOf the 696 potentially eligible trials, 79 trials including almost 4000 patients with short-term metamizole use of less than two weeks met our inclusion criteria. Fewer AEs were reported for metamizole compared to opioids, RR = 0.79 (confidence interval 0.79 to 0.96). We found no differences between metamizole and placebo, paracetamol and NSAIDs. Only a few SAEs were reported, with no difference between metamizole and other analgesics. No agranulocytosis or deaths were reported. Our results were limited by the mediocre overall quality of the reports.ConclusionFor short-term use in the hospital setting, metamizole seems to be a safe choice when compared to other widely used analgesics. High-quality, adequately sized trials assessing the intermediate- and long-term safety of metamizole are needed.
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Project description:IntroductionMassage therapy (MT) is frequently used in children. No study has systematically assessed its safety in children and adolescents. We systematically review adverse events (AEs) associated with paediatric MT.MethodsWe searched seven electronic databases from inception to December 2018. We included studies if they (1) were primary studies published in a peer-reviewed journal, (2) involved children aged 0-18 years and (3) a type of MT was used for any indication. No restriction was applied to language, year of publication and study design. AEs were classified based on their severity and association to the intervention.ResultsLiterature searches identified 12 286 citations, of which 938 citations were retrieved for full-text evaluation and 60 studies were included. In the included studies, 31 (51.6%) did not report any information on AEs, 13 (21.6%) reported that no AE occurred and 16 studies (26.6%) reported at least one AE after MT. There were 20 mild events (grade 1) that resolved with minimal intervention, 26 moderate events (grades 2-3) that required medical intervention, and 18 cases of severe AEs (grades 4-5) that resulted in hospital admission or prolongation of hospital stay; of these, 17 AEs were volvulus in premature infants, four of which were ultimately fatal events.ConclusionWe identified a range of AEs associated with MT use, from mild to severe. Unfortunately, the majority of included studies did not report if an AE occurred or not, leading to publication bias. This review reports an association between abdominal massage with volvulus without malrotation in preterm infants; it is still to be defined if this is casual or not, but our findings warrant caution in the use of abdominal massage in preterm infants.
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