Characterizing Adverse Events Reported Immediately After Osteopathic Manipulative Treatment.

CONTEXT: Although adverse events in various types of manual therapy have been previously investigated, little is known about the incidence and types of adverse events that occur after osteopathic manipulative treatment (OMT). OBJECTIVE: To estimate the incidence and characterize the types of adverse events that patients report after OMT and prior to leaving the office to increase the likelihood of identifying adverse events caused by OMT. METHODS: As part of a prospective study evaluating the use and effectiveness of OMT, patients assessed how they felt immediately after OMT compared with before OMT using a 5-point ordinal rating scale (much better, better, about the same, worse, much worse). For patients who indicated they felt their condition had changed, a follow-up, open-ended question asked them to describe how it had changed. Patients who felt worse or much worse were considered to have experienced an adverse event. Two reviewers independently coded the types of adverse events based on the descriptions provided by the patients. Generalized logistic regression models were used to calculate incidence rates and 95% CIs for the types of adverse events. These models were also used to calculate the ORs and 95% CIs for associations of adverse events with demographic characteristics and with individual OMT techniques after accounting for demographic characteristics. RESULTS: Immediately after OMT, 884 patients provided data at 1847 office visits (663 [76%] women; 794 [92%] identified as white; mean [SD] age, 51.8 [15.8] years). Patients reported they felt worse or much worse immediately after OMT at 45 office visits; the incidence rate for adverse events was 2.5% (95% CI, 1.3%-4.7%). Pain/discomfort was the most commonly identified type of adverse event (16 [0.9%]; 95% CI, 0.5%-1.6%). Insufficient information was provided to determine the type of adverse event at 20 office visits. Women reported adverse events more frequently than men (OR, 13.9; 95% CI, 1.7-115.6; P=.01). CONCLUSION: The incidence of adverse events immediately after OMT, most commonly pain/discomfort, was lower than previous reports from other manual medicine disciplines. Larger studies are needed to determine the incidence of serious adverse events and to assess adverse events that occur in the days following OMT.

Optimising nutrition in chronic renal insufficiency--growth.

The need to optimise nutrition to promote growth in infants with chronic renal insufficiency (CRI) is well recognised, but there is less enthusiasm for such an approach in older children and those with milder degrees of CRI. Energy intakes and growth outcomes were prospectively monitored over a 2-year period in children aged 2-16 years with differing levels of severity of CRI, as part of their ongoing joint medical/ dietetic care. Children were grouped following [(51)Cr]-labelled EDTA glomerular filtration rate (GFR, ml/min per 1.73 m(2)) estimations, into 'normal' kidney function [GFR >75, mean 106 (SD 19.5), n =58], providing baseline data only, mild (GFR 51-75, n =25), moderate (GFR 25-50, n =21), and severe (GFR <25, n=19) CRI. Children were followed for 2 years, with 51 completing the study (19 mild, 19 moderate, 13 severe CRI), and were excluded if they required dialysis. None received growth hormone. Regular dietary advice was provided and yearly 3-day semi-quantitative dietary diaries and baseline and 6-monthly anthropometric measurements were obtained. Mean height standard deviation score (SDS) was maintained in those with mild and moderate CRI and significantly increased in children with severe CRI [0.1 SDS (0.32 SD), F =9.45, 1 df, P =0.003]. There was a non-significant reduction in energy intake from dietary records overall (median -8.5% estimated average requirement), associated with poor adherence to supplements in severe CRI and under-reporting in the mild group. An increase in height or body mass index SDS, however, was observed in all children who took the supplements as prescribed. A correlation between change in energy intake and change in height SDS was observed in severe CRI ( r(2)=0.58, P =0.011). Regular dietetic advice, with particular attention to adherence to optimise energy intake, may improve growth, irrespective of age and should form an integral part of the clinical care package.

Optimising nutrition in chronic renal insufficiency--progression of disease.

There is a lack of evidence to support the belief that dietary measures are beneficial in slowing the progression of chronic renal insufficiency (CRI). We prospectively monitored nutrient intakes and progression of CRI over a 2-year period in children aged 2-16 years with differing levels of severity of CRI, as part of their ongoing joint medical/dietetic care. Children were grouped following [5'Cr]-labelled EDTA glomerular filtration rate(GFR, ml/min per 1.73 m 2) estimations, into 'normal'kidney function [GFR >75, mean 106 (SD 19.5), n=58],providing baseline data only, mild (GFR 51-75, n=25),moderate (GFR 25-50, n =21), and severe (GFR <25, n=19) CRI. Children with CRI were followed for 2 years,with 51 completing the study (19 mild, 19 moderate, 13 severe CRI) and were excluded if they subsequently required dialysis. Regular medical and dietary advice was provided and yearly 3-day semi-quantitative dietary di-aries and baseline and 6-monthly measurements of blood pressure and urinary protein/creatinine ratio were obtained. Mean reductions in estimated GFR over 2 years were -9.4, -5.8, and -6.0 ml/min per 1.73 m2 for mild,moderate, and severe CRI, respectively. Mean systolic blood pressure standard deviation score (SDS) fell significantly in all groups by 0.7 SDS, whereas there was little change in proteinuria. From reported dietary intakes,median sodium intakes increased (+10 mmol/day) and protein intakes decreased (-0.4 g/kg per day). Median phosphate intakes did not change significantly, where as calcium intakes fell in all groups, with an overall median of -20% reference nutrient intake (RNI) (F=33.3,P<0.001). Of children with moderate CRI, 65% finished with calcium intakes below 80% RNI, and parathyroid hormone (PTH) concentrations significantly increased in this group (F=6.0, P=0.021). Higher phosphate and sodium intakes were associated with greater deterioration in estimated GFR in children with mild CRI (r2=0.30,P=0.02; r-=0.31, P=0.02, respectively). There was no such correlation for protein intake or PTH. This study emphasises the need for a joint medical and dietetic approach and indicates a number of interventions other than protein restriction, which could be commenced early in children with CRI in an attempt to delay progression.