C. Genty

Spa therapy in the treatment of knee osteoarthritis: a large randomised multicentre trial

Objective To determine whether spa therapy, plus home exercises and usual medical treatment provides any benefit over exercises and usual treatment, in the management of knee osteoarthritis. Methods Large multicentre randomised prospective clinical trial of patients with knee osteoarthritis according to the American College of Rheumatology criteria, attending French spa resorts as outpatients between June 2006 and April 2007. Zelen randomisation was used so patients were ignorant of the other group and spa personnel were not told which patients were participating. The main endpoint criteria were patient self-assessed. All patients continued usual treatments and performed daily standardised home exercises. The spa therapy group also received 18 days of spa therapy (massages, showers, mud and pool sessions). Main Endpoint The number of patients achieving minimal clinically important improvement (MCII) at 6 months, defined as ≥19.9 mm on the visual analogue pain scale and/or ≥9.1 points in a normalised Western Ontario and McMaster Universities osteoarthritis index function score and no knee surgery. Results The intention to treat analysis included 187 controls and 195 spa therapy patients. At 6 months, 99/195 (50.8%) spa group patients had MCII and 68/187 (36.4%) controls (χ2=8.05; df=1; p=0.005). However, no improvement in quality of life (Short Form 36) or patient acceptable symptom state was observed at 6 months. Conclusion For patients with knee osteoarthritis a 3-week course of spa therapy together with home exercises and usual pharmacological treatments offers benefit after 6 months compared with exercises and usual treatment alone, and is well tolerated. Trial registration number NCT00348777.

Detecting active pelvic arterial haemorrhage on admission following serious pelvic fracture in multiple trauma patients

BACKGROUNDnThe early diagnosis of pelvic arterial haemorrhage is challenging for initiating treatment by transcatheter arterial embolization (TAE) in multiple trauma patients. We use an institutional algorithm focusing on haemodynamic status on admission and on a whole-body CT scan in stabilized patients to screen patients requiring TAE. This study aimed to assess the effectiveness of this approach.nnnMETHODSnThis retrospective cohort study included 106 multiple trauma patients admitted to the emergency room with serious pelvic fracture [pelvic abbreviated injury scale (AIS) score of 3 or more].nnnRESULTSnOf the 106 patients, 27 (25%) underwent pelvic angiography leading to TAE for active arterial haemorrhage in 24. The TAE procedure was successful within 3h of arrival in 18 patients. In accordance with the algorithm, 10 patients were directly admitted to the angiography unit (n=8) and/or operating room (n=2) for uncontrolled haemorrhagic shock on admission. Of the remaining 96 stabilized patients, 20 had contrast media extravasation on pelvic CT scan that prompted pelvic angiography in 16 patients leading to TAE in 14. One patient underwent a pelvic angiography despite showing no contrast media extravasation on pelvic CT scan. All 17 stabilized patients who underwent pelvic angiography presented a more severely compromised haemodynamic status on admission, and they required more blood products during their initial management than the 79 patients who did not undergo pelvic angiography. The incidence of unstable pelvic fractures was however comparable between the two groups. Overall, haemodynamic instability and contrast media extravasation on the CT-scan identified 26 out of the 27 patients who required subsequent pelvic angiography leading to TAE in 24.nnnCONCLUSIONSnAn algorithm focusing on haemodynamic status on arrival and on the whole-body CT scan in stabilized patients may be effective at triaging multiple trauma patients with serious pelvic fractures.

A multicenter randomized controlled trial evaluating balneotherapy in patients with advanced chronic venous insufficiency

BACKGROUNDnApart from compression therapy, physical therapy has scarcely been evaluated in the treatment of chronic venous disorders (CVDs). Spa treatment is a popular way to administer physical therapy for CVDs in France, but its efficacy has not yet been assessed in a large trial. The objective was to assess the efficacy of spa therapy for patients with advanced CVD (CEAP clinical classes C4-C5).nnnMETHODSnThis was a single-blind (treatment concealed to the investigators) randomized, multicenter, controlled trial (French spa resorts). Inclusion criteria were primary or post-thrombotic CVD with skin changes but no active ulcer (C4a, C4b, or C5). The treated group had the usual 3-week spa treatment course soon after randomization; the control group had spa treatment after the 1-year comparison period. All patients continued their usual medical care including wearing compression stockings. Treatment consisted of four balneotherapy sessions per day for 6 days a week. Follow-up was performed at 6, 12 and 18 months by independent blinded investigators. The main outcome criterion was the incidence of leg ulcers at 12 months. Secondary criteria were a modified version of the Venous Clinical Severity Score, a visual analog scale for leg symptoms, and the Chronic Venous Insufficiency Questionnaire 2 and EuroQol 5D quality-of-life autoquestionnaires.nnnRESULTSnFour hundred twenty-five subjects were enrolled: 214 in the treatment group (Spa) and 211 in the control group (Ctr); they were similar at baseline regarding their demographic characteristics, the severity of the CVD, and the outcome variables. At 1 year, the incidence of leg ulcers was not statistically different (Spa: +9.3%; 95% confidence interval [CI], +5.6 - +14.3; Ctr: +6.1%; 95% CI, +3.2 - +10.4), whereas the Venous Clinical Severity Score improved significantly in the treatment group (Spa: -1.2; 95% CI, -1.6 - -0.8; Ctr: -0.6; 95% CI, -1.0 - -0.2; P = .04). A significant difference favoring spa treatment was found regarding symptoms after 1 year (Spa: -0.03; 95% CI, -0.57 - +0.51; Ctr: +0.87; 95% CI,+0.46 - +1.26; P = .009). EuroQol 5D improved in the treatment group (Spa: +0.01; 95% CI, -0.02 - +0.04) while it worsened (Ctr: -0.07; 95% CI, -0.10 - -0.04) in the control group (P < .001). A similar pattern was found for the Chronic Venous Insufficiency Questionnaire 2 scale (Spa: -2.0; 95% CI, -4.4 - +0.4; Ctr: +2.4; 95% CI, +0.2 - +4.7; P = .008). The control patients showed similar improvements in clinical severity, symptoms, and quality of life after their own spa treatment (day 547).nnnCONCLUSIONSnIn this study, the incidence of leg ulcers was not reduced after a 3-week spa therapy course. Nevertheless, our study demonstrates that spa therapy provides a significant and substantial improvement in clinical status, symptoms, and quality of life of patients with advanced venous insufficiency for at least 1 year.

Crenobalneotherapy (spa therapy) in patients with knee and generalized osteoarthritis: a post-hoc subgroup analysis of a large multicentre randomized trial.

OBJECTIVEnTo determine whether the addition of spa therapy to home exercises provides any benefit over exercises and the usual treatment alone in the management of generalised osteoarthritis associated with knee osteoarthritis.nnnMETHODSnThis study was a post-hoc subgroup analysis of our randomised multicentre trial (www.clinicaltrial.gov: NCT00348777). Participants who met the inclusion criteria of generalized osteoarthritis (Kellgren, American College of Rheumatology, or Dougados criteria) were extracted from the original randomised controlled trial. They had been randomised using Zelen randomisation. The treatment group received 18days of spa treatment in addition to a home exercise programme. Main outcome was number of patients achieving minimal clinically important improvement at six months (MCII) (≥-19.9mm on the VAS pain scale and/or ≥-9.1 points in a WOMAC function subscale), and no knee surgery. Secondary outcomes included the patient acceptable symptom state (PASS) defined as VAS pain ≤32.3mm and/or WOMAC function subscale ≤31 points.nnnRESULTSnFrom the original 462 participants, 214 patients could be categorized as having generalised osteoarthritis. At sixth month, 182 (88 in control and 94 in SA group) patients, were analysed for the main criteria. MCII was observed more often in the spa group (n=52/94 vs. 38/88, P=0.010). There was no difference for the PASS (n=19/88 vs. 26/94, P=0.343).nnnCONCLUSIONSnThis study indicates that spa therapy with home exercises may be superior to home exercise alone in the management of patients with GOA associated with knee OA.

Impact of information leaflets on behavior of patients with gastroenteritis or tonsillitis: a cluster randomized trial in French primary care.

ABSTRACTOBJECTIVETo assess the impact of four patient information leaflets on patients’ behavior in primary care.DESIGNCluster randomized multicenter controlled trial between November 2009 and January 2011.PARTICIPANTSFrench adults and children consulting a participating primary care physician and diagnosed with gastroenteritis or tonsillitis. Patients were randomized to receive patient information leaflets or not, according to the cluster randomization of their primary care physician.INTERVENTIONAdult patients or adults accompanying a child diagnosed with gastroenteritis or tonsillitis were informed of the study. Physicians in the intervention group gave patients an information leaflet about their condition. Two weeks after the consultation patients (or their accompanying adult) answered a telephone questionnaire on their behavior and knowledge about the condition.MAIN MEASURESThe main and secondary outcomes, mean behavior and knowledge scores respectively, were calculated from the replies to this questionnaire.RESULTSTwenty-four physicians included 400 patients. Twelve patients were lost to follow-up (3xa0%). In the group that received the patient information leaflet, patient behavior was closer to that recommended by the guidelines than in the control group (mean behavior score 4.9 versus 4.2, pu2009<u20090.01). Knowledge was better for adults receiving the leaflet than in the control group (mean knowledge score 4.2 versus 3.6, pu2009<u20090.01). There were fewer visits for the same symptoms by household members of patients given leaflets (23.4xa0% vs. 56.2xa0%, pu2009<u20090.01).CONCLUSIONPatient information leaflets given by the physician during the consultation significantly modify the patient’s behavior and knowledge of the disease, compared with patients not receiving the leaflets, for the conditions studied.

Prescribing nonopioids in mechanically ventilated critically ill patients

PURPOSEnWe searched for factors independently associated with the prescription of multimodal (balanced) analgesia in mechanically ventilated critically ill patients.nnnMETHODSnIn this post hoc analysis of a cohort study, 172 patients who received a combination of 1 opioid with nonopioids, that is, paracetamol and/or nefopam, (multimodal analgesia), were compared with 302 patients who received opioid only on day 2 of their stay in the intensive care unit.nnnRESULTSnPatients given multimodal analgesia were more likely to have fewer organ failures and received fewer hypnotics compared with patients who received opioid only. They self-reported more frequently their pain level. There were no differences in the daily dose of opioids between the 2 groups. A low illness severity score, no more than 1 organ failure on day 2, the ability to self-rate pain, and a moderate-to-severe pain rated on day 2 were factors independently associated with the prescription of multimodal analgesia on day 2 (all P < .01).nnnCONCLUSIONSnIn mechanically ventilated patients, the addition of nonopioids to opioids is mostly prescribed for patients with lower illness severity scores and who are able to self-rate their pain intensity. These findings suggest that the concept of multimodal analgesia must be promoted in the intensive care unit.