Crenobalneotherapy for low back pain: systematic review of clinical trials.

Crenobalneotherapy is a treatment commonly used in Europe and Middle East. It uses mineral water sometimes combined with different hydrotherapy techniques. Most patients treated in spa centers suffer from low back pain. The purpose of this work is to identify clinical trials on crenobalneotherapy for low back pain. Publication research was performed on Medline, Cochrane, and PEDRO databases. Clinical trials were analyzed for internal validity, external validity, quality of statistical analysis, and quality of collection of adverse events. We present the best level of evidence. Bibliographic research identified 21 clinical trials and the coauthors added 5 references. The 26 trials represent 2695 patients. Some have good methodological quality and allow considering crenobalneotherapy as a potential treatment for low back pain, even if the role of mineral water remains uncertain. The methodological quality of therapeutic trials should be improved. These trials should be analyzed in the future guidelines on low back pain.

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

OBJECTIVE: To 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. METHODS: This 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. RESULTS: From 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). CONCLUSIONS: This 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.

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 > or =19.9 mm on the visual analogue pain scale and/or > 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 (chi(2)=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.

[Are SPA therapy and pulsed electromagnetic field therapy effective for chronic neck pain? Randomised clinical trial. Second part: medicoeconomic approach]. / Y a-t-il un effet des soins thermaux et des champs électromagnétiques pulsés sur la cervicalgie chronique? Essai clinique randomisé. Deuxième partie: approche médicoéconomique.

UNLABELLED: We report the results of a cost-effectiveness evaluation of pulsed electromagnetic field (PEMF) therapy and spa therapy (ST) versus usual care (control) for chronic neck pain. MATERIALS AND METHODS: Inclusion criteria were age 18 to 80 years with pain in the neck area of more than 3 months' duration and no contraindications for PEMF therapy and ST. Randomization to the ST (n=25) and PEMF groups (n=26) was blinded, as was collection of data. Non-included subjects (n=29) underwent usual care. The trial respected the Helsinki declaration, and informed consent was obtained from subjects. The analysis was intent to treat; the main outcome measure was increase in health dimension scores on the MOS SF-36 in terms of increase in French health care costs from 6 months preceding to 6 months after the start of the study. RESULTS: The increase in health care costs was less for the PEMF group (+68 euro+/-539 [95% confidence interval (CI)]: -145.0+281) than the ST and control groups. The increase tended to be less, but not significantly, for the ST group (+373+/-938 euro [95% CI, -14.0+76.0]) than for controls (+618+/-2715 euro [95% CI, -434.0+167.0]). The gain of one physical MOS SF-36 unit during one year cost 3400 euro [95% CI, -6759+13 100] for the PEMF group, 29,000 euro [95% CI, -1093+59 375] for the ST group and 95076 euro [95% CI, -66 769+256 923] for the control group, but the differences were not significant. COMMENTARY: These results suggest a potential cost-effectiveness for ST and particularly PEMF as compared to usual care in chronic cervical pain. Our results perhaps lack significance probably because of lack of statistical power and do not distinguish costs related or not to chronic cervical pain.

[Are SPA therapy and pulsed electromagnetic field therapy effective for chronic neck pain? Randomised clinical trial First part: clinical evaluation]. / Y a-t-il un effet des soins thermaux et des champs électromagnétiques pulsés sur la cervicalgie chronique? Essai clinique randomisé. Première partie: étude clinique.

OBJECTIVES: The purpose of this study was to compare SPA therapy (ST) with pulsed electromagnetic field (PEMF) therapy in chronic neck pain. MATERIALS AND METHODS: Inclusion criteria were age between 18 and 80 years, neck pain of more than 3 months' duration and pain score>30 mm on a visual analog scale (VAS). Exclusion criteria were contraindication to ST or PEMF. The protocol was approved by the ethics committee of Grenoble Hospital. Randomisation to the ST (n=44) and PEMF groups (n=42) was blinded. The main outcome measure was number of improved patients at 6 months in each group. A patient was considered improved if pain score decreased by more than 20%. Secondary measures were score on the Copenhagen and MOS SF-36 scales. Evaluation and intent-to-treat analysis were also blinded. RESULTS: Patients' preferences were for PEMF. At 6 months, in the PEMF group, 33 patients were improved, 5 not improved and 4 lost to follow-up. In the ST group, 24 patients were improved, 14 not improved and 6 lost to follow-up, for significantly greater improvement in the PEMF than ST group (p=0.02). Significant improvement was seen in both groups in terms of pain score, Copenhagen scale score and score on some dimensions of the MOS SF-36 survey. CONCLUSION: PEMF seems to be superior to standard ST without massage in control of neck pain. The difference between groups, although perhaps biased, seem to suggest the importance of our conclusions.

[Validity parameters of clinical trial and their influence on evidence based medicine conception: a review]. / Les paramètres de validité d'un essai thérapeutique et leur influence sur l'élaboration d'une médecine fondée sur les preuves: revue de la littérature.

INTRODUCTION: The purpose of this study was to review the validity of clinical trials and checklists used to evaluate them in systematic reviews and meta-analyses. METHODS: We researched Medline and bibliographies of relevant articles with use of keywords and author names. RESULTS: Methodological choices that have a demonstrated influence on the results of clinical trials include collecting informed consent, comparison of publication with protocol, selection of patients, randomization procedure, number of subjects to include, number lost to follow-up, blinding of patients and evaluation. The type of comparison (with placebo and classic treatment, adjustment of level of significance to the number of measures and number of criteria) and intent-to-treat analysis has a demonstrated influence. The level of this influence is not always precisely determined. In some other fields we didn't find any scientific demonstration even if they have a potential effect. CONCLUSION: The validity of quantitative checklists is low because of lack of scientific demonstration of their relevance.

[Radiography scale in rheumatology. State of the art and consequences for clinical practice]. / L'échelle des clichés radiologiques en rhumatologie. Etat des lieux et conséquences pour la pratique clinique.

PURPOSE: Realize a "state of the art" of numerization and reduction or magnification scale of musculoskeletal radiography. Looking for the factors associated with this scale variation. How do they influence rheumatology practice. MATERIALS AND METHODS: The study recenced all the numerized (RN) and conventional radiography (RC) of one hundred consecutive patients consulting a rheumatologist practitioner. The scale was read directly or on gradations on the side of the radio. All the measure was made with a graduated magnifying glass. RESULTS: This study confirms that RN gradually replace RC in musculoskeletal radiology (0% before 1994, 65% in 1999). It also confirms that reducing scale is more frequent (50% in 1994, 82% in 1999). The scale of reduction is significantly different depending on some anatomic area, some diagnosis and some geographical provinces. These scale modifications disturb some recommended measures in rheumatology practice. The significant correlation between reducing scale and joint space (r=-0,32; p=0, 009; n=67) tend to show that scale reduction provide an overestimation of joint space. CONCLUSION: Given the perturbation induced in rheumatology practice it would be better to keep the scale of 100% until relevance of reducing scale has been demonstrated.

Magnitude and duration of the effects of two spa therapy courses on knee and hip osteoarthritis: an open prospective study in 51 consecutive patients.

OBJECTIVE: To evaluate the effects of spa therapy on knee and hip osteoarthritis by studying patients given the same treatment on two different occasions. PATIENTS AND METHODS: A prospective study of two medically-supervised, 3-week spa therapy courses performed at an interval of about 1 year in 51 consecutive patients with knee and/or hip osteoarthritis, most of whom were overweight (mean body mass index, 30 +/- 5 kg/m2). Mean age was 66 years. Study data were collected over a 17-month period. RESULTS: Lequesne's algofunctional index was significantly improved 5 and 8 months after the first course (by 1.74 +/- 2.2, P < 0.0001; and by 0.89 +/- 2.4, P = 0.017; respectively) and 5 months after the second course (by 1.26 +/- 3, P = 0.008). Walking distance showed comparable improvements. The decrease in medication use was not significant. No significant differences were found between the effects of the two courses after 20 days and 5 months. The advantages and drawbacks of the repeated treatment design used in this study are discussed. CONCLUSION: Although some sources of bias could not be eliminated, our data suggest that spa therapy may be effective in knee and hip osteoarthritis. The repeated treatment design may prove useful for evaluating treatments to which patients cannot be blinded.

Follow-up of bone mineral density in 27 cases of anorexia nervosa.

Cortical and trabecular bone loss can lead to osteoporosis in chronic forms of anorexia nervosa (AN). As there is some debate about the reversibility of this condition, we performed a longitudinal follow-up study of 27 cases in which clinical, biological, X-ray and lumbar and femoral neck dual photon absorptiometry examinations were conducted every 6 months for up to 30 months. Three groups were distinguished: G1, untreated amenorrheic AN (N = 14, total follow-up 126 months); G2, effectively treated AN (N = 11, total follow-up 192 months), with two subgroups: fluoride (N = 5) and estrogen (N = 6); and G3, remitting AN with normalization of the gonadic function (N = 2, total follow-up 36 months). Results were adjusted for each patient to a 6-month variation. Semestrial variations in lumbar bone mineral density (BMD) were -2.1 +/- 1.3%, +2.8 +/- 1.5%, and -0.3 +/- 1.3% (mean +/- SEM), respectively for G1, G2 and G3; those for femoral neck BMD semestrial variations were -5.9 +/- 2.1%, -3.8 +/- 1.2% and -1.0 +/- 0.6%. Femoral neck and lumbar BMD variations for G1 were mainly correlated positively with bone-forming markers (serum osteocalcin, alkaline phosphatase) and negatively with initial lumbar BMD. Estrogen alone increased lumbar BMD by +1.4 +/- 2.3% every 6 months but did not stabilize femoral neck BMD (-3.5 +/- 1.4%). Fluoride increased lumbar BMD by 4.8 +/- 1.8%. Both lumbar and femoral neck BMD were stabilized in the remission group (-0.3 +/- 1.3% and -1.0 +/- 0.6%), despite half of the follow-up time with amenorrhea. In conclusion, untreated AN is associated with a marked trabecular and cortical bone loss (4-10% per year), which can lead to osteoporotic fractures. In prevention of bone loss, the efficacy of estrogen is difficult to investigate in AN, even with a well-controlled trial. Our study could provide argument that, when the observance of this preventive treatment is assessed, lumbar BMD can be stabilized in chronic forms of AN.

[A medical evaluation mission to the mountain tribes on the high plateaus of central Vietnam]. / Une mission d'évaluation médicale dans les tribus montagnardes des Hauts Plateaux du centre Vietnam.

The Vietnamity Association and Association for Aid to Ethnic Minorities in Vietnam is sponsoring a health plan for the mountain tribes living on the high plateaux of central Vietnam in the Kontum region. Within this framework a team of doctors undertook a medical evaluation mission in several villages in the region. The purpose of this report is to describe observation made in the subjects who consulted on a voluntary basis without active screening. A total of 618 subjects including 400 children were examined. Fifty Blood smears and 12 direct stool examinations were performed. Otorhinolaryngologic, respiratory, parasitic, and digestive disorders due mainly to poor hygiene of the skin and teeth were the most frequent reasons for consultation. Management of malaria and tuberculosis are urgent problems. Several realistic proposals are made based on the diseases observed, the populations involved, and the facilities at the disposal of the commissioning associations.

[Study of bone repercussion in 33 cases with anorexia nervosa which 8 with fracture osteoporosis]. / Etude du retentissement osseux dans 33 cas d'anorexie mentale dont 8 avec une osteoporose fracturaire.

A national survey has regrouped 33 cases of anorexia nervosa (AN) with osseous investigations, in particular an absorptiometry of the lumbar spine. 2 groups have been defined: 25 patients without fracture (F-) and 8 patients with osteoporotic fractures (F+), including 5 cases with 12 vertebral fractures and 5 with non vertebral fractures: 31/33 have a low lumbar bone mineral content (BMC). The lumbar BMC of the F+ is significantly lower than the F-: -4.1 +/- 1.6 DS versus -2.2 +/- 1.2 DS (p less than 0.001). 5 F+ patients are under the fracture threshold (FT), (O F-), 2 F+ are on the same level as the FT, and the last F+ has a lumbar BMC 15% above the FT, but an osteoporotic wrist fracture and a very low femoral neck BMC (0.64 g/m2, normal 1.06 +/- 0.15). F+ are older (35.2 year old versus 23.6, p less than 0.001), owing the fact that the duration of the AN (+ 9.2 years, p less than 0.005) and of the amenorrhea (+ 9.8 years, p less than 0.001) are longer, although the AN began at the same age in the 2 groups. The minimum weight, the body mass index, the percentage of loss of weight are similar in the 2 groups. Phosphocalcic biological studies, which show rather high osteocalcinemia and hydroxyprolinuria (hyperremodeling), with rather high serum 1-25 OH vitamin D, do not differ between the 2 groups. Endocrinologic evaluations, with a constant hypooestradiolemia of hypothalamic origin, low somatomedinemia and normal cortisolemia, are not different between the 2 groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Midwifery in France.

PIP: Describes the scope of midwifery practice in France and outlines the program of study and requirements for registration. In France, midwifery is considered a medical profession. Under French law, the practice of midwifery includes all acts that are necessary to the diagnosis of pregnancy, prenatal care, psychoprophylactic preparation for delivery, supervision and care during delivery, and postnatal care of the mother and infant. Midwives may also prescribe some medications and conduct laboratory and radiographic studies. They practice in hospitals, clinics, private practices, and special programs. All of the 33 midwife schools in France are associated with a University Hospital Center. Before entering a midwife program, candidates must pass written exams on the level of a B.A. in Science. The midwife program is 3 years of full-time study; students are continuously tested. To be certified, a student must pass written and oral tests and must attend 40 deliveries, including 2 breech births. In 1983, an agreement became effective in France and throughout the European Economic Community (EEC) which enabled any midwife who obtained her diploma in the EEC to practice in any of its 9 member countries. This required the EEC countries to establish equivalents for the diplomas awarded by different nations. It is difficult for French midwives, who are considered medical professionals in their own country, to understand why midwives in other countries do not hold similar status since they have the same responsibilities and competence.^ieng

[Neurologic complications of ciguatera]. / Complication neurologique de la ciguatera.

The authors report a case of severe two phases fish poisoning, treated at hospital and ruled by a complex neurological picture with both central and peripheric manifestations. The detailed data, they have got about the disease, are an opportunity to discuss the various pathogenic procedures of human ciguatera.