Controlled trial of balneotherapy in treatment of low back pain. Randomized, controlled study comparing sitz-bath and no-sitz-bath treatments in patients with acute anal fissures. The effect of balneotherapy on patients with ankylosing spondylitis. Combined spa-exercise therapy is effective in patients with ankylosing spondylitis: a randomized controlled trial. Spa therapy for gonarthrosis: a prospective study. Balneotherapy for rheumatoid arthritis at the Dead Sea. Study of efficacy and safety of a new local cream ('healer') in the treatment of chronic anal fissure: a prospective, randomized, single-blind, comparative study. Efficacy and safety of silver textile in the treatment of atopic dermatitis (AD). Evaluation of a silver-releasing hydroalginate dressing in chronic wounds with signs of local infection.
Three treatments for non-specific lumbar pain--balneotherapy, underwater traction bath, and underwater massage--were assessed in a randomised prospective controlled trial in 158 outpatients. Each group was treated for four weeks and patients were reviewed at the end of this period and at 12 months after entry to the trial. The prescription of analgesics and the pain score were significantly reduced in all three treated groups, but there was no difference between the three groups. No significant change occurred in spinal motion and the straight leg raising test. After one year only the analgesic consumption was significantly lower than in the control group. To determine the efficacy and safety of sitz baths in the management of acute anal fissures.
                Individual patients were randomized to either receive sitz baths or no sitz baths for 4 weeks in addition to oral psyllium husk. Patients were asked to soak their hips and buttocks in a tub containing plain lukewarm water for 10 min, once after defecation in the morning and again at bedtime. Each week, the patients were called to assess pain scores and healing of fissures, whereas the level of satisfaction was recorded at the end of 4 weeks. Main outcome measures were validated pain scores and levels of satisfaction.
                Fifty-eight subjects were recruited for this study. In all, 52 of them completed the trial (27 in the sitz bath group and 25 in the control group). Although the pain score was lesser in the sitz bath group than in the control group, it failed to reach statistical significance. There were no significant differences in fissure healing between the two groups over the 4-week study period. However, patients in the sitz bath group reported better satisfaction levels than the control group (P < 0.01). Although no serious adverse effects were observed, two patients from sitz bath group developed perianal skin rash.
                This study suggests that sitz baths improve patient satisfaction in acute anal fissures. However, the healing and overall pain relief was not significant enough to attract attention. It was also found to be associated with adverse effects in few patients. To compare the effect of balneotherapy on physical activity and quality of life as well as the symptoms of pain and stiffness with exercise alone in ankylosing spondylitis (AS) patients.
                A total of 60 patients who had a diagnosis of AS according to the modified New York criteria were included in the study. The patients were randomly assigned to two groups. In Group I (n = 30) the patients received balneotherapy in a therapeutic pool for 30 min once a day for 3 weeks. All patients received instructions on the exercise programme, which they were requested to repeat once a day for 30 min during the study. The patients in this group continued the same exercise programme after the end of the balneotherapy protocol to complete a course of 6 months. In Group II the patients were given the same exercise protocol but did not receive balneotherapy. Patients were evaluated before the start of the study and at 3 weeks and 24 weeks. Evaluation parameters were daily and night pain, morning stiffness, the patient's global evaluation and the physician's global evaluation (according to a scoring system of 1 to 5), the Bath Ankylosing Spondilitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Dougados Functional Index (DFI), tragus-wall distance, chest expansion, modified Shober test (MST), fingertip-fibula head distance, and Nottingham Health Profile (NHP).
                Evaluations were completed in 54 patients in the two groups. Comparison of the groups showed significantly superior results for Group I for parameters of BASDAI, NHP total, pain, physical activity, tiredness and sleep score, patient's global evaluation and the physician's global evaluation at 3 weeks, but only for the parameters of patient's global evaluation and MST at 24 weeks.
                Balneotherapy has a supplementary effect on improvement in disease activity and functional parameters in AS patients immediately after the treatment period. However, in the light of our medium-term evaluation results, we suggest that further research is needed to assess the role of balneotherapy applied for longer durations in AS patients. To determine the efficacy of combined spa-exercise therapy in addition to standard treatment with drugs and weekly group physical therapy in patients with ankylosing spondylitis (AS).
                A total of 120 Dutch outpatients with AS were randomly allocated into 3 groups of 40 patients each. Group 1 (mean age 48 +/- 10 years; male:female ratio 25:15) was treated in a spa resort in Bad Hofgastein, Austria; group 2 (mean age 49 +/- 9 years; male:female ratio 28:12) in a spa resort in Arcen, The Netherlands. The control group (mean age 48 +/- 10 years; male:female ratio 34:6) stayed at home and continued their usual drug treatment and weekly group physical therapy during the intervention weeks. Standardized spa-exercise therapy of 3 weeks duration consisted of group physical exercises, walking, correction therapy (lying supine on a bed), hydrotherapy, sports, and visits to either the Gasteiner Heilstollen (Austria) or sauna (Netherlands). After spa-exercise therapy all patients followed weekly group physical therapy for another 37 weeks. Primary outcomes were functional ability, patient's global well-being, pain, and duration of morning stiffness, aggregated in a pooled index of change (PIC).
                Analysis of variance showed a statistically significant time-effect (P < 0.001) and time-by-treatment interaction (P = 0.004), indicating that the 3 groups differed over time with respect to the course of the PIC. Four weeks after start of spa-exercise therapy, the mean difference in PIC between group 1 and controls was 0.49 (95% confidence interval [CI] 0.16-0.82, P = 0.004) and between group 2 and controls was 0.46 (95% CI 0.15-0.78, P = 0.005). At 16 weeks, the difference between group 1 and controls was 0.63 (95% CI 0.23-1.02, P = 0.002) and between group 2 and controls was 0.34 (95% CI--0.05-0.73; P = 0.086). At 28 and 40 weeks, more improvement was found for group 1 compared with controls (P = 0.012 and P = 0.062, respectively) but not for group 2 compared with controls.
                In patients with AS, a 3-week course of combined spa-exercise therapy, in addition to drug treatment and weekly group physical therapy alone, provides beneficial effects. These beneficial effects may last for at least 40 weeks. The objective of this study was to evaluate the effect of spa therapy on clinical parameters of patients with gonarthrosis. Patients with gonarthrosis (n = 33) underwent a 2-week spa therapy using three treatment regimes and a 20-week follow-up as follows: group I (n = 11) had mineral water baths and hot native mineral mud packs, group II (n = 12) had mineral water baths and rinsed mineral-free mud packs and group III (n = 10) had tap water baths and mineral-free mud packs. The patients and the assessing rheumatologist were blinded to the difference in the treatment protocols. A significant improvement in the index of severity of the knee (ISK), as well as night pain scores, was achieved in group I. Improvement in physical findings and a reduction in pain ratings on a visual analogue scale (VAS) did not reach statistical significance. Analgesic consumption was significantly decreased in both groups I and III for up to 12 weeks. Global improvement assessed by patients and physician was observed in all three groups up to 16 weeks but persisted to the end of the follow-up period in group I only. Patients with gonarthrosis seemed to benefit from spa therapy under all three regimes. However, for two parameters (night pain and ISK) the combination of mineral water baths and mud packs (group I) appeared to be superior. Thirty-six patients with active rheumatoid arthritis were treated for 12 days at the Ein Gedi Spa. The patients were allocated randomly to four study groups. Group 1 (n = 9) was treated with daily baths in the Dead Sea, group 2 (n = 9) was treated with daily sulphur baths, group 3 (n = 10) was treated with a combination of daily Dead Sea bathing and sulphur baths, and group 4 (n = 8) served as a control group. All patients were assessed by a rheumatologist who was blinded to the treatment modalities and group allocation. Clinical parameters assessed included: duration of morning stiffness, 15 m walk time, grip strength, activities of daily living, patient's assessment of disease severity, number of active joints, and the Ritchie articular index. Statistically significant improvement lasting up to 3 months was observed only in the three treatment groups. To determine the efficacy and safety of 'healer' cream as monotherapy in the treatment of acute and chronic anal fissure.
                A prospective, randomized, single blinded, comparative trial.
                Sixty patients suffering from anal fissure were included in the study. Patients were randomly divided into three groups: group A: treated with 'healer' local cream application 3 times daily; group B: treated with nitroglycerine 0.25% local cream 3 times daily; group C: treated with a lidocaine 2% cream applied locally 3 times daily. All the followings were followed up and compared between groups. (1) Visual pain analogue score after defecation; (2) severity of straining and discomfort during defecation; (3) frequency of ulcer healed at 30 days; (4) any side effects or complications.
                The pain scoring after defecation was significantly reduced in the three treatment groups. The group treated with 'healer' isosorbide-di-nitrate showed the greatest reduction of the visual pain analogue score median from 9 before treatment to 3 & 1 after 10 and 20 days respectively, while the median visual pain analogue score in group B treated with nitroglycerine cream was 9 reduced to 4 & 2 after 10 and 20 days respectively, and the median visual pain analogue score in lidocaine group only dropped from 9 to 6 and 4, respectively. The reduction of both pain scoring and defecation scoring with 'healer' was statistically significantly greater than the other two treatments by Kruskal-Wallis test, P<0.001. The number of patients experiencing complete relief and passing stools easily after 10 days was significantly higher in 'healer' group, by Pearson Chi square = 22.94, P<0.001. After 30 days, the fissures were healed in 18 (90%) of 20 patients in the 'healer' group and in 12 (60%) of 20 in the nitroglycerin group, while only 6 (30%) of patients treated with lidocaine cream had their fissures healed by the 30 days treatment. Chi square = 15 (P = 0.001).
                'Healer' is a promising effective and safe line of treatment in acute and chronic anal fissure. The characteristic pharmacokinetics of isosorbide-di-nitrate leads to a better effect than nitroglycerin in healing (more prolonged action). Also the less fast absorption than nitroglycerin leading to a smoother dose concentration curve, may be the cause that headache is less frequent and less severe in 'healer' treatment versus nitroglycerin. Patients with atopic dermatitis (AD) have an increased tendency to develop bacterial skin infections. Colonization with Staphylococcus aureus is known to be a major trigger and might also play a pathophysiological role. Because of their antiseptic action, silver-coated textiles suppress S. aureus colonization and toxin formation, thus damping the inflammatory reaction.
                To evaluate the clinical effectiveness and safety of a special silver textile in the treatment of patients suffering from acute AD.
                In a randomized phase II monocenter parallel-group comparative study 30 patients were recruited (average age 25.5 years, min. 4 years, max. 70 years) who were affected by AD in an acute phase. During the first study phase from Day 1 to Day 14, 10 patients received a silver textile (Group 1), 10 a silver-free textile (Group 2), and 10 prednicarbate ointment (Group 3). In the second phase from Day 15 to Day 28 all patients wore the silver textile, and during the follow-up period from Day 28 to Day 56 no textiles were used. Prednicarbate ointment was allowed as emergency medication, but ointment consumption was measured. The overall severity of the disease was evaluated using the SCORAD index as the primary efficacy parameter. Secondary parameters included severity of pruritus and the patients' assessment of their disease control (uncontrolled, limited, good or complete). Safety tests included hematology, blood chemistry, urinalysis for silver, and physical examination for silver deposits in the skin and mucous membranes.
                The initial SCORAD was 61.6 (IQR 26.6, min. 30.6, max. 99.9). At the end of the Study Phase 1 the SCORAD had improved significantly in the patients of Groups 1 (74.6-29.9, p = 0.005) and 3 (57.8-24.0, p = 0.009). During Study Phase 2 healing of eczema continued in Group 1 (SCORAD 29.9-18.1, p = 0.037), was observed in Group 2 (48.2-24.1, p = 0.015), and remained at an improved level in Group 3 (SCORAD 24-23.5). Consumption of prednicarbate ointment (Phase 1, Phase 2, follow-up period, medians are given): Group 1: 135 g, 10 g, 45 g; Group 2: 13 g, 0 g, 0 g; Group 3: 145 g, 30 g, 90 g. Silver textiles reduced the severity of the pruritus (p = 0.031); silver-free textiles (n.s.) and prednicarbate (n.s.) were less effective. No undesired events were observed.
                The elastic silver textile worn directly against the skin led to an impressive improvement of AD and a reduction in the use of prednicarbate ointment. To evaluate the clinical impact of using a silver-releasing hydroalginate dressing to minimise the risk of local infection in colonised chronic wounds.
                This was a randomised (stratification according to wound type) open-label multicentre comparative two-arm parallel-group study. Thirteen centres recruited 99 patients with either a venous leg ulcer or a pressure ulcer. None of the wounds required systemic antibiotics or were associated with lymphangitis and/or fever, but at least two of the following criteria had to be present: continuous pain; erythema; oedema; heat; and moderate to high levels of serous exudate. Patients were allocated to receive either a silver-releasing hydroalginate dressing (Silvercel, the test group) or a pure calcium alginate dressing (Algosteril, the control group). Wounds were assessed daily over 14 days to complete a modified ASEPSIS index to evaluate risk of infection, and then weekly for two additional weeks. A global wound severity score and area tracings were recorded weekly.
                Fifty-one and 48 patients were randomised in the test and control groups respectively: 28 pressure ulcers and 71 venous leg ulcers. The total mASEPSIS score over 14 days did not differ significantly between groups: 95.4 +/- 62.2 and 104.2 +/- 72.8 in control and test groups respectively (p = 0.791). Of the patients who completed the total four-week study duration, four out of 38 (10.5%) in the control group and none of the 40 in the test group were treated with systemic antibiotics at the final visit (p = 0.053). According to the investigators, fewer wounds developed a clinical infection over the four-week follow-up in the test group (33% versus 46%; p = 0.223). Overall, the four-week closure rate was statistically greater in the test group (0.32 +/- 0.57cm2/day versus 0.16 +/- 0.40cm2/day; p = 0.024). Compared with baseline, the absolute decrease in wound severity score at week four was higher in the test group (-5.6 +/- 3.2 versus -4.1 +/- 4.3; p = 0.063); this was also true of the percentage reduction (-32 +/- 17% versus -23 +/- 25%; p = 0.034). Poor dressing acceptability and/or tolerability was noted in five out of 48 patients (10.4%) in the control group and in five out of 51 (9.8%) in the test group.
                This study suggests that the use of silver-releasing dressings in the management of wounds at high risk of infection may have a clinically favourable influence on wound prognosis; the dressings also appeared to be well tolerated. However, the evaluation of these advantages in controlled clinical trials is complex and requires potent studies and the development of more specific endpoints than those currently used.
Silver level evidence was found for one study in favour of mineral baths compared to drug treatment at eight weeks. Insufficient evidence was found for all other comparisons. However the scientific evidence is insufficient because of poor methodological quality. Therefore, the noted "positive findings" should be viewed with caution. Because of the methodological flaws, an answer about the apparent effectiveness of balneotherapy cannot be provided at this moment.