Randomized, controlled study comparing sitz-bath and no-sitz-bath treatments in patients with acute anal fissures. A 3-year double-blind, randomized, controlled study on the influence of two oral contraceptives containing either 20 microg or 30 microg ethinylestradiol in combination with levonorgestrel on bone mineral density. Spa therapy for gonarthrosis: a prospective study. Efficacy of homeopathic treatment of skin reactions during radiotherapy for breast cancer: a randomised, double-blind clinical trial. Controlled trial of balneotherapy in treatment of low back pain. Efficacy and safety of silver textile in the treatment of atopic dermatitis (AD). Evaluation of specific and non-specific effects in homeopathy: feasibility study for a randomised trial. Therapeutic massage and healing touch improve symptoms in cancer. The effects of whirlpools baths in labor: a randomized, controlled trial.
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. In this first prospective, double-blind, randomized, parallel-group study we evaluated the influence of two combined oral contraceptives on bone mineral density (BMD) and metabolic bone parameters. One dose-reduced preparation contained 20 microg ethinylestradiol (EE) in combination with 100 microg levonorgestrel (LNG) (20/100) was compared with the reference preparation which contained 30 microg EE in combination with 150 microg LNG (30/150). Data from 48 volunteers aged 20-35 years were obtained over an observation period of 36 treatment cycles. The direction of the change (increase or decrease) in all investigated bone-related variables was similar in both treatment groups. As compared to baseline, bone mineral density decreased by 0.4% in the 20/100 group and by 0.8% in the 30/150 group after 36 treatment cycles. These changes were not significantly different between the two treatment groups (p = 0.902). For bone-specific alkaline phosphatase, we measured a mean increase of 55.4% (20/100 group) and of 113.2% (30/150 group) after 36 treatment cycles. The two treatments did not differ statistically significantly (p = 0.522). With respect to cross-linked N-telopeptides (NTx), we detected a decrease of the mean NTx urine concentrations of 21.1% (20/100) and of 13.4% (30/150). These changes also did not significantly differ between the two treatments (p = 0.613). Both study treatments were safe and well-tolerated by all volunteers participating in the study. In conclusion, BMD did not change during the 3-year observation period. Thus, both trial preparations containing either 20 or 30 microg EE in combination with LNG were capable of maintaining BMD in young fertile women. There is no reason to assume that the EE dose reduction had any negative impact on BMD. Because there were no differences in BMD between the treatment groups, it can be assumed that even lower dosages than 20 microg EE might be sufficient for bone protection. Biochemical markers provided evidence for a reduced bone resorption. 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. The aim of this study was to assess the effects of Belladonna 7cH and X-ray 15cH associated in the treatment of acute radiodermatitis. A randomized double-blind placebo-controlled clinical trial involving 66 patients who had been operated on for breast cancer and were undergoing radiotherapy was conducted. The following parameters were assessed over ten weeks: breast skin colour, warmth, swelling and pigmentation. The efficacy of the treatment was assessed by the comparison of these parameters taken individually and by calculating an Index of Total Severity (sum of the scores of the four parameters) during radiotherapy, and during recovery, 15 and 30 d after the end of the radiotherapy. The differences of the scores of the Index of Total Severity during Radiotherapy were not statistically significant, but showed a trend towards a better activity of the homoeopathic medicine compared to placebo. Analysis of the data on Total Severity during recovery, showed a statistically significant benefit of the active medicines over placebo. The homeopathic medicines had particular effectiveness on the heat of the skin. The limited number of patients observed and the posology employed could have interfered with the significance of the results. Chemotherapy and hormonotherapy do not seem to affect the results. 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. 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 determine the feasibility, in terms of acceptability to patients, physicians and other staff; data return and statistical power of a study to elucidate the relative contributions of specific and non-specific effects in homeopathic treatment of dermatitis.
                Randomised, controlled 4-arm trial, 2 arms double-blind.
                Outpatient clinic, Royal London Homoeopathic Hospital.
                Seventy-five adult patients with dermatitis.
                Patients were randomly allocated to: 'fast track' open verum homeopathy, 'fast track' double-blind verum homeopathy, 'fast track' double-blind placebo homeopathy or waiting list control.
                One hundred millimeter visual analogue scale of overall symptom severity; 10 point digital scores of sleep, itching, skin condition; weekly 5-point Likert scale of topical steroid use; Dermatology Life Quality Index at entry and completion.
                Recruitment was below target, but the study was acceptable to staff and feasible. Blinded patients were more likely to withdraw (P=0.021, chi2 test). After correction for baseline differences and multiple comparisons, no outcome measure showed statistically significant between group differences. Blindness appeared to have a negative effect, but this was confounded by differential withdrawal.
                A definitive trial of this design is unlikely to discriminate the relative contributions of the non-specific and specific effects to the outcome of homeopathic treatment of dermatitis, because of patient preference issues. Complementary therapies are increasingly used to reduce side effects of cancer treatment, without evidence for their effectiveness. In a randomized, prospective, 2-period, crossover intervention study, the authors tested the effects of therapeutic massage (MT) and healing touch (HT), in comparison to presence alone or standard care, in inducing relaxation and reducing symptoms in 230 subjects. MT and HT lowered blood pressure, respiratory rate (RR), and heart rate (HR). MT lowered anxiety and HT lowered fatigue, and both lowered total mood disturbance. Pain ratings were lower after MT and HT, with 4-week nonsteroidal antiinflammatory drug use less during MT. There were no effects on nausea. Presence reduced RR and HR but did not differ from standard care on any measure of pain, nausea, mood states, anxiety, or fatigue. MT and HT are more effective than presence alone or standard care in reducing pain, mood disturbance, and fatigue in patients receiving cancer chemotherapy. Showers and tubs in labor were not generally used in our center. When three whirlpool baths (Jacuzzis) were ordered as part of our renovations, a randomized, controlled trial was initiated to explore their effects on narcotic and epidural requirements.
                This study employed an intent-to-treat design, and the sample size was estimated to account for the fact that some women would be unable to use the tub. The experimental group of 393 women was offered the tub during labor and the control group of 392 women received conventional care.
                No births occurred in the tub. The tub group required fewer pharmacologic agents than controls (66% vs 59%, p = 0.06), experienced fewer deliveries by forceps and vacuum (p = 0.019), and were more likely to have an intact perineum than the standard-care group (p = 0.019). Labor was longer for the tub group (p = 0.003), who coincidentally were more primiparous and in earlier labor on admission. No differences were noted in the low rates of maternal and newborn signs of infection in women with ruptured membranes. A subset of mothers expressed satisfaction with the tub experience and labor support. The cesarean rate among both groups was lower (8.9%) than our overall rate (16.6%) during the study period.
                Whirlpool baths in labor have positive effects on analgesia requirements, instrumentation rates, condition of the perineum, and personal satisfaction. Further study is being planned.
We found silver level evidence (www.cochranemsk.org) concerning the beneficial effects of mineral baths compared to no treatment. Of all other balneological treatments no clear effects were found. However, the scientific evidence is weak because of the poor methodological quality and the absence of an adequate statistical analysis and data presentation. Therefore, the noted "positive findings" should be viewed with caution.