[Effectiveness and safety of a homeopathic drug combination in the treatment of chronic low back pain. A double-blind, randomized, placebo-controlled clinical trial]. / Wirksamkeit und Sicherheit eines homöopathischen Komplexpräparates bei chronischen Rückschmerzen. Doppelblinde, randomisierte, placebokontrollierte, klinische Studie.

BACKGROUND: The homeopathic drug combination Lymphdiaral Basistropfen is established in the treatment of edema and swellings. This is the first time the effectiveness and safety was investigated in the treatment of chronic low back pain. METHODS: The study is a randomized, double-blind, placebo-controlled trial. From December 2003 to May 2007 248 patients aged 18 to 75 years were screened, 228 were randomized, 221 started therapy, in 192 the progress was measured (103 verum vs. 89 placebo), 137 completed the study (72 verum vs. 65 placebo). They received 10 drops of verum or placebo solution three times daily for 105 days additionally to an inpatient complex naturopathic treatment. RESULTS: The hannover functional ability questionnaire score (primary outcome measure) tends to increase in the intention-to-treat-analysis (verum: 6.6 vs. placebo: 3.4; p = 0.11) and increases significantly in the per-protocol-analysis (verum: 9.4 vs. placebo: 4.1; p = 0.029). The treatment was well tolerated (92.9% vs. 95.4%). The incidence of adverse reactions and serious adverse reactions was similar in both treatment groups. CONCLUSIONS: This first randomized, double-blind, placebo-controlled trial shows, that the homeopathic drug combination can improve the treatment of chronic low back pain.

[Naturopathic and orthopaedic in-patient treatment of chronic back pain--a comparison study]. / Naturheilkundliche und orthopädische station are Behandlung bei chronischen Rückenschmerzen: Eine Vergleichsstudie.

BACKGROUND: This study compares orthopaedic and naturopathic inpatient treatment concepts for back pain with regards to therapeutic efficacy. PATIENTS AND METHODS: A controlled prospective cohort study is presented. 187 conservatively treated patients of an orthopaedic clinic and 161 patients of a clinic for naturopathy were recruited for the study, if they needed inpatient treatment because of chronic back pain.The results were measured with the Oswestry Score for orthopaedic symptoms as primary endpoint and the SF-36 for life quality before treatment (T0), after 3 (T2) and 6 months (T3), plus the SES for pain intensity and pain quality (T0, T1 = at discharge, T2, T3). Accompanying diseases were documented with anamnesis and catamnesis sheets. The whole collectives were evaluated. Additionally a gender specific analysis was performed. RESULTS: For the main and secondary objectives no differences between the naturopathic and orthopaedic treatment groups (screened patients with back pain for naturopathy 286, 187 for orthopedics, in the study included patients 161 respectively 140 after 2 weeks, 62 respectively 68 after 6 months; mean age 57.1 respectively 54.0 years, female 85.1 respectively 63.6%) could be verified (Oswestry Score at T0: 43.0, 95%-confidence-interval 39.6-45.3; at T2: 40.7, 95%-confidence-interval 37.4-44.0). Only in the subgroup of women, who account for 86% of the naturopathic patients, a difference in the main objective (Oswestry Score) was found (p = 0.014) in favour of naturopathy (T2: 32.6, 95%-confidence-interval 24.9-40.2) compared to orthopedics (T2: 45.1,95%-confidence-interval 41.2-49.1). CONCLUSION: Treatment results of naturopathic, complex" inpatient treatment of chronic back pain are comparable to conventional orthopaedic treatment at all points of time T1 to T3. The study design does not allow the conclusion, that the therapeutical concept can be changed forthetwo groups of patients with the same chance of good therapeutical efficacy. The result of the study is limited in this respect as the therapeutic effect cannot be claimed to be the same if the treatment groups were exchanged. Thus the improvement is only comparable.

[Comparison of treatment expenses of naturopathic and orthopedic in-patient treatment]. / Kostenvergleichsuntersuchung zur naturheilkundlichen und konventionellen orthopädischen stationären Behandlung.

BACKGROUND: In health services research comparative studies between orthopaedics and naturopathy are necessary. They allow evidence based decisions between individual therapeutical alternatives as well as decisions on health politics, e.g. concerning allocation of resources. PATIENTS AND METHODS: A controlled prospective cohort study is presented. Conservatively treated patients were recruited for the study, if they needed in-patient treatment because of chronic back pain. The conservative orthopaedic treatment including Minimal invasive Therapy (MIT) was compared to in-patient naturopathic "complex"-treatment. The real costs to the public health insurance system are unknown--relating to both the individual patient and the physician. Hence an approximation was attempted on the basis of the billing of the concerned hospitals, the analysis of extensive patient interviews, randomly selected evaluation of in- and out-patient records, validated by an expert panel. RESULTS: Costs for medication decreased in the post stationary phase after orthopedic and naturopathic treatment. Rehabilitation measures and treatments at a health resort increased after orthopedic treatment, whereas the frequency of specialist consultation decreased in both cohorts indicating the efficacy of the in-patient treatment. Incidence of psychotherapy was highest in the naturopathic group before admission to hospital and decreased afterwards. The gathered data point to a reduction of the total outpatient treatment costs in both cohorts. There were treatment-specific differences when regarding single components. CONCLUSION: Naturopathic complex in-patient treatment is a cost-efficient complement of the conventional orthopedic treatment options.

Lycopus europaeus (Gypsywort): effects on the thyroidal parameters and symptoms associated with thyroid function.

The aim of the prospective two-armed open study was to examine the effect of Lycopi europaei herba on thyroid function and on associated symptoms during a 3-month follow-up phase. The study population consisted of patients with a basal TSH<1.0 mU/l and hyperthyroidism-associated symptoms. For the first time, the T3/T4 excretion in 24h urine was measured as a primary objective parameter. As secondary parameters, further hormones, the general condition and the symptoms associated with hyperthyroidism were registered. The urinary T4 excretion was significantly increased in Lycopus europaeus-treated patients (p=0.032). It is supposed that renal mechanisms cause the increased T4 excretion either by a modification within the glomeruli or by impaired reabsorption. Symptoms being specific to the thyroid gland were diminished, as e.g. the increased heart rate in the morning. The Lycopus europaeus preparation showed a good tolerance. These findings confirm positive effects of Lycopus europaeus in slight forms of hyperthyroidism.

Oscillating prostacyclin and thromboxane generation by human vessels: biological and mathematical evidence for negative feedback control.

The presented study investigates the time-dependent release of PGI2 and TXA2 by isolated human umbilical veins in vitro using the radioimmunoassay for measurement. After changing the nutritional fluid--Krebs-Henseleit solution at pH 7.4, 37 degrees C, 95% O2/5% CO2--the release graph oscillates. These oscillations with time were verified by variance analysis and are very similar for both substances. This indicates one or several negative feedback mechanisms acting on the common path of synthesis from the membrane-bound phospholipids to PGH2, which are effective in the regulation of eicosanoid biosynthesis in vitro. A mathematical function describing the observed PGI2 and TXA2 synthesis is communicated.