[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.

[Efficacy of a combination therapy with vitamins B6, B12 and folic acid for general feeling of ill-health. Results of a non-interventional post-marketing surveillance study]. / Wirksamkeit einer Vitamin-B6-, -B12- und Folsäure-Kombinationstherapie bei Befindlichkeitsstörungen. Ergebnisse einer Anwendungsbeobachtung.

OBJECTIVE: In the present non-interventional postmarketing surveillance study, patients with symptoms of an inadequate supply of vitamins were tested for how a treatment with a combination vitamin injection consisting of vitamins B6, B12 and folic acid affects mood and fitness. The evaluation of the efficacy and tolerability as well as the documentation of adverse drug reactions were carried out by the physician. METHODS: The patient collective included 1430 patients (70.8% women, average age 67.1 years, average BMI 25.5 kg/m2). The average duration of treatment was 4.5 weeks with an average of 8.3 intramuscular injections. The principal method for determining the efficacy was the self-assessment scale of well-being (Bf-S) according to Zerssen (sum score with a value range between 0 and 56 points). RESULTS: The sum score of the Bf-S decreased from 37.5 (+/-10.1) points at admission to 15.6 (+/- 9.4) points after four weeks of treatment. The subjective impression improved correspondingly in 96.3% of the patients. The improvement of the Bf-S was equally good in women and men. The number of injections correlated with the improvement in the sum score. The tolerability was mainly rated as very good or good. CONCLUSIONS: Eight vitamin infections over four weeks led to a clear improvement in the mood and vitality of patients with symptoms of intracellular vitamin B deficiency.

High-dose intravenous vitamin C is not associated with an increase of pro-oxidative biomarkers.

OBJECTIVE: High-dose vitamin C therapy might mediate beneficial clinical effects by counteracting reactive oxygen species. However, concerns are raised whether this approach might provoke diametrical (ie pro-oxidative) effects. The objective was to determine ascorbyl free radical (AFR) concentrations and potential variables of pro-oxidative damage. DESIGN: Crossover study; six healthy males received daily infusions of 750 or 7500 mg vitamin C for six consecutive days. Fasting concentrations of vitamin C and AFR were determined daily. On day 1, concentrations of vitamin C and AFR were measured at 0.25, 0.5, 1, 2, 4 and 8 h post infusion. Plasma concentrations of thiobarbituric acid-reactive substances (TBARS), tocopherol and urine concentrations of 8-oxoguanosine were determined on days 1 and 6. RESULTS: Kinetic studies on day 1 showed that concentrations of vitamin C and AFR displayed parallel dose- and time-dependent kinetics and elimination was highly efficient. Vitamin C and AFR fasting concentrations on days 2-6 were slightly above the baseline, suggesting new, stable steady states. TBARS decreased in both groups, whereas tocopherol and 8-oxoguanosine concentrations remained unchanged. CONCLUSION: Kinetics of AFR largely depend on plasma vitamin C concentrations and AFR is eliminated efficiently. Our data do not support induction of pro-oxidative effects in healthy volunteers given intravenous high-dose vitamin C. SPONSORSHIP: Pascoe Pharmazeutische Präparate GmbH, Giessen, Germany.