[Homeopathy in acute rhinosinusitis: a double-blind, placebo controlled study shows the efficiency and tolerability of a homeopathic combination remedy]. / Homöopathie bei akuter Rhinosinusitis: Eine doppelblinde, placebokontrollierte Studie belegt die Wirksamkeit und Verträglichkeit eines homöopathischen Kombinationsarzneimittels.

BACKGROUND: The efficacy and tolerability of a homeopathic combination remedy for the treatment of acute rhinosinusitis was investigated. PATIENTS AND METHODS: A total of 144 patients with acute rhinosinusitis were treated in a randomized, double-blind study either with a homeopathic remedy (n=72) or placebo (n=72). At the control examinations after 7, 14 and 21 days, five sinusitis-typical symptoms were measured with scores from 0 (absent) to 4 (very strong). The change of sum score of the sinusitis-typical symptoms (max. 20 points) during the treatment served as the primary efficacy criterion. RESULTS: In the homeopathic treatment group, the average sum score dropped from initially 12.1+/-1.6 to 5.9+/-2.0 points after 7 days. In the placebo group it decreased from 11.7+/-1.6 to 11.0+/-2.9 points (p<0.0001). The homeopathic treatment resulted in freedom from complaints in 90.3% of the patients and improvement in a further 8.3%, whereas in the placebo group, the complaints remained unchanged or became worse in 88.9% of the patients. Only one adverse event occurred in one patient from the placebo group. CONCLUSION: The homeopathic product allows an effective and tolerable treatment of acute rhinosinusitis.

A non-randomised pilot study to compare complementary and conventional treatments of acute sinusitis.

BACKGROUND: It is still under discussion whether antibiotics are effective in the treatment of acute sinusitis. Moreover, they are known to have considerable side-effects. In contrast, complementary approaches are reported to have little side-effects and an equivalent efficiency. OBJECTIVES: To assess the success of conventional and complementary treatments of acute sinusitis and to estimate the patient numbers needed to confirm therapeutic equivalence. Treatment success was measured by three different scores, assessed by both patients and physicians. METHODS: Multicentre (2 complementary and 3 conventional ENT centres), non-randomised, controlled clinical trial with 63 patients (complementary group 30, conventional group 33 patients). To control for confounders treatment differences were estimated by propensity score techniques. TREATMENTS: The choice of medication was entirely left to the physician. We recommended to use antibiotics, secretolytics and symptomimetics in the conventional group and a combination of the herbal remedy Sinupret((R)) and the homeopathic remedy Cinnabaris 3X in the complementary group. RESULTS: Treatment differences varied substantially depending on the outcome measure, but they were always not clinically relevant. Conventional treatment was slightly better when the outcome was assessed by the physicians (1.8 score points) but slightly worse when it was assessed by patients (0.2 score points) or in terms of the HCG-5 quality of life score (0.8 score points). p values were always > 0.3. CONCLUSIONS: Both treatments appear to be equally effective (or ineffective). Results might be biased because both treatment groups differed substantially. Randomised trials including at least 400 patients are needed to produce valid results.

An example on the value of non-randomisation in clinical trials in complementary medicine.

BACKGROUND: Randomised clinical trials may in principle show a small external validity. Non-randomised clinical trials therefore are sometimes regarded as an appropriate alternative when complementary and conventional treatments are compared. OBJECTIVES: To assess the value of advanced statistical methods in the process of estimating differences between a complementary and a conventional treatment of acute sinusitis in a non-randomised clinical trial. METHODS: Multicentre, non-randomised, controlled clinical trial comparing 2 complementary and 3 conventional ENT centres. Patients were free to choose the physician (and hence the therapy). Treatment differences were estimated by controlling for confounders in analyses of covariance or by propensity score techniques. RESULTS: Most potential confounders (sex, age, life-style parameters) did not have significant effects on the choice of therapy. Disease severity and previous ENT surgery were the main confounding factors. At study onset they almost cause a defined separation of both treatment groups. As a result estimated treatment differences vary substantially depending on the chosen statistical model. CONCLUSIONS: When comparing complementary and conventional treatments, non-randomised clinical trials may be misleading. Results may be strongly biased even when advanced statistical methods are used. Trials of complex statistical designs are needed to give valid results.

[Alternative treatment methods in ENT]. / Alternative Behandlungsverfahren in der HNO-Heilkunde.

In this review, the most important complementary und alternative therapies are discussed, focusing particularly on their use in otorhinolaryngology. These therapies include balneology, Kneipp therapy, microbiological therapy, fasting, excretion therapy, different oxygen therapies, hydro-colon therapy, urine therapy, own-blood therapy, Bach therapy, orthomolecular therapy, order therapy, environmental medicine, phytotherapy, homeopathy, complex homeopathy, anthroposophy, neural therapy, electroaccupuncture according to Voll and similar therapies, nasal reflex therapy, reflex-zone massage, manual therapy, massage, lymph drainage, aroma therapy, thermotherapy, bioresonance, kinesiology, hopi candles, and dietetics. Some of these methods and regimens can be recommended, but others should be rejected. In universities, these methods are only represented to a minor extend, but are more accepted by otorhinolaryngologists in practice. This paper provides a guide to which alternative therapies are sensible and possible in otorhinolaryngology. The aim is to stimulate interest in these methods. It is necessary to discuss these alternative methods reasonably and credibly with patients.

[Homeopathic treatment of adenoid vegetations. Results of a prospective, randomized double-blind study]. / Die homöopathische Behandlung von adenoiden Vegetationen. Ergebnisse einer prospektiven, randomisierten Doppelblindstudie.

In a monocenter prospective randomized double-blind clinical trial the efficacy of homeopathic treatment was investigated on children with adenoid vegetations justifying an operation. Patients were treated with either homeopathic remedies such as Nux vomica D200, Okoubaka D3, Tuberculinum D200, Barium jodatum D4 and Barium jodatum D6 or with placebo. The duration of the study for each patient was 3 months. Examination of the ears using a microscope, rhinoscopy, stomatoscopy and pharyngoscopy, as well as tympanometry and audiometry were performed after 4, 8 and 12 weeks. Out of a total of 97 children studied between the ages of 4 to 10 years 82 could be analyzed. At the end of the study no operation was required in 70.7% of the placebo-treated children and in 78.1% of the children treated with homeopathic preparations. These results show no statistical significance.

The homoeopathic treatment of otitis media in children--comparisons with conventional therapy.

In a prospective observational study carried out by 1 homoeopathic and 4 conventional ENT practitioners, the 2 methods of treating acute pediatric otitis media were compared. Group A received treatment with homoeopathic single remedies (Aconitum napellus, Apis mellifica, Belladonna, Capsicum, Chamomilla, Kalium bichromicum, Lachesis, Lycopodium, Mercurius solubilis, Okoubaka, Pulsatilla, Silicea), whereas group B received nasal drops, antibiotics, secretolytics and/or antipyretics. The main outcome measures were duration of pain, duration of fever, and the number of recurrences after 1 year, whereby alpha < 0.05 was taken as significance level. The secondary measures were improvement after 3 hours, results of audiometry and tympanometry, and necessity for additional therapy. These parameters were only considered descriptively. The study involved 103 children in group A and 28 children in group B, aged between 6 months and 11 years in both groups. For duration of pain, the median was 2 days in group A and 3 days in group B. For duration of therapy, the median was 4 days in group A and 10 days in group B: this is due to the fact that antibiotics are usually administered over a period of 8-10 days, whereas homoeopathics can be discontinued at an earlier stage once healing has started. Of the children treated, 70.7% were free of recurrence within a year in group A and 29.3% were found to have a maximum of 3 recurrences. In group B, 56.5% were free of recurrence, and 43.5% had a maximum of 6 recurrences. Out of the 103 children in group A, 5 subsequently received antibiotics, though homoeopathic treatment was carried through to the healing stage in the remaining 98. No permanent sequels were observed in either group.

[Acute otitis media in children. Comparison between conventional and homeopathic therapy]. / Otitis media acuta bei Kindern. Vergleich zwischen konventioneller und homöopathischer Therapie.

Within a prospective group study of five practicing otorhinolaryngologists, conventional therapy of acute otitis media in children was compared with homeopathic treatments. Group A (103 children) was primarily treated with homeopathic single remedies (Aconitum napellus, Apis mellifica, Belladonna, Capsicum, Chamomilla, Kalium bichromicum, Lachesis, Lycopodium, Mercurius solubilis, Okoubaka, Pulsatilla, Silicea). Group B (28 children) was treated by decongestant nose-drops, antibiotics, secretolytics and/or antipyretics. Comparisons were done by symptoms, physical findings, duration of therapy and number of relapses. The children of the study were between 1 and 11 years of age. The difference in numbers was explained by the children with otitis media being primarily treated by pediatricians using conventional methods. The median duration of pain in group A was 2 days and in group B 3 days. Median therapy in group A lasted 4 days and in group B 10 days. Antibiotics were given over a period of 8-10 days, while homeopathic treatments were stopped after healing. In group A 70.7% of the patients were free of relapses within 1 years and 29.3% had a maximum of three relapses. Group B had 56.5% without relapses and 43.5% a maximum of six relapses. Five children in group A were given antibiotics and 98 responded solely to homeopathic treatments. No side effects of treatment were found in either group.

Chromate nephrotoxicity in developing rats. Significance of Cr(VI) reduction in rat kidney tissue.

Chromate reduction was studied in 9000 x g supernatant of renal tissue. It was shown that GSH plays an important role. Additionally, heat-sensitive factor(s) seem to be involved. Age differences in chromate nephrotoxicity parallel differences in chromate reduction in vitro. The lower reductive activity of young rats can be raised to adult values by GSH-addition. Fasting reduces GSH concentration, as well as chromate nephrotoxicity, in vivo.

Percutaneous absorption of mercury vapor by rats.

With respect to occupational exposure situations, more information is needed to assess the importance of the skin absorption route for elemental mercury. The purpose of the experiments reported here is to prove the suitability of the rat tail as a model of Hg skin uptake. A vapor generation system used with a tail-only exposure system is described and first results are reported. An Hg uptake via the rat tail skin could be confirmed. The Hg uptake rate cannot be estimated quantitatively by these experiments.

Influence of metyrapone and phenobarbital on sodium dichromate nephrotoxicity in developing rats.

After the administration of equal doses of sodium dichromate, chromium concentrations in the kidney were lower in young than in adult rats. To test the age-dependent sensitivity to the nephrotoxicity of dichromate, young and adult rats were given doses to achieve identical chromium concentrations in the kidney. At equal renal concentrations, young rats had less functional and morphological damage than adult rats. As phenobarbital treatment in young rats enhanced the symptoms of nephrotoxicity and metyrapone treatment in adult rats decreased the symptoms of nephrotoxicity, age-dependent differences in chromate nephrotoxicity may be linked to an increase in the enzymatic reduction of Cr(VI) with age.