The first report of classical homeopathy is relatively recent, dating in 1997 when Friese et al. reported an open study comparing the results obtained treating otitis media in children, treated using two different medical approaches. They compared classical unitary homeopathic remedies (Aconitum, Apis mel., Belladonna, Lachesis, Pulsatilla, Silicea, Lycopodium, Chamomilla and Capsicum) prescribed after an individual homeopathic case analysis, with conventional therapy based on antibiotics, mucolytics and antipyretics. The duration of pain was 2 days in the homeopathic group and 3 days in the conventional therapy group and the duration of therapy was 4 and 10 days, respectively. The latter difference was statistically significant, but it should be noted that the duration of antibiotic therapy for these conditions cannot be shorter than a week, so this comparison may not reflect the clinical outcomes. In brief, this pragmatic study comparing homeopathic with conventional therapy showed that results were similar, but with a trend in favor of homeopathy.

In an open, prospective, multicenter study, Kruse evaluated a group of children with otitis media for 6 weeks, controlling results against conventional therapy. The homeopathy group was treated with single remedies like Aconitum 30x, Apis 6x, Belladonna 30x, Capsicum 6x, Chamomilla 3x, Lachesis 12x and other remedies; the reference group was treated with antibiotics, secretolytics, antipyretics and sympathomimetics such as nasal sprays. In the two groups the number of children remaining relapse-free and the average duration of pain were similar.

Observations of Benefit

The purpose of the observational study of Frei and Thurneysen was to determine how many children with acute otitis media are relieved of pain with individualized homeopathic treatment. Children with this condition received a first individualized homeopathic medicine in the pediatric office. If pain reduction was not sufficient after 6 h, a second (different) homeopathic medicine was given. After a further 6 h, children who had not reached pain control were started on antibiotics. Pain control was achieved in 39% of the patients after 6 h, another 33% after 12 h. Compared with literature's data, the authors stated that the resolution rate is 2.4 times faster than in untreated cases. The six more frequently prescribed remedies were Pulsatilla, Belladonna, sulphur, phosphorus, calcium carbonicum, Lycopodium.

An interesting multicenter, prospective, observational study in a real world medical setting compared the effectiveness of homeopathy with conventional medicine. Thirty investigators with conventional medical licenses at six clinical sites in four countries enrolled a series of patients with at least one of the following three complaints: upper respiratory tract complaints including allergies; lower respiratory tract complaints including allergies; or ear complaints. Four hundred and fifty-six patient visits were compared. In any case, homeopathy appeared to be at least as effective as conventional medical care in the treatment of patients with these three conditions.

A randomized double-blind placebo control pilot study was conducted in children with otitis media. Subjects having middle ear effusion and ear pain and/or fever for no more than 36 h entered into the study. They received either an individualized homeopathic medicine or a placebo administered orally three times daily for 5 days, or until symptoms subsided. There were fewer treatment failures in the group receiving homeopathy, but these differences were not statistically significant. Diary scores showed a significant decrease in symptoms after treatment in favor of homeopathy (P < 0.05).

Fixed Prescription of Low-Potencies

Although people are best treated with an individualized homeopathic remedy chosen by a professional homeopath, several trials have found that some common homeopathic remedies or their combinations may be at least as effective as conventional medications.

An early study on the effect of a low-dilution homeopathic medicine on the common cold was done by Gassinger. The authors compared the effect of Eupatorium perfoliatum 2x with that of acetylsalicylic acid. Neither the subjective symptoms, nor body temperature, nor laboratory data showed any significant differences in the two groups, which led the authors to conclude that the homeopathic treatment was as effective as the allopathic treatment. Of course, this is not a direct evidence of the efficacy of homeopathy, mostly because even the effectiveness of analgesic/antipyretic medications in the common cold is uncertain.

Wiesenauer et al compared the effects of three different homeopathic treatments and placebo in patients with acute and chronic sinusitis. In this randomized, double-blind study the patients were divided into four groups: group A: Luffa operculata 4x + Kalium bichromicum 4x + Cinnabaris 3x; group B: K. bichromicum 4x + Cinnabaris 3x; group C: Cinnabaris 3x; and group D: placebo. The study did not reveal any difference in therapeutic effects in the four groups. Their conclusion was that, unless other data emerge from a study of individual homeopathic prescriptions (‘repertorization’), the drugs should not be considered active in acute or chronic sinusitis in the general population; they also pointed out that similar negative results have been obtained with antibiotics, nasal decongestants and drainage of the nasal cavities.

Complex Formulations

To cure one or few symptoms, particularly in short-lasting and acute conditions, complex formulations or mixtures of homeopathic remedies are often used. The complex homeopathy was born a little after the original discovery of Hahnemann and it is not fully comparable with homotoxicology which is a specific methodological way to prescribe complex homeopathic drugs. The latter procedure, also called ‘Biological medicine’, was developed in the second half of twentieth century, starting from Germany. Although homotoxicology is characterized by methods of diagnosis and prescription very different from Hahnemann's original homeopathy, most of the formulations have their roots in the materia medica of single components and have the recognition of ‘homeopathic medicines’ by EU drug legislation.

Trials assessing the effectiveness of complex medicines in relieving specific symptoms are easier to be conducted as compared with those that require individualized treatment and continuous adjustment of therapy. Moreover, there is much higher commercial interest to such formulations than to single remedies, which cannot be patented. These reasons explain why there are relatively more studies of complex formulations than of single homeopathic remedies.

The primary objective of treating of inflammatory diseases of upper respiratory tract (rhinitis, uncomplicated sinusitis) is to relieve obstruction and to improve associated symptoms. In this respect, a homeopathic remedy may be seen much like a local decongestant helping restoration of unrestricted respiration and drainage of nasal sinuses, factors that reduce the risk of further complications and of chronicity. However, many homeopathic formulations contain remedies that are expected to act as immunostimulators and/or according to isopathic principles of cure.

A homeopathic remedy, L52, a complex formulation containing E. perfoliatum 3x, Aconitum napellus 4x, Bryonia alba 3x, Arnica montana 4x, Gelsemium sempervirens 6x, Cinchona 4x, Belladonna 4x, Drosera 3x, Senega 3x showed promising results, in a double-blind study against placebo, for relief of symptoms of URTI , but not in prevention of flu in a large double-blind, placebo-controlled study (1200 participants).

In a single-blind randomized trial, army soldiers suffering from common cold were treated with aspirin or with a complex homeopathic preparation called Grippheel (Aconitum 4x, Bryonia 4x, Lachesis 12x, E. perfoliatum 3x, phosphorus 5x). Comparison between the changes in clinical status and in subjective disorders on days 4 and 10 and between the duration of the periods off work in two groups revealed no significant differences, leading to the conclusion that the two drugs are equieffective. More recently, the same medicine has been evaluated in a prospective, observational cohort study in patients affected by mild viral infections of upper respiratory tract with encouraging results, consisting of an equivalent effectiveness of homeopathy and conventional medications.

In the field of respiratory diseases, mention must be made of a study by some French researchers who treated dry cough with a syrup based on the plant Drosera and another nine substances in 3c dilution, and found that it was much better than placebo: after 1 week of therapy, the symptom had become less severe or had disappeared in 20 out of 30 treated patients, as against only 8 out of 30 in placebo group.

Euphorbium

Sprenger conducted an open study of a low-dilution complex homeopathic preparation, Euphorbium compositum, used as a nasal spray in patients with acute or chronic rhinitis. The product consisted of Euphorbium resinifera 4x, Pulsatilla pratensis 2x, L. operculata 2x, Mercurius iodatus ruber 6x, Mucosa nasalis suis 6x, Hepar sulphuris calcareum 10x, Argentum nitricum 10x and Sinusitis nosode 13x, and was administered at a dose of 1–2 puffs per nostril 3–5 times a day. The physician's judgment of the therapy was good in 83% of cases, whereas tolerability was excellent in 55.4% of cases and good in 44.6%. Another observational, uncontrolled study on patients suffering from chronic rhinopathy associated with a previous long-term application of medication (abuse of nasal spray) showed positive results in 22 out of 26 patients, with normalization of rhinomanometric tests.

Subsequently, Weiser and Clasen studied the clinical effectiveness of the same complex E. compositum in a double-blind, randomized, placebo-controlled study in subjects with chronic sinusitis. The treated group showed a significant improvement in terms of subjective symptoms such as respiratory obstruction, sensation of internal pressure and pain, but there was no substantial variation in instrumental tests. An overall evaluation showed a better improvement in verum group as in placebo group.

A further open, multicenter, prospective, active-controlled cohort study was carried out more recently on the homeopathic complex E. compositum (nasal drops), whose effectiveness and tolerability was compared with the reference allopathic drug xylometazoline. Clinically relevant reductions in intensities of disease-specific symptoms were observed with both groups. Non-inferiority of the homeopathic complex remedy to xylometazoline could be shown for all studied variables. Tolerability was good for both therapies. Interestingly, it has been reported that some components of this medicine, e.g. Euphorbium and Pulsatilla, but not Luffa, as plant extract (not homeopathic preparations), have a direct antiviral (respiratory syncytial virus and herpes simplex virus type 1) effect in vitro.

Other Low-Dilution Complexes

Zenner and Metelmann published the results of an open study of a complex preparation, Lymphomyosot drops (Myosotis arvensis 3x, Veronica officinalis 3x, Teucrium scorodonia 3x, Pinus sylvestris 4x, and even other 13 plant or mineral components) in treatment of pharyngitis and tonsillitis. In a group of patients with tonsillitis, most of them recorded ‘excellent, good or satisfactory’ improvements after treatments lasting between 1 and 6 months.

A different complex that has been used in this kind of respiratory complaints is Engystol-N (made of Vincetoxicum 6x, 10x and 30x, sulfur 4x and 10x). A randomized, double-blind, placebo-controlled trial assessed the efficacy of this formulation, administered twice weekly as intravenous injection, for prophylaxis of common cold and flu. The frequency of occurrence of flu or common cold was not changed by treatments, but the average length of illness and the severity of symptoms were less for the verum group than for the placebo group. No statistical analysis of data was provided.

The efficacy of three plants used in homeopathy to treat acute tonsillitis was evaluated with an open trial. A fixed combination of low dilutions of three plant substances (Phytolacca americana, Guajacum officinale and Capsicum annuum) was used in patients with this condition and no antibiotics were used. According to materia medica, this homeopathic complex remedy should be characterized by immunomodulatory, analgesic and anti-inflammatory properties. A decrease in objective and subjective symptoms of acute tonsillitis symptoms was observed after treatment startup; no serious adverse effects were reported.

The efficacy and safety of a fixed combination homeopathic medication (Sinusitis PMD) consisting of Lobaria pulmonaria, L. operculata and potassium dichromate were investigated in an open-label practice-based study of patients with acute sinusitis. Most patients received only test medication and no antibiotics. After 4 days of treatment, secretolysis had increased significantly and typical sinusitis symptoms, such as headache, pressure pain at nerve exit points and irritating cough, were reduced. The average treatment duration was 2 weeks. At the end of treatment, most patients described themselves as symptom-free or significantly improved. Adverse drug effects were not reported.

A Remedy for Stomatitis

An Israeli team assessed a complex homeopathic preparation (Traumeel-S, containing 4x–12x potencies of A. montana and other plant extracts and minerals) for its effect in chemotherapy-associated stomatitis, a common consequence of chemotherapy and a condition for which there is little effective treatment. The study was conducted in children and young adults who had undergone stem cell transplantation, in a randomized, placebo-controlled, double-blind clinical trial. The medicine was administered as a mouth rinse, five times daily. Thirty-three percent of patients in active treatment group did not develop stomatitis, compared with only 7% in placebo group. Stomatitis worsened in 47% of patients in active treatment group compared with 93% in placebo group. The stomatitis scores were better in verum group (P < 0.01). It is worth noting that, at variance with respect to most homeopathic medicines, the efficacy and the action mechanisms of Traumeel were repeatedly characterized also in pre-clinical studies, as described in previous reviews of this series.