In 9 clinical studies including 1151 patients with Sinusitis, Enzyme Therapy has proven to be beneficial alone or in combination with antibiotic.
In a retrolective study, including 797 patients, it is demonstrated that a higher number of patients treated with Enzyme therapy are without complain than when treated with Diclofenac or Ibuprofen (Conrad 2000)
The treatment of sinusitis with enzymes was first described by Sasaki 1965 and Yamasaki 1965. Calabria 1966 treated 13 patients with an enzyme-antibiotic combination (trypsin, chymotrypsin, cloranphenicol, streptomycin) and compared them with antibiotic treated patients. The authors described a lesser number of punctures necessary in the oral enzyme treated patients. When chronic sinusitis was classified in 4 different types of affection, it was found that types 1 and 2 were highly responsive to the treatment of enzymes, but in types 3 and 4 this treatment was ineffective in topical use (Ota 1966).
Saporiti 1966 published a successful therapy with alpha chymotrypsin (Chymoser) as local instillation by puncture of the maxillary sinus in patients with purulent chronic maxillary sinusitis.
Kaneko 1967 treated children with paranasal sinusitis successful with enzymes. In a study of patients with chronic sinusitis, Kagitomi 1972 published that ananase (bromelain) in combination with antibiotics was effective, whereas ananase used alone showed very little effect. In a double-blind clinical evaluation of bromelain in the treatment of acute sinusitis the author (Ryan 1967) described that mucosal inflammation was reduced in 83% of those receiving bromelain as compared to only 52% of those receiving placebo. Breathing difficulty was relieved in 78% of patients on bromelain therapy and in 68% of patients on placebo. In summary, good to excellent results were observed in approximately 87% of patients receiving bromelain compared to 68% of those on placebo. Seltzer 1967 comes to about the same results. In a double blind, placebo-controlled study, 49 patients with sinusitis received either bromelain or placebo, in addition to antibiotics. Good to excellent response was demonstrated in 80% of those receiving bromelain as compared to 50% of those on placebo. Complete relief of nasal mucosal edema and inflammation, nasal discomfort, breathing difficulties, headache and pain were evident in a higher percentage of patients on bromelain. The mean standard treatment time required for a therapeutic response was 10 days for those receiving bromelain in contrast to 16 days for those receiving placebo. S. Hine 1966 employed bromelain in treatment of non-operative cases of chronic rhino-sinusitis and described the affectivity as 64%.
Alpha-chymotrypsin was administered oral or by local instillation in patients with paranasal sinusitis. The authors (Sakakura 1966) observed effectiveness in 70% of the patients.
Keller and Maurer 1967 investigated the effect of a new enzyme preparation composed of Lysozym, Papain and Bactricin (LysopainEnzyme Therapy) as sublingual tablets. This preparation was very effective in different inflammations like Laryngitis, c, herpes zoster etc. The authors observed also a benefit in sinusitis in 6 of 11 patients.
In the same year, Taub 1967 published his results with enzyme therapy in a higher number of patients with acute or chronic sinusitis. He treated in a placebo controlled study 59 (30 / 29) patients with bromelain in conjunction with antibiotics. Symptoms and signs of nasal mucosal inflammation and edemas as well as those of breathing difficulties and nasal discharge were improved in a majority of the patients receiving the enzyme + antibiotic medication as compared to a minority of the 30 patients receiving placebo. No side effects were reported. A new enzyme preparation Sfericase is proposed 1983 by Yoshida. Sfericase, produced by a strain of Bacillus sphaericus, has been proven to be effective in some chronic inflammations, such as chronic sinusitis and difficult expectoration associated with bronchopulmonary diseases. Miyoshi 1984 published results with this preparation (orally Sfericase) on 40 patients with chronic sinusitis. After 4 weeks of treatment, a reduction of subjective symptoms for postnasal rhinorrhea of 81.6%, 66.7% for rhinorrhea, and 46.6% for nasal obstruction was observed. However, with respect to objective symptoms, the efficacy rate was 28.9% for redness and 30.8% for swelling of the nasal mucosa, with a somewhat lower rate than that obtained for subjective symptoms. According to the patients’ and physicians’ global assessments, Sfericase was effective in 65 and 57.5% of the cases. None of the patients showed undesirable reactions to sfericase.
Serratopeptidase, a proteolytic enzyme was investigated for the influence on the elasticity and viscosity of the nasal mucus in adult patients with chronic sinusitis. After 4 weeks treatment Serratopeptidase reduced the viscosity but not the elasticity of the nasal mucus. These findings are discussed in relation to mucociliary clearance (Majima 1988).
Wohlrab 1993 published the results from a prospective, randomized, double blind study with 40 patients suffering of sinusitis acuta. The patients were treated with a combination of different enzymes or Diclofenac. After 2 weeks there was no difference in sum-score as well as single score (headache, toothache and edema). But after 2 weeks, the side effects of Diclofenac therapy increase, whereas the side effects of Enzyme Therapy were negligible. The numbers of recidivist was smaller in the enzyme treated group.
Meletis 2000 as well as Maurer 2001 included in their publications the beneficial effect of bromelain for the treatment of sinusitis.
Summarizing, in 11 clinical studies (one of them is retrolective) including 1161 patients it is demonstrated that Enzyme therapy alone (early stages) or in combination with antibiotics (later stages) reduce healing time for more that 20%, reduce recidivists and has practically no side effect.
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