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LE Magazine September 2003

Serrapeptase-induced lung injury manifesting as acute eosiniphilic pneumonia.
An 84-year-old man was referred to our hospital because of fever, cough and hemoptysis. The patient had acute respiratory failure (PaO2 < 40 mmHg) on admission, with diffuse interstitial infiltration and bilateral pleural effusion. The bronchoalveolar lavage fluid was bloody, and contained a high percentage of eosinophils (32%). A diagnosis of acute eosinophilic pneumonia was established, and the patient made a rapid recovery after corticosteroids were administered. When the DLST (drug lymphocyte stimulation test) was performed after the corticosteroid therapy was stopped, it was positive for serrapeptase, which had been prescribed for chronic cystitis for three months before the onset of the pneumonia. This was a case of drug (serrapeptase)-induced pneumonitis manifesting as acute eosinophilic pneumonia.

Nihon Kokyuki Gakkai Zasshi. 2000 Jul;38(7):540-4.

The treatment of breast engorgement with Serrapeptase (Danzen): a randomised double-blind controlled trial.
We evaluated an anti-inflammatory enzyme drug Danzen (Serrapeptase: Takeda Chemical Industries, Ltd.) on 70 patients complaining of breast engorgement. These patients were randomly divided into two groups, a treatment group and a placebo group. A single observer, unaware of the group the patients were in, assessed the severity of each of the symptoms and signs of breast engorgement before treatment was commenced, and daily for three days, during which therapy was administered. Danzen was noted to be superior to placebo for improvement of breast pain, breast swelling and induration, and while 85.7% of the patients receiving Danzen had “Moderate to Marked” improvement, only 60.0% of the patients receiving placebo had a similar degree of improvement. “Marked” improvement was found in 22.9% of the treatment group and 2.9% of the placebo group. These differences were statistically significant (P less than 0.05). No adverse reactions were reported with the use of Danzen. Danzen is a safe and effective method for the treatment of breast engorgement.

Singapore Med J 1989 Feb;30(1):48-54.

A preliminary trial of serratiopeptidase in patients with carpal tunnel syndrome.
OBJECTIVES: This study was planned to assess the response of serratiopeptidase in patients with carpal tunnel syndrome (CTS). METHODS: Twenty patients with CTS were evaluated clinically. After baseline electrophysiological studies, these patients were given serratiopeptidase 10 mg twice daily with initial short course of nimesulide. Clinical and electrophysiological reassessment was done after six weeks. RESULTS: Mean age was 43.9 years with male to female ratio of 1:2.33. Sixty five percent cases showed significant clinical improvement which was supported by significant improvement in electrophysiological parameters. Recurrence was reported in four cases. No significant side effect was observed. CONCLUSIONS: Serratiopeptidase therapy may proved to be a useful alternative mode of conservative treatment. Larger study may be further helpful to establish the role of serratiopeptidase in CTS.

J Assoc Physicians India 1999 Dec;47(12):1170-2.

A multi-center, double-blind study of serrapeptase versus placebo in post-antrotomy buccal swelling.
A multi-center, double-blind, placebo-controlled trial was carried out to investigate the clinical efficacy of the anti-inflammatory enzyme serrapeptase in a total of 174 patients who underwent Caldwell-Luc antrotomy for chronic empyema. Eighty-eight patients received 10 mg serrapeptase three times on the day before operation, once on the night of the operation and three times daily for five days after operation; the other 86 received placebo. Changes in buccal swelling after operation were observed as a parameter of the response to treatment. The degree of swelling in the serrapeptase-treated patients was significantly less than that in the placebo-treated patients at every point of observation after operation up to the fifth day (p less than 0.01 to p less than 0.05). Maximal swelling throughout all the post-operative points of observation was also significantly smaller in size in the serrapeptase-treated group than in the placebo-treated group. No side effects were reported.

Pharmatherapeutica 1984;3(8):526-30

Evaluation of Serratia peptidase in acute or chronic inflammation of otorhinolaryngology pathology: a multicentre, double-blind, randomized trial versus placebo.
The efficacy and tolerability of Serratia peptidase were evaluated in a multicentre, double-blind, placebo-controlled study of 193 subjects suffering from acute or chronic ear, nose or throat disorders. Treatment lasted seven to eight days, with the drug or placebo being administered at a rate of two tablets three times a day. After three to four days’ treatment, significant symptom regression was observed in peptidase-treated patients. There was also a significant reduction in symptoms after seven to eight days for patients in both treatment groups but the response was more marked in those patients receiving the active drug. Statistical comparison between the two groups confirmed the greater efficacy and rapid action of the peptidase against all the symptoms examined at both stages. Tolerance was found to be very good and similar for both groups. It is concluded that Serratia peptidase has anti-inflammatory, anti-oedemic and fibrinolytic activity and acts rapidly on localized inflammation.

J Int Med Res 1990 Sep-Oct;18(5):379-88.

Sun damage

Elderly and sun-affected skin. Distinguishing between changes caused by aging and changes caused by habitual exposure to sun.
OBJECTIVE: To review and distinguish between skin changes produced by aging and changes produced by habitual exposure to sun. QUALITY OF EVIDENCE: The literature was searched from 1969 to 1999 for articles on dermatoheliosis and sun-damaged skin. Surprisingly few were found comparing the difference between elderly skin and sun-damaged skin. A few articles focused on certain small aspects of sun-damaged skin. Many excellent articles described particular changes (e.g., actinic keratosis), but few covered all the changes due to aging and to sun. MAIN MESSAGE: Skin changes due to aging can be distinguished from those due to sun damage. All changes due to sun exposure can be grouped under the term dermatoheliosis; five parts of the skin are involved: epidermis (actinic keratosis), dermis (solar elastosis), blood vessels (telangiectasia), sebaceous glands (solar comedones) and melanocytes (diffuse or mottled brown patches). Habitual exposure to sun and a white skin are prerequisites for developing these changes. Knowing the difference between changes caused by sun and by aging can help physicians predict which patients are most likely to get skin cancers. CONCLUSION: Knowledge of these common skin changes will help physicians diagnose and manage the skin abnormalities of elderly people and of people with dermatoheliosis.

Can Fam Physician 2001 Jun;47:1236-43.

Determinants of melanocyte density in adult human skin.
The distribution of melanocytes in human skin has been observed to vary within and among individuals, yet little is known of the factors that determine the density of these pigment cells. These factors were explored in a molecular epidemiological study conducted among a population-based sample of 97 male subjects aged over 50 years in Queensland, Australia. Information relating to environmental and phenotypic factors was collected through face-to-face interviews and physical examination of all participants. In addition, 2-mm biopsies of representative skin were taken from the dorsum of the hand and another anatomical site. Melanocytes were identified by cytoplasmic staining with the B8G3 (anti-TRP1) monoclonal antibody using standard immunohistochemical techniques. Melanocyte counts were performed blind by two observers. On crude analysis, melanocyte density decreased with advancing age (P = 0.0002), and increased with increasing number of naevi (P = 0.01). Other pigmentary characteristics (such as hair and eye colour and depth of tan) were not associated with epidermal melanocyte density. Melanocyte density varied significantly by anatomical site (P = 0.02), with highest densities observed on the back/shoulders (n = 50, 17.1 +/- 8.8 cells/mm, mean +/- SD) followed by the upper limbs (n = 11, 12.6 +/- 8.8 cells/mm) and lower limbs (n = 14, 14.4 +/- 5.9 cells/mm). Lowest melanocyte densities were recorded on the anterior trunk (n = 3, 3.2 +/- 2.4 cells/mm). These findings confirm the results of earlier studies in which site-specific differences in melanocyte density have been found. We speculate that the unequal distribution of melanocytes may partially explain the site-specific incidence of melanoma, offering fresh perspectives on the aetiology of this cancer.

Arch Dermatol Res. 1999 Sep;291(9):511-6.

A randomized controlled trial to assess sunscreen application and beta carotene supplementation in the prevention of solar keratoses.
BACKGROUND: Solar keratoses (SKs) are among the strongest determinants of skin cancer, but little is known about the success of measures to control these common skin tumors. OBJECTIVE: To determine whether daily sunscreen application and/or beta carotene supplementation retards the rate of occurrence of SKs in adults in the medium term. DESIGN: Randomized controlled trial conducted between February 1992 and August 1996. SETTING: General community of the subtropical township of Nambour, Australia (latitude, 26 degrees south). PARTICIPANTS: A total of 1,621 adults aged 25 to 74 years. Interventions Participants were randomized to daily use of sunscreen (application of a high-protection sunscreen to their head, neck, arms and hands every morning) or application of sunscreen at their usual discretionary rate. They were also randomly assigned to take either one 30 mg tablet of beta carotene or one placebo tablet each day. MAIN OUTCOME MEASURE: Change in the prevalent number of SKs in the intervention group relative to change in the control group. RESULTS: The ratio of SK counts in 1994 relative to 1992 was lower in people randomized to daily sunscreen use (1.20; 95% confidence interval, 1.04-1.39) than in those randomized to discretionary sunscreen use (1.57; 95% confidence interval, 1.35-1.84). This 24% reduction is equivalent to the prevention of an average of one additional SK per person over that time. A reduction in the rate of change of SK prevalence was also seen in the sunscreen intervention group relative to the discretionary sunscreen group between 1994 and 1996, but it was not significant. No effect on the rate of change of prevalent SK counts was seen among those taking beta carotene supplements relative to those taking placebo tablets. CONCLUSIONS: Daily application of sunscreen retarded the rate of SK acquisition among adults in a subtropical environment, while a beta carotene supplementation of 30 mg/d had no influence on the occurrence of SKs.

Arch Dermatol. 2003 Apr;139(4):451-5

Mechanisms of sunscreen failure.
Sunscreen is used as a primary strategy to prevent sunburn and later skin cancer. However, sunscreen use has paradoxically been associated with the increasing incidence of skin cancer. One explanation for this puzzling observation is sunscreen failure (sunburn in the setting of sunscreen). Our purpose was to evaluate mechanisms of sunscreen failure in a sunscreen-using population. We carried out an epidemiologic comparison of sunburned and nonsunburned beachgoers who used sunscreen. We found that men were less likely to use sunscreen than women (chi(2) = 11.3, df = 1, P = .001), and when it was used, men were less likely to apply sunscreen to all sunlight-exposed skin (chi(2) = 18.4, df = 1, P = .0001). Swimmers who used sunscreen were significantly more likely to be sunburned compared with nonswimming sunscreen users (Fisher exact test, df = 1). Sunscreen may fail to prevent sunburn if it is washed off during swimming or if it is not applied to all exposed skin. Epidemiologic studies that link sunscreen use to skin cancer should evaluate whether sunburn occurred in this setting.

J Am Acad Dermatol. 2001 May;44(5):781-4.

Cutaneous photodamage, oxidative stress and topical antioxidant protection.
New methods to protect skin from photodamage from sun exposure are necessary if we are to conquer skin cancer and photoaging. Sunscreens are useful, but their protection is not ideal because of inadequate use, incomplete spectral protection and toxicity. Skin naturally uses antioxidants (AOs) to protect itself from photodamage. This scientific review summarizes what is known about how photodamage occurs; why sunscreens—the current gold standard of photoprotection—are inadequate; and how topical AOs help protect against skin cancer and photoaging changes. This review is intended to be a reference source, including pertinent comprehensive reviews whenever available. Although not all AOs are included, an attempt has been made to select those AOs for which sufficient information is available to document their potential topical uses and benefits. Reviewed are the following physiologic and plant AOs: vitamin C, vitamin E, selenium, zinc, silymarin, soy isoflavones and tea polyphenols. Their topical use may favorably supplement sunscreen protection and provide additional anticarcinogenic protection. Learning objective: At the completion of this learning activity, participants should have an understanding of current information about how the sun damages skin to produce skin cancer and photoaging changes, how the skin naturally protects itself from the sun, the shortcomings of sunscreens and the added advantages of topical AOs for photoprotection.

J Am Acad Dermatol. 2003 Jan;48(1):1-19; quiz 20-2