Effective treatment of seborrheic dermatitis using a low dose, oral homeopathic medication consisting of potassium bromide, sodium bromide, nickel sulfate, and sodium chloride in a double-blind, placebo-controlled study - Original research: seborrhea

Alternative Medicine Review, Feb, 2002 by Steven A. Smith, Ardith E. Baker, John H. Williams, Jr.

Abstract

BACKGROUND: Topical over-the-counter remedies exist to aid in the control of seborrheic dermatitis and chronic dandruff on a superficial level. Low-dose systemic oral nickel and bromide therapy has shown promise in providing improvement and eventual clearing of the disease. OBJECTIVE: The purpose of this study was to further evaluate the effect of an orally administered low-dose, homeopathic mineral therapy (Potassium bromide 1X, Sodium bromide 2X, Nickel sulfate 3X, Sodium chloride 6X) on seborrheic dermatitis and chronic dandruff. METHODS: Forty-one patients with seborrheic dermatitis and/or chronic dandruff were assigned to one of two treatment groups: Active (containing the medication) or placebo (vehicle). Study medication was administered in a placebo-controlled, randomly-selected, double-blind study for 10 weeks. At the end of 10 weeks all patients crossed over to the active medication, under a different label for an additional 10 weeks in an open study format. RESULTS: Twenty-nine patients completed the 10-week blinded portion of the study. After 10 weeks of treatment, the disease state of the active patients improved significantly over that of the placebo patients (p < 0.04). The placebo patients' condition before and after crossover to active treatment was also evaluated, showing significant improvement (p < 0.01) 10 weeks after crossing over to active medication. CONCLUSION: Oral therapy using a low-dose homeopathic preparation combining Potassium bromide 1X, Sodium bromide 2X, Nickel sulfate 3X, and Sodium chloride 6X, provides significant improvement in seborrheic dermatitis and dandruff after 10 weeks of dosing.

(Altern Med Rev 2002;7(1):59-67)

Background

Seborrheic dermatitis is a common, chronic, superficial inflammatory disease of the skin, characterized by pruritic, oily, red patches of various sizes and shapes covering inflamed areas of the scalp, face, and ears. (1-3) Other areas are less commonly affected, such as the pre-sternal chest. Rarely there is widespread involvement with erythroderma (reddening of the skin). In recent years it has been shown that at least 50 percent of HIV-infected patients have seborrheic dermatitis. Dandruff is thought to be closely related to seborrheic dermatitis, but is less severe. Although the etiology of this disease spectrum is unknown, recent studies have attributed seborrheic dermatitis to the presence and perhaps over-abundance of Pityrosporum ovale, a naturally-occurring yeast on the surface of the skin. (4-8) Other researchers consider seborrheic dermatitis to be an inherited primary inflammatory process and P. ovale to cause only a secondary aggravation of the condition. (9) Certain features are often suggestive of psoriasis, and many experts believe there is a spectrum of disease with overlap (sebopsoriasis or seboriasis). Conventional treatment includes various non-prescription shampoos (containing tar, zinc pyrithione, selenium sulfide, and/or salicylic acid), topical corticosteroids, and, to control the P. ovale, ketoconazole shampoo or cream. Alternative treatments include topical zinc and/or lithium, essential fatty acids, and various B-vitamins.

Objective

Inorganic bromide has been shown to be effective in the treatment of chronic skin conditions such as psoriasis. (10-12) Other authors have discussed the possible role of nickel in the pathogenesis of psoriasis. (13-19) Based on published and unpublished research, we hypothesize there is a primary biochemical defect in patients with seborrheic dermatitis and dandruff, similar to psoriasis, but to a lesser degree. (20) This study evaluates the therapeutic potential of a low-dose oral administration of potassium bromide, sodium bromide, nickel sulfate, and sodium chloride in a homeopathic formulation.

Methods Study Design

The study design was a placebo-controlled, randomly-selected, double-blind parallel track study conducted at the dermatology offices of Steven A. Smith, MD, in Tulsa, Oklahoma. The active and placebo groups were assigned coded names by the study monitor and randomized in blocks of four. The study investigator was given a list of the randomized, coded dose groups. As patients entered into the study, they were assigned, with no regard to individual characteristics, to the next available randomized, coded dose group on the list. For the first 10 weeks the blinded patients took the assigned study medication and were evaluated at 0, 5, and 10 weeks. At the end of 10 weeks all patients crossed over to the active medication under a separate label for an additional 10-week open study. Double blinding of the study was maintained until all patients completed the first 10-week dosing period. The patients were given a complete history and physical at the beginning and end of the study. Numerous clinical and laboratory parameters were measured at each visit.

Patient Selection

Study patients were recruited from the dermatology practice of Steven A. Smith, MD and by local advertisement. Patients with typical seborrheic dermatitis or dandruff with a minimum of 20-percent affected scalp surface area, a minimum of 20-percent affected face surface area, or a minimum of 20-percent combined affected scalp and face surface area were admitted to the study. Each patient and, if applicable, his/her legal guardian had all risks and possible benefits explained to them in depth. All patients enrolling in the study gave written informed consent. Once admitted to the study, patients were required to discontinue all concomitant seborrhea medications for two weeks before beginning the study and throughout the study. Children under 12 years, patients with inadequate renal function, and women who were pregnant or breast-feeding were excluded from the study. Other papulosquamous diseases (psoriasis, tinea, etc.) were ruled out on clinical and/or laboratory evidence.