When Scientists Get It Wrong

For the most part, scientific research and analysis is an exhaustive, almost pedantic process that attempts to investigate factors that may or may not influence a particular outcome. This usually involves careful consideration of previous studies and their findings. The next step is usually establishing a set of research questions and hypotheses, followed by a careful design of experimental methods, which are then rigorously analysis and reported.

In addition, scientific research proposes that methodologies of any investigation are presented accurately enough so that replication of the experiment by other researchers wishing to test the reported outcomes is possible.

The following journal article released by the American Academy of Dermatology, Inc. is an example of researchers assuming cause and effect without testing of any kind or consideration of possible alternative causes.

It does not propose possible investigations that need to be carried out in order to test their hypothesis nor does it propose a clinical study or in fact any further study at all. It does propose however that because of their observations of only 2 cases, which may have been exposed to the essential oil of Bergamot that resulted in adverse skin reactions, that "... a necessity for strict governmental surveillance and scrutiny of these increasingly popular preparations" is implemented.

This is preposterous and totally against every scientific rule of investigation. Read this article and judge for yourself.

Accidental bullous phototoxic reactions to bergamot aromatherapy oil

Steven Kaddu, MD, Helmut Kerl, MD, and Peter Wolf, MD Graz, Austria

Brief reports J AM ACAD DERMATOL SEPTEMBER 2001

Abstract

Oil of bergamot is an extract from the rind of bergamot orange (Citrus aurantium ssp bergamia) that has a pleasant, refreshing scent; until a few years ago it had been widely used as an ingredient in cosmetics but was restricted or banned in most countries because of certain adverse effects. More recently, oil of bergamot preparations have been gaining renewed popularity in aromatherapy. Oil of bergamot possesses photosensitive and melanogenic properties because of the presence of furocoumarins, primarily bergapten (5-methoxypsoralen [5-MOP]). However, 5-MOP is also potentially phototoxic and photomutagenic. Despite its increasing application, there are only a few recent reports of phototoxic reactions to bergamot aromatherapy oil. We describe two patients with localized and disseminated bullous phototoxic skin reactions developing within 48 to 72 hours after exposure to bergamot aromatherapy oil and subsequent ultraviolet exposure. One patient (case 2) had no history of direct contact with aromatherapy oil but developed bullous skin lesions after exposure to aerosolized (evaporated) aromatherapy oil in a sauna and subsequent UVA radiation in a tanning salon. This report highlights the potential health hazard related to the increasing use of psoralen-containing aromatherapy oils.

Comment: In the paragraph above the publishers clearly state that the 2nd case actually had no direct contact with the supposed aerosolized aromatherapy oil. They also report (source not given) that the oil of bergamot has gained popularity and despite its increase in use, only 2 cases of phototoxic reactions have been reported. This should raise the question of what, other than bergamot oil, may be the cause of the phototoxic reaction in the 2 cases, shouldn't it?

Introduction

Oil of bergamot is an extract from the rind of bergamot orange (Citrus aurantium ssp bergamia) that is grown mainly in southwestern Italy. Because oil of bergamot has a pleasant, refreshing scent and easily blends into perfume formulations, it had long been used as an ingredient in cosmetics until a few years ago when its use in perfumery was restricted or banned in most countries because of the report of adverse effects, primarily phototoxicity and Berloque dermatitis.1 More recently, oil of bergamot is gaining renewed popularity in aromatherapy.2 The photosensitizing and melanogenic properties of oil of bergamot are due to the presence of furocoumarins, mainly bergapten (5-methoxypsoralen [5-MOP]).3-5 Apart from potential phototoxic effects, 5-MOP has also been shown to be photomutagenic and photocarcinogenic.6-8 Consequently in Europe, 5-MOP-containing cosmetics have been banned or restricted to certain concentrations. However, currently there are no official limits to 5-MOP concentrations in aromatherapy oils and no strict legal requirement for placing warning labels on these products in some countries.

Comment: While 5-MOP in isolation may have been shown to be potentially photomutagenic and photocarcinogenic, the pure essential oil of Bergamot (used as a 100% pure essential oil, not testing isolated, extracted ingredients) has not been shown to be photocarinogenic.

It must be said, that many substances including Bergamot oil do cause photosensitivity, for example Hypericum oil may also cause photosensitivity.

In this report, we describe two patients in whom bullous phototoxic reactions developed after unintended contact to bergamot aromatherapy oil and subsequent UVA exposure in sunlight in one patient and in a tanning salon in the other.

CASE REPORTS

Case 1

A 54-year-old woman of Fitzpatrick skin type III presented with painful, red, edematous, sharply demarcated areas with bullae and crusting on the face in a butterfly-like distribution (Fig 1). She gave a history of having unsuspectingly used a bergamot aromatherapy oil preparation 3 days earlier and subsequently stayed outdoors for several hours on a sunny day. She denied a history of using any other creams or taking any medications.

Comment: The patient may not have used a bergamot aromatherapy oil preparation or taken any medication, however, is it not possible that this patient came in contact with an allergen during the 3 days which could have caused the same reaction? Was this investigated?

I am not claiming that it was not the Bergamot oil, however I am suggesting that other possibilities do not appear to have been investigated or considered.

A sample of bergamot aromatherapy oil, which the patient had used, was available for analysis of 5-MOP concentration. High-performance liquid chromatography (HPLC) performed on the aromatherapy oil preparation revealed a very high 5-MOP concentration of 2400 ppm, well above 5-MOP levels officially permitted in cosmetics and tanning agents (0.1 ppm) in Austria.

The patient was treated with a topical steroid cream. Within 7 days, the skin lesions had improved significantly, except for the persistence of mild swelling and blistering on some areas of her face. These lesions also resolved over the next 2 weeks without any complications. The patient was instructed to avoid sun exposure for the next few weeks to prevent post-inflammatory hyperpigmentation. Follow-up examination at 1 year revealed no residual hyperpigmentation on the face in the previously affected areas.

Comment: One has to ask whether the so-called Aromatherapy oil of Bergamot was indeed a 100% pure essential oil of Bergamot, as the label shown in the illustration (not provided here) does not show a manufacturers name or any indication of purity.

Also, I would be interested to read whether the analysis of other brands of Bergamot aromatherapy oil showed similar concentrations of 5-MOP? After all isn't replication one of the key principles in scientific testing?

At the top of the label in the picture provided, it can be discerned that 100g would appear to be the content of the bottle. Essential oils, however, are liquid and are not sold per gram rather they are sold in milliliters. So the question

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