Are over-the-counter medicines effective?

Is there any point in buying non-prescription remedies? asks John Hearne

THINK twice before you go running to the pharmacist for a cough bottle this winter. New research from the UK suggests that there may be no point. In its most recent bulletin, consumer organisation Which? assembled a team of experts to assess the effectiveness of a number of leading over-the-counter medicines. First up was Benylin Chesty Coughs (Non Drowsy).

According to the bottle, the medicine “works deep down to loosen phlegm, clear bronchial congestion, and make your cough more productive”.

But according to Which? the company “provided no evidence of effectiveness”. The panel of experts, which included dieticians, eminent academics, chemists, and doctors reviewed the information provided by the makers of Benylin and concluded that “the evidence base on the active ingredient guaifenesin consists of generally low quality studies.”.

The panel was similarly unimpressed by Benylin Tickly Coughs (Non Drowsy). They said the effectiveness of the active ingredients were unproven. Moreover, they also pointed out that by taking this product, you’ll be getting a lot more than you bargained for. The active ingredients are sugar alcohol (glycerol) and liquid sugar (sucrose), but Benylin Tickly Coughs also contains other sugars, including black treacle. In fact, the report says that if an adult were to take this medicine at maximum dose for a week, it would be the equivalent of eating the sugar contained in five Mars bars.

Bernard Duggan is a pharmacist and chairman of the Irish Pharmacy Union’s Community Pharmacy Committee. He says all medicines available for sale in Ireland — over the counter and prescribed — are licensed by the Irish Medicines Board (IMB). “If it is licensed by the IMB, it has to do what it says. If it’s a dry cough bottle, it would be licensed to help relieve the symptoms of dry cough. The IMB are not going to let a medicine onto the market that’s not safe.”

The IMB confirms this. According to a spokesman, the medicines board assess all licence applications across a wide range of parameters to ensure medicines placed on the market meet strict requirements in terms of safety, quality and efficacy.

“There might be a bit of confusion around this,” says MrDuggan, “because a lot of coughs are caused by viral infections and a lot of viral infections are self-limiting. The virus runs its course over a few days. The cough bottle doesn’t cure the viral infection, it relieves the symptoms of the cough. What it says it does is it suppresses the cough, so it’s providing symptomatic relief.” What the Which? expert panel is saying however is that it doesn’t even do this.

The IMB spokesman agrees with Mr Duggan. He says: “Benylin Non Drowsy for Dry Cough contains dextromethorphan, a cough suppressant and Benylin Non Drowsy for Chesty Coughs contains guaifenesin, an expectorant and menthol which has mild anaesthetic and decongestant properties.”

Benylin are adamant their products work. Their spokesman said as with all licensed medicines, it’s a legal requirement for Benylin to be able to prove that it works. “All Benylin products have demonstrated efficacy and have been granted a licence by the IMB… following a thorough review of the clinical evidence by their independent experts, which considers both the type and size of study.”

So who do we believe? Mr Duggan says he is happy with the robustness of IMB procedures. “If I was to question the IMB, I would have to question every product in my pharmacy.”

But Benylin isn’t the only product in the Which? firing line. Their panel of experts also investigated a range of Boots’ own brand drugs, together with a variety of other ‘household name’ products. None emerged with much credibility.

Take Bach’s Rescue Remedy. According to the manufacturer, Rescue Remedy is used to provide “relief for those everyday stressful moments”. The experts say that the evidence does not back up this claim.

Bach’s Rescue Remedy isn’t a medicine as such, and isn’t licensed by the IMB. Mr Duggan says that while he’s sceptical about the efficacy of the product, a lot of people he speaks to tell him it does work. “I would question the science behind homeopathy. But it’s not a medicine, so it’s not regulated under that guise.”

I asked the makers of Rescue Remedy for a reaction to the Which? report, and for any clinical data on how the product is supposed to relieve stress, but all I got was a woolly statement to the effect that it had been around for eighty years and had been used by millions of people in that time. The statement went on: “They [Bach’s products] are manufactured in accordance to Dr Bach’s original methods to the highest quality and safety standards and are available in over sixty countries worldwide.”

The fact that something is widely used doesn’t of course prove that it works, only that people think it does.

The Which? report said that in trials, the product proved no more effective at relieving stress than a placebo. Let the buyer beware.

Does it work or not?

*Benylin Chesty Coughs (Non-Drowsy)

The company says: “Benylin Chesty Coughs works deep down to loosen phlegm, clear bronchial congestion, and make your cough more productive.”

Which? experts say: “The company provided no evidence of effectiveness. The evidence base on the active ingredient guaifenesin consists of generally low-quality studies.”

* Benylin Tickly Coughs (Non-Drowsy)

The company says: “Soothing effect. Relieves tickly, dry coughs.”

Which? experts say: “The active ingredients are sugar alcohol (glycerol) and liquid sugar (sucrose). This medicine contains other sugars, too, such as black treacle. Their effectiveness is unproven and, in total, Benylin is around half sugar: 7.7g per 10ml dose.”

*Seven Seas Jointcare Be Active

The company says: “Keep really active with this everyday plan to look after your joints.”

Which? experts say: “The active ingredients in this supplement are at well below effective levels, and the dose of fish oil is inadequate to reduce inflammation. The European Food Safety Authority (EFSA) reviewed the evidence and concluded that claims linking the active ingredients glucosamine, chondroitin and omega 3 to joint health are not substantiated, and must be removed from products by December.” Seven Seas Ltd said packs will comply by EFSA’s deadline.

*Bio-Oil

The company says: “A specialist skincare product formulated to help improve the appearance of scars, stretch marks and uneven skin tone… highly effective for ageing and dehydrated skin.”

Which? experts say: “The research isn’t robust and doesn’t show sufficient evidence to back up the claims. Our expert thinks any effect on scarring is likely to be from massage and hydration (you could rub in a much cheaper moisturising product). There is no strong evidence that the scar will end up looking better with Bio-Oil than with cheaper moisturiser.”

* Bach Rescue Remedy Spray

The company says: “To comfort and reassure; provides support at times of emotional demand... relief for those everyday stressful moments.”

Which? experts say: “The claims are not substantiated by the literature supplied by the company, or more recent research. Rescue Remedy has been tested by a sufficient number of independent investigators and was found to be no more effective in relieving stress than a placebo. The active ingredients’ concentrations are extremely dilute and unlikely to have any effect.”

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