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Promising treatment for chronic fatigue syndrome fails large trial

Rituximab has been found to be worse than a placebo at alleviating the symptoms of CFS or ME, suggesting that antibodies aren’t to blame for the condition

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A medicine that people hoped would treat chronic fatigue syndrome (CFS) has failed its first large placebo-controlled trial.

The drug, called rituximab, is used to treat cancer and autoimmune diseases in which the immune system makes antibodies that turn against the body. The medicine works by killing the cells that make antibodies.

A few people who had cancer and also happened to have CFS saw their symptoms of fatigue resolve after taking rituximab. Øystein Fluge of Haukeland University Hospital in Norway thought rogue antibodies could be involved in CFS, also known as myalgic encephalomyelitis (ME).

These initial findings were borne out by some small studies. Fluge and his colleagues’ latest trial was larger, involving 151 people. Half had regular infusions of rituximab for a year, while the rest got placebo infusions. Their symptoms were measured over this time and for a further year, as the drug can take several months to work.

About 25 per cent of people in the treatment group saw their tiredness alleviate – but so did 35 per cent of people in the placebo group. Rituximab also caused a higher rate of side effects that required going to hospital, such as infections.

Fluge says the first people who got better after taking rituximab may have done so because of the placebo effect, or because their condition naturally resolved. Alternatively, they could have been different in some way from other people with CFS.

The results are a blow to the idea that antibodies cause CFS, says Fluge, “but it doesn’t exclude that other parts of the immune system are active in this disease”.

Charles Shepherd of the UK’s ME Association says some people with the condition have travelled to the US to get rituximab treatment even though it isn’t licensed to be used in this way.

Annals of Internal Medicine

Topics: chronic fatigue syndrome / Immune system / Medical drugs