When stud­ies con­tra­dict sci­ence

The Daily Telegraph - - Health & features - James Le Fanu Email med­i­cal ques­tions con­fi­den­tially to Dr James Le Fanu at dr­james @tele­graph.co.uk

When the find­ings of an au­thor­i­ta­tive sci­en­tific study into the ef­fi­cacy of some treat­ment ap­pear to be con­trary to the ex­pe­ri­ence of at least some of those tak­ing it, which is likely to be the more re­li­able?

A cou­ple of years ago, prom­i­nent re­searchers in­volved in a ma­jor clin­i­cal trial claimed to have demon­strated that a com­bi­na­tion of psy­cho­log­i­cal ther­apy and graded ex­er­cise was of sig­nif­i­cant ben­e­fit in two thirds of those de­bil­i­tated by chronic fa­tigue syn­drome (CFS). This prompted a bar­rage of crit­i­cism from more than a thou­sand Daily Tele­graph read­ers, who pointed out, in­ter alia, that ex­ac­er­ba­tion of fa­tigue on ex­er­tion is a defin­ing fea­ture of the con­di­tion and dis­puted the cri­te­ria in the trial for func­tional im­prove­ment.

Their scep­ti­cism is am­ply vin­di­cated by the publicatio­n a fort­night ago in the jour­nal BMC

Psy­chol­ogy of an in­de­pen­dent re-anal­y­sis of the re­sults that shows, on the con­trary, these treat­ments con­fer “no long-stand­ing ben­e­fit at all”. Mean­while, the sup­po­si­tion the trial was in­tended to prove – that CFS (also known as myal­gic en­cephalomye­li­tis, or ME) is pri­mar­ily a psy­cho­log­i­cal con­di­tion – has been un­der­mined by con­vinc­ing ev­i­dence that pa­tients have im­paired func­tion­ing of the au­to­nomic ner­vous sys­tem in re­sponse to “phys­i­cal and cog­ni­tive chal­lenges”.

This dis­so­nance be­tween the sci­en­tif­i­cally sanc­tioned ver­sion of the truth and peo­ple’s sub­jec­tive ex­pe­ri­ence is ap­par­ent too in the vexed is­sue of the ad­verse ef­fects of im­mu­nis­ing young girls against the hu­man pa­pil­loma virus (HPV) in an­tic­i­pa­tion this will re­duce their sub­se­quent risk of de­vel­op­ing cer­vi­cal can­cer.

The back­ground here is the de­vel­op­ment 20 years ago of a novel method for test­ing for HPV that found the virus to be present in can­cer cells. This can­not, how­ever, be the whole story as HPV in­fec­tion is very com­mon, usu­ally re­solv­ing spon­ta­neously, and the virus is not uni­ver­sally found in those with cer­vi­cal can­cer.

None the less, the prospect that it might be pre­ventable in this way seemed a ma­jor break­through, and over the past few years, many coun­tries have in­sti­tuted a pro­gramme of mass im­mu­ni­sa­tion of one or other of the (very costly) vac­cines Cer­varix or Gar­dasil. There is no doubt they work in pro­tect­ing young girls against the virus, though there is as yet no ev­i­dence this has re­duced the in­ci­dence of cer­vi­cal can­cer.

The safety of the vac­cine is ob­vi­ously of paramount im­por­tance. It may cause a lo­cal re­ac­tion at the in­jec­tion site, and tran­sient symp­toms of fever, headache and so on, but a study in Den­mark of nearly one mil­lion girls has shown that those re­ceiv­ing the vac­cine do not suf­fer any long-term ad­verse ef­fects.

Re­as­sur­ing, cer­tainly – but, rare as it may be, some par­ents main­tain the vac­cine is re­spon­si­ble for in­duc­ing in their pre­vi­ously healthy daugh­ters a spec­trum of per­sis­tent dis­abling symp­toms, in­clud­ing chronic pain, im­paired con­cen­tra­tion and ex­er­cise tol­er­ance and re­cur­rent syn­cope. They are the sub­ject of Sac­ri­fi­cial Vir­gins, a re­cent award-win­ning doc­u­men­tary in which, as with chronic fa­tigue syn­drome, par­ents re­port be­ing told their child’s symp­toms are “psy­cho­log­i­cal”.

This is most un­likely – and, in­deed, four re­cent stud­ies from Canada, Den­mark, Italy and Colom­bia now con­firm that, as with CFS, these girls have dis­turbed func­tion­ing of the au­to­nomic ner­vous sys­tem.

The Euro­pean Medicines Agency and sim­i­lar bod­ies as­sert there is no “causal link” to the vac­cine, but par­ents, be­fore giv­ing their in­formed con­sent, should check out the doc­u­men­tary, avail­able to view on Youtube; by Google-search­ing for “se­vere dysau­to­nomic syn­dromes af­ter HPV vac­ci­na­tion”; or at vimeo.com/234652898.

Mask­ing the prob­lem

The plight of a woman af­flicted with pe­ri­odic bouts of ex­cru­ci­at­ing pain and wa­ter­ing of ei­ther the left or right eye has elicited two dif­fer­ent types of ex­pla­na­tion. Sev­eral read­ers re­port sim­i­lar symp­toms with raised pres­sure (glau­coma), or in­flam­ma­tion of the iris (iri­tis) within the eye­ball.

The general con­sen­sus, how­ever, is that this is a clus­ter headache, whose sear­ing, knife­like pain in and around the eye is re­put­edly the worst imag­in­able. It shares some fea­tures in com­mon with mi­graine, but is char­ac­ter­is­ti­cally (if sur­pris­ingly) much im­proved by in­hal­ing oxy­gen through a mask.

Ex­er­cise has been proven to have no real ben­e­fit to suf­fer­ers of CFS

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