Most pa­tients prob­a­bly don’t need them — this is hard for pa­tients and physi­cians to ac­cept be­cause in their ex­pe­ri­ence, pa­tients who got stents got bet­ter,

New Straits Times - - OPINION - writes AARON E. CAR­ROLL

WHEN my chil­dren were lit­tle, if they com­plained about aches and pains, I’d some­times rub some mois­turiser on them and tell them the “cream” would help. It of­ten did. The placebo ef­fect is sur­pris­ingly ef­fec­tive.

Mois­turiser is cheap, it has al­most no side ef­fects, and it got the job done. It was a per­fect so­lu­tion.

Other treat­ments also have a placebo ef­fect, and make peo­ple feel bet­ter. Many of these are dan­ger­ous, though, and we have to weigh the down­sides against that ben­e­fit.

Lots of Amer­i­cans have chest pain be­cause of a lack of blood and oxy­gen reach­ing the heart. This is known as angina. For decades, one of the most com­mon ways to treat this was to in­sert a mesh tube known as a stent into ar­ter­ies sup­ply­ing the heart. The stents held the ves­sels open and in­creased blood flow to the heart, the­o­ret­i­cally fix­ing the prob­lem.

Car­di­ol­o­gists who in­serted these stents found that their pa­tients re­ported feel­ing bet­ter. They seemed to be health­ier. Many be­lieved that these stents pre­vented heart at­tacks and maybe even death. Per­cu­ta­neous coro­nary in­ter­ven­tion, the pro­ce­dure by which a stent can be placed, be­came very com­mon.

Then, in 2007, a ran­domised con­trolled trial was pub­lished in The New Eng­land Jour­nal of Medicine. The main out­comes of in­ter­est were heart at­tacks and death. Re­searchers gath­ered al­most 2,300 pa­tients with sig­nif­i­cant coro­nary artery dis­ease and proof of re­duced blood flow to the heart. They as­signed them ran­domly to a stent with med­i­cal ther­apy or to med­i­cal ther­apy alone.

They fol­lowed the pa­tients for years. The re­sult? The stents didn’t make a dif­fer­ence be­yond med­i­cal treat­ment in prevent­ing these bad out­comes.

The prob­lem was that it was dif­fi­cult to know whether the stents were lead­ing to pain re­lief, or whether it was the placebo ef­fect. The placebo ef­fect is very strong with re­spect to pro­ce­dures, af­ter all. What was needed was a trial with a sham con­trol, a pro­ce­dure that left pa­tients un­clear whether they’d had a stent placed.

Many physi­cians op­posed such a study. They ar­gued that the vast ex­pe­ri­ence of car­di­ol­o­gists showed that stents worked, and there­fore ran­domis­ing some pa­tients not to re­ceive them was un­eth­i­cal. Oth­ers ar­gued that ex­pos­ing pa­tients to a sham pro­ce­dure was also wrong be­cause it left them sub­ject to po­ten­tial harm with no ben­e­fit. More scep­ti­cal ob­servers might note that some doc­tors and hos­pi­tals were also fi­nan­cially re­warded for per­form­ing this pro­ce­dure.

Re­gard­less, such a trial was done, and the re­sults were pub­lished this year.

Re­searchers gath­ered pa­tients with se­vere coro­nary dis­ease at five sites in Bri­tain, and ran­domised them to one of two groups.

All were given med­i­ca­tion ac­cord­ing to a pro­to­col for a pe­riod of time. Then, the first group of pa­tients re­ceived a stent. In the sec­ond, pa­tients were kept se­dated for at least 15 min­utes, but no stent was placed.

Six weeks later, all the pa­tients were tested on a tread­mill. Ex­er­cise tends to bring out pain in such pa­tients, and mon­i­tor­ing them while they’re un­der stress is a com­mon way to check for angina. At the time of test­ing, nei­ther the pa­tient nor the car­di­ol­o­gist knew whether a stent had been placed. And, based on the re­sults, they couldn’t fig­ure it out even af­ter test­ing: There was no dif­fer­ence in the out­comes of in­ter­est be­tween the in­ter­ven­tion and placebo groups.

Stents didn’t ap­pear even to re­lieve pain.

Some caveats: All the pa­tients were treated rig­or­ously with med­i­ca­tion be­fore get­ting their pro­ce­dures, so many had im­proved sig­nif­i­cantly be­fore get­ting (or not get­ting) a stent. Some pa­tients in the real world won’t stick to the in­ten­sive med­i­cal ther­a­pies, so there may be a ben­e­fit from stents for those pa­tients (we don’t know). The fol­low-up was only at six weeks, so longer-term out­comes aren’t known. These re­sults also ap­ply only to those with sta­ble angina. There may be more of a place for stents in pa­tients who are sicker, who have dis­ease in more than one blood ves­sel, or who fail to re­spond to med­i­cal ther­apy.

But many, if not most pa­tients, prob­a­bly don’t need them. This is hard for pa­tients and physi­cians to wrap their heads around be­cause, in their ex­pe­ri­ence, pa­tients who got stents got bet­ter. They seemed to re­ceive a ben­e­fit from the pro­ce­dure. But that ben­e­fit ap­pears to be be­cause of the placebo ef­fect, not any phys­i­cal change from im­proved blood flow. The pa­tients in the study felt bet­ter from a pro­ce­dure in the same way that my chil­dren did when I rubbed mois­turiser on them.

The dif­fer­ence is that while the mois­turiser can’t re­ally harm, stent place­ment can. Even in this study, two per cent of pa­tients had a ma­jor bleed­ing event. Re­mem­ber that hun­dreds of thou­sands of stents are placed every year. Stents are also ex­pen­sive. They can add at least US$10,000 (RM39,300) to the cost of ther­apy.

Stents still have a place in care, but much less of one than we used to think. Yet, many physi­cians, as well as pa­tients, will still de­mand them, point­ing out that they lead to im­prove­ments in some peo­ple, even if that im­prove­ment is from a placebo ef­fect.

Stents are prob­a­bly not alone in this re­spect. It’s pos­si­ble that many pro­ce­dures aren’t bet­ter than shams. Although we would never ap­prove a drug with­out know­ing its ben­e­fits above a placebo, we don’t hold de­vices to the same stan­dard. As Rita Red­berg noted in The New Eng­land Jour­nal of Medicine in 2014, only one per cent of ap­proved med­i­cal de­vices are ap­proved by a process that re­quires the sub­mis­sion of clin­i­cal data, and that data is al­most al­ways from one small trial with lim­ited fol­low-up. Ran­domised con­trolled tri­als are very rare. The placebo ef­fect is not.

Yet, many physi­cians, as well as pa­tients, will still de­mand them, point­ing out that they lead to im­prove­ments in some peo­ple, even if that im­prove­ment is from a placebo ef­fect.

One of the most com­mon ways to treat chest pains is for doc­tors to in­sert a stent into the ar­ter­ies sup­ply­ing blood and oxy­gen to the heart.

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