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Need to test the validity of theories in practice

Advice, apparently rational in theory...Some treatments are in use for a long time before it is realized that they can do more harm than good.

Based on untested theory, Benjamin Spock, the influential American child health expert, informed the readers of his bestselling book ‘Baby and Child Care’ that a disadvantage of babies sleeping on their backs was that, if they vomited, they would be more likely to choke. Dr Spock therefore advised his millions of readers to encourage babies to sleep on their tummies.

Dr Spock’s bestselling book contained harmful advice on babies’ sleeping position

Advice on babies’ sleeping position

Advice on babies’ sleeping position

With seemingly irrefutable logic – and certainly a degree of authority – from the 1956 edition of Dr Benjamin Spock book until the late 1970s he argued

https://en.testingtreatments.org/book/2-hoped-for-effects-that-dont-materialize/advice-on-babies-sleeping-position/

‘There are two disadvantages to a baby’s sleeping on his back. If he vomits he’s more likely to choke on the vomitus. Also he tends to keep his head turned towards the same side . . . this may flatten the side of the head . . . I think it is preferable to accustom a baby to sleeping on his stomach from the start.’

Gilbert systematic review

"Advice to put infants to sleep on the front for nearly a half century was contrary to evidence available from 1970 that this was likely to be harmful..."

There is evidence of damageee

First recommendations of the American Academy of Pediatrics

INFO

Gilbert R, Salanti G, Harden M, et al. Infant sleeping position and the sudden infant death syndrome: systematic review of observational studies and historical review of clinicians’ recommendations from 1940-2000.Infant sleeping position and the sudden infant death syndrome: systematic review of observational studies and historical review of recommendations from 1940 to 2002Background Before the early 1990s, parents were advised to place infants to sleep on their front contrary to evidence from clinical research. Methods...OUP Academic/doi.org/10.1093/ije/dyi088

Gilbert systematic review

Recommended infant sleeping position in books on infant care

INFO

Gilbert R, Salanti G, Harden M, et al. Infant sleeping position and the sudden infant death syndrome: systematic review of observational studies and historical review of clinicians’ recommendations from 1940-2000.Infant sleeping position and the sudden infant death syndrome: systematic review of observational studies and historical review of recommendations from 1940 to 2002Background Before the early 1990s, parents were advised to place infants to sleep on their front contrary to evidence from clinical research. Methods...OUP Academic/doi.org/10.1093/ije/dyi088

Gilbert systematic review

"Systematic review of preventable risk factors for SIDS from 1970 would have led to earlier recognition of the risks of sleeping on the front and might have prevented over 10 000 infant deaths in the UK and at least 50 000 in Europe, the USA, and Australasia....This phenomenon is likely to be a general problem in the use of observational studies for assessing the safety of health promotion".

Hormone Replacement Therapy (HRT)

In women going through the menopause, hormone replacementtherapy (HRT) is very effective in reducing hotflushes,prevent osteoporosis, prevention of heart attacks and stroke.

For over 20 years millions of women began using HRT for longer

HRT was soheavily promoted specifically as a way of reducing heart attacksand stroke.

In 1997 Researchers from Finland and the UK reviewed, systematically, the results of well-conducted studies. They found that, far from reducing heart disease, HRT might actually increase it.

Hemminki E, McPherson K. Impact of postmenopausal hormone therapy on cardiovascular events and cancer: pooled data from clinical trials. BMJ 1997;315:149-53.

But the advice is wrong:

Now know that HRT increases the risk of stroke and of developing breast cancer.

Anonymous. HRT: update on the risk of breast cancer and long-term safety. Current Problems in Pharmacovigilance 2003;29:1-3. Citing results of Women’s Health Initiative randomized controlled trial (JAMA 2003;289:3243-53) and Million Women Study (Lancet 2003;362:419-27).

Key points

1

Neither theory nor professional opinion is a reliableguide to safe, effective treatments

2

Just because a treatment is ‘established’ does notmean it does more good than harm

3

Even if patients do not suffer from inadequately testedtreatments, using them can waste individual andcommunity resources

In more depth

Why treatment uncertainties should be addressed. In: Clarke M, Atkinson P, Badenoch D, Chalmers I, Glasziou P, Podolsky S, Tröhler U. The James Lind Library´s Introduction to fair test of treatments. Available: http://www.jameslindlibrary.org/essays/1-1-why-treatment-uncertainties-should-be-addressed/

Evans I, Thornton H, Chalmers I and Glasziou P (2011). Testing Treatments, 2nd Edition; London: Pinter and Martin. Available: https://en.testingtreatments.org/book/2-hoped-for-effects-that-dont-materialize/