Treatment for pre-term rupture of membranes in pregnancy

Another large international trial is published, and another standard practice based on little more than our bias towards doing something rather than doing nothing is reversed.

Book review, of my book: Surgery, the ultimate placebo.

This will be a test of how unbiased I am. Writing a review of my own book (regardless of any bias) seems like shameless self-promotion, but what the hell, it's better than just saying "Hey, I wrote a book".

Knee arthroscopy for "mechanical symptoms"

I have previously written about the (non) role of arthroscopy for osteoarthritis or degenerative meniscus tears in the knee (here, here and here). Surgeons have continued to operate, based on a belief that (now) centres on the presence of mechanical symptoms. An analysis of the recent sham surgery trial of arthroscopic partial meniscectomy (APM), which showed APM to be no better than sham for patients with meniscus tears without arthritis, has shown that this procedure is no better than sham surgery for patients with mechanical symptoms.

Laparoscopy for bowel adhesions

Laparoscopy is keyhole surgery of the abdomen in which a camera and instruments are inserted through holes in the skin, into the abdomen to see the structures within (diagnostic laparoscopy) and to correct pathology where possible (therapeutic laparoscopy). In patients that have had previous pathology or surgery to the abdomen, adhesions can develop whereby loops of bowel can get caught up in scar tissue. If this causes an obstruction of the bowel, it can be very serious, but often people just have abdominal pain that coexists with adhesions.

Prophylactic mastectomy

Prophylactic mastectomy reduces the risk of getting breast cancer (here), but does it reduce your overall risk of dying? And what are the other risks?

Sham physical therapy

Paradoxically, it is easier to perform a sham trial in surgery, the most invasive physical act, than in physiotherapy because the patient is asleep when it is delivered. Physical therapy involves physical acts that are hard to imitate as placebo treatment, but the influence of the patient-therapist interaction makes it important to tease out any placebo effect. Researchers have, however, performed sham trials in physiotherapy.

Fixing a hole

Migraine is common, affecting millions of people worldwide. A patent foramen ovale (PFO – a ‘hole in the heart’ that lets blood cross from the right heart to the left) is common as well, present in about 30% of people. When cardiologists started surgically closing PFOs, they noticed that many patients with migraine got better. As with the discovery of any association in medicine, theories of a causal link soon followed, and doctors started treating migraine by closing the hole in the heart; before properly testing it, of course.

Placebo trials of surgery

In a recent systematic review of placebo trials of surgery (here) it was found that in half of the 53 trials found, surgery was not better than placebo treatment. And in the ones where it was better, the difference wasn’t great. This may not be big news to my readers, but this review was important because it highlighted many of the problems with surgery, namely that:
1) placebo studies are needed to determine the true effectiveness of surgical procedures, but …
2) surgery and associated devices are regulated less strictly than drugs, consequently …
3) surgery is often not subjected to placebo / sham studies, even though …
4) such studies are ethical and practical.

My right foot: predicament versus illness

My right foot hurts. It hurts in the middle, underneath, but not all the time, and only when I walk or take any weight on it, especially when I get up in the morning, when it becomes difficult to walk. It has been hurting on and off since I did an 80km trek three months ago. It could be a stress fracture, or some kind of fasciitis, soft tissue tear, fatigue, injury or degeneration, but I don't really care, because I am not going to have any tests or see any health care practitioners to get their version of a diagnosis. I'm just going to leave it alone. I am going to be a person with a predicament that I can cope with, and not a patient with an illness.

Do shoulder fractures need surgery?

Fractures that occur at the upper end of the humerus near the shoulder (called humeral neck fractures) are common. They are often treated with surgery despite a lack of supporting evidence for this, particularly in older, osteoporotic patients. Now, thanks to a recent study from the UK, it is possible that most of these fractures don’t need surgery, even in young patients. This is big news, but will this research jump the gap from research into practice and influence the decision making of the end users – the patient and their surgeon?

Predatory publishing: when scientific quality gets in the way of a good business model

Science progresses because it is open to scrutiny. For findings to be accepted, they must pass peer-review and must be presented to other scientists for them to question, refute, or confirm. Publication in a scientific journal (and presentation at conferences) is key to this process. However, the number of journals and conferences have increased massively over the last 10 -20 years, and many of them are not the real thing – so called ‘predatory’ publishing and predatory conferences have sprung up everywhere. The problem with this is that there is no clear line between what is real and what is fake.

Lessons from history #13: Hormone replacement therapy

Hormone replacement therapy (HRT) for post-menopausal women was thought to decrease the chance of cardiovascular problems like heart attack and stroke. This ‘made sense’ because the risk of cardiovascular disease in women rose sharply after menopause, indicating that female hormones had a protective effect. Many large observational studies supported this belief, and HRT was widely prescribed in the 1980s and 1990s. Later evidence from large, placebo controlled, randomised trials failed to show any cardiovascular benefit. Again, observational evidence was shown to overestimate the effectiveness of a common medical treatment and again, practice became established before the definitive trials were done.

Surgery for high blood pressure

The most recent casualty of the sham surgery trial, adding to the list of operations that looked good and had good results until put to the leased biased test, is a procedure called renal denervation (cutting the nerves to the kidney). Years of good results showing that this procedure lowered blood pressure are now met with a blinded sham-controlled trial that showed no significant benefit over placebo.

The replication problem

One of the fundamental principles of science is that the results of any experiment should be reproducible. Reproducibility is essential because it means that the results can be relied upon, as they are more likely to be true. Unfortunately, there is little fame in replicating someone else’s study; it is also hard to get such studies funded (because they are not ‘novel’). Consequently, many studies are not repeated and many findings stand alone without verification from separate, independent researchers. This is a problem because often when studies are replicated, they fail to reproduce the original findings.

Astroturfing

Patients should have a voice in medical policy and treatment. ‘Grass-roots’ groups of patients are more likely to have that voice heard and to effect change if they are organised and well funded. Patient advocacy groups can therefore be more effective if they accept industry (pharma) funding. However, such groups can also serve the interests of the industry doing the funding. It is even better for the industry, however, if they organise the grass-roots patient advocacy group from the start; so-called ‘astroturfing’.

Lessons from history #12: Lobotomy

In the 1940s and 50s (tapering into the 70s and 80s) tens of thousands of prefrontal lobotomies (severing the front part of the brain) were performed in Europe and North America for many types of mental conditions. It was done because doctors at that time believed that it worked, and they didn’t have many effective alternatives. However, it didn’t work, it made people worse and it even killed a few, despite a Nobel prize being awarded to one of the developers of the procedure.

Lessons from history #11: Extra- to Intra-cranial Bypass Surgery

This story is about a procedure that made sense and had supporting evidence, became common practice, but was later discontinued because a high quality study showed it to be ineffective. The story of extra-cranial intra-cranial bypass surgery ticks all the boxes: overestimation of benefit, seduction by the theory, unrecognised bias in studies, and just plain ineffectiveness despite our best effort and beliefs.

Lessons from history #10: How magnesium lost its mojo

Wouldn’t it be great if there was a cheap, non-proprietary, readily available treatment for patients with heart attacks (acute myocardial infarction - AMI)? That’s what doctors wanted to believe, so when they saw the early results of magnesium therapy, they did exactly that. Magnesium therapy for AMI has been labelled a “lesson in medical humility”, but I see it as another example of the pervasive bias amongst researchers, doctors and the public that leads them to overestimate the effectiveness of medical therapies. Put simply, it was another case of ‘believing is seeing’.

Animal research: just another WOFTAM?

The idea is that experiments are first performed in the lab, are then performed in animals, and these experiments inform the eventual human studies. As a (seemingly) necessary step in this chain, animal experiments are (rightly or wrongly) tolerated based on their eventual benefit to humans. Animal studies however, are not good predictors of human trials, often do not inform human trials, and are methodologically inferior to human trials, so much so, that the results from animal studies are unreliable and biased. In other words, animal studies are often of no benefit to humans. Arguably, they do not benefit humans at all, let alone enough to justify their use. We either need to fix the problem or get out of the animal research game.

Surgery for shoulder impingement

When you raise your arm, the top of your humerus, where the rotator cuff tendons attach, “impinge” against your acromion. When this hurts, it is called impingement syndrome. “Decompressing” the joint by taking some bone off the acromion (an "acromioplasty”) makes sense, and seems to work well. The operation has been around for a long time, and there have been many studies looking at different ways of doing this operation, but very few studies looking at whether or not it works better than not operating. Interestingly, all of the studies that have been done conclude that this operation adds nothing.