In an episode of ABC’s Four Corners this week, the use of spinal cord stimulators for chronic back pain was brought into question.

Spinal cord stimulators are devices implanted surgically which deliver electric impulses directly to the spinal cord. They’ve been used to treat people with chronic pain since the 1960s.

Their design has changed significantly over time. Early models required an external generator and invasive surgery to implant them. Current devices are fully implantable, rechargeable and can deliver a variety of electrical signals.

However, despite their long history, rigorous experimental research to test the effectiveness of spinal cord stimulators has only been conducted this century. The findings don’t support their use for treating chronic pain. In fact, data points to a significant risk of harm.

What does the evidence say?

One of the first studies used to support the effectiveness of spinal cord stimulators was published in 2005. This study looked at patients who didn’t get relief from initial spinal surgery and compared implantation of a spinal cord stimulator to a repeat of the spinal surgery.

Although it found spinal cord stimulation was the more effective intervention for chronic back pain, the fact this study compared the device to something that had already failed once is an obvious limitation.

Later studies provided more useful evidence. They compared spinal cord stimulation to non-surgical treatments or placebo devices (for example, deactivated spinal cord stimulators).

A 2023 Cochrane review of the published comparative studies found nearly all studies were restricted to short-term outcomes (weeks). And while some studies appeared to show better pain relief with active spinal cord stimulation, the benefits were small, and the evidence was uncertain.

Only one high-quality study compared spinal cord stimulation to placebo up to six months, and it showed no benefit. The review concluded the data doesn’t support the use of spinal cord stimulation for people with back pain.

What about the harms?

The experimental studies often had small numbers of participants, making any estimate of the harms of spinal cord stimulation difficult. So we need to look to other sources.

A review of adverse events reported to Australia’s Therapeutic Goods Administration found the harms can be serious. Of the 520 events reported between 2012 and 2019, 79% were considered “severe” and 13% were “life threatening”.

We don’t know exactly how many spinal cord stimulators were implanted during this period, however this surgery is done reasonably widely in Australia, particularly in the private and workers compensation sectors. In 2023, health insurance data showed more than 1,300 spinal cord stimulator procedures were carried out around the country.

In the review, around half the reported harms were due to a malfunction of the device itself (for example, fracture of the electrical lead, or the lead moved to the wrong spot in the body). The other half involved declines in people’s health such as unexplained increased pain, infection, and tears in the lining around the spinal cord.

More than 80% of the harms required at least one surgery to correct the problem. The same study reported four out of every ten spinal cord stimulators implanted were being removed.

High costs

The cost here is considerable, with the devices alone costing tens of thousands of dollars. Adding associated hospital and medical costs, the total cost for a single procedure averages more than $A50,000. With many patients undergoing multiple repeat procedures, it’s not unusual for costs to be measured in hundreds of thousands of dollars.

Rebates from Medicare, private health funds and other insurance schemes may go towards this total, along with out-of-pocket contributions.

Insurers are uncertain of the effectiveness of spinal cord stimulators, but because their implantation is listed on the Medicare Benefits Schedule and the devices are approved for reimbursement by the government, insurers are forced to fund their use.

Industry influence

If the evidence suggests no sustained benefit over placebo, the harms are significant and the cost is high, why are spinal cord stimulators being used so commonly in Australia? In New Zealand, for example, the devices are rarely used.

Doctors who implant spinal cord stimulators in Australia are well remunerated and funding arrangements are different in New Zealand. But the main reason behind the lack of use in New Zealand is because pain specialists there are not convinced of their effectiveness.

In Australia and elsewhere, the use of spinal cord stimulators is heavily promoted by the pain specialists who implant them, and the device manufacturers, often in unison. The tactics used by the spinal cord stimulator device industry to protect profits have been compared to tactics used by the tobacco industry.

A 2023 paper describes these tactics which include flooding the scientific literature with industry-funded research, undermining unfavourable independent research, and attacking the credibility of those who raise concerns about the devices.

It’s not all bad news

Many who suffer from chronic pain may feel disillusioned after watching the Four Corners report. But it’s not all bad news. Australia happens to be home to some of the world’s top back pain researchers who are working on safe, effective therapies.

New approaches such as sensorimotor retraining, which includes reassurance and encouragement to increase patients’ activity levels, cognitive functional therapy, which targets unhelpful pain-related thinking and behaviour, and old approaches such as exercise, have recently shown benefits in robust clinical research.

If we were to remove funding for expensive, harmful and ineffective treatments, more funding could be directed towards effective ones.

Ian Harris, Professor of Orthopaedic Surgery, UNSW Sydney; Adrian C Traeger, Research Fellow, Institute for Musculoskeletal Health, University of Sydney, and Caitlin Jones, Postdoctoral Research Associate in Musculoskeletal Health, University of Sydney

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Kaitlin Day, RMIT University and Sharayah Carter, RMIT University

Intermittent fasting has gained popularity in recent years as a dietary approach with potential health benefits. So you might have been surprised to see headlines last week suggesting the practice could increase a person’s risk of death from heart disease.

The news stories were based on recent research which found a link between time-restricted eating, a form of intermittent fasting, and an increased risk of death from cardiovascular disease, or heart disease.

So what can we make of these findings? And how do they measure up with what else we know about intermittent fasting and heart disease?

The study in question

The research was presented as a scientific poster at an American Heart Association conference last week. The full study hasn’t yet been published in a peer-reviewed journal.

The researchers used data from the National Health and Nutrition Examination Survey (NHANES), a long-running survey that collects information from a large number of people in the United States.

This type of research, known as observational research, involves analysing large groups of people to identify relationships between lifestyle factors and disease. The study covered a 15-year period.

It showed people who ate their meals within an eight-hour window faced a 91% increased risk of dying from heart disease compared to those spreading their meals over 12 to 16 hours. When we look more closely at the data, it suggests 7.5% of those who ate within eight hours died from heart disease during the study, compared to 3.6% of those who ate across 12 to 16 hours.

We don’t know if the authors controlled for other factors that can influence health, such as body weight, medication use or diet quality. It’s likely some of these questions will be answered once the full details of the study are published.

It’s also worth noting that participants may have eaten during a shorter window for a range of reasons – not necessarily because they were intentionally following a time-restricted diet. For example, they may have had a poor appetite due to illness, which could have also influenced the results.

Other research

Although this research may have a number of limitations, its findings aren’t entirely unique. They align with several other published studies using the NHANES data set.

For example, one study showed eating over a longer period of time reduced the risk of death from heart disease by 64% in people with heart failure.

Another study in people with diabetes showed those who ate more frequently had a lower risk of death from heart disease.

A recent study found an overnight fast shorter than ten hours and longer than 14 hours increased the risk dying from of heart disease. This suggests too short a fast could also be a problem.

But I thought intermittent fasting was healthy?

There are conflicting results about intermittent fasting in the scientific literature, partly due to the different types of intermittent fasting.

There’s time restricted eating, which limits eating to a period of time each day, and which the current study looks at. There are also different patterns of fast and feed days, such as the well-known 5:2 diet, where on fast days people generally consume about 25% of their energy needs, while on feed days there is no restriction on food intake.

Despite these different fasting patterns, systematic reviews of randomised controlled trials (RCTs) consistently demonstrate benefits for intermittent fasting in terms of weight loss and heart disease risk factors (for example, blood pressure and cholesterol levels).

RCTs indicate intermittent fasting yields comparable improvements in these areas to other dietary interventions, such as daily moderate energy restriction.

So why do we see such different results?

RCTs directly compare two conditions, such as intermittent fasting versus daily energy restriction, and control for a range of factors that could affect outcomes. So they offer insights into causal relationships we can’t get through observational studies alone.

However, they often focus on specific groups and short-term outcomes. On average, these studies follow participants for around 12 months, leaving long-term effects unknown.

While observational research provides valuable insights into population-level trends over longer periods, it relies on self-reporting and cannot demonstrate cause and effect.

Relying on people to accurately report their own eating habits is tricky, as they may have difficulty remembering what and when they ate. This is a long-standing issue in observational studies and makes relying only on these types of studies to help us understand the relationship between diet and disease challenging.

It’s likely the relationship between eating timing and health is more complex than simply eating more or less regularly. Our bodies are controlled by a group of internal clocks (our circadian rhythm), and when our behaviour doesn’t align with these clocks, such as when we eat at unusual times, our bodies can have trouble managing this.

So, is intermittent fasting safe?

There’s no simple answer to this question. RCTs have shown it appears a safe option for weight loss in the short term.

However, people in the NHANES dataset who eat within a limited period of the day appear to be at higher risk of dying from heart disease. Of course, many other factors could be causing them to eat in this way, and influence the results.

When faced with conflicting data, it’s generally agreed among scientists that RCTs provide a higher level of evidence. There are too many unknowns to accept the conclusions of an epidemiological study like this one without asking questions. Unsurprisingly, it has been subject to criticism.

That said, to gain a better understanding of the long-term safety of intermittent fasting, we need to be able follow up individuals in these RCTs over five or ten years.

In the meantime, if you’re interested in trying intermittent fasting, you should speak to a health professional first.

Kaitlin Day, Lecturer in Human Nutrition, RMIT University and Sharayah Carter, Lecturer Nutrition and Dietetics, RMIT University

This article is republished from The Conversation under a Creative Commons license. Read the original article.

Cinnamon has been long used around the world in both sweet and savoury dishes and drinks.

But a new TikTok trend claims adding a teaspoon of cinnamon to your daily coffee (and some cocoa to make it more palatable) for one week can help you burn fat. Is there any truth to this?

Not all cinnamon is the same

There are two types of cinnamon, both of which come from grinding the bark of the cinnamomum tree and may include several naturally occurring active ingredients.

Cassia cinnamon is the most common type available in grocery stores. It has a bitter taste and contains higher levels of one of the active ingredient cinnamaldehyde, a compound that gives cinnamon its flavour and odour. About 95% of cassia cinnamon is cinnamaldehyde.

The other is Ceylon cinnamon, which tastes sweeter. It contains about 50-60% cinnamaldehyde.

Does cinnamon burn fat? What does the research say?

A review of 35 studies examined whether consuming cinnamon could affect waist circumference, which is linked to increased body fat levels. It found cinnamon doses below 1.5 grams per day (around half a teaspoon) decreased waist circumference by 1.68cm. However, consuming more than 1.5g/day did not have a significant effect.

A meta-analysis of 21 clinical trials with 1,480 total participants found cinnamon also reduced body mass index (BMI) by 0.40kg/m² and body weight by 0.92kg. But it did not change the participants’ composition of fat or lean mass.

Another umbrella review, which included all the meta-analyses, found a small effect of cinnamon on weight loss. Participants lost an average of 0.67kg and reduced their BMI by 0.45kg/m².

So overall, the weight loss we see from these high-quality studies is very small, ranging anywhere from two to six months and mostly with no change in body composition.

The studies included people with different diseases, and most were from the Middle East and/or the Indian subcontinent. So we can’t be certain we would see this effect in people with other health profiles and in other countries. They were also conducted over different lengths of time from two to six months.

The supplements were different, depending on the study. Some had the active ingredient extracted from cinnamon, others used cinnamon powder. Doses varied from 0.36g to 10g per day.

They also used the two different types of cinnamon – but none of the studies used cinnamon from the grocery store.

How could cinnamon result in small amounts of weight loss?

There are several possible mechanisms.

It appears to allow blood glucose (sugar) to enter the body’s cells more quickly. This lowers blood glucose levels and can make insulin work more effectively.

It also seems to improve the way we break down fat when we need it for energy.

Finally, it may make us feel fuller for longer by slowing down how quickly the food is released from our stomach into the small intestine.

What are the risks?

Cinnamon is generally regarded as safe when used as a spice in cooking and food.

However, in recent months the United States and Australia have issued health alerts about the level of lead and other heavy metals in some cinnamon preparations.

Lead enters as a contaminant during growth (from the environment) and in harvesting. In some cases, it has been suggested there may have been intentional contamination.

Some people can have side effects from cinnamon, including gastrointestinal pain and allergic reactions.

One of the active ingredients, coumarin, can be toxic for some people’s livers. This has prompted the European Food Authority to set a limit of 0.1mg/kg of body weight.

Cassia cinnamon contains up to 1% of coumarin, and the Ceylon variety contains much less, 0.004%. So for people weighing above 60kg, 2 teaspoons (6g) of cassia cinnamon would bring them over the safe limit.

What about the coffee and cocoa?

Many people may think coffee can also help us lose weight. However there isn’t good evidence to support this yet.

An observational study found drinking one cup of regular coffee was linked to a reduction in weight that is gained over four years, but by a very small amount: an average of 0.12kg.

Good-quality cocoa and dark chocolate have also been shown to reduce weight. But again, the weight loss was small (between 0.2 and 0.4kg) and only after consuming it for four to eight weeks.

So what does this all mean?

Using cinnamon may have a very small effect on weight, but it’s unlikely to deliver meaningful weight loss without other lifestyle adjustments.

We also need to remember these trials used products that differ from the cinnamon we buy in the shops. How we store and how long we keep cinnamon might also impact or degrade the active ingredients.

And consuming more isn’t going to provide additional benefit. In fact, it could increase your risk of side effects.

So if you enjoy the taste of cinnamon in your coffee, continue to add it, but given its strong taste, you’re likely to only want to add a little.

And no matter how much we’d like this to be true, we certainly won’t gain any fat-loss benefits by consuming cinnamon on doughnuts or in buns, due to their high kilojoule count.

If you want to lose weight, there are evidence-backed approaches that won’t spoil your morning coffee.

Evangeline Mantzioris, Program Director of Nutrition and Food Sciences, Accredited Practising Dietitian, University of South Australia

This article is republished from The Conversation under a Creative Commons license. Read the original article.