If high quality clinical trials confirm lasting benefits and key features, apps could become cornerstone of global tobacco control efforts, suggest researchers

Smartphone apps—particularly those based on psychological theories—are 3 times as effective as no/minimal support at helping people who smoke stub out their tobacco use long term, suggests a pooled data analysis of the available evidence, published in the online journal BMJ Evidence Based Medicine.

If high quality clinical trials can confirm lasting benefits and key features, these apps could become a cornerstone of global tobacco control efforts, suggest the researchers.

Smartphone apps offer an accessible and versatile approach to smoking cessation efforts. But the current body of evidence has been hindered by small study numbers and app obsolescence, say the researchers.

Most currently available smoking cessation apps adopt either traditional behavioural frameworks, focused on directly modifying smoking behaviour, or psychological-behavioural theories, targeting cognition, emotion regulation, and motivation through techniques such as cognitive behavioural therapy (CBT), acceptance and commitment therapy, and mindfulness, explain the researchers.

But it’s not clear which approach might be more effective for improving sustained abstinence.

To strengthen and update the evidence base, the researchers assessed the effectiveness of smartphone apps, when used alone or when combined with traditional approaches, such as nicotine replacement therapy and counselling, for helping people quit smoking and stay away from tobacco long term (6 months continuously).

They trawled research databases for relevant randomised controlled trials published up to August 2025 of people aged at least 15 who planned to quit smoking. Comparisons included: no intervention; minimal smoking cessation support; traditional interventions; and apps based on traditional behavioural interventions.

Certainty of the evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.

The data from a total of 31 eligible studies, involving 12,802 participants, were pooled. Low certainty evidence from 4 studies (1402 participants) suggests that smartphone apps used alone may nearly triple the rate of 6-month continuous abstinence, increasing the number of ‘abstainers’ by 40 in every 1000, compared with no or minimal smoking cessation support.

When combined with traditional interventions, these apps may nearly double 6-month continuous abstinence compared with traditional interventions alone (4 studies involving 2163 participants; low certainty evidence).

And based on data from 3 studies (1502 participants; low certainty evidence), these apps plus pharmacotherapy may improve 6-month continuous abstinence by 77% compared with pharmacotherapy alone.

High certainty evidence indicated that apps based on psychological behavioural theories significantly increased abstinence in the short term at 3 months (69%; 2 studies, 2565 participants) and in the long term at 6 months (36%; 4 studies, 3258 participants) compared with apps based on traditional behavioural interventions.

“Smartphone apps can deliver intensive, interactive and real-time behavioural support, exceeding the effect of brief advice. A clear dose–response relationship exists between counselling intensity and quit success, and apps help meet this need while bypassing barriers such as limited clinic capacity, staff time, and declining use of telephone quitlines,” point out the researchers.

“Consequently, smartphone apps represent a scalable alternative or adjunct to traditional cessation services, particularly in resource-limited settings,” they suggest.

But the certainty of the evidence remains low due to limited sample sizes and methodological limitations, including design variations in the apps and their use, caution the researchers, adding that the findings “should be viewed as generating a hypothesis for future research rather than as a definitive conclusion.”

They conclude: “Should future evidence confirm lasting benefits and pinpoint key features, rigorously validated apps could become a cornerstone of global tobacco control efforts.”

13/01/2025

Notes for editors
Research: Efficacy of smartphone apps used alone or with traditional interventions for smoking cessation: a systematic review and meta- analysis Doi: 10.1136/bmjebm- 2025-113971
Journal: BMJ Evidence Based Medicine

External funding: China Association on Tobacco Control for Health

Link to Academy of Medical Sciences press release labelling system
http://press.psprings.co.uk/AMSlabels.pdf

Externally peer reviewed? Yes
Evidence type: Systematic review + meta analysis
Subjects: People

The post Phone apps nearly 3 times as good as no/basic support for quitting smoking long term first appeared on BMJ Group.

Tools already widely used amid few institutional policies and regulatory guidance
Medical education must adjust curricula + training to mitigate risks, warn experts

Overreliance on generative AI risks eroding new and future doctors’ critical thinking skills, while potentially reinforcing existing data bias and inequity, warns an editorial published in the online journal BMJ Evidence Based Medicine.

GenAI tools are already being widely used amid few institutional policies and regulatory guidance, point out the authors, who urge medical educators to exercise vigilance and adjust curricula and training to mitigate the technology’s pitfalls.

The use of AI is now used in a vast array of different tasks, but along with its burgeoning potential comes an increasing risk of overreliance on it and a host of potential issues for medical students and trainee doctors, note the authors from the University of Missouri, Columbia, USA.

These include:

●       automation bias—uncritical trust of automated information after extended use

●       cognitive off-loading and outsourcing of reasoning—shifting information retrieval, appraisal, and synthesis to AI, so undermining critical thinking and memory retention

●       Deskilling—blunting skills, which is especially important for medical students and newly qualified doctors who are learning the skill in the first place and who lack the experience to probe AI’s advice

●       reinforcing existing data biases and inequity

●       hallucinations—fluent and plausible, but inaccurate, information

●       breaches of privacy, security, and data governance—a particular issue for the sensitive nature of healthcare data

The authors suggest various changes to help minimise these risks, including grading the process, rather than only the end product in educational assessments, on the assumption that learners will have used AI.

Critical skills assessments that exclude AI need to be designed, using supervised stations or in-person examinations—especially important, for bedside communication, physical examination, teamwork,  and professional judgement—suggest the authors.

And it may be prudent to evaluate AI itself as a competency, because “data literacy and teaching AI design, development, and evaluation are more important now than ever, and this knowledge is no longer a luxury for medical learners and trainees,” they add.

Medical trainees need to understand the principles and concepts underpinning Ai’s strengths and weaknesses as well as where and how AI tools can be usefully incorporated into clinical workflows and care pathways. And trainees also need to know how to evaluate their intended performance and potential biases over time, they emphasise.

“Enhanced critical thinking teaching is especially needed, which can be achieved by building cases where the AI outputs are a mix of correct and intentionally flawed responses…. Learners would then accept, amend, or reject, and justify their decision with primary evidence- based sources,” suggest the authors.

Regulators, professional societies, and educational associations around the globe also need to play their part, by producing and regularly updating guidance on the impact of AI on medical education, urge the authors.

They conclude: “Generative AI has documented and well-researched benefits, but it is not without pitfalls, particularly to medical education and novice learners. These tools can fabricate sources, encode bias, lead to over-reliance and have negatively disruptive effects on the educational journey.

“Medical programmes must be vigilant about these risks and adjust their curricula and training programmes to stay ahead of them and mitigate their likelihood.”

02/12/2025

Notes for editors
Editorial: Potential risks of GenAI on medical education Doi: 10.1136/ bmjebm-2025-114339
Journal: BMJ Evidence Based Medicine

External funding: None declared

Link to Academy of Medical Sciences press release labelling system
http://press.psprings.co.uk/AMSlabels.pdf

Externally peer reviewed? Yes
Evidence type: Opinion
Subjects: Doctors

The post Overreliance on AI risks eroding new and future doctors’ critical thinking while reinforcing existing bias first appeared on BMJ Group.

While it likely increases the risk of serious side effects, including heart disease
Potential harms probably outweigh benefits, and use should be minimised, say researchers

The strong opioid painkiller, tramadol, is not that effective at easing chronic pain for which it’s widely prescribed, finds a pooled data analysis of the available research, published online in BMJ Evidence Based Medicine.

And it likely increases the risk of serious side effects, including heart disease, the findings indicate, prompting the researchers to conclude that the potential harms of tramadol probably outweigh its benefits, and that its use should be minimised.

Tramadol is a dual action opioid widely prescribed for the treatment of moderate to severe acute and chronic pain. As such, it’s recommended in several medical guidelines for pain management, note the researchers.

Its use has surged in recent years, and it’s now among the most commonly prescribed opioids in the US, possibly because of its perceived lower risk of side effects and the widespread belief that it is safer and less addictive than other short-acting opioids, they add.

Although tramadol has been included in previous systematic reviews, none has provided a comprehensive assessment of tramadol’s efficacy and safety in a range of chronic pain conditions, they say.

In a bid to plug this knowledge gap, the researchers scoured research databases for randomised clinical trials published up to February 2025 that compared tramadol with placebo (dummy treatment) for patients with chronic pain, including cancer pain.

Nineteen clinical trials involving 6506 participants with chronic pain were eligible for inclusion in the analysis. Five looked at the impact of tramadol on neuropathic pain; nine focused on osteoarthritis; four looked at chronic low back pain; and one focused on fibromyalgia.

The average age of the trial participants was 58, but ranged from 47 to 69. Tablets were the primary formulation used; only one trial included topical cream. Length of treatment ranged from 2 to 16 weeks while length of follow up ranged from 3 to 15 weeks.

Pooled data analysis of the trial results showed that while tramadol eased pain, the effect was small and below what would be considered clinically effective.

Eight of the trials reported on the proportion of serious side effects arising after treatment during follow up periods of between 7 and 16 weeks.

Statistical analysis of these trials results indicated a doubling in the risk of harms associated with tramadol compared with placebo, mainly driven by a higher proportion of ‘cardiac events,’ such as chest pain, coronary artery disease, and congestive heart failure.

Use of tramadol was also associated with a heightened risk of some cancers, although the follow up period was short, making this finding “questionable,” say the researchers.

Pooled data analysis of all the trial results indicated that tramadol treatment was associated with a heightened risk of several milder side effects, including nausea, dizziness, constipation, and sleepiness.

The researchers acknowledge that the outcome results were at high risk of bias, but this increases the likelihood that the findings overestimate the beneficial effects and underestimate the harmful effects of tramadol, they suggest.

They point out: “Approximately 60 million individuals worldwide experience the addictive effects of opioids. In 2019, drug use was responsible for approximately 600,000 deaths, with nearly 80% of these fatalities associated with opioids and approximately 25% resulting from opioid overdose.

“In the United States, the number of opioid-related overdose deaths increased from 49,860 in 2019 to 81,806 in 2022. Given these trends and the present findings, the use of tramadol and other opioids should be minimised to the greatest extent possible.”

They conclude: “Tramadol may have a slight effect on reducing chronic pain (low certainty of evidence) while likely increasing the risk of both serious (moderate certainty of evidence) and non- serious adverse events (very low certainty of evidence). The potential harms associated with tramadol use for pain management likely outweigh its limited benefits.”

07/10/25

Notes for editors
Research: Tramadol versus placebo for chronic pain: a systematic review with meta- analysis and trial sequential analysis Doi: 10.1136/bmjebm-2025-114101
Journal: BMJ Evidence Based Medicine

Link to Academy of Medical Sciences press release labelling system
http://press.psprings.co.uk/AMSlabels.pdf 

Externally peer reviewed? Yes
Evidence type: Systematic review + meta-analysis
Subjects: People

The post Widely prescribed opioid painkiller tramadol not that effective for easing chronic pain first appeared on BMJ Group.

Even light drinking is unlikely to be protective; risk rises in tandem with quantity consumed

Drinking any amount of alcohol likely increases the risk of dementia, suggests the largest combined observational and genetic study to date, published online in BMJ Evidence Based Medicine.

Even light drinking—generally thought to be protective, based on observational studies—is unlikely to lower the risk, which rises in tandem with the quantity of alcohol consumed, the research indicates.

Current thinking suggests that there might be an ‘optimal dose’ of alcohol for brain health, but most of these studies have focused on older people and/or didn’t differentiate between former and lifelong non-drinkers, complicating efforts to infer causality, note the researchers.

To try and circumnavigate these issues and strengthen the evidence base, the researchers drew on observational data and genetic methods (Mendelian randomisation) from two large biological databanks for the entire ‘dose’ range of alcohol consumption.

These were the US Million Veteran Program (MVP), which includes people of European, African, and Latin American ancestry, and the UK Biobank (UKB), which includes people of predominantly European ancestry.

Participants who were aged 56–72 at baseline, were monitored from recruitment until their first dementia diagnosis, death, or the date of last follow-up (December 2019 for MVP and January 2022 for UKB), whichever came first. The average monitoring period was 4 years for the US group, and 12 for the UK group.

Alcohol consumption was derived from questionnaire responses—over 90% of participants said they drank alcohol—and the Alcohol Use Disorders Identification Test (AUDIT-C) clinical screening tool. This screens for hazardous drinking patterns, including the frequency of binge drinking (6 or more drinks at a time).

In all, 559,559 participants from both groups were included in observational analyses, 14,540 of whom developed dementia of any type during the monitoring period:10,564 in the US group; and 3976 in the UK group. And 48,034 died: 28,738 in the US group and 19,296 in the UK group.

Observational analyses revealed U-shaped associations between alcohol and dementia risk: compared with light drinkers (fewer than 7 drinks a week) a 41% higher risk was observed among non-drinkers and heavy drinkers consuming 40 or more drinks a week, rising to a 51% higher risk among those who were alcohol dependent.

Mendelian randomisation genetic analyses drew on key data from multiple large individual genome-wide association studies (GWAS) of dementia, involving a total of 2.4 million participants to ascertain lifetime (rather than current) genetically predicted risks.

Mendelian randomisation leverages genetic data, minimising the impact of other potentially influential factors, to estimate causal effects: genomic risk for a trait (in this case, alcohol consumption) essentially stands in for the trait itself.

Three genetic measures related to alcohol use were used as different exposures, to study the impact on dementia risk of alcohol quantity, as well as problematic and dependent drinking.

These exposures were: self-reported weekly drinks (641 independent genetic variants);  problematic ‘risky’ drinking (80 genetic variants); and alcohol dependency (66 genetic variants).

Higher genetic risk for all 3 exposure levels was associated with an increased risk of dementia, with a linear increase in dementia risk the higher the alcohol consumption.

For example, an extra 1-3 drinks a week was associated with a 15% higher risk. And a doubling in the genetic risk of alcohol dependency was associated with a 16% increase in dementia risk.

But no U-shaped association was found between alcohol intake and dementia, and no protective effects of low levels of alcohol intake were observed. Instead, dementia risk steadily increased with more genetically predicted drinking.

What’s more, those who went on to develop dementia typically drank less over time in the years preceding their diagnosis, suggesting that reverse causation—whereby early cognitive decline leads to reduced alcohol consumption—underlies the supposed protective effects of alcohol found in previous observational studies, say the researchers.

They acknowledge that a principal limitation of their findings is that the strongest statistical associations were found in people of European ancestry, because of the numbers of participants of this ethnic heritage studied. Mendelian randomisation also relies on assumptions that can’t be verified, they add.

Nevertheless, they suggest that their findings “challenge the notion that low levels of alcohol are neuroprotective.”

And they conclude: “Our study findings support a detrimental effect of all types of alcohol consumption on dementia risk, with no evidence supporting the previously suggested protective effect of moderate drinking.

“The pattern of reduced alcohol use before dementia diagnosis observed in our study underscores the complexity of inferring causality from observational data, especially in ageing populations.

“Our findings highlight the importance of considering reverse causation and residual confounding in studies of alcohol and dementia, and they suggest that reducing alcohol consumption may be an important strategy for dementia prevention.”

23/09/2025

Notes for editors
Research: Alcohol use and risk of dementia in diverse populations: evidence from cohort, case–control and Mendelian randomisation approaches Doi:10.1136/bmjebm2025-113913
Journal: BMJ Evidence Based Medicine

External funding: Department of Veterans Affairs Office of Research and Development, Million Veteran Program; VA Cooperative Studies Program

Link to Academy of Medical Sciences press release labelling system
http://press.psprings.co.uk/AMSlabels.pdf 

Externally peer reviewed? Yes
Evidence type: Observational + Mendelian randomisation study
Subjects: People

The post Drinking any amount of alcohol likely increases dementia risk first appeared on BMJ Group.

Findings back use of exercise as primary treatment strategy for poor sleep, say researchers

Yoga, Tai Chi, walking and jogging may be the best forms of exercise to improve sleep quality and ease insomnia, suggest the findings of a comparative pooled data analysis published in the online journal BMJ Evidence Based Medicine.

The findings back the use of exercise as a primary treatment strategy for poor sleep patterns, say the researchers.

Characterised by difficulties falling and staying asleep, and early morning awakening, the prevalence of insomnia ranges from 4-22%, note the researchers. It is associated with heightened risks of various mental and physical health conditions, including dementia and cardiovascular disease.

Drug treatments for insomnia are not without their side effects, and cognitive behavioural therapy (CBT), while effective, isn’t always available due to the shortage of trained therapists, explain the researchers.

An emerging body of research suggests that exercise is helpful, but current guidelines don’t specify which types of exercise might be most beneficial. The researchers therefore set out to plug this knowledge gap, with a view to informing clinical practice and helping patients choose the most appropriate exercise for managing their insomnia.

They scoured research databases looking for relevant randomised clinical trials published up to April 2025 and included 22 in a network meta analysis—a statistical technique used to simultaneously compare multiple interventions.

The trials involved 1348 participants and 13 different treatment approaches to ease insomnia, seven of which were exercise based: yoga; Tai Chi; walking or jogging; aerobic plus strength exercise; strength training alone; aerobic exercise combined with therapy; and mixed aerobic exercises. These programmes ranged from 4 up to 26 weeks in length.

The other approaches included CBT; sleep hygiene; Ayurveda; acupuncture/massage; nothing; and existing treatment, such as usual care and/or lifestyle changes, the durations of which ranged from 6 to 26 weeks.

Validated scoring systems for sleep quality and insomnia severity —PSQI and the ISI45—as well as subjective and objective measures of total sleep time, sleep efficiency (percentage of time spent asleep while in bed), number of awakenings after going to sleep, and time taken to fall asleep (sleep latency) were used to assess sleep patterns.

Compared with existing treatment, CBT is likely to result in a large increase in total sleep time based on subjective sleep diary data. It may also improve sleep efficiency, and shorten the amount of time spent awake after falling asleep as well as sleep latency, with sustained improvements, the findings suggest.

But some of the exercise-based interventions also seemed to be effective, when compared with existing treatment.

Yoga likely results in a large increase in total sleep time of nearly 2 hours and may improve sleep efficiency by nearly 15%. It may also reduce the amount of time spent awake after falling asleep by nearly an hour, and shorten sleep latency by around half an hour.

Walking or jogging may result in a large reduction in insomnia severity of nearly 10 points, while Tai Chi may reduce poor sleep quality scores by more than 4 points, increase total sleep time by more than 50 minutes, and reduce time spent awake after falling asleep by over half an hour. It may also shorten sleep latency by around 25 minutes.

Further in-depth analyses revealed that Tai Chi performed significantly better on all subjectively and objectively assessed outcomes than existing treatments for up to 2 years.

There are potentially plausible biological explanations for the findings, say the researchers.

With its focus on body awareness, controlled breathing, and attentional training, yoga may alter brain activity, thereby alleviating anxiety and depressive symptoms which often interfere with a good night’s sleep, they suggest.

Tai Chi emphasises breath control and physical relaxation and has been shown to decrease  sympathetic nervous system activity, dampening down hyperarousal, they add. And its combination of meditative movement and mindfulness may promote emotional regulation, deactivate ‘mental chatter’, and reduce anxiety. It may also help to curb the production of inflammatory chemicals over longer periods, they suggest.

Walking or jogging may improve sleep by increasing energy expenditure, curbing cortisol production, improving emotional regulation, boosting secretion of the sleep hormone melatonin, and enhancing the amount of deep sleep, they continue.

The researchers acknowledge that 15 (68%) of the included trials contained design and methodological flaws. And there were no standardised, quantifiable metrics for the frequency or intensity of exercise interventions, while the sample sizes of some of the studies were small.

Nevertheless, they conclude: “The findings of this study further underscore the therapeutic potential of exercise interventions in the treatment of insomnia, suggesting that their role may extend beyond adjunctive support to serve as viable primary treatment options.

“Although current clinical guidelines make only limited mention of exercise, this study provides relatively comprehensive comparative evidence that may inform the development of more specific and actionable clinical recommendations.

“Given the advantages of exercise modalities such as yoga, Tai Chi, and walking or jogging—including low cost, minimal side effects, and high accessibility—these interventions are well-suited for integration into primary care and community health programmes.”

And there may well be one type of exercise that is best suited to easing a particular symptom of insomnia, they suggest, which further research may clarify.

16/07/2025

Notes for editors
Research: Effects of various exercise interventions in insomnia patients: a systematic review and network meta analysis Doi: 10.1136/bmjebm-2024-113512
Journal: BMJ Evidence Based Medicine

External funding: National Natural Science Foundation of China

Link to Academy of Medical Sciences press release labelling system
http://press.psprings.co.uk/AMSlabels.pdf 

Externally peer reviewed? Yes
Evidence type: Systematic review + network meta analysis
Subjects: People

The post Yoga, Tai Chi, walking and jogging may be best forms of exercise for insomnia first appeared on BMJ Group.

Premenstrual syndrome (PMS) symptoms eased after taking open-label placebos and women had no substantial side effects

Women affected by premenstrual syndrome (PMS) appear to experience less intense and debilitating symptoms after taking placebo pills even when told they do not contain any active medication, suggests a study published in the open-access journal BMJ Evidence-Based Medicine.

PMS can result in significant distress for women of reproductive age and cause psychological symptoms such as irritability, depressed mood, and mood swings as well as physical symptoms including breast tenderness, bloating, and joint pain.

Women with PMS are also more likely to feel suicidal, experience depression, have eating disorders and migraines.

Often prescribed medical treatments to help with PMS, such as selective serotonin reuptake inhibitors (SSRIs) and hormonal agents like oral contraceptives and danazol are often associated with side-effects including dizziness, nausea, tremor, weight gain, gastrointestinal symptoms, and depression.

Open-label placebos (OLPs) – placebos that are provided with full transparency – have been shown to have positive effects on various complaints, including irritable bowel syndrome, chronic low back pain, and menopausal hot flushes.

Researchers in Switzerland set out to examine whether these OLPs could have a positive impact on PMS symptoms.

They carried out a trial involving 150 women aged 18 to 45 years old who had PMS or premenstrual dysphoric disorder.

Between August 2018 and December 2020, the participating women were randomly allocated into three groups to receive treatment as usual, receive OLPs with no further explanation than that they were receiving placebos, or receive OLPs in pill form with an explanation of what they were and why OLPs could potentially ease PMS symptoms.

The researchers found that placebos reduced the intensity of PMS symptoms and interference in their social, educational and working lives considerably in women with moderate to severe PMS or premenstrual dysphoric disorder when they were provided with an explanation of the treatment.

For their study, they measured primary outcomes defined as PMS symptom intensity and interference in their lives between groups across three menstrual cycles, and safety by adverse events, measured at weeks 3 and 6 after the start of the intervention. They also measured secondary outcomes, which were psychological and physical subscales of PMS symptom intensity and adherence.

For the primary outcomes, placebos provided twice a day for 6 weeks with an explanation resulted in a 79.3% reduction in symptom intensity amongst these women and an 82.5% reduction in interference in their lives – underlining the importance of adequately providing the treatment explanation when giving placebos, said the researchers.

Women receiving a placebo with no explanation reported a 50.4% reduction in the intensity of their symptoms and a 50.3% drop in interference in their lives.

In contrast, women who received treatment as usual reported a 33% reduction in their symptom intensity and a 45.7% reduction in interference in their lives.

There were also very few and not serious side effects amongst women in both placebo groups.

For secondary outcomes, women in the placebo with explanation group had the highest decrease (70.7%) of psychological symptom intensity between menstrual cycles, followed by the placebo with no explanation group which reported a 42.6% fall in symptom intensity, compared with a decrease of just 29.1% in the women receiving treatment as usual.

Women in the placebo with explanation group also reported the highest reduction (82.5%) of physical symptom intensity between menstrual cycles, followed by women in the placebo with no explanation group (50.3%), and women in the traditional treatment group (45.7%).

The study had some limitations, with the authors acknowledging that when they advertised the trial as a study for a side-effect free intervention for PMS, they might have attracted participants who were more open to unconventional treatments and/or being dissatisfied with their current treatment, which could have limited how much the results were generalisable. Also, the results were reliant on self-reporting so this could bias the results.

Nevertheless, the researchers concluded: “Administering OLPs with a treatment rationale to women with PMS can decrease symptom intensity and interference considerably in the absence of substantial side-effects and with full transparency.

“Considering our results as much as the individual and societal burden of PMS, OLP treatment could serve as an acceptable, efficacious, and safe intervention for PMS.”

26/03/2025

Notes for editors
Research: Efficacy of open-label placebos for premenstrual syndrome: a randomised controlled trial Doi: 10.1136/bmjebm-2024-112875
Journal: BMJ Evidence-Based Medicine

External funding: Swiss National Science Foundation

Link to Academy of Medical Sciences press release labelling system
http://press.psprings.co.uk/AMSlabels.pdf

Externally peer reviewed? Yes
Evidence type: Controlled trial
Subjects: People

The post Open-label placebo appears to reduce premenstrual symptoms, study suggests first appeared on BMJ Group.

And pain relief only marginally better than placebo, pooled data analysis shows

Only around 1 in 10 common non-surgical and non-invasive treatments for lower back pain is effective, suggests a pooled data analysis of the available research, published online in BMJ Evidence Based Medicine.

And the pain relief they offer is only marginally better than that achieved with a placebo, the findings indicate.

Low back pain is common and debilitating, and 80%-90% of it is categorised as non-specific, because there’s no immediately identifiable cause, note the researchers.

Non-surgical and non-invasive approaches are recommended as the initial treatment approach. But many such options are available, and it’s not always easy to know which ones are effective, point out the researchers.

To build on the evidence base, the researchers scoured research databases for published randomised placebo-controlled trials of non-surgical and non-interventional treatments for people with non-specific low back pain, with the aim of pooling the results.

The approaches included were pharmacological, such as non-steroidal anti-inflammatory drugs (NSAIDs) and muscle relaxants, and non-pharmacological, such as exercise, massage, and spinal manipulation.

A total of 301 trials investigating 56 different treatments or treatment combinations were included in the pooled data analysis. The trials were carried out in a total of 44 countries in Africa, North America, South America, Asia, Australia, and Europe.

The most common interventions were NSAIDs (27 trials), opioids (26 trials), laser and light therapy (25), acupuncture (24), and gentle manual therapy (mobilisation; 19 trials).

Fifty two trials sampled participants with acute low back pain; 228 trials with chronic low back pain; and 21 trials participants with both types. Pain intensity was most often assessed using the Visual Analogue Scale or the Numeric Rating Scale.

Of the 69 treatment comparisons included in the trials, the certainty of the evidence was moderate for 11 (16%), low for 25 (36%), and very low for 33 (48%), as assessed by the GRADE system.

The pooled data analysis showed that compared with placebo, no non-pharmacological treatments and only NSAIDs emerged as effective for acute low back pain; exercise, spinal manipulation, and taping, antidepressants and drugs that target pain receptors (TRPV1 agonists) emerged as effective for chronic low back pain.

But the effects were small.

Moderate quality evidence showed that treatments for acute low back pain that weren’t effective included exercise, steroid injections and paracetamol, while anaesthetics (i.e. Lidocaine) and antibiotics weren’t effective for chronic low back pain, the analysis showed.

The evidence was inconclusive for 10 non-pharmacological and 10 pharmacological treatments for acute low back pain. It was also inconclusive for a wide range of 22 non-pharmacological treatments, including acupuncture, massage, osteopathy and TENS, and 16 pharmacological treatments, including antidepressants + paracetamol, complementary medicines, bisphosphonates, and muscle relaxants for chronic back pain.

The researchers point out that many of the available trials included only a few participants and reported inconsistent results, added to which, the type and quality of some of the placebos used varied considerably, potentially affecting the certainty of the findings.

But they say: “Our review did not find reliable evidence of large effects for any of the included treatments, which is consistent with clinical guidelines and our previous review. While we would like to provide more certain recommendations for where to invest and disinvest in treatments, it is not possible at this time.”

They emphasise: “There is a clear need for large, high-quality, placebo-controlled trials to reduce uncertainty in efficacy estimates for many non-surgical and non-interventional treatments.”

19/03/2025

Notes for editors
Research: Analgesic effects of non-surgical and non-interventional treatments for low back pain: a systematic review and meta-analysis of placebo-controlled randomised trials  Doi: 10.1136/bmjebm-2024-112974
Journal: BMJ Evidence Based Medicine

External funding: None declared

Link to Academy of Medical Sciences press release labelling system
http://press.psprings.co.uk/AMSlabels.pdf 

Externally peer reviewed? Yes
Evidence type: Systematic review + meta analysis
Subjects: People

The post Only around 1 in 10 common non-surgical and non-invasive treatments for back pain effective first appeared on BMJ Group.

Unhealthy lifestyle linked to 78% heightened risk of death, regardless of ‘good/bad’ genes

A healthy lifestyle may offset the effects of life-shortening genes by more than 60%, suggests an analysis of the findings from several large long term studies, published online in the journal BMJ Evidence Based Medicine.

While genes and lifestyle seem to have an additive effect on a person’s lifespan, an unhealthy lifestyle is independently linked to a 78% heightened risk of dying before one’s time, regardless of genetic predisposition, the research indicates.

The polygenic risk score (PRS) combines multiple genetic variants to arrive at a person’s overall genetic predisposition to a longer or shorter lifespan. And lifestyle—tobacco use, alcohol consumption, diet quality, sleep quota and physical activity levels—is a key factor.

But it’s not clear the extent to which a healthy lifestyle might offset genetic predisposition to a shortened lifespan, say the researchers.

To explore this further, they drew on a total of 353,742 adults, recruited to the UK Biobank between 2006 and 2010, and whose health was tracked up until 2021.

A polygenic risk score was derived for long (20% of participants), intermediate (60%), and short (20%) lifespan risks, using data from the LifeGen cohort study.

And a weighted healthy lifestyle score, to include no current smoking, moderate alcohol consumption, regular physical activity, healthy body shape, adequate sleep, and a healthy diet, was categorised into favourable (23% of participants), intermediate (56%), and unfavourable (22%) lifestyles, using data from the US NHANES study.

During an average tracking period of nearly 13 years, 24,239 participants died. 

Those genetically predisposed to a short lifespan were 21% more likely to die early than those genetically predisposed to a long life, regardless of their lifestyle.

Similarly, those who had an unfavourable lifestyle were 78% more likely to die before their time than those with a favourable lifestyle, irrespective of their genetic predisposition.

And those at high genetic risk of a shortened lifespan and who had an unfavourable lifestyle were twice as likely to die as those genetically predisposed to a long life and who had a favourable lifestyle.

Four factors in particular seemed to make up the optimal lifestyle combination: not smoking; regular physical activity; adequate nightly sleep; and a healthy diet. 

This is an observational study, and as such, no definitive conclusions can be reached about cause and effect, added to which the researchers acknowledge various limitations to their findings.

Lifestyle was assessed at only one point in time, for example, and lifestyle choices differ by age. Participants were also all of European ancestry, which may limit the generalisability of the findings, say the researchers.

Nevertheless, they suggest that their findings indicate that the genetic risk of a shorter lifespan or premature death might be offset by a favourable lifestyle by around 62%. 

Those at high genetic risk of a shortened lifespan could extend their life expectancy by nearly 5.5 years at the age of 40 with a healthy lifestyle, they suggest, adding that given how lifestyle habits tend to be cemented before middle age, steps to mitigate genetic predisposition to a shortened life are needed before then.

“This study elucidates the pivotal role of a healthy lifestyle in mitigating the impact of genetic factors on lifespan reduction,” they conclude. “Public health policies for improving healthy lifestyles would serve as potent complements to conventional healthcare and mitigate the influence of genetic factors on human lifespan.”

30/04/2024 

Notes for editors
Research: Genetic predisposition, modifiable lifestyles, and their joint effects on human lifespan: evidence from multiple cohort studies  Doi: 10.1136/bmjebm-2023-112583
Journal: BMJ Evidence Based Medicine

Link to Academy of Medical Sciences labelling system
http://press.psprings.co.uk/AMSlabels.pdf 

Externally peer reviewed? Yes
Evidence type: Observational cohort study
Subjects: People

The post Healthy lifestyle may offset effects of life-shortening genes by 60%+ first appeared on BMJ Group.

Flawed body of research indicates true ‘long COVID’ risk likely exaggerated

Overly broad definitions and lack of comparator groups have distorted risk, say researchers
Leading to increased public anxiety and healthcare spend; misdiagnoses; diversion of funds

Major flaws in the current body of published research on ‘long COVID’ have likely greatly exaggerated the true risks of developing the condition, suggests an analysis published in BMJ Evidence Based Medicine.

Overly broad definitions, a lack of appropriate, or any, comparison groups, among other things, in studies looking at the incidence, prevalence, and control of the condition—epidemiology—have distorted the risks, say the researchers.

This is further compounded by inclusion of poorly conducted studies into systematic reviews and pooled data analyses that end up overstating the risk yet again, they add. 

The likely consequences of this include, but aren’t limited to, increased public anxiety and healthcare spend; misdiagnoses; and diversion of funds from those who really do have other long term conditions secondary to COVID-19 infection, suggest the researchers.

Many after effects of COVID-19 infection include post-ICU syndrome—a constellation of health issues that are present when the patient is in intensive care and which persist after discharge home—and shortness of breath following pneumonia. Trouble is: these are common to many upper respiratory viruses, point out the researchers.

None of the working definitions of ‘long COVID’ used by influential health bodies, such as the US Centers for Disease Control and Prevention, the World Health Organization, the UK National Institute for Health and Care Excellence (NICE), Scottish Intercollegiate Guidelines Network (SIGN), and the Royal College of General Practitioners requires a causal link between the virus responsible for COVID-19 (SARS-CoV2) and a range of symptoms. 

Not only should comparator (control) groups be included in ‘long COVID’ studies, when they often aren’t, but they should also be properly matched to cases, ideally by age, sex, geography, socioeconomic status and, if possible, underlying health and health behaviours, which they rarely are, say the researchers.

During the early stages of the pandemic, when SARS-CoV-2 testing wasn’t widely available, studies were more likely to include a non-representative sample of SARS-CoV-2-positive patients by including fewer patients with mild or no symptoms.

This is known as sampling bias, which occurs when certain members of a population have a higher probability of being included in a study sample than others, potentially limiting the generalisability of a study’s findings, explain the researchers.

“Our analysis indicates that, in addition to including appropriately matched controls, there is a need for better case definitions and more stringent [‘long COVID’] criteria, which should include continuous symptoms after confirmed SARS-CoV-2 infection and take into consideration baseline characteristics, including physical and mental health, which may contribute to an individual’s post COVID experience, “ they write, adding that the umbrella term ‘long COVID’ should be jettisoned in favour of different terms for specific after effects.

While the results of high quality population studies on ‘long COVID’ in adults and children have been reassuring, they point out,  the body of research “is replete with studies with critical biases” they add, setting out common pitfalls.

“Ultimately, biomedicine must seek to aid all people who are suffering. In order to do so, the best scientific methods and analysis must be applied. Inappropriate definitions and flawed methods do not serve those whom medicine seeks to help,” they insist.

“Improving standards of evidence generation is the ideal method to take long COVID seriously, improve outcomes, and avoid the risks of misdiagnosis and inappropriate treatment,” they include.

25/09/23

Notes for editors
Analysis: How methodological pitfalls have created widespread misunderstanding about long COVID doi 10.1136/bmjebm-2023-112338
Journal: BMJ Evidence Based Medicine

Funding: None declared

Link to Academy of Medical Sciences labelling system
http://press.psprings.co.uk/AMSlabels.pdf 

Externally peer reviewed? Yes
Evidence type: Analysis
Subjects: Published research

The post Flawed body of research indicates true ‘long covid’ risk likely exaggerated first appeared on BMJ Group.

Findings may justify considering its use in clinical practice, suggest researchers

A natural compound found in the culinary spice turmeric may be as effective as omeprazole—a drug used to curb excess stomach acid—for treating indigestion symptoms, suggests the first study of its kind, published online in the journal BMJ Evidence-Based Medicine.

Turmeric is derived from the root of the Curcuma longa plant. It contains a naturally active compound called curcumin thought to have anti-inflammatory and antimicrobial properties, and has long been used as a medicinal remedy, including for the treatment of indigestion, in South East Asia.

But it’s not clear how well it compares with conventional drugs for this indication, largely because there have been no head to head studies.

The researchers therefore randomly assigned 206 patients aged 18-70 with recurrent upset stomach (functional dyspepsia) of unknown cause, recruited from hospitals in Thailand between 2019 and 2021, to one of three treatment groups for a period of 28 days.

These were: turmeric (two large 250 mg capsules of curcumin 4 times a day) and one small dummy capsule (69 patients); omeprazole (one small 20 mg capsule daily and two large dummy capsules 4 times a day (68 patients); and turmeric plus omeprazole (69 patients).

Omeprazole is a proton pump inhibitor, or PPI for short. PPIs are used to treat functional dyspepsia, the symptoms of which include feeling excessively full after food (postprandial fullness), feeling full up after only a little food (early satiety), and pain and/or burning sensation in the stomach and/or food pipe (epigastric pain).

But long term use of PPIs has been linked to increased fracture risk, micronutrient deficiencies, and a heightened risk of infections, note the researchers.

Of the 206 patients enrolled, 151 completed the study, with 20 in the curcumin group;19 in the omeprazole group; and 16 in the combined treatment group, dropping out.

Patients in all three groups had similar clinical characteristics and indigestion scores, as assessed by the Severity of Dyspepsia Assessment score or SODA, at the start of the trial. Patients were reassessed after 28 days and then again after 56 days.

SODA scores indicated significant reductions in symptom severity by day 28 for pain (−4.83, –5.46 and −6.22) and other symptoms (−2.22, –2.32, and −2.31) for those in the combined, curcumin alone, and omeprazole alone groups, respectively.

These improvements were even stronger after 56 days for pain (−7.19, –8.07 and −8.85, respectively) and other symptoms (−4.09, –4.12 and −3.71, respectively).

SODA also captures satisfaction scores: these scarcely changed over time among the curcumin users, which might possibly be related to its taste and/or smell, suggest the researchers.

No serious side effects were reported, although liver function tests indicated some level of deterioration among curcumin users carrying excess weight, note the researchers.

They acknowledge the small size of the study, as well as several other limitations, including the short intervention period and lack of long-term monitoring data. Further larger, long term studies are needed, they say.

Nevertheless, they conclude: “This multicentre randomised controlled trial provides highly reliable evidence for the treatment of functional dyspepsia,” adding that “the new findings from our study may justify considering curcumin in clinical practice.”

11/09/2023

Notes for editors
Research: Curcumin and proton pump inhibitors for functional dyspepsia: a randomised, double blind controlled trial doi 10.1136/bmjebm-2022-112231
Journal: BMJ Evidence-Based Medicine

Funding: Thai Traditional and Alternative Medicine Fund

Link to Academy of Medical Sciences labelling system
http://press.psprings.co.uk/AMSlabels.pdf

Externally peer reviewed? Yes
Evidence type: Randomised double-blind controlled trial
Subjects: People

The post Turmeric may be as good for treating indigestion as drug to curb excess stomach acid first appeared on BMJ Group.