The European Medicines Agency pointed out at the same time as the FDA that the increase in cardiovascular risk was only observed for high-dose ibuprofen (2400 mg/day or greater) but not over-the-counter doses (up to 1200 mg/day).
It should be noted that non-steroidal anti-inflammatory drugs (NSAID) other than aspirin, such as ibuprofen and naproxen, are associated with an increased risk of heart attacks and strokes. The FDA has warned about this since 2005 and it strengthened its warning in 2015.
On the other hand...
While I do not understand the technicalities of the work, the main findings in Figure 2 (panels A, B, E and F) do not seem to be suggestive of major differences between controls and patients, whether at baseline or post-CPET, especially with such a small sample size.
Caption:
Thank you — IQWiG could have added a footnote with a reference to their methodological guideline in the report to clear up the origin of this rule.
I remain perplexed by this rule. It would, for instance, allow including trials for Covid where 20% of patients have the flu, which has a better...
Leonard Jason and colleagues have previously published an article on the risk factors for suicide among 64 people with ME, 17 of whom had taken their lives. The data of the deceased patients were collected from their relatives...
The authors’ logic seems to be that, given that both symptoms significantly overlap, there is no reason to make either optional; they should both be compulsory symptoms.
“‘There have been one or two times where I have been worried because they have got angry at the patients...that anger has been communicated to the patients. Their frustration has reached the point where they sort of boiled over... there is sort of feeling that the patient should be grateful and...
The researcher is on Twitter: https://twitter.com/tarnjitsidhu
Here is a short although undated interview: https://www.1mwis.com/profiles/Tarnjit-Sidhu
If I understand correctly, IQWiG’s sensitivity analyses showed that, had CBT in PACE given either a positive or negative result for patients with PEM but that was on the verge of statistical significance, the patients without PEM would have had to score -13 or -33 points, respectively, to obtain...
Single-molecule reading of proteins
Modern DNA-sequencing methods can interrogate single molecules in extremely high throughput, but protein sequencing typically uses ensemble techniques and requires larger amounts of relatively pure material.
Reed et al. generated a set of labeled proteins...
I strongly disagree that 80% is an acceptable rate given the results of GET trials. PACE reported that approximately 20% in the GET arm “recovered” while there were 18% who did not have PEM (according to NICE). It is not implausible that these participants could have been the major contributors...
Millisecond neural activation tracking
Functional magnetic resonance imaging (fMRI) has made profound contributions to our understanding of the human brain. However, limitations in the temporal and spatial resolution of the underlying signal have prevented this technique from providing...
Prof Carmen Scheibenbogen:
“It is obvious that my expertise was not taken into account in this preliminary report. There is now the opportunity to submit statements, which should be used by everyone who can competently say something about it.
The claim that GET is effective is rejected by all...
GSK’s older adult respiratory syncytial virus (RSV) vaccine candidate shows 94.1% reduction in severe RSV disease and overall vaccine efficacy of 82.6% in pivotal trial
Data to be presented at IDWeek 2022 showed overall vaccine efficacy against RSV-lower respiratory tract disease (LRTD) in...
The authors recognize the main symptoms (PEM first and foremost) and degrees of severity of ME. They recommend a full biological workup, a neurological evaluation and also advise screening for POTS.
However they advise against oversleeping, prolonged bed rest and complete inactivity as they say...
Interestingly, the protocol (April 2003 version) mentions actigraphy coupled with an activity diary as a secondary endpoint (pages 2-3 & 11). Patients were to wear a waist-worn actimeter, with data being collected over 15 day cycles, and add an entry to their diary if an activity was sustained...
Two notes on IV saline:
1) The paper does not mention when the last infusion was given to participants, and more precisely whether it was administered on the day that they did the treadmill walking test. If not, given that the effects of IV saline are short-lived, they would not have carried...
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