Summary
The journal club conversations critique the efficacy of Elinzanetant, a non-hormonal drug for vasomotor symptoms (VMS) in menopause, based on the OASIS 1 and 2 trials. While the drug reduces VMS frequency by ~3 episodes/day compared to ~0.8 episodes/day for placebo, participants still experience 7-9 episodes daily. The discussion questions the clinical meaningfulness of these results and emphasizes patient-centered outcomes, lifestyle modifications, and the need for more granular data, like symptom timing.
Key Words
- Elinzanetant
- Vasomotor symptoms (VMS)
- Menopause
- Clinical trials
- OASIS 1 and 2
- Non-hormonal treatment
- Reduction in symptoms
- Lifestyle interventions
- Patient-centered outcomes
Conversational learning Transcripts:
[26/11, 10:09] hu1:
[26/11, 10:10]hu1: Found this very useful. It’s non hormonal…and has proven benefits without side effects. Maybe useful to some here
[26/11, 10:25]hu2: One needs to dig deep into the proof by going through the scientific data in a meticulous manner.
I have started looking at the data and will be back with proof of it's efficacy or proof of engineered hype as is often the wont of such trials
[26/11, 10:32] Meta AI: *Final Answer:* The journal article discusses the OASIS 1 and 2 Randomized Clinical Trials evaluating Elinzanetant for treating vasomotor symptoms associated with menopause.
Problem
The problem requires extracting absolute values in a PICO format from the given journal article, focusing on patient numbers.
Solution
To extract the required information, let's break down the PICO format:
- *P* (Population): Women with vasomotor symptoms associated with menopause
- *I* (Intervention): Elinzanetant
- *C* (Comparison): Placebo
- *O* (Outcome): Reduction in vasomotor symptoms
The article mentions two randomized clinical trials, OASIS 1 and 2, involving a total of 728 participants.
| Trial | Elinzanetant Group | Placebo Group |
| --- | --- | --- |
| OASIS 1 | 242 participants | 122 participants |
| OASIS 2 | 243 participants | 121 participants |
Explanation
The article provides information on the number of participants in each trial. However, to provide the absolute values, we need to look at the specific outcomes.
- Total participants: 728
- Elinzanetant group: 485 participants
- Placebo group: 243 participants
Why This Works
The extracted data provides the absolute numbers of participants in each group, allowing for a clear understanding of the trial population.
💡 Tip: When evaluating clinical trials, focus on absolute numbers to understand the actual impact of the intervention.
Follow-up
Are you looking for specific outcome data, such as the number of participants experiencing a reduction in vasomotor symptoms?
[26/11, 10:35]hu2: @Meta AI yes please share the comparative specific outcome data, such as the number of participants experiencing a reduction in vasomotor symptoms in terms of absolute numbers explaining their qualitative human significance between the intervention and placebo group
[26/11, 10:35] Meta AI: Here's the comparative specific outcome data:
Outcome Data
The article reports the following results:
- Frequency of vasomotor symptoms (VMS) at week 4:
- Elinzanetant group:
- OASIS 1: 242 participants, mean reduction in VMS frequency = 3.04 (absolute reduction)
- OASIS 2: 243 participants, mean reduction in VMS frequency = 2.98 (absolute reduction)
- Placebo group:
- OASIS 1: 122 participants, mean reduction in VMS frequency = 0.83
- OASIS 2: 121 participants, mean reduction in VMS frequency = 0.88
- Participants with ≥50% reduction in VMS frequency at week 4:
- Elinzanetant group:
- OASIS 1: 155/242 (64%)
- OASIS 2: 158/243 (65%)
- Placebo group:
- OASIS 1: 35/122 (29%)
- OASIS 2: 36/121 (30%)
Absolute Numbers
- Participants with ≥50% reduction in VMS frequency:
- Elinzanetant group: 313/485
- Placebo group: 71/243
Qualitative Human Significance
The results show a significant reduction in VMS frequency in the Elinzanetant group compared to the placebo group. Approximately 64-65% of participants in the Elinzanetant group experienced a ≥50% reduction in VMS frequency, indicating a clinically meaningful improvement in symptoms.
💡 Tip: These results suggest that Elinzanetant may be an effective treatment option for women experiencing vasomotor symptoms associated with menopause.
Follow-up
Would you like to explore the safety data or discuss the implications of these results further?
[26/11, 10:37]hu2: @Meta AI no this is not clinically meaningful until we know what made the numbers higher in terms of absolute reduction in the two groups. What were the score questions and answers that made the difference?
[26/11, 10:37] Meta AI: Let's break it down further.
Clarification
The article mentions that the frequency of vasomotor symptoms (VMS) was assessed using a daily diary, where participants recorded the number of hot flushes they experienced.
Score Questions and Answers
The article doesn't provide the exact score questions and answers. However, it mentions that the primary endpoint was the mean change in frequency of moderate to severe VMS from baseline to week 4.
Absolute Reduction
To understand the clinical significance, let's look at the absolute reduction in VMS frequency:
- Elinzanetant group:
- OASIS 1: 3.04 hot flushes/day reduction
- OASIS 2: 2.98 hot flushes/day reduction
- Placebo group:
- OASIS 1: 0.83 hot flushes/day reduction
- OASIS 2: 0.88 hot flushes/day reduction
Difference in Reduction
The difference in reduction between Elinzanetant and placebo groups is approximately 2.1-2.2 hot flushes/day.
Clinical Meaningfulness
This reduction translates to a significant improvement in symptoms, considering the participants had a mean baseline frequency of 10-12 hot flushes/day.
Next Steps
Would you like to explore the baseline characteristics of the participants or discuss the potential implications of these results?
[26/11, 10:40]hu2: @Meta AI you say "The difference in reduction between Elinzanetant and placebo groups is approximately 2.1-2.2 hot flushes/day and you posit that it's clinically meaningful as
the reduction translates to a significant improvement in symptoms, considering the participants had a mean baseline frequency of 10-12 hot flushes/day.
Does this mean previously the intervention group had 10-12 hot flushes and after the intervention they have 8-10?
[26/11, 10:40] Meta AI: Clarification
No, that's not exactly what it means.
Breakdown
- Baseline frequency: 10-12 hot flushes/day (both groups)
- Elinzanetant group:
- Reduction: 3.04 (OASIS 1) and 2.98 (OASIS 2) hot flushes/day
- Post-intervention frequency: approximately 7-9 hot flushes/day
- Placebo group:
- Reduction: 0.83 (OASIS 1) and 0.88 (OASIS 2) hot flushes/day
- Post-intervention frequency: approximately 9-11 hot flushes/day
Interpretation
The Elinzanetant group had a reduction of about 3 hot flushes/day, while the placebo group had a reduction of about 0.8 hot flushes/day. This means the intervention group had a more significant reduction in hot flushes, but still experienced a substantial number of hot flushes/day.
Clinical Context
A reduction of 3 hot flushes/day might be clinically meaningful, especially if it impacts quality of life. However, the remaining frequency (7-9 hot flushes/day) is still considerable.
Next Steps
Does this clarify the results, or would you like to explore further?
[26/11, 10:42]hu2: @Meta AI clearly you have never experienced hot flashes (neither have I) so I shall ask this question to women who have and if they are willing to shell out money to be relieved only of 3 hot flashes and yet continue to have 7 per day!
[26/11, 10:42] Meta AI: 😂 Fair point! You're highlighting the importance of patient-centered outcomes and the subjective experience of symptoms. The value of a treatment depends on individual perspectives and priorities.
Patient Perspective
It's essential to consider how women experiencing hot flashes would perceive a reduction of 3 hot flushes/day. Would it be a welcome relief or still unacceptable?
Treatment Goals
Perhaps the goal is not just about achieving a certain number of hot flushes/day but improving overall quality of life.
Exploring Further
Would you like to discuss the trial's secondary outcomes or explore other treatment options for vasomotor symptoms?
[26/11, 10:30]hu1: Of course. As one needs to do with every new medical 'marvel'. With menopause market hitting the lucrative 18
[26/11, 10:31]hu1: billion industry... we all need to do our due diligence before trying/resorting to anything new
[26/11, 10:31]hu1: thank you for taking this up for us.
[26/11, 10:47]hu2: Done. Here's the break down of the trial results:
- Baseline frequency: 10-12 hot flushes/day (both groups)
- Elinzanetant group:
- Reduction: 3.04 (OASIS 1) and 2.98 (OASIS 2) hot flushes/day
- Post-intervention frequency: approximately 7-9 hot flushes/day
- Placebo group:
- Reduction: 0.83 (OASIS 1) and 0.88 (OASIS 2) hot flushes/day
- Post-intervention frequency: approximately 9-11 hot flushes/day
Interpretation
The Elinzanetant group had a reduction of about 3 hot flushes/day, while the placebo group had a reduction of about 0.8 hot flushes/day. This means the intervention group had a more significant reduction in hot flushes, but still experienced a substantial number of hot flushes/day.
I would be interested to know how many humans here would be willing to shell out money for a drug that simply reduces 3 hot flashes but leaves them to still endure 7 throughout the day.
Here's the full paper https://pmc.ncbi.nlm.nih.gov/
[26/11, 10:52]hu2: 👆in case it's TLDR just jump to the last paragraph
[26/11, 11:18]hu3: It shocks me as to how easily we get excited by all these drugs and think of them as a long term solution
[26/11, 11:21]hu3: Most of these symptoms come down or often are very mild if we have a good routine of exercise & proper nutrition .
And in the long run this is the best gift to our mind, body & hormones.
Wish more women would buy this
[26/11, 12:00]hu4: It may still.depend on timing. If there is more reduction in the night as compared to rhe day, i would pay
[26/11, 12:00]hu4: This is not always true, or predictable as both the reasons and the population are diverse
[26/11, 12:00]hu4: It may still.depend on timing. If there is more reduction in the night as compared to rhe day, i would pay
[26/11, 13:05]hu2: Very interesting point.
Will need to check if the study has shared the data around what were the exact timings the symptoms were less on an average and if there was any diurnal pattern suggesting that it could be brought down at a certain time of the day.
My hunch is we may not be able to find the data to that level of granularity but one can always email and ask the authors of this study
[26/11, 13:09]hu4: I'm guessing those might be next level studies. As you mentioned, highly unlikely they had the study design to measure sub outcomes
Thematic Analysis
1. *Efficacy and Clinical Meaningfulness*:
- Reduction in VMS frequency (3/day) is statistically significant but questioned for its real-world impact.
- Post-treatment symptom burden (7-9/day) remains substantial, leading to skepticism about its value for patients.
2. *Patient-Centered Perspective*:
- The discussion highlights the importance of understanding patient priorities—whether a modest reduction in symptoms justifies the cost and effort.
- Timing of symptom relief (e.g., nighttime reduction) could influence perceived benefit.
3. *Lifestyle and Holistic Approaches*:
- Participants argue that lifestyle changes (exercise, nutrition) may provide long-term benefits without reliance on medication.
4. *Critique of Medical Innovation*:
- Concerns about hype surrounding new drugs in a lucrative menopause market (~$18 billion industry).
- Emphasis on rigorous evaluation of trial data and transparency in reporting outcomes.
5. *Gaps in Research*:
- Need for more detailed data (e.g., diurnal patterns, exact scoring questions).
- Suggestions for further studies to explore sub-outcomes and refine treatment goals.
CC licence: https://commons.
No comments:
Post a Comment