The capsicum plaster study employed a comprehensive set of outcome measures to evaluate efficacy and safety. Primary outcomes focused on pain reduction using the Arhus low back rating scale's compound pain subscore (continuous data) and a 30% responder threshold (binary data). Secondary measures assessed functional improvement, global perceptions of treatment success, and tolerability through mobility tests, disability indices, physician/patient ratings, and adverse event tracking. Results showed statistically significant advantages for capsicum over placebo across multiple endpoints, with 42% pain reduction versus 31%, and 67% responder rate versus 49%. Safety monitoring revealed manageable local reactions (7.5% capsicum vs. 3.1% placebo) without systemic effects.
Key Points Explained:
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Primary Efficacy Measures
- Compound Pain Subscore: Continuous variable from the Arhus scale quantifying baseline-to-endpoint pain reduction (42% capsicum vs. 31% placebo).
- 30% Responder Rate: Binary metric defining clinically meaningful improvement (67% capsicum vs. 49% placebo, p=0.002).
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Secondary Functional Assessments
- Disability/Mobility Subscores: Components of the Arhus scale evaluating back-related functional limitations.
- Total Arhus Score: Aggregate measure combining pain, disability, and mobility metrics.
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Global Efficacy Evaluations
- Investigator Ratings: 74% of capsicum patients deemed "excellent/good" vs. 36% placebo.
- Patient Self-Reports: 82% capsicum users felt "symptom-free/improved" vs. 50% placebo.
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Safety and Tolerability
- Adverse Events: Local reactions (e.g., skin irritation) occurred in 7.5% capsicum vs. 3.1% placebo groups.
- Systemic Safety: No non-localized side effects observed in either group.
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Patient-Reported Experience
- Included questionnaires on plaster usability and comfort, providing practical insights for real-world application.
The study's multidimensional approach balanced objective clinical metrics (pain scores, mobility tests) with subjective evaluations (patient/investigator ratings), offering a holistic view of capsicum plaster's therapeutic profile. This design is particularly valuable for purchasers assessing trade-offs between efficacy, safety, and user acceptability in pain management products.
Summary Table:
| Category | Key Metrics | Results (Capsicum vs. Placebo) |
|---|---|---|
| Primary Efficacy | - Compound Pain Subscore (Arhus scale) - 30% Responder Rate |
42% vs. 31% pain reduction 67% vs. 49% |
| Secondary Assessments | - Disability/Mobility Subscores - Total Arhus Score |
Improved functional outcomes |
| Global Evaluations | - Investigator Ratings (Excellent/Good) - Patient Self-Reports (Improved) |
74% vs. 36% 82% vs. 50% |
| Safety & Tolerability | - Local Adverse Events (e.g., skin irritation) - Systemic Side Effects |
7.5% vs. 3.1% None observed |
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