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Related Concept Videos

The Placebo Effect01:54

The Placebo Effect

The placebo effect occurs when people's expectations or beliefs influence or determine their experience in a given situation. In other words, simply expecting something to happen can actually make it happen.
Randomized Experiments01:13

Randomized Experiments

The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Blinding01:11

Blinding

Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
Hazard Ratio01:12

Hazard Ratio

The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial evaluating a...

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Radiotherapy for Graves' orbitopathy: randomised placebo-controlled study.

M P Mourits1, M L van Kempen-Harteveld, M B García

  • 1Donders Institute of Ophthalmology (Orbital Unit), University Medical Centre, Utrecht, The Netherlands.

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Radiotherapy improved outcomes for moderately severe Graves' orbitopathy, particularly motility impairment, but did not significantly reduce proptosis or eyelid swelling. Further strabismus surgery was still required for many patients.

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Area of Science:

  • Ophthalmology
  • Endocrinology
  • Radiation Oncology

Background:

  • Graves' orbitopathy is a self-limiting condition with uncertain optimal treatment for moderate severity.
  • Current treatment options include steroids, irradiation, or combination therapy.
  • The efficacy of external beam irradiation versus sham-irradiation for this condition requires investigation.

Purpose of the Study:

  • To evaluate the efficacy of external beam irradiation compared to sham-irradiation in patients with moderately severe Graves' orbitopathy.
  • To assess treatment outcomes using both qualitative and quantitative measures.

Main Methods:

  • A double-blind, randomized clinical trial was conducted with 60 patients.
  • Patients received either radiotherapy (20 Gy in ten fractions) or sham-irradiation.
  • Outcomes were assessed at 24 weeks using major/minor criteria, eyelid aperture, proptosis, eye movements, and clinical activity scores.

Main Results:

  • Qualitative outcomes were successful in 60% of irradiated patients versus 31% of sham-irradiated patients (p=0.04).
  • Improvements were noted in diplopia and eye elevation, but not proptosis or eyelid swelling.
  • Binocular single vision fields improved in the radiotherapy group, though 25% still needed strabismus surgery.

Conclusions:

  • Radiotherapy demonstrated efficacy in improving certain aspects of moderately severe Graves' orbitopathy.
  • The primary benefit of radiotherapy appears to be in treating motility impairment.
  • Its use should be specifically considered for motility issues in Graves' orbitopathy.