Clinical Studies
Research & Clinical Studies
Explore the research behind photobiomodulation through plain-language summaries and links to the original publications.
Each overview explains the experiment, its main findings and important limitations. These studies investigate particular devices and protocols; they are not clinical tests of EternaGlow products.
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HUMAN STUDIES
Skin Appearance and Collagen Measurements
Study: Wunsch and Matuschka, 2014.
Participants: 136 adults aged 27–79; 113 assigned to treatment groups and 23 untreated controls. The main results table included 105 treated participants.
Purpose: To investigate changes in skin appearance, roughness and ultrasound-assessed collagen density.
Method: Four treatment groups received 30 sessions, twice weekly, using specialised lamps. Researchers used questionnaires, skin-surface measurements, ultrasound and photographs assessed by three blinded physicians.
Findings: Both light-treatment categories improved skin roughness and collagen intensity scores. Between-group comparisons reported p = 0.003 for roughness and p < 0.001 for collagen scores. The broader-spectrum treatment showed no clear advantage over predominantly red light.
Limitations: Controls were not randomly assigned and received no sham treatment. Participants knew whether they received treatment. Ultrasound scores were indirect collagen measurements, not biopsies. The study was company-funded, with investigators paid by the sponsor. These were lamp systems rather than typical home LED masks.
If you’d like to look into this further, here’s the original study:
https://doi.org/10.1089/pho.2013.3616
Pattern Hair Loss
Study: Jimenez and colleagues, 2014.
Participants: 269 adults were randomised across four trials: 128 men and 141 women. Forty-four were lost to follow-up; 225 were included in the efficacy analysis.
Purpose: To test whether particular laser combs increased terminal hair density—the number of thicker hairs per square centimetre.
Method: Randomised, double-blind trials compared active laser combs with look-alike sham devices. Participants treated their scalp three times weekly for 26 weeks, with sessions lasting 8–15 minutes depending on the model. Hair counts were assessed using standardised photographs.
Findings: Across the trials, the combined analysis estimated 15.27 additional terminal hairs/cm² with active treatment compared with sham treatment (p < 0.0001). No serious treatment-related adverse events were reported; mild effects included dryness and itching.
Limitations: The study concerned pattern hair loss, not every cause of hair loss. Follow-up losses and the 26-week duration limit interpretation. The manufacturer partly funded the research and supplied equipment. Results for laser combs cannot automatically be applied to LED caps.
If you’d like to look into this further, here’s the original study:
https://doi.org/10.1007/s40257-013-0060-6
Muscle Soreness and Recovery After Exercise
Study: De Marchi and colleagues, 2017.
Participants: 40 healthy, untrained men.
Purpose: To compare three light-treatment protocols for recovery after demanding thigh-muscle exercise.
Method: A randomised, double-blind, placebo-controlled experiment compared placebo, high-powered continuous light, low-powered continuous light and low-powered pulsed light. Active treatments delivered 180 joules to the quadriceps. Researchers measured strength, soreness and blood creatine kinase—a marker associated with muscle damage—through 96 hours after exercise.
Findings: The low-powered pulsed treatment produced less soreness than the other groups and better strength preservation than placebo and high-powered treatment, with reported comparisons reaching p < 0.05. High-powered treatment showed no benefit and increased creatine kinase compared with placebo during the first 24 hours.
Limitations: This was a small, short-term study in untrained men. The devices differed in several characteristics, so the results do not isolate power or pulsing as the sole explanation. Creatine kinase is an indirect marker, not a direct measurement of tissue repair.
If you’d like to look into this further, here’s the original study:
https://pubmed.ncbi.nlm.nih.gov/28319422/
Chronic Neck Pain
Study: Chow, Heller and Barnsley, 2006.
Research type: Human randomised, double-blind, placebo-controlled trial.
Participants: 90 people with chronic neck pain.
Purpose: To investigate whether a specific near-infrared laser treatment reduced neck pain.
Method: Participants received either active 830 nm laser treatment, with an output of 300 mW, or sham treatment to tender neck areas. They underwent 14 treatments over seven weeks. Assessments occurred before treatment, after seven weeks and at 12 weeks from baseline.
Findings: Average pain scores on a 10 cm scale improved by 2.7 cm in the active group and worsened by 0.3 cm in the placebo group. The between-group difference was 3.0 cm, with a reported 95% confidence interval of approximately 2.1–3.8 cm.
Several disability and physical quality-of-life measures also improved, but mental quality-of-life scores did not differ significantly.
Limitations: Follow-up extended only to 12 weeks from baseline. This tested targeted laser treatment, not a home LED panel or belt, and does not establish results for every cause of neck pain.
If you’d like to look into this further, here’s the original study:
https://pubmed.ncbi.nlm.nih.gov/16806710/
Knee osteoarthritis: Adding Light Therapy to Exercise
Study: Jorge and colleagues, 2023.
Research type: Human randomised, placebo-controlled trial with blinded assessment.
Participants: 127 adults aged 40–75: 41 received exercise alone, 44 exercise plus active PBM, and 42 exercise plus placebo PBM.
Purpose: To determine whether PBM provided additional benefits beyond a strengthening programme.
Method: Treatment was scheduled three times weekly for eight weeks. Active treatment used an 808 nm laser at eight knee points, delivering 6 joules per point and 48 joules per session. Researchers assessed pain, function and quality of life immediately after treatment and at three- and six-month follow-ups.
Findings: All groups improved, but the authors found no additional benefit from active PBM. Immediately after treatment, average resting pain fell from 5.62 to 1.86 with active PBM and from 5.48 to 1.94 with placebo PBM on a 0–10 scale.
Limitations: Dropout rates reached approximately 30% at three months and 45% at six months. This evaluated PBM alongside exercise, not PBM alone, and tested one specific protocol.
If you’d like to look into this further, here’s the original study:
https://pmc.ncbi.nlm.nih.gov/articles/PMC10440468/
Preventing Severe Mouth Inflammation During Cancer Treatment
Study: Antunes and colleagues, 2013.
Research type: Human randomised, double-blind, placebo-controlled phase III trial.
Participants: 94 patients receiving chemotherapy and radiotherapy for head and neck cancer.
Purpose: To investigate whether preventive laser treatment reduced severe oral mucositis—painful inflammation and ulceration inside the mouth caused by cancer treatment.
Method: Patients received active low-level laser treatment or placebo alongside their cancer care. The active protocol used a 660 nm laser, 100 mW output and 4 J/cm². Researchers assessed mouth inflammation using established grading scales and quality of life using questionnaires.
Findings: Severe grade 3–4 mucositis occurred in 6.4% of the active-treatment group versus 40.5% of the placebo group: an absolute difference of 34.1 percentage points. The reported relative risk was 0.158, with a 95% confidence interval of 0.050–0.498. Several quality-of-life measures also favoured treatment.
Limitations: This concerns specialist supportive care during cancer treatment. It does not show that light treats cancer or that home devices can reproduce the results. This overview uses the published abstract rather than a full-text assessment.
If you’d like to look into this further, here’s the original study:
https://pubmed.ncbi.nlm.nih.gov/24044799/
Red Light Alone for Mild-to-Moderate Acne
Study: Na and Suh, 2007.
Research type: Human randomised, single-blinded, split-face trial.
Participants: 28 volunteers with mild-to-moderate acne.
Purpose: To investigate whether portable red-light treatment improved acne without blue light.
Method: One side of each participant’s face was randomly selected for treatment; the other served as the control. Treatment lasted 15 minutes twice daily for eight weeks. Researchers assessed photographs, acne lesion counts and visual analogue scores at baseline and weeks 1, 2, 4 and 8.
Findings: The treated side showed significantly greater improvement in both inflammatory lesions and non-inflammatory lesions, such as blackheads and whiteheads, compared with the control side (p < 0.005). The reported visual analogue score decreased from 3.9 to 1.9 on the treated side. The abstract does not provide exact percentage reductions in lesion counts.
Limitations: This was a small, eight-week study with single blinding. It does not establish long-term results, effectiveness for severe acne or equivalent results from other devices. The study schedule is not a universal recommendation.
If you’d like to look into this further, here’s the original study:
https://pubmed.ncbi.nlm.nih.gov/17903156/
Achilles Tendon Pain: Light Therapy Alongside Exercise
Study: Stergioulas and colleagues, 2008.
Research type: Human randomised, blinded, placebo-controlled trial.
Participants: 52 recreational athletes with chronic Achilles tendinopathy.
Purpose: To investigate whether adding laser treatment to eccentric exercises improved recovery. Eccentric exercises involve loading a muscle while it lengthens.
Method: Participants received exercise plus either active or placebo laser treatment over eight weeks. Active treatment used an 820 nm laser, with 12 sessions targeting six points along the tendon. Reported irradiance was 60 mW/cm², with 5.4 joules delivered per session.
Findings: Activity-related pain on a 100 mm scale was lower with active treatment:
• Week 4: 53.6 versus 71.5 mm; p = 0.0003.
• Week 8: 37.3 versus 62.8 mm; p = 0.0002.
• Week 12: 33.0 versus 53.0 mm; p = 0.007.
Lower scores indicate less pain. Several secondary measures also favoured active treatment.
Limitations: This tested laser treatment alongside exercise, not light alone. Follow-up lasted 12 weeks, and reduced symptoms do not directly demonstrate tendon regeneration or establish equivalent outcomes with home LED devices.
If you’d like to look into this further, here’s the original study:
https://pubmed.ncbi.nlm.nih.gov/18272794/
Diabetic Foot Ulcers: A Small Home-Treatment Pilot
Study: Haze and colleagues, published online in 2021; journal issue 2022.
Research type: Human randomised, double-blind, sham-controlled pilot trial.
Participants: 20 patients—13 men and 7 women—with an average age of 63 years. They had insulin-treated type 2 diabetes, severe foot ulcers and substantial accompanying health conditions. Ten received active treatment and ten received sham treatment.
Purpose: To assess whether a particular home-use laser improved ulcer healing alongside standard medical care.
Method: Daily active or sham treatment continued for up to 12 weeks. Active treatment used a pulsed 808 nm near-infrared laser, 250 mW output and 8.8 J/cm². Researchers measured wound-size reduction and adverse effects.
Findings: Greater than 90% wound closure occurred in 7 of 10 active-treatment patients versus 1 of 10 sham patients (70% versus 10%; p = 0.006). Overall wound-size reduction also favoured active treatment (p = 0.018). No device-related adverse effects were observed.
Limitations: Only 20 patients participated. Greater than 90% closure does not necessarily mean complete healing. This tested a specific medical laser alongside standard care, not ordinary consumer panels or belts, and does not support replacing medical wound care.
If you’d like to look into this further, here’s the original study:
https://pubmed.ncbi.nlm.nih.gov/34052927/
Red Light and Blood Glucose After a Glucose Drink
Study: Powner and Jeffery, 2024.
Research type: Human randomised, placebo-controlled experiment.
Research institutions: City, University of London, and University College London (UCL).
Participants: 30 healthy adults, with 15 assigned to red light and 15 to placebo.
Purpose: To investigate whether red-light exposure changed the blood-glucose response to a glucose drink.
Method: Participants completed two fasting glucose-tolerance tests. Before the second test, the treatment group received 15 minutes of 670 nm LED light on their upper back at 40 mW/cm². The placebo group underwent the same setup without light. Both consumed 75 grams of glucose; blood glucose was measured every 15 minutes for two hours.
Findings: Compared with placebo, the rise above baseline glucose, integrated over two hours, was 27.7% lower (p = 0.0002). Total glucose exposure over that period was 7.3% lower (p = 0.0061). These are different measurements—not a 27.7% reduction in overall blood sugar.
Limitations: This small experiment involved healthy adults, not people with diabetes. BMI was not recorded. It does not establish long-term benefits or a diabetes treatment.
If you’d like to look into this further, here’s the original study:
https://doi.org/10.1002/jbio.202300521
Deep Red Light and Colour-Contrast Vision
Study: Shinhmar and colleagues, 2021.
Research type: Human exploratory study using repeated measurements and no-light controls.
Research institution: UCL Institute of Ophthalmology.
Participants: 24 people appeared across overlapping experimental groups. The main morning-exposure experiment involved 20; the no-light comparison involved 10. Some participants took part in several experiments, so these numbers should not be added together.
Purpose: To investigate whether a brief 670 nm exposure changed colour-contrast sensitivity—the ability to distinguish colours with small differences in contrast.
Method: A specially configured device delivered three minutes of light to the dominant eye at approximately 8 mW/cm². Researchers tested colour contrast before exposure and three hours afterwards. Smaller groups tested afternoon exposure and persistence after one week.
Findings: Morning exposure reduced blue–yellow detection thresholds by approximately 17% and red–green thresholds by 12% (both p < 0.0001). Lower thresholds indicate better sensitivity. Smaller improvements remained after one week in 10 participants. Afternoon exposure showed no significant benefit in six participants.
Limitations: Small groups, no randomised sham-controlled design and variable responses. This measured colour contrast, not general eyesight or eye-disease treatment, and does not establish eye safety for consumer devices.
If you’d like to look into this further, here’s the original study:
https://doi.org/10.1038/s41598-021-02311-1
Near-Infrared Light and Depression: The ELATED-2 Pilot Trial
Study: Cassano and colleagues, 2018.
Research type: Human randomised, double-blind, sham-controlled pilot trial.
Research institutions: Massachusetts General Hospital, with collaborators affiliated with Harvard Medical School and other institutions.
Participants: 21 treated participants were included in the baseline-carried-forward analysis; 13 completed the study.
Purpose: To investigate specialised transcranial photobiomodulation as an additional treatment for major depressive disorder.
Method: Active or sham treatment was delivered over both sides of the forehead twice weekly for eight weeks. Active treatment used 823 nm near-infrared light at 36.2 mW/cm², with sessions lasting 20–30 minutes. Researchers assessed changes using the Hamilton Depression Rating Scale.
Findings: Reported between-group effect sizes were 0.90, 0.75 and 1.50, depending on how incomplete observations were handled. These standardised effect sizes describe differences between groups; they are not percentages of improvement. No serious adverse events were reported.
Limitations: Very small sample, substantial non-completion and results sensitive to analysis method. The findings need replication. This tested specialised forehead treatment, not ordinary home panels or masks, and does not establish a replacement for depression care. This overview uses the published abstract and accessible study excerpts.
If you’d like to look into this further, here’s the original study:
https://pubmed.ncbi.nlm.nih.gov/30346890/
Whole-Body Light Therapy for Fibromyalgia: A Feasibility Study
Study: Fitzmaurice and colleagues, 2023.
Research type: Human single-arm feasibility study, without a placebo group.
Research institutions: University of Birmingham and Sandwell and West Birmingham NHS Trust.
Participants: 21 people entered the trial; 19 completed treatment.
Purpose: To assess whether whole-body PBM was practical and acceptable for people with fibromyalgia, and explore changes in symptoms.
Method: Participants received 18 sessions over approximately six weeks using a NovoTHOR light bed emitting 660 nm red and 850 nm near-infrared light. Sessions increased from six to twelve minutes, then twenty minutes. Researchers used symptom questionnaires, physical assessments and interviews, with follow-up at 24 weeks.
Findings: Average Revised Fibromyalgia Impact Questionnaire scores fell from 79.7 to 55.3 at six weeks—an improvement of approximately 24.4 points (p ≤ 0.001). Scores averaged 65.7 at 24 weeks, remaining better than baseline but showing some loss of improvement.
Limitations: The small, uncontrolled design cannot separate treatment effects from expectations, natural symptom fluctuations or other care. This supports further controlled research rather than proving effectiveness. Results from this light bed cannot automatically be applied to home mats or panels.
If you’d like to look into this further, here’s the original study:
https://doi.org/10.3390/bs13090717
Laser Therapy for Arm Lymphoedema After Breast Cancer Surgery
Study: Carati and colleagues, 2003.
Research type: Human randomised, double-blind, placebo-controlled trial with crossover.
Research institutions: Flinders University and Flinders Medical Centre, South Australia.
Participants: 61 women initially entered: 33 in the active group and 28 in the placebo group.
Purpose: To investigate whether targeted laser treatment reduced persistent arm swelling after breast cancer surgery.
Method: A pulsed 904 nm laser was applied to 17 points around the armpit. Each treatment block involved nine sessions over three weeks. The active group received two blocks separated by eight weeks; the placebo group later crossed over to active treatment. Researchers measured arm volume, tissue fluid, hardness and movement.
Findings: At three months, two active-treatment blocks produced an average arm-volume reduction of 89.7 mL, compared with a 32.1 mL increase after placebo (p = 0.017). Approximately 31% achieved a reduction greater than 200 mL. Arm movement did not improve.
Limitations: Benefits were delayed and varied between participants. Withdrawals, crossover and pooled observations complicate interpretation. An investigator disclosed consulting for the laser manufacturer. This tested specialist lymphoedema treatment, not consumer devices.
If you’d like to look into this further, here’s the original study:
https://doi.org/10.1002/cncr.11641
Low-Level Laser Therapy for Carpal Tunnel Syndrome
Study: Nalbant and colleagues, published online in 2021; journal issue 2022.
Research type: Human randomised, double-blind, sham-controlled trial.
Research institution: Conducted at Başkent University, Turkey.
Participants: 42 adults with mild-to-moderate carpal tunnel syndrome: 22 received active treatment and 20 sham treatment. Their average age was 50.4 years.
Purpose: To examine symptoms, hand function, nerve conduction and ultrasound findings after treatment.
Method: Both groups wore neutral wrist splints. Participants received 15 sessions of active or sham laser treatment. Active treatment used 670 nm light, delivering 4 joules per session over the carpal tunnel.
Findings: Active-group symptom-severity scores improved from 2.5 to 2.0 (within-group p < 0.001). However, the post-treatment comparison with sham was not statistically significant (p = 0.144). Pain prevalence fell from 68.2% to 40.9% in the active group, but the between-group comparison was also non-significant (p = 0.217). Some nerve-conduction and ultrasound measures improved.
Limitations: Small sample and short-term assessment. Improvement within one group does not prove superiority over placebo. Both groups used splints, and the study does not establish equivalent results with home LED devices.
If you’d like to look into this further, here’s the original study:
https://pmc.ncbi.nlm.nih.gov/articles/PMC9326377/
Light Therapy for Jaw Joint and Muscle Pain
Study: Aisaiti and colleagues, 2021.
Research type: Human randomised, double-blind, placebo-controlled trial.
Research institutions: Nanjing Medical University, with collaborators from universities including Aalborg and Aarhus.
Participants: 175 people were initially assessed; 147 were randomised and 100 completed all sessions and were included in the analysis.
Purpose: To investigate whether PBM improved jaw-muscle pain or temporomandibular joint pain.
Method: Participants received active or placebo treatment daily for seven days. Active treatment used an 810 nm laser at 6 J/cm², applied to the painful muscle or joint region. Researchers assessed pain ratings, pressure sensitivity and jaw movement.
Findings: Pain improved in both active and placebo groups. For jaw-muscle pain, the difference between treatments was not statistically significant (p = 0.074). For joint pain, the analysis favoured active treatment (p = 0.014), although the authors described the additional benefit as small. Some jaw-movement measures also favoured active treatment.
Limitations: Substantial participant losses and very short-term assessment. The authors questioned whether the small differences were clinically meaningful. Results do not establish long-term effectiveness or equivalent outcomes from consumer devices.
If you’d like to look into this further, here’s the original study:
https://pmc.ncbi.nlm.nih.gov/articles/PMC8079391/
Near-Infrared Light, Attention and Memory in Healthy Adults
Study: Barrett and Gonzalez-Lima, 2013.
Research type: Human randomised, placebo-controlled experiment.
Research institution: University of Texas at Austin.
Participants: 40 healthy volunteers, with 20 assigned to active treatment and 20 to placebo.
Purpose: To investigate whether specialised forehead laser stimulation influenced attention, short-term memory and emotional state.
Method: Participants received a single active or placebo session. Active treatment used a 1064 nm laser at 250 mW/cm². Computer-based attention and memory tests were performed before and after treatment; emotional-state questionnaires were repeated two weeks later.
Findings: Changes in attention-test reaction time favoured active treatment (p = 0.047). Memory-retrieval speed also improved more with treatment (p = 0.021), as did the number of correct memory responses (p = 0.012). The emotional-state analysis favoured treatment at two weeks (p = 0.043).
Limitations: Small sample of healthy adults and short follow-up. One outlier was excluded from the memory-speed analysis. Better performance on laboratory tasks does not establish treatment for dementia, ADHD or other conditions. This used a specialised laser rather than a home LED panel.
If you’d like to look into this further, here’s the original study:
https://pubmed.ncbi.nlm.nih.gov/23200785/
Light Therapy Before Resistance Training: A Trial Finding No Benefit
Study: Orssatto and colleagues, 2020.
Research type: Human randomised, double-blind, placebo-controlled crossover trial.
Research institutions: Queensland University of Technology, Federal University of Amazonas and Federal University of Santa Catarina.
Participants: 14 well-trained adults: seven women and seven men.
Purpose: To investigate whether PBM increased exercise repetitions or reduced discomfort during demanding calf exercises.
Method: Each participant underwent both active and placebo conditions on separate visits. Active treatment delivered 60 joules at each of six calf-muscle sites, totalling 360 joules per limb. Five minutes later, participants performed six sets of calf raises until they could no longer complete a repetition.
Findings: Total repetitions averaged 55.4 with PBM versus 54.8 with placebo, without a significant difference (p = 0.764). Force declined by 7.7% after PBM versus 10.0% after placebo, also without a significant difference (p = 0.815). The tested treatment did not reduce exercise discomfort.
Limitations: Small sample and one exercise protocol. This assessed immediate performance rather than recovery over subsequent days. It does not establish that every PBM protocol is ineffective. This overview uses the published abstract.
If you’d like to look into this further, here’s the original study:
https://pubmed.ncbi.nlm.nih.gov/32758087/
Red and Near-Infrared LEDs for Facial Wrinkles
Study: Lee and colleagues, 2007.
Research type: Human randomised, placebo-controlled, double-blinded, split-face trial.
Research institution: National Medical Center, Seoul, South Korea.
Participants: 76 people with facial wrinkles.
Purpose: To investigate changes in wrinkles, skin elasticity and skin tissue following LED treatment.
Method: Participants were allocated to four groups receiving 830 nm near-infrared light, 633 nm red light, both wavelengths, or sham treatment. Treatment was applied to the right half of the face twice weekly for four weeks, with three months of follow-up. Assessments included photographs, skin-surface measurements, elasticity testing and examination of skin specimens.
Findings: Active-treatment groups showed reductions in measured wrinkles of up to 36% and increases in elasticity of up to 19% compared with baseline. Skin specimens showed increased collagen and elastic fibres. No adverse effects were reported.
Limitations: The percentages are maximum reported improvements, not the average result for every participant or the treatment advantage over placebo. The abstract does not provide complete group-level statistics. Findings relate to the tested devices and protocols, not every red-light mask.
If you’d like to look into this further, here’s the original study:
https://pubmed.ncbi.nlm.nih.gov/17566756/
Multiwavelength Light Treatment for Dry Macular Degeneration: LIGHTSITE III
Study: Boyer and colleagues, 2024—13-month analysis.
Research type: Human multicentre, randomised, double-masked, sham-controlled trial.
Research institutions: Ten US centres, with collaborators including Duke University and Stanford University.
Participants: 100 people with dry age-related macular degeneration, contributing 148 study eyes. Eyes are not separate participants.
Purpose: To investigate whether a specialised ophthalmic PBM device improved visual acuity.
Method: Participants received Valeda treatment using 590, 660 and 850 nm light, or reduced-light sham treatment. Nine-session treatment series were repeated every four months. This publication reports the prespecified 13-month results.
Findings: Average improvement on a standardised vision chart was 5.4 letters with active treatment versus 3.0 with sham—an additional 2.4 letters favouring PBM (p approximately 0.02).
Limitations: The average additional benefit was modest. Seventeen participants discontinued by month 13. The manufacturer partly supported the study, and several authors had company affiliations. This tested a specialist eye-treatment system, not consumer masks or panels, and does not establish their safety for direct eye exposure.
If you’d like to look into this further, here’s the original study:
https://pubmed.ncbi.nlm.nih.gov/37972955/
A Large Stroke Trial Finding No Benefit: NEST-3
Study: Hacke and colleagues, 2014.
Research type: Human multicentre, randomised, double-blind, sham-controlled phase III trial.
Research institutions: An international collaboration involving university and hospital stroke researchers.
Participants: 630 people were randomised. An interim analysis included 566 participants with completed outcome assessments.
Purpose: To test whether transcranial laser treatment improved functional recovery after an acute ischaemic stroke.
Method: Active or sham laser treatment was administered within 24 hours of stroke onset. Participants had not received thrombolytic treatment. Researchers assessed disability and independence at 90 days using the modified Rankin Scale.
Findings: A favourable functional outcome occurred in 140 of 282 active-treatment patients (49.6%) versus 140 of 284 sham patients (49.3%). The trial stopped early because the interim results indicated that demonstrating benefit was unlikely. Analysis of all 630 randomised patients remained negative: adjusted odds ratio 1.024, with a 95% confidence interval of 0.705–1.488.
Limitations: Early termination reduced the planned sample of 1,000. The result concerns this particular acute-stroke protocol; it does not determine effectiveness for unrelated applications. This overview uses the published abstract.
If you’d like to look into this further, here’s the original study:
https://pubmed.ncbi.nlm.nih.gov/25293665/