A randomized, placebo-controlled, crossover clinical trial of super blue-green algae in patients with essential blepharospasm or Meige syndrome
To evaluate the effectiveness of super blue-green algae (SBGA) supplements on the severity of essential blepharospasm treated with botulinum toxin A injections. Double-masked, placebo-controlled, two-period, crossover randomized trial. The study was carried out in patients with essential blepharospa...
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| Veröffentlicht in: | American journal of ophthalmology 2004-07, Vol.138 (1), p.18-32 |
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| creator | Vitale, Susan Miller, Neil R. Mejico, Luis J. Perry, Julian D. Medura, Marianne Freitag, Suzanne K. Girkin, Christopher |
| description | To evaluate the effectiveness of super blue-green algae (SBGA) supplements on the severity of essential blepharospasm treated with botulinum toxin A injections.
Double-masked, placebo-controlled, two-period, crossover randomized trial.
The study was carried out in patients with essential blepharospasm or Meige syndrome undergoing routine treatment with botulinum toxin A injections.
Patients were randomly assigned to either SBGA capsules or placebo. After 6 months of treatment, patients underwent a 6-month washout period with no treatment, then were administered the alternate treatment for an additional 6 months, thus serving as their own controls.
Video documentation of blink rate and involuntary facial movements, time between botulinum toxin A injections, and patients' subjective assessment of the impact of blepharospasm on functioning were obtained at the beginning and end of the first and second (crossover) treatment periods.
A total of 24 patients (10 men, 14 women; aged 42 to 83 years) completed both treatment periods. Mean within-patient difference in blink rate between SBGA and placebo periods was −2.1 blinks per 2 minutes (95% confidence interval [CI]: −20.8–+31.9), not statistically different from zero (
P = .83). Mean within-patient difference in time between injections between SBGA and placebo periods was 4.6 days (95% CI: −13.3–+22.5), not statistically different from zero (
P = .62). The lack of statistical significance may have been because of small sample size. There were no significant differences in severity of involuntary movement between SBGA and placebo treatment periods. However, patients were more likely to report limitation in function during the period they took SBGA than during the period they took placebo (odds ratio, 0.2;
P = .03).
Overall, we found no evidence of a beneficial effect of SBGA as an adjunct to botulinum toxin A injections; however, a few patients, all younger than 60 years, did appear to benefit from SBGA. |
| doi_str_mv | 10.1016/j.ajo.2004.02.062 |
| format | Article |
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Double-masked, placebo-controlled, two-period, crossover randomized trial.
The study was carried out in patients with essential blepharospasm or Meige syndrome undergoing routine treatment with botulinum toxin A injections.
Patients were randomly assigned to either SBGA capsules or placebo. After 6 months of treatment, patients underwent a 6-month washout period with no treatment, then were administered the alternate treatment for an additional 6 months, thus serving as their own controls.
Video documentation of blink rate and involuntary facial movements, time between botulinum toxin A injections, and patients' subjective assessment of the impact of blepharospasm on functioning were obtained at the beginning and end of the first and second (crossover) treatment periods.
A total of 24 patients (10 men, 14 women; aged 42 to 83 years) completed both treatment periods. Mean within-patient difference in blink rate between SBGA and placebo periods was −2.1 blinks per 2 minutes (95% confidence interval [CI]: −20.8–+31.9), not statistically different from zero (
P = .83). Mean within-patient difference in time between injections between SBGA and placebo periods was 4.6 days (95% CI: −13.3–+22.5), not statistically different from zero (
P = .62). The lack of statistical significance may have been because of small sample size. There were no significant differences in severity of involuntary movement between SBGA and placebo treatment periods. However, patients were more likely to report limitation in function during the period they took SBGA than during the period they took placebo (odds ratio, 0.2;
P = .03).
Overall, we found no evidence of a beneficial effect of SBGA as an adjunct to botulinum toxin A injections; however, a few patients, all younger than 60 years, did appear to benefit from SBGA.</description><identifier>ISSN: 0002-9394</identifier><identifier>EISSN: 1879-1891</identifier><identifier>DOI: 10.1016/j.ajo.2004.02.062</identifier><identifier>PMID: 15234278</identifier><identifier>CODEN: AJOPAA</identifier><language>eng</language><publisher>New York, NY: Elsevier Inc</publisher><subject>Adult ; Aged ; Aged, 80 and over ; Algae ; Bacterial Proteins - therapeutic use ; Biological and medical sciences ; Blepharospasm - drug therapy ; Blinking - drug effects ; Botulinum Toxins, Type A - therapeutic use ; Botulism ; Clinical trials ; Cross-Over Studies ; Cyanobacteria ; Cyanobacteria - chemistry ; Double-Blind Method ; Drug Therapy, Combination ; Eye ; Female ; Humans ; Male ; Medical sciences ; Meige Syndrome - drug therapy ; Middle Aged ; Muscle Relaxation ; Neuromuscular Agents - therapeutic use ; Patients ; Pharmacology. Drug treatments ; Treatment Outcome</subject><ispartof>American journal of ophthalmology, 2004-07, Vol.138 (1), p.18-32</ispartof><rights>2004 Elsevier Inc.</rights><rights>2004 INIST-CNRS</rights><rights>Copyright Elsevier Limited Jul 2004</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c407t-96c480778fb9cbd38ed08b5e3de3153b3fe1b612734522733538ba326515fdc53</citedby><cites>FETCH-LOGICAL-c407t-96c480778fb9cbd38ed08b5e3de3153b3fe1b612734522733538ba326515fdc53</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.ajo.2004.02.062$$EHTML$$P50$$Gelsevier$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=15945737$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/15234278$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Vitale, Susan</creatorcontrib><creatorcontrib>Miller, Neil R.</creatorcontrib><creatorcontrib>Mejico, Luis J.</creatorcontrib><creatorcontrib>Perry, Julian D.</creatorcontrib><creatorcontrib>Medura, Marianne</creatorcontrib><creatorcontrib>Freitag, Suzanne K.</creatorcontrib><creatorcontrib>Girkin, Christopher</creatorcontrib><title>A randomized, placebo-controlled, crossover clinical trial of super blue-green algae in patients with essential blepharospasm or Meige syndrome</title><title>American journal of ophthalmology</title><addtitle>Am J Ophthalmol</addtitle><description>To evaluate the effectiveness of super blue-green algae (SBGA) supplements on the severity of essential blepharospasm treated with botulinum toxin A injections.
Double-masked, placebo-controlled, two-period, crossover randomized trial.
The study was carried out in patients with essential blepharospasm or Meige syndrome undergoing routine treatment with botulinum toxin A injections.
Patients were randomly assigned to either SBGA capsules or placebo. After 6 months of treatment, patients underwent a 6-month washout period with no treatment, then were administered the alternate treatment for an additional 6 months, thus serving as their own controls.
Video documentation of blink rate and involuntary facial movements, time between botulinum toxin A injections, and patients' subjective assessment of the impact of blepharospasm on functioning were obtained at the beginning and end of the first and second (crossover) treatment periods.
A total of 24 patients (10 men, 14 women; aged 42 to 83 years) completed both treatment periods. Mean within-patient difference in blink rate between SBGA and placebo periods was −2.1 blinks per 2 minutes (95% confidence interval [CI]: −20.8–+31.9), not statistically different from zero (
P = .83). Mean within-patient difference in time between injections between SBGA and placebo periods was 4.6 days (95% CI: −13.3–+22.5), not statistically different from zero (
P = .62). The lack of statistical significance may have been because of small sample size. There were no significant differences in severity of involuntary movement between SBGA and placebo treatment periods. However, patients were more likely to report limitation in function during the period they took SBGA than during the period they took placebo (odds ratio, 0.2;
P = .03).
Overall, we found no evidence of a beneficial effect of SBGA as an adjunct to botulinum toxin A injections; however, a few patients, all younger than 60 years, did appear to benefit from SBGA.</description><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Algae</subject><subject>Bacterial Proteins - therapeutic use</subject><subject>Biological and medical sciences</subject><subject>Blepharospasm - drug therapy</subject><subject>Blinking - drug effects</subject><subject>Botulinum Toxins, Type A - therapeutic use</subject><subject>Botulism</subject><subject>Clinical trials</subject><subject>Cross-Over Studies</subject><subject>Cyanobacteria</subject><subject>Cyanobacteria - chemistry</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination</subject><subject>Eye</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Meige Syndrome - drug therapy</subject><subject>Middle Aged</subject><subject>Muscle Relaxation</subject><subject>Neuromuscular Agents - therapeutic use</subject><subject>Patients</subject><subject>Pharmacology. Drug treatments</subject><subject>Treatment Outcome</subject><issn>0002-9394</issn><issn>1879-1891</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2004</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kctu1TAQhi0EoofCA7BBlhA7kvqW2BGrquImFXUDa8uXyamjJA52UtS-BK-MD-dIsOpmrBl9_4z1_wi9pqSmhLYXQ22GWDNCRE1YTVr2BO2okl1FVUefoh0hhFUd78QZepHzUNpWCvkcndGGccGk2qHflziZ2ccpPIB_j5fROLCxcnFeUxzHw8ylmHO8g4TdGObgzIjXFEqNPc7bUuZ23KDaJ4AZm3FvAIcZL2YNMK8Z_wrrLYacS3MQ2RGWW1NWLiZPOCb8DcIecL6ffYoTvETPejNmeHV6z9GPTx-_X32prm8-f726vK6cIHKtutYJRaRUve2c9VyBJ8o2wD1w2nDLe6C2pUxy0bBSecOVNZy1DW167xp-jt4e9y4p_twgr3qIW5rLSU1bIZRUVNJC0SP114MEvV5SmEy615ToQwR60CUCfYhAE6ZLBEXz5rR5sxP4f4qT5wV4dwJMLmb2xX8X8n9cJxrJZeE-HDkoPtwFSDq7YqkDHxK4VfsYHvnGHzdjpXs</recordid><startdate>20040701</startdate><enddate>20040701</enddate><creator>Vitale, Susan</creator><creator>Miller, Neil R.</creator><creator>Mejico, Luis J.</creator><creator>Perry, Julian D.</creator><creator>Medura, Marianne</creator><creator>Freitag, Suzanne K.</creator><creator>Girkin, Christopher</creator><general>Elsevier Inc</general><general>Elsevier</general><general>Elsevier Limited</general><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>K9.</scope><scope>NAPCQ</scope></search><sort><creationdate>20040701</creationdate><title>A randomized, placebo-controlled, crossover clinical trial of super blue-green algae in patients with essential blepharospasm or Meige syndrome</title><author>Vitale, Susan ; Miller, Neil R. ; Mejico, Luis J. ; Perry, Julian D. ; Medura, Marianne ; Freitag, Suzanne K. ; Girkin, Christopher</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c407t-96c480778fb9cbd38ed08b5e3de3153b3fe1b612734522733538ba326515fdc53</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2004</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Algae</topic><topic>Bacterial Proteins - therapeutic use</topic><topic>Biological and medical sciences</topic><topic>Blepharospasm - drug therapy</topic><topic>Blinking - drug effects</topic><topic>Botulinum Toxins, Type A - therapeutic use</topic><topic>Botulism</topic><topic>Clinical trials</topic><topic>Cross-Over Studies</topic><topic>Cyanobacteria</topic><topic>Cyanobacteria - chemistry</topic><topic>Double-Blind Method</topic><topic>Drug Therapy, Combination</topic><topic>Eye</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Meige Syndrome - drug therapy</topic><topic>Middle Aged</topic><topic>Muscle Relaxation</topic><topic>Neuromuscular Agents - therapeutic use</topic><topic>Patients</topic><topic>Pharmacology. Drug treatments</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Vitale, Susan</creatorcontrib><creatorcontrib>Miller, Neil R.</creatorcontrib><creatorcontrib>Mejico, Luis J.</creatorcontrib><creatorcontrib>Perry, Julian D.</creatorcontrib><creatorcontrib>Medura, Marianne</creatorcontrib><creatorcontrib>Freitag, Suzanne K.</creatorcontrib><creatorcontrib>Girkin, Christopher</creatorcontrib><collection>Pascal-Francis</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Premium</collection><jtitle>American journal of ophthalmology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Vitale, Susan</au><au>Miller, Neil R.</au><au>Mejico, Luis J.</au><au>Perry, Julian D.</au><au>Medura, Marianne</au><au>Freitag, Suzanne K.</au><au>Girkin, Christopher</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomized, placebo-controlled, crossover clinical trial of super blue-green algae in patients with essential blepharospasm or Meige syndrome</atitle><jtitle>American journal of ophthalmology</jtitle><addtitle>Am J Ophthalmol</addtitle><date>2004-07-01</date><risdate>2004</risdate><volume>138</volume><issue>1</issue><spage>18</spage><epage>32</epage><pages>18-32</pages><issn>0002-9394</issn><eissn>1879-1891</eissn><coden>AJOPAA</coden><abstract>To evaluate the effectiveness of super blue-green algae (SBGA) supplements on the severity of essential blepharospasm treated with botulinum toxin A injections.
Double-masked, placebo-controlled, two-period, crossover randomized trial.
The study was carried out in patients with essential blepharospasm or Meige syndrome undergoing routine treatment with botulinum toxin A injections.
Patients were randomly assigned to either SBGA capsules or placebo. After 6 months of treatment, patients underwent a 6-month washout period with no treatment, then were administered the alternate treatment for an additional 6 months, thus serving as their own controls.
Video documentation of blink rate and involuntary facial movements, time between botulinum toxin A injections, and patients' subjective assessment of the impact of blepharospasm on functioning were obtained at the beginning and end of the first and second (crossover) treatment periods.
A total of 24 patients (10 men, 14 women; aged 42 to 83 years) completed both treatment periods. Mean within-patient difference in blink rate between SBGA and placebo periods was −2.1 blinks per 2 minutes (95% confidence interval [CI]: −20.8–+31.9), not statistically different from zero (
P = .83). Mean within-patient difference in time between injections between SBGA and placebo periods was 4.6 days (95% CI: −13.3–+22.5), not statistically different from zero (
P = .62). The lack of statistical significance may have been because of small sample size. There were no significant differences in severity of involuntary movement between SBGA and placebo treatment periods. However, patients were more likely to report limitation in function during the period they took SBGA than during the period they took placebo (odds ratio, 0.2;
P = .03).
Overall, we found no evidence of a beneficial effect of SBGA as an adjunct to botulinum toxin A injections; however, a few patients, all younger than 60 years, did appear to benefit from SBGA.</abstract><cop>New York, NY</cop><pub>Elsevier Inc</pub><pmid>15234278</pmid><doi>10.1016/j.ajo.2004.02.062</doi><tpages>15</tpages></addata></record> |
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| ispartof | American journal of ophthalmology, 2004-07, Vol.138 (1), p.18-32 |
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| subjects | Adult Aged Aged, 80 and over Algae Bacterial Proteins - therapeutic use Biological and medical sciences Blepharospasm - drug therapy Blinking - drug effects Botulinum Toxins, Type A - therapeutic use Botulism Clinical trials Cross-Over Studies Cyanobacteria Cyanobacteria - chemistry Double-Blind Method Drug Therapy, Combination Eye Female Humans Male Medical sciences Meige Syndrome - drug therapy Middle Aged Muscle Relaxation Neuromuscular Agents - therapeutic use Patients Pharmacology. Drug treatments Treatment Outcome |
| title | A randomized, placebo-controlled, crossover clinical trial of super blue-green algae in patients with essential blepharospasm or Meige syndrome |
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