Double‐Blind, Randomized, Placebo‐Controlled Clinical Trials with Non‐Prescription Medications for the Treatment of Obesity
GREENWAY, FRANK, DAVID HEBER, WILLIAM RAUM, AND SILVIA MORALES. Double‐blind, randomized, placebo‐controlled clinical trials with non‐prescription medications for the treatment of obesity. Obes Res. Objective: Phenylpropanolamine (PPA) and benzocaine are non‐prescription medications approved for tre...
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| Veröffentlicht in: | Obesity research 1999-07, Vol.7 (4), p.370-378 |
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| creator | Greenway, Frank Heber, David Raum, William Morales, Silvia |
| description | GREENWAY, FRANK, DAVID HEBER, WILLIAM RAUM, AND SILVIA MORALES. Double‐blind, randomized, placebo‐controlled clinical trials with non‐prescription medications for the treatment of obesity. Obes Res.
Objective: Phenylpropanolamine (PPA) and benzocaine are non‐prescription medications approved for treating obesity. The dose of PPA for weight loss is 75 mg/day. PPA has the same chemical similarity to pseudoephedrine that amphetamine has to methamphetamine. Because benzocaine causes weight loss by altering taste and PPA by central appetite suppression, they may induce additional weight loss when combined. These studies explore the safety and efficacy of low‐dose PPA, pseudoephedrine, and PPA with benzocaine in causing weight loss.
Research Methods and Procedures: Study 1 compared PPA 12. 5 mg tid with 25 mg tid and placebo in a 6‐week trial in 108 obese subjects. Study 2 compared pseudoephedrine 120 mg/day and a placebo in a 12‐week trial with 72 obese subjects. Study 3 compared 4 groups of 20 obese subjects using PPA 75 mg/day, benzocaine gum 96 mg/day, PPA with benzocaine gum, and a placebo over 12 weeks.
Results: Both doses of PPA gave twice the weight loss of placebo, but the difference did not reach statistical significance. Pseudoephedrine was no different than placebo in inducing weight loss. The PPA with benzocaine group had more adverse events than the benzocaine group (p = 0. 03), the placebo group (p = 0. 03), or the PPA group (p = 0. 09) without additional weight loss.
Discussion: We conclude that further studies with low‐dose PPA for weight loss are indicated, that pseudoephedrine is not effective for weight loss, and that adding benzocaine to phenylpropanolamine increases adverse effects without increasing weight loss. |
| doi_str_mv | 10.1002/j.1550-8528.1999.tb00420.x |
| format | Article |
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Objective: Phenylpropanolamine (PPA) and benzocaine are non‐prescription medications approved for treating obesity. The dose of PPA for weight loss is 75 mg/day. PPA has the same chemical similarity to pseudoephedrine that amphetamine has to methamphetamine. Because benzocaine causes weight loss by altering taste and PPA by central appetite suppression, they may induce additional weight loss when combined. These studies explore the safety and efficacy of low‐dose PPA, pseudoephedrine, and PPA with benzocaine in causing weight loss.
Research Methods and Procedures: Study 1 compared PPA 12. 5 mg tid with 25 mg tid and placebo in a 6‐week trial in 108 obese subjects. Study 2 compared pseudoephedrine 120 mg/day and a placebo in a 12‐week trial with 72 obese subjects. Study 3 compared 4 groups of 20 obese subjects using PPA 75 mg/day, benzocaine gum 96 mg/day, PPA with benzocaine gum, and a placebo over 12 weeks.
Results: Both doses of PPA gave twice the weight loss of placebo, but the difference did not reach statistical significance. Pseudoephedrine was no different than placebo in inducing weight loss. The PPA with benzocaine group had more adverse events than the benzocaine group (p = 0. 03), the placebo group (p = 0. 03), or the PPA group (p = 0. 09) without additional weight loss.
Discussion: We conclude that further studies with low‐dose PPA for weight loss are indicated, that pseudoephedrine is not effective for weight loss, and that adding benzocaine to phenylpropanolamine increases adverse effects without increasing weight loss.</description><identifier>ISSN: 1071-7323</identifier><identifier>EISSN: 1550-8528</identifier><identifier>DOI: 10.1002/j.1550-8528.1999.tb00420.x</identifier><identifier>PMID: 10440593</identifier><language>eng</language><publisher>Oxford, UK: Blackwell Publishing Ltd</publisher><subject><![CDATA[Adolescent ; Adult ; Aged ; Appetite Depressants - administration & dosage ; Appetite Depressants - therapeutic use ; benzocaine ; Benzocaine - administration & dosage ; Benzocaine - therapeutic use ; blood pressure ; Delayed-Action Preparations - administration & dosage ; Delayed-Action Preparations - therapeutic use ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Therapy, Combination ; Ephedrine - administration & dosage ; Ephedrine - therapeutic use ; Female ; Humans ; Male ; Middle Aged ; Nonprescription Drugs - administration & dosage ; Nonprescription Drugs - therapeutic use ; Obesity - drug therapy ; phenylpropanolamine ; Phenylpropanolamine - administration & dosage ; Phenylpropanolamine - therapeutic use ; pseudoephedrine ; Weight Loss]]></subject><ispartof>Obesity research, 1999-07, Vol.7 (4), p.370-378</ispartof><rights>1999 North American Association for the Study of Obesity (NAASO)</rights><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c4220-d5fc863fad8545e67d5b07efef656e86adf1b4dc85d34c4a2d09a6162a5f646e3</citedby><cites>FETCH-LOGICAL-c4220-d5fc863fad8545e67d5b07efef656e86adf1b4dc85d34c4a2d09a6162a5f646e3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fj.1550-8528.1999.tb00420.x$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fj.1550-8528.1999.tb00420.x$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>315,782,786,1419,1435,27931,27932,45581,45582,46416,46840</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/10440593$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Greenway, Frank</creatorcontrib><creatorcontrib>Heber, David</creatorcontrib><creatorcontrib>Raum, William</creatorcontrib><creatorcontrib>Morales, Silvia</creatorcontrib><title>Double‐Blind, Randomized, Placebo‐Controlled Clinical Trials with Non‐Prescription Medications for the Treatment of Obesity</title><title>Obesity research</title><addtitle>Obes Res</addtitle><description>GREENWAY, FRANK, DAVID HEBER, WILLIAM RAUM, AND SILVIA MORALES. Double‐blind, randomized, placebo‐controlled clinical trials with non‐prescription medications for the treatment of obesity. Obes Res.
Objective: Phenylpropanolamine (PPA) and benzocaine are non‐prescription medications approved for treating obesity. The dose of PPA for weight loss is 75 mg/day. PPA has the same chemical similarity to pseudoephedrine that amphetamine has to methamphetamine. Because benzocaine causes weight loss by altering taste and PPA by central appetite suppression, they may induce additional weight loss when combined. These studies explore the safety and efficacy of low‐dose PPA, pseudoephedrine, and PPA with benzocaine in causing weight loss.
Research Methods and Procedures: Study 1 compared PPA 12. 5 mg tid with 25 mg tid and placebo in a 6‐week trial in 108 obese subjects. Study 2 compared pseudoephedrine 120 mg/day and a placebo in a 12‐week trial with 72 obese subjects. Study 3 compared 4 groups of 20 obese subjects using PPA 75 mg/day, benzocaine gum 96 mg/day, PPA with benzocaine gum, and a placebo over 12 weeks.
Results: Both doses of PPA gave twice the weight loss of placebo, but the difference did not reach statistical significance. Pseudoephedrine was no different than placebo in inducing weight loss. The PPA with benzocaine group had more adverse events than the benzocaine group (p = 0. 03), the placebo group (p = 0. 03), or the PPA group (p = 0. 09) without additional weight loss.
Discussion: We conclude that further studies with low‐dose PPA for weight loss are indicated, that pseudoephedrine is not effective for weight loss, and that adding benzocaine to phenylpropanolamine increases adverse effects without increasing weight loss.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Appetite Depressants - administration & dosage</subject><subject>Appetite Depressants - therapeutic use</subject><subject>benzocaine</subject><subject>Benzocaine - administration & dosage</subject><subject>Benzocaine - therapeutic use</subject><subject>blood pressure</subject><subject>Delayed-Action Preparations - administration & dosage</subject><subject>Delayed-Action Preparations - therapeutic use</subject><subject>Dose-Response Relationship, Drug</subject><subject>Double-Blind Method</subject><subject>Drug Therapy, Combination</subject><subject>Ephedrine - administration & dosage</subject><subject>Ephedrine - therapeutic use</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Nonprescription Drugs - administration & dosage</subject><subject>Nonprescription Drugs - therapeutic use</subject><subject>Obesity - drug therapy</subject><subject>phenylpropanolamine</subject><subject>Phenylpropanolamine - administration & dosage</subject><subject>Phenylpropanolamine - therapeutic use</subject><subject>pseudoephedrine</subject><subject>Weight Loss</subject><issn>1071-7323</issn><issn>1550-8528</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>1999</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNqVkc-KFDEYxIMo7rr6ChI8eLLbpDtJd3sQ3PEvrM4i68FTSCdf2Azpzphk2B1P-gY-o09imhnEq6cUfL-qQBVCTyipKSHN801NOSdVz5u-psMw1HkkhDWkvr2DTv-e7hZNOlp1bdOeoAcpbQihgvX0PjqhhDHCh_YU_XwddqOH3z9-nXs3m2f4s5pNmNx3KPrSKw1jKMdVmHMM3oPBq8I5rTy-ik75hG9cvsafwlyoywhJR7fNLsz4I5iCLTJhGyLO11AsoPIEc8bB4vUIyeX9Q3TPlhx4dHzP0Je3b65W76uL9bsPq1cXlWZNQyrDre5Fa5XpOeMgOsNH0oEFK7iAXihj6ciM7rlpmWaqMWRQgopGcSuYgPYMPT3kbmP4toOU5eSSBu_VDGGXpBgG1nVDV8AXB1DHkFIEK7fRTSruJSVyGUBu5NKyXFqWywDyOIC8LebHx1924wTmH-uh8QK8PAA3zsP-P6Ll-vxrEe0frgWbWA</recordid><startdate>199907</startdate><enddate>199907</enddate><creator>Greenway, Frank</creator><creator>Heber, David</creator><creator>Raum, William</creator><creator>Morales, Silvia</creator><general>Blackwell Publishing Ltd</general><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>7X8</scope></search><sort><creationdate>199907</creationdate><title>Double‐Blind, Randomized, Placebo‐Controlled Clinical Trials with Non‐Prescription Medications for the Treatment of Obesity</title><author>Greenway, Frank ; Heber, David ; Raum, William ; Morales, Silvia</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c4220-d5fc863fad8545e67d5b07efef656e86adf1b4dc85d34c4a2d09a6162a5f646e3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>1999</creationdate><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Appetite Depressants - administration & dosage</topic><topic>Appetite Depressants - therapeutic use</topic><topic>benzocaine</topic><topic>Benzocaine - administration & dosage</topic><topic>Benzocaine - therapeutic use</topic><topic>blood pressure</topic><topic>Delayed-Action Preparations - administration & dosage</topic><topic>Delayed-Action Preparations - therapeutic use</topic><topic>Dose-Response Relationship, Drug</topic><topic>Double-Blind Method</topic><topic>Drug Therapy, Combination</topic><topic>Ephedrine - administration & dosage</topic><topic>Ephedrine - therapeutic use</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Nonprescription Drugs - administration & dosage</topic><topic>Nonprescription Drugs - therapeutic use</topic><topic>Obesity - drug therapy</topic><topic>phenylpropanolamine</topic><topic>Phenylpropanolamine - administration & dosage</topic><topic>Phenylpropanolamine - therapeutic use</topic><topic>pseudoephedrine</topic><topic>Weight Loss</topic><toplevel>online_resources</toplevel><creatorcontrib>Greenway, Frank</creatorcontrib><creatorcontrib>Heber, David</creatorcontrib><creatorcontrib>Raum, William</creatorcontrib><creatorcontrib>Morales, Silvia</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Obesity research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Greenway, Frank</au><au>Heber, David</au><au>Raum, William</au><au>Morales, Silvia</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Double‐Blind, Randomized, Placebo‐Controlled Clinical Trials with Non‐Prescription Medications for the Treatment of Obesity</atitle><jtitle>Obesity research</jtitle><addtitle>Obes Res</addtitle><date>1999-07</date><risdate>1999</risdate><volume>7</volume><issue>4</issue><spage>370</spage><epage>378</epage><pages>370-378</pages><issn>1071-7323</issn><eissn>1550-8528</eissn><abstract>GREENWAY, FRANK, DAVID HEBER, WILLIAM RAUM, AND SILVIA MORALES. Double‐blind, randomized, placebo‐controlled clinical trials with non‐prescription medications for the treatment of obesity. Obes Res.
Objective: Phenylpropanolamine (PPA) and benzocaine are non‐prescription medications approved for treating obesity. The dose of PPA for weight loss is 75 mg/day. PPA has the same chemical similarity to pseudoephedrine that amphetamine has to methamphetamine. Because benzocaine causes weight loss by altering taste and PPA by central appetite suppression, they may induce additional weight loss when combined. These studies explore the safety and efficacy of low‐dose PPA, pseudoephedrine, and PPA with benzocaine in causing weight loss.
Research Methods and Procedures: Study 1 compared PPA 12. 5 mg tid with 25 mg tid and placebo in a 6‐week trial in 108 obese subjects. Study 2 compared pseudoephedrine 120 mg/day and a placebo in a 12‐week trial with 72 obese subjects. Study 3 compared 4 groups of 20 obese subjects using PPA 75 mg/day, benzocaine gum 96 mg/day, PPA with benzocaine gum, and a placebo over 12 weeks.
Results: Both doses of PPA gave twice the weight loss of placebo, but the difference did not reach statistical significance. Pseudoephedrine was no different than placebo in inducing weight loss. The PPA with benzocaine group had more adverse events than the benzocaine group (p = 0. 03), the placebo group (p = 0. 03), or the PPA group (p = 0. 09) without additional weight loss.
Discussion: We conclude that further studies with low‐dose PPA for weight loss are indicated, that pseudoephedrine is not effective for weight loss, and that adding benzocaine to phenylpropanolamine increases adverse effects without increasing weight loss.</abstract><cop>Oxford, UK</cop><pub>Blackwell Publishing Ltd</pub><pmid>10440593</pmid><doi>10.1002/j.1550-8528.1999.tb00420.x</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Obesity research, 1999-07, Vol.7 (4), p.370-378 |
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| source | MEDLINE; Access via Wiley Online Library; EZB-FREE-00999 freely available EZB journals; Wiley Online Library (Open Access Collection) |
| subjects | Adolescent Adult Aged Appetite Depressants - administration & dosage Appetite Depressants - therapeutic use benzocaine Benzocaine - administration & dosage Benzocaine - therapeutic use blood pressure Delayed-Action Preparations - administration & dosage Delayed-Action Preparations - therapeutic use Dose-Response Relationship, Drug Double-Blind Method Drug Therapy, Combination Ephedrine - administration & dosage Ephedrine - therapeutic use Female Humans Male Middle Aged Nonprescription Drugs - administration & dosage Nonprescription Drugs - therapeutic use Obesity - drug therapy phenylpropanolamine Phenylpropanolamine - administration & dosage Phenylpropanolamine - therapeutic use pseudoephedrine Weight Loss |
| title | Double‐Blind, Randomized, Placebo‐Controlled Clinical Trials with Non‐Prescription Medications for the Treatment of Obesity |
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