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
Hauptverfasser: Greenway, Frank, Heber, David, Raum, William, Morales, Silvia
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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.
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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. 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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. 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dosage</subject><subject>Nonprescription Drugs - therapeutic use</subject><subject>Obesity - drug therapy</subject><subject>phenylpropanolamine</subject><subject>Phenylpropanolamine - administration &amp; 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 &amp; dosage</topic><topic>Appetite Depressants - therapeutic use</topic><topic>benzocaine</topic><topic>Benzocaine - administration &amp; dosage</topic><topic>Benzocaine - therapeutic use</topic><topic>blood pressure</topic><topic>Delayed-Action Preparations - administration &amp; 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 &amp; dosage</topic><topic>Ephedrine - therapeutic use</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Nonprescription Drugs - administration &amp; dosage</topic><topic>Nonprescription Drugs - therapeutic use</topic><topic>Obesity - drug therapy</topic><topic>phenylpropanolamine</topic><topic>Phenylpropanolamine - administration &amp; 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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source Wiley Online Library - AutoHoldings Journals; MEDLINE; 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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