Multi Centre Study

8/6/2019 Multi Centre Study

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'I lfernntio!lfl / Medica l R esearch

n McnsChen In clner ungewoh n rolygrophis.chc R e g i . ~ t n e r u n s c n ciDem bnrbiluntlrrcien St:hl.. frnll tel . 'u"l. 23, 11 J) :ur d e ~ I O r l e n S c h 1 i l r p o r l l ~ . _ nter5l1chllnsen mil meth aq llil lC"ln_n a \ i o n ~ p r i ! . r M ' t 1 A(l!" Pr r."rl.\" 25.

t::rap ic von S c h \ a f n . l r t Po l) _..s tne rung cn des Schlal p ro h bl lafstC.Ir u l,gcn noeh Anw enO;Jllg \" 0'1lI,iflO: da i'drdi::.in92 , )4 $>ro blem de r Effeklc yon le nHa\'mak:l ~ u r den R F.MA nr o..:ii t il>..uchungc-n yon hbhercil Dosen V(ll lI J " h " I ' l l ' d i l f " , 92 , 1090

.""aJ.:in g C)"c1e in hea lthy Su.bJU! \s.piJf1{ I, 7

& Schllrf " I Bi :lltere d sleep-dream p


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860f non-drug therapy in a weight reductionprogramme.

MetbodT he protocols used for. tb e ,four s tudies atseparate locations were Identical e x c ~ p t thaton e s tudy utilized behavioural modlficallooin addition to medicat ion in order 10 promoteweight loss. The method of behaviouralmodification used has been described elsewhere (Stuart 1976). Th e remaining threest ud ies specified no attempt to utilize diet,exercise, drugs (including diuretics), or othermeans that might cause weight loss. A totalo f 245 patieDts, between J8 and 70 years ofage, were ent e red into the four, studies all. of'' ''hom were al Jeasl15% Qver",cIght according10 criteria modified from statistical tables ofth e Metropolitan Life Insurance Company(Metropolitan Lire Insurance CompanyStatistical Bulletin J959 and J966). NODe ofthe- pAtients had any clinic.ally i g n i t i c a ~ t abnormalities otber than obesIty and they ~ l d no t use an\' anorectics just prior to o r dUringtb e study . Informed consent was obtainedfrom th e patient s..Maz.indo{ wa!' supplied in 2 mg opaquecapsules jdentical to that of place boo Throughou t tb e s tudy, medication was given ODceda ily o ne hou r before Lhe noon r o e ~ 1 . Following randomization, ~ 1 1 o f thc patlcnts wcrctreated fo r ODe week with placebo in order tominimiz.e th e sub seq uent placebo e-ffect.After this wee\..:, the patients entered the sixweek double-blind portion of the s tudy.Pre-treatment weights were calculated OD thebasis of tbe patients' weigbts at the end ofthe placebo period. Twicc as mnny patientswere i g n e d ra ndomly to maz.indo l therapy:1S comp nred to placebo therapy.

laboratory stud ies (ebe, urinalysis, SMA12. chest X-rays, EKG's, ophthalmologiCe . ' ( ~ m i n a t i o n s . his tory and p h y ~ j c a l examineIk/ (iom) wer e pe rrormed before, du r ing aod at111( \ . ( l n 0: the


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87R Walker, I M Ballard and J A Gold'llel'nOfiono l Medicol Restorchi .IoI(A1f \!jl lt li' ( W I \ ' C I OIlIIlN(; pv(no OR H t " O l w ( U P V 11...ll PO\ I J(N ISmore rrequent with acti veoratory te sts showed no ' JcHug except ro r one mazind ol \ ./t wbo developed a mild. ":>peni:l. which m ay have been f oCo mplete opbthalmologic

owed no cha nges. ~ 1and ma z.indol groups prove deqUivalent in their demo cteristics in di ca ting the , .,e init ia l rf'ndomization .d an d seven pfllients (4 3 %) r..rrom the studie ) largely ror i


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The Journa l of inrernat ional Medical R ese(Jrcll88W. AN WlICI

~ b r l n' l l "IIUl nOlll ,,lb, "Fill

taking mazin dol anu 4 2 ~ < ' of th ose receivingplacebo lo st I pound o r mo re per week . .

Swtisticfll analyses were p er formed u SlogdJt' pa ired 'I ' a nd nna lysis of cova riancewit bin and among trea tment groups. Norelat ionship was found by covariant anaJ)'5isbetween th e degree of weight Jo ss aDd th e pretreatmen t we ight level. Consequently,o.tbsolute weig ht Jos s was lIsee! as the measureof efficacy. Fo r signlficaoce to bepresent , a si g.n iticance level of 0 0) Or less\ \ i " ~ used see n in T::Jhle 1. ne ither thein dividual s tlHlies Ill)!" the po oled d ata showed:1 a l l 3 . ( ! 1 ) ' !. igmficilnt we lghl loss fo r th epla .: ebo trou p C"\a p! for i l l! 0 ) " ( ' :' II HI : where~ : h : l \ : ( ' l I mcddII.:HI :e Jl wns u!>cd Thern .:v indol group sho \\ cd a st.:Hl sllc a lly sig nifl..;an l weight loss compared 10 th e pl(lcebngroup fo r the pooled u i e ~ as we ll as a ll th eincli ....idurt l studies, again with tbe exceptionof the oo e usmg be havio ur a. l modlfica ti on . Inthe latler study, the greater mean we ight los sof 2 4 po unds/pat ient by the IUnindol

_ _ _ _ pU.C{IO

J( U ~

" " \I "" " "

pa ti en ts compared to the placebo over six weeks was no t statistically s li'goJo in each group . Compared t reatme nt, the p oo led an d at! moz indol groups showed f\ significant weight loss .

Discu3sioo Th e effectiveness of a m p h e t a m l D e ~ J i k dm gs as ano rec tics bas rece ntl y been ScoviUe utilizjnl; d(ll a from over con trolled puaJlcl studic!:a sub mi u ed rD A (Sco'lile J97b). T he mean :lve rag ed O 56 pound3. p: r week p:lItc nts rece iving acti \'c dr ug th an re cej"ing placebo . EYJ luJling the te rms or t h ~ pe rcen ta ge of p atient s one pound o r n1MC per week showed ove r [our wceks. 6 8 / ~ of those receiving ad, dr ug an d 46 % of th ose receivin adueved this deg ree of wcight Joss. 'HI)wt,vei

B R Walke r, 1 Iv ( Bollard

Melin ' fe li,:llf c : h a p o u n d s , '

PhtC""ebo - 0n == (lO)Vfaz iouol -7

"Behavioural motlific31iont4 Stl1! isIJc


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nrerflorlonal Medical Research B R Walker, I M Ballard and J A Gold 89

"Table IM un weight ehange.!i (pounds/patient) ufter ..Ix weeks of mAzindol or placebo tbnapy

Sludy

PlaceboMa7inda )

n=

I+0 , )(10)- 7 S ...,. ,(21)

2

+26(.I)-74-...( II )

3- 0 ,9(J )- 5 ,]".. ,(J )

4 '- 6 ' 0"(12)- 8' 4' "(26) ii

1- )+0, ](21)- 6 ' 5 ", ..(12)

1-4-I 4(40)- 7 0 ".. ,(98)

.BehAvioural mo dification w;od in bo t h gro ups"" Slat S lica lly signIfican t d ifierence from pre treatment (p < O' 01) SI:'I.t h ticaHy signiti co1n l d iffe rencc from placebo (p < OOJ).

II" \2

iH l:" Li to the placebo patienrs5was no t !itatisticaJly s ignificaut.)ecause of the small numbers ofI each group. C o m p a r e ~ t?the po oled oDd all the I n ~ l v ~ d ~grol1pS showed a statl stlca.lyweight loss.

I 'ss or ampbetamine-like d rugs , .... recently been reviewed byllc" l ; ..... '"100utilizing daHl from. over - hI parallel ~ t u d i c s s u b m l t t t ! ~ to t'II jt"}"!6). The me ;\n weIght ' l o 0 \ - lurO' _6 i' o un ds pe r week more . . d tha n for e ceIving 5 averaged ,bout I pound/patient/week greater with mazindol therap)' comparedto placebo therapy 10 those pll.tien1 s whorccci\'ed medica tioo only. Drop-outs du e top ~ : l i e n t di ssatisfac tion with Jack of weigh Iloss were higher ii i the placebo g roup. WhenI hI! prvgr


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Multi Centre Study