'Ilfernnt io!

lfl / Medica l R esearch

n McnsChen In clner ungewoh n
--':. rolygrophis.chc
ciDem bnrbiluntlrrcien St:hl.. frnll tel .
'u"l. 23, 11 J)
:ur
_' nter5l1chllnsen mil methaq llil lC"ln_
A(l!" Prr."rl.\" 25.
t::rapic von Po l) _
..stne rungcn des Schlal prohb
l lafstC.Irul, gcn noeh AnwenO;J llg \" 0'1
lI,iflO: da i'drdi::.in 92, )4$
>roblem der Effeklc yon lenHa\
'mak:l den R F.MAnr o..:ii til>..
uchungc-n yon hbhercil Dosen V(lll
92, 1090
.""aJ.:in g C)"c1e in healthy Su.bJU! \s.
piJf1{ I, 7
& Schllrf "I B
i :llt ered sleep-drea m p<ttlct n 1.
I PJyrh/(H(y, 23, 211
Ir"", E J, Scharf' M B & Rubin"k J'
and biocbemlCal ch:lngc!
Id with, lrawil l 0:' hypno ti c, In K :l1es
IIIld POllt%gf. A !:'y mpo.l i,lllr.
:::0. Phil ll :md Toronto
5k.i D R, F.ist1b lcin R B & Kell y 0 ,-\.
hUO'liln sleep arter t"lenl o':"o:l rbl ta1.
colo!!)' I) nd TlrerCJpffufl o . 13, n I
Imkins D
'Orll IOT)' adaplil lion in norm;Ji .!.u bject'l
)H!icnl1- r 'F:(SI n1pht effcc, ") !::Iarrt) .
" (mil Cllluw/ l .!,
rf M Morales F
'-- ., le un derivado bcnzoci:u.eprnico,
el EEG y e1 cicio de .Hleno en' 'Y
ISOl flr'lia. ACIO LIIII/Ion:,.er
rger R J
holia and A cont ro. led
J eye mQllemell! study of 510.
'hiUffJ 1{)9, 66
.,
iest R
te' t".scope the slee ping pi li h .. t"HL
j Juun li1f, 2, 1093
J rCI.:()rding or normal ond di u!!
In . Imi'ln. PrugrrJJ il/ Brall/
A & K;lifS A
1TI1IJo i of SWrldnrriiud TCT/ll inll /Ji> '.
... 1 Sr,''''' .',)"ff
A
'" /tlr S ftt"/l S
Pubh: St n iI.);, {jo\ en.
SU" i D .C.
J Inl Med Res (1977) S, 85
A Multicentre Study Comparing Mazindol and Placebo in
Obese Patients
Barry R Walker", :YID, Ian M Ballard, MD and Jerome A Gold, MD. Labo)' arones,
Radllor, Pennsylvania, USA
r J"Waz{mJol is chemically unrelated 10 the phent'thyJamilles find IWJ IIOt
Jhuwn the side-effects or abuse pOlen/ial of the amphnamillc ClJlorectics .
To further define ils pOlentiJ:Jl lo! causing wl'igh, loss, {j six-wC"ek (:allble
blinn pluabo con/ rolled stud)' was undaraken in (ollr ccntN!5. A cumlnUI1
pru/ocD' 'NllS used e.'Capl that in aile cenlre, belt(Jvlr!Ural modiflOliuli also
Well' employed, whereas ill the other centres, no addiliollfll mea5llreS I',.ere
I/!,'ed /0 calise weigh I loss. TIVO hundred and forly-five ohe.u palienls Wffre
(lssilfled !andolnly 10 tWl) mazindol groups and one placebo group ilt each
rentr'. find forty parien/!J' rel:eivillg mazirrdol alld plut"l-oO
respect ively completed Ihe protocol, The conclusions were: (a) 110 Sigl1ificoll/
clilliraf or lab.oratory nfmnrrna/il ies o(;wrred Irom fl/ fl z;IIdo/ therapy,
(b) I/I e: placebo therapy patiems di d nor loslo! weight willwul
mod.'ficlltiun, ( /') /;', J,larc/'n rherupy Kroup had a It iklter drop-out ra/I'
compau '" to tile mn=indo/ rherapy group flll ribulob/e 10 the potielJ l s' dis
satisiaction with fuil ure to fose weigll/, (d) 1nm:;ffdol therapy wi/haUl
bl'ilfHic>uru( modifica/ioll and beha",iollral mOdificarion alone both rnulln!
in a slatisficully slgnijicw/l mt"all wt'igltr loss all poundl patiC'fl l / lvaA. ilnd
(e) mo.zilldul plus hrhal'ioura/ modificalion uSII/red in (J greruer mean
II'('/KIII /VSJ of l J2 pUIIIIJ!paticlIl/wr:ek !hWI wifh m odlpca/1U1I
alune. Hence, ma-rindo! 0/ value in !he Initial therapy of obesl?'J
Introduction ca use weight loss has been reviewed r ecently
(Eva n, & Wall ace 1975, Gomel 1975,
apparently because il is not
Hebel )975, Sedgwi ck 1975). HOW'''Cf, in
Che mically rel<ltcd !O the phcnclhylamines,
most of these studies, the possi ble concomi
not shown the si dceffects or abuse
(8.nt effect of dietary restriction has 'H.H
(I(1lenfill! of the anorecti cs
well defillcd. In order 10 c:v(\ !uate marc
( Dyke s 1974). The ab'lily or maLindo) 10
dclinlt el y the value of mali ndo! in weight
reduction in the abse:lce ofdif' lary res.rriCli t1 n,
a mullicentre sludy involvi ng larger numbers
"'Send rqm nt reqll ests 10 : B arry R. Walker, MD
of pati ents than previously reported WJ S
S":lII or D ircctor of
undertaken. In addition, one of the studi es
W yclh
empl oyed beh<lviouraJ modifi cation in In
P.O . "Box 8299
Philadelphia, Pennsylvania 19101 , U.S A.
attempt to c-vn!uate the comparJtive benefit s
Material may be protected by copyright law (Title 17, U.S. Code)
86
0f non-drug therapy in a weight reduction
programme.
Metbod
The protocols used for. tbe ,four studies at
separate locations were Identical that
one study utilized behavioural modlficalloo
in addition to medicat ion in order 10 promote
weight loss. The method of behavioural
modification used has been described else
where (Stuart 1976). The remaining three
st udies specified no attempt to utilize diet,
exercise, drugs (including diuretics), or other
means that might cause weight loss. A total
of 245 patieDts, between J8 and 70 years of
age, were ent ered into the four, studies all. of
''''hom were al Jeasl15% Qver",cIght according
10 criteria modified from statistical tables of
the Metropolitan Life Insurance Company
(Metropolitan Lire Insurance Company
Statistical Bulletin J959 and J966). NODe of
the- pAtient s had any clinic.ally
abnormalities otber than obesIty and they
not use an\' anorectics just prior to o r dUring
tbe study. Informed consent was obtained
from the patient s..
Maz.indo{ wa!' supplied in 2 mg opaque
capsules jdentical to that of place boo Through
out tbe study, medicati on was given ODce
daily o ne hou r before Lhe noon Follow
ing randomization, o f thc patlcnts wcrc
treated for ODe week with placebo in order to
minimiz.e the subsequent placebo e-ffect.
After this wee\..:, the patients entered the six
week double-blind portion of the study.
Pre-treatment weights were calculated OD the
basis of tbe patients' weigbts at the end of
the placebo period. Twicc as mnny patients
were ra ndomly to maz.indo l therapy
:1S compnred to placebo therapy.
laboratory studies (ebe, urinalysis, SMA
12. chest X-rays, EKG's, ophthalmologiC
his tory and examine
Ik/
(iom) wer e perrormed before, dur ing aod at
111( 0: the <;fu dy.
Reo;ults
During the studies, no adverse effects were
reported other than tho)e previously reported
wit h rna.z.in dol (e.g. nervousness , dry mouth,
diZZiness, elc.). No changes in vitaJ
signs were found. Side-effects were mild and
The Journal 0/ lnternaf;onallv(edica{ Research
were omy slightly more frequent with active
therapy. The laboratory tests showed no
changes due to drug ex.cept for ooe mazindol
treated patient who developed a mild,
reve rsible leUkopenia whicb may have been
drug-related. Complete ophthalmologic
examinations showed no cbanges.
The pl Hcebo and mazindol groups proved
to be statistically equivalent in tbejr demo
graphIC characteristics indicating tbe
adequacy of the initial rando mizati o n.
One hundred and seven patients (43 %)
were excluded from the sludies largely for
non-compliance with the protocol. Tbose
included in the efficacy analyses were
approximately equally distrjbuted between
the pooled placebo and mazindol groups i.e.
98 of tbe J 58 patients (62 %) originally in lbe
placebo group . Drop-outs seemed to be more
frequent in the placebo group because of
patient dissatisraction with the failur e [Q
weight.
Figure I shows the mean weight chBng!:s
of the l38 patient s in [he four studies who
completed tho 6 week double-bliod study. The
mazin dol treated pa.tients lost a mean or
5'6 pounds/patient more than the placebo
patients over the 6 weeks. The placebo group
lost a mean of J7 pounds/patioDl.
Figure 2 shows the mean weight changes of
the three studies of tbose patients completing
sill weeh in wbicb no modality ot her thau
drug or placebo therapy was employed that
might encourage weight loss . The results
remain esse nliaJJy the same although, by
excluding the single study eDlploying
behavi oural modificati on, no weight loss
occurred in the pooled place-bo group while
the pooled mazindol patients lost a mean or
6 6 pounds/patient more tban tbe place bo
patients after six weeks of tberapy.
3 shows the weight loss jn bo th the
pl acebo and maz.jndol groups in the one !:. t uuy
where behavioural modification was used.
Compared 10 the control perjocl, the placebo
paticolS lost a meZln of 6 pounds/patient;
where:!", t he mazindol palie nts lost a me-;J.:1
or 8 4 potlO(h! p.<Iti cnt over six weeks.
Fif1v-six per ceot of those patients recei ving
mazindol and 7 %of those re-ceiving pl acebo
lost I pound or more per week excluding the
!:>tudy using behavioural therapy.
behavioural ther:lpy was used , ijS %of those
- .,
B R Walker , I ;If BaJ
t
r
r
1
J. BI
,

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Fig 1
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3 .,(

.,

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..,

Material may be protecled by copyright law (Title 17, U,S. Code)
- ---
87
B R Walker, I M Ballard and J A Gold
'llel'nOfionol Medicol Restorch
i
.IoI(A1f \!jl ltli' OIlIIlN(; pv(no OR 11....ll PO\ I J(N IS
more rrequent with acti ve
orat ory tests showed no
' J
'-"cHug except ro r one mazind ol \ ./
t wbo developed a mild.
"
::>peni:l. which may have been f
o
Complete opbthalmologic
bowed no changes. 1
and maz.indol groups proved
ally eqUivalent in their demo
racteristics indi cating the
,
.,
Ie init ial rf'ndomization.
:d and seven pfllients (4 3 %)
r
..,
rrom the studie ) largely ror
i <
;e wjth the prot ocol. Those
the eAicacy analyses were
. J
equall y distributed between ..
lcebo and ma.z.indol groups i.c.
patient s (62 %) originall y in tbe
\. T)rop-out s seemed to be mo re
."
.,Iacebo group because or
.ion with (he failure to lose
hows the mean weight
atieots in the four studies who
,6 week uouble- blind S1udy. The
Fig 1
:ated patient s lost a mean or
patieot more than the: placebo
WAN
the 6 weeks. The placebo group
of 17 pounds/patient.
.J
1""'''S the mean weight chan ges of
.J
or those pC:ltients completing
.,
.lich no modality other than
'!!6o therapy was employed that
urage weight loss. The results
nt ially tbe SaJT1e although, by
the si ngle study employing
I
'l. ,\f
modification, no weight loss
tbe pooled placebo group while .} '.,1

g .J
g . .....
j , maz.indol patients lost a mean or
z .J
./patient more than the pl ficeb0
_)':1\ J ../---_ . - --
! r - weeks of thNap)".
, ., 51. .. the weight loss in both the
mazindol in t he one study
..
Ivioural modification was used.
. 0 the conlrol per iod. the placebo
.,
i l 3. of 6 pounds, pali" :H:
TO
(" p:J li cnts iml a jTI<,:t! n
ld s/ p:1ti cnt ove r si.'(
r
)
per of those pJ. tie nts receivi ng
W[(lS
od 7% or those recdving placebo /1
!'ll lt\XI
"
17 /I /I
d or more per week excl uding "
"n 11 10 11
g Ihua py. Wht' n " "
I therapy was used, 85 % or those
---- ' tAcno
- MA Z'''OOl
'.."<>.
- .... -0-- - - - .. __ ___ 000-. - __ "
., ,.
..
.,
..
"
WEICH! CIWVG( DlAI:1 NG
---- f'Vl.C(SO
-- MAZlkOOl
__ _ -o- ___-c::- ___ ... --<>----o
Material may be prolected by copyrighllaw (Title 17, U.S . Code)
The Journal of inrernat ional Medical R ese(Jrcll
88
W. AN WlICI<! OURI NG PLACi IO 'lMl l';DOI IHf 1iAPY
II I
COMIIN( I:)
:Jl
.,
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1
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IIUl ln Olll ,,lb
1- ,
"
Fi ll
.j' 'k
taking mazindol anu of those recei ving
placebo lost I pound or more per week . .
Swtist icfll analyses were performed uSl og
dJt' paired 'I' and nnalysis of covariance
wit bin and among treatment groups. No
relat ionship was found by covariant anaJ)'5is
between the degree of weight Joss aDd the pre
treatment weight level. Consequentl y,
o.tbsolute weight Jos s was lIsee! as the measure
of efficacy. For signlfi caoce to be
present , a si g.n iticance level of 0 0) Or less
r'
used seen in T::Jhle 1. neit her the
I"
in dividual stlHlies Ill)!" the pooled d ata showed
I ' :1 !. igmficilnt welghl loss for the
,. pla.: ebo trou p C"\ a p! for ill! 0 )"(' :' II HI: where
mcddII.: HI :e' Jl wns u!>cd The
rn.:v indol group sho\\ cd a st.:Hl sllcall y signifl.
.;anl weight loss compared 10 the pl(lcebn
group fo r the pool ed as well as all the
incli ....idurt l studi es, again with tbe exception
of the ooe usmg behavio ura. l modlfica ti on . In
i
the latler study, the greater mean weight loss
,.
of 2 4 pounds/pat ient by the IUnindol
.
___ _ pU.C{IO
J

"
"
\I
"
0
" " "
pa ti ents compared to t he placebo
over six weeks was not statistically sli'goJo<:
probably because of the numbers
patient> in each group. Compared
t reatment, the pooled and at!
mozindol groups showed f\
significant weight loss .
Discu3sioo
The effective ness of dmgs
as ano rectics bas recently been
ScoviUe utilizjnl; d(ll a from over
controlled puaJlcl studic!:a submi ued
rDA (Sco'lile J97b). T he mean
:lve raged O 56 pound3. p: r week
p:lItc nts receiving acti \'c dr ug than
recej"ing placebo. EYJ luJling the
terms or percen tage of patient s
one pound o r n1MC per week showed
ove r [our wceks. of those recei ving ad,
dr ug and 46 % of those recei vin
adueved this degree of wcight Joss. 'HI)wt, vei
B R Walker, 1 Iv( Bollard arr )
Melin ' fe li,:llf

PhtC""ebo
- 0). I
n == (lO) I
Vfaziouol
-7 l..1
"Behavioural motlific31ion U$td
t4 Stl1! isIJc<llIy differw
f' _ Stali slically uifTC' rc n
io only 40 %of the studie.
receivi ng D.c tj ve drug Jose .sip I
(p < O 05) than did'
receivi ng p lacebo. rODcom
re.s: riction, present in maay Ot\
cowld be responsible both for If
in the gro up th.' ,
. cant difference between the pi<IC
ther.apy groups in thc majority (
Uolortunmely. Scovi lle did " 1
effect o( d ietary n:strictioo
.The present six-week mun' .
parallel studv ,
usefdllt' 'i'i of malindol in J
of In o rder to more n
1hef
realisti, conditions, di et wa5
Weighlloss averaged abo ut I
week greater wi th malindo! the
placebo therapy in thost
meciica[ion o nly.
pallent wi!.!
loss were higher in the plan
the pr ogr.lI nmc of compreheilSi\,
moji/ication designed to redu,,;::
"'.:1$ added 10 t)r rl:J /li
m eaD \\eight loss Wil !; Itbt'tI
g reat er in the
pat lC ltS. This in
Oct ween acti ve and placebo
that by Scovi lle
restnC'lion also was lIliJized in
Huoies mcluded jn his pooled
1976) . In ou r st udy, mazindol
to pre
the individual
slatis1ically
'
to

revjewe<i by
: 00
to the' .
weigh t loss
more for
lo r :110:-(
da tJ In
l osi ng.
.
10
Materi al may be protecled by copynght law (Tille 17. U.S. Code)

I
---
nrerflorlonal Medical Research
B R Walker, I M Ballard and J A Gold 89
"
Table I
Mun weight ehange.!i (pounds/ patient) ufter ..Ix weeks of mAzindol or placebo tbnapy
Sludy
Placebo
Ma7inda)

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)
i
i
1- )
+0, ]
(21)
-6'5"
, ..
(12)
1-4
-I 4
(40)
- 7 0"
.. ,
(98)
.BehAvioural mo dification w;od in bot h groups
"" Slat iS li cally signIficant d ifierence from pre treatment (p < O' 01) .
SI:'I.t h ticaHy signitico1n l diffe rencc from placebo (p < OOJ).
II
"
\2

iHl:" Li to the placebo patienrs
'-...... 5was not !itatisticaJly significaut.
)ecause of the small numbers of
I each group. t?
the pooled oDd all the
grol1pS showed a statl stlca.ly
weight loss.
I
'ss or ampbetamine-like d r ugs
, .... <> recently been reviewed by
ll c" l;..... '"100
utilizing daHl from. over - h
I parallel to t
, 'II jt"}"!6). The me;\n weIght
0\ - lur
O' _6 i'o unds per week more
. . d t han for
receIving <tt:t lve rug .
placebo. Evaluating the don n . In
, the percentage of patiepts l O') lpg
k howed th,t
.nd or more per wee S . . '\'c
r weeks, 68 %of act!
,d 46 % of lbos
e
. reCC:l
v1
n
g
}j()w,:ver;i!'1!\
I tbis degree of weight loss.
in only 40% or the studies did the patients
receiving acti ve drug lose significantly more
weight (p < 0'05) thao did the patients
recei ving placebo. Concomitant dietary
restncllon, present in many or these studies,
could be respon si ble bot h for the weight loss
in the placebo group "nd the Jack of signifi
cant difference between the pl acebo and active
1her... py groups in the majority of tbe patiems.
Unfortunately, Sco",jlie did not report oc the
eHect of dielary res triction in the studies.
The present multicentre placebo
conlrolleJ par;dlel study confirmed the
usefulness o r mfl/.indol in the initial therapy
0: 1n order to more nearly simulate
realis tic conditions, diet was unrestricted.
Weight 10>5 averaged ,bout I pound/patient/
week greater with mazindol therap)' compared
to placebo therapy 10 those pll.tien1s who
rccci\'ed medi ca tioo only. Drop-outs due to
di ssatisfaction with Jack of weighI
loss were higher iii the placebo g roup. When
I hI! prvgr<llllme of comprehenSive be haviou ral
;r;odincBlion designed 10 red uce caloric int ake
\\i.tS added t o place bo or mn indol Lhe-rapy,
n )eil lJ. IVrl S sliH <IDOlIl J/l pound/
PJ ti cnt,'wcek grc:llcr in the m(l l indol trealed
p:ltients. This difference in weight loss
between active and placebo groups is identical
to that reported by Sco\'i lle where dietary
lI.Jso was utilized in many of the
. included in hi s pooled data (Scoville
.10 our study, mazindollherapy without
behavioural modification resulted in the same
mean weight loss of 1 pound/patient/week
afier six weeks as did behavioural mOdifi ca
tion alone.
No single method of produci og weight loss
in unselected groups of patients has proved
to be totally satisfaclory. Attempt s II I dietar),
restriction alone, even with such complex
and costly methods behavioural modifica
ti on, orten result in high drop-out rates due
to patien t d..isS'Hisfaction with the early rate
of weight loss . Consequently, jt would seem
that an Dno rectic drug with rew si de-effects
such as mnziodol, is n userul nddition to the
inilial therapy or obesity. Mazindol has
several unique potenlial advantages over
amphetamine aoorectics. For example, of all
the anorectic drugs
l
onl y mazindol
to be without effect on lipid metabolism;
whereas. the amphetamine drugs all increase
the plasma concentration of f ree fatty aCId
and glycerol (Sinori, Hurwitz & . Azarnofl'
1971 ). Malindol al so appears to have a
unique fiction o n the sept al region or (he
brain, resulting in it s cenlrll) effecI o n appe- t ife
(Gogerly "I 1975) , In add ition, ma / indol
seems to prOID(l(e a wasting of calorIes,
lead ing to weight by a peripheral
u1i1i la ti on or energy SHbSl rates (Kirby &
Turner 1976). For these re:1sons, mazindol
may be the prererred anorectic where
adj uactive drug therapy is utilized jo a weight
reduction programme.
Material may be protected by copyright law (Title 17, U.S. Code)
, , !
'. . /i
90
'.
AcknowJedgemen Is
'I
Appreciation is expressed t o Hyman
Menduke, PhD for the statislical analysis.
ii,
_I l!
Doctors Cob eo, Goodner and McMahon for
conductj ng tbe individual studies 00 which
"
tbe pooled data was based and Misl E
DrusciLla Mutin and Mrs Diane S McKibben
for secretarial assistance.
The study was supponed by graots ffClm
Wyeth Laboratories, Radnor, Pennsylvania,
USA.
REFERENCES
Dl' kESMH M
(1 Y74) I'slualion or T hrte Clorlermine
HydrocW0ridc l Vanni), Fcnflurarnine Hydrochlorice
(Pondimin), aod Mazinda) lSanore:t). Th,. Journal
nf (ht A meriroll ."vIt'.hcnl ASSOClJ liOn 230, '270
.E vans: E R & WSl Uace l\1 G
(J97.5) A Tri31 or Malindal ('Teronac')
in General Praccice in Trel<1nd . Medir:nl
Re;cnrr/J and Opjlli(JlI 3, 132
Gogerty J PenbeJ1hy C, loda L C & J H
' .'
(1975) Pharamcological Analysis or a Nc,w Anon:.\ic
5-H.vdro;\y5 (4CblorophenyJ)2, 3-Dihy
;.
:1"
,'
dro-.5 H]midazo-(l, J A) l soindole ( Milz..i ndol).
, ! '
The Journal of Inl emotioonl .tfedicul R"s(!nrr/;
Archil'fS of III/ e,."ot ional P/rnfIllQCodnlClf1liC" s . ,
114. 285 . CII..
Comet: G
(1975) Obese Pl\tienls in GeoerolPractic<: : A Compa, '
son of the Anorectic Effect of Mnzindot, ,
and Plactbo. Clinical Trials IVlullo/H, ) 8 ne
Heber K R
(J 9?5) Do ublc:-Blind Tr;31 or in Overv. t' i&ht
PatlcnlS_J\.fedlC"ollourfll1f of Aumolio 1, 566
Kir by M J & Tomer P
( 1976) Do " Anorectic" Drugs Produce Wetght Lu' s
by Appetite Suppress .on ' . LLIm:et J, j66 '
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D.C., 11,44) , '
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(1975) Mat indol in .be Trca(meru or Obes il y_ TIlt'
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11 441
A Comparative S '.
in the Treatment 0

ij
A Has.'li3u, MD, A. bbossia
J .C:ippel, US Nnvol JVedic
Z Fari d, US No val Medica ,
S S Tadros, E R Squibb &
:"\"1 Brian, Abbassia Fe ver If,
(' f;'
,
10o
Ll'
.....it
fail
afr
/1I t"
chemically design
p rru no-,' -(1 4-cycJobex;,die
LlcicJ, IS a DC
, stnlc[uraJly reJated
Epid ll in has been
lmcnt o r U(in:H"y tract Ii ,
& A damson
1973) rt ld in upp.-r respirat or'
(C;tHd io En:). Eiftcacy 01
e.... In 603 p::n;e:1 S
, ,md Gramneg
.. m of the Icspi ra
Olesri nal t ract, skin a
salisrac lory response (Be
1971).
aim of tbis work is t
ef.",,,, of oral epicillin and c "
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