am j clin nutr 1976 stein 940 8

7/27/2019 Am J Clin Nutr 1976 Stein 940 8

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o rig in al c ommun ic atio n s

94 0 The Am erican Journal of C linica l Nutrition29 : SEPTEM BER 1976, pp. 940- 948. P rin ted in U .S .A .

Ineffectiveness of hum an chorionic gonadotropin

in weight reduction: a double-blind study13

Mark R. Ste in ,4MD ., Rona ld E . Julis, M .D ., Carl C . Peck,5M .D ., W illiam H inshaw ,6M .S .

Hosp. Pharm ., John E. Sawicki, M .D ., and John J. Deller, J r.,7M .D .

ABSTRACT Our investigation was designed to rete st the hypothesis of the efficacy of human

cho rionic gonado tropin (HCG) on weight reduction in obese women in a clinic setting . W e sough t to

dup lica te the A sher-Ha rpe r study (1973 ) wh ich had found tha t the com bination of 500 cal d iet andHCG had a statistically significant benefit over the die t and placebo combina tion as evidenced by

g rea ter we igh t lo ss and decrea se in hunge r. Fifty-one wom en be tw een the ages o f 18 and 60

pa rtic ipa ted in our 32-day prospective , random ized, doub le-blind comparison o f HCG versus

placebo . Each patien t was g iven the sam e d iet (the one prescribed in the A she r-H arpe r study), was

weighed daily Monday through Sa tu rday and was counselled by one o f the investigato rs who

adm inis tered the in jections. Laborato ry studies were pe rfo rm ed at the tim e o f initia l physical

exam inations and at the end of the study. Twenty of 25 in the HCG and 21 of 26 pa tients in the

placebo g roups com ple ted 28 in jections. There was no statistically sign ifican t difference in the m eans

of the two groups in num ber o f in jections received, we ight loss, percen t of w eight loss, hip and waist

circum ference, w eight loss per injection , o r in hunge r ratings. HCG does not appear to enhance the

e ffectiveness o f a rig idly im posed reg imen for weight reduction .Am.J. Clin. Nutr. 29: 940 -948,1976 .

In 1954 , Sim eons (I) published his tech-nique for obese persons to achieve rapid

weight loss w ithout severe hunger. The pro-

gram was designed for clinic patients. H is

method, which has undergone some m inor

modifica tions (2), consists of a rig idly struc-

tured 500 calorie diet and intram uscular

injections of 125 units of human chorionic

gonadotropin (HCG) given during clin icweight checks 6 days per week (1-5). Sim eons

(1-3) has cla imed that weight loss with this

combination is more successful than weight

loss achieved w ith a 500 calorie die t a lone

because HCG suppresses appetite and

im proves m ood; thus, the patient compliesbetter w ith the prescribed die t. H e cla im ed

patients w ill lose an average of 250 to 600 g

per day. The reported side-effects were hypo-

glycem ia, increased lib ido, and gout (1).

Numerous reports have been published

attempting to support (5-10) or to disprove

(11-15) the Sim eons theory on the usefulnessof HCG in weight reduction. However, until

A sher and Harpers report (4), there had not

been a well-designed, prospective , random -

ized, double-blind study comparing HCG and

From the Departmept o f M edicine, Pharm acy Se rv-

ice, and Department of P athology, Le tterman A rm y

Medical Cente r, and Letterm an A rm y Institute of

R esea rch , P re sid io of San Francisco, Ca lifo rn ia .

2 The opin ions and asse rtions con tained herein a re the

priva te views of the au tho rs and a re not to be construed

as officia l or as reflecting the view s of the Depa rtm en t of

the A rm y or the Depa rtm en t o f Defense .Addre ss rep rin t requests to Techn ica l P ub lica tions

Editor, Letterman A rmy Medical C en te r, P residio o f

San Francisco, C aliforn ia 94129 .

Curren t add ress: Depa rtm en t of M ed icine, Fitzsi-

mons A rm y Medical C en ter, D enve r, Co lo rado80240. B lood Transfu sion D ivision, Le tte rm an

Army Institute of R esearch. e Curren t add ress: 7454

M ill Run, G erm an town, Tennessee 38138 . Chie f,

D epartment o f Medicine, Letterman A rm y Med ica l C en -

ter.


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HCG IN WEIGHT REDUCTION 94 1

placebo in the setting designed to test the true

Simeons technique. Their study (4) yieldedevidence that HCG had a statistical ly signif i -

cant benef i t over placebo; this was reflected

by a signif icantly greater mean weight loss,mean weight loss as percentage of ini tialweight, mean weight loss per injection, and

decrease in hunger.W e reviewed A sher and Harper s original

article (4); the analysis of the investigators

statistical presentation by Hirsch and V anItal l ie (16); the rebuttal by A sher and Harper

(17), and the Food and Drug A dministra-

tion s reports (18, 19) which asserted that

HCG has not been demonstrated to be anef fective adjunctive therapy in weight reduc-

tion programs. W e reviewed the original

protocol of the A sher-Harper study, (D r. W .L . A sher kindly provided us w ith a copy of

the original A sher-Harper protocol , enti tledA SB Double-bl ind HCG Study ). Then we

designed our investigation to retest the hy-pothesis of the eff icacy of HCG and incorpo-

rated into our design the essential features ofthe A sher-Harper study. W e hoped that a

duplicate study performed by a differentgroup could help to settle the controversy

about the role of HCG in the treatment of

obesity.

M aterials and methods

Pa tients we re solicited for the study by an announce -ment in the medica l centers bulle tin. All respondentswe re screened by a questionna ire and each received a full

explana tion of the double-blind nature of the study.

E ach patient selected gave he r informed consent to

pa rticipa te . A pa rticipant was given a complete physical

examination and a battery of labora tory tests including a

complete hemogram, chemistry screening tests, thyroid

and pituita ry function tests, and was then was assigned a

pa tient number. (The sequence in which pa tients took the

physical examina tion arbitra rily determined the identifi-

ca tion number.) The numbers were randomized into two

treatment groups by a registered hospita l pha rmacist. All

subjects we re given thorough instructions on the diet planby two sta ff dieticians. The entire study group began the

injections and diet on the same day. The study pe riod,

lasting 32 days (April 21 to May 22, 1975 ), did not

include any holidays traditiona lly celebrated in theU nited S tates.

P atie nt se le ctio n

All patients were women between 18 and 60 years ofage who voluntarily responded to the announcement.Race was not a factor in the selection. No one with more

than minimal health problems was accepted. In particu-

lar, pa tients with a history of heart disease, renal disea se ,

asthma, gout, hypoglycemia, migra ine , genita l malig-

nancy, or brea st ma lignancy were excluded. All patients

had to be well-motivated, be willing to obtain a postagesca le to we igh the ir food, and be ava ilable to come for a

clinic visit every morning Monday through S aturday forthe entire study pe riod of 32 days. A person was excluded

if she I) had been trea ted with HCG previously; 2) ha d

taken appe tite suppressants in the preceding 3 months;3)

had a base-line weight which was greate r than or less

than 10 lb of wha t it had been 3 months be fore the study:4) was pregnant, within 4 months postpartum, or nursing

an infant; or 5) had been taking medications othe r than

estrogens or birth control pills, (exceptions a re noted inTable I). Pa rticipants had to bebetween 20 and 60pounds ove r the idea l we ight pe r given he ight. Ideal

we ight was de fined as the midpoint of range a t a given

height for the appropria te frame size according to

M etropolitan Life Insurance tables, (exceptions are

noted in Table I).

P aram ete rs m easured

On -a da ily basis, during the morning clinic hours

(be tween 8:00 and 11 :00 AM ) Monday through S atur-day, each patient, wearing only minimal unde rclothes,

was weighed after voiding. The same two nurses regis-te red the weights throughout the study. At this time, thepatient a lso indica ted her degree of appetite according to

the following five -point scale :I) absence of appe tite (can

hardly ea t all the food pe rmitted): 2) norm al appetite

(content with the food allowed); 3) mildly hungry (would

ea t more food if permitted); 4 ) mode rta tely hungry

(desire for food is bothersome); and5) se ve re h un ge r(de sire more food most of the time and have been

tempted or have eaten more ). E ach patient had he r

progre ss reviewed by one of the investigators who was

unaware of the pa tients trea tment group.

On a weekly basis, a sitting blood pressure , and hipand wa ist measurements were obtained by the same

nurse. E ach patient had at le ast a weekly inte rview with

th e d ie tic ia n .

A the conclusion of the test period, a second comple tephysica l examination was performed and the labora tory

survey was repeated for each participant.

injections

The HCG was purchased from Park-Davis and Com-pany, De troit, M ich. A registe red hospita l pha rmacist

packaged each individua l dose in a gla ss (disposable)

syringe , labeled with the corre sponding patient number.Each syringe conta ined a 1 ml volume of e ithe r 125 units

of HCG or norma l saline (the standard diluent for this

HCG), and each appeared identica l. A fresh supply for

each pa tient was prepa red eve ry 10 days and kept un-der refrige ration. One ml injections of still cold solution

were given deep intramuscula rly in the uppe r outer

quadrant of the buttocks by a nurse who did not know

the contents of the syringe. P atients returned to the

clinic, which was conducted on the Metabolic W ard,

Le tte rman Army Institute of Research, 6 days eachweek for 28 consecutive injections over a 32 -day te st

period.


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94 2 STEIN ET AL.

Die t

The die t was identical to tha t used in the protocol of

Ashe r and Harpe r, (W . L. Ashe r, M .D ., E xecutive

Director, American Society of Bariatric P hysicians,pe rsona l communication). Pa tients were encouraged to

drink 8 to 10 glasses of wa ter da ily and were advised of

the need for strict compliance with the diet. Our die tinstruction sheets ended with the sta tement, Any slight

change in the above die t rule s will result in downright

disappointment. The patients we re encouraged to keep

a food dia ry and were impressed that a reason must be

found if daily weight loss was not achieved.

Misce l l aneous

Patients we re advised to avoid all medications other

than those prescribed by one of the three physicians (M .

S ., R . J. or J. D .) who would see them daily. They wereadvised to avoid laxa tive s but we re permitted a Fleets

enema, if needed. For more persistent constipa tion,dioctyl sodium sulfosuccina te was prescribed.

Patients were advised to avoid the use of a ll cosmetics

conta ining fa ts or oils, a s well as any skin contact withfats or oils.

S ta tistic a l m eth od s

Outcome measure s of we ight reduction (we ight loss,

percentage of initia l weight loss, weight loss per injection)

and comparability of treatment group sta tistics (age ,

height, initia l weight, initia l blood pressure, ra ce ) were a ll

tested (untransformed) for trea tment diffe rences using

th e S tu de nts t test (20 ) or F ishers exact te st (21 ). In

addition, the arcsine transforma tion (20) was applied to

the fractional we ight loss and fractiona l weight loss pe rinjection in an attempt to stabilize the va riance of the

proportions: again students t test was applied. In order

to improve upon the lack of robustness of S tudents t test

to depa rtures of the da ta from norma lity, the M ann-W hitney U test was applied to all untransformed out-

come measure s (21 ). The hunger ratings for each treat-

ment group were te sted by using the Mann-W hitney U

te st for two independent sample s making the correction

for tie s suggested by Hollande r and W olfe (22). The

blood test results we re entered into a two-way ana lysis ofvariance (ANOVA), repeated measure s design, and the

analysis of va riance table s were examined for time -

dependent diffe rences, tre atment group differences, aswe ll a s tre atment-time interactions (BMD-08V (23)

implemented via remote te rmina l on CDC 7600 Law-

rence Berkeley Laboratorie s, S t. Paul, M inn.). In orde rto provide the required equa l ns for the program for

this analysis, one case in the placebo group (patient 20 )was randomly de leted from the 23 comple te se ts of bio-

chemical da ta . D ifferences were considered sta tistica lly

significant if the one -ta iled P value was less than 0 .05when the differences were in the same direction as those

found by Asher and Harper (4): a two-ta iled test was

used when no notion as to the direction of possible differ-

ences were agreed upon before the tria l.

Results

O f the 51 patients (9 blacks and 42 cauca-sians) starting the study , 20 of 25 in the HCG

group and 21 of the 26 in the placebo group

com pleted 28 injections; there w as no signif i-

cant dif f erence betw een the groups in the

m ean num ber of injections received (T able 1).

D ata on all starting patients w ere included inthe f inal analy sis w henev er possible. Patients12 and 28 lost their m otivation and stopped

participation. Patient 55 receiv ed transf er

orders. Patient 19 lef t on em ergency leave,

and patient 26 lef t on an unanticipated v aca-

tion. L aboratory studies on patient 39 show ed

ev idence of hypothy roidism and she w as

started on thy roid replacem ent af ter receiv ing

her tw entieth injection. B ecause of this, she

w as listed dropped from study . O ther

patients w ho m issed an occasional injection

claim ed their absence w as due to either illnessor business responsibilities. T able 2 summ a-

rizes the m easures used to satisfy the require-m ent of com parability of groups and ade-

quacy of random ization. N o statistically sig-nif icant dif f erences em erged.

W eight reduction data are listed in T able 1.

R aw w eight loss (colum n 6) w as used to

com pute other w eight reduction m easures,

w hich tak e into account in itial body w eight

and num ber of injections. These appear sepa-

rately in colum ns 7 and 8 and are com bined in

colum n 9. A ll analy ses outlined in the

M ethods section w ere perform ed; no statis-

tically signif icance dif f erences w ere found

betw een the tw o treatm ent groups on any test.A lthough the direction of the dif ferences

f avored the HCG group, the dif f erences w ere

sm all and in no instance w as theP value(one-tailed) less than 0.25; neither w ere there

statistically signif icant dif f erences betw een

the tw o treatm ent groups w hen all of the

patients w ho did not m eet all the study

criteria w ere om itted f rom the analy ses and

the analy ses w ere repeated.

A som ew hat heterogeneous distribution of

the proportion of responses in each hunger

category em erged betw een the treatm ent

groups (T able 3). How ever, no statistically

signif icant dif f erence could be found using

the M ann-W hitney U test (corrected for ties),

a test that specif ically tak es into account

the ordering im plied by the response rank -

ings (1+ to 5+) (21; G . N oether, Professor,

University of Connecticut; personal com -

m unication w ith Carl C . Peck , M .D .).

T he m ean percentage changes in w aist and


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HCG I N WEI GHT REDUCTI ON 943

TABLE ISummary o f pa tients and weight reduction data

AgeP atient (yrs)

Height(in)

No. o finjec-tions

Startingweight(Ib)

Loss(Ib)

Percentbodyweight

loss

Loss,lbpe r

injection

Percentweightlo ss p er

injection

HCG gr oup3 4 2 6 1 . 5 2 8 1 7 2 . 8 2 0 . 1 1 1 . 6 0 . 7 1 8 0 . 4 1 5

4 42 64 .5 28 152.0 14.3 9.4 0.511 0.336

6 27 60 .5 28 160.0 17.2 10.8 0.614 0.384

8 30 70 .0 28 164.8 19.4 11 .8 0 .693 0.420

9 21 61 .0 28 142.0 13.7 9.6 0.489 0.345

12 25 61 .0 23 160.0 9.8 6.1 0 .426 0.27813 28 63 .0 28 153 .4 16.0 10.4 0.571 0.373

17 25 66 .0 27 181.4 15 .0 8.3 0 .556 0.306

18 42 61 .0 28 158.4 17.4 11.0 0 .621 0.392

19 33 65 .0 23 175.8 10 .8 6.1 0 .470 0.27922 26 64 .0 28 178.2 19.6 11 .0 0 .700 0.393

27 27 65 .0 28 161 .8 19 .3 11.9 0 .689 0.426

31 53 65 .0 28 145.0 15.4 10.6 0.550 0.37932 64 65 .0 28 159 .4 11.8 7 .4 0 .421 0 .264

35#{176} 26 64 .0 28 220.4 30.7 13.9 1.096 0 .49838 32 61 .0 28 176 .0 15 .2 8.6 0 .543 0.308

39 35 68 .0 20 196 .2 12.6 6 .4 0 .630 0.338

41 48 64 .0 28 159 .8 17.3 10.8 0.618 0 .387

450 52 65 .0 28 184 .0 17 .9 9 .7 0.639 0 .347

46 21 63 .0 28 167 .6 19 .6 11.7 0.700 0 .418

47 34 67 .0 28 168 .8 14 .2 8 .4 0.507 0 .300

51 25 61 .0 28 155 .0 12 .3 7 .9 0.439 0 .283

52 26 66.0 28 143 .0 14 .5 10.1 0.518 0 .362

55 19 65 .0 9 147 .0 9 .9 6 .7 1.100 0 .748

58 34 68 .0 28 165 .8 10 .7 6 .5 0.382 0 .231

M ean 33 .5 64 .2 26 .5 165 .9 15 .8 9 .5 0.61 0 .37

SEM 2.3 0.5 0 .8 3 .5 0 .9 0.4 0.04 0 .02

P lacebo g roup42 67 .0 28 172 .0 18 .9 11 .0 0.675 0 .392

2 34 57.0 28 144 .0 15.2 10.6 0.543 0.377

7 38 68 .0 28 182 .8 23 .4 12 .8 0.836 0.457

10 25 62 .5 28 168 .8 21 .4 12 .6 0 .764 0.453II 25 64 .0 28 159 .8 13 .7 8 .6 0 .489 0.306

14 52 61.0 28 152 .2 17 .8 11.7 0 .636 0.418

15 32 65 .0 27 154 .5 15 .7 10 .2 0.581 0.376

16 34 62.5 28 149.4 11 .0 7.4 0 .393 0.263

20 39 62.8 28 170.6 17.7 10 .4 0 .632 0.371

21 20 70.0 26 174 .0 9.2 5.3 0 .341 0 .196

23 31 64.0 28 147.6 12.7 8.6 0 .454 0.307

26#{176} 22 53.0 21 194.4 16 .6 8.5 0 .755 0 .388

28 20 67.0 6 156 .8 5.2 3.3 0 .867 0.553

29 50 65.0 28 142.0 14.3 10 .1 0 .511 0.36030 45 59.5 27 141.6 13.3 9 .4 0 .493 0.348

33 51 60.0 28 136 .2 12 .7 9.3 0 .454 0.33334 o 26 64.0 28 188.8 13.6 7.2 0.486 0 .257

36 23 71.0 28 182.4 15.4 8.4 0 .550 0.302

37 51 62.0 28 167 .4 12.4 7.4 0 .443 0 .265

42#{176} 36 71.0 28 247.2 22.2 9.0 0 .793 0 .321

430 38 66.0 28 205.0 25.4 12 .4 0 .907 0 .44349 20 66.0 28 157.8 10.0 6.3 0.357 0 .226

50 24 68.0 28 169.2 20.0 11 .8 0 .714 0 .422

53 24 70 .0 28 181.8 16.9 9.3 0.604 0 .332

54 30 63.0 28 147.0 18.2 12 .4 0.650 0.442

56 27 62.0 28 165.8 10.7 6.5 0.382 0 .231

Mean 33.0 64.3 26.8 167.7 15.5 9.3 0.59 0.35SEM 2.1 0.8 0 .9 4 .7 0 .9 0 .5 0.03 0.02

#{176}Patients w eight exceeded 60 lb over the idea l we igh t per g iven height. P atien t 20 was taking Thoraiine

(ch lorp romazine); patien t 33 was taking Syn throid (levothyroxine): patien t 37 was taking tolbutam ide .


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94 4 STEIN ET AL.

NS, not sta tistica lly significant at the one -tailed, P < 0.05 level.

hip circumferences are summarized in Table4. A lthough both treatment groupsexperienced signif icant decreases in these cir-cumferences, the HCG group did not have a

signif icantly greater reduction compared tothe placebo group.

Complete sets of pretreatment and post-treatment biochemical data were obtained

from 22 patients in the HCG group and 23patients in the placebo group. Table 5 sum-marizes the changes in blood studies as wellas the two-way repeated measures analysis ofvariance. The mean changes (column 4)

include al l complete sets of data, whereas, theF ratios w ith P values (columns 5 and 6) are

based on 22 sets of data in each test group

(see Sta tis tica l methods). The i ndep en dent

ef fect of HCG versus placebo on the changein each measurement is ref lected by thetime-treatment interaction F-ratio (column

6). During the treatment period, both groupsshowed signif icant decreases (


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TABLE 5Changes in b lood m easu rem en ts

Treat-men tgroup

No. ofpat ients

M ea n cha ng e(SEM)

F,#{176}(P va lue ) F ,,#{176} (P value)

Hem atocrit(% ) HCG

Placebo

22

23

-2.00(0.55)

-2.74(0.55)21 .24 (


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94 6 STEIN ET AL.

tions. Perhaps the most cri tical diff erencesbetween the two studies were the time period

chosen for the investigation (i .e., 32 daysw ithout intervening holidays) and a patient-

physician consul tation on each visi t. In theA sher-Harper study (4), a period of A ugust toFebruary was reported and the patients were

seen by a physician only at the time of theini tial and final visi ts. The patients in ourstudy received 28 injections on consecutive

days, except Sundays; the A sher-Harperstudy required 36 injections, but none wererequired on holidays or at the time of heavy

menstrual f low (4, 17). Therefore, this impliesthat in their study not every patient was on

the diet for the same period of time while

completing the 36 injections.In comparing the weight reduction resul ts,

i t is necessary to remember that patients inour study received 28 injections over a 32-day

period of time while their patients received 36injections over a variable number of days

(exact information not published) (4). Theirreport (4) makes assessment of compliancew ith diet and comparable weight loss dif f icul t

for any patient w ithin one treatment group aswell as the comparison of the two treatment

groups.A nother point of dif ference between these

two studies is that al l the patients in our study

group had the added reinforcement to complyby peer pressure as they al l reported dai ly to

the cl inic at the same time and developed acertain group spiri t which the A sher-Harp-

er patients did not have. The importance ofthis in overriding any small effect of HCGwithout this added force in a control group

can not be answered.Compar ison of data. The mean total

weight loss in our study was 15.79 lb for the

HCG group and 15.52 lb for the placebogroup; theirs was 19.96 and 11.05 Ib, respec-tively. The percentage body weight loss in this

study was 9.48 for the HCG group and 9.25 inthe placebo group; theirs was 11.47 and 6.77,

respectively. However, the average raw

weight loss and percentage weight loss isvirtual ly identical in the two study groups:

raw weight loss, A sher and Harper= 15.51 6.5 lb and Stein et al .= 15.65 4.5 lb. per-

centage weight loss, A sher and Harper =

9.12 4.5 lb and Stein et al .= 9.35 3.2 lb.W eight loss per injection in this study was

0.61 lb for the HCG group and 0.59 for theplacebo group; theirs was 0.585 and 0.403 lb.respectively. Our placebo group achieved the

same weight loss in pounds per injection as

their HCG group. Clearly, A sher and Harp-er s placebo group stands alone in regardto weight loss compared to their HCG group

and our two groups. In our study, none of theweight loss measures showed a statistical lysi gni fi cant di ff erence.

The mean number of injections per patientin this study was 26.5 in the HCG group and26.8 in the placebo group; theirs was 33.85

and 29.05, respectively. W e have accountedfor al l missed injections (see Results f irst

paragraph). A sher and Harper, in their letter

of rebuttal (17), were only able to provide areason for the missed injections in 11 of 18

patients who fai led to receive the ful l 36injections. In the group of 7 patients w ithout

a reason listed for missed injections, f ive ofthese patients were in the placebo group (4,17). A s H irsch and V an I tal l ie (16) noted,

One must ask why the placebo groupreceived fewer injections on the average thanthose in the treatment group? If al l patientswho did not receive 36 injections were deleted

f rom their study, their P value for meanpercentage weight loss would fal l from lessthan 0.001 to a value close to 0.02 (16, 17).W ith that change, the probabil i ty of this

occurring by chance alone drops from less

than one in 1,000 to close to 2 in 100. I t wouldappear that a number of uncontrol led varia-bles in their study may have resul ted in a disadvantaged placebo group and an unin-

tentional bias in their resul ts. A sher andHarper (4) noted that, The resul ts of ourstudy were quite unexpected by the authorresponsible for study design because the

resul ts of our ini tial study were negative, ashave been most double-bl ind studies reportedi n the l iteratur e.

Additional findings (Letterman Army Medi-

cal Center study)

Laboratory data. The laboratory studieswere original ly designed to help explain amechanism for the ef fects of HCG on weight

reduction, in addition to detecting possibleadverse ef fects of the treatment program.

Table 5 shows that both treatment groups


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HCG I N WEI GHT REDUCTI ON 94 7

had a signif icant decrease in hematocri t,white blood cel l count, blood urea ni trogen,

cholesterol , triglyceride, and total protein.These f indings are expected changes due to

the diet and coincident weight reduction.Other semistarvation diets have been associ-ated w ith a loss of vi tamins and minerals, lossof body protein, and a lowering of serum

lipids (25). L oss of protein, vi tamins, oressential minerals may account for the milddrop in hematocri t and white blood cel l countthrough any of a number of conceivablecombinations of deficiencies (25-27). Thef indings of an increase in uric acid has beennoted previously and is associated w ith the

competi tion between ketoacids and uric acidfor renal tubular transport (28, 29). The

signif icant increases in fasting glucose and the

difference in the increase between the treat-

ment groups are unexplained. Both the pre-study and poststudy glucose determinationswere performed by the same method. Agradual fal l in blood sugar in the absence ofexogenous carbohydrate has been reported(25); symptoms of hypoglycemia as a compli-

cation were noted by Simeons (I ).Both of our groups experienced a decrease

in blood pressure which would be expectedw ith the weight loss and this type of diet (25).The changes in hip and waist measurements

are also expected w ith this amount of weightloss. Simeons (1) has claimed that his tech-

nique leads to a more signif icant loss of fat in

these two areas. The resul ts in Table 4 showsno signif icant dif ference between the two

groups in terms of percentage change in these

two measu remen ts.Complica t ions . Throughout our study,

patients were observed for possible complica-tions. A large number of patients suf feredf rom severe headaches of brief duration in the

f irst week of treatment. The two most com-mon complaints were constipation andfatigue. Delayed onset of menses was also

seen. These problems were experiencedequal ly by members in both groups. Twounexpected complications occurred in theHCG group. Patient 9, during the last weekof treatment, developed a severe gastri tiswhich was documented by gastroscopy and

required a brief hospi tal ization. Patient 35,who had a problem with inferti li ty before

entering the study, did not have her usual

expected menses during the study period andwas subsequently found to be pregnant.

Patient 42 in the placebo group developedacute cholecysti tis 2 days fol low ing termina-

tion of the study and diet; she subsequentlyhad a cholecystectomy. In addition to these

possible complications of therapy, there were

other minor problems requiring treatmentthat arose during the study. These includedcolds, sinusi tis, and gastroenteri tis.

Conclusions

W e attempted to answer one question in

this study-is HCG an ef fective adjunct to arigidly imposed dietary regimen for weightreduction? On the basis of our resul ts, the

answ er is negative.

The mil ieu under which this program wasadministered to a highly motivated group ofwomen proved effective in achieving the

desired resul t-rapid weight reduction. In ourcl inical setting, however, HCG per se of feredno advantage over placebo injections in

regard to weight loss, distribution of fat lost,

or hunger index during weight reduction.

Our data to date can not answer thequestion of the safety of HCG. A dditional

studies are underway to address this question.W e also have not resolved completely why

our data refute the f indings reported by A sher

and Harper (4), but we have proposed several

areas which may account for the differences.Our study, performed in a manner similar tocurrent Simeons-type programs, casts seriousdoubt of any inherent eff icacy that HCG mayhave as an adjunct to a weight reductionprogram.

We w ish to exp re ss ou r since re appreciation for the

assis tance in conducting th is s tudy to the p rofessional

sta ff o f the Me tabolic W ard , Letterm an A rm y Institute

of Research. S pecifica lly, we acknow ledge LTC C la ra L.

M iller (D ietitian ), CPT Barbara B . M cCarty (D ie titian),MAJ Susie M . She rrod (Nurse), CPT Susan P . N icho ls

(Nurse).

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