Oral Contraceptive Program, Synchronized

with Moon Phase

JOHN C. COBB, M.D., SIKANDER FARHAT, M.B., B.S.,

NASIM A. SHAH, M.B., B.S., SAFIA I. AMEEN, M.B., B.S.,
and PAUL HARPER, M.D.

A PRELIMINARY repore describes the setting of this study and the method
used. It was a trial of oral contraceptives in rural villages near Lahore,
West Pakistan, in which administration of the pills was synchronized with
the phases of the moon. Illiterate village women who could not use a
calendar were able to follow the phases of the moon.
The present report includes a second group of women receiving free
tablets of 4 mg. of norethisterone acetate with 0.05 mg. ethinyloestradiol
(Anovlar*) as well as the group previously reported who were receiving
free tablets of 5 mg. norethynodrel with 0.075 mg. ethinyloestradiol 3-
methyl-ether (Conovid t ).
There were 45 women who participated, taking the tablets for a total of
685 lunar months (406 for Conovid and 279 for Anovlar). The average
duration was 1.5 lunar months and the range was from 5 to 25.

METHOD AND MATERIALS

Selection of Study Group

Women were offered the opportunity to participate in the study pro-
vided that they were not pregnant, were known to be fertile, and had no
obvious illness that would preclude the use of oral contraceptives. In
general they were women well known through association with the long-
established Female Dispensary and Maternity and Child Care Centre at
Ali Raza Abad, and they came from this village of about 4000 population or
from nearby villages. It is probably important for the success of this study
From tht' Medical Social Ht's!'arch Projeet, Lahore, Pakistan, and the School of Hygiene and
Puhlic Health, .Johns Hopkins University, Baltimore, Md.
Additional data, in the form of tables omitted from this report, are ava;lahle from the
authors on request.
*Courtesy of Schering, AG, ''''est Bt'rlin, Germany.
tCourtesy of G. D. Searle Ltd., High Wycombe, Bucks, England.

559
560 COBB ET AL. FERTILITY & STERILITY

that one of us (S.F.) was full-time resident Woman Medical Officer at the
Dispensary and was available for consultation at any time. Women who
were nursing were accepted only if they were ready and willing to wean
the baby.
The age and pregnancy history of the 45 participants are shown in Table
1. The women's ages ranged from 20 to 45 years with a mean of 33; 57%
were between 30 and 39 and 24% were between 40 and 45. An average of
7.7 pregnancies per woman was reported, of which an average of 5.5 chil-
dren was still living. More than three-fourths of the participants had been
pregnant within the past 2 years, but the 24% who were 40 years old or
more probably had low fecundity.
About three-fourths of the participants and one-half of their husbands
were reported to be illiterate or only able to read the Quran. The median
per capita income for the whole group was Rs. 160 (U. S. $34.00), which
is about one-half of the national average per capita income (Rs. 319 for
1959-60) reported by Sadik. Half of the husbands were agricultural labor-
ers or artisans of relatively low status; 20% of the husbands earned Rs. 300
or more; 22% were government servants. These families, then, were con-
siderably older and somewhat better educated than the average family in
Pakistan. Their family economic situation, although considerably lower
than the national average, fell within the normal range for rural areas of
Pakistan. The occupational distribution was somewhat atypical in that
there were more than normal numbers of agricultural laborers of lower
status, and government servants of higher status.

Procedure
•
All candidates received an initial general physical examination and pelvic
examination including a vaginal smear for detection of cancer. In order to
rule out pregnancy and minimize the risk of pregnancy during the first
cycle, the women were given a short course of 12 tablets beginning on the

TABLE 1. Average Number of Previous Pregnancies by Age of Mother and

Outcome
Offspring

Dead, born Stillbirths, Total

Age (yr.) Participants Living alive abortions pregnancie.~

20-29 8 4.0 0.3 0.5 4.8

30-39 26 5.6 1.3 0.8 7.7
40-49 11 6.6 0.3 0.3 7.2
TOTAL 45 5.5 1.5 0.7 7.7
VOL. 17, No.4, 1966 CONTRACEPTION BY MOON PHASE 561

eleventh day of the lunar month; only those women were accepted who had
withdrawal bleeding after stopping the short course. Four women were
found to be pregnant and excluded by this means.
On the first day of the new moon, the regular course of 22 tablets was
started. The participants were instructed to take 1 a day at bedtime until
the bottle was empty; then to wait until the next new moon to begin the
next course. Thus they generally experienced withdrawal bleeding during
the dark of the moon.
All women were interviewed each month (usually at their homes) by
the Lady Health Visitor from the Maternity and Child Care Centre. This
interview provided a spot check on their faithfulness in taking the pills.
As all the women started on the first day of the new moon each month, the
number of pills missed could easily be calculated from the number remain-
ing on the day of visit. A questionnaire form served to record these data
each month as well as any complications such as bleeding, spotting, amenor-
rhea, etc.
The study was conducted from April 1962 to May 1964, at which time the
participants were offered free insertion of an intrauterine contraceptive
device or the opportunity to continue with the pills at the cost of Rs. 1.00
(U. S. $0.21) per lunar month, or other conventional contraceptives at
nominal cost.

RESULTS

Synchronization with Moon Phases

Of 45 participants, 37 were easily synchronized with the phases of the
moon from the very first cycle. For 6 synchronization required 3 cycles; it
was these patients who had breakthrough bleeding during the initial
cycles. In the first group taking Conovid, 2 participants were not synchro-
nized within 3 cycles, and had excessive breakthrough bleeding which
could not be controlled with the initial tablet used. After the fourth cycle
these 2 were given Anovlar tablets. One of them responded well to the
change of drug, but the other was not synchronized even with the change
of drug and continued to have breakthrough bleeding. She was not reliable
in taking her pills and admitted that because of heavy family responsibili-
ties she frequently forgot to take her medication. At the end of 6 cycles she
decided not to use oral contraceptives and was excluded from the study at
that point. In the remainder of this report, the woman successfully chang-
ing to Anovlar is included in the Anovlar group; the other is included in the
Conovid group.
Synchronization was established for 97.8% of the 45 participants: for 37
562 COBB ET AL. FERTILITY & STERILITY

in the first cycle, 6 in the third cycle, and 1 in the sixth cycle. One patient
was not synchronized.

Side Effects
The reactions reported by the largest number of participants were, in
order of frequency, numbness of extremities, chloasma, spotting, and break-
through bleeding (Table 2). The reactions diminished in severity with the
continuance of treatment, except for chloasma (face pigmentation) which
became more marked. Several participants reported symptoms during the
initial cycles which they associated with pregnancy.
One of the participants early in the study developed an apparently
hysterical anesthesia of her hands which was probably related to her marital
problems. Later, at a time of emotional crisis, she developed a clear-cut
hysterical paralysis and anesthesia of her left arm and leg, which disap-
peared in a few days leaving only a "shoe" anesthesia of the left foot. At
the time she was examined by 3 of us (S.F., S.A., and J.C.C.). The condi-
tion subsequently cleared up without treatment. A review of her history
showed other probably hysterical phenomena, even before she had started
taking oral contraceptives.
This case is reported here because of the importance of being alert for
group suggestion phenomena in such trials, especially in small communities
where participants are closely associated with each other, uneducated, and

TABLE 2. Incidence of Side Effects

Drug group (%)*

Conovid Anovlar
Symptom (25 women) (20 women)

Numbness of extremitiest 44 30
Chloasma=i= 32 5
Spotting§ 24 15
Breakthrough bleeding 20 15
Menorrhagia 20 5
Scanty menstruation 4 20
Increased vaginal discharge 16 10
Palpitations 12 5
Amenorrhea 4 10
Nausea 4 o
*Perccntage of women in each drug group who reported symptom.
tVariable onset and duration, may have been influenced by suggestion.
tAppeared within first 7 months and usually lasted until after drug discontinued.
§Occurred mainly in first 3 months with Conovid, and after 9 months of Anovlar.
VOL. 17, No.4, 1966 CONTRACEPTION BY MOON PHASE 563

likely to be highly suggestible. It is possible that the close association of

this hysterical woman with the other participants, combined with her im-
portant status in the community, may have influenced the other participants
who reported similar symptoms.
The chloasma, on the other hand, was undoubtedly a direct result of the
drug in these women of medium skin coloration. It was similar to the
pigmentation they had experienced during pregnancy. Possibly it was re-
lated to their poor nutritional status. It was not considered a serious prob-
lem by the participants and was not given as a reason for stopping the
contraception program.
Except for the differences in incidence of chloasma, menorrhagia, and
scanty menstruation, the number of participants was too small and the
reliability of reporting too uncertain for any comparisons to be made be-
tween the two drugs.
In the first group, of 25 participants taking Conovid, 21 reported one or
more side effects during the course; in the second group, of 20 taking
Anovlar, 14 experienced one or more side effects during the somewhat
shorter course.

Characteristics of Menstrual Cycles

The menstrual cycles synchronized with the moon were 29-30 days long
and were, as expected, more regular than previously. The majority of the
cycles had previously been 25-27 days in length with a flow of 3-4 days'
duration. The amount of menstrual flow diminished in 5 cases. Six partici-
pants had heavier menstrual periods. Three participants developed amenor-
rhea during the course of medication. There was a noted decrease in the
incidence of dysmenorrhea during the time of medication.
Bleeding during the course of medication occurred in a total of 16 par-
ticipants: 8 had spotting, 7 had breakthrough bleeding, and 1 had both
spotting and bleeding. One participant withdrew from the study because
of bleeding. After the sixth cycle, the incidence of bleeding decreased.

Weight Changes
Weight changes were determined by noting the difference between initial
and final weight as recorded (usually monthly) for each participant in the
study.
Of the 45 participants, 20 remained within 5 lb. of their original weight.
Twenty-one gained more than 5 lb. and 2 of these gained more than 25 lb.
(There were only 2 who objected to the weight gain.) Four participants
lost more than 5 lb. while taking the drug.
564 COBB ET AL. FERTILITY & STERILITY

TABLE 3. Reasons for Withdrawal from Study (Number of Participants)

RA(!SOn for withd1'awal
P(!1"ticipant.~ in study For con- Pregnancy
Regularity of venience of Desired during Intolerance
taking pills Entering Remaining thl! study pregTlrtncy study to druf!

Regular (none
missed, none
extra) 24 22 0 1 0 1
Took all pills in
each cycle but
irregularly 2 1 1 0 0 0
Omitted 1 pill in
any cycle 4 4 0 0 0 0
Omitted 2 or more
pills in any
cycle 15 7 2 0 5 1
TOTAL 45 34 3 1 5 2

Dropouts During the Study

The maximum duration of the trial with Conovid was 25 cycles, and with
Anovlar, 16. A total of 11 participants (Table 3) were dropped from the
study. Five became pregnant while taking the pills irregularly; 3 were
dropped for the convenience of the study because of geographic location;
1 withdrew to plan a pregnancy; and the other 2 withdrew because of
intolerance to the drug (one had continuous breakthrough bleeding even
after a change of drug, and the other complained of a sensation of heat
in her whole body). Thirty-four participants continued to use the medica-
tion up to the termination of the study.

Regularity of Taking Pills

On the basis of information obtained on home visits and clinic visits, 24
( 53%) of the women took the pills regularly (Table 3). Two women took all
the pills, but irregularly, sometimes taking more than 1 per day. Four
women omitted 1 pill, but never more than 1, in at least 1 cycle during the
trial period. Fifteen women omitted 2 or more pills in at least one cycle.

Contraceptive Effectiveness
Pregnancies occurred only among the group of 15 women who were
found to have omitted 2 or more pills in at least 1 cycle. During the total
of 685 cycles of contraceptive use, including those of the women who did
not follow instructions, there were 5 pregnancies (pregnancy rate, 9.5/100
woman-years of exposure).
VOL. 17, No.4, 1966 CONTRACEPTION BY MOON PHASE 565

Selection of Contraceptive Method After Study

At the conclusion of this study in April-June 1964, the remammg 34
participants were offered supplies of pills at la nominal price of Rs. 1.00
(U. S. $0.21) per cycle (a service charge) or the choice of other contracep-
tives, including IUD (intrauterine device) insertion of which was to be
done free of charge.
Of the 34 women who were still taking oral contraceptives when the
free supply was exhausted, 28 accepted IUD insertion. Eighteen of these
women said that they could not afford oral medication, 7 of them objected
to the side effects of oral pills, and 3 said that they "preferred an IUD."
Two women continued with oral contraception. One adopted Durafoam*
(liquid and sponge). The remaining 3 women stated that they did not
want to continue with any contraceptive; 1 of them desired to become
pregnant and the other 2 had had side effects while they were taking the
pills and did not wish to try other contraceptives.

DISCUSSION

Of the participants in this study, 53% were faithful in taking their pills
regularly, which may in part be due to the confidence they had in the Lady
Doctor at the Female Dispensary. There was probably a reinforcement
effect from the monthly home visits by the Lady Health Visitor, who
checked on the number of pills and talked about any problems. Such a
home visiting program would be desirable but prohibitively expensive for
a nationwide program in Pakistan; we cannot say how effective oral con-
traception would be without this reinforcement.
The over-all pregnancy rate of 9.5 is 11 times higher than the correspond-
ing rate in Puerto Rico reported by Garcia, 0.85 for women using the 5-mg.
Enovidt pills (16 pregnancies in 1858 woman years of exposure). It is
comparable to the pregnancy rate found in the United Kingdom by Peberdy,
which was 9.0 among a group of problem families, that is couples who had
experienced high pregnancy rates while using cervical caps or condoms.
In view of the generally unfavorable experience in villages of Pakistan with
conventional contraceptives, one might presume that the group in the
present study could be similarly classified.
The overwhelming switch to the intrauterine devices at the end of the
free trial period was evidently largely due to the newly imposed charge
for continuing with pills (1 rupee per month), but other influences may
have been important: (1) These women seemed to act as a group following
*Durex Co., New York, N. Y.
tG. D. Searle & Co., Chicago, Ill.
.566 COBB ET AL. FERTILITY & STERILITY

the lead of a few influential individuals. (2) Some of them who had been
having scanty menstruation or other side effects, welcomed the IUD be-
cause it made them feel "normal" again. ( 3) Probably all of the women
developed confidence in the doctor through the use of the pills; when she
recommended the new intrauterine method, they were more ready to try
it than they might have heen hefore taking the pills. Perhaps a course of
pills for a few weeks or months is a good way of preparing women for
the IUD. This method has recently been used very successfully.* It allows
women to be protected against pregnancy while waiting for the arrival of
an itinerant IUD team even in remote areas, and it makes it possible to get
a group of women ready for IUD insertion on a certain day with the assur-
ance that they are not pregnant and are at the right stage of the menstrual
cycle for IUD insertion.
As a complementary study, we are now offering oral contraceptives in
another town (Lulliani) where the IUD has been the main contraceptive
recommended hitherto. Women who do not want an IUD, who cannot
wear an IUD for various reasons, or who just want to try something new
may he good candidates for the oral method. A family planning program
which offers both the IUD and the pill will probably reach a significantly
larger population than would he reachable by either method alone. One
problem which must he faced in a program utilizing the pill is the im-
portance of an effective distribution system, so that women who have start-
ed taking the pills will always be able to get their supplies. If they miss
for only part of a month, their chances of becoming pregnant are very high.l
Perhaps an easier way of ruling out pregnancy than the method we used
would now be one of the new immunologic pregnancy tests. However, the
ll-day starting course probably had the added advantage of reducing the
risk of pregnancy during the first full cycle before the new rhythm had been
established.
In our study the precaution of excluding lactating mothers was probably
unnecessary. Since the question of whether various oral contraceptives
inhibit lactation has not been settled, we felt it would not be wise to
administer them in this rural area to any woman who needed to continue
nursing a bahy. If a mother's milk had failed, there would have heen no
easy and safe way to keep the infant alive on artificial feeding. To settle
this question, a study would have to be done in a place where artificial
feeding of infants is safe and easy, and it should be done as a double-blind
study. (The participants could be protected against pregnancy by an IUD.)
Milk production of the mothers and weight gain of the infants would have
to be measured at regular intervals.
*By Dr. Hugh Davis, .Tohns Hopkins Hospital.
VOL. 17, No.4, 1966 CONTRACEPTION BY MOON PHASE 567

It should be noted that our survey of nearby Chamrupur village revealed

that 37 of 120 (31% of all) married women under the age of 40 years were
nursing an infant under 1 year of age. This finding is probably typical of
rural India and Pakistan since the median interval between births is about
2~~ years 5 and almost all babies are nursed for at least 1 year. Thus at any
given time, one would expect to find at least one-third of all fertile married
women nursing and another third pregnant.

SUMMARY AND CONCLUSIONS

A trial of oral contraceptives in rural villages of West Pakistan was at-

tempted, in which administration of the pills was synchronized with the
phases of the moon because the illiterate women could not use calendars.
Two groups of mostly illiterate women received 22 pills a month starting
each month on the first day of the new moon. The first group, 25, received
5 mg. of norethynodrel with 0.075 mg. of ethinyloestradiol 3-methyl-ether;
the second group, 20, received 4 mg. of norethisterone acetate with 0.05
mg. of ethinyloestradiol.
Synchronization with the phases of the moon was established in all but
1 (97.8%). The pregnancy rate was 9.5 per 100 woman years after an
accumulation of 685 cycles of use.
Discussion of the problems involved in the general application of this
method to rural Pakistan suggests that it would be acceptable and workable
under close supervision by a doctor who had a favorable relationship with
the participants, in special situations such as for short-term use by women
who do not want or cannot have an intrauterine contraceptive device.
Department of Preventive Medicine
University of Colorado
Medical Center
Denver 20, Colo.
REFERENCES

1. CARCIA, C. R. "Clinical Studies on Human Fertility Control." In Human Fertility

and Population Problems. Creep, R. 0., Ed., Shenkman, Cambridge, Mass., 1963.
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Mears, K, Ed. Churchill, London, 1965.
3. SADIK, N. I. "The Population Program in Pakistan, Program and Policies." In Report
of Proceedings of the International Conference on Population at fohns Hopkins
University, May 1964. Johns Hopkins Press, Baltimore, in press.
4. SHAH, N. A., and COBB, J. C. A Preliminary Report on the Use of Oral Contracep-
tive Pills Synchronized with the Phases of the Moon. International Congress Series
No. 72, Excerpta Medica, Amsterdam, 1964.
5. WYON, J. B., and CORDON, J. K "A Long Term Prospective-Type Field Study of
Population Dynamics in the Punjab, India." In Research in Family Planning. Kiser,
C. V., Ed. Princeton, 1962.