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Contraception 84 (2011) e17 e22

Original research article

Health-related quality of life changes among users of depot


medroxyprogesterone acetate for contraception,
Sikolia Z. Wanyonyi, William R. Stones, Evan Sequeira
Department of Obstetrics and Gynaecology, Aga Khan University Hospital, Nairobi; 3rd Parklands Avenue, Box 30270, Nairobi 00100, Kenya
Received 27 March 2011; revised 27 May 2011; accepted 28 May 2011

Abstract
Background: Depot medroxyprogesterone acetate (DMPA) may have other noncontraceptive effects that could impact on the quality of life.
The objective of this study was to assess the health-related quality of life changes associated with the use of DMPA for contraception.
Study Design: A prospective, observational study using the Short Form-36 quality of life questionnaire.
Results: After 6 months of use, the participants had an improved physical summary score, mean change [5.64 (95% confidence interval [CI],
1.879.4), p=.054]. There was no significant change in sexual function [5.33 (95% CI, 2.15 to 12.81), p=.0858] and mental summary score
[0.51 (95% CI, 1.90 to 2.92), p=.432]. The main side effect of DMPA was menstrual irregularity (32.5%); 17.2% of the participants found
amenorrhea desirable.
Conclusion: Besides its contraceptive efficacy, DMPA is associated with an improvement in perceived physical health with no apparent
adverse effect on mental health and sexual function.
2011 Elsevier Inc. All rights reserved.
Keywords: Depo medroxyprogesterone acetate; Health-related quality of life; Contraception; SF-36

1. Introduction
Depot medroxyprogesterone acetate (DMPA) is a medium-term reversible contraceptive method, with a low failure
rate, 0.3 to 3 per 100 woman-years [1]. However, its effectiveness for child spacing in sub-Saharan Africa has been
questioned, though its popularity remains high in the region
[2,3]. There have been reports linking the use of DMPA with
an increased risk of HIV transmission, but recent work has
reliably disapproved possible association [4,5]. Besides contraceptive effects, DMPA also possesses other benefits, for
example, reduction in risk of endometrial carcinoma, reduced
incidence of iron deficiency anemia and dysmenorrheal [6]. Its
action on the cervical mucus has also been thought to be
protective against pelvic inflammatory disease [7,8].

Conflict of interest: None.


Funding: We received funding from the Aga Khan University
research grant for postgraduate medical education.
Corresponding author. P.O. Box 16963-00100 Nairobi, Kenya
00254723250061.
E-mail address: sikolia.wanyonyi@aku.edu (S.Z. Wanyonyi).

0010-7824/$ see front matter 2011 Elsevier Inc. All rights reserved.
doi:10.1016/j.contraception.2011.05.022

Similar to other hormonal contraceptives, users of DMPA


may experience various side effects. Most of these side
effects are related to the suppression of ovarian estradiol
production. These include unscheduled bleeding and amenorrhea. Minor side effects include nausea, dizziness, weight
gain, hair loss, acne and headaches. Accompanying mood
changes related to some of these side effects are documented
[9,10]. Alteration in the sexual drive among DMPA users has
been reported. These effects are, however, reversible upon
discontinuation of the method [1114]. There have also been
concerns about the effects of DMPA on the bone mineral
density. This effect is minimal and reversible but may be
associated with early onset osteoporosis if DMPA is used
before attainment of peak bone mass [11].
All these side effects have varying influence on the
acceptability of this method for contraception. Irregular
bleeding, for instance, accounts for most discontinuations in
the first 69 months of use [1,13,14]. These side effects and
their influence on discontinuation rates has led to focus on
contraceptive research being mainly on the burden of gynecological and other related medical conditions, with little
attention on how they affect the user's quality of life (QoL).
It is now widely acknowledged that the personal burden of

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S.Z. Wanyonyi et al. / Contraception 84 (2011) e17e22

illness cannot be described fully by measures of disease


status alone. Psychosocial factors such as apprehension,
functional impairment, difficulty in fulfilling personal and
family responsibilities, financial burden and diminished
cognition must also be encompassed [15]. Some lifestyle
choices such as contraception may have effects on daily life
and life satisfaction besides providing fertility control. These
effects could be evaluated using either the existing generic
instruments or condition-specific QoL assessment tools.
There are several generic health-related QoL tools in existence, and these have been widely used in other disciplines
with reliable outcomes [1618].
This study aims to assess the health-related QoL changes
among Kenyan women using DMPA for contraception by
utilizing the Short Form (SF)-36 questionnaires besides
evaluating for other side effects associated with the method.
2. Materials and methods
A prospective, observational study was carried out at the
Aga Khan University Hospital and the Family Health
Options clinics in Nairobi, Kenya.
The study was conducted for a period of 10 months
starting from December 2008 to September 2009.
The broad objective of our study was to assess the healthrelated QoL changes among women using DMPA for
contraception. The specific objectives are as follows: (i) to
determine the characteristics of women using DMPA for
contraceptive, (ii) to establish the reasons for choosing to use
or discontinue the method, (iii) to evaluate the changes in
QoL among women using DMPA and (iv) to explore the side
effects associated with its use.
2.1. Recruitment of participants
All clients desiring contraceptives were counseled on the
available methods including DMPA. This was done in both
clinics by a family planning provider. The method chosen by
the client was then administered in the usual way.
Those who chose DMPA were approached for recruitment into the study. If they met the eligibility criteria and
agreed to participate, a brief description of the study was read
to them and an informed consent obtained. The sociodemographic data were captured, and a brief clinical history
was sought. The SF-36 was then introduced to the client for
self-administration. The questionnaires were completed in
the clinic. Any woman requesting to complete the questionnaire later was requested to return it at the earliest
opportunity. An addressed, stamped envelope was provided
when desired. However, only four participants opted for this
alternative, and three of them failed to return the questionnaires despite constant reminders. They were consequently
excluded from the study.
Upon returning the questionnaire, it was checked for
completeness. Difficulties encountered during completion
were ascertained. Assistance was provided as desired.

At 6-month follow-up, the questionnaire was given to the


respondents prior to the clinical consultation. Participants
were also reminded by a telephone call on their scheduled
appointment in the event that they did not return as expected.
The SF-36 was completed in the same manner as before,
and information on experience with DMPA and any side
effects, either desirable or unwanted, was sought during the
consultation. In case of discontinuation, the reasons were
explored further.
2.2. Study sample
Consecutive sampling technique was used to recruit study
participants. Every participant meeting the inclusion criteria
was approached for possible recruitment to the study after
giving an informed written consent.
Fig. 1 shows the flow of the study.
Estimates of sample size were derived from the SF-36
health survey manual by Ware [19]. These are predetermined
sample size calculations based on a healthy US population
and widely used in QoL studies utilizing the SF-36. A
sample size of 105 participants was needed to detect a
5-point difference in the mental summary score (MCS)
changes over time within the same group. A power calculation of 80% was used given a two-tailed t test with an
value of .05 and an intertemporal correlation between
scores of 0.60. A 5-point difference was deemed to be both
clinically and socially relevant [19].
We included women who were aged 1849 years and
willing to give informed consent and to continue follow-up
at our study clinics. All participants had to fulfill the World
Health Organization medical eligibility criteria [12] for the
use of DMPA.
Any woman who had used DMPA within the previous
12 months at the time of recruitment or did not meet the
World Health Organization eligibility criteria for use of
DMPA was excluded from the study. Those with history of
chronic illness, current menstrual abnormalities or previous
mental illness were also excluded. Women who were less
than 6 months postpartum were not eligible for the study.
2.3. Outcome measures
The primary outcome measure was the MCS of SF-36.
Other outcome measures included physical summary score
(PCS) and sexual function summary score. The secondary
outcome measures were discontinuation rates for DMPA,
reasons for initiation and discontinuation of DMPA and side
effect profile of DMPA.
2.4. Data management
Data were collected using a self-administered 36-item
SF-36 health survey at 0 and 6 months, questionnaire for
sociodemographic variables and clinical history and a questionnaire for follow-up on 6-month experience with DMPA.
Sexual function data were collected using four items
derived from the medical outcomes survey questionnaire [20].

S.Z. Wanyonyi et al. / Contraception 84 (2011) e17e22

e19

147 women screened


16 declined
participation
131 recruited

24 excluded (not eligible)


14 were <6 months postpartum, 6
already using DMPA, 2 menstrual
abnormalities, 2 chronic disease

107 met eligibility criteria


Assigned for the six months of follow-up

9 Lost to follow-up
3 declined interview at
6 months, 6 could not
be traced

Follow up

98 included in the final 6-month


analysis

Fig. 1. Flow of study.

Quantitative data were entered into the statistical software


spreadsheet. Incomplete SF-36 forms were excluded from
the final analysis.
2.5. Minimization of bias
Consecutive sampling was used, giving all the users an
equal chance to participate in the study. This minimized selection bias and intentional recruitment of study participants.
On follow-up, the respondents were required to complete the questionnaires before being attended to by a family
planning provider. This was to ensure that the response they
gave was not influenced in any way by the consultation.
2.6. Scoring and calculation for the SF-36
Scoring for the SF-36 was performed using the RAND36-item health survey technique [20]. A three-step approach
was used involving (i) standardization of scale, (ii)
aggregation of scale scores and (iii) transformation of
summary scores in line with recommendation from the SF36 manual. This method described by Ware [19] is
reproducible with a reliability coefficient of 0.780.93.
The advantage of using the PCS and MCS is that it reduces
the SF-36 to two summary measures without substantial loss
of information.
2.7. Data analysis
Analysis was performed using the SPSS version 15 and
STATA version 10. Statistical tests were two-sided, and a
statistical test with a p value of b.05 was considered
statistically significant. Comparison between means was
undertaken using the Student's t test with 95% confidence

intervals (CI) for normally distributed data. The median


value with interquartile range (IQR) was used to describe
nonparametric data. A comparison of the medians was performed using the Wilcoxon rank test and the Student's t test
for means. Subanalysis was done using multivariate
regression models for probable confounders.
2.8. Ethical considerations
The study was approved by the Aga Khan University
ethics and research committee. Informed written consent was
obtained from all participants.
Confidentiality and anonymity were maintained throughout the study by identifying participants by their unique
medical record numbers only.

3. Results
A total of 147 participants were screened, of which 131
were recruited to the study, but only 107 met the eligibility
criteria and were assigned to the 6-month follow-up. Of
these, 98 (91.6%) completed the study (see Fig. 1).
3.1. Sociodemographic characteristics
The participants had a mean age of 30.7 (SD, 5.5) years.
The average family size was 1.7 (SD, 1.1), with the desired
number of children being 2.7 (SD, 1.1). The mean age of
first pregnancy was 22.4 (SD, 8.4) years; 10.3% of the
respondents were nulliparous. The other sociodemographic
characteristics are presented in Table 1.

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S.Z. Wanyonyi et al. / Contraception 84 (2011) e17e22

3.2. Contraceptive history

Table 2
Prior contraceptive use

The majority of the participants (72%; 95% CI, 47.2


62.2) were contraceptively naive. Table 2 presents the different methods the clients had used 12 months prior to
choosing DMPA.
3.3. Reasons for choosing DMPA
The reasons for opting to use DMPA varied, with 72%
(95% CI, 65.380.6) choosing it for convenience (Table 3).
3.4. Heath-related QoL changes

Contraceptive method

Frequency

Percentage

95% CI

None
Combined oral pills
Natural fertility awareness method
Progestin-only pills
IUDa
Implants
Barrier
Othersb
Total

56
17
3
11
7
4
6
3
107

72.0
15.9
28.0
10.3
6.5
3.7
5.6
2.8
100

47.262.2
8.822.9
0.06.0
10.416.1
1.811.3
0.07.4
1.210.0
0.04.5

a
b

The PCS improved significantly over the 6-month period,


with no changes noted in the MCS. There was an
improvement in the sexual function score, though this was
not statistically significant (Table 4).
The various changes in the individual HRQL component
scores are presented in Table 5. There was improvement in
the physical functioning [baseline vs. 6-month median score
(IQR), 90 (20) vs. 95 (15); p=.0235; general health, 75 (25)
vs. 85 (15); p=.0011]. The other scales did not show any
significant improvement.
There was no significant influence of sociodemographic
characteristics on the summary scores. Primary level of
education had a small influence to the change in PCS, but
there were only three respondents (2.8%; 95% CI, 0.0-6.0)
with a primary level of education; hence, this effect did not
significantly affect the results. There was also no influence of
marital status, presence of dysmenorrhea and prior use of
contraceptives on both the PCS and MCS changes.
3.5. Side effects of DMPA
After 6 months of use of DMPA, 40 participants (40.8%;
95% CI, 38.6-49.2) reported undesirable side effects, while
58 respondents (59.2%; 95% CI, 52.6-67.3) did not
experience any. These are shown in Table 6.

Table 1
Sociodemographic characteristics
Characteristics
Level of education (n=107)
Primary
Secondary
Tertiarya
University
Marital status (n=107)
Single
Married
Widowed
Occupation (n=107)
Student
Formal employment
Informal sector
Unemployed

Frequency

Percentage

95% CI

3
18
49
37

2.8
16.8
45.8
34.6

0.06.0
9.624.0
36.255.4
25.443.7

7
99
1

6.5
92.5
0.9

1.811.3
87.597.6
0.02.8

3
67
21
16

2.8
62.6
19.6
15.0

0.06.0
53.371.9
12.027.3
8.121.8

a
Tertiary includes any education beyond secondary but excluding
university education.

IUD, intrauterine contraceptive device.


Others included Chinese pills, traditional methods and herbs.

3.6. Reasons for discontinuing the method


A total of 15 participants (15.3%) discontinued DMPA
within the study period (4 participants at 3 months and 11 at
6 months of follow-up). The main reasons for discontinuing
the method were menstrual irregularity (26.6%), reduced
libido (13.3%), need for longer acting method (20%) and
weight gain (20%). Only 6.7% of the participants discontinued the method following medical advice.
3.7. Participants satisfaction with DMPA
Table 7 shows the reasons for satisfaction with the use
of DMPA.

4. Discussion
In this prospective study, women using DMPA for
contraception had improved physical functioning and
general health after only 6 months. There was a general
improvement in the PCS among users of DMPA, with the
primary outcome of measure (MCS) remaining the same.
This confirmed our null hypothesis for the primary outcome
measure. There was also an improvement in sexual function,
though this change was not statistically significant. However, we found this to be a clinically relevant finding in our
study as DMPA has been associated with a reduction in
sexual arousal, libido and pleasure [1214]. Based on the
CIs around the mean changes seen, the possible effects of

Table 3
Reasons for choosing DMPA
Reason

Number

Percentage

95% CI

Convenience
Efficacy
Lack of preferred method
Medical advice
Peer advice
Trial of method
None stated
Total

77
4
7
11
2
4
2
107

72.0
3.7
6.5
10.3
1.9
3.7
1.9
100

63.380.6
0.07.4
1.811.3
4.416.1
0.04.5
0.07.4
0.04.5

S.Z. Wanyonyi et al. / Contraception 84 (2011) e17e22


Table 4
Six-month mean changes in the summary scale score

Table 6
Undesirable side effects

Summary scales Baseline,


6 months, Mean change
(0100)
mean (SD) mean (SD) (95% CI)

p value

PCS
50.9 (16.6) 56.5 (23.7) 5.64 (1.87 to 9.40)
.0054
MCS
50.6 (13.5) 50.1 (15.8) 0.51 (1.90 to 2.92) .4320
Sexual function 76.0 (37.5) 81.3 (43.7) 5.33 (2.15 to 12.81) .0858

DMPA could have ranged from 2-point deterioration in the


sexual function scale to a 13-point improvement (95% CI,
2.15 to 12.81). We could therefore assert based on our
results that DMPA did not adversely affect sexual function
after all.
The improvement in health-related QoL for women using
DMPA was encouraging for a method widely used in Kenya.
Having recorded an improvement in the contraceptive
prevalence rate from 39% to 46% among women aged 15
49 years between 2004 and 2009 and with an upward trend in
uptake of injectable contraceptives [2], our results, though
not generalizable, should be encouraging for users of
DMPA. This reflects the fact that besides its contraceptive
efficacy, DMPA could possess other noncontraceptive
benefits that improve the QoL. These outcomes were not
influenced by sociodemographic characteristics like age,
level of education, occupation, marital status and previous
use of contraceptives.
Women can realize their reproductive goals only when
they use contraceptive methods continuously. A prominent
concern for most family planning providers is the
discontinuation of methods. In our study, despite 40.8%
of the women reporting adverse side effects with use of
DMPA, this was not reflected in the discontinuation rate
(15.3%). The 6-month discontinuation rate is comparable
to that quoted in other studies [1,13]. Aruasa and
Wanyoike [21] found a 6-month discontinuation rate of
16% locally among users of DMPA despite subjective

Table 5
A comparison of baseline and 6-month HQRLa component scores

RAND-36 (scale 0100)


Physical functioning
Role functioning/physical
Role functioning/emotional
Energy/fatigue
Emotional well-being
Social functioning
Pain
General health
Sexual function (scale 0-100)
Sexual interest
Enjoyment
Arousal
Orgasm
a

Baseline,
median (IQR)

6 months,
median (IQR)

90 (20)
100 (25)
100 (25)
70 (25)
72 (28)
75 (25)
87.5 (42.5)
75 (25)

95 (15)
100 (25)
100 (66.7)
70 (21.25)
76 (28)
80 (25)
87.5 (32.5)
85 (15)

75
75
75
75

HQRL, health-related quality of life.

(50)
(50)
(50)
(50)

e21

75 (50)
100 (50)
75 (50)
100 (50)

Side effect

Number

Percentage

Irregular menstruation and spotting


Reduced libido
Weight gain
Aching joints and muscles
Hair loss
Insomnia
Nausea
Mood swings

13
9
5
6
2
1
2
2

32.5
22.5
12.5
15.0
5.0
2.5
5.0
5.0

reports of adverse events being higher. Important to note is


that the 12-month discontinuation rate for injectable
contraceptives reported in the Kenya demographic health
surveys was higher (29%); however, it was the family
planning method with the least discontinuation rate [2]. It
therefore follows that the presence of unwanted side effects
does not necessarily equate to discontinuation regardless of
the population being studied. Most women chose the
method for convenience and found it so after 6 months of
use. The added advantage of improvement in certain
aspects of QoL could also have enhanced its continued use
despite the side effects.
This study had several limitations. It was restricted to an
urban population with a high level of education and presumably a higher socioeconomic status in a country where
more than 80% of the reproductive health population is rural
[2]. It may be difficult to extrapolate the results to other users
with different demographics.
However, this study was adequately powered to detect a
5-point difference that was considered clinically relevant
with an 80% precision. It was also prospective in design with
very minimal loss to follow-up. Up to 91.6% of the participants completed the 6-month follow-up. The method of
contraceptive chosen was the most preferred with the least
discontinuation rate, hence reflecting a larger proportion
of contraceptive users. Restriction to one method ensured
uniformity of the outcomes since different contraceptive
methods have different effects. Despite being mainly urban,
the Kenya demographic and health surveys 2009 showed
that the majority (53%) of the contraceptive users were

Table 7
Reasons for satisfaction with DMPA
Reason

Number (n=98)

Percentage

Convenience
Amenorrhea
Ease of administration
Effectiveness
Lack of undesired side effects
Privacy
Frequent visits to clinic
Smooth skin
Nothing

46
16
13
5
5
3
3
3
4

46.9
17.3
13.2
5.1
5.1
3.1
3.1
3.1
4.1

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S.Z. Wanyonyi et al. / Contraception 84 (2011) e17e22

married women in urban areas. Furthermore, modern


methods use was generally higher in urban (47%) than in
rural areas, and more than 60% of the contraceptive users had
at least some secondary level of education [2]. The results
of this study could therefore still be descriptive of the
pattern of modern Kenyan contraceptive users.
We used generic tools that were tested and found to be
reliable for the study population, making the results comparable to other QoL study results. However, caution needs
to be exercised in interpreting our results as the SF-36 may
sometime produce different results from those of primary
efficacy outcomes [22].
However, these results are clinically relevant for family planning providers faced with the task of counseling
women on noncontraceptives benefits of DMPA. Women
will often be apprehensive on how the methods chosen will
impact on their general well-being and sexuality. Women
will need to balance between the contraceptive benefits of
birth spacing and fertility control and other noncontraceptive benefits. Besides the unwanted side effects, women
should be informed about the possibility of improvement in
physical well-being.
While there was no statistically significant change in
sexual function, the CIs tended more toward improved
sexual function as opposed to deterioration. This is relevant
in counseling women who are concerned about the effect of
DMPA on sexual function. The mental well-being of women
on DMPA was also not affected over time, and this could be
encouraging for users fearful of the impact of the method on
their psychological well-being. The presence of unwanted
side effects should not deter one from choosing a method as
they could still derive other benefits from it.
The public health implication of our findings is that
DMPA might improve some aspects of health-related QoL in
women. These gains can be factored in to a woman's choice
of contraception. This benefit must be weighed against the
overall short- and long-term risks, which must be individualized based on medical and reproductive history. Further
research with either generic or method-specific tools is
needed to assess the impact of other contraceptives on QoL.
The studies should also address the wider rural and low
socioeconomic populations. In light of the findings of this
study, more QoL consideration should be given to contraceptive research.
5. Conclusion
This longitudinal study showed a significant improvement in certain aspects of QoL associated with a method
widely used in this country. It shows that besides conferring
highly effective fertility control, contraceptives could also
confer other unintended health benefits to its users.
Contraceptive users should be informed of these additional
benefits with increased promotion of the noncontraceptive
effects of family planning methods.

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