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Health-related quality of life changes among users of depot medroxyprogesterone acetate for contraception

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 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],1.87–9.4), 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 foundamenorrhea desirable.
Conclusion: Besides its contraceptive efficacy, DMPA is associated with an improvement in perceived physical health with no apparentadverse 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 Similar to other hormonal contraceptives, users of DMPA may experience various side effects. Most of these side Depot medroxyprogesterone acetate (DMPA) is a medi- effects are related to the suppression of ovarian estradiol um-term reversible contraceptive method, with a low failure production. These include unscheduled bleeding and amen- rate, 0.3 to 3 per 100 woman-years . However, its effec- orrhea. Minor side effects include nausea, dizziness, weight tiveness for child spacing in sub-Saharan Africa has been gain, hair loss, acne and headaches. Accompanying mood questioned, though its popularity remains high in the region changes related to some of these side effects are documented . There have been reports linking the use of DMPA with . Alteration in the sexual drive among DMPA users has an increased risk of HIV transmission, but recent work has been reported. These effects are, however, reversible upon reliably disapproved possible association Besides con- discontinuation of the method . There have also been traceptive effects, DMPA also possesses other benefits, for concerns about the effects of DMPA on the bone mineral example, reduction in risk of endometrial carcinoma, reduced density. This effect is minimal and reversible but may be incidence of iron deficiency anemia and dysmenorrheal . Its associated with early onset osteoporosis if DMPA is used action on the cervical mucus has also been thought to be protective against pelvic inflammatory disease All these side effects have varying influence on the acceptability of this method for contraception. Irregularbleeding, for instance, accounts for most discontinuations inthe first 6–9 months of use These side effects and their influence on discontinuation rates has led to focus on ☆☆ Funding: We received funding from the Aga Khan University contraceptive research being mainly on the burden of gyne- research grant for postgraduate medical education.
cological and other related medical conditions, with little ⁎ Corresponding author. P.O. Box 16963-00100 Nairobi, Kenya attention on how they affect the user's quality of life (QoL).
It is now widely acknowledged that the personal burden of 0010-7824/$ – see front matter 2011 Elsevier Inc. All rights reserved.
S.Z. Wanyonyi et al. / Contraception xx (2011) xxx–xxx illness cannot be described fully by measures of disease At 6-month follow-up, the questionnaire was given to the status alone. Psychosocial factors such as apprehension, respondents prior to the clinical consultation. Participants functional impairment, difficulty in fulfilling personal and were also reminded by a telephone call on their scheduled family responsibilities, financial burden and diminished appointment in the event that they did not return as expected.
cognition must also be encompassed . Some lifestyle The SF-36 was completed in the same manner as before, choices such as contraception may have effects on daily life and information on experience with DMPA and any side and life satisfaction besides providing fertility control. These effects, either desirable or unwanted, was sought during the effects could be evaluated using either the existing generic consultation. In case of discontinuation, the reasons were instruments or condition-specific QoL assessment tools.
There are several generic health-related QoL tools in exis- tence, and these have been widely used in other disciplineswith reliable outcomes .
Consecutive sampling technique was used to recruit study This study aims to assess the health-related QoL changes participants. Every participant meeting the inclusion criteria among Kenyan women using DMPA for contraception by was approached for possible recruitment to the study after utilizing the Short Form (SF)-36 questionnaires besides evaluating for other side effects associated with the method.
shows the flow of the study.
Estimates of sample size were derived from the SF-36 health survey manual by Ware . These are predetermined sample size calculations based on a healthy US populationand widely used in QoL studies utilizing the SF-36. A A prospective, observational study was carried out at the sample size of 105 participants was needed to detect a Aga Khan University Hospital and the Family Health 5-point difference in the mental summary score (MCS) changes over time within the same group. A power calcu- The study was conducted for a period of 10 months lation of 80% was used given a two-tailed t test with an starting from December 2008 to September 2009.
α value of .05 and an intertemporal correlation between The broad objective of our study was to assess the health- scores of 0.60. A 5-point difference was deemed to be both related QoL changes among women using DMPA for contraception. The specific objectives are as follows: (i) to We included women who were aged 18–49 years and determine the characteristics of women using DMPA for willing to give informed consent and to continue follow-up contraceptive, (ii) to establish the reasons for choosing to use at our study clinics. All participants had to fulfill the World or discontinue the method, (iii) to evaluate the changes in Health Organization medical eligibility criteria for the QoL among women using DMPA and (iv) to explore the side Any woman who had used DMPA within the previous 12 months at the time of recruitment or did not meet theWorld Health Organization eligibility criteria for use of All clients desiring contraceptives were counseled on the DMPA was excluded from the study. Those with history of available methods including DMPA. This was done in both chronic illness, current menstrual abnormalities or previous clinics by a family planning provider. The method chosen by mental illness were also excluded. Women who were less the client was then administered in the usual way.
than 6 months postpartum were not eligible for the study.
Those who chose DMPA were approached for recruit- ment into the study. If they met the eligibility criteria and agreed to participate, a brief description of the study was readto them and an informed consent obtained. The socio- The primary outcome measure was the MCS of SF-36.
demographic data were captured, and a brief clinical history Other outcome measures included physical summary score was sought. The SF-36 was then introduced to the client for (PCS) and sexual function summary score. The secondary self-administration. The questionnaires were completed in outcome measures were discontinuation rates for DMPA, the clinic. Any woman requesting to complete the question- reasons for initiation and discontinuation of DMPA and side naire later was requested to return it at the earliest opportunity. An addressed, stamped envelope was provided when desired. However, only four participants opted for thisalternative, and three of them failed to return the question- Data were collected using a self-administered 36-item naires despite constant reminders. They were consequently SF-36 health survey at 0 and 6 months, questionnaire for sociodemographic variables and clinical history and a ques- Upon returning the questionnaire, it was checked for tionnaire for follow-up on 6-month experience with DMPA.
completeness. Difficulties encountered during completion Sexual function data were collected using four items were ascertained. Assistance was provided as desired.
derived from the medical outcomes survey questionnaire S.Z. Wanyonyi et al. / Contraception xx (2011) xxx–xxx 147 women screened
16 declined
131 recruited
24 excluded (not eligible)
107 met eligibility criteria
9 Lost to follow-up
Follow up
98 included in the final 6-month
analysis
Quantitative data were entered into the statistical software intervals (CI) for normally distributed data. The median spreadsheet. Incomplete SF-36 forms were excluded from value with interquartile range (IQR) was used to describe nonparametric data. A comparison of the medians was per-formed using the Wilcoxon rank test and the Student's t test for means. Subanalysis was done using multivariate Consecutive sampling was used, giving all the users an regression models for probable confounders.
equal chance to participate in the study. This minimized selec-tion bias and intentional recruitment of study participants.
On follow-up, the respondents were required to com- The study was approved by the Aga Khan University plete the questionnaires before being attended to by a family ethics and research committee. Informed written consent was planning provider. This was to ensure that the response they gave was not influenced in any way by the consultation.
Confidentiality and anonymity were maintained through- 2.6. Scoring and calculation for the SF-36 out the study by identifying participants by their uniquemedical record numbers only.
Scoring for the SF-36 was performed using the RAND- 36-item health survey technique A three-step approachwas used involving (i) standardization of scale, (ii) aggregation of scale scores and (iii) transformation ofsummary scores in line with recommendation from the SF- A total of 147 participants were screened, of which 131 36 manual. This method described by Ware is were recruited to the study, but only 107 met the eligibility reproducible with a reliability coefficient of 0.78–0.93.
criteria and were assigned to the 6-month follow-up. Of The advantage of using the PCS and MCS is that it reduces these, 98 (91.6%) completed the study (see ).
the SF-36 to two summary measures without substantial lossof information.
The participants had a mean age of 30.7 (SD, 5.5) years.
Analysis was performed using the SPSS® version 15 and The average family size was 1.7 (SD, 1.1), with the desired STATA® version 10. Statistical tests were two-sided, and a number of children being 2.7 (SD, 1.1). The mean age of statistical test with a p value of b.05 was considered first pregnancy was 22.4 (SD, 8.4) years; 10.3% of the statistically significant. Comparison between means was respondents were nulliparous. The other sociodemographic undertaken using the Student's t test with 95% confidence S.Z. Wanyonyi et al. / Contraception xx (2011) xxx–xxx The majority of the participants (72%; 95% CI, 47.2– 62.2) were contraceptively naive. presents the dif- ferent methods the clients had used 12 months prior to The reasons for opting to use DMPA varied, with 72% (95% CI, 65.3–80.6) choosing it for convenience ().
a IUD, intrauterine contraceptive device.
b Others included Chinese pills, traditional methods and herbs.
The PCS improved significantly over the 6-month period, with no changes noted in the MCS. There was an 3.6. Reasons for discontinuing the method improvement in the sexual function score, though this wasnot statistically significant ( A total of 15 participants (15.3%) discontinued DMPA The various changes in the individual HRQL component within the study period (4 participants at 3 months and 11 at scores are presented in . There was improvement in 6 months of follow-up). The main reasons for discontinuing the physical functioning [baseline vs. 6-month median score the method were menstrual irregularity (26.6%), reduced (IQR), 90 (20) vs. 95 (15); p=.0235; general health, 75 (25) libido (13.3%), need for longer acting method (20%) and vs. 85 (15); p=.0011]. The other scales did not show any weight gain (20%). Only 6.7% of the participants discon- tinued the method following medical advice.
There was no significant influence of sociodemographic characteristics on the summary scores. Primary level of 3.7. Participants’ satisfaction with DMPA education had a small influence to the change in PCS, but shows the reasons for satisfaction with the use there were only three respondents (2.8%; 95% CI, 0.0-6.0) with a primary level of education; hence, this effect did notsignificantly affect the results. There was also no influence ofmarital status, presence of dysmenorrhea and prior use of contraceptives on both the PCS and MCS changes.
In this prospective study, women using DMPA for contraception had improved physical functioning and After 6 months of use of DMPA, 40 participants (40.8%; general health after only 6 months. There was a general 95% CI, 38.6-49.2) reported undesirable side effects, while improvement in the PCS among users of DMPA, with the 58 respondents (59.2%; 95% CI, 52.6-67.3) did not primary outcome of measure (MCS) remaining the same.
This confirmed our null hypothesis for the primary outcomemeasure. There was also an improvement in sexual function,though this change was not statistically significant. Howev- er, 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 . Based on the CIs around the mean changes seen, the possible effects of Tertiary includes any education beyond secondary but excluding S.Z. Wanyonyi et al. / Contraception xx (2011) xxx–xxx Six-month mean changes in the summary scale score 50.9 (16.6) 56.5 (23.7) 5.64 (1.87 to 9.40) 50.6 (13.5) 50.1 (15.8) −0.51 (−1.90 to 2.92) 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 ourresults that DMPA did not adversely affect sexual function reports of adverse events being higher. Important to note is that the 12-month discontinuation rate for injectable The improvement in health-related QoL for women using contraceptives reported in the Kenya demographic health DMPA was encouraging for a method widely used in Kenya.
surveys was higher (29%); however, it was the family Having recorded an improvement in the contraceptive planning method with the least discontinuation rate . It prevalence rate from 39% to 46% among women aged 15– therefore follows that the presence of unwanted side effects 49 years between 2004 and 2009 and with an upward trend in does not necessarily equate to discontinuation regardless of uptake of injectable contraceptives , our results, though the population being studied. Most women chose the not generalizable, should be encouraging for users of method for convenience and found it so after 6 months of DMPA. This reflects the fact that besides its contraceptive use. The added advantage of improvement in certain efficacy, DMPA could possess other noncontraceptive aspects of QoL could also have enhanced its continued use benefits that improve the QoL. These outcomes were not influenced by sociodemographic characteristics like age, This study had several limitations. It was restricted to an level of education, occupation, marital status and previous urban population with a high level of education and pre- sumably a higher socioeconomic status in a country where Women can realize their reproductive goals only when more than 80% of the reproductive health population is rural they use contraceptive methods continuously. A prominent . It may be difficult to extrapolate the results to other users concern for most family planning providers is the discontinuation of methods. In our study, despite 40.8% However, this study was adequately powered to detect a of the women reporting adverse side effects with use of 5-point difference that was considered clinically relevant DMPA, this was not reflected in the discontinuation rate with an 80% precision. It was also prospective in design with (15.3%). The 6-month discontinuation rate is comparable very minimal loss to follow-up. Up to 91.6% of the parti- to that quoted in other studies Aruasa and cipants completed the 6-month follow-up. The method of Wanyoike found a 6-month discontinuation rate of contraceptive chosen was the most preferred with the least 16% locally among users of DMPA despite subjective discontinuation rate, hence reflecting a larger proportionof contraceptive users. Restriction to one method ensureduniformity of the outcomes since different contraceptive methods have different effects. Despite being mainly urban, A comparison of baseline and 6-month HQRLa component scores the Kenya demographic and health surveys 2009 showed that the majority (53%) of the contraceptive users were HQRL, health-related quality of life.
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