What reasons make combined oral contraceptive pills (COC) users to discontinue?

Dr. Naser O Malas*, M D,Dr. Ehab Al-Rayyan*, M D. Dr.Wasef Al Dukum**, M D.

Objective: The purpose of this study was to study the reasons for quitting the use of combined oral contraceptive pills (COC) and their relation to the age of users and duration of using the pills. Setting: Princess Haya Military Hospital, Aqaba-Jordan. Materials and methods A retrospective study was conducted in which we reviewed the family planning clinic files. 240 cases identified for women with previous use of combined oral contraceptive pills from Jan.2006 till Dec.2007, we analyzed them according to the reasons of discontinuation and there relation to age of users at the time of quitting the use of the pills as well as the duration of using the pills. Results: Only 25 % of cases discontinued the pills because of their desire to get pregnant, while more than half of the users 52.5 % of cases stopped the contraceptive pills due to side effects. Other causes as method related and personal causes formed 13% and 9% respectively. The most common side effect reported by the COC users was breast discomfort (60%). Most of the patients who stopped using the pills due to side effects are of young age group <25 years (61%). Nevertheless, 64% of the users discontinued the method within the first 6 month of its use. However, 90% of the users stopped it within the first 12 months. Conclusion: More than half of COC users discontinued the method due to undesired side effects, however, carefully selected clients and providing them a good counseling about the method would make tolerance much better, and reduces this compliance by them. Key words:

Combined oral contraception (COC), reasons and discontinuation.

Department of obstetric and gynecology, Princess Haya Hospital* and King Hussein Medical Centre**.

Introduction:
Oral contraceptives are the most commonly used form of reversible contraception in the United States (1). At least 10 million women in the United States and 100 million women worldwide use COC pills (estrogenprogestin) (2). While COC have several mechanisms of action, the most important for providing contraception is estrogen-induced inhibition of the mid cycle surge of gonadotropin secretion, so that ovulation does not occur (3). When used properly, Oral contraceptives are highly effective in preventing pregnancy; about 5 women per 100 typical users and fewer than 1 per 100 women with perfect use become pregnant per year (2). An increased risk of unintended pregnancy has been documented among women who have reported missing pills but this risk can be modified by two factors: the timing of coitus and the use of backup contraception as the increased risk was most likely during the first seven days and during the third cycle of pill use (4,5). Oral contraceptives provide high degree contraceptive efficacy and a range of short- and long-term non-contraceptive health benefits. They include protection from ovarian cancer (up to 80%), endometrial cancer (up to 40%50%), ectopic pregnancy, pelvic inflammatory disease, acne, menstrual disorders, any many others (6-9). Although oral contraceptive pills are highly reliable method, one third of the unintended pregnancies that occur each year in the United States are because of pills misuse, failure, or discontinuation (10). It should be useful to quantify and analyze the causes of discontinuation COC methods, to prevent unplanned and unwanted pregnancies. Some studies have documented that side effects were the most common reasons given for discontinuing Oral contraception use. The most common treatment-related adverse effects are breast discomfort, mood changes weight gain headache, nausea and vomiting, dizziness, irregular bleeding, and others (1, 11). This study identifies factors associated with discontinuation of OCC use, where discontinuation refers to cessation of COC use in the 6 months prior to our study.

Materials and methods:

A retrospective study was conducted after obtaining the ethical approval from the ethical committee of the Jordanian Royal Medical Services. We reviewed the files and records of the family planning clinic at Princess Haya

Military Hospital at south of Jordan. This study was based on 240 married women aged between 18-42 years who were previously used at least once a combined oral contraceptive pills. The period of study was from January 2006 until December 2007. The information on womens past contraceptive behavior was based on her self report of the reasons that lie behind quitting the use of the pills. The clients were using 28-day pill pack with a 21 and 7 pills as combined oral contraceptive and iron pills respectively. The data obtained from the files were analyzed according to the reasons for discontinuation the use of COC pills and the relations between these variable reasons to the age at the time of quitting this contraceptive method and the duration of using the pills. The reasons studded for discontinuation the method were the desire for getting pregnancy, side effects of the pills, method related causes, and other unidentified personal causes. Types of side effects experienced while using the pills and leading to discontinuation in using this method were examined in the present study.

Results:
As shown In table one only 25% of cases (60/240) stopped using the method due to desired pregnancy or no need for further contraception, while the other 75% of the users stopped it due to side effects, method related (causes as poor compliance to method or patients concerns regarding hormonal content), and other personal unspecified causes were as 52.5%(126/180 cases), 13.3% (32/180 cases), and 9.2%(22/180 cases) respectively. This table shows that side effects of the pills was the most common cause of quitting the use of this method, it forms more than half of the method users. Table two showed the percentage of side effects as reported by our patients. Most of the clients used to report one or more side effects and then we tabled these side effects and their percentage against the total number of patients who quitted the pills due to side effects (120 cases). Breast discomfort was the most common side effect reported and it formed about 60.3% (76/126 cases). Mood changes, weight gain, headache were reported as the following percentages 56.3%, 53.2%, and 51.6% respectively. These were followed by nausea and vomiting, dizziness, and irregular bleeding and formed 44.4%, 32.5%, and 30.2% respectively. However, only 10.3% (13/126) of cases stopped the pills due to recommendation of clinician to stop using it.

Table three showed that most of the patients who stopped using the pills due to side effects are of young age group <25 years as it formed about 61% (77/126 cases). Also this table showed that those patients <25years of age formed more than half of cases 53% (17/32 cases) for discontinuation the pills due to method related causes like bad compliance to the method. For those who wanted to have pregnancy the percentage were almost the same for the three age groups (<25, 26-35, and>36 years), and were 32%, 35 %, and 33% respectively. Regarding personal causes the percentage were 27.2%, 36.4%, and 36.4% respectively for the same age groups mentioned above. Table four showed the period that clients used the COC. Among those who wanted pregnancy, 85% (51/60 cases) used the pills for more than 2 years. However, only 3% (2/60 cases) stopped using it before ending the first year of use. Those users who developed side effects, 64% (81/126 cases) discontinued the method within the first 6 month of commencing its use. Nevertheless, the number rises to 90% (113/126 cases) for the first 12 months of its usage. However, only 10% (12/126 cases) of the users tolerated side effects more than 12 months and none of them used it for the third year. For those who had methods related causes for discontinuation OC, 72% (23/32 cases) stopped using the pills within the first year of usage. However, the percentage was consistently decreasing with increasing the duration of using this method. Finally, among the personal causes of discontinuation the pills, no significant difference noticed for the stopping the method in relation to the same of the above mentioned periods.

Discussion:
Oral contraceptives were introduced in the late 1950's (12). By the end of 1980's, an estimated 63 million married women around the world were using this method (13). It has been described as the most significant medical advance of the 20th century (14). Hormonal contraception can be safely provided after a careful personal and family medical history and an accurate blood pressure measurement (15). While breast exams, pap smears, and screening for sexually transmitted diseases are important, most groups, including the American College of Obstetricians, the World Health Organization, and the Royal College of Obstetricians and Gynecologists agree that these procedures are not necessary before a first prescription for COC (16).

The actual incidence of discontinuation the use of COC varies between different studies. A study done by Khan in total of 1600 COC users, current or past, aged 15 to 49 years, 36% discontinued COC use because of different reasons (11). This incidence was not included in our study. Despite the occurrence of considerable COC discontinuation, few studies have attempted to examine the factors that are associated with COC discontinuation. The reasons reported for discontinuation the use of pills were: wanting a child, husband's disapproval, the cost of COC, the desire for a more effective contraceptive method, the unavailability and inconvenience of taking the pill, and many others. Our study showed the occurrence of side effects was most frequently cited as the reason for stopping COC use as it formed about 52.5% , this finding is consistent with other studies (6,10,11). In a recent study done in rural Bangladesh, 53% of the women who discontinued oral contraceptives did so because of side effects, and 20% due to desire for more children (7). Nevertheless, the rate was reported 46% by another study (10). The incidence and frequency of side effects reported varied between different studies. In one study Khan reported dizziness to form the most widely reported side effect, mentioned by 57% of the women, followed by weakness or sickness by 29%, vomiting tendency by 23%, and burning sensation in the body by 10%. (7). However, other study reported weight gain as the most frequent side effect experienced by 60% of users, breast discomfort by 55%, mode changes 54%, nausea 46%, spotting 44% (1). However, our study showed breast discomfort was the most common side effect reported and it formed about 60.3% of users. Mood changes, weight gain, headache were reported as the following percentages 56.3%, 53.2%, and 51.6% respectively. Other side effects cited in the studies were irregular bleeding, nausea, headache, breast tenderness, irritability, Depression, and vaginal dryness (17). These varieties may be related on the user's memory for past events. One study revealed that discontinuation of COC use was not significantly associated with the number of side effects experienced during the first 3 months of COC use (7). However, a previous study in the United States demonstrated that discontinuation more likely to occur if side effects happened suddenly and specially if they were multiple because the probability of its occurrence increase disproportionately with each additional side effect experienced; a single side effect increasing the risk by 50%, two by 220%, and three by 320% (10). Its is well documented that most side-effects are expected during the first few months of starting COC use and most of them disappear after a few

cycles, this may be explained by woman's body adjusts to the hormones present in COC. Good counseling, particularly that focused on low impact adverse effects, is an important instrument to reduce dropout rate (18). The findings of the present study also demonstrated that we have to concentrate on patients <25 years old during family planning counseling as they form the most majority of cases who discontinue using the pills due to un-tolerated side effects or poor compliance in using the method especially during the first year of usage. This finding in our study were consistence with another study that showed 57% of COC discontinuation users were below 25 years of age (10). However, other study reported no significant association between the age of the COC users and their discontinuation of COC use; however, the proportion of discontinuation was relatively higher for women aged 35 years or more compared to their younger counterparts (7). The findings of the present study also suggest that COC users who developed side effects, 64% discontinued the method within the first 6 month of commencing its use. Nevertheless, the number rises to 90% for the first 12 months of its usage. This finding is consistent with the results of other studies. Khan 2001, reported 59.5% of all the patients who discontinued the use of oral contraceptives, did so before 12 months of usage, women with side effect experience in the first 3 months of COC use were 1.4 times more likely to discontinue COC use than were women who did not have such an experience(7). However, 1995 national survey of family growth reported overall 3% of women discontinue use of COs for a method-related reason within six months of starting use, and 6.9% do so within 12 months (19). Potential limitations of this study should be considered. First, this was a convenience sample that may not be representative of the broad population of COC users. Second, are the small sample size and the substantial initial loss to follow-up some patients. Finally, we relied on the user's memory for past events, such as reason of discontinuation and type of side effects. Most women who reported having discontinued COC because of side effects had switched to less effective methods. In a recent study, approximately 10% of formal COC users switched to withdrawal as their primary method of contraception (20). However, another study reported that more than four fifths of women who discontinued oral contraceptives but remained at high risk of unintended pregnancy either failed to adopt another method or adopted a less effective method, the author advised follow-up visits for 1 to 2 months after a prescription is written (6). Khan reported in his study that about 70% of the women who discontinued COC use and wanted no more

children were using no method of contraception, thus leaving them with an increase risk of unwanted pregnancies; he explained this finding due to either the woman's inability to access a reliable method, or limited choices of alternative contraceptive methods (11). It is imperative that parallel to promoting contraceptive use, the new effort should be paid in minimizing the discontinuation of its use, especially among women who are reluctant to use other contraceptive methods following COC discontinuation.

Conclusion:
The relatively high rate of the discontinuation COC with reasons for stopping it, indicate the potential for improving management of COC use in our institution. Firstly, counseling should include the consideration of potential side effects of COC use, how long they last, how to manage them. Second, counseling should include what method should be used if COC did not work out. Finally, we suggest that monthly follow up visits for the first 6 months of commencing COC should be scheduled. Clinicians may need to encourage their patients to discuss their reasons for wanting to discontinue the use of an effective contraceptive method and assist them with their concerns or to switch to other effective methods to protect themselves from unintended pregnancy.

References:
1- Rosenberg MJ, Waugh MS, Burnhill MS. Compliance, Counseling and Satisfaction with Oral Contraceptives: A Prospective Evaluation. Family Planning Perspectives 1998;30(2). 2- Petitti DB. Clinical practice. Combination estrogen-progestin oral contraceptives. N Engl J Med 2003; 349(15):1443-50. 3- Webberley H, Mann Melanie. Oral contraception-Update. Current Obstetrics & Gynaecology 2006;16:21-29 4- Oakley D, Potter L, Leon-Wong E, Visness C. Oral Contraceptive use and protective behavior after missed pills. Family Planning Perspectives 1997;29:277-79. 5- Mansour D, Fraser I. Missed contraceptive pills and the critical pill-free interval. The Lancet 2005;365:1670-1. 6- Rosenberg MJ, Waugh MS. Oral contraceptive discontinuation: A prospective evaluation of frequency and reasons. Am J Obstet Gynecol 1998;179:577-82. 7- Khan MA. Side effects and oral contraceptive discontinuation in rural Bangladesh. Contraception 2001;64:16167. 8- Burkman R, Collins J, Shulman LP, et al. Current perspectives on oral contraceptive use. Am J Obstet Gynecol 2001;185:S4-12.

9- D'Souza RE. Risks and benefits of oral contraception pills. Best Practice & Research Clinical Obstet and Gynecol 2002;16(2):133-54. 10- Rosenberg MJ; Waugh MS; Meehan TE .Use and misuse of oral contraceptives: risk indicators for poor pill taking and discontinuation. Contraception 1995;51(5):283-8. 11- Khan MA. Factors associated with oral contraceptive discontinuation in rural Bangladesh. Health Policy And Planning 2003;18(1):101-8. 12- Middeldorp S. Oral contraceptives and the risk of venous thromboembolism. Gend Med.2005;2;S3-S9. 13- Hannaford PC. Combined oral contraceptives: Do we know all of their effects? Contraception 1995;51:325-7. 14- Chen J, Smith KB, Morrow S, et al. The acceptability of combined oral hormonal contraceptives in shanghai, people's republic of china. Contraception 2003;67:281-5. 15- Hannaford PC, Webb AM. Evidence-Guided prescribing of combined oral contraceptives: Consensus statement. Contraception 1996;54:125-29. 16- Stewart FH; Harper CC; Ellertson CE; Grimes DA; Sawaya GF; Trussell J. Clinical breast and pelvic examination requirements for hormonal contraception: Current practice vs evidence. JAMA 2001;285(17):2232-9. 17- Sabatini R, Cagiano R. Comparison profiles of cycle control, side effects and sexual satisfaction of three hormonal contraceptives. Contraception accepted 20 March 2006. 18- Colli E, Tong D, Penhallegon R, et.a. Reasons for contraceptive discontinuation in women 20-39 years old in New Zealand. Contraception 1999; 59:227-31. 19- Trussell J, Vaughan B. Contraceptive failure, method-related discontinuation and resumption of use: Results from the 1995 national survey of family growth. Family planning perspectives 1999;31(2):64-72. 20- Brunner Huber LR, Hogue C, Stein A, Drews C, Zieman M. Contraception use and discontinuation: Findings from the contraceptive history, initiation, and choice study. Am J Obstet Gynecol 2006;194:1290-5.

Table (1) Reasons of discontinuation the use of COC

CAUSE 240 cases DESIRED PREGANACY SIDE EFFECTS METHOD RELATED PERSONAL CAUSES (No cause) NO. 60/240 126/240 32/240 22/240 % 25% 52.5% 13.3% 9.2%

Table (2) % of Side effects among COC users

CAUSE (126 cases) NO. 76/126 71/126 67/126 65/126 56/126 41/126 38/126 13/126 11/126 % 60.3% 56.3% 53.2% 51.6% 44.4% 32.5% 30.2% 10.3% 8.7%

BREAST DISCOMFORT MOOD CHANGES WEIGHT GAIN HEADACHE NAUSIA / VOMITTING DIZENESS IRREGULAR BLEEDING CLINICIANM RECOMENDATION OTHERS

Table (3) Age at time of COC discontinuation.

Causes(240 cases) DESIRED PREGANACY (60) SIDE EFFECTS (126) METHOD RELATED (32) PERSONAL CAUSES (No cause)( 22) <25 Y 19(32%) 77(61%) 17(53%) 6(27.2%) 26-35 Y 21(35%) 45(35%) 8(25%) 8(36.4%) > 36 Y 20(33%) 4(3.1%) 7(22%) 8(36.4%)

Table (4) The Duration of using COC in relation to the cause of discontinuation.
Causes (240) DESIRED PREGNANCY (60) SIDE EFFECTS (126) METHOD RELATED (32) PERSONAL CAUSES (22) 0-6 months 0(0%) 81(64%) 12(37.5%) 4(18.2%) 7-12 months 2(3%) 33(26%) 11(34.4%) 6(27.3%) 13-24 months 7(12%) 12(10%) 6(18.8%) 5(22.7%) >24 months 51(85%) 0(0%) 3(9.3%) 7(31.8%)

13%

9%

DESIRED PREGANACY

25%

SIDE EFFECTS METHOD RELATED

53%

PERSONAL CAUSES (No cause)

Reasons of discontinuation the use of O

80 70 60 50 40 30 20 10 0

77

45 20 21 19

17

7 8 6

<25 Y

8
PERSONAL CAUSES (22)

8
Over 36 Y <25 Y

26-35 Y Over 36 Y

DESIRED PREGANACY (60)

SIDE EFFECTS (126)

Age at time of OC discontinuation.

METHOD RELATED (32)

90 80 70 60 50 40 30 20 10 0

81 51

33 7 0
Desired Pregnancy (60)

12 0

0 - 6 months

2
Side effects (126)

116 3 12

6 4
Personal causes (22)

7
13 - 24 months 0 - 6 months

7-12 months 13 - 24 months >24 months

Duration of using OC in relation to the cause of discontinuation.

Method related (32)