CONTENTS

        Chapters
  1. Research and Regulatory Approval
  2. Use of Injectables
  3. Effectiveness and Reversibility
  4. Side Effects and Complications
  5. More Evidence in the Cancer Debate
  6. Noncontraceptive Health Benefits
  7. Counseling Issues
  8. Communicating with the Public
  9. Maximizing Access and Quality

Published with this issue:

HIGHLIGHTS


Published by the Population Information Program, Center for Communication Programs, The Johns Hopkins School of Public Health, 111 Market Place, Suite 310, Baltimore, Maryland 21202-4012, USA

Volume XXIII, Number 2 August 1995

Other Effects

After menstrual changes, weight gain, headache, and dizziness are the most common side effects reported by users of progestin-only injectables. Other reported side effects include abdominal distension or discomfort, acne, anxiety, backache, decreased libido, fatigue, hair loss, moodiness, tender breasts, and weight loss. Rates of discontinuation for all these side effects combined have ranged from 3% to 9% after 12 months in WHO trials (336, 338, 340, 342). Progestin-only injectables change cholesterol metabolism in ways that are suspected to increase users' risk of atherosclerosis (thickening and hardening of arterial walls).

Weight gain. Most users of injectables gain weight. On average, DMPA users gain 1.5 kg to 2.0 kg in the first year (285, 333, 338, 341). Some users may continue to gain weight thereafter at about the same rate (276). A Thai study found that long-term DMPA users gained weight steadily for five years and then stopped gaining weight (315). NET EN users gained an average of 1.5 kg in a 1-year WHO trial (341). Among users of Cyclofem and Mesigyna in a WHO trial, weight gain averaged 0.8 kg per year (336). In contrast, the vast majority of women using OCs do not gain weight (116).

The range of weight change is wide. In studies some users have gained considerably more than 2 kg a year, others' weight has not changed, and some women have lost weight (8, 54, 122, 190, 270, 285, 338). In a 1-year trial, for ex- ample, the average weight gain among 607 DMPA users was 1.5 kg, but six women discontinued because they gained between 4 kg and 13 kg (338). A study of NET EN users found an average gain of 5 kg among 20% of women and an average loss of 5 kg among 15% of the women after one year (122). In a 3-year study of Mesigyna, one-third of users gained 3 to 8 kg (157).

The reason for weight gain is unclear. The extra weight is mainly from fat rather than water retention. Some users report increased appetite (8, 112, 315). In contrast, among OC users both increased water retention and fat may cause the occasional weight gain (116). Some weight gain is normal with increasing age, of course. For example, in a multiyear Swedish study, normal weight gain accounted for about half of the average weight gain of DMPA users (285).

Few women discontinue injectables because of weight gain. Among DMPA and NET EN users in a 2-year WHO trial, the rate of discontinuation for weight gain was about 2 per 100 woman-years (342). There are regional differences in women's perceptions of weight gain, perhaps reflecting cultural differences in women's ideal weight. In a WHO introductory trial of Cyclofem, rates of discontinuation for weight gain ranged from 0.4 per 100 after one year in Indonesia to 4.0 per 100 in Thailand (110).

Cholesterol metabolism. Most studies find that DMPA and NET EN increase levels of low-density lipoprotein (LDL) cholesterol and decrease levels of high-density lipoprotein (HDL) cholesterol (see Table 4). LDL cholesterol has been linked to atherosclerosis, while HDL cholesterol reduces the risk of atherosclerosis. Atherosclerosis is a major cause of heart attack, stroke, and other vascular disease (360). There is little direct epidemiologic information, however, on the risk of vascular disease among users of injectables.

Headache and dizziness. In clinical trials anywhere from 3% to 19% of users of injectables have reported headache or dizziness. Few women discontinue use for these reasons (80, 270, 336, 340, 341, 342). For example, among DMPA and NET EN users in one clinical trial, the rate of discontinuation for headache in both groups after two years was about 2 per 100 woman-years of use. The rate of discontinuation for dizziness was 1.2 per 100 woman-years among DMPA users and 1.6 per 100 among NET EN users (342). Among 2,320 users of monthly injectables in a one-year study, about 2% had headaches or dizziness, but less than half of these women discontinued for these reasons (336).

Headaches may not be caused by injectables but rather may occur at rates typical of the general population. In a comparative trial of IUD and Norplant users, for example, 7% to 10% of IUD users reported headaches (253). Most headaches in adults are caused primarily by muscle tension rather than vascular problems and thus clearly are not related to hormonal contraception (366). There is no medical reason for women to discontinue injectables because of headaches, even migraine headaches, unless they are accompanied by focal neurologic symptoms—difficulty seeing, speaking, or moving (332). Women may choose to discontinue for personal reasons, however.

Clinical implications. For women reporting side effects on return visits, providers should first consider other causes. For women with severe headaches, providers should consider sinus infection, high blood pressure, and stroke. Anemia, high or low blood pressure, or low blood sugar could cause dizziness. Lack of exercise or pregnancy could cause weight gain. In some instances providers can encourage women concerned about weight gain to diet and exercise more.

If other causes are unlikely, these side effects often can be handled through counseling. Clients may need reassurance that these side effects are not dangerous and are not symptoms of more serious problems. If, after counseling, a client insists that side effects are unacceptable, providers should recommend that she choose another method and help her to do so without expressing criticism or disapproval (259).

To provide support and reassurance, providers emphasize that clients should return for help whenever they have problems or questions. If possible, clients who receive injections at a clinic should return there for help because those providers are trained to handle side effects of injectables. Inexperienced providers at other clinics may respond inappropriately—for example, treating bleeding by dilation and curettage (23).

Because of the effect of progestin-only injectables on cholesterol levels, a group of experts assembled by WHO recommends that women with severe vascular diseases (such as severe hypertension, a history of stroke, or ischemic heart disease) or with diabetes involving vascular complications should not use these injectables unless other methods are not available, or, in a provider's careful clinical judgment, other methods would not be acceptable. Women who develop these conditions while using progestin-only injectables or who develop recurrent severe headaches with focal neurologic symptoms should see a doctor or nurse and switch to a nonhormonal contraceptive method because there is some concern that such headaches sometimes progress to stroke (332) (see Chapter 9.3 Eligibility Criteria.


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