Medical abortion: misoprostol alone works well

 As many areas in the United States are making mifepristone illegal, and the US Supreme Court will be weighing in on the potential of a federal ban soon, it is noteworthy that several studies have found that single agent misoprostol is quite effective, similar to its standard combination with mifepristone. A recent study documented the safety and effectiveness of self-managed abortion in the US using misoprostol alone through an online telemedicine service (see abortion misoprostol single agent telemed PerspecSexReproducHealth2023 in dropbox, or  doi.org/10.1363/psrh.12219) . Thanks to Paul Susman for sending me a great article on this: https://societyfp.org/wp-content/uploads/2023/02/SFP_ScienceSays_misoprostol.pdf

 

Details: 

-- 1016 women received prescriptions for misoprostol from Aid Access in the month of June 2020 

    -- Aid Access is a non-profit based in Vienna, Austria, but is the only telemedicine organization providing abortion services to all 50 US states for pregnant women, transgender men, and gender non-binary individuals up to 10 weeks' gestation. individuals were given 3 doses of 800 mcg misoprostol for a $35 donation. the process was through an on-line consultation form for medical information, with gestation dating by ultrasound or last menstrual period, then sending the meds to the individuals or to a pharmacy for pickup

   -- 568 women confirmed use of the medication  (i will use the term "women" for ease of writing/reading, but this also includes transgender men and gender non-binary individuals who were pregnant)

-- age 18-24yo in 29%/25-29yo in 33%/30-34yo in 22%/35-39yo in 9%/>40yo in 5% 

-- ultrasound done in 11%, IUD in place in 0.2%, living within 60 minutes of a hospital in 97% 

-- 96% were at or less than 10 weeks gestation/4% were longer 

-- Main outcomes: proportion of people who reported ending their pregnancy without instrumentation intervention, and the proportion who received treatment for serious adverse events 

 Results: 

--  women who reported successfully ending their pregnancy without instrumentation: 88% (84.6%-90.2%)

    -- in women 10 weeks or under gestation: 90.3% successful (87.4%-92.6%)

    -- in woman over 10 weeks' gestation 75.0% successful (53%-89%)

-- no difference in outcomes if those pregnant got the meds through the mail service or having them sent to a retail pharmacy for pickup [no comment on whether the pharmacist helped the individual understand how to take the meds or not, or even if they played a role in dissuading individuals from using them??]

-- adverse events:

    -- 12 of those pregnant (2%) reported experiencing one or more serious adverse events

        -- hospital admission: 3 women (0.5%)

        -- blood transfusion: 3 women (0.5%)

        -- ED treatment: 12 women (2%)

        -- IV antibiotics: 3 women (0.5%)

        -- death: 0

    -- 20 (4%) reported experiencing a symptom of a potential complication

        -- heavy bleeding (more than 2 maxi pads per hour for more than 2 hours): 14 women

        -- fever at least 102°F: 2 women

        -- discharge with a bad odor: 1 woman

        -- severe pain that would not go away after the abortion: 14 women

 

Commentary:

-- misoprostol was approved by the FDA in1988 for the specific indication of decreasing the risk of upper GI bleeds in people on NSAIDs or aspirin. It is still used for that indication

-- the FDA approved mifepristone in 2000 specifically for its use in abortions

-- the World Health Organization and the American College of Obstetricians and Gynecologists as well as other many international organizations recommend 2 regimens for safe and effective medical abortions: mifepristone with misoprostol as well as misoprostol as single therapy (especially when mifepristone is unavailable or too expensive). The WHO guidelines recommend either regimen for self-managed abortions up to 12 weeks' gestation

-- many other studies have found that misoprostol-only regimens were safe and effective, with reports of 84% to 93% of pregnancies less than 70 days' gestation having a complete abortion without need of procedural interventions, assessed at 7-14 days (see https://societyfp.org/wp-content/uploads/2023/02/SFP_ScienceSays_misoprostol.pdf for more details)

    -- and, a slew of international studies have confirmed very high effectiveness, in the 94%-100% range

        -- for example, a study published last year in Lancet Global Health analyzed outcomes of 961 patients in Argentina and Nigeria, finding that 99% on misoprostol alone and 94% on the combined regimen had a complete abortion without surgical intervention. And for those with self-managed medication abortions and pregnancies less than 9 weeks' gestation, both regimens were non-inferior to the effectiveness of clinician-managed medication abortion administered in a clinical setting (see abortion meds misoprostol single agent LancetGlobHlth2022 in dropbox, or https://www.thelancet.com/journals/langlo/article/PIIS2214-109X(21)00461-7/fulltext )

-- these studies consistently showed that misoprostol was safe, with a meta-analysis of 12,184 women noting that “at most 26 … were transfused or hospitalized for abortion-related reasons”: see abortion misoprostol alone first trimester review ObGyn2019 in dropbox, or  doi:10.1097/AOG.0000000000003017 )

-- a 2022 study assessed women's comprehension of OTC drug facts for mifepristone and misoprostol, finding that 93-99% of women met their performance criteria for 10 of 11 primary communication objectives, with 36% of the participants aged 12 to 17 (see abortion both meds high level of understanding ObGyn2022 in dropbox or DOI: 10.1097/AOG.0000000000004757  ), though in this study about ¼ of the women had "limited" literacy level and these women did not meet performance criteria by 3 of the primary objectives; this study lacked statistical power (too few people) to draw real conclusions about outcomes

-- common adverse effects of misoprostol include nausea, lower abdominal pain/cramping, diarrhea, and fever/chills. The mean duration of bleeding following itsmisoporostol use is 11.5 days. Studies suggest that nausea is quite common (50% range), diarrhea (35% range), and fever (28% range)

-- as a perspective, pregnancy is associated with similar reactions, but more mortality/morbidity: in the US there were 32.9 deaths per 100,000 live births in 2021, and 6-8% of pregnant women have "high-risk complications" [ie, way more problems than for the abortion pills]

-- not so shockingly, it turns out the Aid Access has been swamped with requests from the US now for the pills (they are giving out both misoprostol and mifepristone)

Limitations:

-- there was only a 60% followup rate for those requesting the med (though not so different from other studies, including the clinical studies)

-- all of the data, from the initial data input in the on-line consultation questionnaire, to whether the women took the meds, to the outcomes (positive or negative), were all self-reported and open to inaccuracies

-- the study had few women who stated they were >10 weeks' gestation, so the sample size was too small to evaluate effectiveness (and this can lead to the lower success rates with wide confidence intervals); other studies have reported better outcomes in those >10 weeks

-- this study was done when abortion was legal in all 50 states. this could limit the generalizability to the current situation, given the much added stress and anxiety about abortion in so many US states, and this could affect outcomes

    -- there is also a selection bias when assessing women who want a self-administered medical abortion when there was much easier access to all types of abortion vs those currently who have no choice: were the former women more educated middle-class women vs the mix of women with no choice now??)

-- one big issue here is overall generalizability to the full population of women who might want access to misoprostol: in the US we have the rather unfortunate problem that many of those states with the most restrictive abortion laws are the same ones having the lowest literacy levels, the least access to health care (many rural areas, no medicaid waiver, and lots of people who have no insurance), and the highest levels of poverty (and perhaps the least able to afford a smartphone, and the least able to go to a state that would provide abortion coverage)

    -- for example, in Texas when they enacted a restrictive abortion law in 2013, there was a large decrease in abortion facilities, and a dramatic decrease in abortions done: there was a 1.3% decline if living near one of the facilities bit a 50% decline in those >100 miles from a facility: see http://gmodestmedblogs.blogspot.com/2017/01/texas-abortion-law-changes-and-its.html )

so,  though science and logic are not contributing to the attempts to outlaw mifepristone in the US  (which has been used safely as part of the medical abortion treatment with misoprostol for 23 years), a few points:

-- many, many studies have confirmed the high success rate with misoprostol alone around the world. this study provides a large US database confirming that

-- the telemedicine process allowed for rapid patient evaluation (through their on-line consultation), finding excellent results without any on-site clinical evaluation/supervision

    -- in that sense it really empowered women to take care of the abortion themselves, instead of being more passively involved

-- studies have confirmed effectiveness of misoprostol up to 12 weeks (and that is recommended by the WHO)

-- this study confirmed many others documenting the low risk of significant adverse events associated with the misoprostol, much lower than pregnancy (despite "fake news" to the contrary)

-- misoprostol alone seems to be a very important means for a self-managed abortion, especially since many people globally do not have easy access to medical care, or can afford the high cost of mifepristone (including in the US, where so many people are uninsured)

-- so, the loss of mifepristone is terrible (especially as a marker of the effectiveness of the anti-abortion lobby, despite >60% of the US population wanting abortion to be legal)

    -- and, if the anti-abortion law is codified by the US Supreme Court, we do need to extend the fight to make sure that misoprostol is not also outlawed (even though misoprostol is widely availbale in the US for upper GI protection from bleeding)

        -- as well as many other drugs that republicans seem not to like....  

        -- maybe we are reaching the time of the not-so-distant past when medication prescribing was actually a conversation between clinicians, who seem to know more about the meds than politicians, and the individual patients who can make an informed decision about themselves????

        -- and, maybe we can also reinstate a return to science as important and not vilified???

geoff

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