Table 15Nonsurgical harmsa reported in placebo-controlled studies

Reported EventPlaceboGnRH AgonistsSERMMedroxyprogesteroneb
Range of % of participants with adverse event
(number of studies reporting event)
Amenorrhea4
(1)
98
(1)
NRNR
Depression22
(1)
NRNRNR
Headache20-22
(2)
NR21
(1)
NR
Hot flushes26
(1)
80
(1)
NRNR
Ovarian cyst11
(1)
NR17
(1)
NR
Reduction/discontinuation of drug44-49
(2)
NR32
(1)
37
(1)
Sleep changesNR40
(1)
NRNR
Leg color changeNRNRNR0.9
(1)
Benign breast lumpNRNRNR0.9
(1)
Sheath accidentNRNRNR0.9
(1)

GnRH = gonadotropin releasing hormone; NR = not reported; SERM = selective estrogen receptor modulator.

a

Studies report harms for all participants only (vs. only those participants with noncyclic pain)

b

Study notes that women in the treatment group experienced headache, nausea, vomiting, hot flushes, bloating, and mood changes and women in the placebo group experienced headache, bloating, weight gain, hot flushes, mastalgia, nausea, and vomiting, but numbers experiencing each event are not reported.

NOTE: An RCT of botulinum toxin A compared with placebo95 did not allow for calculation of percentages but reported total events per group (botulinum toxin/placebo): headache (20/20), cold/flu symptoms (33/42), pelvic/back pain (26/30), gastroenterological symptoms (11/8).

From: Results

Cover of Noncyclic Chronic Pelvic Pain Therapies for Women: Comparative Effectiveness
Noncyclic Chronic Pelvic Pain Therapies for Women: Comparative Effectiveness [Internet].
Comparative Effectiveness Reviews, No. 41.
Andrews J, Yunker A, Reynolds WS, et al.

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