Burden of Menstrual Pain Measured by Heatmap Visualization of Daily Patient-Reported Data in Japanese Patients Treated with Ethinylestradiol/Drospirenone: A Randomized Controlled Study

Figures & data

Table 1 Baseline Dysmenorrhea Score (Sum of Two Sub-Scores)

Sub-Score	Severity	Definition	Score
Severity of dysmenorrhea sub-score	None	No impairment of work, including schoolwork and housework	0
	Mild	Slight impairment of work, including schoolwork and housework	1
	Moderate	Desire to lie down to rest. Discomfort interferes with work, including schoolwork and housework	2
	Severe	Necessary to stay in bed all day. Discomfort causes inability to work, including schoolwork and housework	3
Use of analgesics sub-score	None	No pain	0
	Mild	Use of analgesics for 1 day during the previous(or current) menstrual period	1
	Moderate	Use of analgesics for 2 days	2
	Severe	Use of analgesics for 3 or more days	3

Table 2 Evaluation Criteria for Menstrual Pain and the Coloration Used for the Heatmap

Severity	Definition	Coloration Used for Heatmap
None	No pain.	White
Mild	No need for analgesics and no impairment of daily activities.	Light orange
Moderate	Moderate menstrual pain requiring analgesics. The pain is relieved by taking analgesics. Discomfort interferes with usual daily activities.	Orange
Severe	Advanced menstrual pain requiring analgesics. The pain may not be relieved by taking analgesics. Discomfort causes inability to work or perform usual activities.	Dark orange

Figure 1 Overall menstrual pain scores over 24 weeks in the full analysis set following treatment with the flexible extended regimen (A) and the 28-day cyclic regimen (B), as shown with heatmapping. The reference line at Day 0 indicates the first day of study drug administration. Lower baseline dysmenorrhea scores (3–4) are shown in the top half of the heatmap, and higher baseline dysmenorrhea scores (5–6) in the bottom half.

Table 3 Number of Patients with Menstrual Pain by Intensity

Dysmenorrhea Score at Baseline		Flexible Extended Regimen		28-Day Cyclic Regimen
Total	n	105	100.0%	107	100.0%
	None	0		1	0.9%
	Mild	31	29.5%	20	18.7%
	Moderate	58	55.2%	57	53.3%
	Severe	16	15.2%	29	27.1%
3–4	n	38	100.0%	46	100.0%
	None	0		1	2.2%
	Mild	16	42.1%	15	32.6%
	Moderate	18	47.4%	24	52.2%
	Severe	4	10.5%	6	13.0%
5–6	n	67	100.0%	61	100.0%
	None	0		0
	Mild	15	22.4%	5	8.2%
	Moderate	40	59.7%	33	54.1%
	Severe	12	17.9%	23	37.7%

Table 4 Rate Ratios for Severe Menstrual Pain for the 28-Day Cyclic Regimen vs Flexible Extended Regimen According to Baseline Dysmenorrhea Score

Dysmenorrhea Score at Baseline	Treatment Group	Total Number of Days Assessed	Total Number of Days with Severe Pain Score (%)	RR:28-Day Cyclic Regimen Group/Flexible Extended Regimen (95% CI)
Total	Flexible extended regimen group	13,884	32 (0.23)	2.478 (1.182–5.196)
	28-day cyclic regimen group	13,377	78 (0.58)
3–4	Flexible extended regimen group	5037	5 (0.10)	1.624 (0.456–5.778)
	28-day cyclic regimen group	5531	9 (0.16)
5–6	Flexible extended regimen group	8847	27 (0.31)	2.832 (1.251–6.408)
	28-day cyclic regimen group	7846	69 (0.88)

Abbreviations: RR, rate ratio; CI, confidence interval.

Figure 2 Mean cumulative function of the flexible extended regimen and the 28-day cyclic regimen.

Figure 3 Menstrual pain scores as shown by heatmapping after treatment with the flexible extended regimen (A) or the 28-day cyclic regimen (B) in the group with primary dysmenorrhea. Lower baseline dysmenorrhea scores (3–4) are shown in the top half of the heatmap, and higher baseline dysmenorrhea scores (5–6) in the bottom half.

Figure 4 Menstrual pain scores as shown by heatmapping after treatment with the flexible extended regimen (A) or the 28-day cyclic regimen (B) in the group with secondary dysmenorrhea. Lower baseline dysmenorrhea scores (3–4) are shown in the top half of the heatmap, and higher baseline dysmenorrhea scores (5–6) in the bottom half.