Table 1.
Data of included subjects, diagnosis, study design, outcome variables, assessment time point, and instrument
| Included studies
|
|||
|---|---|---|---|
| Rubi-Klein et al43 | Wayne et al41 | Highfield et al39 | |
| Number of patients and age | 101, 20–40 years | 18, 13–22 years | Two adolescent, one 17 years |
| Diagnose – laparoscopy stage I–IV, ASRM | Stage II–IV | Stage I–III | Stage I |
| Study design | Prospective randomized single-blind, placebo controlled, crossover week 2 menstrual cycles between 2 treatment units | Prospective randomized single-blind, sham controlled | Retrospective case series study |
| Rated pain intensity at start | >5, VAS (no pain-worst possible pain, 0–10) | 2–8 NRS (no pain-worst possible pain, 0–10) | 5–8 NRS (no pain-worst possible pain, 0–10) |
| Outcome variable | Rated pain intensity, pain disability, HRQOL, treatment expectation (high, intermediate, and low); absentee days; take home baby rate; analgesic intake | Rated pain intensity, (actual and during the past 4 weeks), HRQOL, perceived stress; measured serum inflammatory markers | Rated pain intensity, symptom of greatest concern, eg, fatigue, constipation, medication, attendance at school |
| Assessment per variable | Pain intensity: | Pain intensity: | Pain intensity: |
| a. Time point b. Instrument |
a. Before, after each unit (evaluated 4 times) b. VAS (see “Rated pain intensity at start”), VRS (no-slight-average-severe) Pain disability: a. Before, after the study (twice) b. PDI HRQOL: a. Before, after each unit (4 times) b. SF-36 Analgesic intake: a. Daily b. Diary Treatment expectation: a. Before Number of absentee days: a. Before, after study, 6 months follow-up b. – Take home baby rate: a. Before, after study, 6 months follow-up b. – |
a. Before 4 weeks, 8 weeks, 6 months following start of treatment b. NRS (no pain-worst possible pain, 0–10) Symptom severity: a. Before, 4 weeks, 8 weeks, 6 months following start of treatment b. The Endometriosis Symptom Severity scale HRQOL: a. Before, 4 weeks, 8 weeks, 6 months following start of treatment b. Endometriosis Health Profile-30; The Paediatric Quality of Life Inventory; The Perceived Stress Scale; participant-generated list of three activities made difficult due to pelvic pain Serum inflammatory markers: a. Before, 4 weeks, 8 weeks, 6 months following start of treatment b. I L-6, TNF-α |
a. Before, after treatment b. NRS (no pain-worst possible pain, 0–10) |
Notes: The Endometriosis Symptom Severity scale instrument required – dysmenorrhea, dyspareunia, and non-menstrual pain is rated with VRS (absent, mild, moderate, and severe); Endometriosis Health Profile-30, 30 rated items divided in five subscales (pain, control/powerlessness, emotional wellbeing, social support, and self image) were each is rated with VAS (best possible health status to worst possible health status, 0–100); The Paediatric Quality of Life Inventory, 23-item multidimensional instrument rated with VRSs (never a problem; almost never a problem; sometimes a problem; often a problem; almost always a problem) divided into four domains (physical functioning, emotional functioning, social functioning, and school functioning); The Perceived Stress Scale, A 10-item instrument each scored from “not at all” to “very much” (0–4); A participant-generated list of three activities made difficult due to pelvic pain rated with NRS, not difficult-most difficult (0–10). PDI is to what degree pain disables seven aspects of life are disrupted by chronic pain rated by NRS (no disability-worst disability, 0–10) family/home responsibilities, recreation, social activity, occupation, sexual behavior, self care, and life-support activities. The SF36 is to what extent 36 rated items, based on different number of VRSs, grouped into vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health are affected by the pain.
Abbreviations: ASRM, American Society for Reproductive Medicine; HRQOL, health-related quality of life; IL, interleukin; NRS, Numeric Rating Scale; PDI, Pain Disability Index; TNF-α, tumor necrosis factor alpha; VAS, Visual Analog Scale; VRS, Verbal Rating Scale.