| Literature DB >> 27069371 |
Iréne Lund1, Thomas Lundeberg2.
Abstract
INTRODUCTION: Endometriosis is a multifactorial, estrogen-dependent, inflammatory gynecological condition - often with long-lasting visceral pelvic pain of different origin, and infertility among women. Current management options for patients' are often inadequate, with side effects for many for whom acupuncture techniques could be an alternative. Earlier studies have discussed the efficacy of acupuncture, but not its methodological aspects.Entities:
Keywords: STRICTA; acupuncture; endometriosis; individual responses; pain treatment; pelvic pain
Year: 2016 PMID: 27069371 PMCID: PMC4818044 DOI: 10.2147/JPR.S55580
Source DB: PubMed Journal: J Pain Res ISSN: 1178-7090 Impact factor: 3.133
Data of included subjects, diagnosis, study design, outcome variables, assessment time point, and instrument
| Included studies
| |||
|---|---|---|---|
| Rubi-Klein et al | Wayne et al | Highfield et al | |
| 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 | a. Before, after each unit (evaluated 4 times) | a. Before 4 weeks, 8 weeks, 6 months following start of treatment | a. Before, after treatment |
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.
Methodological aspects of acupuncture treatment according to items in STRICTA, 2010
| STRICTA items and details | Included studies
| ||
|---|---|---|---|
| Rubi-Klein et al | Wayne et al | Highfield et al | |
| 1. Acupuncture rationale | |||
| a. Style of acupuncture | a. TCM | a. Japanese acupuncture following Japanese acupuncture training curriculum at the New England School of Acupuncture | a. TCM |
| 2. Details of needling | |||
| a. Number of needle insertions per subject per session | a. 10 | a. 8–12 | a. Case 1–11; Case 2–7 |
| 3. Treatment regimen | |||
| a. Number of treatment sessions | a. 10 | a. 16 | a. Case 1 - 9 treatments; Case 2 – 15 treatments |
| 4. Other components of treatment | |||
| a. Details of other interventions administeredto the acupuncture group | a. Additional analgesic interventions permitted. Moxa was applied to needles in presence of cold syndrome | a. – | a. Continuation with regular medication including hormonal based treatment and different sorts of NSAIDs |
| 5. Practitioner background | |||
| Description of participating acupuncturists | Four general practitioners, average 15 years in acupuncture practice associated with Austrian Society of Acupuncture distributed treatments | Seven licensed acupuncturists with formal training in Japanese acupuncture | One licensed acupuncturists with experience within the field of gynecology |
| 6. Controls or comparator interventions | |||
| a. Rationale for the control or comparatorin the context of the research question | a. Placebo, to evaluate differences in changes between groups | a. Sham; to evaluate differences in changes between groups | – |
Abbreviations: BL, bladder; CV, conception vessel; EX, extra; GB, gall bladder; KI, kidney; LR, liver; LU, lung; NSAIDs, nonsteroidal anti-inflammatory drugs; PC, pericardium; SP, spleen; ST, stomach; STRICTA, STandards for Reporting Interventions in Clinical Trials of Acupuncture; TCM, traditional Chinese medicine; SI, small intestine.
Described results on rated pain, health-related quality of life, and additional endometriosis-related variables in the evaluated studies
| Outcome variables, type of comparisons of change before–after treatment | Included studies, number of included patients in analysis
| ||
|---|---|---|---|
| Rubi-Klein et al, | Wayne et al, | Highfield et al, | |
| Rated pain intensity | |||
| Within groups | Ratings at the lower half of the scale in the acupuncture group unchanged in placebo group | Ratings at the lower half of the scale in both groups | Decreased rating in both patients |
| Between groups | Lower levels in acupuncture group as compared to placebo group | No differences between the groups | |
| Rated pain disability | |||
| Within groups | Lower rated levels in both groups | – | – |
| Between groups | No difference when compared after crossover | ||
| Rated HRQOL | |||
| Within groups | Increased in seven of eight items of | Increased in acupuncture group | – |
| Between groups | SF36 in both groups | No differences | |
| Social efficiency, psychological wellbeing higher in acupuncture group than in placebo group | |||
| Additional variables | Take home baby rate: 5 (5 of 7) women pregnant women ended their pregnancy successful (group allocation unspecified) | Perceived stress: decrease in both groups | Social activity and attendance in school activity: increased in both patients |
Abbreviations: HRQOL, health-related quality of life; SF36, short form (36); IL, interleukin; TNF-α, tumor necrosis factor α.