Shin 2009.
Methods | Randomised, non‐blinded, parallel 2‐arms trial | |
Participants | Country: Korea
Site: the laboratory of Ewha Woman's University College of Nursing
Recruitment: 185 women were recruited through a posted advertisement placed in a university hospital, of these 30 volunteers were enrolled and randomly divided into three groups (Hand Acupuncture Therapy, Hand Moxibustion Therapy, control group) of 10 each. There were respectively 7, 8, 7 volunteers in each group completed. Hand acupuncture group versus control group were included in this review. Inclusion: women aged 20 to 35 years meeting ICD‐10 criteria for PMS. Exclusion: 1. menstrual irregularity (fewer than 20 days or more than 36 days) in the previous 3 months; 2. pregnancy or breastfeeding; hysterectomy; 3. oral contraceptive use in the previous 3 months; antidepressant, benzodiazepine, or psychotropic drug use; 4. diagnosed with thyroid disorder; and a history of depression or anxiety disorder. |
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Interventions | Screening: three menstrual cycles were screened prior to intervention using the Menstrual Symptom Severity Scale and used as baseline data. Intervention group: hand acupuncture therapy: (n = 10) Treatments were applied to the basic female corresponding hyuls on the Im Ki Mek of both hands: A5, A6, A8, A12, A16, A18; Liver Ki Mek N18; and Spleen Ki Mek F6, Needles were inserted into either hand at an approximate penetration depth of less than 1 mm. After needle insertion, the women were instructed to keep their hands still for 15 minutes. Control group: no treatment control group. (n = 10) Women did not receive any treatment but were contacted at the time of follow‐up assessment. Duration: 10 sessions for 4 weeks Timing of administration: 10 times treatments in the 4‐week period, once every 3 days at Ewha University Medical Center. Summary measures: score change of severity of menstrual symptoms between the first pretreatment luteal phase (5 days prior to menses) and the first post‐treatment luteal phase (5 days prior to menses) |
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Outcomes | The Menstrual Symptom Severity developed by Mitchell, Woods, and Lentz (1992) | |
Notes | NICMAN score: 19 Funding: not reported Conflict of Interest: not reported Date study was conducted: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: “ Women were randomly divided into three groups (i.e., HAT, HMT, control) of 10 each” (pg 175). Method of randomisation not reported. |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding possible due to no treatment control group. Likely to affect outcome. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | High risk | 14 women completed (7 in the HAT group, and 7 in the control group). During the intervention phase, 6 women withdrew for a variety of reasons (e.g., work schedule, personal plans, wedding, school, vacation, and so forth). |
Selective reporting (reporting bias) | Unclear risk | No protocol published |
Other bias | Low risk | None noted |