Park 2009.
Methods | Randomized, clinical trial. 3 groups: moxibustion 1, moxibustion 2, and waiting list | |
Participants | 28 perimenopausal or postmenopausal women aged 45‐60 years experiencing at least 5 moderate (warm sensation with a transient and insignificant impact on the participant's activity) to severe (hot sensation with sweating that caused significant disruption to a participant's daily activity) hot flushes every 24 h and had natural or surgical menopause Women having uncontrolled hypertension, diabetes mellitus requiring insulin injections, any type of thyroid dysfunction, past or current malignant tumours, severe dyslipidaemia, other infectious diseases or systemic diseases; using hormones, antidepressants, gabapentin, SSRIs, or sedatives; using transdermal HT within 4 weeks or oral hormone medication within 8 weeks were excluded Women were recruited from Daejeon, South Korea using local newspaper advertisements and notices posted at various clinics Setting: South Korea |
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Interventions | Moxibustion 1: Moxibustion capsules formulated as a disposable adhesive, and were composed of a moxa pillar attached to the base of the device. Total length of the moxibustion device was 25 mm, of which 18 mm constituted the moxa pillar. Acupoints used were consistent with evidence from clinical practice. There were 4 acupoints: CV12, CV4, bilateral ST36, SP6. 5 moxibustion capsules used at each point in a single session. Treatment procedures were identical in Moxa 1 and Moxa 2. Treatments were given for 4 weeks (4 times per week for the first 2 weeks and 3 times per week for the 2 remaining weeks) by a qualified acupuncture doctor licensed in the Republic of Korea having had 6 years of training in acupuncture and moxibustion Moxibustion 2: The same moxibustion capsules were used in Moxa 1 and Moxa 2. Acupoints used were consistent with evidence in published literature. 5 moxibustion capsules were used at each point in a single session. There were 4 acupoints: GV4, CV3, CV6, bilateral UB23. Participants received this type of acupuncture 4 times per week for the first 2 weeks and 3 times per week for the 2 remaining weeks. Treatments were given for 4 weeks (4 times per week for the first 2 weeks and 3 times per week for the 2 remaining weeks) by a qualified acupuncture doctor licensed in the Republic of Korea having had 6 years of training in acupuncture and moxibustion Waiting list: The 10 participants in this group did not received any treatment for 5 weeks (including the 1‐week follow‐up period) |
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Outcomes | Primary outcomes:
Time of assessment of the main outcomes: at baseline, during treatment (at 1, 2, and 3 weeks), at the end of treatment (week 4), and for a 2‐week follow‐up period (week 6) Secondary outcomes:
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Source of funding | Korea Institute of Oriental Medicine (K08010) | |
Notes | Follow‐up: 2 weeks (after completion of treatment); and 1 week for the waiting list group | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was performed by the study coordinator using a computerized list with an assignment ratio of 2:2:1 (Moxa 1/Moxa 2/control)” |
Allocation concealment (selection bias) | Unclear risk | Method not reported |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "All analyses were conducted blind to group allocation” "[The participants] were not told which treatment they would received. In addition, to eliminate observation bias, the two assessors were blind to the intervention group before analysis of data" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "Analyses were performed with the ''intention to treat'' population for which all participants were randomised at least once after moxibustion treatment (missing data were replaced with the last observation value)'' Moderate dropout rate (10% for both moxibustion group 1 and 2; 0% for the waiting list) Reasons for dropouts are mentioned |
Selective reporting (reporting bias) | Low risk | The published report included all expected outcomes |
Other bias | Low risk | This study appeared to be free of other sources of bias |