Suen 2002.
Methods | Design: parallel‐group
Randomisation method: information not available Method of allocation concealment: information not available Blinding: double‐blind (patients and assessors) Stratification: not used |
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Participants | Inclusion: age >= 60, suffering from sleep disturbances, sleeping poorly on at least 3 nights per week, insomnia lasted for a minimum 6 months, actigraph monitoring of sleep efficiency of < 85%
Exclusion: patients with serious physical and psychological illness, such as stroke, mental illness, dementia, major depression and impairment such as being bedridden, sleep apnoea, regular use of a hypnotic medication or other psychotropic medication with an inability or unwillingness to discontinue medication, wearing pacemaker, or implanted electrical device, having a sleep partner, infection or abscess of external ear were excluded Number of participants: intervention 1 (magnetic acupressure): 68; intervention 2 (acupressure): 36; control (placebo acupressure): 35 Number of males: overall 10 Age: overall mean 81.66 (SD 5.8) Specific diagnoses/diagnostic subtypes: "Excess" syndrome and "Deficiency" syndrome based on Traditional Chinese Medicine theory Associated disease: 96% reported having good or acceptable health condition. Diabetes mellitus and hypertension, which were under control by regular treatment, were most commonly reported among the participants Duration of disorder: range 6 months to > 20 years Previous treatments: information not available |
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Interventions | Intervention group 1 (magnetic acupressure): auricular acupressure using magnetic pearl with a magnetic flux densities ranging from 0.01 mT to 2 T were stick to seven sterilised auricular points: Shenmen, heart, kidney, liver, spleen, occiput and subcortex areas. The pearls were applied to the most sensitive area of each selected auricular point. The sensitive point was detected by means of an electrical detector (Potentiometer). The pearls were replaced every 3 days. Intervention group 2 (acupressure): auricular acupressure using Semen vaccariae. The procedure and acupoints used were the same as the intervention group 1. Control (placebo acupressure): placebo acupressure using Junci Medulla (placebo), the procedure and acupoints used were the same as the intervention group 1. Junci Medulla is a soft material that does not induce any pressure on the acupoints. Duration of treatment: 3 weeks | |
Outcomes | 1. Total sleep duration by actigraphy 2. Sleep onset latency by actigraphy 3. Total wake time by actigraphy 4. Wake after sleep onset by actigraphy 5. Number of awakenings by actigraphy 6. Sleep efficiency by actigraphy |
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Notes | Duration of follow‐up: 3 weeks
Dropouts: 8 in intervention group 1, 11 in intervention group 2 and control group. Reasons were home leave (n = 8), refusal to wear an actigraph as a monitoring device (n = 3), admission to hospital (n = 2), being treated for influenza (n = 3), unreported reasons (n = 3). Dropouts were replaced. Comparability of groups at baseline: no significant differences between the groups in exercise level, anxiety level, depression level, or sleep parameters at baseline Risk of bias: high |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Sequence generation was not described |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment was not described |
Blinding (performance bias and detection bias) All outcomes | Low risk | Both the patients and assessors were blind to treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | High risk | Distribution of reasons for dropouts among the treatment groups were not clearly described |
Selective reporting (reporting bias) | Unclear risk | Trial protocol was not available to judge whether there was selective reporting |
Other bias | Low risk | No other bias was apparent |