Shi 2003.
| Methods | Quasi‐randomized trial. Patients were allocated according to the entry sequence. Blinding: The patients and acupuncture practitioners could not be blinded and it was unclear if the outcome assessors were blinded. Dropout/withdrawals: no statement. |
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| Participants | Setting: Hospital outpatient, China. Demographics: aged 30 to 69 yrs; 64 male, 56 female. Baseline comparability: Yes. Diagnosis: Patients with primary RLS diagnosed according to the criteria established by IRLSSG. Number of patients: 120 (40/40/40). |
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| Interventions | 3 arms: Group 1: scalp and body acupuncture plus fuming and washing with herbs. Group 2: oryzanol 20mg three times a day plus diazepam 5mg before bedtime. Group 3: scalp and body acupuncture. Comparison eligible: scalp and body acupuncture versus oryzanol and diazepam. Acupuncture treatment: (1) Acupuncture rationale: traditional Chinese medical theories and modern theories of cerebral cortical function. (2) Needle type: sterilised stainless steel, body acupuncture: 50 mm in length and 0.30 mm in diameter, 75 mm in length and 0.30 mm in diameter; scalp acupuncture: 50 mm in length and 0.35 mm in diameter. (3) Acupuncture prescriptions: body acupoints: ST36, GB34, SP10, BL56 and BL57; scalp treatment zones: MS5 (from GV20 to GV21), the upper 1/5th of MS7 (from GV20 to GB7) and MS8 (extending for 1.5 Cun from BL7 along the Bladder Meridian of Foot‐Taiyang). (4) Depth of needle insertion: body acupuncture: 40 mm to 62.5 mm; scalp acupuncture: 40 mm. |
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| Outcomes | Only one outcome reported: Ordinal outcome (immediately following treatment): (a) Cured: disappearance of all symptoms; Group 1: 27/40, Group 2: 18/40, Group 3: 19/40. (b) Marked effective: most of the symptoms disappeared and sleep was occasionally disturbed by unpleasant sensations and the urge to move the legs; Group 1: 8/40, Group 2: 6/40, Group 3: 6/40. (c) Improved: symptoms were partially relieved, but sleep was often disturbed by unpleasant sensations and the urge to move the legs; Group 1: 4/40, Group 2: 7/40, Group 3: 5/40. (d) No effect: symptoms were unchanged after treatment. Group 1: 1/40, Group 2: 9/40, Group 3: 10/40. |
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| Notes | Author's conclusion: Acupuncture plus fuming was significantly better than Western medications or acupuncture. No significant difference was detected between Western medications and acupuncture alone. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment? | High risk | C ‐ Inadequate |