| Methods |
Randomised trial with concurrent eligible patients outside of the RCT. The non‐RCT patients refused randomization because of preference for treatment, but consented to follow up. The non‐RCT patients were followed‐ up identically to the RCT patients. Adult patients undergoing endoscopic investigation of upper GI tract. Two (14%) patients were lost to follow up in the RCT sedation group, none were lost to follow up in the non‐RCT sedation group. |
| Data |
Characteristics of non‐RCT patients presented and compared to RCT patients who received the same treatment. RCT acupuncture patients were mean 69 (17) years, 5 women, 7 men. Non‐RCT acupuncture patients were mean 62 (16) years, 10 women, 11 men. |
| Comparisons |
Two RCT arms, each of them were compared with similarly treated eligible non‐RCT patients. Experimental: sedation with Midazolam during endoscopy. Control: acupuncture during endoscopy. |
| Outcomes |
Clinical outcomes were assessed in all patients. Patients were followed up for 2 hours. Main outcome was patient assessment of troublesomeness. |
| Notes |
The experimental arm of the RCT was more effective than no treatment. |
