Table 2.
Pre-randomization characteristics of efficacy-study subjects
| Mean (data interval) |
||
|---|---|---|
| Characteristics | Placebo (n = 16) | Active (n = 14) |
| Demographic/anthropometric | ||
| Age (years) | 63 (45, 81) | 59 (41, 78) |
| Gendera | 13 M, 3 F | 6 M, 8 F |
| Height (m) | 1.72 (1.57, 1.88) | 1.69 (1.48, 1.89) |
| Weight (kg) | 80.9 (53.8, 108.2) | 77.9 (50.5, 105.2) |
| Mini-mental score (maximum 30)b | 28 (27, 29.5) | 29 (29, 30) |
| Modified Tooting Bec score (16)b | 15.25 (15, 16) | 15.75 (15, 16) |
| Beck’s Hopelessness score (20)b | 3 (1, 5) | 3.5 (2, 6) |
| Background anti-parkinsonian medication (no/yes) | 8/8 | 9/5 |
| Brady/hypokinesia | ||
| Mean stride length (mm) | 1244 (909, 1579) | 1222 (806, 1638) |
| Free-walking speed (m/second) | 1.20 (0.79, 1.60) | 1.14 (0.64, 1.65) |
| Rigidity | ||
| Mean torque to extend forearm (Nm × 10−3)c | 400 (156, 1026) | 463 (160, 1335) |
| Mean torque to flex (Nm × 10−3)c | 290 (111, 756) | 326 (165, 643) |
| Tremor rating (100 none, 0 worst) global scale | ||
| Mean tremor seated restb | 96.7 (83.4, 100) | 92.2 (69.5, 97.5) |
| Mean tremor seated, stressb | 88.8 (74.3, 100) | 88.0 (62.0, 98.5) |
| Mean tremor during stance/walkb | 92.3 (89.3, 100) | 95.4 (96.9, 100) |
| Postural abnormality | ||
| Mean body sway, eyes open°C | 5.6 (2.2, 14.4) | 5.1 (2.2, 11.5) |
| Mean body sway, eyes closed°C | 9.1 (3.1, 27.1) | 8.2 (2.8, 24.1) |
| Mean foot separation (mm) | 198 (149, 247) | 194 (144, 244) |
| Psychomotor and psychometric measures | ||
| Mean unwarned reaction time (ms)c | 608 (408, 907) | 566 (369, 868) |
| Mean warned reaction time (ms)c | 366 (206, 653) | 347 (197, 611) |
| Histopathology and microbiology, gastric biopsiesa | ||
| Helicobacter-like organisms on histologyd | 15 | 14 |
| Culture +ve | 16 | 13e |
| Metronidazole resistance, antral biopsyf | 6 (1) | 5 (2) |
| Metronidazole resistance, corporalf | 6 (1) | 3 (2) |
| Immunoblot +ve for CagA antibody | 13 | 13 |
Inspection shows no evidence of a pre-randomization characteristic (except gender) being associated, by chance, with a randomization category. In the analysis, outcome measures are corrected for personal characteristics (including gender), where pre-determined to be appropriate.
Count.
Median (interquartile range).
Exponential of loge transformation (see Statistical Methods).
Pangastritis (n = 12), antral predominant (17), corpus predominant (1). Chronic inflammatory activity (grading normal as 0, mild 1, moderate 2, marked 3) not significantly different for active and placebo randomizations in antrum (median (interquartile range) 2(2, 2), 2(1, 2), respectively) or corpus 1(0, 2), 1(1, 1), nor was polymorphonuclear activity (antrum: 1(1, 1), 1(1, 2); corpus: 1(0, 1), 1(0, 1)) or Helicobacter pylori density (antrum: 2(2, 2), 2(2, 3); corpus: 1(1, 2), 1(1, 2)). Atrophy (n = 5 (marked in 1, moderate 2, mild 2); intestinal metaplasia in 4 of these (marked 2, mild 2)) not associated with randomisation category.
In remaining subject, PCR for H. pylori (vacA) positive on both biopsies, clarithromycin mutation assay showing wild (sensitive) type.
Number with metronidazole resistance (intermediate susceptibility). All cultures sensitive to clarithromycin, amoxicillin, and tetracycline. Second-line anti-microbial regimen prescribed in four subjects (blinded active randomization) because of history of intolerance: Rx clarithyromycin with metronidazole in three, with tetracycline in one.