Table 1.
Baseline characteristics by treatment arm
| Parameter | DHAPP arm N = 53 | DHAPP + SLDPQ arm N = 56 | P value |
|---|---|---|---|
| Age in years | 20 (14–31) [6–76] | 24.5 (17.5–32) [4–65] | 0.25 |
| Age ≤ 12 y | 12 (22.6) | 9 (16.1) | 0.38 |
| Sex M:F | 44:9 | 44:12 | 0.56 |
| Occupation | |||
| Farmer | 40 (75.5) | 46 (83.6) | 0.29 |
| Symptoms | n = 53 | n = 55 | |
| VAS scorea | 2 (2–2) [2, 3] | 2 (2–2) [1–3] | 0.45 |
| Fever | 52 (98.1) | 53 (96.4) | 0.58 |
| Chills | 51 (96.2) | 53 (96.4) | 0.97 |
| Headache | 49 (92.5) | 54 (98.2) | 0.16 |
| Anorexia | 1 (1.9) | 0 (0) | 0.31 |
| Nausea | 49 (92.5) | 41 (74.6) | 0.01 |
| Vomiting | 51 (96.2) | 53 (96.4) | 0.97 |
| Abdominal pain | 4 (7.6) | 4 (7.3) | 0.96 |
| Palpitations | 3 (5.7) | 9 (16.4) | 0.08 |
| Cough | 3 (5.7) | 3 (5.5) | 0.96 |
| Muscle aches | 4 (7.6) | 7 (12.7) | 0.37 |
| Passing normal colour urine | 53 (100) | 55 (100) | – |
| Physical signs | |||
| Temperature 0C | 38 (38–38.5) [38–41] | 38 (38–38.5) [38–40] | 0.75 |
| Weight kg | 48 (36–55) [17–73] | 50.5 (40–55.5) [10–74] | 0.32 |
| Respiratory rate / minute | 30 (26–30) [20–34] | 30 (28–30) [20–32] | 0.58 |
| Normal colour of lips | 53 (100) | 55 (100) | – |
| Pale conjunctivae/palms/tongue | 0 (0) | 0 (0) | – |
| Palpable liver | 0 (0) | 0 (0) | – |
| Palpable spleen | 0 (0) | 0 (0) | – |
| G6PD data | |||
| G6PD activity median U/g Hb | 10.45 (7.9–12.9) [0.4–17.9] | 10.15 (6.7–11.7)[0.4–25] | 0.23 |
| G6PD deficient by FSTb | 3 (5.7) | 6 (10.9) | 0.49 |
| G6PD deficient by RDTc | 3 (5.7) | 6 (10.9) | 0.49 |
| G6PD Viangchan | 3 | 9 (42.8) | 0.69 |
| Haemoglobin electrophoresis | n = 52 | n = 54 | |
| Normal haemoglobin | 23 (44.2) | 28 (51.8) | 0.34 |
| Haemoglobin E | 22 (42.3) | 19 (35.2) | |
| Mixed Hb E alpha thalassemia | 3 (5.8) | 1 (1.8) | |
| Mixed Hb E beta thalassemia | 0 | 3 (5.6) | |
| Alpha thalassemia | 3 (5.8) | 3 (5.6) | |
| Heterozygous foetal haemoglobin | 1 (1.9) | 0 | |
| Full blood count | |||
| Haemoglobin g/dL | 12.63 (2.29) [6.9–18.2] | 13.19 (2.1) [8.7–18] | 0.19 |
| Reticulocyte count % | 1.5 (1–2)[0.4–4.2] | 1.65 (1.05–2.6) [0.3–9.2] | 0.13 |
| Methaemoglobin % | 1.5 (1.3–1.8) [0.7–1.9] | 1.3 (1.2–1.7) [0.6–2] | 0.90 |
| Total white cell count × 103/μL | 5.6 (4.5–7.0) [1.5–13] | 5.45 (4.45–6.3) [1.6–10.3] | 0.50 |
| Platelet count ×103/μL | 89 (49–122) [12–336) | 101.5 (76–156.5) [10–328] | 0.04 |
| Biochemical parameters | |||
| Total bilirubin μmol/L | 15.65 (8.6–19.4) [3.7–56.1] | 13.35 (10.1–22.1) [3.7–90.5] | 0.87 |
| Conjugated bilirubin μmol/L | 6.35 (4.1–9.2) [1.3–16.7] | 5.85 (4.45–9.25) [2.3–20.4] | 0.70 |
| Free bilirubin μmol/L | 8.2 (5.2–10.9) [2.2–49.0) | 7.4 (5.75–12.5) [1.4–70.1] | 0.97 |
| AST IU/L | 26 (22–38) [12–133] | 28 (22–38) [15–84] | 0.99 |
| ALT IU/L | 21 (16–28) [6–125] | 23.5 (15.5–35.5) [4–140] | 0.42 |
| LDH IU/L | 250 (222–347) [137–772] | 225.5 (200–285) [59–657] | 0.04 |
| Haptoglobin g/L | 0.69 (0.1–1.43) [0.03–2.24] | 0.59 (0.1–1.53) [0.01–2.64] | 0.60 |
| Creatinine μmol/L | 63 (49–74) [29–112] | 63.5 (44.5–72) [18–120] | 0.53 |
| Parasite data | |||
| Falciparum parasitaemia N/μL | 19,800 (5800-68,119) [1–350,000] | 18,600 (3923–36,093 [40–800,200] | 0.40 |
| Urine | |||
| Hillmen colour scale | 3 (3–3) [1–4] | 3 (3–3) [1–4] | 0.57 |
a VAS – visual analogue scale from 1 to 5
Continuous data are median (interquartile range) [full range], except the haemoglobin concentration [mean (standard deviation)
Categorical data are n (%)
b Fluorescent spot test
c Rapid diagnostic test
Continuous data are median (interquartile range) [full range], except the haemoglobin concentration: mean (standard deviation) [range]
Categorical data are n (%)
Entries in bold are statistically significant