Table 7.

Palpated, Operated, and Evaluated Nodules and Sites^a

Study Time Point	No. of Nodules		No. of Sites
	Doxycycline	Placebo	Doxycycline	Placebo
Baseline
No. of patients	71	76	71	76
Total No. of nodules/sites	178	182	114	116
Mean ± SD	2.51 ± 1.40	2.39 ± 1.86	1.61 ± 0.78	1.53 ± 0.81
Min–Max	1–6	1–11	1–4	1–4
Median	2	2	1	1
25th, 75th percentiles	1, 3	1, 3	1, 2	1, 2
P valueb	P = .151		P = .378
20 mo
No. of patients	67	69	67	69
Total No. of nodules/sites	137	150	98	104
Mean ± SD	2.04 ± 1.32	2.17 ± 1.68	1.46 ± 0.68	1.51 ± 0.87
Min–Max	1–6	0–8	1–4	0–4
Median	2	2	1	1
25th, 75th percentiles	1, 3	1, 2	1, 2	1, 2
P valueb	P = .858		P = .903
Difference 20 mo – baseline
No. of patients	67	69	67	69
Mean ± SD	−0.43 ± 1.03	−0.09 ± 1.00	−0.12 ± 0.54	0.01 ± 0.56
Min–Max	−5 to 2	−4 to 2	−1 to 1	−2 to 1
Median	0	0	0	0
25th, 75th percentiles	−1, 0	0, 0	0, 0	0, 0
P valueb	P = .015		P = .109
Operatedc
No. of patients	66	66	66	66
Total No. of nodules/sites	182	227	99	108
Mean ± SD	2.76 ± 2.18	3.44 ± 2.79	1.5 ± 0.75	1.64 ± 0.97
Min–Max	1–13	1–14	1–4	1–5
Median	2	2.5	1	1
25th, 75th percentiles	1, 3	2, 4	1, 2	1, 2
P valueb	P = .126		P = .591
Evaluatedd
No. of patients	56	63	56	63
Total No. of nodules/sites	152	199	79	97
Mean ± SD	2.71 ± 2.02	3.16 ± 2.39	1.41 ± 0.73	1.54 ± 0.84
Min–Max	1–11	1–12	1–4	1–4
Median	2	2	1	1
25th, 75th percentiles	1, 3	2, 4	1, 2	1, 2
P valueb	P = .277		P = .412

Abbreviation: SD, standard deviation.

^a The set used here (Treatment-per protocol) includes all people who took the treatment (doxycycline or placebo) according to protocol.

^b Mann–Whitney U test.

^c In 4 participants, no nodule was found before or after incision.

^d Thirteen participants and, in total, 11.5% (n = 47) of all nodules could not be analyzed for parasitic status; the reasons for this exclusion included extensive calcification of the nodule, or being of nononchocercal origin (eg, foreign body granulomas, lipomas, or lymph nodes). An additional 11 nodules were subtracted for containing newly acquired worms only.