Benefits and harms of doxycycline treatment for Gulf War veterans' illnesses: a randomized, double-blind, placebo-controlled trial.

BACKGROUND: It has been hypothesized that certain Mycoplasma species may cause Gulf War veterans' illnesses (GWVIs), chronic diseases characterized by pain, fatigue, and cognitive symptoms, and that affected patients may benefit from doxycycline treatment. OBJECTIVE: To determine whether a 12-month course of doxycycline improves functional status in Gulf War veterans with GWVIs. DESIGN: A randomized, double-blind, placebo-controlled clinical trial with 12 months of treatment and 6 additional months of follow-up. SETTING: 26 U.S. Department of Veterans Affairs and 2 U.S. Department of Defense medical centers. PARTICIPANTS: 491 deployed Gulf War veterans with GWVIs and detectable Mycoplasma DNA in the blood. INTERVENTION: Doxycycline, 200 mg, or matching placebo daily for 12 months. MEASUREMENTS: The primary outcome was the proportion of participants who improved more than 7 units on the Physical Component Summary score of the Veterans Short Form-36 General Health Survey 12 months after randomization. Secondary outcomes were measures of pain, fatigue, and cognitive function and change in positivity for Mycoplasma species at 6, 12, and 18 months after randomization. RESULTS: No statistically significant differences were found between the doxycycline and placebo groups for the primary outcome measure (43 of 238 participants [18.1%] vs. 42 of 243 participants [17.3%]; difference, 0.8 percentage point [95% CI, -6.5 to 8.0 percentage points]; P > 0.2) or for secondary outcome measures at 1 year. In addition, possible differences in outcomes at 3 and 6 months were not apparent at 9 or 18 months. Participants in the doxycycline group had a higher incidence of nausea and photosensitivity. LIMITATIONS: Adherence to treatment after 6 months was poor. CONCLUSION: Long-term treatment with doxycycline did not improve outcomes of GWVIs at 1 year.

Yield of transbronchial needle aspiration in diagnosis of mediastinal lesions.

STUDY OBJECTIVES: To determine the transbronchial needle aspiration (TBNA) yield for procedures performed by fellows in training, and the predictors of positive TBNA yield at our center. DESIGN: Retrospective chart review. SETTING: A tertiary teaching hospital. PATIENTS: One hundred seventy patients who underwent fiberoptic bronchoscopy with TBNA of mediastinal lesions from January 1991 to July 1999. RESULTS: Final diagnoses were available for 166 patients. TBNA was diagnostic in 104 patients (61%) and nondiagnostic in 66 patients (39%). Of 170 cases, 123 patients (72%) had malignancies, 30 patients (18%) had benign disease, and 13 patients (8%) were normal. Of 123 malignancies, 85 patients (69%) had a positive result by TBNA. Of 30 cases with benign disease, 11 patients (37%) had positive TBNA findings. Eight of 13 patients (62%) with a normal diagnosis had diagnostic TBNA (normal lymphoid tissue). There were statistically significant correlations between TBNA result and cell type of the lesion (p < 0.001), size of the lesion (p < 0.05), and type of malignancy (small cell carcinoma more than non-small cell carcinoma more than lymphoma, p < 0.05). We did not find any significant difference for aspiration yield between carinal and tracheal sites (p > 0.05). Logistic regression analysis indicated that the presence of malignancy is the major determinant of TBNA yield (p = 0.009). In addition, lesion size does affect yield after being adjusted for diagnosis (one-sided p = 0.04). CONCLUSIONS: TBNA is a minimally invasive diagnostic technique with a high yield, even in hands of less experienced operators. Malignancy, lesion size, and type of malignancy are major determinants of TBNA yield.