Orthosiphon versus placebo in nephrolithiasis with multiple chronic complaints: a randomized control trial.

Nephrolithiasis in the communities of Northeast Thailand frequently presents with multiple chronic health complaints, i.e. myofascial pain, back pain, dyspepsia, arthralgia, headache, fatigue, frank paresthesia, dysuria and any of these aggravated by purine-rich food (PRF). We assessed the efficacy of Orthosiphon in treating subjects with at least two active symptoms and negative for urine white blood cells. Subjects were randomly allocated to two groups. Crude extract of Orthosiphon given in a capsule (equivalent to 1.6-1.8 g of dried leaves of Orthosiphon) two times a day to Group 1 (n = 36) and a placebo to Group 2 (n = 40) for 14 days. The medication for each subject was packed and its code kept secret until the data analysis. Both groups were asked not to consume any of 25 purine-rich foods (PRFs) during treatment. The primary measure was the reduced sum of active severity symptoms as recorded using the visual analog scale before and after therapy (i.e. on day 7 and 14). The data on 76 subjects were processed. The mean of the total scores (95% CI) of the symptoms in each group were decreased significantly (P < 0.001); 185.6 (153.3, 218.0) to 94.7 (58.2, 131.2) in the Orthosiphon group and 196.1 (164.4, 227.8) to 89.6 (62.8, 116.5) in the placebo group. When comparing between groups, no statistically significant difference was found. The mean consumption in PRFs was significantly decreased (P < 0.001) in both groups; however, Orthosiphon did not have additional benefit over placebo at 7 and 14 days of treatment during which they reduced these foods.