Literature Briefs-With Analysis by Cydney E. McQueen, PharmD
Andrographis for Cold Symptoms
Source: Caceres DD, et al. Use of visual analogue scale measurements (VAS) to assess the effectiveness of standardized Andrographis paniculata extract SHA-10 in reducing the symptoms of common cold. A randomized double-blind placebo study. Phytomedicine 1999;6:217-223.
Objective: To demonstrate that A. paniculata extract decreased the intensity of common cold symptoms compared to placebo.
Design and Setting: Randomized, double-blind, controlled trial (RDBCT) in Valdivia, Chile, in the winter of 1995.
Subjects: One hundred fifty-eight patients ages 25-50, with cold symptoms for less than two days, and not taking prescription or over-the-counter medications.
Treatment: 100 mg standardized A. paniculata extract SHA-10 tablets or placebo.
Dose/Route/Duration: 1,200 mg/d (4 tablets tid) for five days.
Outcome Measures: Patients were instructed to use a visual analog scale (VAS) to record symptoms of headache, fatigue, earache, sleep disturbance, sore throat, nasal secretions, expectoration, and cough frequency and severity at baseline, treatment day 2, and day 4 after treatment. (A VAS is a 10-cm line on which patients mark their level of discomfort—the left end is equivalent to absence of symptom; the right end indicates highest severity. A linear measurement was used in analysis.)
Results: Analysis was per protocol and on an intent-to-treat basis, in which dropouts had baseline scores carried through to days 2 and 4. At day 2, differences in VAS scores were statistically significant (P = 0.001-0.05) in favor of SHA-10 for fatigue, sleep disturbance, sore throat, and nasal secretions. At day 4, difference in severity was significant (P = 0.001-0.03) for SHA-10 in all assessment measures, but especially in earache, sleep disturbance, nasal secretions, and sore throat.
Strengths/Limitations: Power was calculated (n = 208) but not met (158 at end). Effect on duration of symptoms was not evaluated; side effects were not monitored. No objective outcome measures (e.g., labs, tissue counts) were included.
Level of Evidence: Treatment reduced severity of symptoms, but clinical significance is ill defined. Level II, major limitations
Comment: Investigators attributed the high dropout rate to scheduling conflicts (winter holiday). Lack of difference in improvement in all symptoms casts doubt on the clinical impact of the statistically significant changes. A. paniculata, or nees, is not widely sold in pharmacies, but more patients may be asking for information about products purchased at health food stores or on the Internet. Despite positive results, this study’s usefulness lies primarily in pointing out potential for benefit and the need for further research.
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