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                Efficacy and Safety of Traditional Thai Herbal Formulary: A-Paisalee Recipe
                in Patients with Mild to Moderate Stable Chronic Obstructive Pulmonary
                Disease (COPD)

                                      §
                Wiwan Worakunphanich*, , Monthaka Teerachaisakul*, Anutida Tabmee*,
                                     †                    ‡
                Manatchaya Mukanachot , Nattawat Peamnguleum
                * Institute of Thai Traditional Medicine, Department of Thai Traditional and Alternative Medicine, Ministry of Public
                health, Nonthaburi 11000, Thailand
                †
                Mae Lao hospital, Amphoe Mae Lao, Chiang Rai province, 57250 Thailand
                ‡
                Lom Kao hospital, Amphoe Lom Kao, Pretchaboon province, 67120 Thailand
                §
                Corresponding: toon_punch@hotmail.com
                                                 Abstract

                    Chronic obstructive pulmonary disease (COPD) is a major health concern. Thoeng Hospital reported a
                good result of using A-Paisalee herbal drug combined with the standard treatment in patients with COPD but
                no clinical trial has been conducted yet. This study, therefore, aimed to evaluate the efficacy and safety of A-
                Paisalee herbal recipe in patients with mild to moderately stable COPD.  This randomized double-blinded
                placebo-controlled trial enrolled 66 outpatients diagnosed with mild to moderate COPD and got them
                randomized into 2 groups, 33 each. The treatment group was treated with A-Paisalee, while the control group
                received a placebo.  All volunteers were treated with the standard treatment as a basis. The outcomes were
                evaluated every 30 days, totally 5 times.  Inhaled drug use history was taken; oxygen saturation and lung
                function were measured; and six-minute walk test, Modified Medical Research Council Dyspnea Score and
                COPD Assessment Test were measured or performed. Blood examinations were undertaken on day 0 and day
                90. Data were analyzed using independent t-test, chi-square and repeated one-way ANOVA.  Intention-to-treat
                was applied to the analysis.  The results showed that oxygen saturation values and distance in the six-minute
                walk test of the treatment group significantly increased compared with those in the control group (p < 0.05).
                Also a significantly higher Borg dyspnea score in six-minute walk test was observed in the treatment group
                compared with that in the control group (p < 0.05).  The results of blood examination were in normal range.
                Additionally, the COPD Assessment Test scores of the treatment group significantly decreased after receiving
                A-Paisalee (p < 0.05). In conclusion, this is the first randomized controlled trial evidence that co-treatment
                with A-Paisalee and standard medicines effectively increases oxygen saturation values and improves the
                ability to perform daily living in patients with stable mild to moderate COPD.

                    Key words: chronic obstructive pulmonary disease, traditional Thai herbal formulary, A-Paisalee,
                               efficacy, safety


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