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OBJECTIVES: Andrographis paniculata tablets (AS201-01) have previously been shown to have potent bioactivity as an antimalarial and to produce no unwanted side effects in animal models. Here, we present the phase 1 clinical trial conducted to evaluate the safety of AS201-01 tablets in healthy volunteers. METHODS: The study was a randomized, double-blind controlled cross-over, a placebo-controlled design consisting of a 4-day treatment of AS201-01 tablets. A total of 30 healthy human volunteers (16 males and 14 females) were divided into two groups, and each group was given 4 tablets, twice daily for 4 days. Group 1 received AS201-01, while group 2 received placebo tablets. Volunteers were given a physical examination before the treatment. The effects of AS201-01 on random blood glucose, biochemical, and hematological as well as urine profiles were investigated. RESULTS: There were no changes in observed parameters as a result of AS201-01 being administered. Statistical analysis showed no significant difference (p>0.05) between the test and control group regarding hematology profile, biochemical profile, and random blood glucose. Increased appetite and better sleep, which categorized as grade 1 adverse event was reported after treatment with AS201-01 tablet. CONCLUSIONS: The outcome supports our previous observation that the AS201-01 tablet, given twice a day for 4 days, is safe and nontoxic.
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Background: Pain is a major complaint in cancer patients and a global problem that requires medical attention, including pain in cervical cancer. Although pharmacotherapy has been used for the treatment of cancer pain, there are still around 40% cannot be treated only with pharmacotherapy. Objectives: To determine the effects of electroacupuncture (EA) on pain in stage III cervical cancer patients. Methods: Twenty-eight stage III cervical cancer patients were divided into two groups (14 treatments and 14 controls) with randomized control trial design. The treatment group received EA with a frequency of 2/20-25 Hz at points of ST36, SP6, LI4 and LR3 for 30 minutes, while the control group did not receive EA. Both groups were given paracetamol and codeine at the same dose. Assessment was carried out by measuring pain scale (VAS), plasma ß-endorphin levels, and quality of life/QoL (EORTC QLQ-C30) before and after therapy. Results: The average reduction in VAS in the treatment group (2.71 ± 1.14) compared to the control group (0.71 ± 1.33; p < 0.001), average increase in plasma ß-endorphin levels in the treatment group (88.57 ± 52.46 pg/ml) compared to the control group (12.86 ± 56.76 pg/ml; p = 0.001), and in QoL, there were significant differences in symptom improvement between the treatment and control groups in the domain of fatigue, pain, insomnia and overall QoL (p < 0.05). Conclusion: Medical therapy combined with EA decreased pain scale, increased plasma ß-endorphin levels, and improved the QoL for stage III cervical cancer patients.
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Eletroacupuntura , Neoplasias do Colo do Útero , Feminino , Humanos , Dor , Qualidade de Vida , Neoplasias do Colo do Útero/terapia , beta-EndorfinaRESUMO
Background: The prevalence of pain at advanced cervical cancer stages is increasing. Existing World Health Organization recommendations for management comprises a 3-step ladder of analgesic therapy but this still cannot address this pain optimally. An alternative therapy used to reduce pain, acupuncture, is almost without side-effects, is safe, and is easy to implement. This study compared electroacupuncture (EA) versus paracetamol 500 mg +10-mg codeine therapy for patients with stage-IIIB cervical cancer post cisplatin chemotherapy. Materials and Methods: Participants were divided into 2 groups (treatment and control groups). A quasiexperimental study was conducted using a nonequivalent control group pretest-post-test design. Participants in the treatment group were given EA for 30 minutes 10 times over 3 weeks, while participants in the control group were given paracetamol 3 × 500 mg and codeine 3 × 10 mg orally every day for 3 weeks. Statistical analysis used paired t-tests, a Wilcoxon test, an independent t-test, or a Mann-Whitney-U test with P < 0.05. Results: Pretest and post-test pain-scale levels were 5.39 ± 0.62 and 4.57 ± 0.88, respectively (P < 0.001). Average endorphin-ß levels at pretest and post-test were 571.80 ± 281.13 and 491.14 ± 272.14, respectively (P = 0.818). Median values of quality of life at pretest and post-test were 681.75 (range: 503.80-915.20) and 635.25 (range: 538.20-781.20; P = 0.383), respectively. Conclusions: Pain-control therapy using drugs or EA produces similar results. However, EA, subjectively, produces improved pain-scale results better than pharmaceuticals.
