| Randomizedcontrolled trials on acupuncture (except researches conducted in China) published on SCI source journals in2011were collected. The details of the reports were extracted according to CONSORT(Consolidated Standards of Reporting Trials)and STRICTA(Standards for Reporting Interventions in Clinical Trials of Acupuncture), the characteristics on methodology and intervention were analyzed so as to provide some suggestion for the designation and practice of acupuncture randomized clinical trials.BackgroundWith the development of Evidence based medicine, an increasing number of therapeutic evaluation were carried out at home or abroad. However, the results of the researches conducted abroad are usually different from those conducted in China. At home, the positive rate of clinical trials is almost100%while lots of trials conducted abroad produce negative results or placebo results. The summarization about the RCTs most focuses on the form, publication country, disease, result, acupoint selection and intervention. Although a few summarization have noticed the differences of the results between the trials carried at home and abroad, the reasons were rarely analyzed. Some scholars have done some reflection but the focus was mostly on the scientificity of the controlled settings.Consequently, the systematic and comprehensive summarization of the reasons contributing to the difference between the RCTs conducted at home or abroad is a blank spot on the international. Analyzing the advantages and shortcomings of the RCTs at home or abroad respectively will surely have great significance in building the therapeutic evaluation system that fits the acupuncture characteristics.ObjectiveTo make some suggestions for Chinese acupuncture clinical trials and provide the references for building therapeutic evaluation system that fits the acupuncture characteristics and also the international consensus.MethodLiterature research method was adopted and Randomized controlledtrials on acupuncture (except researches conducted in China) published on SCI source journals in2011was collected. A data collection table was built according to CONSORT(Consolidated Standards of Reporting Trials)and STRICTA(Standards for Reporting Interventions in Clinical Trials of Acupuncture).The literature collected was extracted and recorded in the data collection table. Then the trails collected were analyzed in3level:①The94acupuncture clinical trials were analyzed from the perspective of bibliometrics and the foreign researches about acupuncture was summarized;②Thirty-three RCTs were evaluated according to CONSORTand STRICTA and the standardization of composition was examined;③For the10trials with negative or placebo results, the rationality of the therapeutic principle, acupoint selection, operational approach, indication and the adopted interventions along with the scientificity of presented placebo control were analyzed, the differences between trials conducted at home or abroad were compared.ResultsAccording to theretrieval type,33acupuncture RCTs were retrieved and10of which were negative or placebo results.According to the analysis from the perspective of bibliometrics for the94clinical trials, the foreign clinical trials are increasing steadily. The European or American countries which are Economically developed and Asian countries which have regionaladvantages has greater publication rate; The distribution is mostly the top4complementary and alternative medicine journal, and spreaded over multiple medical fields; the research disease are numerous while nervoussystemdisease accounts most; as to the controlled settings, the most control groups were sham acupuncture; there are 14%percent of negative trials, most of which are predominant of acupuncture.According to the extraction of the33RCTs, the characteristics of methodology and intervention in foreign trials can be concluded. Nearly a half reports have neglected the "conflict of interest statement", it will harm the objectivity of the research and ruin the public reputation; Only12reports have claimed the registration of the trial, which will seriously affect the reliability of the evidence; as tothe Sample SizeCalculation,50%reports haven’t mention, this will ruin the accuracy of the result and will result in risk in generating evidence; a same percentage of reports haven’t mention the follow up visit; twelve reports have mentioned the ITT analysis while most of reports cannot ensure the integrity of the data;80%reports have accurately explained the limitation of the trial and the rigorous attitude of foreign researchers is worth learning for the Chinese researchers; as to the side effect, seldom reported the side effect, which proved the safety of the acupuncture;31reports have adopted the international evaluation system, which is apt to quantization and repeat. The intervention of the observation group were most acupuncture, acupuncture plus conventional western medicine, what’s more, electro-acupuncture, acupressure, acupoint injection, moxibustion, cupping can be seen, the controlled settings are most blank control, conventional western medicine, sham acupuncture and so on; the qualification of the acupuncturist was alarming, because only less than a half of the acupuncturist have had the certification, the management should be strenghtend;9reports adopted only one acupoint and none of them have taken syndrome differentiation into consideration; few reports mentioned the inserting direction and only9reports mentioned deqi; as to the retention time, most of the reports has the same average time with Chinese trials. In conclusion, according to the CONSORT and STRICTA, the33RCTs have relatively low reporting quality. The standardized designation and composition of randomized controlled trials is still urgently to be solved for all the acupuncture researchers around the world.After analyzing the10negative or placebo resulted reports, it turned out that the difference between the methodology (Jadad) scores of the two types of research reports does not constitute statistical significance (P>0.05). The researches with the negative or placebo results show the following deficiencies in intervention details:①improper intervention;②fewer syndrome differentiation and treatment;③) incompletely rational acupoint selection;④negligence of needling response to acupuncture operation;⑤inconsistent ability of acupuncturists;⑥low frequency of acupuncture;⑦irrational presentation of placebo control.ConclusionAlthough the number of foreign acupuncture clinical trials is increasing steadily, the quality of the RCT reports is relatively low. The standardized designation and composition of randomized controlled trials is still urgently to be solved for all the acupuncture researchers around the world. The problems of intervention details and controlled settings existing in the negative or placebo resulted RCTs have seriously affected the scientificity of the trials. It is urgent for all the acupuncture researchers around the world to design and compose randomized controlled trials according to CONSORT and carry out the acupuncture intervention correctly according to STRICTA, only in this way, the fair outcomes of the trials could be obtained. |
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