Acupuncture and Chinese herbal medicine in the treatment of patients with seasonal allergic rhinitis: a randomized‐controlled clinical trial

The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group, and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes six items and 17 sub-items. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background, and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word "controlled" in STRICTA is replaced by "clinical," to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA, in conjunction with both the main CONSORT Statement and extension for nonpharmacologic treatment, will raise the quality of reporting of clinical trials of acupuncture.

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“…. In addition to the basic formula, every patient received a second additional formula tailored to his or her individual TCM diagnosis (46).…”

Section: Examplesmentioning

confidence: 99%

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT Statement

MacPherson¹,

Altman²,

Hammerschlag³

et al. 2010

J Evidence Based Medicine

347

178

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“…For instance, one study with a mixture of 18 Chinese herbs showed a significant efficacy of the treatment in seasonal rhinitis (symptoms and QoL) [53], and another the Chinese herb formulation biminne was statistically effective in perennial rhinitis [54]. One recent study using a combination of acupuncture and Chinese herbs found a significant effect on symptom scores and quality of life in seasonal allergic rhinitis [55]. On the other hand, a rigorous double blind randomized controlled trial showed that grapeseed extract was not more effective than placebo for ragweed induced rhinitis [56].…”

Section: Phytotherapymentioning

confidence: 99%

Complementary and alternative medicine for the treatment and diagnosis of asthma and allergic diseases

Passalacqua

Compalati

Schiappoli³

et al. 2005

Monaldi Arch Chest Dis

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The use of Complementary/Alternative Medicines (CAM) is largely diffused and constantly increasing, especially in the field of allergic diseases and asthma. Homeopathy, acupuncture and phytotherapy are the most frequently utilised treatments, whereas complementary diagnostic techniques are mainly used in the field of food allergy- intolerance. Looking at the literature, the majority of clinical trials with CAMS are of low methodological quality, thus difficult to interpret. There are very few studies performed in a rigorously controlled fashion, and those studies provided inconclusive results. In asthma, none of the CAM have thus far been proved more effective than placebo or equally effective as standard treatments. Some herbal products, containing active principles, have displayed some clinical effect, but the herbal remedies are usually not standardised and not quantified, thus carry the risk of toxic effects or interactions. None of the alternative diagnostic techniques (electrodermal testing, kinesiology, leukocytotoxic test, iridology, hair analysis) have been proved able to distinguish between healthy and allergic subjects or to diagnose sensitizations. Therefore these tests must not be used, since they can lead to delayed or incorrect diagnosis and therapy.

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“…(iii) Chinese herbal medicine was to be taken three times per day over a period of 6 weeks and parallel to acupuncture treatment… All herbs used in the present study were imported from China by a single TCM herbal medicine import company (Sinores, Lueneberg, Germany)… All herbs were prepared in dried, minced pieces and then sealed in generic paper sachets by a pharmacist in order to render the herbal formulation non-identifiable for patients… In addition to the basic formula, every patient received a second additional formula tailored to his or her individual TCM diagnosis [46].…”

Section: Item 4amentioning

confidence: 99%

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT Statement

MacPherson

Altman

Hammerschlag

et al. 2010

Medical Acupuncture

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IntroductionThe STRICTA (Standards for Reporting Interventions in Clinical Trials of Acupuncture) reporting guidelines, first published in 2001 [1][2][3][4][5][6][7][8][9], were designed to improve the completeness and transparency of reporting of interventions in controlled trials of acupuncture, in order that such trials may be more accurately interpreted and readily replicated. STRICTA comprised a checklist that expanded the generic content of Item 4 of the CONSORT statement [10,11], which relates to the reporting of the intervention.A survey of authors of clinical trials and systematic reviews was subsequently conducted to determine the usefulness of STRICTA in helping them write their reports [12]. In addition, a survey of 90 acupuncture trials was undertaken to assess whether use of the STRICTA checklist was associated with improved reporting over time [13]. The results of these initiatives led to conclusions that most STRICTA items were found to be necessary and easy to use, though some were seen as poorly reported, ambiguous or possibly redundant, and a number of suggestions were made for additional items. A revision of STRICTA was therefore proposed.Meanwhile, extensions to CONSORT have been developed to cover the reporting of non-pharmacological treatments [14,15] and pragmatic trials [16]. Since there are acupuncture specific aspects to reporting not covered by these extensions, it was decided that STRICTA should be revised in a manner congruent with CONSORT and its extensions for non-pharmacological treatments and pragmatic trials.The combination of these developments led to an agreement between the CONSORT Group and the STRICTA Group, in collaboration with the Chinese Cochrane Centre and the Chinese Centre for Evidence-based Medicine, to revise STRICTA as a formal extension to CONSORT. The revision processes have been described in more detail elsewhere [17]. This paper describes the outcome in terms of a new checklist, updated explanations, and published examples of good reporting. MethodsIn the summer of 2008, a group of 47 experts from the original STRICTA Group, the CONSORT Group, the World Federation of Acupuncture and Moxibustion Societies, the Acupuncture Trialists ' Collaboration [18], the Society for Acupuncture Research [19], and clinical trial authors were surveyed [12]. The experts were from 15 countries, 41 had academic positions, 31 were acupuncturists, 18 were involved with journals, such as board members, 15 were physicians, and 11 had been involved previously in developing reporting guidelines. These experts were consulted in regard to a draft of revised STRICTA items that had evolved from previous research [12,13]. Feedback was collated and forwarded (with permission) to those invited to a consensus development workshop, the next phase of the revision process.Twenty-one individuals attended a workshop in Freiburg, Germany, in October 2008. The attendees included experts in epidemiology, trial methodology, statistics, and medical journal editing. Just over half the participants were ...

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Acupuncture and Chinese herbal medicine in the treatment of patients with seasonal allergic rhinitis: a randomized‐controlled clinical trial

Abstract: The results of this study suggest that traditional Chinese therapy may be an efficacious and safe treatment option for patients with seasonal AR.

Cited by 93 publications

References 34 publications

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT Statement

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT Statement

Complementary and alternative medicine for the treatment and diagnosis of asthma and allergic diseases

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): Extending the CONSORT Statement

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