INTRODUCTION Hyperthyroidism is one of the major global health issues, characterised by accelerated thyroid hormone production and secretion from the thyroid gland. Eventually, the term 'thyrotoxicosis' refers to the clinical state of excess circulating thyroid hormones, regardless of the source.[1] The most common cause of hyperthyroidism is Graves' disease (GD) in all age groups, followed by toxic nodular goitre. The other causes might be thyroiditis, iodine-induced and drug-induced thyroid dysfunction and factitious ingestion of excess thyroid hormones. Hyperthyroidism is usually categorised as primary (overproduction due to intrinsic problems of the gland) and secondary (excess circulating thyroid hormone due to other reasons). The prevalence of hyperthyroidism is diverse, especially in India, depending on different ethnic, geographic areas and the criteria for diagnosis.[2] Subclinical and overt hyperthyroidism were found in 1.6% and 1.3% of participants in a community survey, respectively, in an epidemiological study from Cochin.[3] In a hospital-based study of women from Pondicherry, 0.6% and 1.2% of individuals had subclinical and overt hyperthyroidism, respectively.[4] In the past, this disorder had been found in the young-to-middle-age group whereas it is now well recognised in the elder group. Instead of the diversity of prevalence, hyperthyroidism is about 20 times more common in women than in men.[5] The diagnosis of primary hyperthyroidism is established by a raised serum total or free T4 or T3 hormone levels, reduced thyroid-stimulating hormone (TSH) level and high radioiodine uptake in the thyroid gland along with features of thyrotoxicosis, whereas in secondary hyperthyroidism TSH level is typically normal or low.[6] Patients usually present with symptoms of irritability, heat intolerance and excessive sweating, palpitations, weight loss with increased appetite, increased bowel frequency and oligomenorrhoea. Patients often experience tachycardia, fine tremors, warm and moist skin, muscle weakness and eyelid retraction or lag.[7] Clinical hyperthyroidism can be complicated by severe cardiovascular or neuropsychiatry manifestations requiring admission to hospital or urgent treatment known as thyroid storm.[1] Current treatment options in conventional medicine for thyrotoxicosis include antithyroid medications and radioactive iodine therapy, whereas long-term use of antithyroid medications in toxic nodular goitre is not recommended due to the significant chance of relapse following termination.[8] β-blockers are used in the treatment of symptomatic thyrotoxicosis and may be the sole treatment indicated for thyrotoxicosis that is not characterised by excessive thyroid hormone production and release.[9] Special considerations must be taken when treating thyroid storm and hyperthyroidism during pregnancy and the post-partum period.[2] In homeopathy, patients suffering from any clinical condition are usually approached through a holistic and individualistic approach, and medications are directed according to the symptom-similarity paradox.[10] Medicines are typically selected considering a detailed anamnesis and prescribed in a minimum required dosage.[11] Subsequently, also in hyperthyroidism, similar principles and approaches are applicable. We report a case of a 26-year-old woman, diagnosed with primary hyperthyroidism, completely recovered after 7-month of treatment with individualised homoeopathic medicine, Tarentula hispanica. Recovery was thoroughly assessed by clinical assessment, thyroid function test and anti-thyroid peroxidase (anti-TPO) antibody. The case is reported as recommended in the CARE guideline.[12] It is important to mention that the homeopathic remedy used in this case, Tarentula hispanica was first tested in Spain in the 1800s, with NunÄez[13] documenting the results of several tests. It is used to treat conditions characterised by nervousness or insanity, often accompanied by intense determination and impulsive violence, along with erratic and destructive behaviour. It is also effective for addressing hysterical or sexual escalation, with a noted improvement when exposed to music and rhythmic movement. Physically, it is associated with heightened sensory sensitivity, particularly to bright or intense colours, restlessness and a sensation of constriction throughout the body leading to chest pain. Neuromuscular symptoms primarily affect the lower extremities, resulting in paralysis, weakness, contractions and irregular jerking movements.[14] However, to our knowledge, this is the first reported case where the medicine is used in thyrotoxicosis based on the individualised homoeopathic approaches to the patient. CASE REPORT Patient information A 26-year-old married woman presented with cramping pain in her lower abdomen during menstruation for the last 5 months. It is aggravated in the morning and better by warm application and rubbing. It is associated with itching in the vulva, which is also getting relieved by warm application. She also complained of generalised weakness with weight loss, palpitation and protrusion of the right eye in the last 6 months. The patient suffered from measles at the age of 10 years and has a history of spontaneous abortion 2 years back. She is a housewife having one child. Her diet is regular, non-vegetarian, has no addiction, good living environment and completed vaccination with no adverse reactions. In the family, her grandfather had suffered from bronchial asthma. Physical generals She is having a tendency to catch colds easily. Her thermal relation is hot with intolerance to sun heat, which causes headaches. Her appetite is good with hunger intolerance. She has a desire for meat and chilly food with an aversion to milk and prawns. Her thirst is profuse for large quantities of water around 4 L/day. She has profuse sweat mainly in her palms and soles which is not offensive and leaves no stain on her clothing. She passes stool once every day in the morning which is satisfactory and clear. Her urine is clear, no significant odour from it. Her menstruation is irregular, profuse, early and clotted and persists for 4–5 days with cramping pain in the lower abdomen. Mental generals The patient is anxious about her condition resulting in palpitation. On further enquiry, it was revealed that she is irritable, cannot bear contradiction and gets easily angered resulting in destructive activities and throwing things around. Consolation aggravates her emotions and gets better on listening to music. She is restless and prefers company. She loves listening to music and dancing. Clinical evaluation Appearance-lean, thin and moderately built; pulse rate – 96 bpm; blood pressure – 136/88 mmHg, respiratory rate – 22/min, skin-moist on touch especially palms; body weight – 48 kg. There was protrusion of her right eye as compared to her left. On palpation, the size of the thyroid gland was normal. No other clinically important findings were noted. Diagnostic assessment On the basis of evaluation of clinical symptoms such as weight loss, heat intolerance, restlessness, palpitation, hunger intolerance and profuse sweat along with laboratory investigation for thyroid profile (T3 – 2.03 ng/mL, T4 – 15.18 mg/dL and TSH – 0.06 mIU/mL), the case was diagnosed as primary hyperthyroidism (ICD-11 CODE is 5A03.2Y: Other specified autoimmune thyroiditis). The presence of raised anti-TPO antibodies typically suggests autoimmune thyroid disease, with Hashimoto's thyroiditis and GD being the most common causes. Hashimoto's thyroiditis is an autoimmune condition that often leads to hypothyroidism, whereas GD is another autoimmune condition that causes hyperthyroidism, usually with diffuse goitre. In this particular case, the patient presented with symptoms of hyperthyroidism and elevated anti-TPO levels, suggesting autoimmune thyrotoxicosis as the likely diagnosis. An operational definition for autoimmune thyrotoxicosis may be, 'A clinical syndrome characterised by the presence of characteristic signs and symptoms of hyperthyroidism, including weight loss, increased heart rate, heat intolerance, tremors and fatigue; elevated thyroid hormone levels, the absence of identifiable secondary causes for hyperthyroidism and the presence of specific autoantibodies, such as anti-TPO antibodies and anti-thyrotropin receptor antibodies (TRAb or TSI)'. Therapeutic intervention Based on the symptoms presented, including destructive behaviour, throwing objects, intolerance to contradiction, aggravation from consolation, easily becoming angry over trivial matters, improvement with music, susceptibility to catching colds, intolerance to sun heat, strong desire for meat and spicy foods, aversion to milk and prawns, profound thirst, profuse sweating on palms and soles, cramping pain in the lower abdomen during menstruation that is aggravated in the morning but improved with warm application and rubbing, profuse menstruation, and early itching in the vulva that is improved with warm application, Tarentula hispanica 30c was prescribed in a single dose. Follow-up The case was treated for about 6 months, during which multiple routine follow-ups were conducted, as well as any additional follow-ups deemed necessary based on the patient's response to treatment. The prescriptions and dosages were tailored to the patient's individual needs and adjusted as needed throughout the treatment period. Thyroid function and anti-TPO assessments were conducted at suitable intervals for diagnostic and prognostic purposes. The detailed visits are depicted in Table 1.Table 1: Follow-up and outcomesAfter completing the treatment, the patient was followed-up for an additional 3 months to monitor for any potential relapse. This extended monitoring period allowed for continued evaluation of the patient's condition and ensured that any changes or relapses were identified and addressed promptly. The schematic timeline of the case is shown in Figure 1.Figure 1: Timeline of the case. TSH: Thyroid-stimulating hormone, Anti-TPO: Anti-thyroid peroxidaseClinical outcome The clinical outcome of the case report showed significant improvement in the patient's symptoms and thyroid function test results after being treated with individualised homoeopathic medicine for about 6 months. The patient reported relief from cramping pain, palpitation, perspiration, itching vulva and general weakness, which were some of the symptoms that she had been experiencing. In addition, her thyroid function test results (T3, T4, TSH), and serum anti-TPO levels returned to normal after completing the treatment. Patient's perspective After the treatment the patient narrated, 'I was hesitant to try homoeopathy for my autoimmune thyrotoxicosis, but after conventional treatments caused side effects and little improvement, I gave it a chance. The personalised prescriptions and frequent follow-ups helped me improve my symptoms, such as cramping pain and weakness. My thyroid function test results also returned to normal after treatment. I had a positive experience with homeopathy and would recommend it to others, but it is important to consult with a healthcare professional and monitor for any changes'. DISCUSSION This case report reflects a clinically significant improvement of a 26-year-old married woman diagnosed with thyrotoxicosis, who was treated with individualised homoeopathic medicine, as evidenced by clinical observation and biochemical parameters. The case initially presented with cramping pain in the lower abdomen during menstruation, which was worsened in the morning and improved by warm application and rubbing. She also experienced itching in the vulva, which was relieved by warm application. In addition, she reported general weakness, weight loss, palpitation and protrusion of the right eye for the past 6 months. Her medical history included a past case of measles and a spontaneous abortion 2 years ago. The patient had a good living environment, no addiction, a regular non-vegetarian diet and completed her vaccinations with no adverse reactions. Her grandfather had asthma. The patient had a profuse thirst for water, profuse sweating mainly in the palms and soles and a tendency to catch cold easily. Her appetite was good, and she had a desire for meat and chilly food with an aversion to milk and prawns. Her menstruation was irregular, profuse, early and clotted with cramping pain in the lower abdomen. She had anxiety, irritability and destructive behaviour that worsened with consolation but improved with listening to music. Based on the symptomatic ground, Tarentula hispanica 30c, 1 dose was prescribed. In addition to that, she was also advised with a thyroid function test and serum anti-TPO. In the next follow-up, the thyroid function test reflected a picture of hyperthyroidism. However, a markedly raised anti-TPO also pointed towards autoimmune thyrotoxicosis. Following the start of the treatment, there was continued improvement of various symptomatology. However, in the follow-up at day 124, anxiety and palpitation were found to be increased. Therefore, the medicine was repeated again. The treatment was continued for about 6 months, in which varied interplay of clinical spectrum was observed. The prescriptions were strictly in adherence with homoeopathic principles, with dosages adjusted as needed based on the patient's response to treatment. When there was continued improvement, suggesting the persistent action of the medicines, no active prescription was given and instead, a placebo was prescribed. Once the clinical improvement was assured, a repeat test for thyroid function and anti-TPO levels was conducted and the results indicated a normal picture. The patient was then followed up for an additional 3 months, during which time multiple trivial complaints were reported, but none of the previous complaints were mentioned. Thyroid function and anti-TPO tests were again repeated and found to be normal. In addition to that, the body weight of the patient was found to be improved in different follow-ups. Earlier a case is reported of post-partum thyroiditis improved by homoeopathic medicines.[15] However, as of our knowledge, this is the first case demonstrating the improvement of a case of autoimmune thyrotoxicosis through individualised homoeopathic treatment. The detailed effort in case evaluation, diagnostic procedure and prescription may be consulted for future similar cases. As with any case report, the findings of this case cannot be generalised to the wider population. Moreover, the long-term effects of the treatment and the possibility of relapse or recurrence are unknown as the patient was only followed up for a short period after treatment. It is important to note that case reports cannot provide conclusive evidence and should be considered in the context of larger studies and clinical trials. We recommend that further research may be conducted to investigate the efficacy and safety of homoeopathic treatment for similar cases. This could involve conducting randomised controlled trials with larger sample sizes and longer follow-up periods to provide more robust evidence on the effectiveness of homoeopathy for thyrotoxicosis and other thyroid disorders. In addition, it would be valuable to investigate the potential mechanisms of action of homoeopathic remedies in treating thyroid disorders, as this could help to shed light on the underlying pathology and suggest potential avenues for future treatment. Finally, it would be useful to explore the cost-effectiveness of homoeopathic treatment compared to conventional treatment options, as this could help to inform healthcare policy and resource allocation decisions. CONCLUSION This case report highlights the potential of individualised homoeopathic treatment for autoimmune thyrotoxicosis. The patient demonstrated significant improvement in clinical symptoms and biochemical parameters after 7 months of homoeopathic treatment. However, as with any case report, these findings cannot be generalised to the wider population, and further research is needed to investigate the efficacy and safety of homoeopathy for thyroid disorders. Randomised controlled trials with larger sample sizes and longer follow-up periods are recommended to provide more robust evidence on the effectiveness of homoeopathy for thyrotoxicosis and other thyroid disorders. Declaration of patient consent The authors certify that they have obtained all appropriate patient consent forms. In the form, the patient has given her consent for her images and other clinical information to be reported in the journal. The patient understands that her name and initials will not be published and due efforts will be made to conceal her identity, but anonymity cannot be guaranteed. Financial support and sponsorship Nil. Conflicts of interest There are no conflicts of interest. Declaration of generative AI and AI assisted technologies in the writing process During the preparation of this work, the author(s) did not use any AI tool/service. The author(s) reviewed and edited the content as needed and take(s) full responsibility for the content of the publication.
Introduction Lumbar spondylosis (LS) is a degenerative disorder of the lumbar spine. Despite substantial research efforts, no gold-standard treatment for LS has been identified. The efficacy of individualized homeopathic medicines (IHMs) in LS has remained under-researched. In this study, the efficacy of IHMs was compared with identical-looking placebos in the treatment of low back pain associated with LS. Material A double-blind, randomized (1:1), placebo-controlled trial was conducted at the National Institute of Homoeopathy, West Bengal, India. Patients were randomized to receive IHMs or placebos, along with standardized concomitant care for both the groups. The Oswestry low back pain and disability questionnaire (ODQ) was the primary outcome; the Roland-Morris questionnaire (RMQ) and the short form of the McGill pain questionnaire (SF-MPQ) were the secondary outcomes. Each was measured at baseline and every month for 3 months. The intention-to-treat (ITT) sample was analyzed to detect any inter-group differences using two-way repeated measures analysis of variance models overall and by unpaired t -tests at different time points. Results Enrolment was stopped prematurely because of time restrictions; 55 patients were randomized (verum: 28; control: 27); 49 were analyzed by ITT (verum: 26; control: 23). Inter-group differences in ODQ (F-1,F- 47 = 0.001, p = 0.977), RMQ (F-1,F- 47 = 0.190, p = 0.665) and SF-MPQ total score (F-1,F- 47 = 3.183, p = 0.081) at 3 months were not statistically significant. SF-MPQ total score after 2 months (p = 0.030) revealed inter-group statistical significance, favoring IHMs against placebos. Some of the SF-MPQ sub-scales at different time points were also statistically significant: e.g., the SF-MPQ average pain score after 2 months (p = 0.002) and 3 months (p = 0.007). Rhus toxicodendron, Sulphur and Pulsatilla nigricans were the most frequently indicated medicines. Conclusion Owing to failure in detecting a statistically significant effect for the primary outcome and in recruiting a sufficient number of participants, our trial remained inconclusive.
Context: Gastrointestinal ailments are some of the common conditions treated in homeopathy; yet only a few trials have explored the effects of individualized homeopathic medicines (IHMs) for irritable bowel syndrome (IBS).Objective: To explore the efficacy of IHMs in treatment of IBS.Design: Double-blind, randomized, placebo-controlled trial.Setting: Outpatient departments of Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, India.Patients: Sixty patients suffering from IBS; randomized to receive either IHMs (n = 30) or identical-looking placebo (n = 30).Interventions: IHMs or placebo in the mutual context of concomitant care in terms of dietary advice, yoga, meditation and exercises.Main outcome measures: Primary - IBS quality of life (IBS-QOL) questionnaire; secondary -IBS severity scoring system (IBS-SSS) and EQ-5D-5L scores; all measured at baseline and every month, up to 3 months.Results: Group differences and effect sizes (Cohen's d) were calculated on intention-to-treat (ITT) sample. Groups were comparable at baseline. Recruitment, retention and attrition rates were 64.5%, 91.7% and 8.3% respectively. Group differences in IBS-QOL total scores, IBS-SSS, EQ-5D-5L scores favored IHMs against placebo overall and at all the time points (all P < 0.001). Pulsatilla nigricans (n = 4, 6.7%) and Thuja occidentalis (n = 4, 6.7%) were the most frequently prescribed medicines. Barring some minor events unrelated to interventions, no harms or serious adverse events were recorded in either of the groups. Thus, IHMs acted significantly better than placebos in the treatment of IBS. Independent replications are warranted. [Trial registration: CTRI/2019/10/ 021632]
Background: : Hemiparesis is a serious motor impairment following stroke and affecting around 65% of stroke patients. This trial attempts to study the efficacy of individualized homeopathic medicines (IHMs) in comparison with identical-looking placebos in treatment of post-stroke hemiparesis (PSH) in the mutual context of standard physiotherapy (SP).Methods: : A 3-months, open-label, randomized, placebo-controlled trial (n = 60) was conducted at the Organon of Medicine outpatient departments of National Institute of Homoeopathy, West Bengal, India. Patients were randomized to receive IHMs plus SP (n = 30) or identical-looking placebos plus SP (n = 30). Primary outcome measure was Medical Research Council (MRC) muscle strength grading scale; secondary outcomes were Stroke Impact Scale (SIS) version 2.0, Modified Ashworth Scale (MAS), and stroke recovery 0-100 visual analogue scale (VAS) scores; all measured at baseline and 3 months after intervention. Group differences and effect sizes (Cohen's d) were calculated on intention-to-treat sample.Results: : Although overall improvements were higher in the IHMs group than placebos with small to medium effect sizes, the group differences were statistically non-significant (all P>0.05, unpaired t-tests). Improvement in SIS physical problems was significantly higher in IHMs than placebos (mean difference 2.0, 95% confidence interval 0.3 to 3.8, P = 0.025, unpaired t-test). Causticum, Lachesis mutus, and Nux vomica were the most frequently prescribed medicines. No harms, unintended effects, homeopathic aggravations or any serious adverse events were reported from either group.Conclusion: : There was a small, but non-significant direction of effect favoring homeopathy against placebos in treatment of post-stroke hemiparesis.Trial registration: : CTRI/2018/10/016196; UTN: U1111-1221-7664
Introduction: Psoriasis is a chronic inflammatory skin disorder, affecting the trunk and extensor surfaces of the limbs and scalp predominantly. Worldwide prevalence ranges between 0.1 and 11.4%, and in India between 0.4 and 2.8%; this creates a serious health burden. Psoriasis remains a frequently encountered condition in homeopathy practice, but there is a dearth of conclusive efficacy data supporting its use. Methods: This 6-month, double-blind, randomized trial was conducted on 51 patients suffering from psoriasis at the National Institute of Homoeopathy, India. Patients were randomized to receive either individualized homeopathic medicines (IHMs; n = 25) in LM potencies or identical-looking placebos (n = 26). Psoriasis area and severity index (PASI; primary), psoriasis disability index (PDI), and dermatological life quality index (DLQI; secondary) were measured at baseline and every 2 months, up to 6 months. The intention-to-treat sample was analyzed using a two-way repeated measure analysis of variance. Results: Although intragroup changes were significant in both groups in the outcome measures, improvements were significantly higher in the IHMs group than in placebos in PASI scores after 6 months of intervention (F1, 49 = 10.448, p = 0.002). DLQI daily activity subscale scores also yielded similar significant results favoring IHMs against placebos after 6 months (F1, 49 = 5.480, p = 0.023). Improvement in PDI total (F1, 49 = 0.063, p = 0.803), DLQI total (F1, 49 = 1.371, p = 0.247), and all remaining subscales were higher in the IHMs group than placebos after 6 months, but nonsignificant statistically. Calcarea carbonica, Mercurius solubilis, Arsenicum album, and Petroleum were the most frequently prescribed medicines. Conclusions: IHMs exhibited better results than placebos in the treatment of psoriasis. Further research is warranted.
Background Pre-diabetes (PD) contributes importantly to the disease burden worldwide and is a precursor to stroke, cardiovascular diseases, as well as type-2 diabetes mellitus. Objective In this project, the efficacy of individualized homeopathic medicines (IHMs) was explored against placebos in the treatment of PD. Methods A 6-month, double-blind, randomized, placebo-controlled trial was conducted at the outpatient departments of a homeopathic medical college and hospital in India. Sixty participants with PD were randomized to receive either IHMs (n = 30) or identical-looking placebos (n = 30). Concomitant care measures were advised to both groups of participants in terms of dietary advice, yoga, meditation and exercise. The primary outcome measures were fasting blood sugar (FBS) and the oral glucose tolerance test (OGTT); the secondary outcome was the Diabetes Symptom Checklist-Revised (DSC-R) score. All the outcomes were measured at baseline and after 3 and 6 months of treatment. Inter-group differences and effect sizes (Cohen's d) were calculated using two-way repeated measures analysis of variance models after adjusting baseline differences using analysis of co-variance on the intention-to-treat data. Results Between-group differences in FBS were statistically significant, favored IHMs against placebos (F-1,F-58 = 7.798, p = 0.007) but not for OGTT (F-1,F-58 = 1.691, p = 0.199). The secondary outcome, DSC-R total score, favored IHMs significantly compared with placebos (F-1,F-58 = 15.752, p<0.001). Calcarea Carbonicum, Thuja occidentalis and Sulphur were the most frequently prescribed medicines. No harm or serious adverse events were recorded from either of the participant groups. Conclusion IHMs produced significantly better results than placebos in FBS and in DSC-R scores but not in OGTT. Independent replications with larger sample sizes are warranted to substantiate the findings.
BACKGROUND:Atopic dermatitis (AD) is a chronic relapsing and remitting inflammatory skin disease that can have a significant impact on quality of life. During the last four decades, a rising trend in AD has been observed in India. Homeopathic medicines are claimed to be beneficial in AD; however, convincing research evidence has been lacking. We compared the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of AD. METHODS:In this double-blind, randomized, placebo-controlled trial of 6 months' duration (n = 60), adult patients were randomized to receive either IHMs (n = 30) or identical-looking placebos (n = 30). All participants received concomitant conventional care, which included the application of olive oil and maintaining local hygiene. The primary outcome measure was disease severity using the Patient-Oriented Scoring of Atopic Dermatitis (PO-SCORAD) scale; secondary outcomes were the Atopic Dermatitis Burden Scale for Adults (ADBSA) and Dermatological Life Quality Index (DLQI) - all were measured at baseline and every month, up to 6 months. Group differences were calculated on the intention-to-treat sample. RESULTS:After 6 months of intervention, inter-group differences became statistically significant on PO-SCORAD, the primary outcome (-18.1; 95% confidence interval, -24.0 to -12.2), favoring IHMs against placebos (F 1, 52 = 14.735; p <0.001; two-way repeated measures analysis of variance). Inter-group differences for the secondary outcomes favored homeopathy, but were overall statistically non-significant (ADBSA: F 1, 52 = 0.019; p = 0.891; DLQI: F 1, 52 = 0.692; p = 0.409). CONCLUSION:IHMs performed significantly better than placebos in reducing the severity of AD in adults, though the medicines had no overall significant impact on AD burden or DLQI.
Abstract Introduction Tinea corporis (TC; ringworm or dermatophytosis) is a superficial skin infection caused by Microsporum , Epidermophyton and Trichophyton genera of dermatophytes. We compared the effects of individualized homeopathic medicines (IHMs) in fifty-millesimal (LM) potencies against placebo in TC. Methods A double-blind, randomized, placebo-controlled, two parallel arms trial was conducted on 62 individuals suffering from TC at the National Institute of Homoeopathy, India. Participants were randomized in a 1:1 ratio to receive either IHMs in LM potencies or identical-looking placebos for a period of 3 months. The primary outcome measure was the number of participants showing complete disappearance of skin lesions after 3 months. Secondary outcomes were a numeric rating scale (NRS) measuring intensity of itching and the Skindex-29 questionnaire (overall, and three sub-scales – degree of symptoms, psychological functioning, emotional status). All were assessed at baseline and every month, up to 3 months. The intention-to-treat sample was analyzed to detect inter-group differences using two-way repeated measures analysis of variance after adjusting for baseline differences. Results The primary outcome revealed no improvement in either of the groups ( χ 2 = 0.012, p = 0.999). Inter-group differences in some of the secondary outcomes favored IHMs against placebo – itching NRS (mean group difference after 3 months: −0.7 (95% confidence interval [CI], −1.1 to −0.4; p = 0.001); Skindex-29 overall (mean group difference after 3 months: 3.2 [95% CI, −0.6 to 7.0; p = 0.009]); Skindex-29 degree of symptoms (mean group difference after 3 months: 0.9 [95% CI, −0.2 to 1.9; p = 0.007]); and Skindex-29 psychological functioning (mean group difference after 3 months: 1.7 [95% CI, 0–3.4; p = 0.002]). Conclusion Results were negative on the primary outcome; however, secondary outcomes included some statistically significant results favoring IHMs against placebo after 3 months. Trial registration CTRI/2019/11/021999; UTN: U1111–1242–0070.
Abstract Background Agraphis nutans (AN) is a potential homeopathic medicine in the treatment of chronic tonsillitis, but has remained under-researched. This trial attempts to compare the effects of AN with individualised homeopathic medicines (IHMs) in the treatment of chronic tonsillitis in adults. Methods An open, randomised, pragmatic, equivalence trial was conducted to compare the effects of AN with IHMs. Sixty adults suffering from chronic tonsillitis were randomised to receive either AN (n = 30) or IHMs (n = 30). Three visual analogue scales (VASs) in the sore throat pain model (STPM) – sore throat pain intensity scale (STPIS), difficulty swallowing scale (DSS) and swollen throat scale (swoTS)—were used as the primary outcome while tonsil and adenoid health status instrument (TAHSI) and Glasgow benefit inventory (GBI) as the secondary outcomes; and they were measured after 6 and 12 weeks. Intention-to-treat sample was analysed to detect non-inferiority of AN against IHMs and group differences using two-ways (split-half) repeated measure analysis of variance and unpaired t-tests. Results Reductions in all three STPM-VASs, TAHSI and GBI total and subscale scores were significant in the IHMs group (all p < 0.001, except TAHSI halitosis and nocturnal breathing subscale scores), but not in the AN group. Still, except GBI, non-inferiority was exhibited by AN against IHMs in rest of the outcomes after 6 and 12 weeks (all p < 0.001). Hepar sulphuris calcareum (n = 11; 36.7%) and Mercurius solubilis (n = 3; 10%) were the most frequently prescribed remedies in the IHMs group. Conclusion AN performed non-inferior to IHMs in treatment of chronic tonsillitis in adults; however, it may result from suppression of symptoms. Rigorous and larger trials are warranted. Trial Registration: CTRI/2018/10/016233; UTN: U1111–1221–8221.
Abstract Introduction Epilepsy, one of the most common neurological diseases, contributes to 0.5% of the total disease burden. The burden is highest in sub-Saharan Africa, central Asia, central and Andean Latin America, and south-east Asia. Asian countries report an overall prevalence of 6/1,000 and that in India of 5.59/1,000. We examined whether individualized homeopathic medicines (IHMs) can produce a significantly different effect from placebos in treatment of pediatric epilepsy in the context of ongoing standard care (SC) using anti-epileptic drugs (AEDs). Methods The study was a 6-month, double-blind, randomized, placebo-controlled trial ( n = 60) conducted at the pediatric outpatient department of a homeopathic hospital in West Bengal, India. Patients were randomized to receive either IHMs plus SC ( n = 30) or identical-looking placebos plus SC ( n = 30). The primary outcome measure was the Hague Seizure Severity Scale (HASS); secondary outcomes were the Quality of Life in Childhood Epilepsy (QOLCE-16) and the Pediatric Quality of Life inventory (PedsQL) questionnaires; all were measured at baseline and after the 3 rd and 6 th month of intervention. The intention-to-treat sample was analyzed to detect group differences and effect sizes. Results Recruitment and retention rates were 65.2% and 91.7% respectively. Although improvements were greater in the IHMs group than with placebos, with small to medium effect sizes, the inter-group differences were statistically non-significant – for HASS ( F 1, 58 = 0.000, p = 1.000, two-way repeated measures analysis of variance), QOLCE-16 ( F 1, 58 = 1.428, p = 0.237), PedsQL (2–4 years) ( F 1, 8 = 0.685, p = 0.432) and PedsQL (5–18 years) ( F 1, 47 = 0.000, p = 0.995). Calcarea carbonica , Ignatia amara , Natrum muriaticum and Phosphorus were the most frequently prescribed medicines. No serious adverse events were reported from either of the two groups. Conclusion Improvements in the outcome measures were statistically non-significantly greater in the IHMs group than in the placebos group, with small effect sizes. A different trial design and prescribing approach might work better in future trials. Trial registration CTRI/2018/10/016027
Sir: I thoroughly enjoyed the recent survey by Slavin, Slavin, and Goldwyn in the September issue of the Journal1 on the topic of operating on family members. It was vintage Goldwyn—a quick informative, useful, relevant, and amusing read. It made for the rare article in the Journal that we can share around the dinner table. The two open questions from the article are as follows: (1) If we do not countenance making lovers out of patients, shouldn't we refrain from making patients out of lovers? (2) Can our relentless marketing to each other, to patients, and colleagues ever allow us to climb down from the “Lake Wobegon effect”? Humorist Garrison Keillor's mythical hometown is Lake Wobegon, “where all the children are above average,” which of course by definition can be only half above average (and thus half below). Interestingly, 67 percent of the surgeon respondents to the survey identified themselves as the best surgeon for the job! The article was immensely useful and illuminating to me and, I would expect, to much of the readership. Navin K. Singh, M.D., M.B.A., M.Sc. Potomac, Md.
HomeCirculationVol. 110, No. 9"Shrink-Wrapped" Permanent Pacemaker Free AccessReview ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessReview ArticlePDF/EPUB"Shrink-Wrapped" Permanent Pacemaker Charles A. Henrikson, MD, Navin K. Singh, MD, Julianna F. Bolt, RN BSN and Ronald D. Berger, MD PhD Charles A. HenriksonCharles A. Henrikson From the Division of Cardiology (C.A.H., J.F.B., R.D.B.) and Division of Plastic and Reconstructive Surgery (N.K.S.), Johns Hopkins Hospital, Baltimore, Md. , Navin K. SinghNavin K. Singh From the Division of Cardiology (C.A.H., J.F.B., R.D.B.) and Division of Plastic and Reconstructive Surgery (N.K.S.), Johns Hopkins Hospital, Baltimore, Md. , Julianna F. BoltJulianna F. Bolt From the Division of Cardiology (C.A.H., J.F.B., R.D.B.) and Division of Plastic and Reconstructive Surgery (N.K.S.), Johns Hopkins Hospital, Baltimore, Md. and Ronald D. BergerRonald D. Berger From the Division of Cardiology (C.A.H., J.F.B., R.D.B.) and Division of Plastic and Reconstructive Surgery (N.K.S.), Johns Hopkins Hospital, Baltimore, Md. Originally published31 Aug 2004https://doi.org/10.1161/01.CIR.0000140670.63123.80Circulation. 2004;110:e79An 81-year-old woman originally underwent permanent pacemaker placement in 1994 for symptomatic bradycardia in the setting of respiratory distress. When her device was found to be at the elective replacement interval, she was referred for pacemaker generator replacement. She had been treated with high-dose oral corticosteroids for severe chronic obstructive pulmonary disease for several years and had extremely thin skin and subcutaneous tissues. As seen in Figure 1, her skin appeared "shrink-wrapped" onto the pacemaker generator and extrathoracic leads. We felt that routine generator exchange would be impossible, and that skin erosion was imminent. In the electrophysiology suite, the skin and superficial tissues overlying the generator and leads were resected. Sensing and pacing thresholds of the chronic leads were found to be within acceptable limits. A new pocket was formed under the pectoralis muscle, with access via the infraclavicular border. The new device, leads, and suture sleeves were placed in the new pocket. Figure 2 shows the patient at a clinic visit 9 days after the procedure. Download figureDownload PowerPointFigure 1. Photograph of the left infraclavicular region prior to procedure. The patient's skin and subcutaneous tissues appear "shrink-wrapped" over the pacemaker generator and extrathoracic leads.Download figureDownload PowerPointFigure 2. Photograph of the patient 9 days after the pocket revision to a subpectoral plane.FootnotesCorrespondence to Dr R.D. Berger, Division of Cardiology, Johns Hopkins Hospital, Carnegie 568, 600 North Wolfe St, Baltimore, MD 21205. E-mail [email protected] Previous Back to top Next FiguresReferencesRelatedDetailsCited By Henrikson C and Brinker J (2008) How to prevent, recognize, and manage complications of lead extraction. Part I: Avoiding lead extraction—Infectious issues, Heart Rhythm, 10.1016/j.hrthm.2007.10.018, 5:7, (1083-1087), Online publication date: 1-Jul-2008. August 31, 2004Vol 110, Issue 9 Advertisement Article InformationMetrics https://doi.org/10.1161/01.CIR.0000140670.63123.80PMID: 15339867 Originally publishedAugust 31, 2004 PDF download Advertisement SubjectsPacemaker
Holton, Luther H. III M.D.; Rodriguez, Eduardo D. D.D.S., M.D.; Silverman, Ronald P. M.D.; Singh, Navin M.D.; Tufaro, Anthony P. D.D.S., M.D.; Grant, Michael P. M.D., Ph.D. Author Information